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Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for...

July 11, 2014



Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models & Other Revisions to Part B for CY 2015

Proposed rule.

CFR Part: "42 CFR Parts 403, 405, 410, 414, 425, and 498"

RIN Number: "RIN 0938-AS12"

Citation: "79 FR 40318"

Document Number: "CMS-1612-P"

Page Number: "40318"

"Proposed Rules"

SUMMARY: This major proposed rule addresses changes to the physician fee schedule, and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. See the Table of Contents for a listing of the specific issues addressed in this proposed rule.

   DATES: Comment date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on September 2, 2014.

   ADDRESSES: In commenting, please refer to file code CMS-1612-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

   You may submit comments in one of four ways (please choose only one of the ways listed):

   1. Electronically. You may submit electronic comments on this regulation to www.regulations.gov. Follow the instructions for "submitting a comment."

   2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1612-P, P.O. Box 8013, Baltimore, MD 21244-8013.

   Please allow sufficient time for mailed comments to be received before the close of the comment period.

   3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1612-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

   4. By hand or courier. If you prefer, you may deliver (by hand or courier) your written comments before the close of the comment period to either of the following addresses:

a. For delivery in Washington, DC--Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201

   (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)

b. For delivery in Baltimore, MD--

Centers for Medicare & Medicaid Services,

Department of Health and Human Services,

7500 Security Boulevard,

Baltimore, MD 21244-1850.

   If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members.

   Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.

   FOR FURTHER INFORMATION CONTACT: Gail Addis, (410) 786-4552, for issues related to the refinement panel or for any physician payment issues not identified below.

   Chava Sheffield, (410) 786-2298, for issues related to practice expense methodology, impacts, the sustainable growth rate, conscious sedation, or conversion factors.

   Kathy Kersell, (410) 786-2033, for issues related to direct practice expense inputs.

   Jessica Bruton, (410) 786-5991, for issues related to potentially misvalued services or work RVUs.

   Craig Dobyski, (410) 786-4584, for issues related to geographic practice cost indices or malpractice RVUs.

   Ken Marsalek, (410) 786-4502, for issues related to telehealth services.

   Pam West, (410) 786-2302, for issues related to conditions for therapists in private practice.

   Marianne Myers, (410) 786-5962, for issues related to ambulance extender provisions.

   Amy Gruber, (410) 786-1542, for issues related to changes in geographic area designations for ambulance payment.

   Anne Tayloe-Hauswald, (410) 786-4546, for issues related to clinical lab fee schedule.

   Corinne Axelrod, (410) 786-5620, for issues related to Rural Health Clinics or Federally Qualified Health Centers.

   Renee Mentnech, (410) 786-6692, for issues related to access to identifiable data for the Centers for Medicare & Medicaid models.

   Marie Casey, (410) 786-7861, for issues related to local determination process for clinical diagnostic laboratory tests.

   Frederick Grabau, (410) 786-0206, for issues related to private contracting/ opt -out.

   David Walczak, (410) 786-4475, for issues related to payment policy for substitute physician billing arrangements (locum tenens).

   Melissa Heesters, (410) 786-0618, for issues related to reports of payments or other transfers of value to covered recipients.

   Rashaan Byers, (410) 786-2305, for issues related to physician compare.

   Christine Estella, (410) 786-0485, for issues related to the physician quality reporting system.

   Alexandra Mugge (410) 786-4457, for issues related to EHR incentive program.

   Patrice Holtz, (410) 786-5663, for issues related to comprehensive primary care initiative.

   Terri Postma, (410) 786-4169, for issues related to Medicare Shared Savings Program.

   Kimberly Spalding Bush, (410) 786-3232, for issues related to value-based modifier and improvements to physician feedback.

   SUPPLEMENTARY INFORMATION:

   Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to view public comments.

   Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.

Table of Contents

I. Executive Summary and Background

   A. Executive Summary

   B. Background

   C. Health Information Technology

II. Provisions of the Proposed Rule for PFS

   A. Resource-Based Practice Expense (PE) Relative Value Units (RVUs)

   B. Potentially Misvalued Services Under the Physician Fee Schedule

   C. Malpractice Relative Value Units (RVUs)

   D. Geographic Practice Cost Indices (GPCIs)

   E. Medicare Telehealth Services

   F. Valuing New, Revised and Potentially Misvalued Codes

   G. Chronic Care Management (CCM)

   H. Definition of Colorectal Cancer Screening Tests

   I. Payment of Secondary Interpretation of Images

   J. Conditions Regarding Permissible Practice Types for Therapists in Private Practice

   K. Payments for Physicians and Practitioners Managing Patients on Home Dialysis

III. Other Provisions of the Proposed Regulations

   A. Ambulance Extender Provisions

   B. Changes in Geographic Area Delineations for Ambulance Payment

   C. Clinical Laboratory Fee Schedule

   D. Removal of Employment Requirements for Services Furnished "Incident to" Rural Health Clinic (RHC) and Federally Qualified Health Center (FQHC) Visits

   E. Access to Identifiable Data for the Center for Medicare and Medicaid Models

   F. Local Coverage Determination Process for Clinical Diagnostic Laboratory Tests

   G. Private Contracting/Opt-out

   H. Solicitation of Comments on the Payment Policy for Substitute Physician Billing Arrangements

   I. Reports of Payments or Other Transfers of Value to Covered Recipients

   J. Physician Compare Web site

   K. Physician Payment, Efficiency, and Quality Improvements--Physician Quality Reporting System

   L. Electronic Health Record (EHR) Incentive Program

   M. Medicare Shared Savings Program

   N. Value-Based Payment Modifier and Physician Feedback Program

IV. Collection of Information Requirements

V. Response to Comments

VI. Regulatory Impact Analysis

Regulations Text

Acronyms

   In addition, because of the many organizations and terms to which we refer by acronym in this proposed rule, we are listing these acronyms and their corresponding terms in alphabetical order below:

AAA Abdominal aortic aneurysms

ACO Accountable care organization

AMA American Medical Association

ASC Ambulatory surgical center

ATA American Telehealth Association

ATRA American Taxpayer Relief Act (Pub. L. 112-240)

BBA Balanced Budget Act of 1997 (Pub. L. 105-33)

BBRA [Medicare, Medicaid and State Child Health Insurance Program] Balanced Budget Refinement Act of 1999 (Pub. L. 106-113)

CAD Coronary artery disease

CAH Critical access hospital

CBSA Core-Based Statistical Area

CCM Chronic care management

CEHRT Certified EHR technology

CF Conversion factor

CG-CAHPS Clinician and Group Consumer Assessment of Healthcare Providers and Systems

CLFS Clinical Laboratory Fee Schedule

CNM Certified nurse-midwife

CP Clinical psychologist

CPC Comprehensive Primary Care

CPEP Clinical Practice Expert Panel

CPT [Physicians] Current Procedural Terminology (CPT codes, descriptions and other data only are copyright 2013 American Medical Association. All rights reserved.)

CQM Clinical quality measure

CSW Clinical social worker

CT Computed tomography

CY Calendar year

DFAR Defense Federal Acquisition Regulations

DHS Designated health services

DM Diabetes mellitus

DSMT Diabetes self-management training

eCQM Electronic clinical quality measures

EHR Electronic health record

E/M Evaluation and management

EP Eligible professional

eRx Electronic prescribing

ESRD End-stage renal disease

FAR Federal Acquisition Regulations

FFS Fee-for-service

FQHC Federally qualified health center

FR Federal Register

GAF Geographic adjustment factor

GAO Government Accountability Office

GPCI Geographic practice cost index

GPO Group purchasing organization

GPRO Group practice reporting option

GTR Genetic Testing Registry

HCPCS Healthcare Common Procedure Coding System

HHS [Department of] Health and Human Services

HOPD Hospital outpatient department

HPSA Health professional shortage area

IDTF Independent diagnostic testing facility

IPPS Inpatient Prospective Payment System

IQR Inpatient Quality Reporting

ISO Insurance service office

IWPUT Intensity of work per unit of time

LCD Local coverage determination

MA Medicare Advantage

MAC Medicare Administrative Contractor

MAP Measure Applications Partnership

MAPCP Multi-payer Advanced Primary Care Practice

MAV Measure application validity [process]

MCP Monthly capitation payment

MedPAC Medicare Payment Advisory Commission

MEI Medicare Economic Index

MFP Multi-Factor Productivity

MIPPA Medicare Improvements for Patients and Providers Act (Pub. L. 110-275)

MMA Medicare Prescription Drug, Improvement and Modernization Act of 2003 (Pub. L. 108-173, enacted on December 8, 2003)

MP Malpractice

MPPR Multiple procedure payment reduction

MRA Magnetic resonance angiography

MRI Magnetic resonance imaging

MSA Metropolitan Statistical Areas

MSPB Medicare Spending per Beneficiary

MSSP Medicare Shared Savings Program

MU Meaningful use

NCD National coverage determination

NCQDIS National Coalition of Quality Diagnostic Imaging Services

NP Nurse practitioner

NPI National Provider Identifier

NPP Nonphysician practitioner

NQS National Quality Strategy

OACT CMS's Office of the Actuary

OBRA '89 Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239)

OBRA '90 Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101- 508)

OES Occupational Employment Statistics

OMB Office of Management and Budget

OPPS Outpatient prospective payment system

OT Occupational therapy

PA Physician assistant

PAMA Protecting Access to Medicare Act of 2014 (Pub. L. 113-93)

PC Professional component

PCIP Primary Care Incentive Payment

PE Practice expense

PE/HR Practice expense per hour

PEAC Practice Expense Advisory Committee

PECOS Provider Enrollment, Chain, and Ownership System

PFS Physician Fee Schedule

PLI Professional Liability Insurance

PMA Premarket approval

PQRS Physician Quality Reporting System

PPIS Physician Practice Expense Information Survey

PT Physical therapy

PY Performance year

QCDR Qualified clinical data registry

QRUR Quality and Resources Use Report

RBRVS Resource-based relative value scale

RFA Regulatory Flexibility Act

RHC Rural health clinic

RIA Regulatory impact analysis

RUC American Medical Association/Specialty Society Relative (Value) Update Committee

RUCA Rural Urban Commuting Area

RVU Relative value unit

SBA Small Business Administration

SGR Sustainable growth rate

SIM State Innovation Model

SLP Speech-language pathology

SMS Socioeconomic Monitoring System

SNF Skilled nursing facility

TAP Technical Advisory Panel

TC Technical component

TIN Tax identification number

UAF Update adjustment factor

UPIN Unique Physician Identification Number

USPSTF United States Preventive Services Task Force

VBP Value-based purchasing

VM Value-Based Payment Modifier

Addenda Available Only Through the Internet on the CMS Web Site

   The PFS Addenda along with other supporting documents and tables referenced in this proposed rule are available through the Internet on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. Click on the link on the left side of the screen titled, "PFS Federal Regulations Notices" for a chronological list of PFS Federal Register and other related documents. For the CY 2015 PFS proposed rule, refer to item CMS-1612-P. Readers who experience any problems accessing any of the Addenda or other documents referenced in this proposed rule and posted on the CMS Web site identified above should contact Larry.Chan@cms.hhs.gov.

CPT (Current Procedural Terminology) Copyright Notice

   Throughout this proposed rule, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descriptions are copyright 2013 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association (AMA). Applicable Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply.

I. Executive Summary and Background

A. Executive Summary

1. Purpose

   This major proposed rule would revise payment polices under the Medicare Physician Fee Schedule (PFS) and make other policy changes related to Medicare Part B payment. These changes would be applicable to services furnished in CY 2015.

2. Summary of the Major Provisions

   The Social Security Act (the Act) requires us to establish payments under the PFS based on national uniform relative value units (RVUs) that account for the relative resources used in furnishing a service. The Act requires that RVUs be established for three categories of resources: work, practice expense (PE); and malpractice (MP) expense; and, that we establish by regulation each year's payment amounts for all physicians' services, incorporating geographic adjustments to reflect the variations in the costs of furnishing services in different geographic areas. In this major proposed rule, we propose RVUs for CY 2015 for the PFS, and other Medicare Part B payment policies, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. In addition, this proposed rule includes discussions and proposals regarding:

    * Misvalued PFS Codes.

    * Telehealth Services.

    * Chronic Care Management Services.

    * Establishing Values for New, Revised, and Misvalued Codes.

    * Updating the Ambulance Fee Schedule regulations.

    * Changes to Core-Based Statistical Areas for Ambulance Payment.

    * Updating the--

   ++ Physician Compare Web site.

   ++ Physician Quality Reporting System.

   ++ Medicare Shared Savings Program.

   ++ Electronic Health Record (EHR) Incentive Program.

    * Value-Based Payment Modifier and the Physician Feedback Program.

3. Summary of Costs and Benefits

   The Act requires that annual adjustments to PFS RVUs not cause annual estimated expenditures to differ by more than $20 million from what they would have been had the adjustments not been made. If adjustments to RVUs would cause expenditures to change by more than $20 million, we must make adjustments to preserve budget neutrality. These adjustments can affect the distribution of Medicare expenditures across specialties. In addition, several proposed changes would affect the specialty distribution of Medicare expenditures. When considering the combined impact of work, PE, and MP RVU changes, the projected payment impacts are small for most specialties; however, the impact would be larger for a few specialties. The most significant impacts are for radiation therapy centers and radiation oncology for which there would be decreases of 8 and 4 percent, respectively. These reductions primarily stem from a proposal discussed in section II.A. to consider an equipment item as indirect rather than direct practice expense. Payment for chronic care management (CCM) services is projected to have a positive effect on family practice, internal medicine, and geriatrics. This proposed rule includes new proposed MP RVUs based upon CY 2015 five-year review of MP RVUs. For most specialties, the proposed revisions for the five-year review of MP RVUs would result in minor overall changes in RVUs, with only ophthalmology (-2 percent) having a projected change of at least 2 percent.

B. Background

   Since January 1, 1992, Medicare has paid for physicians' services under section 1848 of the Act, "Payment for Physicians' Services." The system relies on national relative values that are established for work, PE, and MP, which are adjusted for geographic cost variations. These values are multiplied by a conversion factor (CF) to convert the RVUs into payment rates. The concepts and methodology underlying the PFS were enacted as part of the Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239, enacted on December 19, 1989) (OBRA '89), and the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted on November 5, 1990) (OBRA '90). The final rule published on November 25, 1991 (56 FR 59502) set forth the first fee schedule used for payment for physicians' services.

   We note that throughout this proposed rule, unless otherwise noted, the term "practitioner" is used to describe both physicians and nonphysician practitioners (NPPs) who are permitted to bill Medicare under the PFS for services furnished to Medicare beneficiaries.

1. Development of the Relative Values

a. Work RVUs

   The work RVUs established for the initial fee schedule, which was implemented on January 1, 1992, were developed with extensive input from the physician community. A research team at the Harvard School of Public Health developed the original work RVUs for most codes under a cooperative agreement with the Department of Health and Human Services (HHS). In constructing the code-specific vignettes used in determining the original physician work RVUs, Harvard worked with panels of experts, both inside and outside the federal government, and obtained input from numerous physician specialty groups.

   As specified in section 1848(c)(1)(A) of the Act, the work component of physicians' services means the portion of the resources used in furnishing the service that reflects physician time and intensity. We establish work RVUs for new, revised and potentially misvalued codes based on our review of information that generally includes, but is not limited to, recommendations received from the American Medical Association/Specialty Society Relative Value Update Committee (RUC), the Health Care Professionals Advisory Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC), and other public commenters; medical literature and comparative databases; as well as a comparison of the work for other codes within the Medicare PFS, and consultation with other physicians and health care professionals within CMS and the federal government. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters, and the rationale for their recommendations.

b. Practice Expense RVUs

   Initially, only the work RVUs were resource-based, and the PE and MP RVUs were based on average allowable charges. Section 121 of the Social Security Act Amendments of 1994 (Pub. L. 103-432, enacted on October 31, 1994), amended section 1848(c)(2)(C)(ii) of the Act and required us to develop resource-based PE RVUs for each physicians' service beginning in 1998. We were required to consider general categories of expenses (such as office rent and wages of personnel, but excluding malpractice expenses) comprising PEs. The PE RVUs continue to represent the portion of these resources involved in furnishing PFS services.

   Originally, the resource-based method was to be used beginning in 1998, but section 4505(a) of the Balanced Budget Act of 1997 (Pub. L. 105-33, enacted on August 5, 1997) (BBA) delayed implementation of the resource-based PE RVU system until January 1, 1999. In addition, section 4505(b) of the BBA provided for a 4-year transition period from the charge-based PE RVUs to the resource-based PE RVUs.

   We established the resource-based PE RVUs for each physicians' service in a final rule, published on November 2, 1998 (63 FR 58814), effective for services furnished in CY 1999. Based on the requirement to transition to a resource-based system for PE over a 4-year period, payment rates were not fully based upon resource-based PE RVUs until CY 2002. This resource-based system was based on two significant sources of actual PE data: The Clinical Practice Expert Panel (CPEP) data and the AMA's Socioeconomic Monitoring System (SMS) data. (These data sources are described in greater detail in the CY 2012 final rule with comment period (76 FR 73033).)

   Separate PE RVUs are established for services furnished in facility settings, such as a hospital outpatient department (HOPD) or an ambulatory surgical center (ASC), and in nonfacility settings, such as a physician's office. The nonfacility RVUs reflect all of the direct and indirect PEs involved in furnishing a service described by a particular HCPCS code. The difference, if any, in these PE RVUs generally results in a higher payment in the nonfacility setting because in the facility settings some costs are borne by the facility. Medicare's payment to the facility (such as the outpatient prospective payment system (OPPS) payment to the HOPD) would reflect costs typically incurred by the facility. Thus, payment associated with those facility resources is not made under the PFS.

   Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L. 106-113, enacted on November 29, 1999) (BBRA) directed the Secretary of Health and Human Services (the Secretary) to establish a process under which we accept and use, to the maximum extent practicable and consistent with sound data practices, data collected or developed by entities and organizations to supplement the data we normally collect in determining the PE component. On May 3, 2000, we published the interim final rule (65 FR 25664) that set forth the criteria for the submission of these supplemental PE survey data. The criteria were modified in response to comments received, and published in the Federal Register (65 FR 65376) as part of a November 1, 2000 final rule. The PFS final rules published in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended the period during which we would accept these supplemental data through March 1, 2005.

   In the CY 2007 PFS final rule with comment period (71 FR 69624), we revised the methodology for calculating direct PE RVUs from the top-down to the bottom-up methodology beginning in CY 2007. We adopted a 4-year transition to the new PE RVUs. This transition was completed for CY 2010. In the CY 2010 PFS final rule with comment period, we updated the practice expense per hour (PE/HR) data that are used in the calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010, we began a 4-year transition to the new PE RVUs using the updated PE/HR data, which was completed for CY 2013.

c. Malpractice RVUs

   Section 4505(f) of the BBA amended section 1848(c) of the Act to require that we implement resource-based MP RVUs for services furnished on or after CY 2000. The resource-based MP RVUs were implemented in the PFS final rule with comment period published November 2, 1999 (64 FR 59380). The MP RVUs are based on commercial and physician-owned insurers' malpractice insurance premium data from all the states, the District of Columbia, and Puerto Rico. For more information on MP RVUs, see section II.C. of this proposed rule.

d. Refinements to the RVUs

   Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no less often than every 5 years. Prior to CY 2013, we conducted periodic reviews of work RVUs and PE RVUs independently. We completed five-year reviews of work RVUs that were effective for calendar years 1997, 2002, 2007, and 2012.

   Although refinements to the direct PE inputs initially relied heavily on input from the RUC Practice Expense Advisory Committee (PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to the use of the updated PE/HR data in CY 2010 have resulted in significant refinements to the PE RVUs in recent years.

   In the CY 2012 PFS final rule with comment period (76 FR 73057), we finalized a proposal to consolidate reviews of work and PE RVUs under section 1848(c)(2)(B) of the Act and reviews of potentially misvalued codes under section 1848(c)(2)(K) of the Act into one annual process.

   With regard to MP RVUs, we completed five-year reviews of MP that were effective in CY 2005 and CY 2010. This proposed rule includes a proposal for a five-year review for CY 2015.

   In addition to the five-year reviews, beginning for CY 2009, CMS and the RUC have identified and reviewed a number of potentially misvalued codes on an annual basis based on various identification screens. This annual review of work and PE RVUs for potentially misvalued codes was supplemented by the amendments to section 1848 of the Act, as enacted by section 3134 of the Affordable Care Act, which requires the agency to periodically identify, review and adjust values for potentially misvalued codes.

e. Application of Budget Neutrality to Adjustments of RVUs

   As described in section VI.C.1. of this proposed rule, in accordance with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions to the RVUs would cause expenditures for the year to change by more than $20 million, we make adjustments to ensure that expenditures do not increase or decrease by more than $20 million.

2. Calculation of Payments Based on RVUs

   To calculate the payment for each physicians' service, the components of the fee schedule (work, PE, and MP RVUs) are adjusted by geographic practice cost indices (GPCIs) to reflect the variations in the costs of furnishing the services. The GPCIs reflect the relative costs of physician work, PE, and MP in an area compared to the national average costs for each component. (See section II.D of this proposed rule for more information about GPCIs.)

   RVUs are converted to dollar amounts through the application of a CF, which is calculated based on a statutory formula by CMS's Office of the Actuary (OACT). The CF for a given year is calculated using (a) the productivity-adjusted increase in the Medicare Economic Index (MEI) and (b) the Update Adjustment Factor (UAF), which is calculated by taking into account the Medicare Sustainable Growth Rate (SGR), an annual growth rate intended to control growth in aggregate Medicare expenditures for physicians' services, and the allowed and actual expenditures for physicians' services. The formula for calculating the Medicare fee schedule payment amount for a given service and fee schedule area can be expressed as:

Payment = [(RVU work x GPCI work) + (RVU PE x GPCI PE) + (RVU MP x GPCI MP)] x CF.

3. Separate Fee Schedule Methodology for Anesthesia Services

   Section 1848(b)(2)(B) of the Act specifies that the fee schedule amounts for anesthesia services are to be based on a uniform relative value guide, with appropriate adjustment of an anesthesia conversion factor, in a manner to assure that fee schedule amounts for anesthesia services are consistent with those for other services of comparable value. Therefore, there is a separate fee schedule methodology for anesthesia services. Specifically, we establish a separate conversion factor for anesthesia services and we utilize the uniform relative value guide, or base units, as well as time units, to calculate the fee schedule amounts for anesthesia services. Since anesthesia services are not valued using RVUs, a separate methodology for locality adjustments is also necessary. This involves an adjustment to the national anesthesia CF for each payment locality.

4. Most Recent Changes to the Fee Schedule

   The CY 2014 PFS final rule with comment period (78 FR 74230) implemented changes to the PFS and other Medicare Part B payment policies. It also finalized many of the CY 2013 interim final RVUs and established interim final RVUs for new and revised codes for CY 2014 to ensure that our payment system is updated to reflect changes in medical practice, coding changes, and the relative values of services. It also implemented section 635 of the American Taxpayer Relief Act of 2012 (Pub. L. 112-240, enacted on January 2, 2013) (ATRA), which revised the equipment utilization rate assumption for advanced imaging services furnished on or after January 1, 2014.

   Also, in the CY 2014 PFS final rule with comment period, we announced the following for CY 2014: the total PFS update of -20.1 percent; the initial estimate for the SGR of -16.7 percent; and a CF of $27.2006. These figures were calculated based on the statutory provisions in effect on November 27, 2013, when the CY 2014 PFS final rule with comment period was issued.

   The Pathway for SGR Reform Act of 2013 (Pub. L. 113-67, enacted on December 26, 2013) established a 0.5 percent update to the PFS CF through March 31, 2014 and the Protecting Access to Medicare Act of 2014 (Pub. L. 113-93, enacted on April 1, 2014) (PAMA) extended this 0.5 percent update through December 31, 2014. As a result, the CF for CY 2014 that was published in the CY 2014 final rule with comment period (78 FR 74230) was revised to $35.8228 for services furnished on or after January 1, 2014 and on or before December 31, 2014. The PAMA provides for a 0.0 percent update to the PFS for services furnished on or after January 1, 2015 and on or before March 31, 2015.

   The Pathway for SGR Reform Act extended through March 31, 2014 several provisions of Medicare law that would have otherwise expired on December 31, 2013. The PAMA extended these same provisions further through March 31, 2015. A list of these provisions follows.

* The 1.0 floor on the work geographic practice cost index

* The exceptions process for outpatient therapy caps

* The manual medical review process for therapy services

* The application of the therapy caps and related provisions to services furnished in HOPDs

   In addition, section 220 of the PAMA included several provisions affecting the valuation process for services under the PFS. Section 220(a) of the PAMA amended section 1848(c)(2) of the Act to add a new subparagraph (M). The new subparagraph (M) provides that the Secretary may collect or obtain information from any eligible professional or any other source on the resources directly or indirectly related to furnishing services for which payment is made under the PFS, and that such information may be used in the determination of relative values for services under the PFS. Such information may include the time involved in furnishing services; the amounts, types and prices of practice expense inputs; overhead and accounting information for practices of physicians and other suppliers, and any other elements that would improve the valuation of services under the PFS. This information may be collected or obtained through surveys of physicians or other suppliers, providers of services, manufacturers and vendors; surgical logs, billing systems, or other practice or facility records; EHRs; and any other mechanism determined appropriate by the Secretary. If we use this information, we are required to disclose the source and use of the information in rulemaking, and to make available aggregated information that does not disclose individual eligible professionals, group practices, or information obtained pursuant to a nondisclosure agreement. Beginning with fiscal year 2014, the Secretary may compensate eligible professionals for submission of data.

   Section 220(c) of the PAMA amended section 1848(c)(2)(K)(ii) of the Act to expand the categories of services that the Secretary is directed to examine for the purpose of identifying potentially misvalued codes. The nine new categories are as follows:

    * Codes that account for the majority of spending under the PFS.

    * Codes for services that have experienced a substantial change in the hospital length of stay or procedure time.

    * Codes for which there may be a change in the typical site of service since the code was last valued.

    * Codes for which there is a significant difference in payment for the same service between different sites of service.

    * Codes for which there may be anomalies in relative values within a family of codes.

    * Codes for services where there may be efficiencies when a service is furnished at the same time as other services.

    * Codes with high intra-service work per unit of time.

    * Codes with high PE RVUs.

    * Codes with high cost supplies.

(See section II.B.2 of this final rule with comment period for more information about misvalued codes.).

   Section 220(i) of the PAMA also requires the Secretary to make publicly available the information we considered when establishing the multiple procedure payment reduction (MPPR) policy for the professional component of advanced imaging procedures. The policy reduces the amount paid for the professional component when two advanced imaging procedures are furnished in the same session. The policy was effective for individual physicians on January 1, 2012 and for physicians in the same group practice on January 1, 2013.

   In addition, section 220 of the PAMA includes other provisions regarding valuation of services under the PFS that take effect in future years. Section 220(d) of the PAMA establishes an annual target from CY 2017 through CY 2020 for reductions in PFS expenditures resulting from adjustments to relative values of misvalued services. The target is calculated as 0.5 percent of the estimated amount of expenditures under the fee schedule for the year. If the net reduction in expenditures for the year is equal to or greater than the target for the year, the funds shall be redistributed in a budget-neutral manner within the PFS. The amount by which such reduced expenditures exceed the target for the year shall be treated as a reduction in expenditures for the subsequent year, for purposes of determining whether the target has or has not been met. The legislation includes an exemption from budget neutrality if the target is not met. Other provisions of section 220 of the PAMA include a 2-year phase-in for reductions in RVUs of at least 20 percent for potentially misvalued codes that do not involve coding changes and certain adjustments to the fee schedule areas in California. These provisions will be addressed as we implement them in future rulemaking.

   On March 5, 2014, we submitted to MedPAC an estimate of the SGR and CF applicable to Medicare payments for physicians' services for CY 2015, as required by section 1848(d)(1)(E) of the Act. The actual values used to compute physician payments for CY 2015 will be based on later data and are scheduled to be published by November 1, 2014, as part of the CY 2015 PFS final rule with comment period.

C. Health Information Technology

   The Department of Health and Human Services (HHS) believes all patients, their families, and their health care providers should have consistent and timely access to their health information in a standardized format that can be securely exchanged between the patient, providers, and others involved in the patient's care. (HHS August 2013 Statement, "Principles and Strategies for Accelerating Health Information Exchange," see http://www.healthit.gov/sites/default/files/acceleratinghieprinciples_strategy.pdf) HHS is committed to accelerating health information exchange (HIE) through the use of electronic health records (EHRs) and other types of health information technology (HIT) across the broader care continuum through a number of initiatives including: (1) Alignment of incentives and payment adjustments to encourage provider adoption and optimization of HIT and HIE services through Medicare and Medicaid payment policies; (2) adoption of common standards and certification requirements for interoperable HIT; (3) support for privacy and security of patient information across all HIE-focused initiatives; and (4) governance of health information networks. These initiatives are designed to encourage HIE among health care providers, including professionals and hospitals eligible for the Medicare and Medicaid EHR Incentive Programs and those who are not eligible for the EHR Incentive Programs, and are designed to improve care delivery and coordination across the entire care continuum. For example, the Transition of Care Measure #2 in Stage 2 of the Medicare and Medicaid EHR Incentive Programs requires HIE to share summary records for more than 10 percent of care transitions. In addition, to increase flexibility in ONC's HIT Certification Program and expand HIT certification, ONC has issued a proposed rule concerning a voluntary 2015 Edition of EHR certification criteria, which would more easily accommodate the certification of HIT used in all health care settings where health care providers are not typically eligible for incentive payments under the EHR Incentive Programs, to facilitate greater HIE across the entire care continuum. We believe that HIE and the use of certified EHRs can effectively and efficiently help providers improve internal care delivery practices, support management of patient care across the continuum, and support the reporting of electronically specified clinical quality measures (eCQMs). More information on the Voluntary 2015 Edition EHR Certification Criteria proposed rule is available at http://healthit.gov/policy-researchers-implementers/standards-and-certification-regulations.

II. Provisions of the Proposed Rule for PFS

A. Resource-Based Practice Expense (PE) Relative Value Units (RVUs)

1. Overview

   Practice expense (PE) is the portion of the resources used in furnishing a service that reflects the general categories of physician and practitioner expenses, such as office rent and personnel wages, but excluding MP expenses, as specified in section 1848(c)(1)(B) of the Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use a resource-based system for determining PE RVUs for each physician's service. We develop PE RVUs by considering the direct and indirect practice resources involved in furnishing each service. Direct expense categories include clinical labor, medical supplies, and medical equipment. Indirect expenses include administrative labor, office expense, and all other expenses. The sections that follow provide more detailed information about the methodology for translating the resources involved in furnishing each service into service-specific PE RVUs. We refer readers to the CY 2010 PFS final rule with comment period (74 FR 61743 through 61748) for a more detailed explanation of the PE methodology.

2. Practice Expense Methodology

a. Direct Practice Expense

   We determine the direct PE for a specific service by adding the costs of the direct resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved with furnishing that service. The costs of the resources are calculated using the refined direct PE inputs assigned to each CPT code in our PE database, which are generally based on our review of recommendations received from the RUC and those provided in response to public comment periods. For a detailed explanation of the direct PE methodology, including examples, we refer readers to the Five-Year Review of Work Relative Value Units under the PFS and Proposed Changes to the Practice Expense Methodology proposed notice (71 FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 69629).

b. Indirect Practice Expense per Hour Data

   We use survey data on indirect PEs incurred per hour worked in developing the indirect portion of the PE RVUs. Prior to CY 2010, we primarily used the practice expense per hour (PE/HR) by specialty that was obtained from the AMA's Socioeconomic Monitoring Surveys (SMS). The AMA administered a new survey in CY 2007 and CY 2008, the Physician Practice Expense Information Survey (PPIS). The PPIS is a multispecialty, nationally representative, PE survey of both physicians and nonphysician practitioners (NPPs) paid under the PFS using a survey instrument and methods highly consistent with those used for the SMS and the supplemental surveys. The PPIS gathered information from 3,656 respondents across 51 physician specialty and health care professional groups. We believe the PPIS is the most comprehensive source of PE survey information available. We used the PPIS data to update the PE/HR data for the CY 2010 PFS for almost all of the Medicare-recognized specialties that participated in the survey.

   When we began using the PPIS data in CY 2010, we did not change the PE RVU methodology itself or the manner in which the PE/HR data are used in that methodology. We only updated the PE/HR data based on the new survey. Furthermore, as we explained in the CY 2010 PFS final rule with comment period (74 FR 61751), because of the magnitude of payment reductions for some specialties resulting from the use of the PPIS data, we transitioned its use over a 4-year period from the previous PE RVUs to the PE RVUs developed using the new PPIS data. As provided in the CY 2010 PFS final rule with comment period (74 FR 61751), the transition to the PPIS data was complete for CY 2013. Therefore, PE RVUs from CY 2013 forward are developed based entirely on the PPIS data, except as noted in this section.

   Section 1848(c)(2)(H)(i) of the Act requires us to use the medical oncology supplemental survey data submitted in 2003 for oncology drug administration services. Therefore, the PE/HR for medical oncology, hematology, and hematology/oncology reflects the continued use of these supplemental survey data.

   Supplemental survey data on independent labs from the College of American Pathologists were implemented for payments beginning in CY 2005. Supplemental survey data from the National Coalition of Quality Diagnostic Imaging Services (NCQDIS), representing independent diagnostic testing facilities (IDTFs), were blended with supplementary survey data from the American College of Radiology (ACR) and implemented for payments beginning in CY 2007. Neither IDTFs, nor independent labs, participated in the PPIS. Therefore, we continue to use the PE/HR that was developed from their supplemental survey data.

   Consistent with our past practice, the previous indirect PE/HR values from the supplemental surveys for these specialties were updated to CY 2006 using the MEI to put them on a comparable basis with the PPIS data.

   We also do not use the PPIS data for reproductive endocrinology and spine surgery since these specialties currently are not separately recognized by Medicare, nor do we have a method to blend the PPIS data with Medicare-recognized specialty data.

   Previously, we established PE/HR values for various specialties without SMS or supplemental survey data by crosswalking them to other similar specialties to estimate a proxy PE/HR. For specialties that were part of the PPIS for which we previously used a crosswalked PE/HR, we instead used the PPIS-based PE/HR. We continue previous crosswalks for specialties that did not participate in the PPIS. However, beginning in CY 2010 we changed the PE/HR crosswalk for portable x-ray suppliers from radiology to IDTF, a more appropriate crosswalk because these specialties are more similar to each other with respect to work time.

   For registered dietician services, the resource-based PE RVUs have been calculated in accordance with the final policy that crosswalks the specialty to the "All Physicians" PE/HR data, as adopted in the CY 2010 PFS final rule with comment period (74 FR 61752) and discussed in more detail in the CY 2011 PFS final rule with comment period (75 FR 73183).

c. Allocation of PE to Services

   To establish PE RVUs for specific services, it is necessary to establish the direct and indirect PE associated with each service.

(1) Direct Costs

   The relative relationship between the direct cost portions of the PE RVUs for any two services is determined by the relative relationship between the sum of the direct cost resources (that is, the clinical staff, equipment, and supplies) typically involved with furnishing each of the services. The costs of these resources are calculated from the refined direct PE inputs in our PE database. For example, if one service has a direct cost sum of $400 from our PE database and another service has a direct cost sum of $200, the direct portion of the PE RVUs of the first service would be twice as much as the direct portion of the PE RVUs for the second service.

(2) Indirect Costs

   Section II.A.2.b. of this proposed rule describes the current data sources for specialty-specific indirect costs used in our PE calculations. We allocated the indirect costs to the code level on the basis of the direct costs specifically associated with a code and the greater of either the clinical labor costs or the physician work RVUs. We also incorporated the survey data described earlier in the PE/HR discussion. The general approach to developing the indirect portion of the PE RVUs is as follows:

    * For a given service, we use the direct portion of the PE RVUs calculated as previously described and the average percentage that direct costs represent of total costs (based on survey data) across the specialties that furnish the service to determine an initial indirect allocator. In other words, the initial indirect allocator is calculated so that the direct costs equal the average percentage of direct costs of those specialties furnishing the service. For example, if the direct portion of the PE RVUs for a given service is 2.00 and direct costs, on average, represented 25 percent of total costs for the specialties that furnished the service, the initial indirect allocator would be calculated so that it equals 75 percent of the total PE RVUs. Thus, in this example, the initial indirect allocator would equal 6.00, resulting in a total PE RVUs of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 percent of 8.00).

    * Next, we add the greater of the work RVUs or clinical labor portion of the direct portion of the PE RVUs to this initial indirect allocator. In our example, if this service had work RVUs of 4.00 and the clinical labor portion of the direct PE RVUs was 1.50, we would add 4.00 (since the 4.00 work RVUs are greater than the 1.50 clinical labor portion) to the initial indirect allocator of 6.00 to get an indirect allocator of 10.00. In the absence of any further use of the survey data, the relative relationship between the indirect cost portions of the PE RVUs for any two services would be determined by the relative relationship between these indirect cost allocators. For example, if one service had an indirect cost allocator of 10.00 and another service had an indirect cost allocator of 5.00, the indirect portion of the PE RVUs of the first service would be twice as great as the indirect portion of the PE RVUs for the second service.

    * Next, we incorporate the specialty-specific indirect PE/HR data into the calculation. In our example, if, based on the survey data, the average indirect cost of the specialties furnishing the first service with an allocator of 10.00 was half of the average indirect cost of the specialties furnishing the second service with an indirect allocator of 5.00, the indirect portion of the PE RVUs of the first service would be equal to that of the second service.

d. Facility and Nonfacility Costs

   For procedures that can be furnished in a physician's office, as well as in a hospital or other facility setting, we establish two PE RVUs: facility and nonfacility. The methodology for calculating PE RVUs is the same for both the facility and nonfacility RVUs, but is applied independently to yield two separate PE RVUs. Because in calculating the PE RVUs for services furnished in a facility, we do not include resources that would generally not be provided by physicians when furnishing the service in a facility, the facility PE RVUs are generally lower than the nonfacility PE RVUs. Medicare makes a separate payment to the facility for its costs of furnishing a service.

e. Services With Technical Components (TCs) and Professional Components (PCs)

   Diagnostic services are generally comprised of two components: a professional component (PC); and a technical component (TC). The PC and TC may be furnished independently or by different providers, or they may be furnished together as a "global" service. When services have separately billable PC and TC components, the payment for the global service equals the sum of the payment for the TC and PC. To achieve this we use a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global service, TCs, and PCs; that is, we apply the same weighted average indirect percentage factor to allocate indirect expenses to the global service, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global under the bottom-up methodology.)

f. PE RVU Methodology

   For a more detailed description of the PE RVU methodology, we refer readers to the CY 2010 PFS final rule with comment period (74 FR 61745 through 61746).

(1) Setup File

   First, we create a setup file for the PE methodology. The setup file contains the direct cost inputs, the utilization for each procedure code at the specialty and facility/nonfacility place of service level, and the specialty-specific PE/HR data calculated from the surveys.

(2) Calculate the Direct Cost PE RVUs

   Sum the costs of each direct input.

   Step 1: Sum the direct costs of the inputs for each service. Apply a scaling adjustment to the direct inputs.

   Step 2: Calculate the aggregate pool of direct PE costs for the current year. This is the product of the current aggregate PE (direct and indirect) RVUs, the CF, and the average direct PE percentage from the survey data used for calculating the PE/HR by specialty.

   Step 3: Calculate the aggregate pool of direct PE costs for use in ratesetting. This is the product of the aggregated direct costs for all services from Step 1 and the utilization data for that service.

   Step 4: Using the results of Step 2 and Step 3, calculate a direct PE scaling adjustment to ensure that the aggregate pool of direct PE costs calculated in Step 3 does not vary from the aggregate pool of direct PE costs for the current year. Apply the scaling factor to the direct costs for each service (as calculated in Step 1).

   Step 5: Convert the results of Step 4 to an RVU scale for each service. To do this, divide the results of Step 4 by the CF. Note that the actual value of the CF used in this calculation does not influence the final direct cost PE RVUs, as long as the same CF is used in Step 2 and Step 5. Different CFs will result in different direct PE scaling factors, but this has no effect on the final direct cost PE RVUs since changes in the CFs and changes in the associated direct scaling factors offset one another.

(3) Create the Indirect Cost PE RVUs

   Create indirect allocators.

   Step 6: Based on the survey data, calculate direct and indirect PE percentages for each physician specialty.

   Step 7: Calculate direct and indirect PE percentages at the service level by taking a weighted average of the results of Step 6 for the specialties that furnish the service. Note that for services with TCs and PCs, the direct and indirect percentages for a given service do not vary by the PC, TC, and global service.

   Step 8: Calculate the service level allocators for the indirect PEs based on the percentages calculated in Step 7. The indirect PEs are allocated based on the three components: The direct PE RVUs; the clinical PE RVUs; and the work RVUs. For most services the indirect allocator is: Indirect PE percentage * (direct PE RVUs/direct percentage) + work RVUs.

   There are two situations where this formula is modified:

    * If the service is a global service (that is, a service with global, professional, and technical components), then the indirect PE allocator is: indirect percentage (direct PE RVUs/direct percentage) + clinical PE RVUs + work RVUs.

    * If the clinical labor PE RVUs exceed the work RVUs (and the service is not a global service), then the indirect allocator is: indirect PE percentage (direct PE RVUs/direct percentage) + clinical PE RVUs.

   ( Note: For global services, the indirect PE allocator is based on both the work RVUs and the clinical labor PE RVUs. We do this to recognize that, for the PC service, indirect PEs will be allocated using the work RVUs, and for the TC service, indirect PEs will be allocated using the direct PE RVUs and the clinical labor PE RVUs. This also allows the global component RVUs to equal the sum of the PC and TC RVUs.)

   For presentation purposes in the examples in Table 1, the formulas were divided into two parts for each service.

    * The first part does not vary by service and is the indirect percentage (direct PE RVUs/direct percentage).

    * The second part is either the work RVU, clinical labor PE RVU, or both depending on whether the service is a global service and whether the clinical PE RVUs exceed the work RVUs (as described earlier in this step).

   Apply a scaling adjustment to the indirect allocators.

   Step 9: Calculate the current aggregate pool of indirect PE RVUs by multiplying the current aggregate pool of PE RVUs by the average indirect PE percentage from the survey data.

   Step 10: Calculate an aggregate pool of indirect PE RVUs for all PFS services by adding the product of the indirect PE allocators for a service from Step 8 and the utilization data for that service.

   Step 11: Using the results of Step 9 and Step 10, calculate an indirect PE adjustment so that the aggregate indirect allocation does not exceed the available aggregate indirect PE RVUs and apply it to indirect allocators calculated in Step 8.

   Calculate the indirect practice cost index.

   Step 12: Using the results of Step 11, calculate aggregate pools of specialty-specific adjusted indirect PE allocators for all PFS services for a specialty by adding the product of the adjusted indirect PE allocator for each service and the utilization data for that service.

   Step 13: Using the specialty-specific indirect PE/HR data, calculate specialty-specific aggregate pools of indirect PE for all PFS services for that specialty by adding the product of the indirect PE/HR for the specialty, the work time for the service, and the specialty's utilization for the service across all services furnished by the specialty.

   Step 14: Using the results of Step 12 and Step 13, calculate the specialty-specific indirect PE scaling factors.

   Step 15: Using the results of Step 14, calculate an indirect practice cost index at the specialty level by dividing each specialty-specific indirect scaling factor by the average indirect scaling factor for the entire PFS.

   Step 16: Calculate the indirect practice cost index at the service level to ensure the capture of all indirect costs. Calculate a weighted average of the practice cost index values for the specialties that furnish the service. (Note: For services with TCs and PCs, we calculate the indirect practice cost index across the global service, PCs, and TCs. Under this method, the indirect practice cost index for a given service (for example, echocardiogram) does not vary by the PC, TC, and global service.)

   Step 17: Apply the service level indirect practice cost index calculated in Step 16 to the service level adjusted indirect allocators calculated in Step 11 to get the indirect PE RVUs.

(4) Calculate the Final PE RVUs

   Step 18: Add the direct PE RVUs from Step 6 to the indirect PE RVUs from Step 17 and apply the final PE budget neutrality (BN) adjustment. The final PE BN adjustment is calculated by comparing the results of Step 18 to the current pool of PE RVUs. This final BN adjustment is required to redistribute RVUs from step 18 to all PE RVUs in the PFS, and because certain specialties are excluded from the PE RVU calculation for ratesetting purposes, but we note that all specialties are included for purposes of calculating the final BN adjustment. (See "Specialties excluded from ratesetting calculation" later in this section.)

(5) Setup File Information

    * Specialties excluded from ratesetting calculation: For the purposes of calculating the PE RVUs, we exclude certain specialties, such as certain NPPs paid at a percentage of the PFS and low-volume specialties, from the calculation. These specialties are included for the purposes of calculating the BN adjustment. They are displayed in Table 1. GOES

Table 1--Specialties Excluded From Ratesetting Calculation Specialty Specialty description code 49 Ambulatory surgical center. 50 Nurse practitioner. 51 Medical supply company with certified orthotist. 52 Medical supply company with certified prosthetist. 53 Medical supply company with certified prosthetist-orthotist. 54 Medical supply company not included in 51, 52, or 53. 55 Individual certified orthotist. 56 Individual certified prosthetist. 57 Individual certified prosthetist-orthotist. 58 Medical supply company with registered pharmacist. 59 Ambulance service supplier, e.g., private ambulance companies, funeral homes, etc. 60 Public health or welfare agencies. 61 Voluntary health or charitable agencies. 73 Mass immunization roster biller. 74 Radiation therapy centers. 87 All other suppliers (e.g., drug and department stores). 88 Unknown supplier/provider specialty. 89 Certified clinical nurse specialist. 96 Optician. 97 Physician assistant. A0 Hospital. A1 SNF. A2 Intermediate care nursing facility. A3 Nursing facility, other. A4 HHA. A5 Pharmacy. A6 Medical supply company with respiratory therapist. A7 Department store. B2 Pedorthic personnel. B3 Medical supply company with pedorthic personnel.



    * Crosswalk certain low volume physician specialties: Crosswalk the utilization of certain specialties with relatively low PFS utilization to the associated specialties.

    * Physical therapy utilization: Crosswalk the utilization associated with all physical therapy services to the specialty of physical therapy.

    * Identify professional and technical services not identified under the usual TC and 26 modifiers: Flag the services that are PC and TC services, but do not use TC and 26 modifiers (for example, electrocardiograms). This flag associates the PC and TC with the associated global code for use in creating the indirect PE RVUs. For example, the professional service, CPT code 93010 (Electrocardiogram, routine ECG with at least 12 leads; interpretation and report only), is associated with the global service, CPT code 93000 (Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report).

    * Payment modifiers: Payment modifiers are accounted for in the creation of the file consistent with current payment policy as implemented in claims processing. For example, services billed with the assistant at surgery modifier are paid 16 percent of the PFS amount for that service; therefore, the utilization file is modified to only account for 16 percent of any service that contains the assistant at surgery modifier. Similarly, for those services to which volume adjustments are made to account for the payment modifiers, time adjustments are applied as well. For time adjustments to surgical services, the intraoperative portion in the work time file is used; where it is not present, the intraoperative percentage from the payment files used by contractors to process Medicare claims is used instead. Where neither is available, we use the payment adjustment ratio to adjust the time accordingly. Table 2 details the manner in which the modifiers are applied. GOES

Table 2--Application of Payment Modifiers to Utilization Files Modifier Description Volume adjustment Time adjustment 80,81,82 Assistant at 16% Intraoperative Surgery portion. AS Assistant at 14% (85% * 16%) Intraoperative Surgery--Physician portion. Assistant 50 or Bilateral Surgery 150% 150% of work time. LT and RT 51 Multiple Procedure 50% Intraoperative portion. 52 Reduced Services 50% 50%. 53 Discontinued 50% 50%. Procedure 54 Intraoperative Preoperative + Preoperative + Care only Intraoperative Intraoperative Percentages on the portion. payment files used by Medicare contractors to process Medicare claims 55 Postoperative Care Postoperative Postoperative only Percentage on the portion. payment files used by Medicare contractors to process Medicare claims 62 Co-surgeons 62.5% 50%. 66 Team Surgeons 33% 33%.



   We also make adjustments to volume and time that correspond to other payment rules, including special multiple procedure endoscopy rules and multiple procedure payment reductions (MPPRs). We note that section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments for multiple imaging procedures and multiple therapy services from the BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These MPPRs are not included in the development of the RVUs.

   For anesthesia services, we do not apply adjustments to volume since the average allowed charge is used when simulating RVUs, and therefore, includes all adjustments. A time adjustment of 33 percent is made only for medical direction of two to four cases since that is the only situation where time units are duplicative.

    * Work RVUs: The setup file contains the work RVUs from this proposed rule with comment period.

(6) Equipment Cost Per Minute

   The equipment cost per minute is calculated as:

(1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1 + interest rate) life of equipment)))) + maintenance)

Where:

minutes per year = maximum minutes per year if usage were continuous (that is, usage = 1); generally 150,000 minutes.

usage = variable, see discussion below.

price = price of the particular piece of equipment.

life of equipment = useful life of the particular piece of equipment.

maintenance = factor for maintenance; 0.05.

interest rate = variable, see discussion below.

   Usage: We currently use an equipment utilization rate assumption of 50 percent for most equipment, with the exception of expensive diagnostic imaging equipment, for which we use a 90 percent assumption as required by Section 1848(b)(4)(C) of the Act.

   Maintenance: This factor for maintenance was proposed and finalized during rulemaking for CY 1998 PFS (62 FR 33164). Several stakeholders have suggested that this maintenance factor assumption should be variable. We solicit comment regarding reliable data on maintenance costs that vary for particular equipment items.

   Per-use Equipment Costs: Several stakeholders have also suggested that our PE methodology should incorporate usage fees and other per-use equipment costs as direct costs. We also solicit comment on adjusting our cost formula to include equipment costs that do not vary based on the equipment time.

   Interest Rate: In the CY 2013 final rule with comment period (77 FR 68902), we updated the interest rates used in developing an equipment cost per minute calculation. The interest rate was based on the Small Business Administration (SBA) maximum interest rates for different categories of loan size (equipment cost) and maturity (useful life). The interest rates are listed in Table 3. (See 77 FR 68902 for a thorough discussion of this issue.) GOES

Table 3--SBA Maximum Interest Rates Price Useful life Interest rate (percent) < $25K <7 Years 7.50 $25K to $50K <7 Years 6.50 > $50K <7 Years 5.50 < $25K 7+ Years 8.00 $25K to $50K 7+ Years 7.00 > $50K 7+ Years 6.00

Table 4--Calculation of PE RVUs Under Methodology for Selected Codes Step Source Formula 99213 33533 Office CABG, visit, arterial, est Non- single facility Facility (1) Labor cost Step 1 AMA 13.32 77.52 5.74 (Lab) (2) Supply cost Step 1 AMA 2.98 7.34 .53 (Sup) (3) Equipment Step 1 AMA 0.17 0.58 6.92 cost (Eqp) (4) Direct cost Step 1 =(1)+(2)+ 16.48 85.45 13.19 (Dir) (3) (5) Direct Steps 2-4 See 0.5898 0.5898 0.5898 adjustment (Dir. footnote Adj.) * (6) Adjusted Steps 2-4 =Lab * =(1) *(5) 7.86 45.72 3.39 Labor Dir Adj (7) Adjusted Steps 2-4 =Eqp * =(2) *(5) 1.76 4.33 .31 Supplies Dir Adj (8) Adjusted Steps 2-4 =Sup * =(3) *(5) .10 0.34 4.08 Equipment Dir Adj (9) Adjusted Steps 2-4 =(6)+(7)+ 9.72 50.40 7.78 Direct (8) (10) Conversion Step 5 PFS 35.8228 35.8228 35.8228 Factor (CF) (11) Adj. labor Step 5 =(Lab * =(6)/(10) 0.22 1.28 0.09 cost converted Dir Adj)/CF (12) Adj. supply Step 5 =(Sup * =(7)/(10) 0.05 0.12 0.01 cost converted Dir Adj)/CF (13) Adj. Step 5 =(Eqp * =(8)/(10) 0.00 0.01 0.11 equipment cost Dir converted Adj)/CF (14) Adj. direct Step 5 =(11)+ 0.27 1.41 0.22 cost converted (12)+(13) (15) Work RVU Setup PFS 0.97 33.75 0.22 File (16) Dir--pct Steps 6,7 Surveys 0.25 0.17 0.29 (17) Ind--pct Steps 6,7 Surveys 0.75 .83 .71 (18) Ind. Alloc. Step 8 See Step ((14)/ ((14)/ ((14)/ Formula (1st 8 (16)) (16)) (16)) part) *(17) *(17) *(17) (19) Ind. Step 8 See 18 0.82 6.67 .53 Alloc.(1st part) (20) Ind. Alloc. Step 8 See Step (15) (15) (15+11) Formula (2nd 8 part) (21) Ind. Step 8 See 20 0.97 33.75 0.31 Alloc.(2nd part) (22) Indirect Step 8 =(19)+(21 1.79 40.42 .84 Allocator (1st + ) 2nd) (23) Indirect Steps 9- See .3813 .3813 .3813 Adjustment (Ind. 11 Footnote Adj.) * * (24) Adjusted Steps 9- =Ind 0.68 15.41 .32 Indirect 11 Alloc * Allocator Ind Adj (25) Ind. Steps 12- 1.07 0.75 .99 Practice Cost 16 Index (IPCI) (26) Adjusted Step 17 = Adj.Ind =(24) 0.73 11.59 .32 Indirect Alloc * *(25) PCI (27) PE RVU Step 18 =(Adj Dir =((14)+ 1.01 13.05 .53 + Adj (26)) * Ind) * Other Other Adj Adj) * The direct adj = [current pe rvus * CF * avg dir pct]/[sum direct inputs] = [step2]/[step3]. * * The indirect adj = [current pe rvus * avg ind pct]/[sum of ind allocators] = [step9]/[step10]. Note: The use of any particular conversion factor (CF) in this table to illustrate the PE calculation has no effect on the resulting RVUs.



3. Changes to Direct PE Inputs for Specific Services

   In this section, we discuss other CY 2015 proposals and revisions related to direct PE inputs for specific services. The proposed direct PE inputs are included in the proposed rule CY 2015 direct PE input database, which is available on the CMS Web site under downloads for the CY 2015 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

a. RUC Recommendation for Monitoring Time Following Moderate Sedation

   We received a recommendation from the RUC regarding appropriate clinical labor minutes for post-procedure moderate sedation monitoring and post-procedure monitoring. The RUC recommended 15 minutes of RN time for one hour of monitoring following moderate sedation and 15 minutes of RN time per hour for post-procedure monitoring (unrelated to moderate sedation). For 17 procedures listed in Table 5, the recommended clinical labor minutes differed from the clinical labor minutes in the direct PE database. We propose to accept, without refinement, the RUC recommendation to adjust these clinical labor minutes as indicated in Table 5 as "Change to Clinical Labor Time." The CY 2015 direct PE database reflects these proposed changes and is available on the CMS Web site under the supporting data files for the CY 2015 PFS proposed rule at http://www.cms.gov/PhysicianFeeSched/. GOES

Table 5--Codes With Proposed Changes to Post-Procedure Clinical Labor Monitoring Time CPT code Current RUC recommended Change to monitoring total clinical labor time post-procedure time (min) monitoring time (min) (min) 32553 30 60 30 35471 21 60 39 35475 60 30 -30 35476 60 30 -30 36147 18 30 12 37191 60 30 -30 47525 6 15 9 49411 30 60 30 50593 30 60 30 50200 15 60 45 31625 20 15 -5 31626 25 15 -10 31628 25 15 -10 31629 25 15 -10 31634 25 15 -10 31645 10 15 5 31646 10 15 5



b. RUC Recommendation for Standard Moderate Sedation Package

   We received a RUC recommendation to modify PE inputs included in the standard moderate sedation package. Specifically, the RUC indicated that several specialty societies have pointed to the need for a stretcher during procedures for which moderate sedation is inherent in the procedure. Although the RUC did not recommend that we make changes to PE inputs for codes at this time, the RUC indicated that its future recommendations would include the stretcher as a direct input for procedures including moderate sedation.

   The RUC recommended three scenarios that future recommendations would use to allocate the equipment time for the stretcher based on the procedure time and whether the stretcher would be available for other patients to use during a portion of the procedure. Although we appreciate the RUC's attention to the differences in the time required for the stretcher based on the time for the procedure, we believe that one of the purposes of standard PE input packages is to reduce the complexity associated with assigning appropriate PE inputs to individual procedures while, at the same time, maintaining relativity between procedures. Since we generally allocate inexpensive equipment items to the entire service period when they are likely to be unavailable for another use during the full service period, we believe it is preferable to treat the stretcher consistently across these services. Therefore, we propose to modify the standard moderate sedation input package to include a stretcher for the same length of time as the other equipment items in the moderate sedation package. The proposed revised moderate sedation input package would be applied to relevant codes as we review them through future notice and comment rulemaking. It would be useful to hear stakeholders' views and the reasoning behind them on this issue, especially from those who think that the stretcher, as expressed through the allocation of equipment minutes, should be allocated with more granularity than the equipment costs that are allocated to other similar items.

c. RUC Recommendation for Migration From Film to Digital Practice Expense Inputs

   The RUC has provided a recommendation regarding the PE inputs for digital imaging services. Specifically, the RUC recommended that we remove a list of supply and equipment items associated with film technology since these items are no longer a typical resource input; these items are detailed in Table 6. The RUC also recommended that the Picture Archiving and Communication System (PACS) equipment be included for these imaging services since these items are now typically used in furnishing imaging services. We received a description of the PACS system as part of the recommendation, which included both items that appear to be direct PE items and items for which indirect PE RVUs are allocated in the PE methodology. As we have previously indicated, items that are not clinical labor, medical supplies, or medical equipment, or are not individually allocable to a particular patient for a particular procedure, are not categorized as direct costs in the PE methodology. Since we did not receive any invoices for the PACS system, we are unable to determine the appropriate pricing to use for the inputs. We propose to accept the RUC recommendation to remove the film supply and equipment items, and to allocate minutes for a desktop computer (ED021) as a proxy for the PACS workstation as a direct expense. Specifically, for the 31 services that already contain ED021, we propose to retain the time that is currently included in the direct PE input database. For the remaining services that are valued in the nonfacility setting, we propose to allocate the full clinical labor intraservice time to ED021, except when there is no clinical labor, in which case we propose to allocate the intraservice work time to ED021. For services valued only in the facility setting, we propose to allocate the post-service clinical labor time to ED021, since the film supply and/or equipment inputs were previously associated with the post-service period. GOES

Table 6--RUC-Recommended Supply and Equipment Items Proposed To Be Removed for Digital Imaging Services CMS code Description SK013 computer media, dvd. SK014 computer media, floppy disk 1.44mb. SK015 computer media, optical disk 128mb. SK016 computer media, optical disk 2.6gb. SK022 film, 8inx10in (ultrasound, MRI). SK025 film, dry, radiographic, 8in x 10in. SK028 film, fluoroscopic 14 x 17. SK033 film, x-ray 10in x 12in. SK034 film, x-ray 14in x 17in. SK035 film, x-ray 14in x 36in. SK037 film, x-ray 8in x 10in. SK038 film, x-ray 8in x 10in (X-omat, Radiomat). SK086 video tape, VHS. SK089 x-ray developer solution. SK090 x-ray digitalization separator sheet. SK091 x-ray envelope. SK092 x-ray fixer solution. SK093 x-ray ID card (flashcard). SK094 x-ray marking pencil. SK098 film, x-ray, laser print. SM009 cleaner, x-ray cassette-screen. ED014 computer workstation, 3D reconstruction CT-MR. ED016 computer workstation, MRA post processing. ED023 film processor, PET imaging. ED024 film processor, dry, laser. ED025 film processor, wet. ED027 film processor, x-omat (M6B). ER018 densitometer, film. ER029 film alternator (motorized film viewbox). ER067 x-ray view box, 4 panel.



   We note that the RUC exempted certain procedures from its recommendation because (a) the dominant specialty indicated that digital technology is not yet typical or (b) the procedure only contained a single input associated with film technology, and it was determined that the sharing of images, but not actual imaging, may be involved in the service. However, we do not believe that the most appropriate approach in establishing relative values for services that involve imaging is to exempt services from the transition from film to digital PE inputs based on information reported by individual specialties. Although we understand that the migration from film technology to digital technology may progress at different paces for particular specialties, we do not have information to suggest that the migration is not occurring for all procedures that require the storage of images. Just as it was appropriate to use film inputs as a proxy for some services for which digital inputs were typical pending these proposed changes in the direct PE input database, we believe it is appropriate to use digital inputs as a proxy for the services that may still use film, pending their migration to digital technology. In addition, since the RUC conducted its collection of information from the specialties over several years, we believe the migration process from film to digital inputs has likely continued over the time period during which the information was gathered, and that the digital PE inputs will reflect typical use of technology for most if not all of these services before the proposed change to digital inputs would take effect beginning January 1, 2015. We also believe that for the sake of relativity, we should remove the equipment and supply inputs noted below from all procedures in the direct PE database, including those listed in Table 7. We seek comment on whether the computer workstation, which we propose to use as a proxy for the PACS workstation, is the appropriate input for the services listed in Table 7, or whether an alternative input is a more appropriate reflection of direct PE costs. GOES

Table 7--Codes Containing Film Inputs But Excluded From the RUC Recommendation HCPCS Short descriptor 21077 Prepare face/oral prosthesis. 28293 Correction of bunion. 61580 Craniofacial approach skull. 61581 Craniofacial approach skull. 61582 Craniofacial approach skull. 61583 Craniofacial approach skull. 61584 Orbitocranial approach/skull. 61585 Orbitocranial approach/skull. 61586 Resect nasopharynx skull. 64517 N block inj hypogas plxs. 64681 Injection treatment of nerve. 70310 X-ray exam of teeth. 77326 Brachytx isodose calc simp. 77327 Brachytx isodose calc interm. 77328 Brachytx isodose plan compl. 91010 Esophagus motility study. 91020 Gastric motility studies. 91034 Gastroesophageal reflux test. 91035 G-esoph reflx tst w/electrod. 91037 Esoph imped function test. 91038 Esoph imped funct test > 1hr. 91040 Esoph balloon distension tst. 91120 Rectal sensation test. 91122 Anal pressure record. 91132 Electrogastrography. 91133 Electrogastrography w/test. 92521 Evaluation of speech fluency. 92523 Speech sound lang comprehend. 92524 Behavioral qualit analys voice. 92601 Cochlear implt f/up exam <7. 92603 Cochlear implt f/up exam 7/>. 92611 Motion fluoroscopy/swallow. 92612 Endoscopy swallow tst (fees). 92614 Laryngoscopic sensory test. 92616 Fees w/laryngeal sense test. 95800 Slp stdy unattended. 95801 Slp stdy unatnd w/anal. 95803 Actigraphy testing. 95805 Multiple sleep latency test. 95806 Sleep study unatt&resp efft. 95807 Sleep study attended. 95808 Polysom any age 1-3> param. 95810 Polysom 6/> yrs 4/> param. 95811 Polysom 6/>yrs cpap 4/> parm. 95812 Eeg 41-60 minutes. 95813 Eeg over 1 hour. 95829 Surgery electrocorticogram. 95950 Ambulatory eeg monitoring. 95953 Eeg monitoring/computer. 95954 Eeg monitoring/giving drugs. 95955 Eeg during surgery. 95956 Eeg monitor technol attended. 95957 Eeg digital analysis. 96904 Whole body photography. G0270 Mnt subs tx for change dx. G0271 Group mnt 2 or more 30 mins.



   Finally, we note that the RUC recommendation also indicated that given the labor-intensive nature of reviewing all clinical labor tasks associated with film technology, these times would be addressed as these codes are reviewed. We agree with the RUC that reviewing and adjusting the times for each code would be difficult and labor-intensive since the direct PE input database does not allow for a comprehensive adjustment of the clinical labor time based on changes in particular clinical labor tasks. To make broad adjustments such as this across codes, the PE database would need to contain the time associated with individual clinical labor tasks rather than reflecting only the sum of times for the pre-service period, service period, and post-service period, as it does now. We recognize this situation presents a challenge in implementing RUC recommendations such as this one, and makes it difficult to understand the basis of both the RUC's recommended clinical labor times and our refinements of those recommendations. Therefore, we are considering revising the direct PE input database to include task-level clinical labor time information for every code in the database. As an example, we refer readers to the supporting data files for the direct PE inputs, which include public use files that display clinical labor times as allocated to each individual clinical labor task for a sample of procedures. We are displaying this information as we attempt to increase the transparency of the direct PE database. We hope that this modification could enable us to more accurately allocate equipment minutes to clinical labor tasks in a more consistent and efficient manner. Given the number of procedures and the volume of information involved, we are seeking comments on the feasibility of this approach. We note that we are not proposing to make any changes to PE inputs for CY 2015 based on this proposed modification to the design of the direct PE input database.

   The CY 2015 direct PE database reflects these proposed changes and is available on the CMS Web site under the supporting data files for the CY 2015 PFS proposed rule at http://www.cms.gov/PhysicianFeeSched/.

d. Inputs for Digital Mammography Services

   Mammography services are currently reported by and paid for using both CPT codes and G-codes. To meet the requirements of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), we established the G-codes for CY 2002 to pay for mammography services using new digital technologies (G0202 screening mammography digital; G0204 diagnostic mammography digital; G0206 diagnostic mammography digital). We continued to pay for mammography billed using the CPT codes when the services were furnished with film technology (77055 mammogram one breast; 77056 mammogram both breasts; 77057 mammogram screening). As we discussed previously in this section, the RUC has recommended that all imaging codes, including mammography, be valued using digital rather than film inputs because film is no longer typical. A review of Medicare claims data shows that the mammography CPT codes are billed extremely infrequently, and that the G-codes are billed for the vast majority of mammography claims, confirming what the RUC has indicated regarding the use of digital technology. It appears that the typical mammography service is furnished using digital technology. As such, we do not believe there is a reason to continue the separate use of the CPT codes and the G-codes for mammography services since both sets of codes would have the same values when priced based upon the typical digital technology. Accordingly, we are proposing to delete the mammography G-codes beginning for CY 2015 and to pay all mammography using the CPT codes.

   Although we believe that the CPT codes should now be used to report all mammography services, we have concerns about whether the current values for the CPT codes accurately reflect the resource inputs associated with furnishing the services. Because the CPT codes have not been recently reviewed and significant technological changes have occurred during this time, we do not believe it would be appropriate to retain the current values for the CPT codes. Therefore, we are proposing to value the CPT codes using the RVUs previously established for the G-codes. We believe these values would be most appropriate since they were established to reflect the use of digital technology, which is now typical.

   As discussed in section II.B.3.b.(4) of this proposed rule, we are proposing these CPT codes as potentially misvalued and requesting that the RUC and other interested stakeholders review these services in terms of appropriate work RVUs, work time assumptions and direct PE inputs.

e. Radiation Treatment Vault

   In previous rulemaking (77 FR 68922; 78 FR 74346), we indicated that we included the radiation treatment vault as a direct PE input for several recently reviewed radiation treatment codes for the sake of consistency with its previous inclusion as a direct PE input for some other radiation treatment services, but that we intended to review the radiation treatment vault input and address whether or not it should be included in the direct PE input database for all services in future rulemaking. Specifically, we questioned whether it was consistent with the principles underlying the PE methodology to include the radiation treatment vault as a direct cost given that it appears to be more similar to building infrastructure costs than to medical equipment costs. Moreover, it is difficult to distinguish the cost of the vault from the cost of the building. In response to this action, we received comments and invoices from stakeholders who indicated that the vault should be classified as a direct cost. However, upon review of the information received, we believe that the specific structural components required to house the linear accelerator are similar in concept to components required to house other medical equipment such as expensive imaging equipment. In general, the electrical, plumbing, and other building specifications are often unique to the intended functionality of a given building, including costs that are attributable to the specific medical equipment housed in the building, but do not represent direct medical equipment costs in our established PE methodology. Therefore we believe that the special building requirements indicated for the radiation treatment vault to house a linear accelerator do not represent a direct cost in our PE methodology, and that the vault construction is instead accounted for in the indirect PE methodology, just as the building and infrastructure costs are treated for other PFS services including those with infrastructure costs based on equipment needs Therefore, we propose to remove the radiation treatment vault as a direct PE input from the radiation treatment procedures listed in Table 8, because we believe that the vault is not, itself, medical equipment, and therefore, is accounted for in the indirect PE methodology. GOES

Table 8--HCPCS Codes Affected by Proposed Removal of Radiation Treatment Vault HCPCS Short descriptor 77373 Sbrt delivery. 77402 Radiation treatment delivery. 77403 Radiation treatment delivery. 77404 Radiation treatment delivery. 77406 Radiation treatment delivery. 77407 Radiation treatment delivery. 77408 Radiation treatment delivery. 77409 Radiation treatment delivery. 77411 Radiation treatment delivery. 77412 Radiation treatment delivery. 77413 Radiation treatment delivery. 77414 Radiation treatment delivery. 77416 Radiation treatment delivery. 77418 Radiation tx delivery imrt.



f. Clinical Labor Input Errors

   Subsequent to the publication of the CY 2014 PFS final rule with comment period, it came to our attention that, due to a clerical error, the clinical labor type for CPT code 77293 (Respiratory Motion Management Simulation (list separately in addition to code for primary procedure)) was entered as L052A (Audiologist) instead of L152A (Medical Physicist), which has a higher cost per minute. We are proposing a correction to the clinical labor type for this service.

   In conducting a routine data review of the database, we also discovered that, due to a clerical error, the RN time allocated to CPT codes 33620 (Apply r&l pulm art bands), 33621 (Transthor cath for stent), and 33622 (Redo compl cardiac anomaly) was entered in the nonfacility setting, rather than in the facility setting where the code is valued. When a service is not valued in a particular setting, any inputs included in that setting are not included in the calculation of the PE RVUs for that service. Therefore, we are proposing to move the RN time allocated to these procedures to the facility setting. The PE RVUs listed in Addendum B reflect these technical corrections.

g. Work Time

   Subsequent to the publication of the CY PFS 2014 final rule with comment period, several inconsistencies in the work time file came to our attention. First, for some services, the total work time, which is used in our PE methodology, did not equal the sum of the component parts (pre-service, intra-service, post-service, and times associated with global period visits). The times in the CY 2015 work time file reflect our proposed corrected values for total work time. Second, for a subset of services, the values in the pre-positioning time, pre-evaluation time, and pre-scrub-dress-wait time, were inadvertently transposed. We note that this error had no impact on calculation of the total times, but has been corrected in the CY 2015 work time file. Third, minor discrepancies for a series of interim final codes were identified between the work time file and the way we addressed these codes in the preamble text. Therefore, we have made adjustments to the work time file to reflect the decisions indicated in the preamble text. The work time file is available on the CMS Web site under the supporting data files for the CY 2015 PFS proposed rule at http://www.cms.gov/PhysicianFeeSched/. Note that for comparison purposes, the CY 2014 work time file is located at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices-Items/CMS-1600-FC.html.

h. Updates to Price for Existing Direct Inputs.

   In the CY 2011 PFS final rule with comment period (75 FR 73205), we finalized a process to act on public requests to update equipment and supply price and equipment useful life inputs through annual rulemaking beginning with the CY 2012 PFS proposed rule. During 2013, we received a request to update the price of SD216 (catheter, balloon, esophageal or rectal (graded distention test)) from $217 to $237.50. We also received a request to update the price of SL196 (kit, HER-2/neu DNA Probe) from $105 to $144.50. We received invoices that documented updated pricing for each of these supply items. We propose to increase the price associated with these supply items.

   We continue to believe it is important to maintain a periodic and transparent process to update the price of items to reflect typical market prices in our ratesetting methodology, and we continue to study the best way to improve our current process. We remind stakeholders that we have previously stated our difficulty in obtaining accurate pricing information. We have also made clear that the goal of the current transparent process is to offer the opportunity for the community to both request supply price updates by providing us copies of paid invoices, and to object to proposed changes in price inputs for particular items by providing additional information about prices available to the practitioner community. We remind stakeholders that PFS payment rates are developed within a budget neutral, relative value system, and any increases in price inputs for particular supply items result in corresponding decreases to the relative values of all other direct PE inputs.

   We note that we continue to have difficulty determining the best way to use the invoices that we receive. In all cases, we attempt to use the price that appears most representative, but it can be difficult to ascertain whether the prices on particular invoices are typical. For example, in some cases, we receive multiple invoices, but are only able to use one of them because the other invoices include additional items and do not separately identify the price of the item in question. In other cases, we receive multiple invoices at one price, which suggests that this price is likely a typical one. In other cases, we receive invoices for items already in the direct PE database that are based on a recent invoice. In these cases, it is not clear whether the new, usually higher priced, invoice reflects a more accurate price than the current price, but we need to determine whether to substitute the new price for the existing price, maintain the existing price, or average the two prices. We continue to seek stakeholder input on the best approach to using the small sample of invoices that are provided to us through this process.

   We also received a RUC recommendation to update the prices associated with two supply items. Specifically, the RUC recommended that we increase the price of SA042 (pack, cleaning and disinfecting, endoscope) from $15.52 to $17.06 to reflect the addition of supply item SJ009 (basin, irrigation) to the pack, and increase the price of SA019 (kit, IV starter) from $1.37 to $1.60 to reflect the addition of supply item SA044 (underpad 2 ft. x 3 ft. (Chux)) to the kit. We are proposing to update the prices for both of these items based on these recommendations. The CY 2015 direct PE database reflects these proposed changes and is available on the CMS Web site under the supporting data files for the CY 2015 PFS proposed rule at http://www.cms.gov/PhysicianFeeSched/.

i. New Standard Supply Package for Contrast Imaging

   The RUC recommended creating a new direct PE input standard supply package "Imaging w/contrast, standard package" for contrast enhanced imaging, with a price of $6.82. This price reflects the combined prices of the medical supplies included in the package; these items are listed in Table 9. We propose to accept this recommendation, but seek comment on whether all of the items included in the package are used in the typical case. The CY 2015 direct PE database reflects this proposed change and is available on the CMS Web site under the supporting data files for the CY 2015 PFS proposed rule at http://www.cms.gov/PhysicianFeeSched/. GOES

Table 9--Standard Contrast Imaging Supply Package Medical supply CMS supply Unit Quantity Price description code Imaging w/Contrast--Standard Package Kit, IV SA019 Kit 1 $1.368 starter Gloves, SB022 Pair 1 0.084 non-sterile Angiocatheter SC001 Item 1 1.505 14g-24g Heparin lock SC012 Item 1 0.917 IV tubing SC019 Foot *3 1.590 (extension) Needle, 18-27g SC029 Item 1 0.089 Syringe 20ml SC053 Item 1 0.558 Sodium SH068 Item 1 0.700 chloride 0.9% inj. bacteriostatic (30ml uou) Swab-pad, SJ053 Item 1 0.013 alcohol TOTAL 6.824 * The price for SC019 (IV tubing, (extension)) is $0.53 per foot.



j. Direct PE Inputs for Stereotactic Radiosurgery (SRS) Services (CPT Codes 77372 and 77373)

   In the CY 2014 PFS final rule with comment period (78 FR 74245), we summarized comments received about whether CPT codes 77372 and 77373 would accurately reflect the resources used in furnishing the typical SRS delivery if there were no coding distinction between robotic and non-robotic delivery methods. Until now, SRS services furnished using robotic methods were billed using contractor-priced G-codes G0339 (Image-guided robotic linear accelerator based stereotactic radiosurgery, complete course of therapy in one session or first session of fractionated treatment), and G0340 (Image-guided robotic linear accelerator-based stereotactic radiosurgery, delivery including collimator changes and custom plugging, fractionated treatment, all lesions, per session, second through fifth sessions, maximum five sessions per course of treatment). We indicated that we would consider these codes in future rulemaking.

   Most commenters suggested that the CPT codes accurately described both services, and the RUC stated that the direct PE inputs for the CPT codes accurately accounted for the resource costs of the described services. One commenter objected to the deletion of the G-codes but did not include any information to suggest that the CPT codes did not describe the services or that the direct PE inputs for the CPT codes were inaccurate. Based on a review of the comments received, we have no indication that the direct PE inputs included in the CPT codes do not reflect the typical resource inputs involved in furnishing an SRS service. Therefore, we propose to recognize only the CPT codes for payment of SRS services, and to delete the G-codes used to report robotic delivery of SRS.

k. Inclusion of Capnograph for Pediatric Polysomnography Services

   We are proposing to include equipment item EQ358, Sleep capnograph, polysomnography (pediatric), for CPT codes 95782 (Polysomnography; younger than 6 years, sleep staging with 4 or more additional parameters of sleep, attended by a technologist) and 95783 (Polysomnography; younger than 6 years, sleep staging with 4 or more additional parameters of sleep, with initiation of continuous positive airway pressure therapy or bi-level ventilation, attended by a technologist). We understand that capnography is a required element of sleep studies for patients younger than 6 years, and propose to allocate this equipment item to 95782 for 602 minutes, and 95783 for 647 minutes. Based on the invoice we received for this equipment item, we propose to price EQ358 at $4,534.23.

l. Nonfacility Direct PE Inputs for Intravascular Ultrasound

   A stakeholder requested that we establish nonfacility PE RVUs for CPT code 37250 (Intravascular ultrasound (non-coronary vessel) during diagnostic evaluation and/or therapeutic intervention; each additional vessel (List separately in addition to code for primary procedure)) and 37251 (Intravascular ultrasound (non-coronary vessel) during diagnostic evaluation and/or therapeutic intervention; each additional vessel (List separately in addition to code for primary procedure)). We seek comment regarding whether it is appropriate to have nonfacility PE RVUs for this code and if so what inputs should assigned to this code.

4. Using OPPS and ASC Rates in Developing PE RVUs

   Accurate and reliable pricing information for both individual items and indirect PEs is critical to establish accurate PE RVUs for PFS services. As we have addressed in previous rulemaking, we have serious concerns regarding the accuracy of some of the information we use in developing PE RVUs. In particular, we have several longstanding concerns regarding the accuracy of direct PE inputs, including both items and procedure time assumptions, and prices of individual supplies and equipment (78 FR 74248-74250). In addition to the concerns regarding the inputs used in valuing particular procedures, we also note that the allocation of indirect PE is based on information collected several years ago (as described above) and will likely need to be updated in the coming years. To mitigate the impact of some of these potentially problematic data used in developing values for individual services, in CY 2014 rulemaking we proposed to limit the nonfacility PE RVUs for individual codes so that the total nonfacility PFS payment amount would not exceed the total combined amount that Medicare would pay for the same code in the facility setting. In developing the proposal, we sought a reliable means for Medicare to set upper payment limits for office-based procedures and believed OPPS and ASC payment rates would provide an appropriate comparison because these rates are based on relatively more reliable cost information in settings with cost structures that generally would be expected to be higher than in the office setting.

   We received many comments regarding our proposal, the vast majority of which urged us to withdraw the proposal. Some commenters questioned the validity of our assumption that facilities' costs for providing all services are necessarily higher than the costs of physician offices or other nonfacility settings. Other commenters expressed serious concerns with the asymmetrical comparisons between PFS payment amounts and OPPS/ASC payment amounts. Finally, many commenters suggested revisions to technical aspects of our proposed policy.

   In considering all the comments, however, we were persuaded that the comparison of OPPS (or ASC) payment amounts to PFS payment amounts for particular procedures is not the most appropriate or effective approach to ensuring that that PFS payment rates are based on accurate cost assumptions. Commenters noted several flaws with the approach. First, unlike PFS payments, OPPS and ASC payments for individual services are grouped into rates that reflect the costs of a range of services. Second, commenters suggested that since the ASC rates reflect the OPPS relative weights to determine payment rates under the ASC payment system, and are not based on cost information collected from ASCs, the ASC rates should not be used in the proposed policy. For these and other reasons raised by commenters, we are not proposing a similar policy for the CY 2015 PFS. If we consider using OPPS or ASC payment rates in developing PFS PE RVUs in future rulemaking, we would consider all of the comments received regarding the technical application of the previous proposal.

   After thorough consideration of the comments regarding the CY 2014 proposal, we continue to believe that there are a various possibilities for leveraging the use of available hospital cost data in the PE RVU methodology to ensure that the relative costs for PFS services are developed using data that is auditable and comprehensively and regularly updated. Although some commenters questioned the premise that the hospital cost data are more accurate than the information used to establish PE RVUs, we continue to believe that the routinely updated, auditable resource cost information submitted contemporaneously by a wide array of providers across the country is a valid reflection of "relative" resources and could be useful to supplement the resource cost information developed under our current methodology based upon a typical case that are developed with information from a small number of representative practitioners for a small percentage of codes in any particular year.

   Section 220(a) of the PAMA added a new subparagraph (M) under section 1848(c)(2) of the Act that gives us authority to collect information on resources used to furnish services from eligible professionals (including physicians, non-physician practitioners, PTs, OTs, SLPs and qualified audiologists), and other sources. It also authorizes us to pay eligible professionals for submitting solicited information. We will be exploring ways of collecting better and updated resource data from physician practices, including those that are provider-based, and other non-facility entities paid through the PFS. We believe such efforts will be challenging given the wide variety of practices, and that any effort will likely impose some burden on eligible professionals paid through the PFS regardless of the scope and manner of data collection. Currently, through one of the validation contracts discussed in section II.B. of this proposed rule, we have been gathering time data directly from physician practices. Through this project, we have learned much about the challenges for both CMS and the eligible professionals of collecting data directly from practices. Our experience has also shown that is difficult to obtain invoices for supply and equipment items that we can use in pricing direct PE inputs. Many specialty societies also have noted the challenges in obtaining recent invoices for medical supplies and equipment (78 FR 74249). Further, PE calculations also rely heavily on information from the Physician Practice Expense Information Survey (PPIS) survey, which, as discussed earlier, was conducted in 2007 and 2008. When we implemented the results of the survey, many in the community expressed serious concerns over the accuracy of this or other PE surveys as a way of gathering data on PE inputs from the diversity of providers paid under the PFS.

   Section 220 of the PAMA also provides authority to use alternative approaches to establish practice expense relative values, including the use of data from other suppliers and providers of services. We are exploring the best approaches for exercising this authority, including with respect to use of hospital outpatient cost data. We understand that many stakeholders will have concerns regarding the possibility of using hospital outpatient cost data in developing PFS PE RVUs, and we want to be sure we are aware of these prior to considering or developing any future proposal relying on those data. Therefore, we are seeking comment on the possible uses of the Medicare hospital outpatient cost data (not the APC payment amount) in potential revisions of the PFS PE methodology. This could be as a means to validate or, perhaps, in setting the relative resource cost assumptions within the PFS PE methodology. We note that the resulting PFS payment amounts would not necessarily conform to OPPS payment amounts since OPPS payments are grouped into APCs, while PFS payments would continue to be valued individually and would remain subject to the relativity inherent in establishing PE RVUs, budget neutrality adjustments, and PFS updates. We are particularly interested in comments that compare such possibilities to other broad-based, auditable, mechanisms for data collection, including any we might consider under the authority provided under section 220(a) of the PAMA. We urge commenters to consider a wide range of options for gathering and using the data, including using the data to validate or set resource assumptions for only a subset of PFS services, or as a base amount to be adjusted by code or specialty-level recommended adjustments, or other potential uses.

   In addition to soliciting comments as noted above, we continue to seek a better understanding regarding the growing trend toward hospital acquisition of physician offices and subsequent treatment of those locations as off-campus provider-based outpatient departments affects payments under PFS and beneficiary cost-sharing. MedPAC continues to question the appropriateness of increased Medicare payment and beneficiary cost-sharing when physician offices become hospital outpatient departments, and to recommend that Medicare pay selected hospital outpatient services at PFS rates (MedPAC March 2012 and June 2013 Report to Congress). We also remain concerned about the validity of the resource data as more physician practices become provider-based. Our survey data reflects the PE costs for particular PFS specialties, including a proportion of practices that may have become provider-based since the survey was conducted. Additionally, as the proportion of provider-based offices varies among physician specialties, so does the relative accuracy of the PE survey data. Our current PE methodology primarily distinguishes between the resources involved in furnishing services in two sites of service: The non-facility setting and the facility setting. In principle, when services are furnished in the non-facility setting, the costs associated with furnishing services include all direct and indirect PEs associated with the work and the PE of the service. In contrast, when services are furnished in the facility setting, some costs that would be PEs in the office setting are incurred by the facility. Medicare makes a separate payment to the facility to account for some portion of these costs, and we adjust PEs accordingly under the PFS. As more physician practices become hospital-based, it is difficult to know which PE costs typically are actually incurred by the physician, which are incurred by the hospital, and whether our bifurcated site-of service differential adequately accounts for the typical resource costs given these relationships. We also have addressed this issue as it relates to accurate valuation of visits within the post-operative period of 10- and 90-day global codes in section II.B.4 of this proposed rule.

   To understand how this trend is affecting Medicare, including the accuracy of payments made through the PFS, we need to develop data to assess the extent to which this shift toward hospital-based physician practices is occurring. To that end, during CY 2014 rulemaking we sought comment regarding the best method for collecting information that would allow us to analyze the frequency, type, and payment for services furnished in off-campus provider-based hospital departments (73 FR 43302). We received many thoughtful comments. However, the commenters did not present a consensus opinion regarding the options we presented in last year's rule. Based on our analysis of the comments, we believe the most efficient and equitable means of gathering this important information across two different payment systems would be to create a HCPCS modifier to be reported with every code for physician and hospital services furnished in an off-campus provider-based department of a hospital. The modifier would be reported on both the CMS-1500 claim form for physicians' services and the UB-04 (CMS form 1450) for hospital outpatient claims. (We note that the requirements for a determination that a facility or an organization has provider-based status are specified in SEC 413.65 and we define a hospital campus to be the physical area immediately adjacent to the provider's main buildings, other areas and structures that are not strictly contiguous to the main buildings but are located within 250 yards of the main buildings, and any other areas determined on an individual case basis, by the CMS regional office.)

   Therefore, we are proposing to collect this information on the type and frequency of services furnished in off-campus provider-based departments in accordance with our authority under section 1834(c)(2)(M) of the Act (as added by section 220(a) of the PAMA) beginning January 1, 2015. The collection of this information would allow us to begin to assess the accuracy of the PE data, including both the service-level direct PE inputs and the specialty-level indirect PE information that we currently use to value PFS services. Furthermore, this information would be critical in order to develop proposed improvements to our PE data or methodology that would appropriately account for the different resource costs among traditional office, facility, and off-campus provider-based settings. We are seeking additional comment on whether a code modifier is the best mechanism for collecting this service-level information.

B. Potentially Misvalued Services Under the Physician Fee Schedule

1. Valuing Services Under the PFS

   Section 1848(c) of the Act requires the Secretary to determine relative values for physicians' services based on three components: Work; PE; and MP. Section 1848(c)(1)(A) of the Act defines the work component to include "the portion of the resources used in furnishing the service that reflects work time and intensity in furnishing the service." In addition, section 1848(c)(2)(C)(i) of the Act specifies that "the Secretary shall determine a number of work relative value units (RVUs) for the service based on the relative resources incorporating physician time and intensity required in furnishing the service."

   Section 1848(c)(1)(B) of the Act defines the PE component as "the portion of the resources used in furnishing the service that reflects the general categories of expenses (such as office rent and wages of personnel, but excluding malpractice expenses) comprising practice expenses." Section 1848 (c)(2)(C)(ii) of the Act requires that PE RVUs be determined based upon the relative PE resources involved in furnishing the service. (See section II.A. of this proposed rule for more detail on the PE component.)

   Section 1848(c)(1)(C) of the Act defines the MP component as "the portion of the resources used in furnishing the service that reflects malpractice expenses in furnishing the service." Section 1848 (c)(2)(C)(iii) of the Act specifies that MP expense RVUs shall be determined based on the relative MP expense resources involved in furnishing the service. (See section II.C. of this proposed rule for more detail on the MP component.)

2. Identifying, Reviewing, and Validating the RVUs of Potentially Misvalued Services

a. Background

   Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a periodic review, not less often than every 5 years, of the RVUs established under the PFS. Section 1848(c)(2)(K) of the Act requires the Secretary to periodically identify potentially misvalued services using certain criteria and to review and make appropriate adjustments to the relative values for those services. Section 1848(c)(2)(L) to the Act also requires the Secretary to develop a process to validate the RVUs of certain potentially misvalued codes under the PFS, using the same criteria used to identify potentially misvalued codes, and to make appropriate adjustments.

   As discussed in section I.B. of this proposed rule, each year we develop appropriate adjustments to the RVUs taking into account recommendations provided by the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC), MedPAC, and others. For many years, the RUC has provided us with recommendations on the appropriate relative values for new, revised, and potentially misvalued PFS services. We review these recommendations on a code-by-code basis and consider these recommendations in conjunction with analyses of other data, such as claims data, to inform the decision-making process as authorized by the law. We may also consider analyses of work time, work RVUs, or direct PE inputs using other data sources, such as Department of Veteran Affairs (VA), National Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS), and the Physician Quality Reporting Initiative (PQRI) databases. In addition to considering the most recently available data, we also assess the results of physician surveys and specialty recommendations submitted to us by the RUC. We also consider information provided by other stakeholders. We conduct a review to assess the appropriate RVUs in the context of contemporary medical practice. We note that section 1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and other techniques to determine the RVUs for physicians' services for which specific data are not available in addition to taking into account the results of consultations with organizations representing physicians. In accordance with section 1848(c) of the Act, we determine and make appropriate adjustments to the RVUs.

   In its March 2006 Report to the Congress, MedPAC discussed the importance of appropriately valuing physicians' services, noting that "misvalued services can distort the price signals for physicians' services as well as for other health care services that physicians order, such as hospital services." In that same report MedPAC postulated that physicians' services under the PFS can become misvalued over time. MedPAC stated, "When a new service is added to the PFS, it may be assigned a relatively high value because of the time, technical skill, and psychological stress that are often required to furnish that service. Over time, the work required for certain services would be expected to decline as physicians become more familiar with the service and more efficient in furnishing it." We believe services can also become overvalued when PE declines. This can happen when the costs of equipment and supplies fall, or when equipment is used more frequently than is estimated in the PE methodology, reducing its cost per use. Likewise, services can become undervalued when physician work increases or PE rises.

   As MedPAC noted in its March 2009 Report to Congress, in the intervening years since MedPAC made the initial recommendations, "CMS and the RUC have taken several steps to improve the review process." Also, since that time Congress added section 1848(c)(2)(K)(ii) to the Act, which augments our efforts. It directs the Secretary to specifically examine, as determined appropriate, potentially misvalued services in the following seven categories:

    * Codes and families of codes for which there has been the fastest growth;

    * Codes and families of codes that have experienced substantial changes in PEs;

    * Codes that are recently established for new technologies or services;

    * Multiple codes that are frequently billed in conjunction with furnishing a single service;

    * Codes with low relative values, particularly those that are often billed multiple times for a single treatment;

    * Codes which have not been subject to review since the implementation of the RBRVS (the so-called `Harvard-valued codes'); and

    * Other codes determined to be appropriate by the Secretary.

   Section 220(c) of the PAMA further expanded the categories of codes that the Secretary is directed to examine by adding nine additional categories. These are:

    * Codes that account for the majority of spending under the PFS;

    * Codes for services that have experienced a substantial change in the hospital length of stay or procedure time;

    * Codes for which there may be a change in the typical site of service since the code was last valued;

    * Codes for which there is a significant difference in payment for the same service between different sites of service;

    * Codes for which there may be anomalies in relative values within a family of codes;

    * Codes for services where there may be efficiencies when a service is furnished at the same time as other services;

    * Codes with high intra-service work per unit of time;

    * Codes with high PE RVUs; and

    * Codes with high cost supplies.

   Section 1848(c)(2)(K)(iii) of the Act also specifies that the Secretary may use existing processes to receive recommendations on the review and appropriate adjustment of potentially misvalued services. In addition, the Secretary may conduct surveys, other data collection activities, studies, or other analyses, as the Secretary determines to be appropriate, to facilitate the review and appropriate adjustment of potentially misvalued services. This section also authorizes the use of analytic contractors to identify and analyze potentially misvalued codes, conduct surveys or collect data, and make recommendations on the review and appropriate adjustment of potentially misvalued services. Additionally, this section provides that the Secretary may coordinate the review and adjustment of any RVU with the periodic review described in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of the Act specifies that the Secretary may make appropriate coding revisions (including using existing processes for consideration of coding changes) that may include consolidation of individual services into bundled codes for payment under the PFS.

b. Progress in Identifying and Reviewing Potentially Misvalued Codes

   To fulfill our statutory mandate, we have identified and reviewed numerous potentially misvalued codes as specified in section 1848(c)(2)(K)(ii) of the Act, and we plan to continue our work examining potentially misvalued codes in these areas over the upcoming years. As part of our current process, we identify potentially misvalued codes for review, and request recommendations from the RUC and other public commenters on revised work RVUs and direct PE inputs for those codes. The RUC, through its own processes, also identifies potentially misvalued codes for review. Through our public nomination process for potentially misvalued codes established in the CY 2012 PFS final rule with comment period, other individuals and stakeholder groups submit nominations for review of potentially misvalued codes as well.

   Since CY 2009, as a part of the annual potentially misvalued code review and the five-year review process, we have reviewed over 1,250 potentially misvalued codes to refine work RVUs and direct PE inputs. We have assigned appropriate work RVUs and direct PE inputs for these services as a result of these reviews. A more detailed discussion of the extensive prior reviews of potentially misvalued codes is included in the CY 2012 PFS final rule with comment period (76 FR 73052 through 73055). In the CY 2012 final rule with comment period, we finalized our policy to consolidate the review of physician work and PE at the same time (76 FR 73055 through 73958), and established a process for the annual public nomination of potentially misvalued services.

   In the CY 2013 final rule with comment period, we built upon the work we began in CY 2009 to review potentially misvalued codes that have not been reviewed since the implementation of the PFS (so-called "Harvard-valued codes"). In CY 2009, we requested recommendations from the RUC to aid in our review of Harvard-valued codes that had not yet been reviewed, focusing first on high-volume, low intensity codes (73 FR 38589). In the Fourth Five-Year Review, we requested recommendations from the RUC to aid in our review of Harvard-valued codes with annual utilization of greater than 30,000 (76 FR 32410). In the CY 2013 final rule with comment period, we identified Harvard-valued services with annual allowed charges that total at least $10,000,000 as potentially misvalued. In addition to the Harvard-valued codes, in the CY 2013 final rule with comment period we finalized for review a list of potentially misvalued codes that have stand-alone PE (codes with physician work and no listed work time and codes with no physician work and have listed work time).

   In the CY 2014 final rule with comment period, we finalized for review a list of potentially misvalued services that included ultrasound guidance codes that had longer procedure times than the typical procedure with which the code is billed to Medicare. We also finalized our proposal to replace missing post-operative hospital evaluation and management (E/M) visit information and work time for approximately 100 global surgery codes. In CY 2014, we also considered a proposal to limit Medicare PFS payments for services furnished in a nonfacility setting when the PFS payment would exceed the combined Medicare payment under the PFS to the practitioner and facility payment made to either the ASC or hospital outpatient. Based upon extensive public comment we did not finalize this proposal. We address our current consideration of the potential use of OPPS data in establishing RVUs for PFS services in section II.A. of this proposed rule.

c. Validating RVUs of Potentially Misvalued Codes

   Section 1848(c)(2)(L) of the Act requires the Secretary to establish a formal process to validate RVUs under the PFS. The Act specifies that the validation process may include validation of work elements (such as time, mental effort and professional judgment, technical skill and physical effort, and stress due to risk) involved with furnishing a service and may include validation of the pre-, post-, and intra-service components of work. The Secretary is directed, as part of the validation, to validate a sampling of the work RVUs of codes identified through any of the 16 categories of potentially misvalued codes specified in section 1848(c)(2)(K)(ii) of the Act. Furthermore, the Secretary may conduct the validation using methods similar to those used to review potentially misvalued codes, including conducting surveys, other data collection activities, studies, or other analyses as the Secretary determines to be appropriate to facilitate the validation of RVUs of services.

   In the CY 2011 PFS proposed rule (75 FR 40068) and CY 2012 PFS proposed rule (76 FR 42790), we solicited public comments on possible approaches, methodologies, and data sources that we should consider for a validation process. A summary of the comments along with our responses are included in the CY 2011 PFS final rule with comment period (75 FR 73217) and the CY 2012 PFS final rule with comment period (73054 through 73055).

   Since that time, we have contracted with two outside entities to develop validation models for RVUs. Given the central role of time in establishing work RVUs and the concerns that have been raised about the current time values used in rate setting, we contracted with the Urban Institute to collect time data from several practices for services selected by the contractor in consultation with CMS. These data will be used to develop time estimates for PFS services. The Urban Institute will use a variety of approaches to develop objective time estimates, depending on the type of service. Objective time estimates will be compared to the current time values used in the fee schedule. The project team will then convene groups of physicians from a range of specialties to review the new time data and their potential implications for work and the ratio of work to time. In its efforts to collect primary data on the time involved in PFS services, the Urban Institute has encountered numerous challenges. An interim report, Development of a Model for the Valuation of Work Relative Value Units, discusses the challenges encountered in collecting objective time data and offers some thoughts on how these can be overcome. This interim report is on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/RVUs-Validation-Urban-Interim-Report.pdf. Collection of time data under this project has just begun. A final report will be available once the project is complete.

   The second contract is with the RAND Corporation, which is using available data to build a validation model to predict work RVUs and the individual components of work RVUs, time, and intensity. The model design was informed by the statistical methodologies and approach used to develop the initial work RVUs and to identify potentially misvalued procedures under current CMS and RUC processes. RAND will use a representative set of CMS-provided codes to test the model. RAND consulted with a technical expert panel on model design issues and the test results. We anticipate a report from this project by the end of the year and will make the report available on the CMS Web site.

   Descriptions of both projects are available on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/RVUs-Validation-Model.pdf.

3. CY 2015 Identification and Review of Potentially Misvalued Services

a. Public Nomination of Potentially Misvalued Codes

   In the CY 2012 PFS final rule with comment period, we finalized a process for the public to nominate potentially misvalued codes (76 FR 73058). The public and stakeholders may nominate potentially misvalued codes for review by submitting the code with supporting documentation during the 60-day public comment period following the release of the annual PFS final rule with comment period. Supporting documentation for codes nominated for the annual review of potentially misvalued codes may include the following:

    * Documentation in the peer reviewed medical literature or other reliable data that there have been changes in physician work due to one or more of the following: technique; knowledge and technology; patient population; site-of-service; length of hospital stay; and work time.

    * An anomalous relationship between the code being proposed for review and other codes.

    * Evidence that technology has changed physician work.

    * Analysis of other data on time and effort measures, such as operating room logs or national and other representative databases.

    * Evidence that incorrect assumptions were made in the previous valuation of the service, such as a misleading vignette, survey, or flawed crosswalk assumptions in a previous evaluation.

    * Prices for certain high cost supplies or other direct PE inputs that are used to determine PE RVUs are inaccurate and do not reflect current information.

    * Analyses of work time, work RVU, or direct PE inputs using other data sources (for example, Department of Veteran Affairs (VA) National Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS) National Database, and the Physician Quality Reporting System (PQRS) databases).

    * National surveys of work time and intensity from professional and management societies and organizations, such as hospital associations.

   We evaluate the supporting documentation submitted with the nominated codes and assess whether the nominated codes appear to be potentially misvalued codes appropriate for review under the annual process. In the following year's PFS proposed rule, we publish the list of nominated codes and indicate whether we are proposing each nominated code as a potentially misvalued code. The public has the opportunity to comment on these and all other proposed potentially misvalued codes. In that year's final rule, we finalize our list of potentially misvalued codes.

   During the comment period on the CY 2014 final rule with comment period, we received nominations and supporting documentation for two codes to be considered as potentially misvalued codes. We evaluated the supporting documentation for each nominated code to ascertain whether the submitted information demonstrated that the code should be proposed as potentially misvalued.

   CPT code 41530 (submucosal ablation of the tongue base, radiofrequency, 1 or more sites, per session) was nominated for review as a potentially misvalued code. The nominator stated that CPT code 41530 is misvalued because there have been changes in the PE items used in furnishing the service. The nominator specifically requested that the SD109 probe (probe, radiofrequency, 3 array (StarBurstSDE)) be replaced with a more typically used probe, which costs less, and that a replacement be used for equipment code EQ214 (radiofrequency generator) to reflect a more appropriate input based on current invoices. We are proposing this code as a potentially misvalued code.

   CPT code 99174 (instrument-based ocular screening (eg, photoscreening, automated-refraction), bilateral) was also nominated for review as a potentially misvalued code. The nominator asserted that CPT code 99174 is misvalued because of outdated capital equipment inputs and the removal of supply code SK110 (fee, image analysis) from the code's direct PE inputs. (The latter change was proposed and finalized during CY 2014 notice and comment rulemaking). In establishing our public nomination process, we specified that the we would only consider nominations of active codes that are covered by Medicare at the time of the nomination stating, "We also are limiting the review of RVUs to codes that are active, covered by Medicare, and for which the RVUs are used for payment purposes under the PFS so that resources are not expended on the review of codes with RVUs that have no financial impact on the PFS." (76 FR 73059). CPT code 99174 is non-covered on the PFS and therefore does not meet the criteria for review as a potentially misvalued code. Accordingly, we are not proposing CPT code 99174 as a potentially misvalued code.

b. Potentially Misvalued Codes

(1) Review of High Expenditure Services Across Specialties With Medicare Allowed Charges of $10,000,000 or More

   We are proposing the approximately 65 codes listed in Table 10 as potentially misvalued codes as a prioritized subset of codes of the newly established statutory category, "codes that account for the majority of spending under the physician fee schedule." As we identify potentially misvalued codes, we prioritize codes that are important to the Medicare program and its beneficiaries, and codes that account for a high level of Medicare expenditures meet this criterion. However, through our usual identification potentially misvalued codes it is possible to miss certain services that are important to a segment of Medicare practitioners and beneficiaries because the specialty that typically furnishes the service does not have high volume relative to the overall PFS utilization. To capture such services in developing this list, we looked at high expenditure services by specialty using a similar approach to the one we used in CY 2012. We believe it is appropriate to repeat this type of analysis periodically.

   To develop the CY 2015 proposed list in this category, we began by identifying the top 20 codes by specialty in terms of allowed charges. For this analysis, we used the same specialties as used for the impact analysis in section VI. of this proposed rule. We excluded codes from our proposed potentially misvalued list that we have reviewed since CY 2009, with fewer than $10 million in allowed charges, and that describe anesthesia or E/M services. We excluded E/M services from the list of proposed potentially misvalued codes for the same reasons that we excluded them in the CY 2012 analysis, which we explained in the CY 2012 final rule with comment period (76 FR 73062 through 73065).

   We believe that a review of the codes in Table 10 is warranted to assess changes in physician work and to update direct PE inputs since these codes have not been reviewed since CY 2009 or earlier. Furthermore, since these codes have significant impact on PFS payment at the specialty level, a review of the relativity of the codes is essential to ensure that the work and PE RVUs are appropriately relative within the specialty and across specialties, as discussed previously. For these reasons, we are proposing the codes listed in Table 10 as potentially misvalued. GOES

Table 10--Proposed Potentially Misvalued Codes Identified Through High Expenditure Specialty Screen HCPCS Short descriptor 11100 Biopsy skin lesion. 11101 Biopsy skin add-on. 11730 Removal of nail plate. 11750 Removal of nail bed. 14060 Tis trnfr e/n/e/l 10 sq cm/. 17110 Destruct b9 lesion 1-14. 31575 Diagnostic laryngoscopy. 31579 Diagnostic laryngoscopy. 36215 Place catheter in artery. 36475 Endovenous rf 1st vein. 36478 Endovenous laser 1st vein. 36870 Percut thrombect av fistula. 51720 Treatment of bladder lesion. 51728 Cystometrogram w/vp. 51798 Us urine capacity measure. 52000 Cystoscopy. 55700 Biopsy of prostate. 65855 Laser surgery of eye. 66821 After cataract laser surgery. 67228 Treatment of retinal lesion. 68761 Close tear duct opening. 71010 Chest x-ray 1 view frontal. 71020 Chest x-ray 2vw frontal&latl. 71260 Ct thorax w/dye. 73560 X-ray exam of knee 1 or 2. 73562 X-ray exam of knee 3. 73564 X-ray exam knee 4 or more. 74183 Mri abdomen w/o & w/dye. 75978 Repair venous blockage. 76536 Us exam of head and neck. 76700 Us exam abdom complete. 76770 Us exam abdo back wall comp. 76775 Us exam abdo back wall lim. 77263 Radiation therapy planning. 77334 Radiation treatment aid(s). 78452 Ht muscle image spect mult. 88185 Flowcytometry/tc add-on. 91110 Gi tract capsule endoscopy. 92136 Ophthalmic biometry. 92250 Eye exam with photos. 92557 Comprehensive hearing test. 93280 Pm device progr eval dual. 93306 Tte w/doppler complete. 93351 Stress tte complete. 93978 Vascular study. 94010 Breathing capacity test. 95004 Percut allergy skin tests. 95165 Antigen therapy services. 95957 Eeg digital analysis. 96101 Psycho testing by psych/phys. 96118 Neuropsych tst by psych/phys. 96372 Ther/proph/diag inj sc/im. 96375 Tx/pro/dx inj new drug addon. 96401 Chemo anti-neopl sq/im. 96409 Chemo iv push sngl drug. 97032 Electrical stimulation. 97035 Ultrasound therapy. 97110 Therapeutic exercises. 97112 Neuromuscular reeducation. 97113 Aquatic therapy/exercises. 97116 Gait training therapy. 97140 Manual therapy 1/> regions. 97530 Therapeutic activities. G0283 Elec stim other than wound.



(2) Epidural Injection and Fluoroscopic Guidance--CPT Codes 62310, 62311, 62318, 62319, 77001, 77002 and 77003

   For CY 2014, we established interim final values for four epidural injection procedures, CPT codes 62310 (Injection(s), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid; cervical or thoracic), 62311 (Injection(s), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid; lumbar or sacral (caudal)), 62318 (Injection(s), including indwelling catheter placement, continuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, includes contrast for localization when performed, epidural or subarachnoid; cervical or thoracic) and 62319 (Injection(s), including indwelling catheter placement, continuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, includes contrast for localization when performed, epidural or subarachnoid; lumbar or sacral (caudal)). These interim final values resulted in CY 2014 payment reductions from the CY 2013 rates for all four procedures.

   In the CY 2014 final rule with comment period (78 FR 74340), we described in detail our interim valuation of these codes. We indicated we established interim final work RVUs for these codes below those recommended by the RUC because we did not believe that the RUC-recommended work RVUs accounted for the substantial decrease in time it takes to furnish these services since the last time they were valued as reflected in the RUC survey data for these four codes. Since the RUC provided no indication that the intensity of the procedures had changed, we believed that the work RVUs should reflect the reduction in time. We also established interim final direct PE inputs for these four codes based on the RUC-recommended inputs without any refinement. These recommendations included the removal of the radiographic-fluoroscopy room for 62310, 62311, and 62318 and a portable C-arm for 62319.

   We received thousands of comments objecting to the CY 2014 interim final values for these codes, many citing concerns with patient access and with the potential for the payment reductions under the PFS to inappropriately incentivize the use of the hospital setting or to encourage the use of other injections. Some suggested these payment rates might affect the rate of opioid use. Although most comments did not address the accuracy of the relative value inputs used in determining PFS payment rates, those that did most often objected to our valuations of the work RVUs and recommended that we instead accept the RUC recommendations. Several commenters objected to our rationale for setting the interim final work RVUs lower than the RUC-recommended values primarily based upon the reduction in time. Commenters gave two primary reasons why this reduction was inappropriate. Some pointed out that a reduction in work based upon a reduction in time presumes that the existing time is correct. These commenters asserted that the existing times were not correct for these codes. For example, the RUC noted that the CY 2013 survey times were from the original 1999 survey and were an outlier when compared to the previously reported code's original Harvard-valued total time of 42 minutes. One commenter noted that CMS indicates that in setting work values, the agency considers time, mental effort, professional judgment, technical skill, physical effort and stress due to risk; but in this case, rather than following our process, we only considered time. Others also said that we did not take into account the intensity, complexity, or risk of performing epidural injections. Commenters disagreed with the use of the lowest RUC survey value as the basis for the work valuation. One commenter said that we failed to explain adequately why our work RVUs were below those recommended by the RUC. One recommended that we assign values more similar to those used for paravertebral injections.

   Two commenters stated that critical PE inputs, including an epidural needle, loss or resistance syringe and spinal needle, were missing from the valuation. One commenter indicated that a radiographic-fluoroscopic room should be included for CPT codes 62310, 62311 and 62318; and a mobile C-Arm should be included for CPT code 62319. Another commenter requested the decreases in the PE RVUs be phased in over a period of years.

   Several commenters objected to the use of the interim final process for valuing these codes, citing the lack of opportunity for public comment and the lack of time to adequately prepare before the cuts to reimbursement took effect. Some suggested a delay in implementation.

   Lastly, several commenters requested refinement panel review of these codes.

   After analyzing the comments and considering valuation of these codes, we believe that we need to reassess our valuation of these codes and require additional information in order to do so. Our data show that these epidural codes are frequently billed with imaging guidance. For example, CPT code 62310 was billed with CPT code 77003 (Fluoroscopic guidance and localization of needle or catheter tip for spine or paraspinous diagnostic or therapeutic injection procedures (epidural or subarachnoid)) 79 percent of the time in the nonfacility setting in CY 2013. CPT code 62319, which is the epidural injection code that is least frequently billed with CPT code 77003 in the nonfacility setting, was still billed with this guidance code 40 percent of the time. These codes were also frequently billed with image guidance in the facility setting. CPT codes 62310 and 62311 were billed with CPT code 77003, 79 percent and 74 percent of the time, respectively in CY 2013. However, in the facility setting CPT codes 62318 and 62319 were much less frequently billed with CPT code 77003, only 3 percent and 11 percent, respectively. In addition, these four epidural injection codes are sometimes billed with other fluoroscopic or imaging guidance codes. Based on the frequency with which these codes are reported with fluoroscopic guidance codes, it appears that fluoroscopic guidance is both typically used and typically reported separately in conjunction with the epidural injection services.

   As we considered the concerns raised regarding the CY 2014 payment changes for the epidural injection procedures, we looked at the values for other injection procedures. Other injection procedures, including some recommended by commenters for use as a reference in valuing these epidural injection codes, include the work and PEs of image guidance in the injection code. For example, transforaminal injections, CPT codes 64479 (Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); cervical or thoracic, single level), 64480 (Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); cervical or thoracic, each additional level (List separately in addition to code for primary procedure)), 64483 (Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); lumbar or sacral, single level) and 64484 (Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); lumbar or sacral, each additional level (List separately in addition to code for primary procedure)) include the image guidance in the injection code. Similarly, the paravertebral injections, CPT code 64490 (Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), cervical or thoracic; single level), 64491 (Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), cervical or thoracic; second level (List separately in addition to code for primary procedure)), 64492 (Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), cervical or thoracic; third and any additional level(s) (List separately in addition to code for primary procedure)), 64493 (Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), lumbar or sacral; single level), 64494 (Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), lumbar or sacral; second level (List separately in addition to code for the primary procedure)) and 64495 (Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), lumbar or sacral; third and any additional level(s)(List separately in addition to code for primary procedure)) each include the image guidance bundled in the injection CPT code.

   Based upon our analysis of the Medicare claims data and comments received on the CY 2014 final rule with comment period, it appears that these codes are typically furnished with imaging guidance. Thus, we believe it would be appropriate for the injection and imaging guidance codes to be bundled and the inputs for image guidance to be included in the valuation of the epidural injection codes as it is for transforaminal and paravertebral codes. We do not believe the epidural injection codes can be appropriately valued without considering the typical use of image guidance. We also believe this will help assure relativity with other injection codes that include the image guidance. To determine how to appropriately value resources for the combined codes, we believe more information is needed. Accordingly, we propose to include CPT codes 62310, 62311, 62318 and 62319 on the potentially misvalued code list so that we can obtain information to support their valuation with the image guidance included. In the meantime, we are proposing to revert to the CY 2013 input values for CPT codes 62310, 62311, 62318 and 62319 for CY 2015. Specifically, we will use the CY 2013 work RVUs, work times, and direct PE inputs to establish payment rates for CY 2015. The work, PE, and MP RVUs for these codes are listed in Addendum B and the time values for all CY 2015 codes are listed in the file "CY 2015 PFS Work Time," available on the CMS Web site under downloads for the CY 2015 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The direct PE inputs are displayed the file "CY 2015 PFS Direct PE Inputs," available on the CMS Web site under downloads for the CY 2015 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

   Because it is clear that the proposed PE inputs for the epidural injection codes include items that are specifically related to image guidance, such as the radiographic fluoroscopic room, we believe separate reporting of the image guidance codes would overestimate the resources used in furnishing the two services together. To avoid this situation, we are also proposing to prohibit the billing of image guidance codes in conjunction with these four epidural injection codes. We believe our two-tiered proposal to utilize CY 2013 input values for this code family, while prohibiting the separate billing of imaging guidance codes in conjunction with epidural injection, would best ensure that appropriate reimbursement continues to be made while we gather additional information and consider the best way to value these services.

   With regard to comments about the time for responding to the interim values, we would refer to section II.F of this proposed rule, which discusses a proposal to make changes in the process used for establishing revised values for codes such as these.

   With regard to the request for refinement, we are denying this request as the comments do not demonstrate that the requirements for refinement were met. Moreover, since we are proposing different values for these codes for CY 2015 (using CY 2013 inputs) there would be no purpose for refinement as the public comment period for this proposed rule will provide the opportunity for the public to share any relevant information on our proposed values.

(3) Neurostimulator Implantation--CPT Codes 64553 and 64555

   A stakeholder raised questions regarding whether CPT codes 64553 (Percutaneous implantation of neurostimulator electrode array; cranial nerve) and 64555 (Percutaneous implantation of neurostimulator electrode array; peripheral nerve (excludes sacral nerve)) included the appropriate direct PE inputs when furnished in the nonfacility setting. It appears that these inputs have not been evaluated recently and, therefore, we are nominating these codes as potentially misvalued for the purpose of ascertaining whether or not there are nonfacility direct PE inputs that are not included in the direct PE inputs that are typical supply costs for these services.

(4) Mammography--CPT Codes 77055, 77056, and 77057, and HCPCS Codes G0202, G0204, and G0206

   Medicare currently pays for mammography services through both CPT codes, (77055 (mammography; unilateral), 77056 (mammography; bilateral) and 77057 (screening mammography, bilateral (2-view film study of each breast)) and HCPCS G-codes, (G0202 (screening mammography, producing direct digital image, bilateral, all views), G0204 (diagnostic mammography, producing direct digital image, bilateral, all views), and G0206 (diagnostic mammography, producing direct digital image, unilateral, all views)). The CPT codes were designed to be used for mammography regardless of whether film or digital technology is used. However, for Medicare purposes, the HCPCS G-codes were created to be used for digital technology in response to special payment rules for digital mammography included in the Medicare Benefit Improvements and Protection Act of 2000.

   As discussed in section II.A., the RUC recommended that CMS update the direct PE inputs for all imaging codes to reflect the migration from film-to-digital storage technologies since digital storage is now the typically used in imaging.

   Our data confirms that the overwhelming majority of all mammography is digital. As a result, we are proposing that the CPT codes 77055, 77056 and 77057 be used for reporting mammography to Medicare regardless of whether film or digital technology is used, and to delete the HCPCS G-codes G0202, G0204, and G0206. We are proposing, for CY 2015, to value the CPT codes using the values established for the digital mammography G-codes since digital technology is now the typical service. (See section II.A. of this proposed rule for more discussion of this proposal.) In addition, since the G-codes values that we propose to use for the CPT codes for CY 2015 have not been reviewed since they were created in CY 2002, we are proposing to include CPT codes 77055, 77056, and 77057 on the list of potentially misvalued codes.

(5) Abdominal Aortic Aneurysm Ultrasound Screening--G0389

   When Medicare began paying for abdominal aortic aneurysm (AAA) ultrasound screening in CY 2007, we created HCPCS code G0389 (Ultrasound, B-scan and/or real time with image documentation; for abdominal aortic aneurysm (AAA) screening), and set the RVUs at the same level as CPT code 76775 (Ultrasound, retroperitoneal (e.g., renal, aorta, nodes), B-scan and/or real time with image documentation; limited). We noted in the CY 2007 final rule with comment period that CPT code 76775 was used to report the service when furnished as a diagnostic test and that we believed the service reflected by G0389 used equivalent resources and work intensity to those contained in CPT code 76775 (71 FR 69664 through 69665).

   In the CY 2014 proposed rule, based on a RUC recommendation, we proposed to replace the ultrasound room included as a direct PE input for CPT code 76775 with a portable ultrasound unit. Since all the RVUs (including the PE RVUs) for G0389 were crosswalked from CPT code 76775, the proposed PE RVUs for G0389 in the CY 2014 proposed rule were reduced significantly as a result of this change to the direct PE inputs for 76775. However, we did not discuss the applicability of this change to G0389 in the proposed rule's preamble and did not receive any comments on G0389 in response to the proposed rule. We finalized the change to CPT code 76775 in the CY 2014 final rule with comment period and the corresponding PE RVUs for G0389 were also reduced.

   Subsequent to the publication of the CY 2014 final rule, a stakeholder suggested that the reduction in the RVUs for G0389 did not accurately reflect the resources involved in furnishing the service and asked that CMS consider using an alternative crosswalk. Specifically, the stakeholder stated that the type of equipment typically used in furnishing G0389 is different than that used for CPT code 76775, the time involved in furnishing G0389 is greater than that of CPT code 76775, and the specialty that typically furnishes G0389 is different than the one that typically furnishes CPT code 76775. The stakeholder suggested an alternative crosswalk of CPT code 76705 (Ultrasound, abdominal, real time with image documentation; limited (eg, single organ, quadrant, follow-up)).

   After considering the issue, we are proposing G0389 as a potentially misvalued code and seeking recommendations regarding the appropriate inputs that should be used to develop RVUs for this code. We have not reviewed the inputs used to develop RVUs for this code since it was established in CY 2007 and the RVUs were directly crosswalked from 76705. Based on the issues raised by stakeholders, we believe that we should value this code through our standard methodologies, including the full PE RVU methodology. In order to do so, we are proposing to include this code on our list of proposed potentially misvalued codes and seek input from the public and other stakeholders, including the RUC, regarding the appropriate work RVU, time, and direct PE inputs that reflect the typical resources involved in furnishing the service.

   Until we receive the information needed to revalue this service, we are proposing to maintain the work RVU for this code and revert to the same PE RVUs we used for CY 2013, adjusted for budget neutrality. We are proposing MP RVUs based on the five-year review update process as described in section II.C of this proposed rule. We believe this valuation will ameliorate the effect of the CY 2014 reduction in G0389 that resulted from reflection of the change in RVUs for the crosswalked code while we assess the valuation of this code through our usual methodologies. The proposed PE RVUs are contained in Addendum B available on the CMS Web site under downloads for the CY 2015 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

(6) Prostate Biopsy Codes--HCPCS Codes G0416, G0417, G0418, and G0419

   For CY 2014, we modified the code descriptors of G0416 through G0419 so that these codes could be used for any method of prostate needle biopsy services, rather than only for prostate saturation biopsies. The CY 2014 descriptions are:

    * G0416 (Surgical pathology, gross and microscopic examination for prostate needle biopsies, any method; 10-20 specimens).

    * G0417 (Surgical pathology, gross and microscopic examination for prostate needle biopsies, any method; 21-40 specimens).

    * G0418 (Surgical pathology, gross and microscopic examination for prostate needle biopsies, any method; 41-60 specimens).

    * G0419 (Surgical pathology, gross and microscopic examination for prostate needle biopsies, any method; greater than 60 specimens).

   Subsequently, we have discussed prostate biopsies with stakeholders, and reviewed medical literature and Medicare claims data in considering how best to code and value prostate biopsy pathology services. In considering these discussions and our review, we have become aware that the current coding structure may be confusing, especially since the number of specimens associated with prostate biopsies is relatively homogenous. For example, G0416 (10-20 specimens) represents the overwhelming majority of all Medicare claims submitted for the four G-codes. Therefore, in the interest of both establishing straightforward coding and maintaining accurate payment, we believe it would be appropriate to use only one code to report prostate biopsy pathology services. Therefore, we propose to revise the descriptor for G0416 to define the service regardless of the number of specimens, and to delete codes G0417, G0418, and G0419. We propose to revise G0416 for use to report all prostate biopsy pathology services, regardless of the number of specimens, because we believe this will eliminate the possible confusion caused by the coding while maintaining payment accuracy.

   Based on our review of medical literature and examination of Medicare claims data, we believe that the typical number of specimens evaluated for prostate biopsies is between 10 and 12. Since G0416 is the code that currently is valued and used for between 10 and 12 specimens, we are proposing to use the existing values for G0416 for CY 2015.

   In addition, we are proposing G0416 as a potentially misvalued code for CY 2015. We seek public comment on the appropriate work RVUs, work time, and direct PE inputs.

(7) Obesity Behavioral Group Counseling--GXXX2 and GXXX3

   Under section 1861(ddd) of the Act, we added coverage for a new preventive benefit, Intensive Behavioral Therapy for Obesity, effective November 29, 2011, and created HCPCS code G0447 (Face-to-face behavioral counseling for obesity, 15 minutes) for reporting and payment of individual behavioral counseling for obesity. Coverage requirements specific to this service are delineated in the Medicare National Coverage Determinations Manual, Pub. 100-03, Chapter 1, Section 210, available at http://www.cms.gov/manuals/downloads/ncd103c1_Part4.pdf.

   It has been brought to our attention that behavioral counseling for obesity is sometimes furnished in group sessions, and questions were raised about whether group sessions could be billed using HCPCS code G0447. To improve payment accuracy, we are creating two new HCPCS codes for the reporting and payment of group behavioral counseling for obesity. Specifically, we are creating GXXX2 (Face-to-face behavioral counseling for obesity, group (2-4), 30 minutes) and GXXX3 (Face-to-face behavioral counseling for obesity, group (5-10), 30 minutes). The coverage requirements for these services would remain in place, as described in the National Coverage Determination for Intensive Behavioral Therapy for Obesity cited in this section of the proposed rule. The practitioner furnishing these services would report the relevant group code for each beneficiary participating in a group therapy session.

   We believe that the face-to-face behavioral counseling for obesity services described by GXXX2 and GXXX3 would require similar per minute work and intensity as HCPCS code G0447, which is a 15-minute code with a work RVU of 0.45. Therefore, to develop proposed work RVUs for HCPCS codes GXXX2 and GXXX3 we scaled the work RVU of HCPCS code G0447 to reflect the differences in the codes in terms of the time period covered by the code and the typical number of beneficiaries per session. Adjusting the work RVU for the longer time of the group codes results in a work RVU of 0.90 for a 30-minute session. Since the services described by GXXX2 and GXXX3 will be billed per beneficiary receiving the service, the work RVUs and work time that we are proposing for these codes are based upon the typical number of beneficiaries per session, 4 and 9, respectively. Accordingly, we are proposing a work RVU of 0.23 with a work time of 8 minutes for GXXX2 and a work RVU of 0.10 with a work time of 3 minutes for GXXX3.

   Using the same logic, we are proposing to use the direct PE inputs for GXXX2 and GXXX3 currently included for G0447, prorated to account for the differences in time and number of beneficiaries described by the new codes. The proposed direct PE inputs for these codes are included in the CY 2015 proposed direct PE input database, available on the CMS Web site under the downloads for the CY 2015 PFS proposed rule at http://www.cms.gov/PhysicianFeeSched/. We are also proposing to crosswalk the malpractice risk factor from HCPCS code G0447 to both HCPCS codes GXXX2 and GXXX3, as we believe the same specialty mix will furnish these services. We request public comment on these proposed values for HCPCS codes GXXX2 and GXXX3.

4. Improving the Valuation and Coding of the Global Package

a. Overview

   Since the inception of the PFS, we have valued and paid for certain services, such as surgery, as part of global packages that include the procedure and the services typically provided in the periods immediately before and after the procedure (56 FR 59502). For each of these codes (usually referred to as global surgery codes), we establish a single PFS payment that includes payment for particular services that we assume to be typically furnished during the established global period.

   There are three primary categories of global packages that are labeled based on the number of post-operative days included in the global period: 0-day; 10-day; and 90-day. The 0-day global codes include the surgical procedure and the pre-operative and post-operative physicians' services on the day of the procedure, including visits related to the service. The 10-day global codes include these services and, in addition, visits related to the procedure during the 10 days following the procedure. The 90-day global codes include the same services as the 0-day global codes plus the pre-operative services furnished one day prior to the procedure and post-operative services during the 90 days immediately following the day of the procedure.

   Section 40.1 of the Claims Processing Manual (Pub. 100-04, Chapter 12 Physician/Nonphysician Practitioners) defines the global surgical package to include the following services when furnished during the global period:

    * Preoperative Visits--Preoperative visits after the decision is made to operate beginning with the day before the day of surgery for major procedures and the day of surgery for minor procedures;

    * Intra-operative Services--Intra-operative services that are normally a usual and necessary part of a surgical procedure;

    * Complications Following Surgery--All additional medical or surgical services required of the surgeon during the postoperative period of the surgery because of complications that do not require additional trips to the operating room;

    * Postoperative Visits--Follow-up visits during the postoperative period of the surgery that are related to recovery from the surgery;

    * Postsurgical Pain Management--By the surgeon;

    * Supplies--Except for those identified as exclusions; and

    * Miscellaneous Services--Items such as dressing changes; local incisional care; removal of operative pack; removal of cutaneous sutures and staples, lines, wires, tubes, drains, casts, and splints; insertion, irrigation and removal of urinary catheters, routine peripheral intravenous lines, nasogastric and rectal tubes; and changes and removal of tracheostomy tubes.

b. Concerns With the 10- and 90-Day Global Packages

   CMS supports bundled payments as a mechanism to incentivize high-quality, efficient care. Although on the surface, the PFS global codes appear to function as bundled payments similar to those Medicare uses to make single payments for multiple services to hospitals under the inpatient and outpatient prospective payment systems, the practical reality is that these global codes function significantly differently than other bundled payments. First, the global surgical codes were established several decades ago when surgical follow-up care was far more homogenous than today. Today, there is more diversity in the kind of procedures covered by global periods, the settings in which the procedures and the follow-up care are furnished, the health care delivery system and business arrangements used by Medicare practitioners, and the care needs of Medicare beneficiaries. Despite these changes, the basic structures of the global surgery packages are the same as the packages that existed prior to the creation of the resource-based relative value system in 1992. Another significant difference between this and other typical models of bundled payments is that the payment rates for the global surgery packages are not updated regularly based on any reporting of the actual costs of patient care. For example, the hospital inpatient and outpatient prospective payment systems (the IPPS and OPPS, respectively) derive payment rates from hospital cost and charge data reported through annual Medicare hospital cost reports and the most recent year of claims data available for an inpatient stay or primary outpatient service. Because payment rates are based on consistently updated data, over time, payment rates adjust to reflect the average resource costs of current practice. Similarly, many of the new demonstration and innovation models track costs and make adjustments to payments. Another significant difference is that payment for the PFS global packages relies on valuing the combined services together. This means that there are no separate PFS values established for the procedures or the follow-up care, making it difficult to estimate the costs of the individual global code component services.

   These unique characteristics have contributed to the significant and numerous concerns that have been raised regarding the accuracy of payment for global codes--especially those that include 10- and 90-day post-operative periods. In the following paragraphs, we address a series of concerns regarding these codes, including: the fundamental difficulties in establishing appropriate relative values for these packages, the potential inaccuracies in the current information used to price these services, the limitations on appropriate pricing in the future, the potential for these packages to create unwarranted payment differentials among specialties, the possibility that the current codes are incompatible with current medical practice, and the potential for these codes to present obstacles to the adoption of new payment models.

   Independently, concerns such as these could be seen as issues that arise when developing many different payment mechanisms, for example: making fee-for-service payment rates, making single payments for multiple services, or paying practitioners for episodes of care over a period of time. However, in the case of the post-operative portion of the 10- and 90-day global codes, we believe these multi-layered concerns create substantial barriers to accurate valuation of these services relative to other PFS services.

(1) Fundamental Limitations in the Appropriate Valuation of the Global Packages With Post-Operative Days

   In general, we face many challenges in valuing PFS services as accurately as possible. However, the unique nature of global surgery packages with 10- and 90-day post-operative periods presents additional challenges distinct from those presented in valuing other PFS services. Our valuation methodology for PFS services generally relies on assumptions regarding the resources involved in furnishing the "typical case" for each individual service unlike other payment systems that rely on actual data on the costs of furnishing services. Consistent with this valuation methodology, the RVUs for a global code should reflect the typical number and level of E/M services furnished in connection with the procedure. However, it is much easier to maintain relativity among the services that are valued on this basis when each of the services is described by codes of similar unit sizes. In other words, because codes with long post-operative periods include such a large number of services, any variations between the "typical" resource costs used to value the service and the actual resource costs associated with particular services are multiplied. The effects of this problem can be two-fold, skewing the accuracy of both the RVUs for individual global codes and the Medicare payment made to individual practitioners. The RVUs of the individual global service codes are skewed whenever there is any inaccuracy in the assumption of the typical number or kind of services in the post-operative periods. This inaccuracy has a greater impact than inaccuracies in assumptions for other PFS services because it affects a greater number of service units over a period of time than for individually priced services. Furthermore, in contrast to prospective payment systems, such inaccuracies under the PFS are not corrected over time through an annual ratesetting process that makes year-to-year adjustments based on data on actual costs. For example, if a 90-day global code is valued based on an assumption that ten post-operative visits is typical, but practitioners reporting the code typically only furnish six visits, then the resource assumptions are overestimated by the value of the four visits multiplied by the number of the times the procedure code is reported. In contrast, when our assumptions are incorrect about the typical resources involved in furnishing a PFS code that describes a single service, any inaccuracy in the RVUs is limited to the difference between the resource costs assumed for the typical service and the actual resource costs in furnishing one individual service. Such a variation between the assumptions used in calculating payment rates and the actual resource costs could be corrected if the payments for packaged services were updated regularly using data on actual services furnished. Although such a mechanism is common in other bundled payment systems, there is no such mechanism under the PFS. To make adjustments to the RVUs to account for inaccurate assumptions under the current PFS methodology, the global surgery code would need to be identified as potentially misvalued, survey data would have to reflect an accurate account of the number and level of typical post-operative visits, and we (with or without a corresponding recommendation from the RUC or others) would have to implement a change in RVUs based on the change in the number and level of visits to reflect the typical service.

   These amplified inaccuracies may also occur whenever Medicare pays an individual practitioner reporting a 10- or 90-day global code. Practitioners may furnish a wide range of post-operative services to individual Medicare beneficiaries, depending on individual patient needs, changes in medical practice, and dynamic business models. Due to the way the 10- and 90-day global codes are constructed, the number and level of services included for purposes of calculating the payment for these services may vary greatly from the number and level of services that are actually furnished in any particular case. In contrast, the variation between the "typical" and the actual resource cost for the practitioner reporting an individually valued PFS services is constrained because the practitioner is only reporting and being paid for a specific service furnished on a particular date.

   For most PFS services, any difference between the "typical" case on which RVUs are based and the actual case for a particular service is limited to the variation between the resources assumed to be involved in furnishing the typical case and the actual resources involved in furnishing the single specific service. When the global surgical package includes more or a higher level of E/M services than are actually furnished in the typical post-operative period, the Medicare payment is based on an overestimate of the quantity or kind of services furnished, not merely an overestimation of the resources involved in furnishing an individual service. The converse is true if the RVUs for the global surgical package are based on fewer or a lower level of services than are typically furnished for a particular code.

(2) Questions Regarding Accuracy of Current Assumptions

   In previous rulemaking (77 FR 68911 through 68913), we acknowledged evidence suggesting that the values included in the post-operative period for global codes may not reflect the typical number and level of post-operative E/M visits actually furnished.

   In 2005, the OIG examined whether global surgical packages are appropriately valued. In its report on eye and ocular surgeries, "National Review of Evaluation and Management Services Included in Eye and Ocular Adnexa Global Surgery Fees for Calendar Year 2005" (A-05-07-00077), the OIG reviewed a sample of 300 eye and ocular surgeries, and counted the actual number of face-to-face services recorded in the patients' medical records to establish whether and, if so, how many post-operative E/M services were furnished by the surgeons. For about two-thirds of the claims sampled by the OIG, surgeons provided fewer E/M services in the post-operative period than were included in the global surgical package payment for each procedure. A small percentage of the surgeons furnished more E/M services than were included in the global surgical package payment. The OIG identified the number of face-to-face services recorded in the medical record, but did not review the medical necessity of the surgeries or the related E/M services. The OIG concluded that the RVUs for these global surgical packages are too high because they include a higher number of E/M services than typically are furnished within the global period for the reviewed procedures.

   Following that report, the OIG continued to investigate E/M services furnished during global surgical periods. In May 2012, the OIG published a report entitled "Musculoskeletal Global Surgery Fees Often Did Not Reflect the Number of Evaluation and Management Services Provided" (A-05-09-00053). For this investigation, the OIG sampled 300 musculoskeletal global surgeries and again found that, for the majority of sampled surgeries, physicians furnished fewer E/M services than were included as part of the global period payment for that service. Once again, a small percentage of surgeons furnished more E/M services than were included in the global surgical package payment. The OIG concluded that the RVUs for these global surgical packages are too high because they include a higher number of E/M services than typically are furnished within the global period for the reviewed procedures.

   In both reports, the OIG recommended that we adjust the number of E/M services identified with the studied global surgical payments to reflect the number of E/M services that are actually being furnished. However, since it is not necessary under our current global surgery payment policy for a surgeon to report the individual E/M services actually furnished during the global surgical period, we do not have objective data upon which to assess whether the RVUs for global period surgical services reflect the typical number or level of E/M services that are furnished. In the CY 2013 PFS proposed rule (77 FR 44738), we previously sought public comments on collecting these data. As summarized in the CY 2013 PFS final rule (77 FR 68913) we did not discover a consensus among stakeholders regarding either the most appropriate means to gather the data, or the need for, or the appropriateness of using such data in valuing these services. In response to our comment solicitation, some commenters urged us to accept the RUC survey data as accurate in spite of the OIG reports and other concerns that have been expressed regarding whether the visits included in the global periods reflected the typical case. Others suggested that we should conduct new surveys using the RUC approach or that we should mine hospital data to identify the typical number of visits furnished. Some comments suggested eliminating the 10- and 90-day global codes.

(3) Limitations on Appropriate Future Valuations of 10- and 90-day Global Codes

   Historically, our attempts to adjust RVUs for global services based on changes in the typical resource costs (especially with regard to site of service assumptions or changes to the number of post-surgery visits) have been difficult and controversial. At least in part, this is because the relationship between the work RVUs for the 10- and 90-day global codes (which includes the work RVU associated with the procedure itself) and the number of included post-operative visits in the existing values is not always clear. Some services with global periods have been valued by adding the work RVU of the surgical procedure and all pre- and post-operative E/M services included in the global period. However, in other cases, as many stakeholders have noted, the total work RVUs for surgical procedures and post-operative visits in global periods are estimated as a single value without any explicit correlation to the time and intensity values for the individual service components. Although we would welcome more objective information to improve our determination of the "typical" case, we believe that even if we engaged in the collection of better data on the number and level of E/M services typically furnished during the global periods for global surgery services, the valuation of individual codes with post-operative periods would not be straightforward. Furthermore, we believe it would be important to frequently update the data on the number and level of visits furnished during the post-operative periods in order to account for any changes in the patient population, medical practice, or business arrangements. Although such information would be available for developing payment rates for bundled services through other Medicare payment systems, practitioners paid through the PFS do not report such data.

(4) Unwarranted Payment Disparities

   Subsequent to our last comment solicitation regarding the valuation of the post-operative periods (77 FR 68911 through 68913), some stakeholders have raised concerns that global surgery packages contribute to unwarranted payment disparities between practitioners who do and do not furnish these services. These stakeholders have addressed several ways the 10- and 90-day global packages may contribute to unwarranted payment disparities.

   The stakeholders noted that, through the global surgery packages, Medicare pays practitioners who furnish E/M services during post-surgery periods regardless of whether the services are actually furnished, while practitioners who do not furnish global procedures with post-operative visits are only paid for E/M services that are actually furnished. In some cases, it is possible that the practitioner furnishing the global surgery procedure may not furnish any post-operative visits. Although we have policies to address the situation when post-operative care is transferred from one practitioner to another, the beneficiary might simply choose to seek care from another practitioner without a formal transfer of care. The other practitioner would then bill Medicare separately for E/M services for which payment was included in the global payment to the original practitioner. Those services would not have been separately billable if furnished by the original practitioner.

   These circumstances can lead to unwarranted payment differences, allowing some practitioners to receive payment for fewer services than reflected in the Medicare payment. Practitioners who do not furnish global surgery services bill and are paid only for each individual service furnished. When global surgery values are based on inaccurate assumptions about the typical services furnished in the post-operative periods, these payment disparities can contribute to differences in aggregate RVUs across specialties. Since the RVUs are intended to reflect differences in the relative resource costs involved in furnishing a service, any disparity between assumed and actual costs results not only in paying some practitioners for some services that are not furnished, it also skews relativity between specialties.

   Stakeholders have also pointed out that payment disparities can arise because E/M services reflected in global periods generally include higher PE values than the same services when billed separately. The difference in PE values between separately billed visits and those included in global packages result primarily from two factors that are both inherent in the PFS pricing methodology.

   First, there is a different mix of PE inputs (clinical labor/supplies/equipment) included in the direct PE inputs for a global period E/M service and a separately billed E/M service. For example, the clinical labor inputs for separately reportable E/M codes includes a staff blend listed as "RN/LPN/MTA" (L037D) and priced at $0.37 per minute. Instead of this input, some codes with post-operative visits include the staff type "RN" (L051A) priced at a higher rate of $0.51 per minute. For these codes, the higher resource cost may accurately reflect the typical resource costs associated with those particular visits. However, the different direct PE inputs may drive unwarranted payment disparities among specialties who report global surgery codes with post-operative periods and those that do not. The only way to correct these potential discrepancies under the current system, which result from the specialty-based differences in resource costs, would be to include standard direct PE inputs for these services regardless of whether or not the standard inputs are typical for the specialties furnishing the services.

   Second, the indirect PE allocated to the E/M visits included in global surgery codes is higher than that allocated to separately furnished E/M visits. This occurs because the range of specialties furnishing a particular global service is generally not as broad as range of specialties that report separate individual E/M services. Since the specialty mix for a service is a key factor in determining the allocation of indirect PE to each code, a higher amount of indirect PE can be allocated to the E/M services that are valued as part of the global surgery codes than to the individual E/M codes. Practitioners who use E/M codes to report visits separately are paid based on PE RVUs that reflect the amount of indirect PE allocated across a wide range of specialties, which has the tendency to lower the amount of indirect PE. For practitioners who are paid for visits primarily through post-operative periods, indirect PE is generally allocated with greater specificity. Two significant steps would be required to alleviate the impact of this disparity. First, we would have to identify the exact mathematical relationship between the work RVU and the number and level of post-operative visits for each global code; and second, we would have to propose a significant alteration of the PE methodology in order to allocate indirect PE that does not correlate to the specialties reporting the code in the Medicare claims data.

   Furthermore, stakeholders have pointed out that the PE RVUs for codes with 10- or 90-day post-operative periods reflect the assumption that all outpatient visits occur in the higher-paid non-facility office setting, when many of these visits are likely to be furnished in provider-based departments, which would be paid at the lower, PFS facility rate if they were billable separately. As we note elsewhere in this proposed rule, we do not have data on the volume of physicians' services furnished in provider-based departments, but public information suggests that it is not insignificant and that it is growing. When these services are paid as part of a global package, there is no adjustment made based on the site of service. Therefore, even though the PFS payment for services furnished in post-operative global periods might include clinical labor, disposable supply, and medical equipment costs (and additional indirect PE allocation) that are incurred by the facility and not the practitioner reporting the service, the RVUs for global codes reflect all of these costs associated with the visits.

(5) Incompatibility of Current Packages With Current Practice and Unreliability of RVUs for Use in New Payment Models

   In addition to these issues, the 10- and 90-day global periods reflect a long-established but no longer exclusive model of post-operative care that assumes the same practitioner who furnishes the procedure typically furnishes the follow-up visits related to that procedure. In many cases, we believe that models of post-operative care are increasingly heterogeneous, particularly given the overall shift of patient care to larger practices or team-based environments.

   We believe that RVUs used to establish PFS payments are likely to serve as critical building blocks to developing, testing, and implementing a number of new payment models, including those that focus on bundled payments to practitioners or payments for episodes of care. Therefore, we believe it is critical for us to ensure that the PFS RVUs accurately reflect the resource costs for individual PFS services instead of reflecting potentially skewed assumptions regarding the number of services furnished over a long period of time in the "typical" case. To the extent that the 10- and 90-day global periods reflect inaccurate assumptions regarding resource costs associated with individual PFS services, we believe they are likely to be obstacles to a wide range of potential improvements to PFS payments, including the potential incorporation of payment bundling designed to foster efficiency and quality care for Medicare beneficiaries.

c. Proposed Transition of 10- and 90-Day Global Packages Into 0-Day Global Packages

   Although we have marginally addressed some of the concerns noted above with global packages in previous rulemaking, we do not believe that we have made significant progress in addressing the fundamental issues with the 10- and 90-day post-operative global packages. In the context of the misvalued code initiative, we believe it is critical for the RVUs used to develop PFS payment rates reflect the most accurate resource costs associated with PFS services. Based on the issues discussed above, we do not believe we can effectively address the issues inherent in establishing values for the 10- and 90-day global packages under our existing methodologies and with available data. As such, we do not believe that maintaining the post-operative 10-and 90-day global periods is compatible with our continued interest in using more objective data in the valuation of PFS services and accurately valuing services relative to each other. Because the typical number and level of post-operative visits during global periods may vary greatly across Medicare practitioners and beneficiaries, we believe that continued valuation and payment of these face-to-face services as a multi-day package may skew relativity and create unwarranted payment disparities within PFS payment. We also believe that the resource based valuation of individual physicians' services will continue to serve as a critical foundation for Medicare payment to physicians, whether through the current PFS or in any number of new payment models. Therefore, we believe it is critical that the RVUs under the PFS be based as closely and accurately as possible on the actual resources involved in furnishing the typical occurrence of specific services

   To address the issues discussed above, we are proposing to retain global bundles for surgical services, but to refine bundles by transitioning over several years all 10- and 90-day global codes to 0-day global codes. Medically reasonable and necessary visits would be billed separately during the pre- and post-operative periods outside of the day of the surgical procedure. We propose to make this transition for current 10-day global codes in CY 2017 and for the current 90-day global codes in CY 2018, pending the availability of data on which to base updated values for the global codes.

   We believe that transitioning all 10- and 90-day global codes to 0-day global codes would:

    * Increase the accuracy of PFS payment by setting payment rates for individual services based more closely upon the typical resources used in furnishing the procedures;

    * Avoid potentially duplicative or unwarranted payments when a beneficiary receives post-operative care from a different practitioner during the global period;

    * Eliminate disparities between the payment for E/M services in global periods and those furnished individually;

    * Maintain the same-day packaging of pre- and post-operative physicians' services in the 0-day global; and

    * Facilitate availability of more accurate data for new payment models and quality research.

   As we transition these codes, we would need to establish RVUs that reflect the change in the global period for all the codes currently valued as 10- and 90-day global surgery services. We seek assistance from stakeholders on various aspects of this task. Prior to implementing these changes, we intend to gather objective data on the number of E/M and other services furnished during the current post-operative periods and use those data to inform both the valuation of particular services and the overall budget neutrality adjustments required to implement this proposal. We seek comment on the most efficient means of acquiring accurate data regarding the number of visits and other services actually being furnished by the practitioner during the current post-operative periods. For all the reasons stated above, we do not believe that survey data reflecting assumptions of the "typical case" meets the standards required to measure the resource costs of the wide range of services furnished during the post-operative periods. We acknowledge that collecting information on these services through claims submission may be the best approach, and we would propose such a collection through future rulemaking. However, we are also interested in alternatives. For example, we seek information on the extent to which individual practitioners or practices may currently maintain their own data on services furnished during the post-operative period, and how we might collect and objectively evaluate that data.

   We also seek comment on the best means to ensure that allowing separate payment of E/M visits during post-operative periods does not incentivize otherwise unnecessary office visits during post-operative periods. If we adopt this proposal, we intend to monitor any changes in the utilization of E/M visits following its implementation but we are also seeking comment on potential payment policies that will mitigate such a change in behavior.

   In developing this proposal, we considered several alternatives to the transformation of all global codes to 0-day global codes. First, we again considered the possibility of gathering data and using the data to revalue the 10- and 90- day global codes. While this option would have maintained the status quo in terms of reporting services, it would have required much of the same effort as this proposal without alleviating many of the problems associated with the 10- and 90-day global periods. For example, collecting accurate data would allow for more accurate estimates of the number and kind of visits included in the post-operative periods at the time of the survey. However, this alternative approach would only mitigate part of the potential for unwarranted payment disparities. For example, the values for the visits in the global codes would continue to include different amounts of PE RVUs than separately reportable visits and would continue to provide incentives to some practitioners to minimize patient visits. Additionally, it would not address the changes in practice patterns that we believe have been occurring whereby the physician furnishing the procedure is not necessarily the same physician conducting the post-procedure follow up.

   This alternative option would also rest extensively on the effectiveness of using the new data to revalue the codes accurately. Given the unclear relationship between the assigned work RVUs and the post-operative visits across all of these services, incorporating objective data on the number of visits to adjust work RVUs would still necessitate extensive review of individual codes or families of codes by CMS and stakeholders, including the RUC. We believe the investment of resources for such an effort would be better made to solve a broader range of problems.

   We also considered other possibilities, such as altering our PE methodology to ensure that the PE inputs and indirect PE for visits in the global period were valued the same as separately reportable E/M codes or requiring reporting of the visits for all 10- and 90-day global services while maintaining the 10- and 90-day global period payment rates. However, we believe this option would require all of the same effort by practitioners, CMS, and other stakeholders without alleviating most of the problems addressed in the preceding paragraphs.

   We also considered maintaining the status quo and identifying each of the 10- and 90-day global codes as potentially misvalued through our potentially misvalued code process for review as 10 and 90 day globals. Inappropriate valuations of these services has a major effect on the fee schedule due to the percentage of PFS dollars paid through 10- and 90-day global codes (3 percent and 11 percent, respectively), and thus, valuing them appropriately is critical to appropriate valuation and relativity throughout the PFS. Through the individual review approach, we could review the appropriateness of the global period and the accurate number of visits for each service. Yet revaluing all 3,000 global surgery codes through the potentially misvalued codes approach would not address many of the problems identified above. Unless such an effort was combined with changes in the PE methodology, it would only partially address the valuation and accuracy issues and would leave all the other issues unresolved. Moreover, the valuation and accuracy issues that could be addressed through this approach would rapidly be out of date as medical practice continues to change. Therefore, such an approach would be only partially effective and would impede our ability to address other potentially misvalued codes.

   We seek stakeholder input on an accurate and efficient means to revalue or adjust the work RVUs for the current 10- and 90-day global codes to reflect the typical resources involved in furnishing the services including both the pre- and post-operative care on the day of the procedure. We believe that collecting data on the number and level of post-operative visits furnished by the practitioner reporting current 10-and 90-day global codes will be essential to ensuring work RVU relativity across these services. We also believe that these data will be necessary to determine the relationship between current work RVUs and current number of post-operative visits, within categories of codes and code families. However, we believe that once we collect those data, there are a wide range of possible approaches to the revaluation of the large number of individual global services, some of which may deviate from current processes like those undertaken by the RUC. To date, the potentially misvalued code initiative has focused on several hundred, generally high-volume codes per year. This proposal requires revaluing a larger number of codes over a shorter period of time and includes many services with relatively low volume in the Medicare population. Given these circumstances, it does not seem practical to survey time and intensity information on each of these procedures. Absent any new survey data regarding the procedures themselves, we believe that data regarding the number and level of post-service office visits can be used in conjunction with other methods of valuation, such as:

    * Using the current potentially misvalued code process to identify and value the relatively small number of codes that represent the majority of the volume of services that are currently reported with codes with post-operative periods, and then adjusting the aggregate RVUs to account for the number of visits and using magnitude estimation to value the remaining services in the family;

    * Valuing one code within a family through the current valuation process and then using magnitude estimation to value the remaining services in the family;

    * Surveying a sample of codes across all procedures to create an index that could be used to value the remaining codes.

   While we believe these are plausible options for the revaluation of these services, we believe there may be others. Therefore, we seek input on the best approach to achieve this proposed transition from 10- and 90-day, to 0-day global periods, including the timing of the changes, the means for revaluation, and the most effective and least burdensome means to collect objective, representative data regarding the actual number of visits currently furnished in the post-operative global periods. We also seek comment on whether the effective date for the transition to 0-day global periods should be staggered across families of codes or other categories. For example, while we are proposing to transition 10-day global periods in 2017 and 90-day global periods in 2018, we seek comment on whether we should consider implementing the transition more or less quickly and over one or several years. We also seek comment regarding the appropriate valuation of new, revised, or potentially misvalued 10- or 90-day global codes before implementation of this proposal.

5. Improving the Valuation of the Global Package

   In the CY 2013 proposed rule, we sought comments on methods of obtaining accurate and current data on E/M services furnished as part of a global surgical package. In addition to receiving the broader comments on measuring post-operative work, we also received a comment from the RUC saying that the hospital inpatient and discharge day management services included in the global period for many surgical procedures were inadvertently removed from the time file in 2007. With its comment letter, the RUC sent us a data file with updated times for these post-operative visits for some services that displayed zero hospital inpatient or discharge day visits in the CMS time file. After extensive review, we concluded that the data were deleted from the time file due to an inadvertent error as noted by the RUC. Therefore, during CY 2014 PFS rulemaking we finalized a proposal to replace the missing postoperative hospital inpatient and discharge day visits for the more than 100 codes that were identified by the RUC.

   Since then, the AMA has identified additional codes with data in the work time file that reflects a similar error. Since we believe these global surgery codes are missing postoperative hospital inpatient and discharge day visits due to an inadvertent error, we are proposing to include a corrected number of visits for the codes displayed in Table 11. This proposal would also alter the total time associated with the codes in the work time file.

TABLE 11--Proposed Work Time Changes in Selected Global Surgical Package Visits CPT Short descriptor Visits included in Global Package code 99231 99232 99233 99238 19367 Breast 3.00 1.00 reconstruction 20802 Replantation arm 6.00 1.00 complete 20805 Replant forearm 6.00 1.00 complete 20808 Replantation hand 5.00 1.00 complete 20972 Bone/skin graft 5.00 1.00 metatarsal 21137 Reduction of 1.00 forehead 21138 Reduction of 1.00 forehead 21150 Lefort ii 1.00 1.00 anterior intrusion 21159 Lefort iii 3.00 1.00 w/fhdw/o lefort i 21160 Lefort iii w/fhd 2.50 1.00 w/lefort i 21172 Reconstruct 1.50 1.00 orbit/forehead 21175 Reconstruct 1.00 1.00 orbit/forehead 21179 Reconstruct 1.00 entire forehead 21180 Reconstruct 1.00 entire forehead 21181 Contour cranial 1.00 1.00 bone lesion 21182 Reconstruct 1.00 1.00 cranial bone 21183 Reconstruct 2.00 1.00 cranial bone 21184 Reconstruct 2.00 1.00 cranial bone 22102 Remove part 3.00 1.00 lumbar vertebra 22310 Closed tx vert fx 3.50 1.00 w/o manj 28122 Partial removal 1.00 of foot bone 33470 Revision of 1.50 1.00 pulmonary valve 33471 Valvotomy 4.00 1.00 pulmonary valve 33476 Revision of heart 1.00 chamber 33478 Revision of heart 1.00 chamber 33610 Repair by 7.00 1.00 enlargement 33720 Repair of heart 1.00 defect 33737 Revision of heart 2.00 1.00 chamber 33755 Major vessel 1.50 1.00 shunt 33762 Major vessel 1.50 1.00 shunt 33766 Major vessel 1.50 1.00 shunt 33775 Repair great 0.50 1.00 vessels defect 33776 Repair great 1.50 1.00 vessels defect 33777 Repair great 3.50 1.00 vessels defect 33813 Repair septal 1.00 1.00 defect 33814 Repair septal 1.00 defect 33822 Revise major 1.00 vessel 50360 Transplantation 1.00 2.00 2.00 1.00 of kidney 61556 Incise 3.00 3.00 1.00 1.00 skull/sutures 61558 Excision of 5.00 1.00 skull/sutures 61559 Excision of 4.00 1.00 skull/sutures 61563 Excision of skull 1.00 2.00 1.00 1.00 tumor 61564 Excision of skull 4.00 1.00 tumor 61580 Craniofacial 3.00 4.00 1.00 approach skull 61581 Craniofacial 1.00 1.00 5.00 1.00 approach skull 61582 Craniofacial 4.00 3.00 1.00 1.00 approach skull 61583 Craniofacial 8.00 1.00 1.00 approach skull 61584 Orbitocranial 2.00 3.00 2.00 1.00 approach/skull 61585 Orbitocranial 1.00 3.00 3.00 1.00 approach/skull 61590 Infratemporal 1.00 7.00 1.00 approach/skull 61591 Infratemporal 3.00 4.00 1.00 approach/skull 61592 Orbitocranial 1.00 3.00 2.00 1.00 approach/skull 61595 Transtemporal 3.00 4.00 1.00 approach/skull 61596 Transcochlear 1.00 4.00 3.00 1.00 approach/skull 61597 Transcondylar 5.00 2.00 1.00 1.00 approach/skull 61598 Transpetrosal 2.00 3.00 1.00 1.00 approach/skull 61600 Resect/excise 6.00 1.00 cranial lesion 61601 Resect/excise 2.00 2.00 2.00 1.00 cranial lesion 61605 Resect/excise 3.00 2.00 1.00 1.00 cranial lesion 61606 Resect/excise 3.00 3.00 1.00 1.00 cranial lesion 61607 Resect/excise 1.00 6.00 1.00 cranial lesion 61608 Resect/excise 3.00 3.00 2.00 1.00 cranial lesion 61613 Remove aneurysm 1.00 6.00 1.00 sinus 61615 Resect/excise 2.00 4.00 2.00 1.00 lesion skull 61616 Resect/excise 5.00 2.00 1.00 1.00 lesion skull 61618 Repair dura 1.00 2.00 1.00 61619 Repair dura 1.00 2.00 1.00 1.00 62115 Reduction of 4.50 1.00 skull defect 62116 Reduction of 1.00 2.00 1.00 1.00 skull defect 62117 Reduction of 2.00 2.00 1.00 skull defect 62120 Repair skull 3.00 1.00 cavity lesion

TABLE 11--Proposed Work Time Changes in Selected Global Surgical Package Visits CPT Short descriptor Visits included in CY 2014 CY 2015 code Global Package time time 99291 99292 19367 Breast 552.00 590.00 reconstruction 20802 Replantation arm 1047.00 1041.00 complete 20805 Replant forearm 1017.00 1012.00 complete 20808 Replantation hand 1177.00 1112.00 complete 20972 Bone/skin graft 918.00 898.00 metatarsal 21137 Reduction of 272.00 310.00 forehead 21138 Reduction of 362.00 400.00 forehead 21150 Lefort ii 1.00 542.00 623.00 anterior intrusion 21159 Lefort iii 2.00 784.00 986.00 w/fhdw/o lefort i 21160 Lefort iii w/fhd 2.50 844.00 1121.00 w/lefort i 21172 Reconstruct 1.50 474.00 641.00 orbit/forehead 21175 Reconstruct 2.00 767.00 731.00 orbit/forehead 21179 Reconstruct 2.00 412.00 590.00 entire forehead 21180 Reconstruct 2.00 492.00 670.00 entire forehead 21181 Contour cranial 338.00 396.00 bone lesion 21182 Reconstruct 2.00 856.00 801.00 cranial bone 21183 Reconstruct 2.00 669.00 891.00 cranial bone 21184 Reconstruct 2.00 774.00 996.00 cranial bone 22102 Remove part 392.00 387.00 lumbar vertebra 22310 Closed tx vert fx 167.00 236.00 w/o manj 28122 Partial removal 230.00 249.00 of foot bone 33470 Revision of 3.50 890.00 769.00 pulmonary valve 33471 Valvotomy 1.00 603.00 572.00 pulmonary valve 33476 Revision of heart 5.00 725.00 859.00 chamber 33478 Revision of heart 5.00 740.00 882.00 chamber 33610 Repair by 770.00 648.00 enlargement 33720 Repair of heart 4.00 633.00 770.00 defect 33737 Revision of heart 3.00 603.00 706.00 chamber 33755 Major vessel 3.50 680.00 750.00 shunt 33762 Major vessel 3.50 740.00 755.00 shunt 33766 Major vessel 3.50 740.00 756.00 shunt 33775 Repair great 6.50 860.00 1043.00 vessels defect 33776 Repair great 6.50 950.00 1096.00 vessels defect 33777 Repair great 4.50 950.00 993.00 vessels defect 33813 Repair septal 3.00 603.00 664.00 defect 33814 Repair septal 5.00 710.00 838.00 defect 33822 Revise major 2.00 430.00 463.00 vessel 50360 Transplantation 664.00 774.00 of kidney 61556 Incise 749.00 692.00 skull/sutures 61558 Excision of 669.00 661.00 skull/sutures 61559 Excision of 662.00 665.00 skull/sutures 61563 Excision of skull 762.00 656.00 tumor 61564 Excision of skull 629.00 623.00 tumor 61580 Craniofacial 1.00 1313.30 1078.30 approach skull 61581 Craniofacial 1.00 1419.40 1214.40 approach skull 61582 Craniofacial 1.00 1185.30 1010.30 approach skull 61583 Craniofacial 1.00 1100.40 906.40 approach skull 61584 Orbitocranial 1.00 1066.40 842.40 approach/skull 61585 Orbitocranial 2.00 1377.70 1101.70 approach/skull 61590 Infratemporal 2.00 1732.40 1418.40 approach/skull 61591 Infratemporal 2.00 1478.85 1254.85 approach/skull 61592 Orbitocranial 2.00 1256.80 1002.80 approach/skull 61595 Transtemporal 1.00 1312.80 1077.80 approach/skull 61596 Transcochlear 1.00 1442.30 1188.30 approach/skull 61597 Transcondylar 2.00 1284.40 1041.40 approach/skull 61598 Transpetrosal 2.00 1253.10 1048.10 approach/skull 61600 Resect/excise 1.00 1328.40 1101.40 cranial lesion 61601 Resect/excise 2.00 1078.90 854.90 cranial lesion 61605 Resect/excise 2.00 1238.60 1052.60 cranial lesion 61606 Resect/excise 2.00 1161.90 926.90 cranial lesion 61607 Resect/excise 2.00 1526.20 1201.20 cranial lesion 61608 Resect/excise 2.00 1326.00 1042.00 cranial lesion 61613 Remove aneurysm 2.00 1416.00 1102.00 sinus 61615 Resect/excise 1.00 1327.20 1092.20 lesion skull 61616 Resect/excise 2.00 1329.80 1116.80 lesion skull 61618 Repair dura 647.10 573.10 61619 Repair dura 683.60 587.60 62115 Reduction of 672.00 678.00 skull defect 62116 Reduction of 737.00 616.00 skull defect 62117 Reduction of 854.00 714.00 skull defect 62120 Repair skull 512.00 523.00 cavity lesion



6. Valuing Services That Include Moderate Sedation as an Inherent Part of Furnishing the Procedure

   The CPT manual includes more than 300 diagnostic and therapeutic procedures, listed in Appendix G, for which CPT has determined that moderate sedation is an inherent part of furnishing the procedure and, therefore, only the single procedure code is appropriately reported when furnishing the service and the moderate sedation. The work of moderate sedation has been included in the work RVUs for these diagnostic and therapeutic procedures based upon their inclusion in Appendix G. Similarly, the direct PE inputs for these services include those inputs associated with furnishing a typical moderate sedation service. To the extent that moderate sedation is typically furnished as part of the diagnostic or therapeutic service, the inclusion of moderate sedation in the valuation of the procedure is appropriate.

   It appears that practice patterns for endoscopic procedures are changing, and anesthesia is increasingly being separately reported for these procedures. For example, one study shows that while the use of a separate anesthesia professional for colonoscopies and upper endoscopies was just 13.5 percent in 2003, the rate more than doubled to 30.2 percent in 2009. An analysis of Medicare claims data shows that a similar pattern is occurring in the Medicare program. We find that, for certain types of procedures such as digestive surgical procedures, a separate anesthesia service is furnished 53 percent of the time. For some of these digestive surgical procedures, the claims analysis shows that this rate is as high as 80 percent.

   Our data clearly indicate that moderate sedation is no longer typical for all of the procedures listed in CPT's Appendix G, and, in fact, the data suggest that the percent of cases in which it is used is declining. For many of these procedures in Appendix G, moderate sedation continues to be furnished. The trend away from the use of moderate sedation toward a separately billed anesthesia service is not universal. It differs by the class of procedures, sometimes at the procedure code level, and is one that continues to evolve over time. Due to the changing nature of medical practice in this area, we are considering establishing a uniform approach to valuation for all Appendix G services for which moderate sedation is no longer inherent, rather than addressing this issue at the procedure level as individual procedures are revalued.

   We are seeking public comment on approaches to address the appropriate valuation of these services. Specifically, we are interested in approaches to valuing Appendix G codes that would allow Medicare to pay accurately for moderate sedation when it is furnished while avoiding potential duplicative payments when separate anesthesia is furnished and billed. To the extent that Appendix G procedure values are adjusted to no longer include moderate sedation, we request suggestions as to how moderate sedation should be reported and valued, and how to remove from existing valuations the RVUs and inputs related to moderate sedation.

   We note that in the CY 2014 PFS final rule with comment period, we established values for many upper gastrointestinal procedures, 58 of which were included in Appendix G. For those interim final values, we included the inputs related to moderate sedation. In the CY 2015 PFS final rule with comment period, we will address these interim final values, and we anticipate establishing CY 2015 inputs for the lower gastrointestinal procedures, many of which are also listed in Appendix G. It is our expectation that we will not change existing policies for valuing moderate sedation as inherent in these procedures until we have the opportunity to assess and respond to the comments on this proposed rule on the overall valuation of Appendix G codes.

C. Malpractice Relative Value Units (RVUs)

1. Overview

   Section 1848(c) of the Act requires that each service paid under the PFS be comprised of three components: Work; PE; and malpractice (MP) expense. As required by section 1848(c) of the Act, beginning in CY 2000, MP RVUs are resource based. Malpractice RVUs for new codes after 1991 were extrapolated from similar existing codes or as a percentage of the corresponding work RVU. Section 1848(c)(2)(B)(i) of the Act also requires that we review, and if necessary adjust, RVUs no less often than every 5 years. For CY 2015, we are proposing to implement the third comprehensive review and update of MP RVUs. For details about prior updates, see the CY 2010 final rule with comment period (74 FR 33537).

2. Methodology for the Proposed Revision of Resource-Based Malpractice RVUs

a. General Discussion

   The proposed MP RVUs were calculated by a CMS contractor based on updated MP premium data obtained from state insurance rate filings. The methodology used in calculating the proposed CY 2015 review and update of resource-based MP RVUs largely parallels the process used in the CY 2010 update. The calculation requires using information on specialty-specific MP premiums linked to a specific service based upon the relative risk factors of the various specialties that furnish a particular service. Because MP premiums vary by state and specialty, the MP premium information must be weighted geographically and by specialty. Accordingly, the proposed MP RVUs are based upon three data sources: CY 2011 and CY 2012 MP premium data; CY 2013 Medicare payment and utilization data; and CY 2015 proposed work RVUs and geographic practice cost indices (GPCIs).

   Similar to the previous update, we calculated the proposed MP RVUs using specialty-specific MP premium data because they represent the actual expense incurred by practitioners to obtain MP insurance. We obtained MP premium data primarily from state departments of insurance. When the state insurance departments did not provide data, we used state rate filing data from the Perr and Knight database, which derives its data from state insurance departments. We used information obtained from MP insurance rate filings with effective dates in 2011 and 2012. These were the most current data available during our data collection process.

   We collected MP insurance premium data from all 50 States, the District of Columbia, and Puerto Rico. Rate filings were not available in American Samoa, Guam, or the Virgin Islands. Premiums were for $1 million/$3 million, mature, claims-made policies (policies covering claims made, rather than those covering services furnished, during the policy term). A $1 million/$3 million liability limit policy means that the most that would be paid on any claim is $1 million and the most that the policy would pay for claims over the timeframe of the policy is $3 million. We made adjustments to the premium data to reflect mandatory surcharges for patient compensation funds (funds to pay for any claim beyond the statutory amount, thereby limiting an individual physician's liability in cases of a large suit) in states where participation in such funds is mandatory. We attempted to collect premium data representing at least 50 percent of the medical MP premiums paid.

   We included premium information for all physician and NPP specialties, and all risk classifications available in the collected rate filings. Most insurance companies provided crosswalks from insurance service office (ISO) codes to named specialties. We matched these crosswalks to Medicare primary specialty designations (specialty codes). We also used information we obtained regarding surgical and nonsurgical classes. Some companies provided additional surgical subclasses; for example, distinguishing family practice physicians who furnish obstetric services from those who do not.

   Although we collected premium data from all states and the District of Columbia, not all specialties had premium data in the rate filings from all states. Additionally, for some specialties, MP premiums were not available from the rate filings in any state. Therefore, for specialties for which there was not premium data for at least 35 states, and specialties for which there was not distinct premium data in the rate filings, we crosswalked the specialty to a similar specialty, conceptually or by available premium data, for which we did have sufficient and reliable data. Additionally, we crosswalked three specialties-- physician assistant, registered dietitian and optometry--for which we had data from at least 35 states to a similar specialty type because the available data contained such extreme variations in premium amounts that we found it to be unreliable. The range in premium amounts for registered dietitians is $85 to $20,813 (24,259 percent), for physician assistants is $614 to $35,404 (5,665 percent), and for optometry is $189 to $10,798 (5,614 percent). Given that the national average premium amount for registered dietitians, physician assistants and optometry is below the national average premium amount for allergy and immunology, we crosswalked these specialties to allergy and immunology, the specialty with the lowest premiums for which we had sufficient and reliable data.

   For the proposed CY 2015 MP RVU update, sufficient and reliable premium data were available for 41 specialty types, which we used to develop specialty-specific malpractice risk factors. (See Table 13 for a list of these specialties.)

   For specialties with insufficient or unreliable premium data, we assigned the premium amounts of a similar specialty type. These specialties and the specialty data that we propose to use are shown in Table 12.

Table 12--Crosswalk of Specialties to Similar Specialties Specialty Medicare specialty name Crosswalk Crosswalk specialty code specialty code 09 Interventional Pain 05 Anesthesiology. Management 12 Osteopathic Manipulative 03 Allergy Immunology. Medicine 15 Speech Language Pathology 03 Allergy Immunology. 17 Hospice and Palliative 03 Allergy Immunology. Care 19 Oral Surgery (dental only) 24 Plastic and Reconstructive Surgery. 21 Cardiac Electrophysiology 06 Cardiology. 23 Sports Medicine 01 General Practice. 27 Geriatric Psychiatry 26 Psychiatry. 32 Anesthesiologist Assistant 05 Anesthesiology. 35 Chiropractic 03 Allergy Immunology. 41 Optometry 03 Allergy Immunology. 42 Certified Nurse Midwife 16 Obstetrics Gynecology. 43 Certified Registered Nurse 05 Anesthesiology. Anesthetist 50 Nurse Practitioner 01 General Practice. 60 Public Health or Welfare 03 Allergy Immunology. Agency 62 Psychologist 03 Allergy Immunology. 64 Audiologist 03 Allergy Immunology. 65 Physical Therapist 03 Allergy Immunology. 67 Occupational Therapist 03 Allergy Immunology. 68 Clinical Psychologist 03 Allergy Immunology. 71 Registered 03 Allergy Immunology. Dietitian/Nutrition Professional 72 Pain Management 05 Anesthesiology. 76 Peripheral Vascular 77 Vascular Surgery. Disease 79 Addiction Medicine 03 Allergy Immunology. 80 Licensed Clinical Social 03 Allergy Immunology. Worker 83 Hematology/Oncology 90 Medical Oncology. 85 Maxillofacial Surgery 24 Plastic and Reconstructive Surgery. 86 Neuropsychiatry 26 Psychiatry. 89 Certified Clinical Nurse 01 General Practice. Specialist 91 Surgical Oncology 02 General Surgery. 94 Interventional Radiology 30 Diagnostic Radiology. 97 Physician Assistant 03 Allergy Immunology. 98 Gynecological/Oncology 16 Obstetrics Gynecology. 99 Unknown Physician 01 General Practice. Specialty C0 Sleep Medicine 01 General Practice.



b. Steps for Calculating Proposed Malpractice RVUs

   Calculation of the proposed MP RVUs conceptually follows the specialty-weighted approach used in the CY 2010 final rule with comment period (74 FR 61758). The specialty-weighted approach bases the MP RVUs for a given service upon a weighted average of the risk factors of all specialties furnishing the service. This approach ensures that all specialties furnishing a given service are accounted for in the calculation of the MP RVUs. The steps for calculating the proposed MP RVUs are described below.

   Step (1): Compute a preliminary national average premium for each specialty.

   Insurance rating area MP premiums for each specialty are mapped to the county level. The specialty premium for each county is then multiplied by the total county RVUs for that specialty (from the Medicare claims data for CY 2013). The product of the MP premiums and total county RVUs is then summed across all counties for each specialty and then divided by total national RVUs for the specialty. This calculation is then divided by the average MP GPCI across all counties for each specialty to yield a normalized national average premium for each specialty. The specialty premiums are normalized for geographic variation so that the locality cost differences (as reflected by the GPCIs) would not be counted twice. Without the geographic variation adjustment, the cost differences among fee schedule areas would be reflected once under the methodology used to calculate the MP RVUs and again when computing the service specific payment amount for a given fee schedule area.

   Step (2): Determine which premium class(es) to use within each specialty.

   Some specialties had premium rates that differed for surgery, surgery with obstetrics, and non-surgery. To account for the presence of different classes in the MP premium data and the task of mapping these premiums to procedures, we calculated distinct risk factors for surgical, surgical with obstetrics, and nonsurgical procedures. However, the availability of data by surgery and nonsurgery varied across specialties. Consistent with the CY 2010 MP RVU update, because no single approach accurately addressed the variability in premium classes among specialties, we employed several methods for calculating average premiums by specialty. These methods are discussed below.

   (a) Substantial Data for Each Class: For 13 out of 41 specialties, we determined that there was sufficient data for surgery and nonsurgery premiums, as well as sufficient differences in rates between classes. These specialties are listed in Table 13. Therefore, we calculated a national average surgical premium and nonsurgical premium.

   (b) Major Surgery Dominates: For 9 surgical specialties, rate filings that included nonsurgical premiums were relatively rare. For most of these surgical specialties, the rate filings did not include an "unspecified" premium. When it did, the unspecified premium was lower than the major surgery rate. For these surgical specialties, we calculated only a surgical premium and used the premium for major surgery for all procedures furnished by this specialty.

   (c) Unspecified Dominates: Many MP rate filings did not include surgery or nonsurgery classes for some specialties; we refer to these instances as unspecified MP rates. For 7 specialty types (listed in Table 13), we selected the unspecified premium as the premium information to use for the specialty. For these specialties, at least 35 states (and as many as 48 states) had MP premium amounts that were not identified as surgery or nonsurgery in rate filings for the specialty.

   (d) Blend All Available: For the remaining specialties, there was wide variation across the rate filings in terms of whether or not premium classes were reported and which categories were reported. Because there was no clear strategy for these remaining specialties, we blended the available rate information into one general premium rate. For these specialties, we developed a weighted average "blended" premium at the national level, according to the percentage of work RVUs correlated with the premium classes within each specialty. For example, the surgical premiums for a given specialty were weighted by that specialty's work RVUs for surgical services; the nonsurgical premiums were weighted by the work RVUs for nonsurgical services and the unspecified premiums were weighted by all work RVUs for the specialty type.

   The four methods for calculating premiums by specialty type are summarized in Table 13. (See Table 14: "Risk Factors by Specialty Type" for the specialty names associated with the specialty codes listed in Table 13.) GOES

Table 13--Proposed Premium Calculation Approach by Specialty Type Method Medicare specialty codes (a) Substantial Data for Each 01, 04, 06, 07, 08 (non-OB), 10, 13, 18, 34, Class (13) 38, 39, 46, 93 (b) Major Surgery Dominates 02, 14, 20, 24, 28, 33, 40, 77, 78 (9) (c) Unspecified Dominates (7) 03, 05, 16 (non-OB), 25, 26, 36, 81 (d) Blend All Available (12) 11, 22, 29, 30, 37, 44, 48, 66, 82, 84, 90, 92



   (e) Premium Calculation for Neurosurgery: For neurosurgery, premium data were available from 24 states; therefore, we did not have sufficient data to calculate a national average premium amount for neurosurgery. As explained above, we typically crosswalk a specialty with insufficient premium data (less than 35 states) to a similar specialty for which we have sufficient data, conceptually or by reported premiums. We considered cross-walking neurosurgery directly to the national average premium for a similar specialty that had sufficient data such as neurology or to another surgical specialty. We did not crosswalk neurosurgery directly to another surgical specialty because no other surgical specialty had similar premium values reported in the rate filings. For instance, the surgical premium for neurosurgery is $123,400 while the surgical premium for the next highest surgical specialty (surgical oncology) is $59,808. We also did not crosswalk neurosurgery directly to neurology because the rate filings for neurology include substantial premium data for both surgery and non-surgery while the rate filings for neurosurgery are dominated by major surgery premiums. We do not believe that it would be appropriate to assign non-surgical premiums reported for neurology to neurosurgery.

   However, the national average surgical premium amount for neurology ($96,970) and the surgical premium amount for neurosurgery are similar. Therefore, we blended the surgical premium data for neurology and neurosurgery instead of crosswalking directly to neurology or directly to another surgical specialty. In other words, we calculated a combined national average surgical premium for neurosurgery and neurology. The reasons as to why we are proposing to blend surgical premiums for neurology and neurosurgery, instead of crosswalking neurosurgery directly to neurology or directly to another surgical specialty, are further explained below.

    * The rate filings for neurosurgery are dominated by major surgery premiums.

    * The rate filings identifying nonsurgical premiums for neurosurgery are sparse.

    * The rate filings for neurology include substantial premium data for both surgery and nonsurgery.

    * Neurology is similar to neurosurgery both conceptually and by reported surgical premium amounts.

    * Surgical premiums from the rate filings for other surgical specialties are lower than for neurosurgery and neurology.

   Given that the rate filings for neurosurgery are dominated by major surgical premiums and that surgical premium amounts for neurology are similar to neurosurgery, we believe that combining the surgical premium data for neurosurgery and neurology is a better representation of the MP premium amounts paid by neurosurgeons than crosswalking neurosurgery directly to neurology or to another surgical specialty.

   Step (3): Calculate a risk factor for each specialty.

   The relative differences in national average premiums between specialties are expressed in our methodology as a specialty risk factor. These risk factors are an index calculated by dividing the national average premium for each specialty by the national average premium for the specialty with the lowest premiums for which we had sufficient and reliable data, allergy and immunology. For specialties with sufficient surgical and nonsurgical premium data, we calculated both a surgical and nonsurgical risk factor. For specialties with rate filings that distinguished surgical premiums with obstetrics from those without, we calculated a separate surgical with obstetrics risk factor. For all other specialties we calculated a single risk factor and applied the specialty risk factor to both surgery and nonsurgery services.

   We note that for determining the risk factor for suppliers of TC-only services, we were not able to obtain more recent premium data than what was used for the CY 2010 update. Therefore, we updated the premium data for IDTFs that we used in the CY 2010 update. These data were obtained from a survey conducted by the Radiology Business Management Association (RBMA) in 2009. We updated the RBMA survey data by the change in non-surgical premiums for all specialty types since the previous MP RVU update and calculated an updated TC specialty risk factor. We applied the updated TC specialty risk factor to suppliers of TC-only services. Table 14 shows the risk factors by specialty type.

Table 14--Risk Factors by Specialty Type Specialty Medicare specialty name Non-surgical Surgical risk code risk factor factor 01 General Practice 1.83 4.11 02 General Surgery 7.30 03 Allergy Immunology 1.00 1.00 04 Otolaryngology 1.95 4.47 05 Anesthesiology 2.42 2.42 06 Cardiology 2.11 7.10 07 Dermatology 1.25 4.11 08 Family Practice 1.77 4.18 08 OB Family Practice w/OB 3.95 09 Interventional Pain Management 2.42 2.42 10 Gastroenterology 2.16 4.45 11 Internal Medicine 2.07 2.07 12 Osteopathic Manipulative 1.00 1.00 Medicine 13 Neurology 2.59 13.04 14 Neurosurgery 13.04 15 Speech Language Pathology 1.00 1.00 16 Obstetrics Gynecology 3.80 3.80 16 OB Obstetrics Gynecology w/OB 8.05 17 Hospice and Palliative Care 1.00 1.00 18 Ophthalmology 1.22 2.21 19 Oral Surgery (dental only) 5.11 20 Orthopedic Surgery 6.38 21 Cardiac Electrophysiology 2.11 7.10 22 Pathology 1.79 1.79 23 Sports Medicine 1.83 4.11 24 Plastic and Reconstructive 5.11 Surgery 25 Physical Medicine and 1.39 1.39 Rehabilitation 26 Psychiatry 1.13 1.13 27 Geriatric Psychiatry 1.13 1.13 28 Colorectal Surgery (formerly 4.08 Proctology) 29 Pulmonary Disease 2.33 2.33 30 Diagnostic Radiology 2.99 2.99 32 Anesthesiologist Assistant 2.42 2.42 33 Thoracic Surgery 7.27 34 Urology 1.61 3.39 35 Chiropractic 1.00 1.00 36 Nuclear Medicine 1.41 1.41 37 Pediatric Medicine 1.82 1.82 38 Geriatric Medicine 1.78 4.83 39 Nephrology 1.71 4.27 40 Hand Surgery 4.71 41 Optometry 1.00 1.00 42 Certified Nurse Midwife 3.80 3.80 42 OB Certified Nurse Midwife w/OB 8.05 43 Certified Registered Nurse 2.42 2.42 Anesthetist (CRNA) 44 Infectious Disease 2.41 2.41 45 Mammography Screening Center 0.90 46 Endocrinology 1.65 4.23 47 Independent Diagnostic Testing 0.90 Facility 48 Podiatry 2.22 2.22 50 Nurse Practitioner 1.83 4.11 60 Public Health or Welfare Agency 1.00 1.00 62 Psychologist 1.00 1.00 63 Portable X-Ray Supplier 0.90 64 Audiologist 1.00 1.00 65 Physical Therapist 1.00 1.00 66 Rheumatology 1.77 1.77 67 Occupational Therapist 1.00 1.00 68 Clinical Psychologist 1.00 1.00 69 Clinical Laboratory 0.90 71 Registered Dietitian/Nutrition 1.00 1.00 Professional 72 Pain Management 2.42 2.42 74 Radiation Therapy Center 0.90 75 Slide Preparation Facilities 0.90 76 Peripheral Vascular Disease 7.19 77 Vascular Surgery 7.19 78 Cardiac Surgery 7.23 79 Addiction Medicine 1.00 1.00 80 Licensed Clinical Social Worker 1.00 1.00 81 Critical Care (Intensivists) 2.83 2.83 82 Hematology 1.81 1.81 83 Hematology/Oncology 1.89 1.89 84 Preventive Medicine 1.44 1.44 85 Maxillofacial Surgery 5.11 86 Neuropsychiatry 1.13 1.13 89 Certified Clinical Nurse 1.83 4.11 Specialist 90 Medical Oncology 1.89 1.89 91 Surgical Oncology 7.30 92 Radiation Oncology 2.36 2.36 93 Emergency Medicine 3.29 5.17 94 Interventional Radiology 2.99 2.99 97 Physician Assistant 1.00 1.00 98 Gynecological/Oncology 3.80 3.80 98 OB Gynecological/Oncology w/OB 8.05 99 Unknown Physician Specialty 1.83 4.11 C0 Sleep Medicine 1.83 4.11 TC IDTFs (TC only) 0.90



   (a) Invasive Cardiology: Consistent with the previous MP RVU update, we continued to classify invasive cardiology services (cardiac catheterizations and angioplasties) that are outside of the surgical HCPCS code range as surgery for purposes of assigning specialty-specific risk factors. We note that since the previous MP RVU update some invasive cardiology service HCPCS codes have been revised. Therefore, we modified the list of invasive cardiology services outside the surgical HCPCS code range that are to be considered surgery in order to correspond conceptually to the list of service codes used for the CY 2010 MP RVU update. We continue to believe that the malpractice risk for cardiac catheterization and angioplasty services are more similar to the risk of surgical procedures than most nonsurgical service codes. As such, we applied the higher cardiology surgical risk factor to cardiology catheterization and angioplasty services.

   For the CY 2015 MP RVU update, we examined the possibility of classifying injection procedures used in conjunction with cardiac catheterization as surgery (for purposes of assigning service specific risk factors). After careful consideration, we believe that injection procedures, when furnished in conjunction with cardiac catheterization, are more akin to the malpractice risk of surgical procedures than most non-surgical services. Therefore we applied the surgical risk factor to injection procedures used in conjunction with cardiac catheterization. Table 15 shows the invasive cardiology services and injection services furnished in conjunction with cardiac catheterization to be considered as surgery for purposes of assigning specialty-specific risk factors. GOES

Table 15--Services Outside of Surgical HCPCS Code Range Considered Surgery HCPCS Short descriptor code 92920 Prq cardiac angioplast 1 art. 92921 Prq cardiac angio addl art. 92924 Prq card angio/athrect 1 art. 92925 Prq card angio/athrect addl. 92928 Prq card stent w/angio 1 vsl. 92929 Prq card stent w/angio addl. 92933 Prq card stent/ath/angio. 92934 Prq card stent/ath/angio. 92937 Prq revasc byp graft 1 vsl. 92938 Prq revasc byp graft addl. 92941 Prq card revasc mi 1 vsl. 92943 Prq card revasc chronic 1vsl. 92944 Prq card revasc chronic addl. 92970 Cardioassist internal. 92971 Cardioassist external. 92973 Prq coronary mech thrombect. 92974 Cath place cardio brachytx. 92975 Dissolve clot heart vessel. 92977 Dissolve clot heart vessel. 92978 Intravasc us heart add-on. 92979 Intravasc us heart add-on. 93451 Right heart cath. 93452 Left hrt cath w/ventrclgrphy. 93453 R&l hrt cath w/ventriclgrphy. 93454 Coronary artery angio s&i. 93455 Coronary art/grft angio s&i. 93456 R hrt coronary artery angio. 93457 R hrt art/grft angio. 93458 L hrt artery/ventricle angio. 93459 L hrt art/grft angio. 93460 R&l hrt art/ventricle angio. 93461 R&l hrt art/ventricle angio. 93462 L hrt cath trnsptl puncture. 93503 Insert/place heart catheter. 93505 Biopsy of heart lining. 93530 Rt heart cath congenital. 93531 R & l heart cath congenital. 93532 R & l heart cath congenital. 93533 R & l heart cath congenital. 93580 Transcath closure of asd. 93581 Transcath closure of vsd. 93582 Perq transcath closure pda. 93583 Perq transcath septal reduxn. 93600 Bundle of his recording. 93602 Intra-atrial recording. 93603 Right ventricular recording. 93609 Map tachycardia add-on. 93610 Intra-atrial pacing. 93612 Intraventricular pacing. 93613 Electrophys map 3d add-on. 93618 Heart rhythm pacing. 93619 Electrophysiology evaluation. 93620 Electrophysiology evaluation. 93621 Electrophysiology evaluation. 93622 Electrophysiology evaluation. 93623 Stimulation pacing heart. 93624 Electrophysiologic study. 93631 Heart pacing mapping. 93640 Evaluation heart device. 93641 Electrophysiology evaluation. 93642 Electrophysiology evaluation. 93650 Ablate heart dysrhythm focus. 93653 Ep & ablate supravent arrhyt. 93654 Ep & ablate ventric tachy. 93655 Ablate arrhythmia add on. 93656 Tx atrial fib pulm vein isol. 93657 Tx l/r atrial fib addl. 93563 Inject congenital card cath. 93564 Inject hrt congntl art/grft. 93565 Inject l ventr/atrial angio. 93566 Inject r ventr/atrial angio. 93567 Inject suprvlv aortography. 93568 Inject pulm art hrt cath. 93571 Heart flow reserve measure. 93572 Heart flow reserve measure.



   Step (4): Calculate malpractice RVUs for each HCPCS code.

   Resource-based MP RVUs were calculated for each HCPCS code that has work or PE RVUs. The first step was to identify the percentage of services furnished by each specialty for each respective HCPCS code. This percentage was then multiplied by each respective specialty's risk factor as calculated in Step 3. The products for all specialties for the HCPCS code were then added together, yielding a specialty-weighted service specific risk factor reflecting the weighted malpractice costs across all specialties furnishing that procedure. The service specific risk factor was multiplied by the greater of the work RVU or PE clinical labor index for that service to reflect differences in the complexity and risk-of-service between services.

   (a) Low volume service codes: As discussed previously in this section, service-specific MP RVUs are determined based on the weighted average risk factor(s) of the specialties that furnish the service. For rarely-billed Medicare services (that is, when CY 2013 claims data reflected allowed services of less than 100), we used only the risk factor of the dominant specialty as reflected in our claims data. Approximately 2,000 services met the criteria for "low volume." The dominant specialty for each "low volume" service was also determined from CY 2013 Medicare claims data. We continue to believe that a balanced approach between including all of the specialties in our claims data and the application of the dominant specialty for each low volume service is the most appropriate approach to the development of malpractice RVUs.

   Step (5): Rescale for budget neutrality.

   The statute requires that changes to fee schedule RVUs must be budget neutral. The current resource-based MP RVUs and the proposed resource-based MP RVUs were constructed using different malpractice premium data. Thus, the last step is to adjust for budget neutrality by rescaling the proposed MP RVUs so that the total proposed resource-based MP RVUs equal the total current resource-based MP RVUs.

   The proposed resource-based MP RVUs are shown in Addendum B, which is available on the CMS Web site under the supporting documents section of the CY 2015 PFS rule at http://www.cms.gov/PhysicianFeeSched/. These values have been adjusted for budget neutrality on the basis of the most recent 2013 utilization data available. We will make a final budget neutrality adjustment in the final rule on the basis of the available 2013 utilization data at that time. We do not believe, however, that the final values will change significantly from the proposed values as a result of the final budget-neutrality adjustment.

   Because of the differences in the sizes of the three fee schedule components, implementation of the resource-based MP RVU update will have much smaller payment effects than implementing updates of resource-based work RVUs and resource-based PE RVUs. On average, work represents about 50.9 percent of payment for a service under the fee schedule, PE about 44.8 percent, and MP about 4.3 percent. Therefore, a 25 percent change in PE RVUs or work RVUs for a service would result in a change in payment of about 11 to 13 percent. In contrast, a corresponding 25 percent change in MP values for a service would yield a change in payment of only about 1 percent. Estimates of the effects on payment by specialty type can be found in section VI. of this proposed rule.

   Additional information on our proposed methodology for updating the MP RVUs may be found in our contractor's report, "Report on the CY 2015 Update of the Malpractice RVUs," which is available on the CMS Web site. It is located under the supporting documents section of the CY 2015 PFS proposed rule located at http://www.cms.gov/PhysicianFeeSched/.

3. MP RVU Update for Anesthesia Services

   Since payment for anesthesia services under the PFS is based upon a separate fee schedule, routine updates must be calculated in a different way than those for services for which payment is calculated based upon work, PE and MP RVUs. To apply certain updates to the anesthesia fee schedule, we usually develop proxy RVUs for individual anesthesia services. However, because work RVUs are integral to the MP RVU methodology and anesthesia services do not have work RVUs, the MP update process for anesthesia services is more complex than for services with work RVUs and clinical labor inputs. Notwithstanding these challenges, we believe that payment rates for anesthesia should reflect relative MP resource costs, including updates to reflect changes over time, as do other PFS payment rates. We are not proposing to include such an adjustment at this time because we believe it would be helpful to receive input from stakeholders on how we could address these challenges and develop a proposal to appropriately update the MP resource costs for anesthesia through future rulemaking. Therefore, we intend to propose an anesthesia adjustment for MP in the CY 2016 PFS proposed rule and are seeking comment in this rule about how to best do so.

   An example of one possible approach would be to calculate imputed work RVUs and MP RVUs for the anesthesia fee schedule services using the work, PE, and MP shares of the anesthesia conversion factor. To reflect differences in the complexity and risk between anesthesia fee schedule services we would then multiply the service-specific risk factor for each anesthesia fee schedule service by the imputed proxy work RVUs (both CY 2015 and Cy 2016 would be based on the same work RVUs) developed for each anesthesia service to determine updated proxy MP RVUs for the CY 2016 year. The aggregate difference between the imputed MP RVUs for CY 2015 the proxy MP RVUs for CY 2016 (both based on the same work RVUs) would be applied to the portion of the anesthesia conversion factor attributable to MP. However, we believe there may be drawbacks to this approach since it relies heavily on the proxy work and MP RVUs for individual anesthesia services. We are requesting public comments on this approach specifically, as well as comments on alternative approaches or methods for updating MP for services paid on the anesthesia fee schedule.

D. Geographic Practice Cost Indices (GPCIs)

1. Background

   Section 1848(e)(1)(A) of the Act requires us to develop separate Geographic Practice Cost Indices (GPCIs) to measure relative cost differences among localities compared to the national average for each of the three fee schedule components (that is, work, PE, and MP). Although the statute requires that the PE and MP GPCIs reflect the full relative cost differences, section 1848(e)(1)(A)(iii) of the Act requires that the work GPCIs reflect only one-quarter of the relative cost differences compared to the national average. In addition, section 1848(e)(1)(G) of the Act sets a permanent 1.5 work GPCI floor for services furnished in Alaska beginning January 1, 2009, and section 1848(e)(1)(I) of the Act sets a permanent 1.0 PE GPCI floor for services furnished in frontier states (as defined in section 1848(e)(1)(I) of the Act) beginning January 1, 2011. Additionally, section 1848(e)(1)(E) of the Act provided for a 1.0 floor for the work GPCIs, which was set to expire on March 31, 2014. However, section 102 of the PAMA extended application of the 1.0 floor to the work GPCI through March 31, 2015.

   Section 1848(e)(1)(C) of the Act requires us to review and, if necessary, adjust the GPCIs at least every 3 years. Section 1848(e)(1)(C) of the Act requires that "if more than 1 year has elapsed since the date of the last previous adjustment, the adjustment to be applied in the first year of the next adjustment shall be 1/2 of the adjustment that otherwise would be made." We completed a review and finalized updated GPCIs in the CY 2014 PFS final rule with comment period (78 FR 74390). Since the last GPCI update had been implemented over 2 years, CY 2011 and CY 2012, we phased in 1/2 of the latest GPCI adjustment in CY 2014. We also revised the cost share weights that correspond to all three GPCIs in the CY 2014 PFS final rule. We calculated a corresponding geographic adjustment factor (GAF) for each PFS locality. The GAFs are a weighted composite of each area's work, PE and MP GPCIs using the national GPCI cost share weights. Although the GAFs are not used in computing the fee schedule payment for a specific service, we provide them because they are useful in comparing overall areas costs and payments. The actual effect on payment for any actual service will deviate from the GAF to the extent that the proportions of work, PE and MP RVUs for the service differ from those of the GAF.

   As previously noted, section 102 of the PAMA extended the 1.0 work GPCI floor through March 31, 2015. Therefore, the CY 2015 work GPCIs and summarized GAFs have been revised to reflect the 1.0 work floor. Additionally, as required by sections 1848(e)(1)(G) and 1848(e)(1)(I) of the Act, the 1.5 work GPCI floor for Alaska and the 1.0 PE GPCI floor for frontier states are permanent, and therefore, applicable in CY 2015. See Addenda D and E for the CY 2015 GPCIs and summarized GAFs.

   As discussed in the CY 2014 PFS final rule with comment period (78 FR 74380) the updated GPCIs were calculated by a contractor to CMS. We used updated Bureau of Labor and Statistics Occupational Employment Statistics (BLS OES) data (2009 through 2011) as a replacement for 2006 through 2008 data for purposes of calculating the work GPCI and the employee compensation component and purchased services component of the PE GPCI. We also used updated U.S. Census Bureau American Community Survey (ACS) data (2008 through 2010) as a replacement for 2006 through 2008 data for calculating the office rent component of the PE GPCI. To calculate the MP GPCI we used updated malpractice premium data (2011 and 2012) from state departments of insurance as a replacement for 2006 through 2007 premium data. We also noted that we do not adjust the medical equipment, supplies and other miscellaneous expenses component of the PE GPCI because we continue to believe there is a national market for these items such that there is not a significant geographic variation in relative costs. Additionally, we updated the GPCI cost share weights consistent with the modifications made to the 2006-based MEI cost share weights in the CY 2014 final rule. As discussed in the CY 2014 final rule with comment period, use of the revised GPCI cost share weights changed the weighting of the subcomponents within the PE GPCI (employee wages, office rent, purchased services, and medical equipment and supplies). For a detailed explanation of how the GPCI update was developed, see the CY 2014 final rule with comment period (78 FR 74380 through 74391).

2. Proposed Changes to the GPCI Values for the Virgin Islands Payment Locality

   The current methodology for calculating locality level GPCIs relies on the acquisition of county level data (when available). Where data for a specific county are not available, we assign the data from a similar county within the same payment locality. The Virgin Islands have county level equivalents identified as districts. Specifically, the Virgin Islands are divided into 3 districts: Saint Croix; Saint Thomas; and Saint John. These districts are, in turn, subdivided into 20 sub-districts. Although the Virgin Islands are divided into these county equivalents, county level data for the Virgin Islands are not represented in the BLS OES wage data. Additionally, the ACS, which is used to calculate the rent component of the PE GPCI, is not conducted in the Virgin Islands, and we have not been able to obtain malpractice insurance premium data for the Virgin Islands payment locality. Given the absence of county level wage and rent data and the insufficient malpractice premium data by specialty type, we have historically set the three GPCI values for the Virgin Islands payment locality at 1.0.

   For CY 2015, we explored using the available data from the Virgin Islands to more accurately reflect the geographic cost differences for the Virgin Islands payment locality as compared to other PFS localities. Although county level data for the Virgin Islands are not represented in the BLS OES wage data, aggregate territory level BLS OES wage data are available. We believe that using aggregate territory level data is a better reflection of the relative cost differences of operating a medical practice in the Virgin Islands payment locality as compared to other PFS localities than the current approach of assigning a value of 1.0. At our request, our contractor calculated the work GPCI, and the employee wage component and purchased services component of the PE GPCI, for the Virgin Islands payment locality using aggregated 2009 through 2011 BLS OES data.

   As discussed above, the ACS is not conducted in the Virgin Islands and we have not been able to obtain malpractice premium data for the Virgin Islands payment locality. Therefore, we assigned a value of 1.0 for the rent index of the PE GPCI and to the MP GPCI.

   Table 16 illustrates the percentage change in GPCI values and summarized GAF for the Virgin Islands payment locality resulting from using BLS OES wage data to calculate the work GPCI and PE GPCI.

TABLE 16--Impact of Using Territory-Level Virgin Islands Data on GPCI Values for the Virgin Islands Payment Locality GPCI/GAF 1/1/2015 through 3/31/2015 4/1/2015 through 12/31/2015 (with 1.0 work GPCI floor) (without 1.0 work GPCI floor) Existing Proposed Percent Existing Proposed Percent CY 2015 CY 2015 change CY 2015 CY 2015 change GPCI GPCI GPCI GPCI values * values values * values Work GPCI 1.000 1.000 0.00% 0.998 0.975 -2.30 PE GPCI 1.005 0.960 -4.48% 1.005 0.960 -4.48 MP GPCI 0.996 0.996 0.00% 0.996 0.996 0.00 GAF 1.002 0.982 -2.00% 1.001 0.969 -3.20 *CY 2015 GPCIs and GAF reflect CMS OACT BN adjustment.



   Using aggregate territory-level BLS OES wage data results in a -2.3 percent decrease in the work GPCI, a -4.48 percent decrease in the PE GPCI, and a -3.2 percent decrease to the GAF for the Virgin Islands payment locality. However, with the application of the 1.0 work GPCI floor, there is no change to the work GPCI and the overall impact of using actual BLS OES wage data on the Virgin Islands payment locality is only reflected by the change in PE GPCI (-4.48 percent) resulting in a -2.00 percent decrease to the GAF. As mentioned previously in this section, since we have not been able to obtain malpractice premium data for the Virgin Islands payment locality we maintained the MP GPCI at 1.0. As such, there is no change in the MP GPCI. We propose to use aggregate BLS OES wage data to calculate the work GPCI and employee wage component of the PE GPCI for the Virgin Islands payment locality beginning for CY 2015, and for future GPCI updates. We are specifically requesting public comments on this proposal. Additional information on our proposal to calculate GPCI values for the Virgin Islands payment locality may be found in our contractor's report, "Revised Final Report on the CY 2014 Update of the Geographic Practice Cost Index for the Medicare Physician Fee Schedule," which is available on the CMS Web site. It is located under the supporting documents section of the CY 2015 PFS proposed rule located at http://www.cms.gov/PhysicianFeeSched/.

E. Medicare Telehealth Services

1. Billing and Payment for Telehealth Services

   Generally, for Medicare payments to be made for telehealth services under the PFS several conditions must be met. Specifically, the service must be on the Medicare list of telehealth services and meet all of the following other requirements for coverage:

    * The service must be furnished via an interactive telecommunications system.

    * The practitioner furnishing the service must meet the telehealth requirements, as well as the usual Medicare requirements.

    * The service must be furnished to an eligible telehealth individual.

    * The individual receiving the services must be in an eligible originating site.

   When all of these conditions are met, Medicare pays an originating site fee to the originating site and provides separate payment to the distant site practitioner for furnishing the service.

   Section 1834(m)(4)(F)(i) of the Act defines Medicare telehealth services to include consultations, office visits, office psychiatry services, and any additional service specified by the Secretary, when furnished via a telecommunications system. We first implemented this provision, which was effective October 1, 2001, in the CY 2002 PFS final rule with comment period (66 FR 55246). We established a process in the CY 2003 PFS final rule with comment period (67 FR 79988) for annual updates to the list of Medicare telehealth services as required by section 1834(m)(4)(F)(ii) of the Act.

   As specified in regulations at SEC 410.78(b), we generally require that a telehealth service be furnished via an interactive telecommunications system. Under SEC 410.78(a)(3), an interactive telecommunications system is defined as multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner. Telephones, facsimile machines, and electronic mail systems do not meet the definition of an interactive telecommunications system. An interactive telecommunications system is generally required as a condition of payment; however, section 1834(m)(1) of the Act allows the use of asynchronous "store-and-forward" technology when the originating site is part of a federal telemedicine demonstration program in Alaska or Hawaii. As specified in regulations at SEC 410.78(a)(1), store-and-forward means the asynchronous transmission of medical information from an originating site to be reviewed at a later time by the practitioner at the distant site.

   Medicare telehealth services may be furnished to an eligible telehealth individual notwithstanding the fact that the practitioner furnishing the telehealth service is not at the same location as the beneficiary. An eligible telehealth individual means an individual enrolled under Part B who receives a telehealth service furnished at an originating site.

   Practitioners furnishing Medicare telehealth services are reminded that the telehealth service provision is subject to the same non-discrimination laws as other services, including the effective communication requirements for persons with disabilities of section 504 of the Rehabilitation Act and language access for persons with limited English proficiency, as required under Title VI of the Civil Rights Act of 1964. For more information, see http://www.hhs.gov/ocr/civilrights/resources/specialtopics/hosptialcommunication.

   Practitioners furnishing Medicare telehealth services submit claims for telehealth services to the Medicare contractors that process claims for the service area where their distant site is located. Section 1834(m)(2)(A) of the Act requires that a practitioner who furnishes a telehealth service to an eligible telehealth individual be paid an amount equal to the amount that the practitioner would have been paid if the service had been furnished without the use of a telecommunications system.

   Originating sites, which are defined as "one of the specified sites where an eligible telehealth individual is located at the time the service is being furnished via a telecommunications system," are paid under the PFS for serving as an originating site for telehealth services. The statute specifies both the types of entities that can serve as originating sites and geographic qualifications for originating sites. With regard to geographic qualifications, our regulations at SEC 410.78 (b)(4) limit originating sites to those located in rural health professional shortage areas (HPSAs) or in a county that is not included in a metropolitan statistical areas (MSAs). Historically, we have defined rural HPSAs to be those located outside of, MSAs. Effective January 1, 2014, we modified the regulations regarding originating sites to define rural HPSAs as those located in rural census tracts as determined by the Office of Rural Health Policy (ORHP) of the Health Resources and Services Administration (HRSA) (78 FR 74811). Defining "rural" to include geographic areas located in rural census tracts within MSAs allows for broader inclusion of sites within HPSAs as telehealth originating sites. Adopting the more precise definition of "rural" for this purpose expands access to health care services for Medicare beneficiaries located in rural areas. HRSA has developed a Web site tool to provide assistance to potential originating sites to determine their geographic status. To access this tool, see the CMS Web site at www.cms.gov/teleheath/.

   An entity participating in a federal telemedicine demonstration project that has been approved by, or received funding from, the Secretary as of December 31, 2000 is eligible to be an originating site regardless of its geographic location.

   Effective January 1, 2014, we also changed our policy so that geographic eligibility for an originating site would be established and maintained on an annual basis, consistent with other telehealth payment policies (78 FR 74400). Geographic eligibility for Medicare telehealth originating sites for each calendar year is now based upon the status of the area as of December 31 of the prior calendar year.

   For a detailed history of telehealth payment policy, see 78 FR 74399.

2. Adding Services to the List of Medicare Telehealth Services

   As noted previously, in the December 31, 2002Federal Register (67 FR 79988), we established a process for adding services to or deleting services from the list of Medicare telehealth services. This process provides the public with an ongoing opportunity to submit requests for adding services. We assign any qualifying request to make additions to the list of telehealth services to one of two categories. In the November 28, 2011Federal Register (76 FR 73102), we finalized revisions to criteria that we use to review requests in the second category. The two categories are:

    * Category 1: Services that are similar to professional consultations, office visits, and office psychiatry services that are currently on the list of telehealth services. In reviewing these requests, we look for similarities between the requested and existing telehealth services for the roles of, and interactions among, the beneficiary, the physician (or other practitioner) at the distant site and, if necessary, the telepresenter, a practitioner with the beneficiary in the originating site. We also look for similarities in the telecommunications system used to deliver the proposed service; for example, the use of interactive audio and video equipment.

    * Category 2: Services that are not similar to the current list of telehealth services. Our review of these requests includes an assessment of whether the service is accurately described by the corresponding code when furnished via telehealth and whether the use of a telecommunications system to deliver the service produces demonstrated clinical benefit to the patient. In reviewing these requests, we look for evidence indicating that the use of a telecommunications system in furnishing the candidate telehealth service produces clinical benefit to the patient. Submitted evidence should include both a description of relevant clinical studies that demonstrate the service furnished by telehealth to a Medicare beneficiary improves the diagnosis or treatment of an illness or injury or improves the functioning of a malformed body part, including dates and findings, and a list and copies of published peer reviewed articles relevant to the service when furnished via telehealth. Our evidentiary standard of clinical benefit does not include minor or incidental benefits.

   Some examples of clinical benefit include the following:

    * Ability to diagnose a medical condition in a patient population without access to clinically appropriate in-person diagnostic services.

    * Treatment option for a patient population without access to clinically appropriate in-person treatment options.

    * Reduced rate of complications.

    * Decreased rate of subsequent diagnostic or therapeutic interventions (for example, due to reduced rate of recurrence of the disease process).

    * Decreased number of future hospitalizations or physician visits.

    * More rapid beneficial resolution of the disease process treatment.

    * Decreased pain, bleeding, or other quantifiable symptom.

    * Reduced recovery time.

   For the list of covered telehealth services, see the CMS Web site at www.cms.gov/teleheath/. Requests to add services to the list of Medicare telehealth services must be submitted and received no later than December 31 of each calendar year to be considered for the next rulemaking cycle. For example, qualifying requests submitted before the end of CY 2014 will be considered for the CY 2016 proposed rule. Each request to add a service to the list of Medicare telehealth services must include any supporting documentation the requester wishes us to consider as we review the request. Because we use the annual PFS rulemaking process as a vehicle for making changes to the list of Medicare telehealth services, requestors should be advised that any information submitted is subject to public disclosure for this purpose. For more information on submitting a request for an addition to the list of Medicare telehealth services, including where to mail these requests, see the CMS Web site at www.cms.gov/telehealth/.

3. Submitted Requests to the List of Telehealth Services for CY 2015

   Under our existing policy, we add services to the telehealth list on a category 1 basis when we determine that they are similar to services on the existing telehealth list with respect to the roles of, and interactions among, the beneficiary, physician (or other practitioner) at the distant site and, if necessary, the telepresenter. As we stated in the CY 2012 proposed rule (76 FR 42826), we believe that the category 1 criteria not only streamline our review process for publically requested services that fall into this category, the criteria also expedite our ability to identify codes for the telehealth list that resemble those services already on this list.

a. Submitted Requests

   We received several requests in CY 2013 to add various services as Medicare telehealth services effective for CY 2015. The following presents a discussion of these requests, and our proposals for additions to the CY 2015 telehealth list. Of the requests received, we find that the following services are sufficiently similar to psychiatric diagnostic procedures or office/outpatient visits currently on the telehealth list to qualify on a category one basis. Therefore, we propose to add the following services to the telehealth list on a category 1 basis for CY 2015:

    * CPT codes 90845 (Psychoanalysis); 90846 (family psychotherapy (without the patient present); and 90847 (family psychotherapy (conjoint psychotherapy) (with patient present);

    * CPT codes 99354 (prolonged service in the office or other outpatient setting requiring direct patient contact beyond the usual service; first hour (list separately in addition to code for office or other outpatient evaluation and management service); and, 99355 (prolonged service in the office or other outpatient setting requiring direct patient contact beyond the usual service; each additional 30 minutes (list separately in addition to code for prolonged service); and,

    * HCPCS codes G0438 (annual wellness visit; includes a personalized prevention plan of service (pps), initial visit; and, G0439 (annual wellness visit, includes a personalized prevention plan of service (pps), subsequent visit).

   We also received requests to add services to the telehealth list that do not meet our criteria for being on the Medicare telehealth list. We are not proposing to add the following procedures for the reasons noted:

    * CPT codes 92250 (fundus photography with interpretation and report); 93010 (electrocardiogram, routine ECG with at least 12 leads; interpretation and report only), 93307 (echocardiography, transthoracic, real-time with image documentation (2d), includes m-mode recording, when performed, complete, without spectral or color Doppler echocardiography; 93308 (echocardiography, transthoracic, real-time with image documentation (2d), includes m-mode recording, when performed, follow-up or limited study); 93320 (Doppler echocardiography, pulsed wave and/or continuous wave with spectral display (list separately in addition to codes for echocardiographic imaging); complete); 93321 (Doppler echocardiography, pulsed wave and/or continuous wave with spectral display (list separately in addition to codes for echocardiographic imaging); follow-up or limited study (list separately in addition to codes for echocardiographic imaging); and 93325 (Doppler echocardiography color flow velocity mapping (list separately in addition to codes for echocardiography).

   These services include a technical component (TC) and a professional component (PC). By definition the TC portion of these services needs to be furnished in the same location as the patient and thus cannot be furnished via telehealth. The PC portion of these services could be furnished without the patient being present in the same location. (Note: Sometimes an entirely different code may be used when only the PC portion of the service is being furnished and other times the same CPT code is used with a -26 modifier.) For example, the interpretation by a physician of an actual electrocardiogram or electroencephalogram tracing that has been transmitted electronically, can be furnished without the patient being present in the same location as the physician. It is not necessary to consider including the PC of these services on the telehealth list for these services to be covered when furnished remotely. Moreover, when these services are furnished remotely they do not meet the definition of Medicare telehealth services under section 1834(m) of the Act. Rather, these remote services are considered physicians' services in the same way as services that are furnished in-person without the use of telecommunications technology; they are paid under the same conditions as in-person physicians' services (with no requirements regarding permissible originating sites), and should be reported in the same way as other physicians' services (that is, without the -GT or -GQ modifiers).

    * CPT codes 96103 (psychological testing (includes psychodiagnostic assessment of emotionality, intellectual abilities, personality and psychopathology, eg, MMPI), administered by a computer, with qualified health care professional interpretation and report); and, 96120 (neuropsychological testing (eg, Wisconsin Card Sorting Test), administered by a computer, with qualified health care professional interpretation and report). These services involve testing by computer, can be furnished remotely without the patient being present, and are payable in the same way as other physicians' services. These remote services are not Medicare telehealth services as defined under the Act, therefore, telehealth restrictions do not apply to these services.

    * CPT codes 90887 (interpretation or explanation of results of psychiatric, other medical examinations and procedures, or other accumulated data to family or other responsible persons, or advising them how to assist patient); 99090 (analysis of clinical data stored in computers (eg, ECGs, blood pressures, hematologic data); 99091 (collection and interpretation of physiologic data (eg, ECG, blood pressure, glucose monitoring) digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified health care professional, qualified by education, training, licensure/regulation (when applicable) requiring a minimum of 30 minutes of time); 99358 (prolonged evaluation and management service before and/or after direct patient care; first hour); and 99359 (prolonged evaluation and management service before and/or after direct patient care; each additional 30 minutes (list separately in addition to code for prolonged service). These services are not separately payable by Medicare. It would be inappropriate to include services as telehealth services when Medicare does not otherwise make a separate payment for them.

    * CPT codes 96101 (psychological testing (includes psychodiagnostic assessment of emotionality, intellectual abilities, personality and psychopathology, eg, MMPI, Rorschach, WAIS), per hour of the psychologist's or physician's time, both face-to-face time administering tests to the patient and time interpreting these test results and preparing the report); 96102 (psychological testing (includes psychodiagnostic assessment of emotionality, intellectual abilities, personality and psychopathology, eg, MMPI and WAIS), with qualified health care professional interpretation and report, administered by technician, per hour of technician time, face-to-face); 96118 (neuropsychological testing (eg, Halstead-Reitan Neuropsychological Battery, Wechsler Memory Scales and Wisconsin Card Sorting Test), per hour of the psychologist's or physician's time, both face-to-face time administering tests to the patient and time interpreting these test results and preparing the report); and, 96119 (neuropsychological testing (eg, Halstead-Reitan Neuropsychological Battery, Wechsler Memory Scales and Wisconsin Card Sorting Test), with qualified health care professional interpretation and report, administered by technician, per hour of technician time, face-to-face). These services are not similar to other services on the telehealth list, as they require close observation of how a patient responds. The requestor did not submit evidence supporting the clinical benefit of furnishing these services on a category 2 basis. As such, we are not proposing to add these services to the list of telehealth services.

    * CPT codes 57452 (colposcopy of the cervix including upper/adjacent vagina; 57454 colposcopy of the cervix including upper/adjacent vagina; with biopsy(s) of the cervix and endocervical curettage); and, 57460 (colposcopy of the cervix including upper/adjacent vagina; with loop electrode biopsy(s) of the cervix). These services are not similar to other services on the telehealth service list. Therefore, it would not be appropriate to add them on a category 1 basis. The requestor did not submit evidence supporting the clinical benefit of furnishing these services on a category 2 basis. As such, we are not proposing to add these services to the list of telehealth services.

    * HCPCS code M0064 (brief office visit for the sole purpose of monitoring or changing drug prescriptions used in the treatment of mental psychoneurotic and personality disorders) is being deleted for CY 2015. This code was created specifically to describe a service that is not subject to the statutory outpatient mental health limitation, which limited payment amounts for certain mental health services. Section 102 of the Medicare Improvements for Patients and Providers Act (Pub. L. 110-275, enacted on July 15, 2008) (MIPPA) required that the 62.5 percent outpatient mental health treatment limitation, in effect since the inception of the Medicare program, be reduced over four years. This limitation limits the percentage of allowed charges that the Medicare program paid for mental health treatment services, thus creating a larger share of beneficiary coinsurance for these services than other Medicare PFS services. Effective January 1, 2014, the limitation percentage is 100 percent, of which Medicare pays 80 percent and the beneficiary pays 20 percent, resulting in the same beneficiary cost sharing as other PFS services. Since the statute was amended to phase out the limitation, and the phase-out was complete effective January 1, 2014, Medicare no longer has a need to distinguish services subject to the mental health limitation from those that are not. Accordingly, the appropriate CPT code can now be used to bill Medicare for the services that would have otherwise been reported using M0064 and M0064 will be eliminated as a telehealth service, effective January 1, 2015.

    * Urgent Dermatologic Problems and Wound Care--The American Telehealth Association (ATA) cited several studies to support adding dermatology services to the telehealth list. However, the request did not include specific codes. Since we did not have specific codes to consider for this request, we cannot evaluate whether the services are appropriate for addition to the Medicare telehealth services list. We note that some of the services that the requester had in mind may be billed under the telehealth office visit codes or the telehealth consultation G-codes.

   In summary, we are proposing to add the following codes to the telehealth list on a category 1 basis:

    * Psychotherapy services CPT codes 90845, 90846 and 90847.

    * Prolonged service office CPT codes 99354 and 99355.

    * Annual wellness visit HCPCS codes G0438 and G0439.

3. Modifying SEC 410.78 Regarding List of Telehealth Services

   As discussed in section II.E.2. of this proposed rule, under the statute, we created an annual process for considering the addition of services to the Medicare telehealth list. Under this process, we propose services to be added to the list in the proposed rule in response to public nominations or our own initiative and seek public comments on our proposals. After consideration of public comments, we finalize additions to the list in the final rule. We also amended the regulation at SEC 410.78(b) each year to include the description of the added services. Because the list of Medicare telehealth services has grown quite lengthy, and given the many other mechanisms by which we can make the public aware of the list of Medicare telehealth services for each year, we are proposing to revise SEC 410.78(b) by deleting the description of the individual services for which Medicare payment can be made when furnished via telehealth. We would continue our current policy to address requests to add to the list of telehealth services through the PFS rulemaking process so that the public would have the opportunity to comment on additions to the list. We are also proposing to revise SEC 410.78(f) to indicate that a list of Medicare telehealth codes and descriptors is available on the CMS Web site.

F. Valuing New, Revised and Potentially Misvalued Codes

   Establishing valuations for newly created and revised CPT codes is a routine part of maintaining the PFS. Since its inception it has also been a priority to revalue services regularly to assure that the payment rates reflect the changing trends in the practice of medicine and current prices for inputs used in the PE calculations. Initially this was accomplished primarily through the five-year review process, which resulted in revised RVUs for CY 1997, CY 2002, CY 2007, and CY 2012. Under the five-year review process, revisions in RVUs were proposed in a proposed rule and finalized in a final rule. In addition to the five-year reviews, in each year beginning with CY 2009, CMS and the RUC have identified a number of potentially misvalued codes using various identification screens, such as codes with high growth rates, codes that are frequently billed together, and high expenditure codes. Section 3134 of the Affordable Care Act codified the potentially misvalued code initiative under section 1848(c)(2)(K) of the Act.

   In the CY 2012 rulemaking process, we proposed and finalized consolidation of the five-year review and the potentially misvalued code activities into an annual review of potentially misvalued codes in order to avoid redundancies in these efforts and better accomplish our goal of assuring regular assessment of code values. Under the consolidated process, we issue interim final RVUs for all revaluations and new codes in the PFS final rule with comment period, and make payment based upon those values during the calendar year covered by the final rule. (Changes in the PFS methodology that may affect valuations of a variety of codes are issued as proposals in the proposed rule). We consider and respond to any public comments on the interim final values in the final rule with comment period for the subsequent year. When consolidating these processes, we indicated that it was appropriate to establish interim values for new, revised and potentially misvalued codes because of the incongruity between the PFS rulemaking cycle and the release of codes by the AMA CPT Editorial Panel and the RUC review process. We stated that if we did not establish interim final values for revalued codes in the final rule with comment period, "a delay in implementing revised values for codes that have been identified as misvalued would perpetuate payment for the services at a rate that does not appropriately reflect the relative resources involved in furnishing the service and would continue unwarranted distortion in the payment for other services across the PFS." We also reiterated that if we did not establish interim final values for new and revised codes, we would either have to delay the use of new and revised codes for one year, or permit each Medicare contractor to establish its own payment rate for these codes. We stated, "We believe it would be contrary to the public interest to delay adopting values for new and revised codes for the initial year, especially since we have an opportunity to receive significant input from the medical community [through the RUC] before adopting the values, and the alternatives could produce undesirable levels of uncertainty and inconsistency in payment for a year."

1. Current Process for Valuing New, Revised, and Potentially Misvalued Codes

   Under the process finalized in the CY 2012 PFS final rule with comment period, in each year's proposed rule, we propose specific codes and/or groups of codes that we believe may be appropriate to consider under our potentially misvalued code initiative. As part of our process for developing the list of proposed potentially misvalued codes, we consider public nominations for potentially misvalued codes under a process also established in the CY 2012 PFS final rule with comment period. If appropriate, we include such codes in our proposed potentially misvalued code list. In the proposed rule, we solicit comments on the proposed potentially misvalued codes. We then respond to comments and establish a final list of potentially misvalued codes in the final rule for that year. These potentially misvalued codes are reviewed and revalued, if appropriate, in subsequent years. In addition, the RUC regularly identifies potentially misvalued codes using screens that have previously been identified by CMS, such as codes performed together more than 75 percent of the time.

   Generally, the first step in revaluing codes that have been identified as potentially misvalued is for the RUC to review these codes through its standard process, which includes active involvement of national specialty societies for the specialties that ordinarily use the codes. Frequently, the RUC's discussion of potentially misvalued codes will lead the CPT Editorial Panel to make adjustments to the codes involved, such as bundling of codes, creation of new codes or revisions of code descriptors. The AMA has estimated that 75 percent of all annual CPT coding changes result from the potentially misvalued code initiative.

   The RUC provides CMS with recommendations for the work values and direct PE inputs for the codes we have identified as potentially misvalued codes or, in the case of a coding revision, for the new or revised codes that will replace these potentially misvalued codes. (This process is also applied to codes that the RUC identifies using code screens that we have identified, and to new or revised codes that are issued for reasons unrelated to the potentially misvalued code process). Generally, we receive the RUC recommendations concurrently for all codes in the same family as the potentially misvalued code(s). We believe it is important to evaluate and establish appropriate work and MP RVUs and direct PE inputs for an entire code family at the same time to avoid rank order anomalies and to maintain appropriate relativity among codes. We generally receive the RUC recommendations for the code or replacement code(s) within a year or two following the identification of the code as potentially misvalued.

   We consider the RUC recommendations along with other information that we have, including information submitted by other stakeholders, and establish interim final RVUs for the potentially misvalued codes, new codes, and any other codes for which there are coding changes in the final rule with comment period for a year. There is a 60-day period for the public to comment on those interim final values after we issue the final rule. For services furnished during the calendar year following the publication of interim final rates, we pay for services based upon the interim final values established in the final rule. In the final rule with comment period for the subsequent year, we consider and respond to public comments received on the interim final values, and make any appropriate adjustments to values based on those comments. We then typically finalize the values for the codes.

   As we discussed in the CY 2012 PFS final rule with comment period, we adopted this consolidated review process to combine all coding revaluations into one annual process allowing for appropriate consideration of relativity in and across code families. In addition, this process assures that we have the benefit of the RUC recommendations for all codes being valued.

2. Concerns With Current Process.

   Some stakeholders who have experienced reductions in payments as the result of interim final valuations have objected to the process by which we revise or establish values for new, revised, and potentially misvalued codes. Some have stated that they did not receive notice of the possible reductions before they occurred. Generally, stakeholders are aware that we are considering changes in the payment rates for particular services either because CPT has made changes to codes or because we have identified the codes as potentially misvalued. As the RUC considers the appropriate value for a service, representatives of the specialties that use the codes are involved in the process. The RUC usually surveys physicians or other practitioners who furnish the services described by the codes regarding the time it takes to furnish the services, and representatives of the specialty(ies) also participate in the RUC meetings where recommendations for work RVUs and direct PE inputs are considered. Through this process, representatives of the affected specialties are generally aware of the RUC recommendations.

   Some stakeholders have asserted that even when they are aware that the RUC has made recommendations, they have no opportunity to respond to the RUC recommendations before we consider them in adopting interim final values because the RUC actions and recommendations are not public. Some stakeholders have also said that the individuals who participate in the RUC review process are not able to share the recommendations because they have signed a confidentiality agreement. We note, however, that at least one specialty society has raised funds via its Web site to fight a "pending cut" based upon its knowledge of RUC recommendations for specific codes prior to CMS action on the recommendation. Additionally, some stakeholders have pointed out that some types of suppliers that are paid under the PFS are not permitted to participate in the RUC process at all.

   We recognize that some stakeholders, including those practitioners represented by societies that are not participants in the RUC process, may not be aware of the specifics of the RUC recommendations before we consider them in establishing interim final values for new, revised, and potentially misvalued codes. We note that, as described above, before we review a service as a potentially misvalued code, we go through notice and comment rulemaking to identify it as a potentially misvalued code. Thus, the public has notice and an opportunity to comment on whether we should review the values for a code before we finalize the code as potentially misvalued and begin the valuation process. As a result, all stakeholders should be aware that a particular code is being considered as potentially misvalued and that we may establish revised interim final values in a subsequent final rule with comment period. As noted above, there may be some codes for which we receive RUC recommendations based upon their identification by the RUC through code screens that we establish. These codes are not specifically identified by CMS through notice and comment rulemaking as potentially misvalued codes. We recognize that if stakeholders are not monitoring RUC activities or evaluating Medicare claims data, they may be unaware that these codes are being reviewed and could be revalued on an interim final basis in a final rule with comment period for a year.

   In recent years, we have increased our scrutiny of the RUC recommendations and have increasingly found cause to modify the values recommended by the RUC in establishing interim final values under the PFS. Sometimes we also find it appropriate, on an interim final basis, to refine how the CPT codes are to be used for Medicare services or to create G-codes for reporting certain services to Medicare. Some stakeholders have objected to such interim final decisions because they do not learn of the CMS action until the final rule with comment period is issued. They believe they do not have an opportunity to meaningfully comment and for CMS to address their comments before the coding or valuation decision takes effect.

   We received comments on the CY 2014 PFS final rule with comment period suggesting that the existing process for review and adoption of interim final values for new, revised, and misvalued codes violates section 1871(a)(2) of the Act, which prescribes the rulemaking requirements for the agency in establishing payment rates. In response to those commenters, we note that the process we use to establish interim final rates is in full accordance with the statute and we do not find this a persuasive reason to consider modifying the process that we use to establish PFS rates.

   Our recent revaluation of the four epidural injection codes provides an example of the concerns that have been expressed with the existing process. In the CY 2014 PFS final rule with comment period, we established interim final values for four epidural injection codes, which resulted in payment reductions for the services when furnished in the office setting of between 35 percent and 56 percent. (In the facility setting, the reductions range from 17 percent to 33 percent). One of these codes had been identified as a potentially misvalued code 2 years earlier. The affected specialties had been involved in the RUC process and were generally aware that the family of codes would be revalued on an as interim basis in an upcoming rule. They were also aware that the RUC had made significant changes to the direct PE inputs, including removal of the radiographic-fluoroscopy room, which explains, in large part, the reduction to values in the office setting. The societies representing the affected specialty were also aware of significant reductions in the RUC-recommended "time" to furnish the procedures based on the most recent survey of practitioners who furnish the services, which resulted in reductions in both the work and PE portion of the values. Although the specialties were aware of the changes that the RUC was recommending to direct PE inputs, they were not specifically aware of how those changes would affect the values and payment rate. In addition, we decreased the work RVUs for these procedures because we found the RUC-recommended work RVUs did not adequately reflect the RUC-recommended decreases in time. This decision is consistent with our general practice when the best available information shows that the time involved in furnishing the service has gone down, and in the absence of information suggesting an increase in work intensity. Since the interim final values for these codes were issued in the CY 2014 PFS final rule with comment period, we have received numerous comments that will be useful to us as we consider finalizing values for these codes. If we had followed a process that involved proposing values for these codes in a proposed rule, we would have been able to consider the additional information contained in these comments prior to making payments for the services based upon revised values. (See section II.B.3.b.2 of this proposed rule for a discussion of proposed valuation of these epidural injection codes for CY 2015).

3. Alternatives to the Current Process

   Although we continue to believe the existing process for new, revised and potentially misvalued codes is an appropriate one given the incongruity between our rulemaking schedule and the CPT and RUC schedules, given our heightened review of the RUC recommendations and the increased concerns expressed by some stakeholders, we believe that an assessment of our process for valuing these codes is warranted. To that end, we have considered potential alternatives to address the timing and rulemaking issues associated with establishing values for new, revised and potentially misvalued codes (as well as for codes within the same families as these codes). Specifically, we have explored three alternatives to our current approach:

    * Propose work and MP RVUs and direct PE inputs for all new, revised and potentially misvalued codes in a proposed rule.

    * Propose changes in work and MP RVUs and direct PE inputs in the proposed rule for new, revised, and potentially misvalued codes for which we receive RUC recommendations in time; continue to establish interim final values in the final rule for other new, revised, and potentially misvalued codes.

    * Increase our efforts to make available more information about the specific issues being considered in the course of developing values for new, revised and potentially misvalued codes to increase transparency, but without making changes to the existing process for establishing values.

   A discussion of each of these alternatives follows.

   (a) Propose work and MP RVUs and direct PE inputs for new, revised and potentially misvalued codes in the proposed rule:

   Under this approach, we would evaluate the RUC recommendations for all new, revised, and potentially misvalued codes, and include proposed work and MP RVUs and direct PE inputs for the codes in the first available PFS proposed rule. We would receive and consider public comments on those proposals and establish final values in the final rule. The primary obstacle to this approach relates to the current timing of the CPT coding changes and RUC activities. Under the current calendar, all CPT coding changes and most RUC recommendations are not available to us in time to include proposed values for all codes in the proposed rule for that year.

   Therefore, if we were to adopt this proposal, which would require us to propose changes in inputs before we revalue codes based upon those values, we would need a mechanism to pay for services for which the existing codes would no longer be available or for which there would be changes for a given year.

   As we noted in the CY 2012 PFS final rule with comment period, the RUC recommendations are an essential element that we consider when valuing codes. Likewise, we recognize the significant contribution that the CPT Editorial Panel makes to the success of the potentially misvalued code initiative through its consideration and adoption of coding changes. Although we have increased our scrutiny of the RUC recommendations in recent years and accepted fewer of the recommendations without making our own refinements, the CPT codes and the RUC recommendations continue to play a major role in our valuations. For many codes, the surveys conducted by specialty societies as part of the RUC process are the best data that we have regarding the time and intensity of work. The RUC determines the criteria and the methodology for those surveys. It also reviews the survey results. This process allows for development of survey data that are more reliable and comparable across specialties and services than would be possible without having the RUC at the center of the survey vetting process. In addition, the debate and discussion of the services at the RUC meetings in which CMS staff participate provides a good understanding of what the service entails and how it compares to other services in the family, and to services furnished by other specialties. The debate among the specialties is also an important part of this process. Although we increasingly consider data and information from many other sources, and we intend to expand the scope of those data and sources, the RUC recommendations remain a vital part of our valuation process.

   Thus, if we were to adopt this approach, we would need to address how to make payment for the services for which new or revised codes take effect for the following year but for which we did not receive RUC recommendations in time to include proposed work values and PE inputs in the proposed rule. Because the annual coding changes are effective on January 1st of a year, we would need a mechanism for practitioners to report services and be paid appropriately during the interval between the date the code takes effect and the time that we receive RUC recommendations and complete rulemaking to establish values for the new and revised codes. One option would be to establish G-codes with identical descriptors to the predecessors of the new and revised codes and, to the fullest extent possible, carry over the existing values for those codes. This would effectively preserve the status quo for one year.

   The primary advantage of this approach would be that the RVUs for all services under the PFS would be established using a full notice and comment procedure, including consideration of the RUC recommendations, before they take effect. In addition to having the benefit of the RUC recommendations, this would provide the public the opportunity to comment on a specific proposal prior to it being implemented. This would be a far more transparent process, and would assure that we have the full benefit of stakeholder comments before establishing values.

   One drawback to such a process is that the use of G-codes for a significant number of codes may create an administrative burden for CMS and for practitioners. Presumably, practitioners would need to use the G-codes to report certain services for purposes of Medicare, but would use the new or revised CPT codes to report the same services to private insurers. The number of G-codes needed each year would depend on the number of CPT code changes for which we do not receive the RUC recommendations in time to formulate a proposal to be included in the proposed rule for the year. To the extent that we receive the RUC recommendations for all new and revised codes in time to develop proposed values for inclusion in the proposed rule, there would be no need to use G-codes for this purpose.

   Another drawback is that we would need to delay for at least one year the revision of values for any misvalued codes for which we do not receive RUC recommendations in time to include a proposal in the proposed rule. For a select set of codes, we would be continuing to use the RVUs for the codes for an additional year even though we know they do not reflect the most accurate resources. Since the PFS is a budget neutral system, misvalued services affect payments for all services across the fee schedule. On the other hand, if we were to take this approach, we would have the full benefit of public comments received on the proposed values for potentially misvalued services before implementing any revisions.

   (b) Propose changes in work and MP RVUs and PE inputs in the proposed rule for new, revised, and potentially misvalued codes for which we receive RUC recommendations in time; continue to establish interim final values in the final rule for other new, revised, and potentially misvalued codes:

   This alternative approach would allow for notice and comment rulemaking before we adopt values for some new, revised and potentially misvalued codes (those for which we receive RUC recommendations in time to include a proposal in the proposed rule), while others would be valued on an interim final basis (those for which we do not receive the RUC recommendations in time). Under this approach, we would establish values in a year for all new, revised, and potentially misvalued codes, and there would be no need to provide for a mechanism to continue payment for outdated codes pending receipt of the RUC recommendations and completion of a rulemaking cycle. For codes for which we do not receive the RUC recommendations in time to include a proposal in the proposed rule for a year, there would be no change from the existing valuation process.

   This would be a balanced approach that recognizes the benefits of a full opportunity for notice and comment rulemaking before establishing rates when timing allows, and the importance of establishing appropriate values for the current version of CPT codes and for potentially misvalued codes when the timing of the RUC recommendations does not allow for a full notice and comment procedure.

   However, this alternative would go only part of the way toward addressing concerns expressed by some stakeholders. For those codes for which the RUC recommendations are not received in time for us to include a proposal in the proposed rule, Medicare payment for one year would still be based on inputs established without the benefit of full public notice and comment. Another concern with this approach is that it could lead to the valuation of codes within the same family at different times depending on when we receive RUC recommendations for each code within a family. As discussed previously, we believe it is important to value an entire code family together in order to make adjustments to account appropriately for relativity within the family and between the family and other families. If we receive RUC recommendations in time to propose values for some, but not for all, codes within a family, we would respond to comments in the final rule to establish final values for some of the codes while adopting interim final values for other codes within the same family. The differences in the treatment of codes within the same family could limit our ability to value codes within the same family with appropriate relativity. Moreover, under this alternative, the main determinant of how a code would be handled would be the timing of our receipt of the RUC recommendation for the code. Although this approach would offer stakeholders the opportunity to comment on specific proposals in the proposed rule, the adoption of changes for a separate group of codes in the final rule could significantly change the proposed values simply due to the budget neutrality adjustments due to additional codes being valued in the final rule.

   (c) Increase our efforts to make available more information about the specific issues being considered in the course of developing values for new, revised and potentially misvalued codes in order to increase transparency, but without a change to the existing process for establishing values:

   The main concern with continuing our current approach is that stakeholders have expressed the desire to have adequate and timely information to permit the provision of relevant feedback to CMS for our consideration prior to establishing a payment rate for new, revised, and potentially misvalued codes. We could address some aspects of this issue by increasing the transparency of the current process. Specifically, we could make more information available on the CMS Web site before interim final values are established for codes. Examples of such information include an up-to-date list of all codes that have been identified as potentially misvalued, a list of all codes for which RUC recommendations have been received, and the RUC recommendations for all codes for which we have received them.

   Although the posting of this information would significantly increase transparency for all stakeholders, it still would not allow for full notice and comment rulemaking procedures before values are established for payment purposes. Nor would it provide the public with advance information about whether or how we will make refinements to the RUC recommendations or coding decisions in the final rule with comment period. Thus, stakeholders would not have an opportunity to provide input on our potential modifications before interim final values are adopted.

4. Proposal To Modify the Process for Establishing Values for New, Revised, and Potentially Misvalued Codes

   After considering the current process, including its strengths and weaknesses, and the alternatives to the current process described previously, we are proposing to modify our process to make all changes in the work and MP RVUs and the direct PE inputs for new, revised and potentially misvalued services under the PFS by proposing the changes in the proposed rule, beginning with the PFS proposed rule for CY 2016. We propose to include proposed values for all new, revised and potentially misvalued codes for which we have complete RUC recommendations by January 15th of the preceding year. For the CY 2016 rulemaking process, we would include in the proposed rule proposed values for all services for which we have RUC recommendations by January 15, 2015.

   For those codes for which we do not receive the RUC recommendations by January 15th of a year, we would delay revaluing the code for one year (or until we receive RUC recommendations for the code before January 15th of a year) and include proposed values in the following year's rule. Thus, we would include proposed values prior to using the new code (in the case of new or revised codes) or revising the value (in the case of potentially misvalued codes). Due to the complexities involved in code changes and rate setting, there could be some circumstances where, even when we receive the RUC recommendations by January 15th of a year, we are not able to propose values in that year's proposed rule. For example, we might not have recommendations for the whole family or we might need additional information to appropriately value these codes. In situations where it would not be appropriate or possible to propose values for certain new, revised, or potentially misvalued codes, we would treat them in the same way as those for which we did not receive recommendations before January 15th.

   For new, revised, and potentially misvalued codes for which we do not receive RUC recommendations before January 15th of a year, we propose to adopt coding policies and payment rates that conform, to the extent possible, to the policies and rates in place for the previous year. We would adopt these conforming policies on an interim basis pending our consideration of the RUC recommendations and the completion of notice and comment rulemaking to establish values for the codes. For codes for which there is no change in the CPT code, it is a simple matter to continue the current valuation. For services for which there are CPT coding changes, it is more complicated to maintain the current payment rates until the codes can be valued through the notice and comment rulemaking process. Since the changes in CPT codes are effective on January 1st of a year, and we would not have established values for the new or revised codes (or other codes within the code family), it would not be practicable for Medicare to use those CPT codes. For codes that were revised or deleted as part of the annual CPT coding changes, when the changes could affect the value of a code and we have not had an opportunity to consider the relevant RUC recommendations prior to the proposed rule, we propose to create G-codes to describe the predecessor codes to these codes. If CPT codes are revised in a manner that would not affect the resource inputs used to value the service, (for example, a grammatical changes to CPT code descriptors,) we could use these revised codes and continue to pay at the rate developed through the use of the same resource inputs. For example, if a single CPT code was separated into two codes and we did not receive RUC recommendations for the two codes before January 15th of the year, we would assign each of those new codes an "I" status indicator (which denotes that the codes are "not valid for Medicare purposes"), and those codes could not be used for Medicare payment during the year. Instead we would create a G-code with the same description as the single predecessor CPT code and continue to use the same inputs as the predecessor CPT code for that G-code during the year.

   For new codes that describe wholly new services, as opposed to new or revised codes that describe services which are already on the PFS, we would make every effort to work with the RUC to ensure that we receive recommendations in time to include proposed values in the proposed rule. However, if we do not receive timely recommendations from the RUC for such a code and we determine that it is in the public interest for Medicare to use a new code during the code's initial year, we would need to establish values for the code's initial year. As we do under our current policy, if we receive the RUC recommendations in time to consider them for the final rule, we propose to establish values for the initial year on an interim final basis subject to comment in the final rule. In the event we do not receive RUC recommendations in time to consider them for the final rule, or in other situations where it would not be appropriate to establish interim final values (for example, because of a lack of necessary information about the work or the price of the PE inputs involved), we would contractor price the code for the initial year.

   We propose to modify the regulation at SEC 414.24 to codify the process described above.

   We recognize that the use of G-codes, especially if there are many of them in a given year, may place an administrative burden on those who bill for services under the PFS. We also recognize that, to the extent we do not receive RUC recommendations in time to include proposed values in the proposed rule, the most updated version of some CPT codes would not be used by the Medicare program for the first year. The AMA has been working to develop timeframes that would allow a much greater percentage of codes to be addressed in the proposed rule and has shared with us some plans to achieve this goal. We appreciate AMA's efforts and are hopeful that if this proposal is adopted the CPT Editorial Panel and the RUC ultimately will be able to adjust their timelines and processes so that most, if not all, of the annual coding changes and valuation recommendations can be addressed in the proposed rule prior to the effective date of the coding changes.

   As discussed previously, the work of the AMA through the CPT Editorial Panel and the RUC are critical elements in the appropriate valuation of services under the PFS. We have proposed implementation of the revised CMS process for establishing values for new, revised, and potentially misvalued codes for CY 2016; but would consider alternative implementation dates to allow time for the CPT Editorial Panel and the RUC to adjust their schedules to avoid the necessity to use G-codes.

   With regard to this proposal, we would be specifically interested in comments on the following topics:

    * Is this proposal preferable to the present process? Is another one of the alternatives better?

    * If we were to implement this proposal, is it better to move forward with the changes, or is more time needed to make the transition such that implementation should be delayed beyond CY 2016? What factors should we consider in selecting an implementation date?

    * Are there alternatives other than the use of G-codes that would allow us to address the annual CPT changes through notice and comment rather than interim final rulemaking?

5. Refinement Panel

   As discussed in the 1993 PFS final rule with comment period (57 FR 55938), we adopted a refinement panel process to assist us in reviewing the public comments on CPT codes with interim final work RVUs for a year and in developing final work values for the subsequent year. We decided the panel would be comprised of a multispecialty group of physicians who would review and discuss the work involved in each procedure under review, and then each panel member would individually rate the work of the procedure. We believed establishing the panel with a multispecialty group would balance the interests of the specialty societies who commented on the work RVUs with the budgetary and redistributive effects that could occur if we accepted extensive increases in work RVUs across a broad range of services.

   Following enactment of section 1848(c)(2)(K) of the Act, which required the Secretary periodically to review potentially misvalued codes and make appropriate adjustments to the RVUs, we reassessed the refinement panel process. As detailed in the CY 2011 PFS final rule with comment period (75 FR 73306), we continued using the established refinement panel process with some modifications.

   As we consider changes to the processes for valuing codes, we are reassessing the role that the refinement panel process plays in the code valuation process. As we note in the discussion above, the current refinement panel process is tied to interim final values. It provides an opportunity for stakeholders to provide new clinical information that was not available at the time of the RUC valuation that might affect work RVU values that are adopted in the interim final value process. If our proposal to modify the valuation process for new, revised and potentially misvalued codes is adopted, there would no longer be interim final values except for a very few codes that describe totally new services. Thus, we are proposing to eliminate the refinement panel process. By using the proposed process for new, revised, and potentially misvalued codes, we believe that the consideration of additional clinical information and any other issues associated with the CMS proposed values could be addressed through the notice and public comment process. Similarly, prior to CY 2012 when we consolidated the five-year valuation, changes made as part of the five-year review process were addressed in the proposed rule and those codes were generally not subject to the refinement process. The notice and comment process would provide stakeholders with complete information on the basis and rationale for our proposed inputs and any relating coding policies. We also note that an increasing number of requests for refinement do not include new clinical information that was not available at the time of the RUC meeting that would justify a change in the work RVUs, in accordance with the current requirements for refinement. Thus, we do not believe the elimination of the refinement panel process would negatively affect the code valuation process. We believe the proposed process, which includes a full notice and comment procedure before values are used for purposes of payment, offers stakeholders a better mechanism for providing any additional data for our consideration and discussing any concerns with our proposed values than the current refinement process.

G. Chronic Care Management (CCM)

   As we discussed in the CY 2013 PFS final rule with comment period, we are committed to supporting primary care and we have increasingly recognized care management as one of the critical components of primary care that contributes to better health for individuals and reduced expenditure growth (77 FR 68978). Accordingly, we have prioritized the development and implementation of a series of initiatives designed to improve payment for, and encourage long-term investment in, care management services. These initiatives include the following programs and demonstrations:

    * The Medicare Shared Savings Program (described in "Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Final Rule," which appeared in the November 2, 2011Federal Register (76 FR 67802)).

    * The testing of the Pioneer ACO model, designed for experienced health care organizations (described on the Center for Medicare and Medicaid Innovation's (Innovation Center's) Web site at http://innovation.cms.gov/initiatives/Pioneer-ACO-Model/index.html).

    * The testing of the Advance Payment ACO model, designed to support organizations participating in the Medicare Shared Savings Program (described on the Innovation Center's Web site at http://innovation.cms.gov/initiatives/Advance-Payment-ACO-Model/).

    * The Primary Care Incentive Payment (PCIP) Program (described on the CMS Web site at www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/PCIP-2011-Payments.pdf).

    * The patient-centered medical home model in the Multi-payer Advanced Primary Care Practice (MAPCP) Demonstration designed to test whether the quality and coordination of health care services are improved by making advanced primary care practices more broadly available (described on the CMS Web site at www.cms.gov/Medicare/Demonstration-Projects/DemoProjectsEvalRpts/downloads/mapcpdemo_Factsheet.pdf).

    * The Federally Qualified Health Center (FQHC) Advanced Primary Care Practice demonstration (described on the CMS Web site at http://www.cms.gov/Medicare/Demonstration-Projects/DemoProjectsEvalRpts/Downloads/FQHC_APCP_Demo_FAQsOct2011.pdf and the Innovation Center's Web site at www.innovations.cms.gov/initiatives/FQHCs/index.html).

    * The Comprehensive Primary Care (CPC) initiative (described on the Innovation Center's Web site at http://innovations.cms.gov/initiatives/Comprehensive-Primary-Care-Initiative/index.html). The CPC initiative is a multi-payer initiative fostering collaboration between public and private health care payers to strengthen primary care in certain markets across the country.

   In addition, HHS leads a broad initiative focused on optimizing health and quality of life for individuals with multiple chronic conditions. HHS's Strategic Framework on Multiple Chronic Conditions outlines specific objectives and strategies for HHS and private sector partners centered on strengthening the health care and public health systems; empowering the individual to use self-care management with the assistance of a healthcare provider who can assess the patient's health literacy level; equipping care providers with tools, information, and other interventions; and supporting targeted research about individuals with multiple chronic conditions and effective interventions. Further information on this initiative is available on the HHS Web site at http://www.hhs.gov/ash/initiatives/mcc/index.html.

   In coordination with all of these initiatives, we also have continued to explore potential refinements to the PFS that would appropriately value care management within Medicare's statutory structure for fee-for-service physician payment and quality reporting. For example, in the CY 2013 PFS final rule with comment period, we adopted a policy to pay separately for care management involving the transition of a beneficiary from care furnished by a treating physician during a hospital stay to care furnished by the beneficiary's primary physician in the community (77 FR 68978 through 68993).

   In the CY 2014 PFS final rule with comment period, we finalized a policy to pay separately for care management services furnished to Medicare beneficiaries with two or more chronic conditions beginning in CY 2015 (78 FR 74414).

1. Valuation of CCM Services--GXXX1

   CCM is a unique PFS service designed to pay separately for non-face-to-face care coordination services furnished to Medicare beneficiaries with two or more chronic conditions. (See 78 FR 74414 for a more complete description of the beneficiaries for whom this service may be billed.) In the CY 2014 PFS final rule with comment period, we indicated that, to recognize the additional resources required to provide CCM services to patients with multiple chronic conditions, we were creating the following code to use for reporting this service (78 FR 74422):

    * GXXX1 Chronic care management services furnished to patients with multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient, that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline; 20 minutes or more; per 30 days.

   Although this service is unique in that it was created to separately pay for care management services, other codes include care management components. To value CCM, we compared it to other codes that involve care management. In doing so, we concluded that the CCM services were similar in work (time and intensity) to that of the non-face-to-face portion of transitional care management (TCM) services (CPT code 99495 (Transitional Care Management Services with the following required elements: Communication (direct contact, telephone, electronic) with the patient and/or caregiver within 2 business days of discharge Medical decision making of at least moderate complexity during the service period Face-to-face visit, within 14 calendar days of discharge)).

   Accordingly, we used the work RVU and work time associated with the non-face-to-face portion of CPT code 99495 as a foundation to determine our proposed values for CCM services. Specifically, we are proposing a work RVU for GXXX1 of 0.61, which is the portion of the work RVU for CPT code 99495 that remains after subtracting the work attributable to the face-to-face visit. (CPT code 99214 (office/outpatient visit est) was used to value CPT code 99495), which has a work RVU of 1.50.) Similarly, we are proposing a work time of 15 minutes for HCPCS code GXXX1 for CY 2015 based on the time attributable to the non-face-to-face portion of CPT 99495. The work time file associated with this PFS proposed rule is available on the CMS Web site in the Downloads section for the CY 2015 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

   For direct PE inputs, we are proposing 20 minutes of clinical labor time. As established in the CY 2014 PFS final rule with comment period, in order to bill for this code, at least 20 minutes of CCM services must be furnished during the 30-day billing interval (78 FR 74422). Based upon input from stakeholders and the nature of care management services, we believe that many aspects of this service will be provided by clinical staff, and thus, clinical staff will be involved in the typical service for the full 20 minutes. The proposed CY 2015 direct PE input database reflects this input and is available on the CMS Web site under the supporting data files for the CY 2015 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The proposed PE RVUs included in Addendum B to this proposed rule reflect the RVUs that result from using these inputs to establish PE RVUs.

   The proposed MP RVU was calculated using the weighted risk factors for the specialties that we believe will furnish this service. We believe this malpractice risk factor appropriately reflects the relative malpractice risk associated with furnishing CCM services. The MP RVU included in Addendum B of this proposed rule reflects the RVU that results from the application of this proposal.

2. CCM and TCM Services Furnished Incident to a Physician's Service Under General Physician Supervision

   In the CY 2014 PFS final rule with comment period (75 FR 74425 through 74427), we discussed how the policies relating to services furnished incident to a practitioner's professional services apply to CCM services. (In this discussion, the term practitioner means both physicians and NPPs who are permitted to bill for services furnished incident to their own professional services.) Specifically, we addressed the policy for counting clinical staff time for services furnished incident to the billing practitioner's services toward the minimum amount of service time required to bill for CCM services.

   We established an exception to the usual rules that apply to services furnished incident to the services of a billing practitioner. Generally, under the "incident to" rules, practitioners may bill for services furnished incident to their own services if the services meet the requirements specified in our regulations at SEC 410.26. One of these requirements is that the "incident to" services must be furnished under direct supervision, which means that the supervising practitioner must be present in the office suite and be immediately available to provide assistance and direction throughout the service (but does not mean that the supervising practitioner must be present in the room where the service is furnished). We noted in last year's PFS final rule with comment period that because one of the required elements of the CCM service is the availability to a beneficiary 24-hours-a-day, 7-days-a-week to address the patient's chronic care needs (78 FR 74426) that we expect the beneficiary to be provided with a means to make timely contact with health care providers in the practice whenever necessary to address chronic care needs regardless of the time of day or day of the week. In those cases when the need for contact arises outside normal business hours, it is likely that the patient's initial contact would be with clinical staff employed by the practice (for example, a nurse) and not necessarily with a practitioner. Under these circumstances, it would be unlikely that a practitioner would be available to provide direct supervision of the service.

   Therefore, in the CY 2014 PFS final rule with comment period, we created an exception to the generally applicable requirement that "incident to" services must be furnished under direct supervision. Specifically, we finalized a policy to require only general, rather than direct, supervision when CCM services are furnished incident to a practitioner's services outside of the practice's normal business hours by clinical staff who are direct employees of the practitioner or practice. We explained that, given the potential risk to patients that the exception to direct supervision could create, we believed that it was appropriate to design the exception as narrowly as possible (78 FR 74426). The direct employment requirement was intended to balance the less stringent general supervision requirement by ensuring that there is a direct oversight relationship between the supervising practitioner and the clinical staff personnel who provide after hours services.

   In this rule, we are proposing to revise the policy that we adopted in the CY 2014 PFS final rule with comment period, and to amend our regulations to codify the requirements for CCM services furnished incident to a practitioner's services. Specifically, we are proposing to remove the requirement that, in order to count the time spent by clinical staff providing aspects of CCM services toward the CCM time requirement, the clinical staff person must be a direct employee of the practitioner or the practitioner's practice. (We note that the existing requirement that these services be provided by clinical staff, specifically, rather than by other auxiliary personnel is an element of the service for both CCM and TCM services, rather than a requirement imposed by the "incident to" rules themselves.) We are also proposing to remove the restriction that services provided by clinical staff under general (rather than direct) supervision may be counted only if they are provided outside of the practice's normal business hours. Under our proposed revised policy, then, the time spent by clinical staff providing aspects of CCM services can be counted toward the CCM time requirement at any time, provided that the clinical staff are under the general supervision of a practitioner and all requirements of the "incident to" regulations at SEC 410.26 are met.

   We are proposing to revise these aspects of the policy for several reasons. First, one of the required elements of the CCM service is the availability of a means for the beneficiary to make contact with health care practitioners in the practice to address a patient's urgent chronic care needs (78 FR 74418 through 74419). Other elements within the scope of CCM services are similarly required to be furnished by practitioners or clinical staff. We believe that these elements of the CCM scope of service require the presence of an organizational infrastructure sufficient to adequately support CCM services, irrespective of the nature of the employment or contractual relationship between the clinical staff and the practitioner or practice. We also believe that the elements of the CCM scope of service, such as the requirement of a care plan, ensure a close relationship between a practitioner furnishing ongoing care for a beneficiary and clinical staff providing aspects of CCM services under general supervision; and that this close working relationship is sufficient to render a requirement of a direct employment relationship or direct supervision unnecessary. Under our proposal, CCM services could be furnished "incident to" under general supervision if the auxiliary personnel providing the services in conjunction with CCM services are clinical staff, and whether or not they are direct employees of the practitioner or practice billing for the service; but the clinical staff must meet the requirements for auxiliary personnel contained in SEC 410.26(a)(1). Other than the exception to permit general supervision for clinical staff, the same requirements apply to CCM services furnished incident to a practitioner's professional services as apply to other "incident to" services. Furthermore, since last year's final rule, we have had many consultations with physicians and others about the organizational structures and other factors that contribute to effective provision of CCM services. These consultations have convinced us that, for purposes of clinical staff providing aspects of CCM services, it does not matter whether the practitioner is directly available to supervise because the nature of the services are such that they can be, and frequently are, provided outside of normal business hours or while the physician is away from the office during normal business hours. This is because, unlike most other services to which the "incident to" rules apply, the CCM services are intrinsically non-face-to-face care coordination services.

   In conjunction with this proposed revision to the requirements for CCM services provided by clinical staff incident to the services of a practitioner, we are also proposing to adopt the same requirements for equivalent purposes in relation to TCM services. As in the case of CCM, TCM explicitly includes separate payment for services that are not necessarily furnished face-to-face, such as coordination with other providers and follow-up with patients. It would also not be uncommon for auxiliary personnel to provide elements of the TCM services when the physician was not in the office. Generally, we believe that it is appropriate to treat separately billable care coordination services similarly whether in the form of CCM or TCM. We also believe that it would be appropriate to apply the same "incident to" rules that we are proposing for CCM services to TCM services. We are not proposing to extend this policy to the E/M service that is a required element of TCM. Rather, the required E/M service must still be furnished under direct supervision.

   Therefore, we are proposing to revise our regulation at SEC 410.26, which sets out the applicable requirements for "incident to" services, to permit TCM and CCM services provided by clinical staff incident to the services of a practitioner to be furnished under the general supervision of a physician or other practitioner. As with other "incident to" services, the physician (or other practitioner) supervising the auxiliary personnel need not be the same physician (or other practitioner) upon whose professional service the "incident to" service is based. We note that all other "incident to" requirements continue to apply and that documentation of services provided must be included in the medical record.

3. Scope of Services and Standards for CCM Services

   In the CY 2014 final rule with comment period (78 FR 74414 through 74428), we defined the elements of the scope of service for CCM services required in order for a practitioner to bill Medicare for CCM services. In addition, we indicated that we intended to develop standards for practices that furnish CCM services to ensure that the practitioners who bill for these services have the capability to fully furnish them (78 FR 74415, 74418). At that time, we anticipated that we would propose these standards in this proposed rule. We actively sought input toward development of these standards by soliciting public comments on the CY 2014 PFS final rule with comment period, through outreach to stakeholders in meetings, by convening a Technical Expert Panel, and by collaborating with federal partners such as the Office of the Assistant Secretary for Planning and Evaluation, the Office of the Assistant Secretary for Health, the Office of the National Coordinator for Health Information Technology, and the Health Resources and Services Administration. Our goal is to recognize the trend toward practice transformation and overall improved quality of care, while preventing unwanted and unnecessary care.

   As we worked to develop appropriate practice standards that would meet this goal, we consistently found that many of the standards we thought were important overlapped in significant ways with the scope of service or with the billing requirements for the CCM services that had been finalized in the CY 2014 final rule with comment period. In cases where the standards we identified were not unique to CCM requirements, we found that the standards overlapped with other Medicare requirements or other federal requirements that apply generally to health care practitioners. Based upon the feedback we had received, we sought to avoid duplicating other requirements or, worse, imposing conflicting requirements on practitioners that would furnish CCM services. Given the standards and requirements already in place for health care practitioners and that will apply to those who furnish and bill for CCM services, we have decided not to propose an additional set of standards that must be met in order for practitioners to furnish and bill for CCM services. Instead of proposing a new set of standards applicable to only CCM services, we have decided to emphasize that certain requirements are inherent in the elements of the existing scope of service for CCM services, and clarify that these must be met in order to bill for CCM services.

   In one area--that of electronic health records--we are concerned that the existing elements of the CCM service could leave some gaps in assuring that beneficiaries consistently receive care management services that offer the benefits of advanced primary care as it was envisioned when this service was created. It is clear that effective care management can be accomplished only through regular monitoring of the patient's health status, needs, and services, and through frequent communication and exchange of information with the beneficiary and among health care practitioners treating the beneficiary. As a part of the CY 2014 PFS final rule with comment period (78 FR 43338 through 43339), we specified that the electronic health record for a patient receiving CCM services should include a full list of problems, medications and medication allergies in order to inform the care plan, care coordination, and ongoing clinical care. Furthermore, those furnishing CCM services must be able to facilitate communication of relevant patient information through electronic exchange of a summary care record with other health care providers as a part of managing health care transitions. We believe that if care is to be coordinated effectively, all communication must be timely, and it must include the information that each team member needs to know to furnish care that is congruent with a patient's needs and preferences. In addition, those furnishing CCM services need to establish reliable flows of information from emergency departments, hospitals, and providers of post-acute care services to track their CCM patients receiving care in those settings. Reliable information flow supports care transitions, and can be used to assess the need for modifications of the care plan that will reduce the risk of readmissions, increased morbidity, or mortality.

   After gathering input from stakeholders, we believe that requiring those who furnish CCM services to utilize electronic health record technology that has been certified by a certifying body authorized by the National Coordinator for Health Information Technology will ensure that practitioners have adequate capabilities to allow members of the interdisciplinary care team to have immediate access to the most updated information informing the care plan. Furthermore, we believe that requiring those that furnish CCM services to maintain and share an electronic care plan will alleviate the development of duplicative care plans or updates and the associated errors that can occur when care plans are not systematically reconciled. To ensure that practices offering CCM services meet these needs, we are proposing a new scope of service requirement for electronic care planning capabilities and electronic health records. Specifically, we are proposing that CCM services must be furnished with the use of an electronic health record or other health IT or health information exchange platform that includes an electronic care plan that is accessible to all providers within the practice, including being accessible to those who are furnishing care outside of normal business hours, and that is available to be shared electronically with care team members outside of the practice. To ensure all practices have adequate capabilities to meet electronic health record requirements, the practitioner must utilize EHR technology certified by a certifying body authorized by the National Coordinator for Health Information Technology to an edition of the electronic health record certification criteria identified in the then-applicable version of 45 CFR part 170. At a minimum, the practice must utilize EHR technology that meets the certification criteria adopted at 45 CFR 170.314(a)(3), 170.314(a)(4), 170.314(a)(5), 170.314(a)(6), 170.314(a)(7) and 170.314(e)(2) pertaining to the capture of demographics, problem lists, medications, and other key elements related to the ultimate creation of an electronic summary care record. For example, practitioners furnishing CCM services beginning in CY 2015 would be required to utilize an electronic health record certified to at least those 2014 Edition certification criteria. Given these certification criteria, EHR technology would be certified to capture data and ultimately produce summary records according to the HL7 Consolidated Clinical Document Architecture standard (see 45 CFR 170.205(a)(3)). When any of the CCM scope of service requirements include a reference to a health or medical record, a system meeting these requirements is required.

   We believe this scope of service element will ensure that practitioners have adequate capabilities to fully furnish CCM services, allow practitioners to innovate around the systems that they use to furnish these services, and avoid overburdening small practices. We believe that allowing flexibility as to how providers capture, update, and share care plan information is important at this stage given the maturity of current electronic health record standards and other electronic tools in use in the market today for care planning.

   In addition to seeking comment on this new proposed scope of service element, we are seeking comment on any changes to the scope of service or billing requirements for CCM services that may be necessary to ensure that the practitioners who bill for these services have the capability to furnish them and that we can appropriately monitor billing for these services.

   To assist stakeholders in commenting, we remind you of the elements of the current scope of service for CCM services that are required in order for a practitioner to bill Medicare for CCM services as finalized in the CY 2014 final rule with comment period. We would note that additional explanation of these elements can be found at 78 FR 74414 through 74428. The CCM service includes:

    * Access to care management services 24-hours-a-day, 7-days-a-week, which means providing beneficiaries with a means to make timely contact with health care providers in the practice to address the patient's urgent chronic care needs regardless of the time of day or day of the week.

    * Continuity of care with a designated practitioner or member of the care team with whom the patient is able to get successive routine appointments.

    * Care management for chronic conditions including systematic assessment of patient's medical, functional, and psychosocial needs; system-based approaches to ensure timely receipt of all recommended preventive care services; medication reconciliation with review of adherence and potential interactions; and oversight of patient self-management of medications.

    * Creation of a patient-centered care plan document to assure that care is provided in a way that is congruent with patient choices and values. A plan of care is based on a physical, mental, cognitive, psychosocial, functional and environmental (re)assessment and an inventory of resources and supports. It is a comprehensive plan of care for all health issues.

    * Management of care transitions between and among health care providers and settings, including referrals to other clinicians, follow-up after a beneficiary visit to an emergency department, and follow-up after discharges from hospitals, skilled nursing facilities, or other health care facilities.

    * Coordination with home and community based clinical service providers as appropriate to support a beneficiary's 's psychosocial needs and functional deficits.

    * Enhanced opportunities for a beneficiary and any relevant caregiver to communicate with the practitioner regarding the beneficiary's care through, not only telephone access, but also through the use of secure messaging, internet or other asynchronous non face-to-face consultation methods.

   Similarly, we remind stakeholders that in the CY 2014 final rule, we established particular billing requirements for CCM services that require the practitioner to:

    * Inform the beneficiary about the availability of the CCM services from the practitioner and obtain his or her written agreement to have the services provided, including the beneficiary's authorization for the electronic communication of the patient's medical information with other treating providers as part of care coordination.

    * Document in the patient's medical record that all of the CCM services were explained and offered to the patient, and note the beneficiary's decision to accept or decline these services.

    * Provide the beneficiary a written or electronic copy of the care plan and document in the electronic medical record that the care plan was provided to the beneficiary.

    * Inform the beneficiary of the right to stop the CCM services at any time (effective at the end of a 30-day period) and the effect of a revocation of the agreement on CCM services.

    * Inform the beneficiary that only one practitioner can furnish and be paid for these services during the 30-day period.

   With the addition of the electronic health record element that we are proposing, we believe that these elements of the scope of service for CCM services, when combined with other important federal health and safety regulations, provide sufficient assurance that Medicare beneficiaries receiving CCM services will receive appropriate services. However, we remain interested in receiving public feedback regarding any meaningful elements of the CCM service or beneficiary protections that may be missing from these scope of service elements and billing requirements. We encourage commenters, in recommending additional possible elements or safeguards, to provide as much specific detail as possible regarding their recommendations and how they can be applied to the broad complement of practitioners who may furnish CCM services under the PFS.

4. Payment of CCM Services in CMS Models and Demonstrations

   As discussed above, several CMS models and demonstrations address payment for care management services. The Multi-payer Advanced Primary Care Practice Demonstration and the Comprehensive Primary Care Initiative both include payments for care management services that closely overlap with the scope of service for the new chronic care management services code. In these two initiatives, primary care practices are receiving per beneficiary per month payments for care management services furnished to Medicare fee-for-service beneficiaries attributed to their practices. We propose that practitioners participating in one of these two models may not bill Medicare for CCM services furnished to any beneficiary attributed to the practice for purposes of participating in one of these initiatives, as we believe the payment for CCM services would be a duplicative payment for substantially the same services for which payment is made through the per beneficiary per month payment. However, we propose that these practitioners may bill Medicare for CCM services furnished to eligible beneficiaries who are not attributed to the practice for the purpose of the practice's participation as part of one of these initiatives. As the Innovation Center implements new models or demonstrations that include payments for care management services, or as changes take place affecting existing models or demonstrations, we will address potential overlaps with CCM and seek to implement appropriate reimbursement policies. We welcome comments on this proposal. We also solicit comments on the extent to which these services may not actually be duplicative and, if so, how our reimbursement policy could be tailored to address those situations.

H. Definition of Colorectal Cancer Screening Tests

   Section 1861(pp) of the Act defines "colorectal cancer screening tests" and, under section 1861(pp)(1)(C), a "screening colonoscopy" is one of the recognized procedures. Among other things, section 1861(pp)(1)(D) of the Act authorizes the Secretary to modify the tests and procedures covered under this subsection, "with such frequency and payment limits, as the Secretary determines appropriate," in consultation with appropriate organizations. The current definition of "colorectal cancer screening tests" at SEC 410.37(a)(1) includes "screening colonoscopies." Until recently, the prevailing standard of care for screening colonoscopies has been moderate sedation provided intravenously by the endoscopist, without resort to separately provided anesthesia. /1/ Based on this standard of care, payment for moderate sedation has accordingly been bundled into the payment for the colorectal cancer screening tests, (for example, G0104, G0105). For these procedures, because moderate sedation is bundled into the payment, the same physician cannot also report a sedation code. An anesthesia service can be billed by a second physician.

   FOOTNOTE 1 Faulx, A.L. et al. (2005). The changing landscape of practice patterns regarding unsedated colonoscopy and propofol use: A national web survey. Gastrointestinal Endoscopy, 62. 9-15. END FOOTNOTE

   However, a recent study in The Journal of the American Medical Association (JAMA) cited an increase in the percentage of colonoscopies and upper endoscopy procedures furnished using an anesthesia professional, from 13.5 percent in 2003 to 30.2 percent in 2009 within the Medicare population, with a similar increase in the commercially-insured population. /2/ A 2010 study projected that the percentage of this class of procedures involving an anesthesia professional would grow to 53.4 percent by 2015. /3/ These studies suggest that the prevailing standard of care for endoscopies in general and screening colonoscopies in particular is undergoing a transition, and that anesthesia separately provided by an anesthesia professional is becoming the prevalent practice. After reviewing these studies, we analyzed Medicare claims data and found that the same trend was observed in screening colonoscopies for Medicare beneficiaries. We found that in 53 percent of screening colonoscopies for which Medicare claims were submitted in 2013 a separate anesthesia claim was reported.

   FOOTNOTE 2 Liu H, Waxman DA, Main R, Mattke S. Utilization of Anesthesia Services during Outpatient Endoscopies and Colonoscopies and Associated Spending in 2003-2009. (2012). JAMA, 307(11):1178-1184. END FOOTNOTE

   FOOTNOTE 3 Inadomi, J.M. et al. (2010). Projected increased growth rate of anesthesia professional-delivered sedation for colonoscopy and EGD in the United States: 2009 to 2015. Gastrointestinal Endoscopy, 72, 580-586. END FOOTNOTE

   In light of these developments, we are concerned that the mere reference to "screening colonoscopies" in the definition of "colorectal cancer screening tests" has become inadequate. Indeed, we are convinced that the growing prevalence of separately provided anesthesia services in conjunction with screening colonoscopies reflects a change in practice patterns. Therefore, consistent with the authority delegated by section 1861(pp)(1)(D) of the Act, we believe it is appropriate to revise the definition of "colorectal cancer screening tests" to adequately reflect these new patterns. Accordingly, we are proposing to revise the definition of "colorectal cancer screening tests" at SEC 410.37(a)(1)(iii) to include anesthesia that is separately furnished in conjunction with screening colonoscopies.

   Our proposal to revise the definition of "colorectal cancer screening tests" in this manner would further reduce our beneficiaries' cost-sharing obligations under Part B. Screening colonoscopies have been recommended with a grade of A by the United States Preventive Services Task Force (USPSTF) and SEC 410.152(l)(5) provides that Medicare Part B pays 100 percent of the Medicare payment amount established under the PFS for colorectal cancer screening tests except for barium enemas (which do not have a grade A or B recommendation from the USPSTF). This regulation is based on section 4104 of the Affordable Care Act, which amended section 1833(a)(1) of the Act to require 100 percent Medicare payment of the fee schedule amount for those "preventive services" that are appropriate for the individual and are recommended with a grade of A or B by the USPSTF. Section 4104 effectively waives any Part B coinsurance that would otherwise apply under section 1833(a)(1) of the Act for certain recommended preventive services, including screening colonoscopies. For additional discussion of the impact of section 4104 of the Affordable Care Act, and our prior rulemaking based on this provision see the CY 2011 PFS final rule with comment period (75 FR 73412 through 73431). We also note that under SEC 410.160(b)(7) colorectal cancer screening tests are not subject to the Part B annual deductible and do not count toward meeting that deductible.

   In implementing the amendments made by section 4104 of the Affordable Care Act, we did not provide at that time for waiving the Part B deductible and coinsurance for covered anesthesia services separately furnished in conjunction with screening colonoscopies. At that time, we believed that our payment for the screening colonoscopy, which included payment for moderate sedation services, reflected the typical screening colonoscopy. Under the current regulations, Medicare beneficiaries who receive anesthesia from a different professional than the one furnishing the screening colonoscopy would be incurring costs for the coinsurance and deductible under Part B for those separate services. With the changes in the standard of care and shifting practice patterns toward increased use of anesthesia in conjunction with screening colonoscopy, beneficiaries who receive covered anesthesia services from a different professional than the one furnishing the colonoscopy would incur costs for any coinsurance and any unmet part of the deductible for this component of the service. However, our proposed revision to the definition of "colorectal cancer screening tests" would lead to Medicare paying 100 percent of the fee schedule amounts for screening colonoscopies, including any portion attributable to anesthesia services furnished by a separate practitioner in conjunction with such tests, under SEC 410.152(l)(5). Similarly, this revision would also mean that expenses incurred for a screening colonoscopy, and the anesthesia services furnished in conjunction with such tests, will not be subject to the Part B deductible and will not count toward meeting that deductible under SEC 410.160(b)(7). If adopted, we believe this proposal will encourage more beneficiaries to obtain a screening colonoscopy, which is consistent with the intent of the statutory provision to waive Medicare cost-sharing for certain recommended preventive services, and is consistent with the authority delegated to the Secretary in section 1861(pp)(1)(D) of the Act.

   In light of the changing practice patterns for screening colonoscopies, continuing to require Medicare beneficiaries to bear the deductible and coinsurance expenses for separately billed anesthesia services furnished and covered by Medicare in conjunction with screening colonoscopies could become a significant barrier to these essential preventive services. As we noted when we implemented the provisions of the Affordable Care Act waiving the Part B deductible and coinsurance for these preventive services, the goal of these provisions was to eliminate financial barriers so that beneficiaries would not be deterred from receiving them (75 FR 73412). Therefore, we are exercising our authority under section 1861(pp)(1)(D) of the Act to propose a revision to the definition of colorectal cancer screening tests to encourage beneficiaries to seek these services by extending the waiver of coinsurance and deductible to anesthesia or sedation services furnished in conjunction with a screening colonoscopy.

   We note that, in implementing these proposed revisions to the regulations, it will be necessary to establish a modifier for use when billing the relevant anesthesia codes for services that are furnished in conjunction with a screening colonoscopy and, thus, qualify for the waiver of the Part B deductible and coinsurance. If we adopt this proposal in the final rule, we will provide appropriate and timely information on this new modifier and its proper use so that physicians will be able to bill correctly for these services when the revised regulations become effective. We also note that the valuation of colonoscopy codes, which include moderate sedation, will be subject to the same proposed review as other codes that include moderate sedation, as discussed in section II.B.6 of this proposed rule.

I. Payment of Secondary Interpretation of Images

   In general, Medicare makes one payment for the professional component of an imaging service for each technical component service that is furnished. Section 100.1, Chapter 13, of the Medicare Claims Processing Manual (Pub. 100-04) explains this policy in the context of EKGs and X-rays furnished in an Emergency Room. The manual section discusses the distinction between a "review" of an X-ray or EKG for which payment is included in the payment for the emergency department E/M payment, and the "interpretation and report" of an X-ray or EKG which can be billed separately and includes a written report addressing "the findings, relevant clinical issues, and comparative data (when available)." The section makes clear that a "professional component" interpretation service should only be billed for a full interpretation and report. The manual section goes on to explain that, in general, Medicare pays for only one interpretation of an EKG or X-ray service furnished to an emergency room patient. However, Medicare can pay for a second interpretation (which is billed using modifier -77) under "unusual circumstances (for which documentation is provided)." For instance, if an emergency room physician conducts an interpretation, identifies a questionable finding, and believes another physician's expertise is needed, then a second claim for an interpretation can be paid when furnished, for example, by a radiologist. The second interpretation must directly contribute to the diagnosis and treatment of the individual patient (rather than serving as a quality control measure), and the second interpretation must also be accompanied by a written report.

   While a separate payment for the professional component for a radiology service is contingent upon meeting the conditions described in this section, practitioners bill Medicare and are paid for reviews of radiology images in other ways. For instance, review of a patient's previous radiology images is included and paid as part of the review of previous documentation in conjunction with E/M services. Reviews of extensive documentation and efforts to obtain previous documentation including existing imaging studies are considerations in deciding the appropriate level of complexity for evaluation and management services. /4/

   FOOTNOTE 4 See, for example, 1997 Documentation Guidelines for Evaluation and Management Service, p. 45. END FOOTNOTE

   In recent years, technological advances such as the integration of picture and archiving communications systems across health systems, growth in image sharing networks and health information exchange platforms through which providers can share images, and consumer-mediated exchange of images, have greatly increased physicians' access to existing diagnostic-quality radiology images. These advances offer new opportunities for physicians to reduce duplicative imaging, particularly with respect to high cost advanced diagnostic imaging modalities. For instance, a trauma patient transferred from a community hospital to a tertiary care center may arrive with high quality CT images sufficient to support an additional professional interpretation service. By accessing and utilizing these images to inform the diagnosis and record an interpretation in the medical record at the tertiary care facility, the provider and physicians may be able to avoid ordering substantially duplicative tests.

   Questions have arisen as to whether and under what circumstances it would be appropriate for Medicare to permit payment under the PFS when physicians furnish subsequent interpretations of existing images, and whether uncertainty associated with payment for secondary interpretations inhibits physicians from seeking out, accessing, and utilizing existing images in cases where avoidance of a new study would result in savings to Medicare. We are seeking comment to assess whether there is an expanded set of circumstances under which it would be appropriate to allow more routine Medicare payment for a second professional component for radiology services, and whether such a policy would be likely to reduce the incidence of duplicative advanced imaging studies.

   Specifically we are seeking comment on the following questions:

    * For which radiology services are physicians currently conducting secondary interpretations, and what, if any, institutional policies are in place to determine when existing images are utilized? To what extent are physicians seeking payment for these secondary interpretations from Medicare or other payers?

    * Should routine payment for secondary interpretations be restricted to certain high-cost advanced diagnostic imaging services, such as those defined as such under section 1834(e)(1)(B) of the Act, for example, diagnostic magnetic resonance imaging, computed tomography, and nuclear medicine (including positron emission tomography)?

    * How should the value of routine secondary interpretations be determined? Is it appropriate to apply a modifier to current codes or are new HCPCS codes for secondary interpretations necessary?

    * We believe most secondary interpretations would be likely to take place in the hospital setting. Are there other settings in which claims for secondary interpretations would be likely to reduce duplicative imaging services?

    * Is there a limited time period within which an existing image should be considered adequate to support a secondary interpretation?

    * Would allowing for more routine payment for secondary interpretations be likely to generate cost savings to Medicare by avoiding potentially duplicative imaging studies?

    * What operational steps could Medicare take to ensure that any routine payment for secondary interpretations is limited to cases where a new imaging study has been averted while minimizing undue burden on providers or Part B contractors? For instance, steps might include restricting physicians' ability to refer multiple interpretations to another physician that is part of their network or group practice, requiring that physicians attach a physician's order for an averted imaging study to a claim for a secondary interpretation, or requiring physicians to identify the technical component of the existing image supporting the claim.

   We seek comments on these questions, and welcome input on any additional considerations not mentioned here regarding the potential impact of allowing payment for secondary interpretation of images under other circumstances. Upon reviewing the comments received, we will consider whether any further action is appropriate, for instance, proposing under a future rulemaking to allow for payment of subsequent interpretations of advanced diagnostic images in lieu of duplicative studies.

J. Conditions Regarding Permissible Practice Types for Therapists in Private Practice

   Section 1861(p) of the Act defines outpatient therapy services to include physical therapy, occupational therapy, and speech-language pathology services furnished by qualified occupational therapists, physical therapists, and speech-language pathologists in their offices and in the homes of beneficiaries. The regulations at SUBSEC 410.59(c), 410.60(c), and 410.62(c) set forth special provisions for services furnished by therapists in private practice, including basic qualifications necessary to qualify as a supplier of occupational therapy (OT), physical therapy (PT), and speech-language pathology (SLP), respectively. As part of these basic qualifications, the current regulatory language includes descriptions of the various practice types for therapists' private practices. Based on our recent review of these three sections of our regulations, we are concerned that the language is not as clear as it could be--especially with regard to the relevance of whether a practice is incorporated. The regulations appear to make distinctions between unincorporated and incorporated practices, and some practice types are listed twice. Accordingly, we are proposing changes to the regulatory language to remove unnecessary distinctions and redundancies within the regulations for OT, PT, and SLP. We note that these proposed changes are for clarification only, and do not reflect any proposed change in our current policy.

   To consistently specify the permissible practice types (a solo practice, partnership, or group practice; or as an employee of one of these) for suppliers of outpatient therapy services in private practice (for occupational therapists, physical therapists and speech-language pathologists), we propose to replace the regulatory text at SEC 410.59(c)(1)(ii)(A) through (E), SEC 410.60(c)(1)(ii)(A) though (E), and SEC 410.62(c)(1)(ii)(A) through (E).

K. Payments for Physicians and Practitioners Managing Patients on Home Dialysis

   In the CY 2005 PFS final rule with comment period (69 FR 66357 through 66359), we established criteria for furnishing outpatient per diem ESRD-related services in partial month scenarios. We specified that use of per diem ESRD-related services is intended to accommodate unusual circumstances when the outpatient ESRD-related services would not be paid for under the monthly capitation payment (MCP), and that use of the per diem services are limited to the circumstances listed below.

    * Transient patients--Patients traveling away from home (less than full month);

    * Home dialysis patients (less than full month);

    * Partial month where there were one or more face-to-face visits without the comprehensive visit and either the patient was hospitalized before a complete assessment was furnished, dialysis stopped due to death, or the patient received a kidney transplant.

    * Patients who have a permanent change in their MCP physician during the month.

   Additionally, we provided billing guidelines for partial month scenarios in the Medicare claims processing manual, publication 100-04, chapter 8, section 140.2.1. For center-based patients, we specified that if the MCP physician or practitioner furnishes a complete assessment of the ESRD beneficiary, the MCP physician or practitioner should bill for the full MCP service that reflects the number of visits furnished during the month. However, we did not extend this policy to home dialysis (less than a full month) because the home dialysis MCP service did not include a specific frequency of required patient visits. In other words, unlike the ESRD MCP service for center-based patients, a visit was not required for the home dialysis MCP service as a condition of payment.

   In the CY 2011 PFS final rule with comment period (75 FR 73295 through 73296), we changed our policy for the home dialysis MCP service to require the MCP physician or practitioner to furnish at least one face-to-face patient visit per month as a condition of payment. However, we inadvertently did not modify our billing guidelines for home dialysis (less than a full month) to be consistent with partial month scenarios for center-based dialysis patients. Stakeholders have recently brought this inconsistency to our attention. After reviewing this issue, we are proposing to allow the MCP physician or practitioner to bill for the age appropriate home dialysis MCP service (as described by HCPCS codes 90963 through 90966) for the home dialysis (less than a full month) scenario if the MCP physician or practitioner furnishes a complete monthly assessment of the ESRD beneficiary and at least one face-to-face patient visit. For example, if a home dialysis patient was hospitalized during the month and at least one face-to-face outpatient visit and complete monthly assessment was furnished, the MCP physician or practitioner should bill for the full home dialysis MCP service. We believe that this proposed change to home dialysis (less than a full month) provides consistency with our policy for partial month scenarios pertaining to patients dialyzing in a dialysis center. If this proposal is adopted, we would modify the Medicare Claims Processing Manual to reflect the revised billing guidelines for home dialysis in the less than a full month scenario.

III. Other Provisions of the Proposed Regulations

A. Ambulance Extender Provisions

1. Amendment to Section 1834(l)(13) of the Act

   Section 146(a) of the MIPPA amended section 1834(l)(13)(A) of the Act to specify that, effective for ground ambulance services furnished on or after July 1, 2008 and before January 1, 2010, the ambulance fee schedule amounts for ground ambulance services shall be increased as follows:

    * For covered ground ambulance transports that originate in a rural area or in a rural census tract of a metropolitan statistical area, the fee schedule amounts shall be increased by 3 percent.

    * For covered ground ambulance transports that do not originate in a rural area or in a rural census tract of a metropolitan statistical area, the fee schedule amounts shall be increased by 2 percent.

   The payment add-ons under section 1834(l)(13) of the Act have been extended several times. Recently, section 1104(a) of the Pathway for SGR Reform Act of 2013, enacted on December 26, 2013, as Division B (Medicare and Other Health Provisions) of Pub L. 113-67, amended section 1834(l)(13)(A) of the Act to extend the payment add-ons described above through March 31, 2014. Subsequently, section 104(a) of the Protecting Access to Medicare Act of 2014 (Pub. L. 113-93, enacted on April 1, 2014) amended section 1834(l)(13)(A) of the Act to extend the payment add-ons again through March 31, 2015. Thus, these payment add-ons also apply to covered ground ambulance transports furnished before April 1, 2015. We are proposing to revise SEC 414.610(c)(1)(ii) to conform the regulations to these statutory requirements. (For a discussion of past legislation extending section 1834(l)(13) of the Act, please see the CY 2014 PFS final rule (78 FR 74438 through 74439)).

   These statutory requirements are self-implementing. A plain reading of the statute requires only a ministerial application of the mandated rate increase, and does not require any substantive exercise of discretion on the part of the Secretary.

2. Amendment to Section 1834(l)(12) of the Act

   Section 414(c) of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (Pub. L. 108-173, enacted on December 8, 2003) (MMA) added section 1834(l)(12) to the Act, which specified that in the case of ground ambulance services furnished on or after July 1, 2004, and before January 1, 2010, for which transportation originates in a qualified rural area (as described in the statute), the Secretary shall provide for a percent increase in the base rate of the fee schedule for such transports. The statute requires this percent increase to be based on the Secretary's estimate of the average cost per trip for such services (not taking into account mileage) in the lowest quartile of all rural county populations as compared to the average cost per trip for such services (not taking into account mileage) in the highest quartile of rural county populations. Using the methodology specified in the July 1, 2004 interim final rule (69 FR 40288), we determined that this percent increase was equal to 22.6 percent. As required by the MMA, this payment increase was applied to ground ambulance transports that originated in a "qualified rural area"; that is, to transports that originated in a rural area included in those areas comprising the lowest 25th percentile of all rural populations arrayed by population density. For this purpose, rural areas included Goldsmith areas (a type of rural census tract). This rural bonus is sometimes referred to as the "Super Rural Bonus" and the qualified rural areas (also known as "super rural" areas) are identified during the claims adjudicative process via the use of a data field included on the CMS-supplied ZIP code File.

   The Super Rural Bonus under section 1834(l)(12) of the Act has been extended several times. Recently, section 1104(b) of the Pathway for SGR Reform Act of 2013, enacted on December 26, 2013, as Division B (Medicare and Other Health Provisions) of Public Law 113-67, amended section 1834(l)(12)(A) of the Act to extend this rural bonus through March 31, 2014. Subsequently, section 104(b) of the Protecting Access to Medicare Act of 2014 (Pub. L. 113-93, enacted on April 1, 2014) amended section 1834(l)(12)(A) of the Act to extend this rural bonus again through March 31, 2015. Therefore, we are continuing to apply the 22.6 percent rural bonus described above (in the same manner as in previous years), to ground ambulance services with dates of service before April 1, 2015 where transportation originates in a qualified rural area. Accordingly, we are proposing to revise SEC 414.610(c)(5)(ii) to conform the regulations to these statutory requirements. (For a discussion of past legislation extending section 1834(l)(12) of the Act, please see the CY 2014 PFS final rule (78 FR 74439 through 74440)).

   These statutory provisions are self-implementing. Together, these statutory provisions require a 15-month extension of this rural bonus (which was previously established by the Secretary) through March 31, 2015, and do not require any substantive exercise of discretion on the part of the Secretary.

B. Proposed Changes in Geographic Area Delineations for Ambulance Payment

1. Background

   Under the ambulance fee schedule, the Medicare program pays for ambulance transportation services for Medicare beneficiaries when other means of transportation are contraindicated by the beneficiary's medical condition, and all other coverage requirements are met. Ambulance services are classified into different levels of ground (including water) and air ambulance services based on the medically necessary treatment provided during transport.

   These services include the following levels of service:

    * For Ground--

++ Basic Life Support (BLS) (emergency and non-emergency)

++ Advanced Life Support, Level 1 (ALS1) (emergency and non-emergency)

++ Advanced Life Support, Level 2 (ALS2)

++ Paramedic ALS Intercept (PI)

++ Specialty Care Transport (SCT)

    * For Air--

++ Fixed Wing Air Ambulance (FW)

++ Rotary Wing Air Ambulance (RW)

a. Statutory Coverage of Ambulance Services

   Under sections 1834(l) and 1861(s)(7) of the Act, Medicare Part B (Supplemental Medical Insurance) covers and pays for ambulance services, to the extent prescribed in regulations, when the use of other methods of transportation would be contraindicated by the beneficiary's medical condition.

   The House Ways and Means Committee and Senate Finance Committee Reports that accompanied the 1965 Social Security Amendments suggest that the Congress intended that--

    * The ambulance benefit cover transportation services only if other means of transportation are contraindicated by the beneficiary's medical condition; and

    * Only ambulance service to local facilities be covered unless necessary services are not available locally, in which case, transportation to the nearest facility furnishing those services is covered (H.R. Rep. No. 213, 89th Cong., 1st Sess. 37 and Rep. No. 404, 89th Cong., 1st Sess. Pt 1, 43 (1965)).

   The reports indicate that transportation may also be provided from one hospital to another, to the beneficiary's home, or to an extended care facility.

b. Medicare Regulations for Ambulance Services

   Our regulations relating to ambulance services are set forth at 42 CFR part 410, subpart B and 42 CFR part 414, subpart H. Section 410.10(i) lists ambulance services as one of the covered medical and other health services under Medicare Part B. Therefore, ambulance services are subject to basic conditions and limitations set forth at SEC 410.12 and to specific conditions and limitations included at SEC 410.40 and SEC 410.41. Part 414, subpart H, describes how payment is made for ambulance services covered by Medicare.

2. Provisions of the Proposed Rule

   Historically, the Medicare ambulance fee schedule has used the same geographic area designations as the acute care hospital inpatient prospective payment system (IPPS) and other Medicare payment systems to take into account appropriate urban and rural differences. This promotes consistency across the Medicare program, and it provides for use of consistent geographic standards for Medicare payment purposes.

   The current geographic areas used under the ambulance fee schedule are based on OMB standards published on December 27, 2000 (65 FR 82228 through 82238) and Census 2000 data and Census Bureau population estimates for 2007 and 2008 (OMB Bulletin No. 10-02). For a discussion of OMB's delineation of Core-Based Statistical Areas (CBSAs) and our implementation of the CBSA definitions under the ambulance fee schedule, we refer readers to the preamble of the CY 2007 Ambulance Fee Schedule proposed rule (71 FR 30358 through 30361) and the CY 2007 PFS final rule (71 FR 69712 through 69716). On February 28, 2013, OMB issued OMB Bulletin No. 13-01, which established revised delineations for Metropolitan Statistical Areas (MSAs), Micropolitan Statistical Areas, and Combined Statistical Areas, and provided guidance on the use of the delineations of these statistical areas. A copy of this bulletin may be obtained at http://www.whitehouse.gov/sites/default/files/omb/bulletins/2013/b-13-01.pdf. According to OMB, "[t]his bulletin provides the delineations of all Metropolitan Statistical Areas, Metropolitan Divisions, Micropolitan Statistical Areas, Combined Statistical Areas, and New England City and Town Areas in the United States and Puerto Rico based on the standards published on June 28, 2010, in the Federal Register (75 FR 37246-37252) and Census Bureau data." OMB defines an MSA as a CBSA associated with at least one urbanized area that has a population of at least 50,000, and a Micropolitan Statistical Area (referred to in this discussion as a Micropolitan Area) as a CBSA associated with at least one urban cluster that has a population of at least 10,000 but less than 50,000 (75 FR 37252). Counties that do not qualify for inclusion in a CBSA are deemed "Outside CBSAs." We note that, when referencing the new OMB geographic boundaries of statistical areas, we are using the term "delineations" consistent with OMB's use of the term (75 FR 37249).

   While the revisions OMB published on February 28, 2013 are not as sweeping as the changes made when we adopted the CBSA geographic designations for CY 2007, the February 28, 2013 OMB bulletin does contain a number of significant changes. For example, if we adopt the revised OMB delineations, there would be new CBSAs, urban counties that would become rural, rural counties that would become urban, and existing CBSAs that would be split apart. Because the bulletin was not issued until February 28, 2013, with supporting data not available until later, and because the changes made by the bulletin and their ramifications needed to be extensively reviewed and verified, we were unable to undertake such a lengthy process before publication of the CY 2014 PFS proposed rule, and thus, did not implement the changes to the OMB delineations under the ambulance fee schedule for CY 2014. We have reviewed our findings and impacts relating to the new OMB delineations, and find no compelling reason to further delay implementation. We believe it is important for the ambulance fee schedule to use the latest labor market area delineations available as soon as reasonably possible in order to maintain a more accurate and up-to-date payment system that reflects the reality of population shifts.

   Additionally, in the FY 2015 IPPS proposed rule (79 FR 28055), we also proposed to adopt OMB's revised delineations to identify urban areas and rural areas for purposes of the IPPS wage index. For the reasons discussed above, we believe it would be appropriate to adopt the same geographic area delineations for use under the ambulance fee schedule as are used under the IPPS and other Medicare payment systems. Thus, we are proposing to implement the new OMB delineations as described in the February 28, 2013 OMB Bulletin No. 13-01 beginning in CY 2015 to more accurately identify urban and rural areas for ambulance fee schedule payment purposes. We believe that the updated OMB delineations more realistically reflect rural and urban populations, and that the use of such delineations under the ambulance fee schedule would result in more accurate payment. Under the ambulance fee schedule, consistent with our current definitions of urban and rural areas ( SEC 414.605), MSAs would continue to be recognized as urban areas, while Micropolitan and other areas outside MSAs, and rural census tracts within MSAs (as discussed below), would be recognized as rural areas.

   In addition to the OMB's statistical area delineations, the current geographic areas used in the ambulance fee schedule also are based on the most recent version of the Goldsmith Modification. Section 1834(l) of the Act requires that we use the most recent version of the Goldsmith Modification to determine rural census tracts within MSAs. These rural census tracts are considered rural areas under the ambulance fee schedule (see SEC 414.605). In the CY 2007 PFS final rule (71 FR 69714 through 69716), we adopted the most recent (at that time) version of the Goldsmith Modification, designated as Rural-Urban Commuting Area (RUCA) codes. RUCA codes use urbanization, population density, and daily commuting data to categorize every census tract in the country. For a discussion about RUCA codes, we refer the reader to the CY 2007 PFS final rule (71 FR 69714 through 69716). As stated previously, on February 28, 2013, OMB issued OMB Bulletin No. 13-01, which established revised delineations for Metropolitan Statistical Areas, Micropolitan Statistical Areas, and Combined Statistical Areas, and provided guidance on the use of the delineations of these statistical areas. Several modifications of the RUCA codes were necessary to take into account updated commuting data and the revised OMB delineations. We refer readers to the U.S. Department of Agriculture'sEconomic Research Service Web site for a detailed listing of updated RUCA codes found at http://www.ers.usda.gov/data-products/rural-urban-commuting-area-codes.aspx. The updated RUCA code definitions were introduced in late 2013 and are based on data from the 2010 decennial census and the 2006-10 American Community Survey. We are proposing to adopt the most recent modifications of the RUCA codes beginning in CY 2015, to recognize levels of rurality in census tracts located in every county across the nation, for purposes of payment under the ambulance fee schedule. If we adopt the most recent RUCA codes, many counties that are designated as urban at the county level based on population would have rural census tracts within them that would be recognized as rural areas through our use of RUCA codes.

   The 2010 Primary RUCA codes are as follows:

   (1) Metropolitan area core: primary flow with an urbanized area (UA).

   (2) Metropolitan area high commuting: primary flow 30 percent or more to a UA.

   (3) Metropolitan area low commuting: primary flow 10 to 30 percent to a UA.

   (4) Micropolitan area core: primary flow within an Urban Cluster of 10,000 to 49,999 (large UC).

   (5) Micropolitan high commuting: primary flow 30 percent or more to a large UC.

   (6) Micropolitan low commuting: primary flow 10 to 30 percent to a large UC.

   (7) Small town core: primary flow within an Urban Cluster of 2,500 to 9,999 (small UC).

   (8) Small town high commuting: primary flow 30 percent or more to a small UC.

   (9) Small town low commuting: primary flow 10 to 30 percent to a small UC.

   (10) Rural areas: primary flow to a tract outside a UA or UC.

   Based on this classification, and consistent with our current policy (71 FR 69715), we would continue to designate any census tracts falling at or above RUCA level 4.0 as rural areas for purposes of payment for ambulance services under the ambulance fee schedule. As discussed in the CY 2007 PFS final rule (71 FR 69715), the Office of Rural Health Policy within the Health Resources and Services Administration (HRSA) determines eligibility for its rural grant programs through the use of the RUCA code methodology. Under this methodology, HRSA designates any census tract that falls in RUCA level 4.0 or higher as a rural census tract. In addition to designating any census tracts falling at or above RUCA level 4.0 as rural areas, under the updated RUCA code definitions, HRSA has also designated as rural census tracts, those census tracts with RUCA codes 2 or 3 that are at least 400 square miles in area with a population density of no more than 35 people. We refer readers to HRSA's Web site: ftp://ftp.hrsa.gov/ruralhealth/Eligibility2005.pdf for additional information. Consistent with the HRSA guidelines discussed above, we are proposing, beginning in CY 2015, to designate as rural areas (1) those census tracts that fall at or above RUCA level 4.0, and (2) those census tracts that fall within RUCA levels 2 or 3 that are at least 400 square miles in area with a population density of no more than 35 people. As discussed in the CY 2007 PFS final rule (71 FR 69715), we continue to believe that HRSA's guidelines accurately identify rural census tracts throughout the country, and thus would be appropriate to apply for ambulance payment purposes. We invite comments on this proposal.

   The adoption of the most current OMB delineations and the updated RUCA codes would affect whether certain areas are recognized as rural or urban. The distinction between urban and rural is important for ambulance payment purposes because urban and rural transports are paid differently. The determination of whether a transport is urban or rural is based on the point of pick-up for the transport, and thus a transport is paid differently depending on whether the point of pick-up is in an urban or a rural area. During claims processing, geographic designation of urban, rural, or super rural is assigned to each claim for an ambulance transport based on the point of pick-up ZIP code that is indicated on the claim.

   Currently, section 1834(l)(12) of the Act (as amended by section 104(b) of the PAMA) specifies that, for services furnished during the period July 1, 2004 through March 31, 2015, the payment amount for the ground ambulance base rate is increased by a "percent increase" (Super Rural Bonus) where the ambulance transport originates in a "qualified rural area," which is a rural area that we determine to be in the lowest 25th percentile of all rural populations arrayed by population density (also known as a "super rural area"). We implement this Super Rural Bonus in SEC 414.610(c)(5)(ii). Adoption of the revised OMB delineations and the updated RUCA codes would have no negative impact on ambulance transports in super rural areas, as none of the current super rural areas would lose their status due to the revised OMB delineations and the updated RUCA codes.

   The adoption of the new OMB delineations and the updated RUCA codes would affect whether or not transports would be eligible for other rural adjustments under the ambulance fee schedule statute and regulations. For ground ambulance transports where the point of pick-up is in a rural area, the mileage rate is increased by 50 percent for each of the first 17 miles ( SEC 414.610(c)(5)(i)). For air ambulance services where the point of pick-up is in a rural area, the total payment (base rate and mileage rate) is increased by 50 percent ( SEC 414.610(c)(5)(i)). Furthermore, under section 1834(l)(13) of the Act (as amended by section 104(a) of the PAMA), for ground ambulance transports furnished through March 31, 2015, transports originating in rural areas are paid based on a rate (both base rate and mileage rate) that is 3 percent higher than otherwise is applicable. (See also SEC 414.610(c)(1)(ii)).

   If we adopt OMB's revised delineations and the updated RUCA codes, ambulance providers and suppliers that pick up Medicare beneficiaries in areas that would be Micropolitan or otherwise outside of MSAs based on OMB's revised delineations or in a rural census tract of an MSA based on the updated RUCA codes (but are currently within urban areas) may experience increases in payment for such transports because they may be eligible for the rural adjustment factors discussed above, while those ambulance providers and suppliers that pick up Medicare beneficiaries in areas that would be urban based on OMB's revised delineations and the updated RUCA codes (but are currently in Micropolitan Areas or otherwise outside of MSAs, or in a rural census tract of an MSA) may experience decreases in payment for such transports because they would no longer be eligible for the rural adjustment factors discussed above.

   The use of the revised OMB delineations and the updated RUCA codes would mean the recognition of new urban and rural boundaries based on the population migration that occurred over a 10-year period, between 2000 and 2010. Based on the latest United States Postal Service (USPS) ZIP code file, there are a total of 42,914 ZIP codes in the U.S. The geographic designations for approximately 99.48 percent of ZIP codes would be unchanged by OMB's revised delineations and the updated RUCA codes. There are a similar number of ZIP codes that would change from rural to urban (122, or 0.28 percent) and from urban to rural (100, or 0.23 percent). In general, it is expected that ambulance providers and suppliers in 100 ZIP codes within 11 states may experience payment increases if we adopt the revised OMB delineations and the updated RUCA codes, as these areas would be redesignated from urban to rural. The state of Ohio would have the most ZIP codes changing from urban to rural with a total of 40, or 2.69 percent. Ambulance providers and suppliers in 122 ZIP codes within 22 states may experience payment decreases if we adopt the revised OMB delineations and the updated RUCA codes, as these areas would be redesignated from rural to urban. The state of West Virginia would have the most ZIP codes changing from rural to urban (17, or 1.82 percent), while Connecticut would have the greatest percentage of ZIP codes changing from rural to urban (15 ZIP codes, or 3.37 percent). Our findings are illustrated in Table 17.

Table 17--ZIP Codes Analysis Based on OMB's Revised Delineations and Updated RUCA Codes State Total Total ZIP Percenta Total Percenta Total Percentage ZIP codes ge of ZIP ge of ZIP of total codes changed total codes total codes ZIP codes rural to ZIP changed ZIP not not changed urban codes urban to codes changed rural AK 276 0 0.00 0 0.00 276 100.00 AL 854 0 0.00 0 0.00 854 100.00 AR 725 0 0.00 3 0.41 722 99.59 AS 1 0 0.00 0 0.00 1 100.00 AZ 569 0 0.00 0 0.00 569 100.00 CA 2723 0 0.00 0 0.00 2723 100.00 CO 677 0 0.00 0 0.00 677 100.00 CT 445 15 3.37 0 0.00 430 96.63 DC 301 0 0.00 0 0.00 301 100.00 DE 99 1 1.01 0 0.00 98 98.99 EK 63 0 0.00 0 0.00 63 100.00 EM 856 0 0.00 3 0.35 853 99.65 FL 1513 5 0.33 0 0.00 1508 99.67 FM 4 0 0.00 0 0.00 4 100.00 GA 1032 4 0.39 0 0.00 1028 99.61 GU 21 0 0.00 0 0.00 21 100.00 HI 143 0 0.00 0 0.00 143 100.00 IA 1080 5 0.46 0 0.00 1075 99.54 ID 335 0 0.00 0 0.00 335 100.00 IL 1628 0 0.00 0 0.00 1628 100.00 IN 1000 1 0.10 14 1.40 985 98.50 KY 1030 0 0.00 0 0.00 1030 100.00 LA 739 2 0.27 0 0.00 737 99.73 MA 751 0 0.00 4 0.53 747 99.47 MD 630 9 1.43 0 0.00 621 98.57 ME 505 0 0.00 0 0.00 505 100.00 MH 2 0 0.00 0 0.00 2 100.00 MI 1185 4 0.34 8 0.68 1173 98.99 MN 1043 1 0.10 0 0.00 1042 99.90 MP 3 0 0.00 0 0.00 3 100.00 MS 541 0 0.00 0 0.00 541 100.00 MT 411 0 0.00 0 0.00 411 100.00 NC 1101 12 1.09 5 0.45 1084 98.46 ND 418 0 0.00 0 0.00 418 100.00 NE 632 0 0.00 0 0.00 632 100.00 NH 292 0 0.00 0 0.00 292 100.00 NJ 747 0 0.00 0 0.00 747 100.00 NM 438 0 0.00 0 0.00 438 100.00 NV 257 0 0.00 0 0.00 257 100.00 NY 2246 4 0.18 0 0.00 2242 99.82 OH 1487 6 0.40 40 2.69 1441 96.91 OK 791 0 0.00 0 0.00 791 100.00 OR 494 6 1.21 0 0.00 488 98.79 PA 2244 8 0.36 0 0.00 2236 99.64 PR 177 0 0.00 0 0.00 177 100.00 PW 2 0 0.00 0 0.00 2 100.00 RI 91 0 0.00 0 0.00 91 100.00 SC 543 7 1.29 0 0.00 536 98.71 SD 418 0 0.00 0 0.00 418 100.00 TN 814 2 0.25 0 0.00 812 99.75



    2726 0 0.00 1 0.04 2725 99.96

UT 359 0 0.00 0 0.00 359 100.00 VA 1277 8 0.63 17 1.33 1252 98.04 VI 16 0 0.00 0 0.00 16 100.00 VT 309 0 0.00 0 0.00 309 100.00 WA 744 2 0.27 0 0.00 742 99.73 WI 919 3 0.33 0 0.00 916 99.67 WK 711 0 0.00 2 0.28 709 99.72 WM 342 0 0.00 0 0.00 342 100.00 WV 936 17 1.82 3 0.32 916 97.86 WY 198 0 0.00 0 0.00 198 100.00 Totals 42914 122 0.28 100 0.23 42692 99.48

   We believe that the most current OMB statistical area delineations, coupled with the updated RUCA codes, more accurately reflect the contemporary urban and rural nature of areas across the country, and thus we believe that use of the most current OMB delineations and RUCA codes under the ambulance fee schedule would enhance the accuracy of ambulance fee schedule payments. We invite comments on our proposal to implement the new OMB delineations and the updated RUCA codes as discussed above beginning in CY 2015, for purposes of payment under the Medicare ambulance fee schedule.

C. Clinical Laboratory Fee Schedule

   In the CY 2014 PFS final rule with comment period (78 FR 74440-74445, 74820), we finalized a process under which we would reexamine the payment amounts for test codes on the Clinical Laboratory Fee Schedule (CLFS) for possible payment revision based on technological changes beginning with the CY 2015 proposed rule, and we codified this process at SEC 414.511. After we finalized this process, Congress enacted the PAMA. Section 216 of the PAMA creates new section 1834A of the Act, which requires us to implement a new Medicare payment system for clinical diagnostic laboratory tests based on private payor rates. Section 216 of the PAMA also rescinds the statutory authority in section 1833(h)(2)(A)(i) of the Act for adjustments based on technological changes for tests furnished on or after April 1, 2014 (PAMA's enactment date). As a result of these provisions, we are not proposing any revisions to payment amounts for test codes on the CLFS based on technological changes and are proposing to remove SEC 414.511. Instead, we will establish through rulemaking the parameters for the collection of private payor rate information and other requirements to implement section 216 of the PAMA.

D. Removal of Employment Requirements for Services Furnished "Incident to" Rural Health Clinics (RHC) and Federally Qualified Health Center (FQHC) Visits

1. Background

   Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) furnish physicians' services; services and supplies incident to the services of physicians; nurse practitioner (NP), physician assistant (PA), certified nurse-midwife (CNM), clinical psychologist (CP), and clinical social worker (CSW) services; and services and supplies incident to the services of NPs, PAs, CNMs, CPs, and CSWs. They may also furnish diabetes self-management training and medical nutrition therapy (DSMT/MNT), transitional care management services, and in some cases, visiting nurse services furnished by a registered professional nurse or a licensed practical nurse. (For additional information on requirements for furnishing services in RHCs and FQHCs, see Chapter 13 of the CMS Benefit Policy Manual.)

   In the May 2, 2014 final rule with comment period (79 FR 25436) entitled "Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics; and Changes to Clinical Laboratory Improvement Amendments of 1988 Enforcement Actions for Proficiency Testing Referral," we removed the regulatory requirements that NPs, PAs, CNMs, CSWs, and CPs furnishing services in a RHC must be employees of the RHC. RHCs are now allowed to contract with NPs, PAs, CNMs, CSWs, and CPs, as long as at least one NP or PA is employed by the RHC, as required under section 1861(aa)(2)(iii) of the Act.

   Services furnished in RHCs and FQHCs by nurses, medical assistants, and other auxiliary personnel are considered "incident to" a RHC or FQHC visit furnished by a RHC or FQHC practitioner. The regulations at SEC 405.2413(a)(6), SEC 405.2415(a)(6), and SEC 405.2452(a)(6) state that services furnished incident to an RHC or FQHC visit must be furnished by an employee of the RHC or FQHC. Since there is no separate benefit under Medicare law that specifically authorizes payment to nurses, medical assistants, and other auxiliary personnel for their professional services, they cannot bill the program directly and receive payment for their services, and can only be remunerated when furnishing services to Medicare patients in an "incident to" capacity.

2. Provisions of Proposed Rule

   To provide RHCs and FQHCs with as much flexibility as possible to meet their staffing needs, we are proposing to revise SEC 405.2413(a)(5), SEC 405.2415(a)(5) and SEC 405.2452(a)(5) and delete SEC 405.2413(a)(6), SEC 405.2415(a)(6) and SEC 405.2452(a)(6) to remove the requirement that services furnished incident to an RHC or FQHC visit must be furnished by an employee of the RHC or FQHC to allow nurses, medical assistants, and other auxiliary personnel to furnish incident to services under contract in RHCs and FQHCs. We believe that removing the requirements will provide RHCs and FQHCs with additional flexibility without adversely impacting the quality or continuity of care.

E. Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models

1. Background and Statutory Authority

   Section 3021 of the Affordable Care Act amended the Social Security Act to include a new section 1115A, which established the Center for Medicare and Medicaid Innovation (Innovation Center). Section 1115A tasks the Innovation Center with testing innovative payment and service delivery models that could reduce program expenditures while preserving and/or enhancing the quality of care furnished to individuals under titles XVIII, XIX, and XX of the Act. The Secretary is also required to conduct an evaluation of each model tested.

   Evaluations will typically include quantitative and qualitative methods to assess the impact of the model on quality of care and health care expenditures. To comply with the statutory requirement to evaluate all models conducted under section 1115A of the Act, we will conduct rigorous quantitative analyses of the impact of the model test on health care expenditures, as well as an assessment of measures of the quality of care furnished under the model test. Evaluations will also include qualitative analyses to capture the qualitative differences between model participants, and to form the context within which to interpret the quantitative findings. Through the qualitative analyses, we will assess the experiences and perceptions of model participants, providers, and individuals affected by the model.

   In the evaluations we use advanced statistical methods to measure effectiveness. Our methods are intended to provide results that meet a high standard of evidence, even when randomization is not feasible. To successfully carry out evaluations of Innovation Center models, we must be able to determine specifically which individuals are receiving services from or are the subject of the intervention being tested by the entity participating in the model test. Identification of such individuals is necessary for a variety of purposes, including the construction of control groups against which model performance can be compared. In addition, to determine whether the observed impacts are due to the model being tested and not due to differences between the intervention and comparison groups, our evaluations will have to account for potential confounding factors at the individual level, which will require the ability to identify every individual associated with the model test, control or comparison groups, and the details of the intervention at the individual level.

   Evaluations will need to consider such factors as outcomes, clinical quality, adverse effects, access, utilization, patient and provider satisfaction, sustainability, potential for the model to be applied on a broader scale, and total cost of care. Individuals receiving services from or who are the subjects of the intervention will be compared to clinically, socio-demographically, and geographically similar matched individuals along various process, outcome, and patient-reported measures. Research questions in a typical evaluation will include, but are not limited to, the following:

    * Clinical Quality:

++ Did the model improve or have a negative impact on clinical process measures, such as adherence to evidence-based guidelines? If so, how, how much, and for which individuals?

++ Did the model improve or have a negative impact on clinical outcome measures, such as mortality rates, and the incidence and prevalence of chronic conditions? If so, how, how much, and for which individuals?

++ Did the model improve or have a negative impact on access to care? If so, how, how much, and for which individuals?

++ Did the model improve or have a negative impact on care coordination among providers? If so, how, how much, and for which individuals?

++ Did the model improve or have a negative impact on medication management? If so, how, how much, and for which individuals?

    * Patient Experience:

++ Did the model improve or have a negative impact on patient-provider communication? If so, how, how much, and for which individuals?

++ Did the model improve or have a negative impact on patient experiences of care, quality of life, or functional status? If so, how, how much, and for which individuals?

    * Utilization/Expenditures:

++ Did the model result in decreased utilization of emergency department visits, hospitalizations, and readmissions? If so how, how much, and for which individuals?

++ Did the model result in increased utilization of physician or pharmacy services? If so how, how much, and for which individuals?

++ Did the model result in decreased total cost of care? Were changes in total costs of care driven by changes in utilization for specific types of settings or health care services? What specific aspects of the model led to these changes? Were any savings due to improper cost-shifting to the Medicaid program?

   To carry out this research we must have access to patient records not generally available to us. As such, we propose to exercise our authority in section 1115A(b)(4)(B) of the Act to establish requirements for states and other entities participating in the testing of past, present, and future models under section 1115A of the Act to collect and report information that we have determined is necessary to monitor and evaluate such models. Thus, we propose to require model participants, and providers and suppliers working under the models operated by such participants to produce such individually identifiable health information and such other information as the Secretary identifies as being necessary to conduct the statutorily mandated research described above. Such research will include the monitoring and evaluation of such models. Further, we view engagement with other payers, both public and private, as a critical driver of the success of these models. CMS programs constitute only a share of any provider's revenue. Therefore, efforts to improve quality and reduce cost are more likely to be successful if signals are aligned across payers. Section 1115A of the Act specifically allows the Secretary of Health and Human Services to consider, in selecting which models to choose for testing, "whether the model demonstrates effective linkage with other public sector or private sector payers." Multi-payer models, such as but not limited to the Comprehensive Primary Care model, will conduct quality measurement across all patients regardless of payer in order to maximize alignment and increase efficiency. Construction of multi-payer quality measures requires the ability to identify all individuals subject to the model test regardless of payer. In addition, section 1115A also permits the Secretary to consider models that allow states to test and evaluate systems of all-payer payment reform for the medical care of residents of the state, including dual eligible individuals. Under the State Innovation Model (SIM), the Innovation Center is testing the ability for state governments to accelerate transformation. The premise of the SIM initiative is to support Governor-sponsored, multi-payer models that are focused on public and private sector collaboration to transform the state's delivery system. States have policy and regulatory authorities, as well as ongoing relationships with private payers, health plans, and providers that can accelerate delivery system reform. SIM models must impact the preponderance of care in the state and are expected to work with public and private payers to create multi-payer alignment. The evaluation of SIM will include all populations and payers involved in the state initiative, which in many cases includes private payers. The absence of identifiable data from private payers would result in considerable limitations on the level of evaluation conducted. Therefore, under this authority, we also propose to require the submission of identifiable health and utilization information for patients of private payers treated by providers/suppliers participating in the testing of a model under section 1115A of the Act when an explicit purpose of the model test is to engage private sector payers. If finalized, this regulation will provide clear legal authority for HIPAA Covered Entities to disclose any required protected health information. Identifiable data submitted by entities participating in the testing of models under section 1115A of the Act will meet CMS Acceptable Risks Safe Guards (ARS) guidelines. When data is expected to be exchanged over the internet such exchange will also meet all E-Gov requirements. In accordance with the requirements of the Privacy Act of 1974, these data will be covered under a CMS established system of records (System No. 09-70-0591), which serves as the Master system for all demonstrations, evaluations, and research studies administered by the Innovation Center. These data will be stored until the evaluation is complete and all necessary policy deliberations have been finalized.

2. Provisions of the Proposed Regulations

   Wherever possible, evaluations will make use of claims, assessment, and enrollment data available through CMS' existing administrative systems. However, evaluations will generally also need to include additional data not available through existing CMS administrative systems. As such, depending on the particular project, CMS or its contractor will require the production of the minimum data necessary to carry out the statutorily mandated research work described in section E.1. of this proposed rule. Such data may include the identities of the patients served under the model, relevant clinical details about the services furnished and outcomes achieved, and any confounding factors that might influence the evaluation results achieved through the delivery of such services. For illustrative purposes, below are examples of some of the types of information that could be required to carry out an evaluation, and for which the evaluator would need patient level identifiers.

    * Utilization data not otherwise available through existing Center for Medicare & Medicaid Services (CMS) systems.

    * Beneficiary, patient, participant, family, and provider experiences.

    * Beneficiary, patient, participant, and provider rosters with identifiers that allow linkages across time and datasets.

    * Beneficiary, patient, participant, and family socio-demographic and ethnic characteristics.

    * Care management details, such as details regarding the provision of services, payments or goods to beneficiaries, patients, participants, families, or other providers.

    * Beneficiary, patient, and participant functional status and assessment data.

    * Beneficiary, patient, and participant health behaviors.

    * Clinical data, such as, but not limited to lab values and information from EHRs.

    * Beneficiary, patient, participant quality data not otherwise available through claims.

    * Other data relevant to identified outcomes--for example, participant employment status, participant educational degrees pursued/achieved, and income.

   We invite public comment on this proposal to mandate the production of the individually identifiable information necessary to conduct the statutorily mandated research under section 1115A of the Act.

   In addition, we are proposing a new subpart K in part 403 to implement section 1115A of the Act.

F. Local Coverage Determination Process for Clinical Diagnostic Laboratory Testing

1. Background

   On April 1, 2014, the PAMA was enacted and section 216 addresses Medicare payment and coverage policies for clinical diagnostic laboratory testing. In regard to coverage policies, section 216 amended the statute by adding section 1834A(g) of the Act, which establishes mandates related to issuance of local coverage policies by the Medicare Administrative Contractors (MACs) for clinical diagnostic laboratory tests. The law states: "A medicare administrative contractor shall only issue a coverage policy with respect to a clinical diagnostic laboratory test in accordance with the process for making a local coverage determination (as defined in section 1869(f)(2)(B)), including the appeals and review process for local coverage determinations under part 426 of title 42, Code of Federal Regulations (or successor regulations)."

   Section 1869(f)(2)(B) of the Act defines a local coverage determination (LCD) as "a determination by a fiscal intermediary or a carrier under Part A or Part B, as applicable, respecting whether or not a particular item or service is covered on an intermediary-or carrier-wide basis under such parts, in accordance with section 1862(a)(1)(A) of the Act."

   Since the new law requires that the process for making local coverage determinations be used as the vehicle for local coverage policies for clinical diagnostic laboratory tests, it is important that we carefully consider the LCD process that is used today and determine if there are certain, limited aspects of the LCD process that may provide an opportunity to better fit the needs of this particular area of medicine. In addition to the current LCD process, we will examine how the LCD process was applied to a pilot project for molecular diagnostic tests as we are learning important lessons from this ongoing pilot. We believe lessons learned from this project can be applied to all clinical diagnostic laboratory testing and not just molecular diagnostic tests (which are encompassed under the PAMA requirement for local coverage policies). In this proposed process, we will review the current LCD process, as well as the pilot in support of a proposal to create, consistent with the requirements set forth under the PAMA, an expedited LCD process for clinical diagnostic laboratory testing.

   The current LCD process (Table 18) requires that a draft LCD be published in the Medicare Coverage Database (MCD). This serves as a public announcement that an LCD is being developed. Once a draft LCD is published, at least 45 calendar days are provided for public comment. We note that the National Coverage Determination (NCD) process only requires a 30-day public comment period after a proposed NCD is published. This timeframe is based on the NCD statutory requirements under 1862(l) of the Act and in our experience at the national policy level, 30 days is generally adequate to allow for robust public comment.

   After the draft LCD is made public, MACs are required to hold an open meeting to discuss the draft LCD with stakeholders. In addition to the open meeting, the MACs present the draft policy to the Carrier Advisory Committee (CAC). These two aspects of LCD development can be time-consuming and may involve logistical complications that extend the length of time it takes to reach a final policy. We note that unlike the national advisory committee, the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC), the CAC meetings and open stakeholder meetings are scheduled to discuss many LCD policies at a time as opposed to narrowly focusing on one policy. Due to the resources required, the constant development of LCDs and scheduling considerations, MACs do not hold ad hoc meetings. Both the open stakeholder meetings and the CAC meetings are scheduled far in advance, generally at the start of the calendar year before MACs know which policies will be presented in these forums. The timing of the open stakeholder meeting, CAC meeting, and public release of the draft LCD are all factors in determining which LCDs are on the agendas. Because of these scheduling issues, some LCDs may not have to wait as long for a CAC meeting or an open stakeholder meeting while others could have lengthy delays. In contrast, at the national level, MEDCACs are not convened for every NCD and separate open meetings are also not a part of the NCD process. Based on our experience with the NCD process over the past decade, we believe that public input is now readily available through more technologically advanced mechanisms of collecting public comment. For example, the information gathered and knowledge gained from the LCD open stakeholder meetings may now be acquired more broadly through the collection of public comments via web-based applications. CMS and its contractors are receiving more input on their policies because of these technology advances, which were not as available to the public when the LCD manual was originally written approximately 25 years ago. Medical literature, clinical practice guidelines, complicated charts and graphs can now be easily submitted electronically through the public comment process. Questions or follow-up information from a specific commenter can be addressed through conference calls or email. In addition, through these processes, all public comments are available to everyone rather than to the few people who attend meetings in person. In addition to publishing a draft LCD, MACs publish a document that provides a summary of all of the comments received and responses to those comments. This allows the public to understand the reasoning behind the final LCD and to know that all of the public comments were taken under consideration as the MAC developed the final policy. Since this information is made readily available in writing, an open meeting is no longer necessary for the public to be heard. There are more efficient methods available to the public to submit comments and additional evidence that supports or rejects the application of a draft LCD.

   Somewhat different considerations apply to CACs, which are state-specific bodies representing the clinical expertise of a geographic area. CACs allow a unique opportunity for CAC members to provide practical information regarding a draft policy since they are the entities actually delivering services in the community. However, like MEDCACs, a CAC may not be needed in all instances for the creation or revision of an LCD. CAC meeting agendas can quickly fill up with draft LCDs since the CAC meetings are scheduled far in advance. We believe CACs may be a better resource and used more efficiently in the development of LCDs if the MAC is able to select which draft LCDs are presented to a CAC for discussion, as opposed to taking all LCDs to the CAC. Of note, NCDs that go before the MEDCAC are selected by the agency and it is not part of the process for every NCD.

   Under the current LCD process, after the close of the comment period and the required meetings, the MAC publishes a final LCD. As stated earlier, the MAC must also respond to any comments received, via a comment/response document. A notice period of at least 45 calendar days is then required before the LCD can take effect. While it takes time for the provider community and the claims processing systems to adapt to changes in coverage, a notice period delays the date of when coverage may be become effective.

   In addition to evaluating the effectiveness of certain aspects of the LCD implementation process, we are also examining a pilot project that CMS launched with a single MAC, Palmetto GBA, on November 1, 2011. While the pilot discussed in this section only includes molecular diagnostic (genetic) laboratory tests, a subset of all clinical diagnostic lab tests, we believe the pilot's design and some of the lessons learned from the pilot can be applied to all clinical diagnostic laboratory tests

   For background, the universe of molecular diagnostic laboratory tests is vast and the current LCD process can be lengthy for some of these innovative tests, which are technically complex. For example, multiple molecular diagnostic tests designated to diagnose the same disease may rely on different underlying technologies and, therefore, have significantly different performance characteristics. It would not be appropriate to assume that all tests for a particular condition behave the same. Because of these complexities, we have an obligation to consider the evidence at a granular level; that is, to ensure coverage of the appropriate test for the appropriate Medicare beneficiary.

   The pilot project's long-term goal was to assist clinicians by determining whether the molecular diagnostic tests they order actually perform as expected and, thus, ultimately improve clinical care. This goal stemmed from concerns that some tests were being marketed directly to physicians without information regarding the test's performance. The pilot project sought to achieve this goal by identifying all of the molecular diagnostic tests that Medicare was covering in the Palmetto MAC jurisdiction. This required the ability to uniquely identify tests through test registration and assignment of an identifier. In addition, the MAC reviewed clinical statements made by the manufacturer for each molecular diagnostic test to ensure the test was delivering what was being claimed. Essentially, the pilot project facilitated claims processing, tracked utilization, and determined clinical validity, utility and coverage through technical assessments of published test data.

   As part of the pilot project, Palmetto wrote a single molecular diagnostic laboratory testing LCD that outlined the framework they would follow in determining coverage of all molecular diagnostic tests in their jurisdiction. Additionally, that LCD included a list of covered molecular diagnostic tests. Moreover, Palmetto issued several articles addressing various other aspects of the LCD implementation process, including coding guidelines, billing and medical review procedures. There is much information that is not contained in the body of an LCD that is necessary for consistent and predictable claims processing and payment.

   We believe a process that ensures transparency and stakeholder participation can be achieved without utilizing the current LCD process in its entirety. Some key aspects of the process should be maintained such as allowing public comment on draft LCDs and requiring MAC responses to public comments. However, we believe other aspects could be streamlined to allow more timely decisions and a more efficient process.

2. Proposed New LCD Process for Clinical Diagnostic Laboratory Tests

   After assessment of the current LCD process, the Palmetto pilot project, the requirements of the PAMA, and the vast field of clinical diagnostic laboratory tests, including molecular diagnostic tests, we are proposing a revised LCD process for all new draft clinical diagnostic laboratory test LCDs published on or after January 1, 2015. This process would carefully balance the need for an expedited process to handle the vast number of clinical diagnostic laboratory tests, including the rapidly growing universe of molecular diagnostic tests. The National Institutes of Health (NIH)-sponsored Genetic Testing Registry (GTR) currently includes 16,000 registered genetic tests for over 4,000 conditions (www.ncbi.nlm.nih.gov/gtr/). We have a responsibility to ensure that appropriate tests are covered by Medicare and that coverage is limited to tests for which the test results are used by the ordering physician in the management of the beneficiary's specific medical problem (as required in SEC 410.32(a)). Coverage for diagnostic laboratory tests may be achieved through various policy vehicles, including an NCD, LCD, or claim-by-claim adjudication at the local contractor level. For most molecular diagnostic tests, coverage has been determined by the MACs, through LCDs or claim-by-claim adjudication. Few such tests have been the subject of an NCD, to date. This concentration of coverage decisions at the local level, and the responsibility of the agency to allow coverage of appropriate tests provide additional reasons to provide MACs with a more streamlined LCD process.

   Based on these considerations, we are proposing a new LCD process that would apply only to clinical diagnostic laboratory tests. Specifically, we are proposing to establish a process MACs must follow when developing clinical diagnostic laboratory test LCDs and encouraging MACs to collaborate on such policies across jurisdictions. We propose that the process apply to all new clinical diagnostic laboratory testing draft LCDs published on or after January 1, 2015. Consistent with Chapter 13, section 13.7.3 of the Medicare Program Integrity Manual (PIM), however, we further propose that this process will not apply to clinical diagnostic laboratory testing LCDs that are being revised for the following reasons: to liberalize an existing LCD; being issued for a compelling reason; making a non-substantive correction; providing a clarification; making a non-discretionary coverage or diagnosis coding update; making a discretionary diagnosis coding update that does not restrict; or revising to effectuate an Administrative Law Judge's decision on a Benefits Improvement and Protection Act (BIPA) 522 challenge.

   The proposed new process would allow any person or entity to request an LCD or the MAC to initiate an LCD regarding clinical diagnostic laboratory testing. After this external request or internal initiation, the MAC would publish a draft LCD in the Medicare Coverage Database (http://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx), thereby making the draft LCD publicly available. Next, a minimum of 30 calendar days for public comment would be required. We note that in the event that stakeholders and/or members of the public are not able to submit comments within the 30 calendar day window, the MAC would have discretion to extend the comment period. We would expect the draft LCDs to outline the criteria the MAC would use when determining whether a specific clinical diagnostic laboratory test or a group of tests are covered or non-covered. The MAC would review, analyze, and take under consideration all public comments on the draft LCD. For draft LCDs where the MAC determines that a CAC meeting would contribute to the quality of the final policy, the MAC has discretion to take draft LCDs to the CAC. In the event the MAC involves the CAC in the development of an LCD, we would require that the public comment period be extended to allow for the CAC to be held before the final policy is issued. The MAC would be required to respond to all public comments in writing and post their responses on a public Web site. As a final step, the MAC would publish the final LCD in the Medicare Coverage Database no later than 45 calendar days after the close of the comment period. We believe 45 days to be an adequate time for the MAC to take all comments under consideration, prepare responses to those comments, and develop a final policy.

   The final LCD would be effective immediately upon publication. This effective date would be different than under the current LCD process (which includes a notice period of at least 45 calendar days before a final LCD is effective); however, based on our experience with NCDs, which are also effective upon publication, we believe this is an efficient mechanism to make tests available to beneficiaries more quickly.

3. Reconsideration Process

   The proposed process for developing clinical diagnostic laboratory testing LCDs would not change the LCD reconsideration process as outlined in the PIM in Chapter 13. This section of the manual allows interested parties the opportunity to request reconsideration of an LCD. Under the proposed process, the MACs would continue to implement all sections of the PIM that relate to the LCD reconsideration process.

4. LCD Challenge Process

   The proposed process for clinical diagnostic laboratory testing LCDs would also not change any of the current review processes available to an aggrieved party. An aggrieved party would continue to be able to challenge an LCD according to the requirements set out in 42 CFR part 426.

   As discussed previously, we believe an administratively more efficient process is needed for local coverage determinations for clinical diagnostic laboratory testing. If we continue to require that MACs follow all steps in the current LCD process, we fear that LCDs will not be able to be finalized quickly enough for even a fraction of the thousands of new clinical diagnostic (particularly molecular) tests developed each year.

   We believe this proposed new process for clinical diagnostic laboratory tests will allow for public dialogue, notification of stakeholders, and expedited beneficiary access to covered tests. Table 18 summarizes the differences between the current LCD process and the proposed new LCD process for the development of clinical diagnostic laboratory testing policies. GOES

Table 18--Comparison of Current LCD Process Versus Proposed LCD Process for Clinical Diagnostic Laboratory Tests Current LCD process Proposed LCD process for clinical diagnostic laboratory tests Issue Draft LCD in Medicare Coverage Issue Draft LCD in Medicare Coverage Database, which identifies criteria Database, which identifies criteria used for determining coverage under used for determining coverage under statutory "reasonable and necessary" statutory "reasonable and necessary" standard standard. Public comment period of 45 calendar Public comment period of 30 calendar days days with option to extend. Present LCD at CAC & discussion at Optional CAC meeting. No requirement open stakeholder meetings for open stakeholder meeting. Publication of Comment/Response Publication of Comment/Response Document and final LCD (no specified Document and final LCD within 45 time of publication after the close of calendar days of the close of the the comment period) draft LCD comment period. Notice period of 45 calendar days with Final LCD effective on the date of the final LCD effective the 46th publication. calendar day Interested parties may request Interested parties may request reconsideration of an LCD reconsideration of an LCD. An aggrieved party may further An aggrieved party may further challenge an LCD challenge an LCD.



   In summary, we believe this proposed process would meet all the requirements of the PAMA, would be open and transparent, would allow for public input, and would be administratively efficient. We are proposing this process only for clinical diagnostic laboratory testing when coverage policies are developed by a MAC through an LCD; it would not apply to the NCD process or other vehicles of coverage including claim-by-claim adjudication. We believe the proposed process would balance stakeholders' concerns about ensuring an open and transparent process with the ability to efficiently review clinical laboratory tests for coverage. We encourage public comment on all aspects of this proposed process.

G. Private Contracting/Opt-Out

1. Background

   Effective January 1, 1998, section 1802(b) of the Act permits certain physicians and practitioners to opt-out of Medicare if certain conditions are met, and to furnish through private contracts services that would otherwise be covered by Medicare. For those physicians and practitioners who opt- out of Medicare in accordance with section 1802(b) of the Act, the mandatory claims submission and limiting charge rules of section 1848(g) of the Act would not apply. As a result, if the conditions necessary for an effective opt-out are met, physicians and practitioners are permitted to privately contract with Medicare beneficiaries and to charge them without regard to Medicare's limiting charge rules. Regulations governing the requirements and procedures for private contracts appear at 42 CFR part 405, subpart D.

a. Opt-Out Determinations ( SEC 405.450)

   The private contracting regulation at SEC 405.450 describes certain opt-out determinations made by Medicare, and the process that physicians, practitioners, and beneficiaries may use to appeal those determinations. Section 405.450(a) describes the process available for physicians or practitioners to appeal Medicare enrollment determinations related to opting out of the program, and SEC 405.450(b) describes the process available to challenge payment determinations related to claims for services furnished by physicians who have opted out. Both provisions refer to SEC 405.803, the Part B claims appeals process that was in place at the time the opt-out regulations were issued (November 2, 1998). When those regulations were issued, a process for a physician or practitioner to appeal enrollment related decisions had not been implemented in regulation. Thus, to ensure an appeals process was available to physicians and practitioners for opt-out related issues, we chose to utilize the existing claims appeals process in SEC 405.803 for both enrollment and claims related appeals.

   In May 16, 2012Federal Register (77 FR 29002), we published a final rule entitled "Medicare and Medicaid Program; Regulatory Provisions to Promote Program Efficiency, Transparency and Burden Reduction." In that final rule, we deleted the provisions relating to initial determinations, appeals, and reopenings of Medicare Part A and Part B claims, and relating to determinations and appeals regarding an individual's entitlement to benefits under Medicare Part A and Part B, which were contained in part 405, subparts G and H (including SEC 405.803) because these provisions were obsolete and had been replaced by the regulations at part 405, subpart I. We inadvertently neglected to revise the cross-reference in SEC 405.450(a) and (b) of the private contracting regulations to direct appeals of opt-out determinations through the current appeal process. However, it is important to note that our policy regarding the appeal of opt-out determinations did not change when the appeal regulations at part 405, subpart I were finalized.

   The procedures set forth in current part 498 establish the appeals procedures regarding decisions made by Medicare that affect enrollment in the program. We believe this process, and not the appeal process in part 405, subpart I, is the appropriate channel for physicians and practitioners to challenge an enrollment related opt-out decision made by Medicare. There are now two different sets of appeal regulations for initial determinations; and the appeal of enrollment related opt-out determinations is more like the types of determinations now addressed under part 498 than those under part 405, subpart I. Specifically, the appeal process under part 405, subpart I focus on reviews of determinations regarding beneficiary entitlement to Medicare and claims for benefits for particular services. The appeal process under part 498 is focused on the review of determinations regarding the participation or enrollment status of providers and suppliers. Enrollment related opt-out determinations involve only the status of particular physician or practitioners under Medicare, and do not involve beneficiary eligibility or claims for specific services. As such, the appeal process under part 498 is better suited for the review of enrollment related opt-out determinations.

   However, we do not believe the enrollment appeals process established in part 498 is the appropriate mechanism for challenging payment decisions on claims for services furnished by a physician and practitioner who has opted out of the program. Appeals for such claims should continue to follow the appeals procedures now set forth in part 405 subpart I.

b. Definitions, Requirements of the Opt Out Affidavit, Effects of Opting Out of Medicare, Application to Medicare Advantage Contracts (SUBSEC 405.400, 405.420(e), 405.425(a), and 405.455)

   Section 405.400 sets forth certain definitions for purposes of the private contracting regulations. Among the defined terms is "Emergency care services" which means services furnished to an individual for treatment of an "emergency medical condition" as that term is defined in SEC 422.2. The cross-referenced regulation at SEC 422.2 included within the definition of emergency care services was deleted on June 29, 2000 (65 FR 40314) and at that time we inadvertently neglected to revise that cross-reference. The cross-reference within the definition of emergency care services should have been amended at that time to cite the definition of "emergency services" in SEC 424.101.

   The private contracting regulations at SEC 405.420(e), SEC 405.425(a) and SEC 405.455 all use the term Medicare+Choice when referring to Part C plans. However, we no longer use the term Medicare+Choice when referring to Part C plans; instead the plans are referred to as Medicare Advantage plans. When part 422 of the regulations was updated on January 28, 2005 (70 FR 4741), we inadvertently neglected to revise SEC 405.420(e), SEC 405.425(a) and SEC 405.455 to replace the term Medicare+Choice with Medicare Advantage plan.

2. Provisions of the Proposed Regulation

   For the reasons discussed above, we propose that a determination described in SEC 405.450(a) (relating to the status of opt-out or private contracts) is an initial determination for purposes of SEC 498.3(b), and a physician or practitioner who is dissatisfied with a Medicare determination under SEC 405.450(a) may utilize the enrollment appeals process currently available for providers and suppliers in part 498. In addition, we propose that a determination described in SEC 405.450(b) (that payment cannot be made to a beneficiary for services furnished by a physician or practitioner who has opted out) is an initial determination for the purposes of SEC 405.924 and may be challenged through the existing claims appeals procedures in part 405 subpart I. Accordingly, we propose that the cross reference to SEC 405.803 in SEC 405.450(a) be replaced with a cross reference to SEC 498.3(b). We also propose that the cross reference to SEC 405.803 in SEC 405.450(b) be replaced with a cross reference to SEC 405.924. We also propose corresponding edits to SEC 498.3(b) and SEC 405.924 to note that the determinations under SEC 405.450(a) and (b), respectively, are initial determinations.

   For the reasons discussed above, we also propose that the definition of Emergency care services at SEC 405.400 be revised to cite the definition of Emergency services in SEC 424.101 and that all references to Medicare+Choice in SEC 405.420(e), SEC 405.425(a) and SEC 405.455 be replaced with the term "Medicare Advantage."

H. Solicitation of Comments on the Payment Policy for Substitute Physician Billing Arrangements

1. Background

   In accordance with section 1842(b)(6) of the Act, no payment under Medicare Part B may be made to anyone other than to the beneficiary to whom a service was furnished or to the physician or other person who furnished the service. However, there are certain limited exceptions to this general prohibition. For example, section 1842(b)(6)(D) of the Act describes an exception for substitute physician billing arrangements, which states that "payment may be made to a physician for physicians' services (and services furnished incident to such services) furnished by a second physician to patients of the first physician if (i) the first physician is unavailable to provide the services; (ii) the services are furnished pursuant to an arrangement between the two physicians that (I) is informal and reciprocal, or (II) involves per diem or other fee-for-time compensation for such services; (iii) the services are not provided by the second physician over a continuous period of more than 60 days or are provided over a longer continuous period during all of which the first physician has been called or ordered to active duty as a member of a reserve component of the Armed Forces; and (iv) the claim form submitted to the [contractor] for such services includes the second physician's unique identifier . . . and indicates that the claim meets the requirements of this subparagraph for payment to the first physician." Section 1842(b)(6) of the Act is self-implementing and we have not interpreted the statutory provisions through regulations.

   In practice, section 1842(b)(6)(D) of the Act generally allows for two types of substitute physician billing arrangements: (1) An informal reciprocal arrangement where doctor A substitutes for doctor B on an occasional basis and doctor B substitutes for doctor A on an occasional basis; and (2) an arrangement where the services of the substitute physician are paid for on a per diem basis or according to the amount of time worked. Substitute physicians in the second type of arrangement are sometimes referred to as "locum tenens" physicians. It is our understanding that locum tenens physicians are substitute physicians who often do not have a practice of their own, are geographically mobile, and work on an as-needed basis as independent contractors. They are utilized by physician practices, hospitals, and health care entities enrolled in Part B as Medicare suppliers to cover for physicians who are absent for reasons such as illness, pregnancy, vacation, or continuing medical education. Also, we have heard anecdotally that locum tenens physicians are used to fill staffing needs (for example, in physician shortage areas) or, on a temporary basis, to replace physicians who have permanently left a medical group or employer.

   We are concerned about the operational and program integrity issues that result from the use of substitute physicians to fill staffing needs or to replace a physician who has permanently left a medical group or employer. For example, although our Medicare enrollment rules require physicians and physician groups or organizations to notify us promptly of any enrollment changes (including reassignment changes) (see SEC 424.516(d)), processing delays or miscommunication between the departing physician and his or her former medical group or employer regarding which party would report the change to Medicare could result in the Provider Transaction Access Number (PTAN) that links the departed physician and his or her former medical group remaining "open" or "attached" for a period of time. During such period, both the departed physician and the departed physician's former medical group might bill Medicare under the departed physician's National Provider Identifier (NPI) for furnished services. This could occur where a substitute physician is providing services in place of the departed physician in the departed physician's former medical group, while the departed physician is also providing services to beneficiaries following departure from the former group. Operationally, either or both types of claims could be rejected or denied, even though the claims filed by the departed physician were billed appropriately. Moreover, the continued use of a departed physician's NPI to bill for services furnished to beneficiaries by a substitute physician raises program integrity issues, particularly if the departed physician is unaware of his or her former medical group or employer's actions.

   Finally, as noted above, section 1842(b)(6)(D)(iv) of the Act requires that the claim form submitted to the contractor include the substitute physician's unique identifier. Currently, the unique identifier used to identify a physician is the physician's NPI. Prior to the implementation of the NPI, the Unique Physician Identification Number (UPIN) was used. Because a substitute physician's NPI is not captured on the CMS-1500 claim form or on the appropriate electronic claim, physicians and other entities that furnish services to beneficiaries through the use of a substitute physician are required to enter a modifier on the CMS-1500 claim form or on the appropriate electronic claim indicating that the services were furnished by a substitute physician; and to keep a record of each service provided by the substitute physician, associated with the substitute physician's UPIN or NPI; and to make this record available to the contractor upon request. (See Medicare Claims Processing Manual (Pub. 100-4), Chapter 1, Sections 30.2.10 and 30.2.11) However, having a NPI or UPIN does not necessarily mean that the substitute physician is enrolled in the Medicare program. Without being enrolled in Medicare, we do not know whether the substitute physician has the proper credentials to furnish the services being billed under section 1842(b)(6)(D) of the Act or if the substitute physician is sanctioned or excluded from Medicare. The importance of enrollment and the resulting transparency afforded the Medicare program and its beneficiaries was recognized by the Congress when it included in the Affordable Care Act a requirement that physicians and other eligible NPPs enroll in the Medicare program if they wish to order or refer certain items or services for Medicare beneficiaries. This includes those physicians and other eligible NPPs who do not and will not submit claims to a Medicare contractor for the services they furnish. We are seeking comments regarding how to achieve similar transparency in the context of substitute physician billing arrangements for the identity of the individual actually furnishing the service to a beneficiary.

2. Solicitation of Comments

   To help inform our decision whether and, if so, how to address the issues discussed in section III.H.1., and whether to adopt regulations interpreting section 1842(b)(6)(D) of the Act, we are soliciting comments on the policy for substitute physician billing arrangements. We note that any regulations would be proposed in a future rulemaking with opportunity for public comment. Through this solicitation, we hope to understand better current industry practices with respect to the use of substitute physicians and the impact that policy changes limiting the use of substitute physicians might have on beneficiary access to physician services. Therefore, we are soliciting comments on the following:

   (1) How physicians and other entities are currently utilizing the services of substitute physicians and billing for such services. We are interested in specific examples, including the circumstances that give rise to the need for the substitute physician, the types of services furnished by the substitute physician, the billing for the services of the substitute physician, the length of time that the substitute physician's services are needed or used, and any other information relevant to the substitute physician billing arrangement.

   (2) When a physician is "unavailable" to provide services for purposes of section 1842(b)(6)(D) of the Act. We are particularly interested in comments from physicians, medical groups and other entities that utilize the services of substitute physicians regarding when a regular physician is "unavailable."

   (3) Whether we should limit substitute physician billing arrangements to those "between the two physicians" (rather than between a medical group, employer or other entity and the substitute physician) as stated in section 1842(b)(6)(D)(ii) of the Act.

   (4) Whether we should permit the sequential use of multiple substitute physicians provided that each substitute physician furnishes services for the unavailable physician for no more than 60 continuous days.

   (5) Whether we should have identical or different criteria for substitute physician billing arrangements under sections 1842(b)(6)(D)(ii)(I) and (II) of the Act; that is, whether we should treat reciprocal substitute physician billing arrangements differently than paid (or locum tenens) substitute physician billing arrangements.

   (6) Whether substitute physicians furnishing services to Medicare beneficiaries should be required to enroll in the Medicare program.

   (7) Whether entities submitting claims for services furnished by substitute physicians should include on the CMS-1500 claim form or on the appropriate electronic claim the identity of the substitute physician and, if so, whether the CMS-1500 claim form or the appropriate electronic claim should be revised to accommodate such a requirement.

   (8) Whether we should place limitations on the use of the substitute physician and billing for his or her services (for example, limits on the length of time that an individual substitute physician may provide services to replace a particular departed physician; limits on the overall length of time that substitute physicians may provide services to replace a particular departed physician; a requirement that the departing physician be a party to the substitute physician billing arrangement; or permitting the use of a substitute physician only where a demonstrated staffing need can be shown). We are also seeking comments regarding whether these limitations should be different depending on the circumstances underlying or requiring the use of the substitute physician.

   (9) Whether we should limit or prohibit the use of substitute physician billing arrangements in certain programs or for certain purposes (for example, the Medicare Shared Savings Program or determining whether a physician is a member of a group practice for purposes of the physician self-referral law).

   (10) The impact of substitute physician billing arrangements on CMS programs that rely on the Provider Enrollment, Chain and Ownership System (PECOS) (for example, the Medicare Shared Savings Program), enforcement of the physician self-referral law, and program integrity oversight.

   (11) Additional program integrity safeguards that should be included in our substitute physician billing policy to protect against program and patient abuse. These could include, but are not limited to, qualifications for substitute physicians related to exclusion status, quality of care, or licensure and certifications.

   (12) Any other issues that we should consider in determining whether to propose regulations interpreting section 1842(b)(6)(D) of the Act.

I. Reports of Payments or Other Transfers of Value to Covered Recipients

1. Background

   In the February 8, 2013Federal Register (78 FR 9458), we published the "Transparency Reports and Reporting of Physician Ownership or Investment Interests" final rule which implemented section 1128G to the Act, as added by section 6002 of the Affordable Care Act. Under section 1128G(a)(1) of the Act, manufacturers of covered drugs, devices, biologicals, and medical supplies (applicable manufacturers) are required to submit on an annual basis information about certain payments or other transfers of value made to physicians and teaching hospitals (collectively called covered recipients) during the course of the preceding calendar year. Section 1128G(a)(2) of the Act requires applicable manufacturers and applicable group purchasing organizations (GPOs) to disclose any ownership or investment interests in such entities held by physicians or their immediate family members, as well as information on any payments or other transfers of value provided to such physician owners or investors. The implementing regulations are at 42 CFR Part 402, subpart A, and Part 403, subpart I. We have organized these reporting requirements under the "Open Payments (Sunshine Act)" program.

   The Open Payments program creates transparency around the nature and extent of relationships that exist between drug, device, biologicals and medical supply manufacturers, and physicians and teaching hospitals (covered recipients and physician owner or investors). The implementing regulations describe procedures for applicable manufacturers and applicable GPOs to submit electronic reports detailing payments or other transfers of value and ownership or investment interests provided to covered recipients and physician owners or investors are codified at SEC 403.908.

   Since the publication and implementation of the February 8, 2013 final rule, various stakeholders have provided feedback to CMS regarding certain aspects of these reporting requirements. Specifically, SEC 403.904(g)(1) excludes the reporting of payments associated with certain continuing education events, and SEC 403.904(c)(8) requires reporting of the marketed name for drugs and biologicals but makes reporting the marketed name of devices or medical supplies optional. We are proposing a change to SEC 403.904(g) to correct an unintended consequence of the current regulatory text. Additionally, at SEC 403.904(c)(8), we are proposing to make the reporting requirements consistent by requiring the reporting of the marketed name for drugs, devices, biologicals, or medical supplies which are associated with a payment or other transfer of value.

   Additionally, at SEC 403.902, we propose to remove the definition of a "covered device" because we believe it is duplicative of the definition of "covered drug, device, biological or medical supply" which is codified in the same section. We also propose to require the reporting of the following distinct forms of payment: stock; stock option; or any other ownership interests specified in SEC 403.904(d)(3) to collect more specific data regarding the forms of payment.

2. Continuing Education Exclusion ( SEC 403.904(g)(1))

   In the February 8, 2013 final rule, many commenters recommended that accredited or certified continuing education payments to speakers should not be reported because there are safeguards already in place, and they are not direct payments to a covered recipient. In the final rule preamble, we noted that "industry support for accredited or certified continuing education is a unique relationship" (78 FR 9492). Section 403.904(g)(1) states that payments or other transfers of value provided as compensation for speaking at a continuing education program need not be reported if the following three conditions are met:

    * The event at which the covered recipient is speaking must meet the accreditation or certification requirements and standards for continuing education for one of the following organizations: the Accreditation Council for Continuing Medical Education (ACCME); the American Academy of Family Physicians (AAFP); the American Dental Association's Continuing Education Recognition Program (ADA CERP); the American Medical Association (AMA); or the American Osteopathic Association (AOA).

    * The applicable manufacturer does not pay the covered recipient speaker directly.

    * The applicable manufacturer does not select the covered recipient speaker or provide the third party (such as a continuing education vendor) with a distinct, identifiable set of individuals to be considered as speakers for the continuing education program.

   Since the implementation of SEC 403.904(g)(1), other accrediting organizations have requested that payments made to speakers at their events also be exempted from reporting. These organizations have stated that they follow the same accreditation standards as the organizations specified in SEC 403.904(g)(1)(i). Other stakeholders have recommended that the exemption be removed in its entirety stating removal of the exclusion will allow for consistent reporting for compensation provided to physician speakers at all continuing education events, as well as transparency regarding compensation paid to physician speakers. Many stakeholders raised concerns that the reporting requirements are inconsistent because certain continuing education payments are reportable, while others are not. CMS' apparent endorsement or support to organizations sponsoring continuing education events was an unintended consequence of the final rule.

   After consideration of these comments, we propose to remove the language in SEC 403.904(g) in its entirety, in part because it is redundant with the exclusion in SEC 403.904(i)(1). That provision excludes indirect payments or other transfers of value where the applicable manufacturer is "unaware" of, that is, "does not know," the identity of the covered recipient during the reporting year or by the end of the second quarter of the following reporting year. When an applicable manufacturer or applicable GPO provides funding to a continuing education provider, but does not either select or pay the covered recipient speaker directly, or provide the continuing education provider with a distinct, identifiable set of covered recipients to be considered as speakers for the continuing education program, CMS will consider those payments to be excluded from reporting under SEC 403.904(i)(1). This approach is consistent with our discussion in the preamble to the final rule, in which we explained that if an applicable manufacturer conveys "full discretion" to the continuing education provider, those payments are outside the scope of the rule (78 FR 9492). In contrast, when an applicable manufacturer conditions its financial sponsorship of a continuing education event on the participation of particular covered recipients, or pays a covered recipient directly for speaking at such an event, those payments are subject to disclosure.

   We considered two alternative approaches to address this issue. First, we explored expanding the list of organizations in SEC 403.904(g)(1)(i) by name, however, we believe that this approach might imply CMS's endorsement of the named continuing education providers over others. Second, we considered expansion of the organizations in SEC 403.904(g)(1)(i) by articulating accreditation or certification standards that would allow a CME program to qualify for the exclusion. This approach is not easily implemented because it would require evaluating both the language of the standards, as well as the enforcement of the standards of any organization professing to meet the criteria. We seek comments on both alternatives presented, including commenters' suggestions about what standards, if any, CMS should incorporate.

3. Reporting of Marketed Name ( SEC 403.904(c)(8))

   Section 1128G(a)(1)(A)(vii) of the Act requires applicable manufacturers to report the name of the covered drug, device, biological or medical supply associated with that payment, if the payment is related to "marketing, education, or research" of a particular covered drug, device, biological, or medical supply. Section 403.904(c)(8)(i) requires applicable manufacturers to report the marketed name for each drug or biological related to a payment or other transfer of value. At SEC 403.904(c)(8)(ii), we require an applicable manufacturer of devices or medical supplies to report one of the following: the marketed name; product category; or therapeutic area. In the February 8, 2013, final rule, we provided applicable manufactures with flexibility when it was determined that the marketed name for all devices and medical supplies may not be useful for the general audience. We did not define product categories or therapeutic areas in SEC 403.904(c). However, since implementation of the February 8, 2013 final rule and the development of the Open Payments system, we have determined that making the reporting requirements for marketed name across drugs, biologics, devices and medical supplies will make the data fields consistent within the system, and also enhance consumer's use of the data.

   Accordingly, we propose to revise SEC 403.904(c)(8) to require applicable manufacturers to report the marketed name for all covered and non-covered drugs, devices, biologicals or medical supplies. We believe this would facilitate consistent reporting for the consumers and researchers using the data displayed publicly on the Open Payments. Manufacturers would still have the option to report product category or therapeutic area, in addition to reporting the market name, for devices and medical supplies.

   Section 403.904(d)(3) requires the reporting of stock, stock option or any other ownership interest. We are proposing to require applicable manufacturers to report such payments as distinct categories. This will enable us to collect more specific data regarding the forms of payment made by applicable manufacturers. After issuing the February 8, 2013 final rule and the development of the Open Payments system, we determined that this specificity will increase the ease of data aggregation within the system, and also enhance consumer's use of the data. We seek comments on the extent to which users of this data set find this disaggregation to be useful, and whether this change presents operational or other issues on the part of applicable manufacturers.

4. Summary of Proposed Changes

   As noted above in this section, we propose the following changes to Part 403, subpart I:

    * Deleting the definition of "covered device" at SEC 403.902.

    * Deleting SEC 403.904(g) and redesignating the remaining paragraphs in that section.

    * Revising SEC 403.904(c)(8) to require the reporting of the marketed name of the related covered and non-covered drugs, devices, biologicals, or medical supplies, unless the payment or other transfer of value is not related to a particular covered or non-covered drug, device, biological or medical supply.

    * Revising SEC 403.904(d) to require the reporting of the reporting of stock, stock option or any other options as distinct categories.

   Data collection requirements would begin January 1, 2015 according to this proposed rule for applicable manufacturers and applicable group purchasing organizations.

J. Physician Compare Web site

1. Background and Statutory Authority

   Section 10331(a)(1) of the Affordable Care Act, required that, by no later than January 1, 2011, we develop a Physician Compare Internet Web site with information on physicians enrolled in the Medicare program under section 1866(j) of the Act, as well as information on other eligible professionals (EPs) who participate in the Physician Quality Reporting System (PQRS) under section 1848 of the Act.

   CMS launched the first phase of Physician Compare on December 30, 2010 (http://www.medicare.gov/physiciancompare). In the initial phase, we posted the names of EPs that satisfactorily submitted quality data for the 2009 PQRS, as required by section 1848(m)(5)(G) of the Act.

   Section 10331(a)(2) of the Affordable Care Act also required that, no later than January 1, 2013, and for reporting periods that began no earlier than January 1, 2012, we implement a plan for making publicly available through Physician Compare information on physician performance that provides comparable information on quality and patient experience measures. We met this requirement in advance of January 1, 2013, as outlined below, and plan to continue addressing elements of the plan through rulemaking.

   To the extent that scientifically sound measures are developed and are available, we are required to include, to the extent practicable, the following types of measures for public reporting:

    * Measures collected under the Physician Quality Reporting System (PQRS).

    * An assessment of patient health outcomes and functional status of patients.

    * An assessment of the continuity and coordination of care and care transitions, including episodes of care and risk-adjusted resource use.

    * An assessment of efficiency.

    * An assessment of patient experience and patient, caregiver, and family engagement.

    * An assessment of the safety, effectiveness, and timeliness of care.

    * Other information as determined appropriate by the Secretary.

As required under section 10331(b) of the Affordable Care Act, in developing and implementing the plan, we must include, to the extent practicable, the following:

    * Processes to ensure that data made public are statistically valid, reliable, and accurate, including risk adjustment mechanisms used by the Secretary.

    * Processes for physicians and eligible professionals whose information is being publicly reported to have a reasonable opportunity, as determined by the Secretary, to review their results before posting to Physician Compare. We have established a 30-day preview period for all measurement performance data that will allow physicians and other EPs to view their data as it will appear on the Web site in advance of publication on Physician Compare (77 FR 69166 and 78 FR 74450). Details of the preview process will be communicated directly to those with measures to preview and will also be published on the Physician Compare Initiative page (http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/physician-compare-initiative/) in advance of the preview period.

    * Processes to ensure the data published on Physician Compare provides a robust and accurate portrayal of a physician's performance.

    * Data that reflects the care provided to all patients seen by physicians, under both the Medicare program and, to the extent applicable, other payers, to the extent such information would provide a more accurate portrayal of physician performance.

    * Processes to ensure appropriate attribution of care when multiple physicians and other providers are involved in the care of the patient.

    * Processes to ensure timely statistical performance feedback is provided to physicians concerning the data published on Physician Compare.

    * Implementation of computer and data infrastructure and systems used to support valid, reliable and accurate reporting activities.

   Section 10331(d) of the Affordable Care Act requires us to consider input from multi-stakeholder groups when selecting quality measures for Physician Compare. We also continue to get input from stakeholders through a variety of means including rulemaking and different forms of stakeholder outreach (Town Hall meetings, Open Door Forums, webinars, education and outreach, Technical Expert Panels, etc.). In developing the plan for making information on physician performance publicly available through Physician Compare, section 10331(e) of the Affordable Care Act requires the Secretary, as the Secretary determines appropriate, to consider the plan to transition to value-based purchasing for physicians and other practitioners that was developed under section 131(d) of the MIPPA.

   Under section 10331(f) of the Affordable Care Act, we are required to submit a report to the Congress by January 1, 2015, on Physician Compare development, and include information on the efforts and plans to collect and publish data on physician quality and efficiency and on patient experience of care in support of value-based purchasing and consumer choice. Section 10331(g) of the Affordable Care Act provides that any time before that date, we may continue to expand the information made available on Physician Compare.

   We believe section 10331 of the Affordable Care Act supports our overarching goals of providing consumers with quality of care information that will help them make informed decisions about their health care, while encouraging clinicians to improve the quality of care they provide to their patients. In accordance with section 10331 of the Affordable Care Act, we plan to publicly report physician performance information on Physician Compare.

2. Public Reporting of Performance and Other Data

   Since the initial launch of the Web site, we have continued to build on and improve Physician Compare. On June 27, 2013, we launched a full redesign of Physician Compare bringing significant improvements including a complete overhaul of the underlying database and a new Intelligent Search feature, addressing two of our stakeholders' primary critiques of the site--the accuracy and currency of the database and the limitations of the search function--and considerably improving Web site functionality and usability. PECOS, as the sole source of verified Medicare professional information, is the primary source of administrative information on Physician Compare. With the redesign, however, we incorporated the use of Medicare Fee-For-Service claims information to verify the information in PECOS to help ensure only the most current and accurate information is included on the site.

   Currently, Web site users can view information about approved Medicare professionals such as name, primary and secondary specialties, practice locations, group affiliations, hospital affiliations that link to the hospital's profile on Hospital Compare as available, Medicare Assignment status, education, languages spoken, and American Board of Medical Specialties (ABMS) board certification information. In addition, for group practices, users can also view group practice names, specialties, practice locations, Medicare assignment status, and affiliated professionals.

   We post on the Web site the names of individual EPs who satisfactorily report under the PQRS, as well as those EPs who are successful electronic prescribers under the Medicare Electronic Prescribing (eRx) Incentive Program. Physician Compare contains a link to a downloadable database of all information on Physician Compare (https://data.medicare.gov/data/physician-compare), including information on this quality program participation. In addition, there is a section on each Medicare professional's profile page indicating with a green check mark the quality programs under which the EP satisfactorily or successfully reported. We propose to continue to include this information annually in the year following the year it is reported (for example, 2015 PQRS reporting will be included on the Web site in 2016).

   With the Physician Compare redesign, we added a quality programs section to each group practice profile page in order to indicate which group practices are satisfactorily participating in the Group Practice Reporting Option (GPRO) under the PQRS or are successful electronic prescribers under the eRx Incentive Program. We have also included a notation and check mark for individuals that successfully participate in the Medicare EHR Incentive Program, as authorized by section 1848(o)(3)(D) of the Act. We propose to continue to include this information annually in the year following the year it is reported (for example, 2015 data will be included on the Web site in 2016).

   As we finalized in the 2014 PFS final rule with comment period (78 FR 74450), we will publicly report the names of those EPs who report the 2014 PQRS Cardiovascular Prevention measures group in support of the Million Hearts Initiative on Physician Compare in 2015 by including a check mark in the quality programs section of the profile page. We propose to also continue to include this information annually in the year following the year it is reported (for example, 2015 data will be included on Physician Compare in 2016). Finally, we will also indicate with a green check mark those individuals who have earned the 2014 PQRS Maintenance of Certification Incentive (Additional Incentive) on the Web site in 2015 (78 FR 74450).

   We continue to implement our plan for a phased approach to public reporting performance information on Physician Compare. The first phase of this plan was finalized with the CY 2012 PFS final rule with comment period (76 FR 73419-73420), where we established that PQRS GPRO measures collected through the GPRO web interface for 2012 would be publicly reported on Physician Compare. The plan was expanded with the CY 2013 PFS final rule with comment period (77 FR 69166), where we established that the specific GPRO web interface measures that would be posted on Physician Compare would include the PQRS GPRO measures for Diabetes Mellitus (DM) and Coronary Artery Disease (CAD), and we noted that we would report composite measures for these measure groups in 2014, if technically feasible. /5/ The 2012 PQRS GPRO measures were publicly reported on Physician Compare in February 2014. Data reported in 2013 on the GPRO DM and GPRO CAD measures and composites collected via the GPRO web interface that meet the minimum sample size of 20 patients and prove to be statistically valid and reliable will be publicly reported on Physician Compare in late CY 2014, if technically feasible. If the minimum threshold is not met for a particular measure, or the measure is otherwise deemed not to be suitable for public reporting, the group's performance rate on that measure will not be publicly reported. We will only publish on Physician Compare those measures that are statistically valid and reliable and therefore most likely to help consumers make informed decisions about the Medicare professionals they choose to meet their health care needs.

   FOOTNOTE 5 By "technically feasible" we mean that there are no operational constraints inhibiting us from moving forward on a given public reporting objective. Operational constraints include delays and/or issues related to data collection which render a set of quality data unavailable in the timeframe necessary for public reporting. END FOOTNOTE

   Measures must be based on reliable and valid data elements to be useful to consumers and thus included on Physician Compare. A reliable data element is consistently measuring the same thing regardless of when or where it is collected, while a valid data element is measuring what it is meant to measure. To address the reliability of performance scores, CMS will measure the extent to which differences in each quality measure are due to actual differences in clinician performance versus variation that arises from measurement error. Statistically, reliability depends on performance variation for a measure across clinicians ("signal"), the random variation in performance for a measure within a clinician's panel of attributed beneficiaries ("noise"), and the number of beneficiaries attributed to the clinician. High reliability for a measure suggests that comparisons of relative performance across clinicians are likely to be stable over different performance periods and that the performance of one clinician on the quality measure can confidently be distinguished from another. Potential reliability values range from zero to one, where one (highest possible reliability) means that all variation in the measure's rates is the result of variation in differences in performance, while zero (lowest possible reliability) means that all variation is a result of measurement error. Reliability testing methods included in the CMS Measures Management System Blueprint include test-retest reliability and analysis of variance (ANOVA). Reliability tests endorsed by the NQF include the beta-binomial model test.

   The validity of a measure refers to the ability to record or quantify what it claims to measure. To analyze validity, CMS can investigate the extent to which each quality measure is correlated with related, previously validated, measures. CMS can assess both concurrent and predictive validity. Predictive validity is most appropriate for process measures or intermediate outcome measures, in which a cause-and-effect relationship is hypothesized between the measure in question and a validated outcome measure. Therefore, the measure in question is computed first, and the validated measure is computed using data from a later period. To examine concurrent validity, the measure in question and a previously validated measure are computed using contemporaneous data. In this context, the previously validated measure should measure a health outcome related to the outcome of interest.

   In the November 2011 Medicare Shared Savings Program final rule (76 FR 67948), we noted that because Accountable Care Organization (ACO) providers/suppliers that are EPs are considered to be a group practice for purposes of qualifying for a PQRS incentive under the Shared Savings Program, we would publicly report ACO performance on quality measures on Physician Compare in the same way as we report performance on quality measures for PQRS GPRO group practices. Public reporting of performance on these measures is presented at the ACO level only. The first sub-set of ACO measures was also published on the Web site in February 2014. ACO measures can be viewed by following the link for Accountable Care Organization (ACO) Quality Data on the homepage of the Physician Compare Web site (http://medicare.gov/physiciancompare/aco/search.html).

   As part of our public reporting plan for Physician Compare, in the CY 2013 PFS final rule with comment period (77 FR 69166-69167), we also finalized the decision to publicly report Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) data for group practices of 100 or more eligible professionals reporting data in 2013 under the GPRO and for ACOs participating in the Shared Savings Program, if technically feasible. We anticipate posting these data on Physician Compare in late 2014, if available.

   We continued to expand our plan for public reporting data on Physician Compare in the CY 2014 PFS final rule with comment period (78 FR 74449). In that final rule we finalized a decision that all measures collected through the GPRO web interface for groups of two or more EPs participating in 2014 under the PQRS GPRO and for ACOs participating in the Medicare Shared Savings Program are available for public reporting in CY 2015. As with all measures we finalized with regard to Physician Compare, these data would include measure performance rates for measures reported that meet the minimum sample size of 20 patients and prove to be statistically valid and reliable. We also finalized a 30-day preview period prior to publication of quality data on Physician Compare. This will allow group practices to view their data as it will appear on Physician Compare before it is publicly reported. We decided that we will detail the process for the 30-day preview and provide a detailed timeline and instructions for preview in advance of the start of the preview period. ACOs will be able to view their quality data that will be publicly reported on Physician Compare through the ACO Quality Reports, which will be made available to ACOs for review at least 30 days prior to the start of public reporting on Physician Compare.

   We also finalized a decision to publicly report in CY 2015 on Physician Compare performance on certain measures that group practices report via registries and EHRs in 2014 for the PQRS GPRO (78 FR 74451). Specifically, we finalized making available for public reporting performance on 16 registry measures and 13 EHR measures (78 FR 74451). These measures are consistent with the measures available for public reporting via the web interface. We will indicate the mechanism by which these data were collected and only those data deemed statistically comparable, valid, and reliable would be published on the site.7

   We also finalized publicly reporting patient experience survey-based measures from the CG-CAHPS measures for groups of 100 or more eligible professionals who participate in PQRS GPRO, regardless of GPRO submission method, and for Shared Savings Program ACOs reporting through the GPRO web interface or other CMS-approved tool or interface (78 FR 74452). For 2014 data, we finalized publicly reporting data for the 12 summary survey measures also finalized for groups of 25 to 99 for PQRS reporting requirements (78 FR 74452). These summary survey measures would be available for public reporting 100 or more EPs participating in PQRS GPRO as well as group practices of 25 to 99 EPs when collected via any certified CAHPS vendor regardless of PQRS participation, as technically feasible. For ACOs participating in the Shared Savings Program, the patient experience measures that are included in the Patient/Caregiver Experience domain of the Quality Performance Standard under the Shared Savings Program (78 FR 74452) are available for public reporting in 2015.

   For 2014, we also finalized publicly reporting 2014 PQRS measure data reported by individual EPs in late CY 2015 for individual PQRS quality measures specifically identified in the final rule with comment period, if technically feasible. Specifically, we finalized to make available for public reporting 20 individual measures collected through a registry, EHR, or claims (78 FR 74453 through 74454). These are measures that are in line with those measures reported by groups via the GPRO web interface.

   Finally, in support of the HHS-wide Million Hearts Initiative, we finalized a decision to publicly report, no earlier than CY 2015, performance rates on measures in the PQRS Cardiovascular Prevention measures group at the individual EP level for data collected in 2014 for the PQRS (78 FR 74454). See Table 19 for a summary of our final policies for public reporting data on Physician Compare. GOES

Table 19--Summary of Previously Finalized Policies for Public Reporting on Physician Compare Data collection Public reporting Reporting Quality measures and year year mechanism(s) data for public reporting 2012 2013 Web Interface Include an indicator (WI), EHR, for satisfactory Registry, Claims reporters under PQRS and PQRS GPRO, successful e-prescribers under eRx, and participants in EHR for groups and individuals as applicable. 2012 2014 WI 5 Diabetes Mellitus (DM) and Coronary Artery Disease (CAD) measures collected via the WI for group practices with a minimum sample size of 25 patients and Shared Savings Program ACOs. 2013 2014 WI, EHR, Include an indicator Registry, Claims for satisfactory reporters under PQRS and PQRS GPRO, successful e-prescribers under eRx, and participants in EHR, as well as for EPs who earn a Maintenance of Certification (MOC) Incentive and EPs who report the PQRS Cardiovascular Prevention measures group in support of Million Hearts. 2013 Expected to be WI Up to 6 DM and 2 CAD December 2014 measures collected via the WI for groups of 25 or more EPs with a minimum sample size of 20 patients. Will include composites for DM and CAD, if feasible. 2013 Expected to be WI 5 CG-CAHPS summary December 2014 measures for groups of 100 or more EPs reporting via the WI and 6 ACO CAHPS summary measures for Shared Savings Program ACOs. 2014 Expected to be WI, EHR, Include an indicator 2015 Registry, Claims for satisfactory reporters under PQRS and PQRS GPRO, participants in EHR, as well as for EPs who earn a Maintenance of Certification (MOC) Incentive and EPs who report the PQRS Cardiovascular Prevention measures group in support of Million Hearts. 2014 Expected to be WI, EHR, All measures reported late 2015 Registry via the GPRO WI, 13 EHR, and 16 Registry GPRO measures are also available for group practices of 2 or more EPs and Shared Savings Program ACOs with a minimum sample size of 20 patients. Include composites for DM and CAD, if feasible. 2014 Expected to be WI, Certified Up to 12 CG-CAHPS late 2015 Survey Vendor summary measures for groups of 100 or more EPs reporting via the WI and group practices of 25 to 99 EPs reporting via a CMS-approved certified survey vendor, as well as 6 ACO CAHPS summary measures for Shared Savings Program ACOs reporting through the GPRO web interface or other CMS-approved tool or interface. 2014 Expected to be Registry, EHR, A sub-set of 20 PQRS late 2015 or Claims measures submitted by individual EPs that align with those available for group reporting via the WI that are collected through a Registry, EHR, or claims with a minimum sample size of 20 patients. 2014 Expected to be Registry, EHR, Measures from the late 2015 or Claims Cardiovascular Prevention measures group reported by individual EPs in support of the Million Hearts Initiative with a minimum sample size of 20 patients.



3. Proposals for Public Data Disclosure on Physician Compare in 2015 and 2016

   We are continuing the expansion of public reporting on Physician Compare by proposing to make an even broader set of quality measures available for publication on the Web site. We started the phased approach with a small number of possible PQRS GPRO web interface measures for 2012, and have been steadily building on this to provide Medicare consumers with more information to help them make informed health care decisions. As a result, we are now proposing to increase the measures available for public reporting.

   We previously finalized in the CY 2014 PFS final rule with comment period (78 FR 74450) to make available for public reporting all PQRS GPRO measures collected in 2014 via the web interface. We now propose to expand public reporting of group-level measures by making all 2015 PQRS GPRO measure sets across group reporting mechanisms--GPRO web interface, registry, and EHR--available for public reporting on Physician Compare in CY 2016 for groups of 2 or more EPs, as appropriate by reporting mechanism. /6/ Similarly, all measures reported by Shared Savings Program ACOs would be available for public reporting on Physician Compare. As with all quality measures proposed for inclusion on Physician Compare, only measures that prove to be valid, reliable, and accurate upon analysis and review at the conclusion of data collection will be included on the Web site. Also, we propose that measures must meet the public reporting criteria of a minimum sample size of 20 patients. We propose to include an indicator of which reporting mechanism was used and only measures deemed statistically comparable would be included on the site. /7/ We propose to publicly report all measures submitted and reviewed and found to be statistically valid and reliable in the Physician Compare downloadable file. However, we propose that not all of these measures necessarily would be included on the Physician Compare profile pages. Consumer testing has shown including too much information and/or measures that are not well understood by consumers on these pages can negatively impact a consumer's ability to make informed decisions. Our analysis of the measure data once collected, consumer testing, and stakeholder feedback would determine specifically which measures are published on profile pages on the Web site. Statistical analyses will ensure the measures included are statistically valid and reliable and comparable across data collection mechanisms. And, stakeholder feedback will ensure all measures meet current clinical standards. CMS will continue to reach out to stakeholders in the professional community, such as specialty societies, to ensure that the measures under consideration for public reporting remain clinically relevant and accurate. As measures are finalized significantly in advance of moment they are collected, it is possible that clinical guidelines can change rendering a measure no longer relevant. Publishing that measure can lead to consumer confusion regarding what best practices their health care professional should be subscribing to.

   FOOTNOTE 6 Tables Q1-Q27 detail proposed changes to available PQRS measures. Additional information on PQRS measures can be found on the CMS.gov PQRS Web site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/index.html. END FOOTNOTE

   FOOTNOTE 7 By statistically comparable, CMS means that the quality measures are analyzed and proven to measure the same phenomena in the same way regardless of the mechanism through which they were collected. END FOOTNOTE

   The primary goal of Physician Compare is to help consumers make informed health care decisions. If a consumer does not properly interpret a quality measure and thus misunderstands what the quality score represents, the consumer cannot use this information to make an informed decision. Through concept testing, CMS will test with consumers how well they understand each measure under consideration for public reporting. If a measure is not consistently understood and/or if consumers do not understand the relevance of the measure to their health care decision making process, CMS will not include the measure on the Physician Compare profile page as inclusion will not aid informed decision making. Finally, consumer testing will help ensure the measures included on the profile pages are accurately understood and relevant to consumers, thus helping them make informed decisions. This will be done to ensure that the information included on Physician Compare is consumer friendly and consumer focused.

   As is the case for all measures published on Physician Compare, group practices will be given a 30-day preview period to view their measures as they will appear on Physician Compare prior to the measures being published. As in previous years, we will detail the process for the 30-day preview and provide a detailed timeline and instructions for preview in advance of the start of the preview period. ACOs will be able to view their quality data that will be publicly reported on Physician Compare through the ACO Quality Reports, which will be made available to ACOs for review at least 30 days prior to the start of public reporting on Physician Compare.

   In addition to making all 2015 PQRS GPRO measures available for public reporting, we seek comment on creating composites using 2015 data and publishing composite scores in 2016 by grouping measures based on the PQRS GPRO measure groups, if technically feasible. We will analyze the data collected in 2015 and conduct psychometric and statistical analyses, looking at how the measures best fit together and how accurately they are measuring the composite concept, to create composites for certain PQRS GPRO measure groups, including but not limited to:

* Care Coordination/Patient Safety (CARE) Measures

* Coronary Artery Disease (CAD) Disease Module

* Diabetes Mellitus (DM) Disease Module

* Preventive (PREV) Care Measures

   We would analyze the component measures that make up each of these measure groups to see if a statistically viable composite can be constructed with the data reported for 2015. We have received ample feedback from stakeholders indicating such scores are strongly desired. Composite scores, generally, have also proven to be critical for providing consumers a better way to understand quality measure data as composites provide a more concise, easy to understand picture of physician quality. Therefore, we plan to analyze the data once collected to establish the best possible composite, which would help consumers use these quality data to make informed health care decisions.

   Similar to composite scores, benchmarks are also important to ensuring that the quality data published on Physician Compare are accurately interpreted and appropriately understood. A benchmark will allow consumers to more easily evaluate the information published by providing a point of comparison between groups. We continue to receive requests from all stakeholders, but especially consumers, to add this information to Physician Compare. As a result, we propose to publicly report on Physician Compare in 2016 benchmarks for 2015 PQRS GPRO data using the same methodology currently used under the Shared Savings Program. This ACO benchmark methodology was previously finalized in the November 2011 Shared Savings Program final rule (76 FR 67898), as amended in the CY 2014 PFS final rule with comment period (78 FR 74759). Details on this methodology can be found on CMS.gov at http://cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/MSSP-QM-Benchmarks.pdf. We propose to follow this methodology using the 2014 PQRS GPRO data, however.

   As outlined for the Shared Savings Program, we propose to calculate benchmarks using data at the group practice TIN level for all EPs who have at least 20 cases in the denominator. A benchmark per this methodology is the performance rate a group practice must achieve to earn the corresponding quality points for each measure. Benchmarks would be established for each percentile, starting with the 30th percentile (corresponding to the minimum attainment level) and ending with the 90th percentile (corresponding to the maximum attainment level). A quality scoring points systems would then be determined. Quality scoring would be based on the group practice's actual level of performance on each measure. A group practice would earn quality points on a sliding scale based on level of performance: Performance below the minimum attainment level (the 30th percentile) for a measure would receive zero points for that measure; performance at or above the 90th percentile of the performance benchmark would earn the maximum points available for the measure. The total points earned for measures in each measure group would be summed and divided by the total points available for that measure group to produce an overall measure group score of the percentage of points earned versus points available. The percentage score for each measure group would be averaged together to generate a final overall quality score for each group practice. The goal of including such benchmarks would be to help consumers see how each group practice performs on each measure, measure group, and overall in relation to other group practices.

   Understanding the value consumers place on patient experience data and the commitment to reporting these data on Physician Compare, we propose publicly reporting in CY 2016 patient experience data from 2015 for all group practices of 2 or more EPs, who meet the specified sample size requirements and collect data via a CMS-specified certified CAHPS vendor. The patient experience data available are specifically the CAHPS for PQRS and CAHPS for ACO measures, which include the CG-CAHPS core measures. For group practices, we propose to publicly report for 2015 data on Physician Compare in 2016 the 12 summary survey measures previously finalized for 2014 data:

* Getting Timely Care, Appointments, and Information

* How Well Providers Communicate

* Patient's Rating of Provider

* Access to Specialists

* Health Promotion & Education

* Shared Decision Making

* Health Status/Functional Status

* Courteous and Helpful Office Staff

* Care Coordination

* Between Visit Communication

* Helping You to Take Medication as Directed

* Stewardship of Patient Resources

   We propose that these 12 summary survey measures would be available for public reporting for all group practices. For ACOs participating in the Shared Savings Program, we propose that the patient experience measures that are included in the Patient/Caregiver Experience domain of the Quality Performance Standard under the Shared Savings Program in 2015 would be available for public reporting in 2016. We would review all quality measures after they are collected to ensure that only those measures deemed valid and reliable are included on the Web site.

   We previously finalized in the 2014 PFS final rule with comment period (78 FR 74454) that 20 2014 PQRS measures for individual EPs collected via registry, EHR, or claims would be available for public reporting in late 2015, if technically feasible. We propose to expand on this in two ways. First, we propose to publicly report these same 20 measures for 2013 PQRS data in early 2015. Publicly reporting these 2013 individual measures will help ensure individual level measures are made available as soon as possible. Consumers are looking for measures about individual doctors and other health care professionals, and this would make these quality data available to the public sooner.

   Second, we propose to make all individual EP-level PQRS measures collected via registry, EHR, or claims available for public reporting on Physician Compare for data collected in 2015 to be publicly reported in late CY 2016, if technically feasible. /8/ This will provide the opportunity for more EPs to have measures included on Physician Compare, and it will provide more information to consumers to make informed decisions about their health care. As with group-level measures, we propose to publicly report all measures submitted and reviewed and deemed valid and reliable in the Physician Compare downloadable file. However, not all of these measures necessarily would be included on the Physician Compare profile pages. Our analysis of the measure data once collected, consumer testing, and stakeholder feedback would determine specifically which measures are published on profile pages on the Web site. In this way, quality information at the individual practitioner level would be available, as has been regularly requested by Medicare consumers, but consumers will not be overwhelmed with too much information on each EPs profile page.

   FOOTNOTE 8 Tables Q1-Q27 detail proposed changes to available PQRS measures. Additional information on PQRS measures can be found on the CMS.gov PQRS Web site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/index.html. END FOOTNOTE

   As noted above for group-level reporting, composite scores and benchmarks are critical in helping consumers best understand the quality measure information presented. For that reason, in addition to making all 2015 PQRS measures available for public reporting, we seek comment to create composites and publish composite scores by grouping measures based on the PQRS measure groups, if technically feasible. We will analyze the data collected in 2015 and conduct psychometric and statistical analyses to create composites for PQRS measure groups to be published in 2016, including:

* Coronary Artery Disease (CAD) (see Table 30)

* Diabetes Mellitus (DM) (see Table 32)

* General Surgery (see Table 33)

* Oncology (see Table 38)

* Preventive Care (see Table 41)

* Rheumatoid Arthritis (RA) (see Table 42)

* Total Knee Replacement (TKR) (see Table 45)

   We would analyze the component measures that make up each of these measure groups to see if a statistically viable composite can be constructed with the data reported for 2015. In addition, we propose to use the same methodology outlined above for group practices to develop benchmarks for individual practitioners. As noted for group practices, we believe that providing composite scores and benchmarks will give consumers the tools needed to most accurately interpret the quality data published on Physician Compare.

   Previously, we indicated an interest in including specialty society measures on Physician Compare. We now seek comment on posting these measures on the Web site. We also seek comment on the option of linking from Physician Compare to specialty society Web sites that publish non-PQRS measures. Including specialty society measures on the site or linking to specific specialty society measures would provide the opportunity for more eligible professionals to have measures included on Physician Compare and thus help Medicare consumers make more informed choices. The quality measures developed by specialty societies that would be considered for future posting on Physician Compare are those that have been comprehensively vetted and tested, and are trusted by the physician community. These measures would provide access to available specialty specific quality measures that are often highly regarded and trusted by the stakeholder community and, most importantly, by the specialties they represent. We are working to identify possible societies to reach out to, and seek comment on the concept, as well as potential specific society measures of interest.

   Finally, we propose to make available on Physician Compare, 2015 Qualified Clinical Data Registry (QCDR) measure data collected at the individual level or aggregated to a higher level of the QCDR's choosing--such as the group practice level, if technically feasible. QCDRs are able to collect both PQRS measures and non-PQRS measures. /9/ We believe that making QCDR data available on Physician Compare further supports the expansion of quality measure data available for EPs and group practices regardless of specialty therefore providing more quality data to consumers to help them make informed decisions. The QCDR would be required to declare during their self-nomination if they plan to post data on their own Web site and allow Physician Compare to link to it or if they will provide data to us for public reporting on Physician Compare. We propose that measures collected via QCDRs must also meet the established public reporting criteria, including a 20 patient minimum sample size. As with PQRS data, we propose to publicly report all measures submitted and reviewed and deemed valid and reliable in the Physician Compare downloadable file. However, not all of these measures necessarily would be included on the Physician Compare profile pages. Our analysis of the measure data once collected, consumer testing, and stakeholder feedback would determine specifically which measures are published on profile pages on the Web site.

   FOOTNOTE 9 http://www.cms.gov/apps/ama/license.asp?file=/PQRS/downloads/2014_PQRS_IndClaimsRegistry_MeasureSpecs_SupportingDocs_12132013.zip. END FOOTNOTE

   Table 20 summarizes the Physician Compare proposals detailed in this section. We solicit comments on all proposals. Increasing the measures available for public reporting on Physician Compare at both the individual and group level will help accomplish the Web site's twofold purpose:

    * Provide more information for consumers to encourage informed patient choice.

    * Create explicit incentives for physicians to maximize performance. GOES

Table 20--Summary of Proposed Data for Public Reporting Data Publication Data type Reporting Proposed collection year mechanism quality year measures and data for public reporting 2013 2015 PQRS Registry, EHR, Twenty 2013 or Claims PQRS individual measures collected through a Registry, EHR, or claims mirroring the measures finalized for 2014 (78 FR 74454). 2015 2016 Multiple Web Interface, Include an EHR, Registry, indicator for Claims satisfactory reporters under PQRS and PQRS GPRO, participants in EHR, and EPs who report the PQRS Cardiovascular Prevention measures group in support of Million Hearts. 2015 2016 PQRS GPRO & Web Interface, All 2015 PQRS ACO GPRO EHR, & GPRO measures Registry reported via the Web Interface, EHR, and Registry are available for public reporting for group practices of 2 or more EPs and all measures reported by ACOs with a minimum sample size of 20 patients. 2015 2016 CAHPS for PQRS CMS-Specified 2015 CAHPS for & CAHPS for Certified PQRS for ACOs CAHPS Vendor groups of 2 or more EPs and CAHPS for ACOs for those who meet the specified sample size requirements and collect data via a CMS-specified certified CAHPS vendor. 2015 2016 PQRS Registry, EHR, All 2015 PQRS or Claims measures for individual EPs collected through a Registry, EHR, or claims. 2015 2016 QCDR data QCDR All 2015 QCDR data available for public report on Physician Compare at the individual level or aggregated to a higher level of the QCDR's choosing.



K. Physician Payment, Efficiency, and Quality Improvements--Physician Quality Reporting System

   This section contains the proposed requirements for the Physician Quality Reporting System (PQRS). The PQRS, as set forth in sections 1848(a), (k), and (m) of the Act, is a quality reporting program that provides incentive payments (ending with 2014) and payment adjustments (beginning in 2015) to eligible professionals and group practices based on whether they satisfactorily report data on quality measures for covered professional services furnished during a specified reporting period or to individual eligible professionals that satisfactorily participate in a qualified clinical data registry (QCDR).

   The proposed requirements will primarily focus on our proposals related to the 2017 PQRS payment adjustment, which will be based on an eligible professional's or a group practice's reporting of quality measures data during the 12-month calendar year reporting period occurring in 2015 (that is, January 1 through December 31, 2015). Please note that, in developing these proposals, we focused on aligning our requirements with other quality reporting programs, such as the Medicare EHR Incentive Program for Eligible Professionals, the Physician Value-Based Payment Modifier (VM), and the Medicare Shared Savings Program, where and to the extent appropriate and feasible. In previous years, we have made various strides in our ongoing efforts to align the reporting requirements in CMS' various quality reporting programs to reduce burden on the eligible professionals and group practices that participate in these programs. Particularly through the QCDR option, we are exploring opportunities to align with quality reporting programs that exist outside of CMS where and to the extent appropriate and feasible. We continued to focus on alignment as we developed our proposals for the 2017 PQRS payment adjustment below.

   The PQRS regulation is located at 42 CFR 414.90. The program requirements for the 2007 through 2014 PQRS incentives and the 2015 and 2016 PQRS payment adjustment that were previously established, as well as information on the PQRS, including related laws and established requirements, are available at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/index.html. In addition, the 2012 PQRS and eRx Experience Report, which provides information about eligible professional participation in PQRS, is available for download at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2012-PQRS-and-eRx-Experience-Report.zip.

   We note that eligible professionals in critical access hospitals (CAHs) were previously not able to participate in the PQRS. Due to a change we made in the manner in which eligible professionals in CAHs are reimbursed by Medicare, it is now feasible for eligible professionals in CAHs to participate in the PQRS. Although eligible professionals in CAHs are not able to use the claims-based reporting mechanism to report PQRS quality measures data in 2014, beginning in 2015, these eligible professionals in CAHs may participate in the PQRS using ALL reporting mechanisms available, including the claims-based reporting mechanism. Finally, please note that in accordance with section 1848(a)(8) of the Act, all eligible professionals who do not meet the criteria for satisfactory reporting or satisfactory participation for the 2017 PQRS payment adjustment will be subject to the 2017 PQRS payment adjustment with no exceptions.

   In addition, in the CY 2013 PFS final rule with comment period, we introduced the reporting of the Agency for Healthcare Research and Quality's (AHRQ's) Clinician & Group (CG) Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey measures, referenced at https://cahps.ahrq.gov/Surveys-Guidance/CG/index.html. AHRQ's CAHPS Clinician & Group Survey Version 2.0 (CG-CAHPS) includes 34 core CG-CAHPS survey questions. In addition to these 34 core questions, the CAHPS survey measures that are used in the PQRS include supplemental questions from CAHPS Patient-Centered Medical Home Survey, Core CAHPS Health Plan Survey Version 5.0, other CAHPS supplemental items, and some additional questions. Since the CAHPS survey used in the PQRS covers more than just the 34 core CG-CAHPS survey measures, we will refer to the CG-CAHPS survey measures used in the PQRS as "CAHPS for PQRS." We propose to make this revision throughout SEC 414.90.

1. Requirements for the PQRS Reporting Mechanisms

   The PQRS includes the following reporting mechanisms: Claims; qualified registry; EHR (including direct EHR products and EHR data submission vendor products); the Group Practice Reporting Option (GPRO) web interface; certified survey vendors, for CG-CAHPS survey measures; and the QCDR. Under the existing PQRS regulation, SEC 414.90(h) through (k) govern which reporting mechanisms are available for use by individuals and group practices for the PQRS incentive and payment adjustment. This section III.K.1 contains our proposals to change the qualified registry, direct EHR and EHR data submission vendor products, QCDR, and GPRO web interface reporting mechanisms. Please note that we are not proposing to make changes to the claims-based reporting mechanism.

a. Proposed Changes to the Requirements for the Qualified Registry

   In the CY 2013 and 2014 PFS final rules with comment period, we established certain requirements for entities to become qualified registries for the purpose of verifying that a qualified registry is prepared to submit data on PQRS quality measures for the reporting period in which the qualified registry seeks to be qualified (77 FR 69179 through 69180 and 78 FR 74456). Specifically, in the CY 2014 PFS final rule with comment period, in accordance with the satisfactory reporting criterion we finalized for individual eligible professionals or group practices reporting PQRS quality measures via qualified registry, we finalized the following requirement that a qualified registry must be able to collect all needed data elements and transmit to CMS the data at the TIN/NPI level for at least 9 measures covering at least 3 of the National Quality Strategy (NQS) domains (78 FR 74456).

   As we explain in further detail in this section III.K, we are proposing that--in addition to proposing to require that an eligible professional or group practice report on at least 9 measures covering 3 NQS domains--an eligible professional or group practice who sees at least 1 Medicare patient in a face-to-face encounter, as we propose to define that term in section III.K.2.a., and wishes to meet the proposed criterion for satisfactory reporting of PQRS quality measures via a qualified registry for the 2017 PQRS payment adjustment would be required to report on at least 2 cross-cutting PQRS measures specified in Table 21. In accordance with this proposal, we are proposing to require that, in addition to being required to be able to collect all needed data elements and transmit to CMS the data at the TIN/NPI level for at least 9 measures covering at least 3 of the NQS domains for which a qualified registry transmits data, a qualified registry would be required to be able to collect all needed data elements and transmit to CMS the data at the TIN/NPI level for ALL cross-cutting measures specified in Table 21 for which the registry's participating eligible professionals are able to report. We are proposing to require that qualified registries be able to report on all cross-cutting measures specified in Table 21 for which the registry's participating eligible professionals are able to report, rather than proposing to require a minimum of 2, so that eligible professionals and group practices using qualified registries to report PQRS measures would have the flexibility in choosing which cross-cutting measures to report, and to report on as many cross-cutting measures specified in Table 21 as they are able.

   Furthermore, in the CY 2013 PFS final rule, we noted that qualified registries have until the last Friday of February following the applicable reporting period (for example, February 28, 2014, for reporting periods ending in 2013) to submit quality measures data on behalf of its eligible professionals (77 FR 69182). We continue to receive stakeholder feedback, particularly from qualified registries currently participating in the PQRS, urging us to extend this submission deadline due to the time it takes for these qualified registries to collect and analyze the quality measures data received after the end of the reporting period. While, at the time, we emphasized the need to have quality measures data received by CMS no later than the last Friday of the February occurring after the end of the applicable reporting period, we believe it is now feasible to extend this deadline. Therefore, we propose to extend the deadline for qualified registries to submit quality measures data, including, but not limited to, calculations and results, to March 31 following the end of the applicable reporting period (for example, March 31, 2016, for reporting periods ending in 2015).

   In addition, we seek comment on whether to propose in future rulemaking to allow more frequent submissions of data, such as quarterly or year-round submissions, rather than having only one opportunity to submit quality measures data as is our current process.

   We invite public comment on these proposals.

b. Proposed Changes to the Requirements for the Direct EHR and EHR Data Submission Vendor Products That Are CEHRT

   In the CY 2013 PFS final rule with comment period, we finalized requirements that although EHR vendors and their products would no longer be required to undergo the previously existing qualification process, we would only accept the data if the data are: (1) Transmitted in a CMS-approved XML format utilizing a Clinical Document Architecture (CDA) standard such as Quality Reporting Data Architecture (QRDA) level 1 (and for EHR data submission vendor products that intend to report for purposes of the proposed PQRS-Medicare EHR Incentive Program Pilot, if the aggregate data are transmitted in a CMS-approved XML format); and (2) in compliance with a CMS-specified secure method for data submission (77 FR 69183 through 69187). To further clarify, EHR vendors and their products must be able to submit data in the form and manner specified by CMS. Accordingly, direct EHRs and EHR data submission vendors must comply with CMS Implementation Guides for both the QRDA-I and QRDA-III data file formats. The Implementation Guides for 2014 are available at http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Downloads/Guide_QRDA_2014eCQM.pdf. Updated guides for 2015, when available, will be posted on the CMS EHR Incentive Program Web site at http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms. These implementation guides further describe the technical requirements for data submission to ensure the data elements required for measure calculation and verification are provided. We propose to continue applying these requirements to direct EHR products and EHR data submission vendor products for 2015 and beyond. For 2015 and beyond, we also propose to have the eligible professional or group practice provide the CMS EHR Certification Number of the product used by the eligible professional or group practice for direct EHRs and EHR data submission vendors.

   We believe this requirement is necessary to ensure that the eligible professionals and group practices that are using EHR technology are using a product that is certified EHR technology (CEHRT) and will allow CMS to ensure that the eligible professional or group practice's data is derived from a product that is CEHRT.

   Additionally, we seek comment on whether to propose in future rulemaking to allow more frequent submissions of data, such as quarterly or year-round submissions, rather than having only one opportunity to submit quality measures data as is our current process.

   We invite public comment on these proposals.

c. Proposed Changes to the Requirements for the QCDR

   In the CY 2014 PFS final rule with comment period, we established certain requirements for entities to become QCDRs for the purpose of having their participating eligible professionals meet the criteria for satisfactory participation in a QCDR for purposes of the PQRS incentives and payment adjustments (78 FR 74465 through 74474).

   Specifically, in accordance with the final criterion that required eligible professionals to report on at least 1 outcome measure, we required that an entity possess at least 1 outcome measure for which its participating eligible professionals may report (78 FR 74470). As we explain in further detail in section III.K. of this proposed rule, we are proposing that an eligible professional wishing to meet the proposed criterion for satisfactory participation in a QCDR for the 2017 PQRS payment adjustment report on at least 3 outcome measures (or if less than 3 outcome measures are available for reporting, report on at least 2 outcome measures and at least 1 of the following types of measures: resource use; patient experience of care; or efficiency/appropriate use). Accordingly, we are proposing to amend the requirement for the 2017 PQRS payment adjustment to require a QCDR to possess at least 3 outcome measures (or, in lieu of 3 outcome measures, at least 2 outcome measures and at least 1 of the following other types of measures--resource use, patient experience of care, or efficiency/appropriate use).

   To establish the minimum number of measures (9 measures covering at least 3 NQS domains) a QCDR may report for the PQRS, we placed a limit on the number of non-PQRS measures (20) that a QCDR may submit on behalf of an eligible professional at this time (78 FR 74476). Although we believe such a limit is still necessary because the QCDR option is still new and we are still gaining familiarity with the measures available for reporting under the QCDRs, we believe it is appropriate to increase the number of non-PQRS that may be reported by QCDRs. We have received comments from entities currently undergoing the QCDR qualification process who wish to submit data on additional measures and we believe that accepting additional quality measures data is important, as it provides a better and more complete picture of the quality of care provided by eligible professionals. Therefore, we are proposing to change this limit from 20 measures to 30. In other words, beginning with the criteria for satisfactory participation for the 2017 PQRS payment adjustment, a QCDR may submit quality measures data for a maximum of 30 non-PQRS measures. Please note that this proposed limit does not apply to measures contained in the PQRS measure set, as QCDRs can report on as many measures in the PQRS measure set as they wish.

   Additionally, CMS' experience during the 2014 self-nomination process shed light on clarifications needed on what is considered a non-PQRS measure. Therefore, to clarify the definition of non-PQRS measures, we propose the following parameters for a measure to be considered a non-PQRS measure:

    * A measure that is not contained in the PQRS measure set for the applicable reporting period.

    * A measure that may be in the PQRS measure set but has substantive differences in the manner it is reported by the QCDR. For example, PQRS measure 319 is reportable only via the GPRO web interface. A QCDR wishes to report this measure on behalf of its eligible professionals. However, as CMS has only extracted the data collected from this quality measure using the GPRO web interface, in which CMS utilizes a claims-based assignment and sampling methodology to inform the groups on which patients they are to report, the reporting of this measure would require changes to the way that the measure is calculated and reported to CMS via a QCDR instead of through the GPRO web interface. Therefore, due to the substantive changes needed to report this measure via a QCDR, PQRS measure 319 would be considered a non-PQRS measure. In addition, CAHPS for PQRS is currently reportable only via a CMS-certified survey vendor. However, although CAHPS for PQRS is technically contained in the PQRS measure set, we consider the changes that will need to be made to be available for reporting by individual eligible professionals (and not as a part of a group practice) significant enough as to treat CAHPS for PQRS as a non-PQRS measure for purposes of reporting CAHPS for PQRS via a QCDR.

   Furthermore, under our authority to establish the requirements for an entity to be considered a QCDR under section 1848(m)(3)(E)(i) of the Act, we established certain requirements for an entity to be considered a QCDR in the CY 2014 PFS final rule with comment period (78 FR 74467 through 74473). Under this same authority, we are proposing here to add the following requirement that an entity must meet to serve as a QCDR under the PQRS for reporting periods beginning in 2015:

    * Require that the entity make available to the public the quality measures data for which its eligible professionals report.

   In the CY 2014 PFS proposed rule, we proposed that, to be considered a QCDR, an entity would be required to demonstrate that it has a plan to publicly report its quality data through a mechanism where the public and registry participants can view data about individual eligible professionals, as well as view regional and national benchmarks (78 FR 43363). Due to stakeholder feedback against this proposal, as well as comments requesting more details surrounding this proposal, we did not finalize this proposed requirement in the CY 2014 PFS final rule with comment period. However, we noted that we would revisit this proposal in future years (78 FR 74471). Because of our ongoing interest in providing transparency to the public for quality measures data that is reported under the PQRS, we again propose the requirement that an entity make available to the public the quality measures data for which its eligible professionals report. To clarify this proposal, we propose that, at a minimum, the QCDR publicly report the following quality measures data information that we believe will give patients adequate information on the care provided by an eligible professional:

    * The title and description of the measures that a QCDR reports for purposes of the PQRS, as well as the performance results for each measure the QCDR reports.

   With respect to when the quality measures data must be publicly reported, we propose that the QCDR must have the quality measures data by April 31 of the year following the applicable reporting period (that is, April 31, 2016, for reporting periods occurring in 2015). The proposed deadline of April 31 will provide QCDRs with one month to post quality measures data and information following the March 31 deadline for the QCDRs to transmit quality measures data for purposes of the PQRS payment adjustments. We also propose that this data be available on a continuous basis and be continuously updated as the measures undergo changes in measure title and description, as well as when new performance results are calculated.

   Please note that, in making this proposal, we defer to the entity in terms of the method it will use to publicly report the quality measures data it collects for the PQRS. For example, to meet this proposed requirement, it would be sufficient for a QCDR to publicly report performance rates of eligible professionals through means such as, but not excluding, board or specialty Web sites, performance or feedback reports, or listserv dashboards or announcements. We also note that a QCDR would meet this public reporting requirement if the QCDR's measures data were posted on Physician Compare. In addition, we defer to the QCDR to determine whether to report performance results at the individual eligible professional level or aggregate the results for certain sets of eligible professionals who are in the same practice together (but we are not registered as a group practice for the purposes of PQRS reporting). We believe it is appropriate to allow a QCDR to publicly report performance results at an aggregate level for certain eligible professionals when those who are in the same practice contribute to the overall care provided to a patient.

   Based on CMS experience with the qualifying entities wishing to become QCDRs for reporting periods occurring in 2014, we received feedback from many organizations who expressed concern that the entity wishing to become a QCDR may not meet the requirements of a QCDR solely on its own. Therefore, we provide the following proposals beginning in 2015 on situations where an entity may not meet the requirements of a QCDR solely on its own but, in conjunction with another entity, may be able to meet the requirements of a QCDR and therefore be eligible for qualification:

    * We propose to allow that an entity that uses an external organization for purposes of data collection, calculation or transmission may meet the definition of a QCDR so long as the entity has a signed, written agreement that specifically details the relationship and responsibilities of the entity with the external organizations effective as of January 1 the year prior to the year for which the entity seeks to become a QCDR (for example, January 1, 2014, to be eligible to participate for purposes of data collected in 2015). We are adding this proposal because we received questions from entities wishing to become QCDRs who are engaged in quality improvement activities but use an external organization for purposes of quality measures data collection, calculation, and transmission. We believe that it may be appropriate to classify the entity as a QCDR so long as the entity meets the definition of a QCDR by the date for which we require that a QCDR must be in existence (that is, January 1 the year prior to the year for which the entity seeks to become a QCDR (78 FR 74467)). Entities that have a mere verbal, non-written agreement to work together to become a QCDR by January 1 the year prior to the year for which the entity seeks to become a QCDR would not fulfill this proposed requirement.

    * In addition, we propose that an entity that has broken off from a larger organization may be considered to be in existence for the purposes of QCDR qualification as of the earliest date the larger organization begins continual existence. We received questions from entities who used to be part of a larger organization but have recently become independent from the larger organization as to whether the entities would meet the requirement established in the CY 2014 PFS final rule with comment period that the entity be in existence as of January 1 the year prior to the year for which the entity seeks to become a QCDR (78 FR 74467). For example, a registry that was previously a part of a larger medical society as of January 1, 2013, could have broken off from the medical society and become an independent registry in 2014. Likewise, a member of a medical society could create a registry separate from the medical society. As such, there would be concern as to whether that entity would meet the requirement of being in existence prior to January 1, 2013, to be considered for qualification for reporting periods occurring in 2014. In these examples, for purposes of meeting the requirement that the entity be in existence as of January 1 the year prior to the year for which the entity seeks to become a QCDR, we may consider this entity as being in existence as of the date the larger medical society was in existence.

   In the CY 2014 PFS final rule with comment period, in accordance with the submission deadline of quality measures data for qualified registries, we noted a deadline of the last Friday in February occurring after the end of the applicable reporting period to submit quality measures data to CMS (78 FR 74471). In accordance with our proposal to extend this deadline for qualified registries, we propose to extend the deadline for QCDRs to submit quality measures data calculations and results by March 31 following the end of the applicable reporting period (that is, March 31, 2016, for reporting periods occurring in 2015).

   Additionally, we seek comment on whether to propose in future rulemaking to allow more frequent submissions of data, such as quarterly or year-round submissions, rather than having only one opportunity to submit quality measures data as is our current process.

   We seek public comment on these proposed changes to the requirements for the QCDR.

d. Proposed Changes to the GPRO Web Interface

   In the CY 2014 PFS final rule with comment period (78 FR 74456), we finalized our proposal to require "that group practices register to participate in the GPRO by September 30 of the year in which the reporting period occurs (that is September 30, 2014 for reporting periods occurring in 2014), as proposed." However, we noted that, in order "to respond to the commenters concerns to provide timelier feedback on performance on CG CAHPS in the future, we anticipate proposing an earlier deadline for group practices to register to participate in the GPRO in future years" (78 FR 74456). Indeed, to provide timelier feedback on performance on CAHPS for PQRS, we propose to modify the deadline that a group practice must register to participate in the GPRO to June 30 of the year in which the reporting period occurs (that is, June 30, 2015, for reporting periods occurring in 2015). Although this proposed GPRO registration deadline would provide less time for a group practice to decide whether to participate in the GPRO, we believe the benefit of providing timelier feedback reports outweighs this concern.

   Furthermore, we seek comment on whether to allow more frequent submissions of data, such as quarterly or year-round submissions, rather than having only one opportunity to submit quality measures data as is our current process.

   We seek public comment on these proposals.

2. Proposed Criteria for the Satisfactory Reporting for Individual Eligible Professionals for the 2017 PQRS Payment Adjustment

   Section 1848(a)(8) of the Act, as added by section 3002(b) of the Affordable Care Act, provides that for covered professional services furnished by an eligible professional during 2015 or any subsequent year, if the eligible professional does not satisfactorily report data on quality measures for covered professional services for the quality reporting period for the year, the fee schedule amount for services furnished by such professional during the year (including the fee schedule amount for purposes of determining a payment based on such amount) shall be equal to the applicable percent of the fee schedule amount that would otherwise apply to such services. For 2016 and subsequent years, the applicable percent is 98.0 percent.

a. Proposed Criterion for the Satisfactory Reporting of Individual Quality Measures via Claims and Registry for Individual Eligible Professionals for the 2017 PQRS Payment Adjustment

   In the CY 2014 PFS final rule with comment period (see Table 47 at 78 FR 74479), we finalized the following criteria for satisfactory reporting for the submission of individual quality measures via claims and registry for the 2014 PQRS incentive: For the 12-month reporting period for the 2014 PQRS incentive, the eligible professional would report at least 9 measures, covering at least 3 of the NQS domains, OR, if less than 9 measures apply to the eligible professional, report 1-8 measures, AND report each measure for at least 50 percent of the Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percent performance rate would not be counted. For an eligible professional who reports fewer than 9 measures covering less than 3 NQS domains via the claims- or registry-based reporting mechanism, the eligible professional would be subject to the measure application validity (MAV) process, which would allow us to determine whether the eligible professional should have reported quality data codes for additional measures.

   To be consistent with the satisfactory reporting criterion we finalized for the 2014 PQRS incentive, we are proposing to modify SEC 414.90(j) and propose the following criterion for individual eligible professionals reporting via claims and registry: For the 12-month reporting period for the 2017 PQRS payment adjustment, the eligible professional would report at least 9 measures, covering at least 3 of the NQS domains AND report each measure for at least 50 percent of the eligible professional's Medicare Part B FFS patients seen during the reporting period to which the measure applies. Of the measures reported, if the eligible professional sees at least 1 Medicare patient in a face-to-face encounter, as we propose to define that term below, the eligible professional would report on at least 2 measures contained in the proposed cross-cutting measure set specified in Table 21. If less than 9 measures apply to the eligible professional, the eligible professional would report up to 8 measure(s), AND report each measure for at least 50 percent of the Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percent performance rate would not be counted.

   We note that, unlike the criterion we finalized for the 2014 PQRS incentive, we are proposing to require an eligible professional who sees at least 1 Medicare patient in a face-to-face encounter, as we propose to define that term below, during the 12-month 2017 PQRS payment adjustment reporting period to report at least 2 measures contained in the proposed cross-cutting measure set specified in Table 21. As we noted in the CY 2014 PFS proposed rule (78 FR 43359), we are dedicated to collecting data that provides us with a better picture of the overall quality of care furnished by eligible professionals, particularly for the purpose of having PQRS reporting being used to assess quality performance under the VM. We believe that requiring an eligible professional to report on at least 2 broadly applicable, cross-cutting measures will provide us with quality data on more varied aspects of an eligible professional's practice. We also note that in its 2014 pre-rulemaking final report (available at http://www.qualityforum.org/Publications/2014/01/MAP_Pre-Rulemaking_Report__2014_Recommendations_on_Measures_for_More_than_20_Federal_Programs.aspx), the Measure Applications Partnership (MAP) encouraged the development of a core measure set (see page 16 of the "MAP Pre-Rulemaking Report: 2014 Recommendations on Measures for More than 20 Federal Programs"). The MAP stated "a core [measure set] would address critical improvement gaps, align payment incentives across clinician types, and reduce reporting burden."

   For what defines a "face-to-face" encounter, for purposes of proposing to require reporting of at least 2 cross-cutting measures specified in Table 21, we propose to determine whether an eligible professional had a "face-to-face" encounter by seeing whether the eligible professional billed for services under the PFS that are associated with face-to-face encounters, such as whether an eligible professional billed general office visit codes, outpatient visits, and surgical procedures. We would not include telehealth visits as face-to-face encounters for purposes of the proposals require reporting of at least 2 cross-cutting measures specified in Table 21.

   In addition, we understand that there may be instances where an eligible professional may not have at least 9 measures applicable to an eligible professional's practice. In this instance, like the criterion we finalized for the 2014 PQRS incentive (see Table 47 at 78 FR 74479), an eligible professional reporting on less than 9 measures would still be able to meet the satisfactory reporting criterion via claims and registry if the eligible professional reports on 1-8 measures, as applicable, to the eligible professional's practice. If an eligible professional reports on 1-8 measures, the eligible professional would be subject to the MAV process, which would allow us to determine whether an eligible professional should have reported quality data codes for additional measures. In addition, the MAV will also allow us to determine whether a group practice should have reported on any of the proposed cross-cutting measures specified in Table 21. The MAV process we are proposing to implement for claims and registry is the same process that was established for reporting periods occurring in 2014 for the 2014 PQRS incentive. For more information on the claims MAV process, please visit http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2014_PQRS_Claims_MeasureApplicabilityValidation_12132013.zip. For more information on the registry MAV process, please visit http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2014_PQRS_Registry_MeasureApplicabilityValidation_12132013.zip.

   We seek public comment on our proposed satisfactory reporting criterion for individual eligible professionals reporting via claims or registry for the 2017 PQRS payment adjustment.

b. Proposed Criterion for Satisfactory Reporting of Individual Quality Measures via EHR for Individual Eligible Professionals for the 2017 PQRS Payment Adjustment

   In the CY 2013 PFS final rule with comment period, we finalized the following criterion for the satisfactory reporting for individual eligible professionals reporting individual measures via a direct EHR that is CEHRT or an EHR data submission vendor that is CEHRT for the 2014 PQRS incentive: Report 9 measures covering at least 3 of the NQS domains. If an eligible professional's CEHRT does not contain patient data for at least 9 measures covering at least 3 domains, then the eligible professional must report all of the measures for which there is Medicare patient data. An eligible professional must report on at least 1 measure for which there is Medicare patient data (see Table 47 at 78 FR 74479).

   To be consistent with the criterion we finalized for the 2014 PQRS incentive, as well as to continue to align with the final criterion for meeting the clinical quality measure (CQM) component of achieving meaningful use under the Medicare EHR Incentive Program, we are proposing to modify SEC 414.90(j) and propose the following criterion for the satisfactory reporting for individual eligible professionals to report individual measures via a direct EHR that is CEHRT or an EHR data submission vendor that is CEHRT for the 2017 PQRS payment adjustment: The eligible professional would report 9 measures covering at least 3 of the NQS domains. If an eligible professional's CEHRT does not contain patient data for at least 9 measures covering at least 3 domains, then the eligible professional would be required to report all of the measures for which there is Medicare patient data. An eligible professional would be required to report on at least 1 measure for which there is Medicare patient data.

   We seek public comment on this proposal.

c. Proposed Criterion for Satisfactory Reporting of Measures Groups via Registry for Individual Eligible Professionals for the 2017 PQRS Payment Adjustment

   In the CY 2013 PFS final rule with comment period, we finalized the following criterion for the satisfactory reporting for individual eligible professionals to report measures groups via registry for the 2014 PQRS incentive: For the 12-month reporting period for the 2014 PQRS incentive, report at least 1 measures group AND report each measures group for at least 20 patients, the majority (11 patients) of which must be Medicare Part B FFS patients. Measures groups containing a measure with a 0 percent performance rate will not be counted (see Table 47 at 78 FR 74479).

   To be consistent with the criterion we finalized for the 2014 PQRS incentive, we are proposing to modify SEC 414.90(j) to indicate the following criterion for the satisfactory reporting for individual eligible professionals to report measures groups via registry for the 2017 PQRS payment adjustment: For the 12-month reporting period for the 2017 PQRS payment adjustment, the eligible professional would report at least 1 measures group AND report each measures group for at least 20 patients, the majority (11 patients) of which would be required to be Medicare Part B FFS patients. Measures groups containing a measure with a 0 percent performance rate would not be counted.

   Although we are proposing satisfactory reporting criterion for individual eligible professionals to report measures groups via registry for the 2017 PQRS payment adjustment that is consistent with criterion finalized for the 2014 PQRS incentive, please note, however, in this section III.K of this proposed rule, we are proposing to change the definition of a PQRS measures group.

   We seek public comment on our proposed satisfactory reporting criterion for individual eligible professionals reporting measures groups via registry for the 2017 PQRS payment adjustment.

3. Satisfactory Participation in a QCDR by Individual Eligible Professionals

   Section 601(b) of the ATRA amended section 1848(m)(3) of the Act, by redesignating subparagraph (D) as subparagraph (F) and adding new subparagraphs (D) and (E), to provide for a new standard for individual eligible professionals to satisfy the PQRS beginning in 2014, based on satisfactory participation in a QCDR.

a. Proposed Criterion for the Satisfactory Participation for Individual Eligible Professionals in a QCDR for the 2017 PQRS Payment Adjustment

   Section 1848(a)(8) of the Act provides that for covered professional services furnished by an eligible professional during 2015 or any subsequent year, if the eligible professional does not satisfactorily report data on quality measures for covered professional services for the quality reporting period for the year, the fee schedule amount for services furnished by such professional during the year shall be equal to the applicable percent of the fee schedule amount that would otherwise apply to such services. For 2016 and subsequent years, the applicable percent is 98.0 percent.

   Section 1848(m)(3)(D) of the Act, as added by section 601(b) of the ATRA, authorizes the Secretary to treat an individual eligible professional as satisfactorily submitting data on quality measures under section 1848(m)(3)(A) of the Act if, in lieu of reporting measures under section 1848(k)(2)(C) of the Act, the eligible professional is satisfactorily participating in a QCDR for the year. "Satisfactory participation" is a new standard under the PQRS and is a substitute for the underlying standard of "satisfactory reporting" data on covered professional services that eligible professionals must meet to avoid the PQRS payment adjustment. Currently, SEC 414.90(e)(2) states that individual eligible professionals must be treated as satisfactorily reporting data on quality measures if the individual eligible professional satisfactorily participates in a QCDR.

   In the CY 2014 PFS final rule with comment period, although we finalized satisfactory participation criteria for the 2016 PQRS payment adjustment that are less stringent than the satisfactory participation criteria we finalized for the 2014 PQRS incentive, we noted that it was "our intention to fully move towards the reporting of 9 measures covering at least 3 domains to meet the criteria for satisfactory participation for the 2017 PQRS payment adjustment" (78 FR 74477). Specifically, we finalized the following two criteria for the satisfactory participation in a QCDR for the 2014 PQRS incentive at SEC 414.90(i)(3): For the 12-month 2014 reporting period, report at least 9 measures available for reporting under the QCDR covering at least 3 of the NQS domains, and report each measure for at least 50 percent of the eligible professional's applicable patients. Of the measures reported via a QCDR, the eligible professional must report on at least 1 outcome measure.

   To be consistent with the number of measures reported for the satisfactory participation criterion we finalized for the 2014 PQRS incentive, for purposes of the 2017 PQRS payment adjustment (which would be based on data reported during the 12-month period that falls in CY 2015), we propose to modify SEC 414.90(k) to add the following criteria for individual eligible professionals to satisfactorily participate in a QCDR for the 2017 PQRS payment adjustment: For the 12-month reporting period for the 2017 PQRS payment adjustment, the eligible professional would report at least 9 measures available for reporting under a QCDR covering at least 3 of the NQS domains, AND report each measure for at least 50 percent of the eligible professional's patients. Of these measures, the eligible professional would report on at least 3 outcome measures, OR, if 3 outcomes measures are not available, report on at least 2 outcome measures and at least 1 of the following types of measures--resource use, patient experience of care, or efficiency/appropriate use.

   Unlike the satisfactory participation criteria that were established for the 2014 PQRS incentive, we are proposing to modify SEC 414.90(k)(4) to require that an eligible professional report on not only 1 but at least 3 outcome measures (or, 2 outcome measures and at least 1 resource use, patient experience of care, or efficiency/appropriate use if 3 outcomes measures are not available). We are proposing this increase because it is our goal to, when appropriate, move towards the reporting of more outcome measures. We believe the reporting of outcome measures (for example, unplanned hospital readmission after a procedure) better captures the quality of care an eligible professional provides than, for example, process measures (for example, whether a Hemoglobin A1c test was performed for diabetic patients). In establishing this proposal, we understand that a QCDR may not have 3 outcomes measures within its quality measure data set. Therefore, as an alternative to a third outcome measure, we are allowing an eligible professional to report on at least 1 resource use, patient experience of care, or efficiency/appropriate use measure in lieu of an outcome measure.

   We seek public comment on these proposals.

4. Proposed Criteria for Satisfactory Reporting for Group Practices Selected to Participate in the Group Practice Reporting Option (GPRO)

   In lieu of reporting measures under section 1848(k)(2)(C) of the Act, section 1848(m)(3)(C) of the Act provides the Secretary with the authority to establish and have in place a process under which eligible professionals in a group practice (as defined by the Secretary) shall be treated as satisfactorily submitting data on quality measures. Accordingly, this section III.K.4 contains our proposed satisfactory reporting criteria for group practices selected to participate in the GPRO. Please note that, for a group practice to participate in the PQRS GPRO in lieu of participating as individual eligible professionals, a group practice is required to register to participate in the PQRS GPRO. For more information on GPRO participation, please visit http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Group_Practice_Reporting_Option.html. For more information on registration, please visit http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/Self-Nomination-Registration.html.

   In the CY 2014 PFS final rule with comment period, we established a deadline of September 30 of the applicable reporting period (that is, September 30, 2014, for reporting periods occurring in 2014) for a group practice to register to participate in the GPRO (78 FR 74456). While we still seek to provide group practices with as much time as feasible to decide whether to register to participate in the PQRS as a GPRO, we weigh this priority with others, such as our desire to provide more timely feedback to participants of the PQRS, as well as other CMS quality reporting programs such as the VM. Since participation in the VM is tied to PQRS participation as discussed in section III.N. of this proposed rule, we have found that having a GPRO registration deadline so late in time would not allow us to collect information related to group practice participation in time to provide PQRS and VM participants with feedback reports earlier in time. Therefore, in an effort to provide timelier feedback, we are proposing to change the deadline by which a group practice must register to participate in the GPRO to June 30 of the applicable 12-month reporting period (that is, June 30, 2015, for reporting periods occurring in 2015). This proposed change would allow us to provide timelier feedback while still providing group practices with over 6 months to determine whether they should participate in the PQRS GPRO or, in the alternative, participate in the PQRS as individual eligible professionals. We invite public comment on this proposal.

a. Proposed Criteria for Satisfactory Reporting on PQRS Quality Measures Via the GPRO Web Interface for the 2017 PQRS Payment Adjustment

   Consistent with the group practice reporting requirements under section 1848(m)(3)(C) of the Act, we propose to modify SEC 414.90(j) to incorporate the following criterion for the satisfactory reporting of PQRS quality measures for group practices registered to participate in the GPRO for the 12-month reporting period for the 2017 PQRS payment adjustment using the GPRO web interface for groups practices of 25-99 eligible professionals: The group practice would report on all measures included in the web interface; AND populate data fields for the first 248 consecutively ranked and assigned beneficiaries in the order in which they appear in the group's sample for each module or preventive care measure. If the pool of eligible assigned beneficiaries is less than 248, then the group practice would report on 100 percent of assigned beneficiaries. In other words, we understand that, in some instances, the sampling methodology CMS provides will not be able to assign at least 248 patients on which a group practice may report, particularly those group practices on the smaller end of the range of 25-99 eligible professionals. If the group practice is assigned less than 248 Medicare beneficiaries, then the group practice would report on 100 percent of its assigned beneficiaries. A group practice would be required to report on at least 1 measure for which there is Medicare patient data.

   In addition, we propose to modify SEC 414.90(j) to incorporate the following criteria for the satisfactory reporting of PQRS quality measures for group practices that registered to participate in the GPRO for the 12-month reporting period for the 2017 PQRS payment adjustment using the GPRO web interface for groups practices of 100 or more eligible professionals: The group practice would report all CAHPS for PQRS survey measures via a certified survey vendor. In addition, the group practice would report on all measures included in the GPRO web interface; AND populate data fields for the first 248 consecutively ranked and assigned beneficiaries in the order in which they appear in the group's sample for each module or preventive care measure. If the pool of eligible assigned beneficiaries is less than 248, then the group practice would report on 100 percent of assigned beneficiaries. A group practice would be required to report on at least 1 measure for which there is Medicare patient data.

   To maintain consistency in this reporting criteria, we note that this proposed criteria is similar to the criterion we finalized for the satisfactory reporting of PQRS quality measures for group practices selected to participate in the GPRO for the 12-month reporting periods for the 2013 and 2014 PQRS incentives for group practices of 100 or more eligible professionals in the CY 2013 PFS final rule with comment period (see Table 49 at 78 FR 74486). However, we are proposing to reduce the patient sample size a group practice is required to report quality measures data from 411 to 248. We examined the sample size of this reporting criterion and determined that the sample size we are proposing reduces provider reporting burden while still allowing for statistically valid and reliable performance results. For the 25-99 sized groups reporting via the web interface, we recognize the proposal to move from reporting 218 to 248 patients per sample represents a slight increase in reporting. However, based on experience with the 218 count and subsequent statistical analysis, we believe that there are increased performance reliabilities and validities gained when changing the minimum reporting requirement to 248. We believe statistical reliability and validity is extremely important when measuring provider performance, particularly given the implications of the Physician VM and Physician Compare public reporting, discussed in section III.N and section III.J respectively. Therefore, we believe this proposed criterion improves on the criterion previously finalized.

   For assignment of patients for group practices reporting via the GPRO web interface, in previous years, we have aligned with the Medicare Shared Savings Program methodology of beneficiary assignment (see 77 FR 69195). We note that, in section III.N. of this proposed rule, we are proposing to use a beneficiary attribution methodology for the VM for the claims-based quality measures and cost measures that is slightly different from the Medicare Shared Savings Program methodology, namely (1) eliminating the primary care service pre-step that is statutorily required for the Shared Savings Program and (2) including NPs, PA, and CNSs in step 1 rather than in step 2 of the attribution process. We believe that aligning with the VM's proposed method of attribution is appropriate, as the VM is directly tied to participation in the PQRS. Therefore, to achieve further alignment with the VM and for the reasons proposed in section III.N., we propose to adopt the attribution methodology changes proposed for the VM into the GPRO web interface beneficiary assignment methodology.

   In addition, we note that, in the past, we have not provided guidance on those group practices that choose the GPRO web interface to report PQRS quality measures but have seen no Medicare patients for which the GPRO measures are applicable, or if they have no (i.e., 0 percent) responses for a particular module or measure. Since we are moving solely towards the implementation of PQRS payment adjustments, we seek to clarify this scenario here. If a group practice has no Medicare patients for which any of the GPRO measures are applicable, the group practice will not meet the criteria for satisfactory reporting using the GPRO web interface. Therefore, to meet the criteria for satisfactory reporting using the GPRO web interface, a group practice must be assigned and have sampled at least 1 Medicare patient for any of the applicable GPRO web interface measures (specified in Table 21). If a group practice does not typically see Medicare patients for which the GPRO web interface measures are applicable, we advise the group practice to participate in the PQRS via another reporting mechanism.

   We invite public comment on these proposals.

b. Proposed Criteria for Satisfactory Reporting on Individual PQRS Quality Measures for Group Practices Registered To Participate in the GPRO via Registry and EHR for the 2017 PQRS Payment Adjustment

   For registry reporting in the GPRO, in the CY 2014 PFS final rule with comment period (see Table 49 at 78 FR 74486), we finalized the following satisfactory reporting criteria for the submission of individual quality measures via registry for group practices comprised of 2 or more eligible professionals in the GPRO for the 2014 PQRS incentive: Report at least 9 measures, covering at least 3 of the NQS domains, OR, if less than 9 measures covering at least 3 NQS domains apply to the group practice, report 1--8 measures covering 1-3 NQS domains for which there is Medicare patient data, AND report each measure for at least 50 percent of the group practice's Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percent performance rate would not be counted. In the CY 2014 PFS final rule with comment period, we signaled that it was "our intent to ramp up the criteria for satisfactory reporting for the 2017 PQRS payment adjustment to be on par or more stringent than the criteria for satisfactory reporting for the 2014 PQRS incentive" (78 FR 74465).

   Consistent with the criterion finalized for the 2014 PQRS incentive and the group practice reporting requirements under section 1848(m)(3)(C) of the Act, for those group practices that choose to report using a qualified registry, we propose here to modify SEC 414.90(j) to include the following satisfactory reporting criterion via qualified registry for ALL group practices who select to participate in the GPRO for the 2017 PQRS payment adjustment: The group practice would report at least 9 measures, covering at least 3 of the NQS domains. Of these measures, if a group practice sees at least 1 Medicare patient in a face-to-face encounter, the group practice would report on at least 2 measures in the cross-cutting measure set specified in Table 21. If less than 9 measures covering at least 3 NQS domains apply to the eligible professional, the group practice would report up to 8 measures covering 1-3 NQS domains for which there is Medicare patient data, AND report each measure for at least 50 percent of the eligible professional's Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percent performance rate would not be counted.

   As with individual reporting, we understand that there may be instances where a group practice may not have at least 9 measures applicable to a group practice's practice. In this instance, like the criterion we finalized for the 2014 PQRS incentive (see Table 49 at 78 FR 74486), a group practice reporting on less than 9 measures would still be able to meet the satisfactory reporting criterion via registry if the group practice reports on as many measures as are applicable to the group practice's practice. If a group practice reports on less than 9 measures, the group practice would be subject to the MAV process, which would allow us to determine whether a group practice should have reported quality data codes for additional measures and/or measures covering additional NQS domains. In addition, if a group practice does not report on at least 1 cross-cutting measure and the group practice has at least 1 eligible professional who sees at least 1 Medicare patient in a face-to-face encounter, the MAV will also allow us to determine whether a group practice should have reported on any of the proposed cross-cutting measures specified in Table 21. The MAV process we are proposing to implement for registry reporting is the same process that was established for reporting periods occurring in 2014 for the 2014 PQRS incentive. For more information on the registry MAV process, please visit http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2014_PQRS_Registry_MeasureApplicabilityValidation_12132013.zip.

   For EHR reporting, consistent with the criterion finalized for the 2014 PQRS incentive that aligns with the criteria established for meeting the CQM component of meaningful use under the EHR Incentive Program and in accordance with the group practice reporting requirements under section 1848(m)(3)(C) of the Act, for those group practices that choose to report using an EHR, we propose to modify SEC 414.90(j) to indicate the following satisfactory reporting criterion via a direct EHR product that is CEHRT or an EHR data submission vendor that is CEHRT for ALL group practices who select to participate in the GPRO for the 2017 PQRS payment adjustment: For the 12-month reporting period for the 2017 PQRS payment adjustment, the group practice would report 9 measures covering at least 3 domains. If the group practice's CEHRT does not contain patient data for at least 9 measures covering at least 3 domains, then the group practice must report the measures for which there is patient data. A group practice must report on at least 1 measure for which there is Medicare patient data.

   We invite public comment on these proposals.

c. Proposed Criteria for Satisfactory Reporting on Individual PQRS Quality Measures for Group Practices Registered To Participate in the GPRO via a CMS-Certified Survey Vendor for the 2017 PQRS Payment Adjustment

   In the CY 2014 PFS final rule with comment period, we introduced satisfactory reporting criterion for the 2014 PQRS incentive related to reporting the CG CAHPS survey measures via a CMS-certified survey vendor (see Table 49 at 78 FR 74486). Consistent with the criterion finalized for the 2014 PQRS incentive and the group practice reporting requirements under section 1848(m)(3)(C) of the Act, we are proposing the following 3 options (of which a group practice would be able to select 1 out of the 3 options) for satisfactory reporting for the 2017 PQRS payment adjustment for group practices comprised of 25 or more eligible professionals:

   Proposed Option 1: If a group practice chooses to use a qualified registry, in conjunction with reporting the CAHPS for PQRS survey measures, for the 12-month reporting period for the 2017 PQRS payment adjustment, the group practice would report all CAHPS for PQRS survey measures via a certified vendor, and report at least 6 additional measures, outside of CAHPS for PQRS, covering at least 2 of the NQS domains using the qualified registry. If less than 6 measures apply to the group practice, the group practice must report all applicable measures. Of these 6 measures, if any eligible professional in the group practice sees at least 1 Medicare patient in a face-to-face encounter, the group practice would be required to report on at least 1 measure in the cross-cutting measure set specified in Table 21. We note that this proposed option to report 6 additional measures, including at least 1 cross-cutting measure if a group practice sees at least 1 Medicare patient in a face-to-face encounter, is consistent with the proposed criterion for satisfactory reporting for the 2017 PQRS payment adjustment via qualified registry. However, unlike the proposed criterion for satisfactory reporting for the 2017 PQRS payment adjustment via qualified registry without CG-CAHPS, we are only proposing the requirement to report 1 measure in the cross-cutting measure set specified in Table 21 instead of 2 measures as the CAHPS for PQRS measures are contained in the cross-cutting measure set.

   Consistent with the proposed group practice reporting option solely using a qualified registry for the 2017 PQRS payment adjustment, we understand that there may be instances where a group practice may not have at least 6 measures applicable to a group practice's practice. In this instance, a group practice reporting on less than 6 measures would still be able to meet the satisfactory reporting criterion via registry if the group practice reports on as many measures as are applicable to the group practice's practice. If a group practice reports on less than 6 individual measures using the qualified registry reporting mechanism in conjunction with a CMS-certified survey vendor to report CAHPS for PQRS, the group practice would be subject to a measure application validity process (MAV), which would allow us to determine whether a group practice should have reported quality data codes for additional measures and/or measures covering additional NQS domains.

   In addition, if a group practice does not report on at least 1 cross-cutting measure and the group practice has at least 1 eligible professional who sees at least 1 Medicare patient in a face-to-face encounter, the MAV will also allow us to determine whether a group practice should have reported on any of the proposed cross-cutting measures specified in Table 21. The MAV process we are proposing to implement for registry reporting is the same process that was established for reporting periods occurring in 2014 for the 2014 PQRS incentive. For more information on the registry MAV process, please visit http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2014_PQRS_Registry_MeasureApplicabilityValidation_12132013.zip.

   Proposed Option 2: If a group practice chooses to use a direct EHR product that is CEHRT or EHR data submission vendor that is CEHRT in conjunction with reporting the CAHPS for PQRS survey measures, for the 12-month reporting period for the 2017 PQRS payment adjustment, the group practice would report all CAHPS for PQRS survey measures via a certified vendor, and report at least 6 additional measures, outside of CAHPS for PQRS, covering at least 2 of the NQS domains using the direct EHR product that is CEHRT or EHR data submission vendor that is CEHRT. If less than 6 measures apply to the group practice, the group practice must report all applicable measures. Of the additional 6 measures that must be reported in conjunction with reporting the CAHPS for PQRS survey measures, a group practice would be required to report on at least 1 measure for which there is Medicare patient data. We note that this proposed option to report 6 additional measures is consistent with the proposed criterion for satisfactory reporting for the 2017 PQRS payment adjustment via EHR without CAHPS for PQRS, since the CAHPS for PQRS survey only addresses 1 NQS domain.

   Proposed Option 3: Alternatively, if a group practice chooses to use the GPRO web interface in conjunction with reporting the CAHPS for PQRS survey measures, we propose the following criterion for satisfactory reporting for the 2017 PQRS payment adjustment: For the 12-month reporting period for the 2017 PQRS payment adjustment, the group practice would report all CAHPS for PQRS survey measures via a certified vendor. In addition, the group practice would report on all measures included in the GPRO web interface; AND populate data fields for the first 248 consecutively ranked and assigned beneficiaries in the order in which they appear in the group's sample for each module or preventive care measure. If the pool of eligible assigned beneficiaries is less than 248, then the group practice would report on 100 percent of assigned beneficiaries. A group practice would be required to report on at least 1 measure for which there is Medicare patient data.

   Furthermore, as was required for reporting periods occurring in 2014 (78 FR 74485), we propose that all group practices comprised of 100 or more eligible professionals that register to participate in the PQRS GPRO, regardless of the reporting mechanism the group practice chooses, would be required to select a CMS-certified survey vendor to administer the CAHPS for PQRS survey on their behalf. As such, for purposes of meeting the criteria for satisfactory reporting for the 2017 PQRS payment adjustment, a group practice participating in the PQRS GPRO would be required to use 1 of these 3 proposed reporting options mentioned above. We note that, for reporting periods occurring in 2014, we stated that we would administer and fund the collection of (CG-CAHPS) data for these groups (of 100 or more eligible professionals using the GPRO web interface that are required to report on CAHPS for PQRS survey measures) (78 FR 74452). We stated that we would bear the cost of administering the CAHPS for PQRS survey measures, as we were requiring the group practices to report on CAHPS for PQRS survey measures. Unfortunately, beginning in 2015, it will no longer be feasible for CMS to continue to bear the cost of group practices of 100 or more eligible professionals to report the CAHPS for PQRS survey measures. Therefore, the group practice would be required to bear the cost of administering the CAHPS for PQRS survey measures.

   However, as CAHPS for PQRS was optional for group practices comprised of 25-99 eligible professionals in 2014 (78 FR 74485) and whereas we are proposing to require reporting of CAHPS for PQRS for group practices comprised of 100 or more eligible professionals, we propose that CAHPS for PQRS would be optional for groups of 25-99 and 2-24 eligible professionals. We note that all group practices that would be required to report or voluntarily elect to report CAHPS for PQRS would need to select and pay for a CMS-certified survey vendor to administer the CAHPS for PQRS survey on their behalf.

   We invite public comment on these proposals.

d. Proposed Criteria for Satisfactory Reporting on Individual PQRS Quality Measures for Group Practices Selected To Participate in the GPRO To Report the CAHPS for PQRS Survey Measures via a CMS-Certified Survey Vendor for the 2018 PQRS Payment Adjustment and Subsequent Years

   We believe these patient surveys are important tools for assessing beneficiary experience of care and outcomes and, moving forward, we would like to emphasize the importance of collecting patient experience of care data through the use of CAHPS for PQRS. Therefore, based on our authority under section 1848(m)(3)(C) of the Act to determine the criteria for satisfactory reporting for group practices under section 1848(m)(3)(C) of the Act, we are proposing to require that, in conjunction with other satisfactory reporting criteria we establish in future years, beginning with the 12-month reporting period for the 2018 PQRS payment adjustment, and for subsequent years, group practices comprised of 25 or more eligible professionals that are participating in the GPRO report and pay for the collection of the CAHPS for PQRS survey measures. We understand that the cost of administering the CAHPS for PQRS survey may be significant, so we are proposing this requirement well in advance of the year in which it would be first effective in order to provide group practices with early notice so that their practices may adjust accordingly.

   We invite public comment on these proposals.

e. The Consumer Assessment of Healthcare Providers Surgical Care Survey (S-CAHPS)

   In addition to CAHPS for PQRS, we received comments last year supporting the inclusion of the Consumer Assessment of Healthcare Providers Surgical Care Survey (S-CAHPS). The commenters stated that the CG-CAHPS survey would not accurately reflect the care provided by single- or multispecialty surgical or anesthesia groups. The commenters noted that S-CAHPS has been tested by the same standards as CG-CAHPS and follows the same collection mechanism as the CG-CAHPS. The S-CAHPS expands on the CG-CAHPS by focusing on aspects of surgical quality, which are important from the patient's perspective and for which the patient is the best source of information. The survey asks patients to provide feedback on surgical care, surgeons, their staff, and anesthesia care. It assesses patients' experiences with surgical care in both the inpatient and outpatient settings by asking respondents about their experience before, during and after surgery. We agree with the commenters on the importance of allowing for the administration of S-CAHPS reporting and wish to allow for reporting of S-CAHPS in the PQRS for reporting mechanisms other than the QCDR. However, at this time, due to the cost and time it would take to find vendors to collect S-CAHPS data, it is not technically feasible to implement the reporting of the S-CAHPS survey measures for the 2017 PQRS payment adjustment. We seek comments on how to allow for reporting of the S-CAHPS survey measures for the 2018 PQRS payment adjustment and beyond.

5. Statutory Requirements and Other Considerations for the Selection of PQRS Quality Measures for Meeting the Criteria for Satisfactory Reporting for 2015 and Beyond for Individual Eligible Professionals and Group Practices

   CMS undergoes an annual Call for Measures that solicits new measures from the public for possible inclusion in the PQRS. During the Call for Measures, we request measures for inclusion in PQRS that meet the following statutory and non-statutory criteria.

   Sections 1848(k)(2)(C) and 1848(m)(3)(C)(i) of the Act, respectively, govern the quality measures reported by individual eligible professionals and group practices under the PQRS. Under section 1848(k)(2)(C)(i) of the Act, the PQRS quality measures shall be such measures selected by the Secretary from measures that have been endorsed by the entity with a contract with the Secretary under section 1890(a) of the Act, which is currently the National Quality Forum (NQF). However, in the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the NQF, section 1848(k)(2)(C)(ii) of the Act authorizes the Secretary to specify a measure that is not so endorsed as long as due consideration is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary, such as the Ambulatory Quality Alliance (AQA). In light of these statutory requirements, we believe that, except in the circumstances specified in the statute, each PQRS quality measure must be endorsed by the NQF. Additionally, section 1848(k)(2)(D) of the Act requires that for each PQRS quality measure, "the Secretary shall ensure that eligible professionals have the opportunity to provide input during the development, endorsement, or selection of measures applicable to services they furnish." The statutory requirements under section 1848(k)(2)(C) of the Act, subject to the exception noted previously, require only that the measures be selected from measures that have been endorsed by the entity with a contract with the Secretary under section 1890(a) of the Act (that is, the NQF) and are silent as to how the measures that are submitted to the NQF for endorsement are developed.

   The basic steps for developing measures applicable to physicians and other eligible professionals prior to submission of the measures for endorsement may be carried out by a variety of different organizations. We do not believe there need to be special restrictions on the type or make-up of the organizations carrying out this basic process of development of physician measures, such as restricting the initial development to physician-controlled organizations. Any such restriction would unduly limit the basic development of quality measures and the scope and utility of measures that may be considered for endorsement as voluntary consensus standards for purposes of the PQRS.

   In addition to section 1848(k)(2)(C) of the Act, section 1890A of the Act, which was added by section 3014(b) of the Affordable Care Act, requires that the Secretary establish a pre-rulemaking process under which certain steps occur with respect to the selection of certain categories of quality and efficiency measures, one of which is that the entity with a contract with the Secretary under section 1890(a) of the Act (that is, the NQF) convene multi-stakeholder groups to provide input to the Secretary on the selection of such measures. These categories are described in section 1890(b)(7)(B) of the Act, and include such measures as the quality measures selected for reporting under the PQRS. In accordance with section 1890A(a)(1) of the Act, the NQF convened multi-stakeholder groups by creating the Measure Applications Partnership (MAP). Section 1890A(a)(2) of the Act requires that the Secretary must make publicly available by December 1st of each year a list of the quality and efficiency measures that the Secretary is considering for selection through rulemaking for use in the Medicare program. The NQF must provide CMS with the MAP's input on the selection of measures by February 1st of each year. The lists of measures under consideration for selection through rulemaking in 2014 are available at http://www.qualityforum.org/map/.

   As we noted above, section 1848(k)(2)(C)(ii) of the Act provides an exception to the requirement that the Secretary select measures that have been endorsed by the entity with a contract under section 1890(a) of the Act (that is, the NQF). We may select measures under this exception if there is a specified area or medical topic for which a feasible and practical measure has not been endorsed by the entity, as long as due consideration is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary. Under this exception, aside from NQF endorsement, we requested that stakeholders apply the following considerations when submitting measures for possible inclusion in the PQRS measure set:

    * Measures that are not duplicative of another existing or proposed measure.

    * Measures that are further along in development than a measure concept.

    * CMS is not accepting claims-based-only reporting measures in this process.

    * Measures that are outcome-based rather than clinical process measures.

    * Measures that address patient safety and adverse events.

    * Measures that identify appropriate use of diagnosis and therapeutics.

    * Measures that include the NQS domain for care coordination and communication.

    * Measures that include the NQS domain for patient experience and patient-reported outcomes.

    * Measures that address efficiency, cost and resource use.

a. Proposed PQRS Quality Measures

   Taking into consideration the statutory and non-statutory criteria we described previously, this section contains our proposals for the inclusion or removal of measures in PQRS for 2015 and beyond. We are classifying all proposed measures against six domains based on the NQS's six priorities, as follows:

   (1) Patient Safety. These are measures that reflect the safe delivery of clinical services in all healthcare settings. These measures may address a structure or process that is designed to reduce risk in the delivery of healthcare or measure the occurrence of an untoward outcome such as adverse events and complications of procedures or other interventions.

   (2) Person and Caregiver-Centered Experience and Outcomes. These are measures that reflect the potential to improve patient-centered care and the quality of care delivered to patients. They emphasize the importance of collecting patient-reported data and the ability to impact care at the individual patient level, as well as the population level. These are measures of organizational structures or processes that foster both the inclusion of persons and family members as active members of the health care team and collaborative partnerships with providers and provider organizations or can be measures of patient-reported experiences and outcomes that reflect greater involvement of patients and families in decision making, self-care, activation, and understanding of their health condition and its effective management.

   (3) Communication and Care Coordination. These are measures that demonstrate appropriate and timely sharing of information and coordination of clinical and preventive services among health professionals in the care team and with patients, caregivers, and families to improve appropriate and timely patient and care team communication. They may also be measures that reflect outcomes of successful coordination of care.

   (4) Effective Clinical Care. These are measures that reflect clinical care processes closely linked to outcomes based on evidence and practice guidelines or measures of patient-centered outcomes of disease states.

   (5) Community/Population Health. These are measures that reflect the use of clinical and preventive services and achieve improvements in the health of the population served. They may be measures of processes focused on primary prevention of disease or general screening for early detection of disease unrelated to a current or prior condition.

   (6) Efficiency and Cost Reduction. These are measures that reflect efforts to lower costs and to significantly improve outcomes and reduce errors. These are measures of cost, resource use and appropriate use of healthcare resources or inefficiencies in healthcare delivery.

   Please note that the PQRS quality measure specifications for any given proposed PQRS individual quality measure may differ from specifications for the same quality measure used in prior years. For example, for the proposed PQRS quality measures that were selected for reporting in 2014 and beyond, please note that detailed measure specifications, including the measure's title, for the proposed individual PQRS quality measures for 2013 and beyond may have been updated or modified during the NQF endorsement process or for other reasons.

   In addition, due to our desire to align measure titles with the measure titles that have been finalized for 2013, 2014, 2015, and potentially subsequent years of the EHR Incentive Program, we note that the measure titles for measures available for reporting via EHR may change. To the extent that the EHR Incentive Program updates its measure titles to include version numbers (77 FR 13744), we will use these version numbers to describe the PQRS EHR measures that will also be available for reporting for the EHR Incentive Program. We will continue to work toward complete alignment of measure specifications across programs whenever possible.

   Through NQF's measure maintenance process, NQF-endorsed measures are sometimes updated to incorporate changes that we believe do not substantively change the nature of the measure. Examples of such changes could be updated diagnosis or procedure codes or changes to exclusions to the patient population or definitions. We believe these types of maintenance changes are distinct from substantive changes to measures that result in what are considered new or different measures. Further, we believe that non-substantive maintenance changes of this type do not trigger the same agency obligations under the Administrative Procedure Act.

   In the CY 2013 PFS final rule with comment period, we finalized our proposal providing that if the NQF updates an endorsed measure that we have adopted for the PQRS in a manner that we consider to not substantively change the nature of the measure, we would use a subregulatory process to incorporate those updates to the measure specifications that apply to the program (77 FR 69207). We believe this adequately balances our need to incorporate non-substantive NQF updates to NQF-endorsed measures in the most expeditious manner possible, while preserving the public's ability to comment on updates that so fundamentally change an endorsed measure that it is no longer the same measure that we originally adopted. We also note that the NQF process incorporates an opportunity for public comment and engagement in the measure maintenance process. We will revise the Specifications Manual and post notices to clearly identify the updates and provide links to where additional information on the updates can be found. Updates will also be available on the CMS PQRS Web site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/index.html.

   CMS is not the measure steward for most of the measures available for reporting under the PQRS. We rely on outside measure stewards and developers to maintain these measures. In Table 24, we are proposing that certain measures be removed from the PQRS measure set due to the measure owner/developer indicating that it will not be able to maintain the measure. We note that this proposal is contingent upon the measure owner/developer not being able to maintain the measure. Should we learn that a certain measure owner/developer is able to maintain the measure, or that another entity is able to maintain the measure in a manner that allows the measure to be available for reporting under the PQRS for the CY 2017 PQRS payment adjustment, we propose to keep the measure available for reporting under the PQRS and therefore not finalize our proposal to remove the measure. In addition, if, after the display of this proposed rule, we discover additional measures within the current PQRS measure set that a measure owner/developer can no longer maintain, we propose to remove these measures from reporting for the PQRS beginning in 2015. We will discuss any such instances in the CY 2015 PFS final rule with comment period.

   In addition, we note that we have received feedback from stakeholders, particularly first-time participants who find it difficult to understand which measures are applicable to their particular practice. In an effort to aide eligible professionals and group practices to determine what measures best fit their practice, and in collaboration with specialty societies, we are beginning to group our final measures available for reporting according to specialty. The current listing of our measures by specialty can be found on our Web site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/index.html. Please note that these groups of measures are meant to provide guidance to those eligible professionals seeking to determine what measures to report. Eligible professionals are not required to report measures according to these suggested groups of measures. In addition to group measures according to specialty, we also plan to have a measure subset for measures that specifically addresses multiple chronic conditions. As measures are adopted or revised, we will continue to update these groups to reflect the measures available under the PQRS, as well as add more specialties.

   In the CY 2014 PFS final rule with comment period, we stated that "unless there are errors discovered in updated electronic measure specifications, the PQRS intends to use the most recent, updated versions of electronically specified clinical quality measures for that year" (78 FR 74489). We propose that, if we discover errors in the most recently updated electronic measure specifications for a certain measure, we would use the version of electronic measure specifications that immediately precedes the most recently updated electronic measure specifications.

   Additionally, we noted that, with respect to the following e-measure CMS140v2, Breast Cancer Hormonal Therapy for Stage IC-IIIC Estrogen Receptor/Progesterone Receptor (ER/PR) Positive Breast Cancer (NQF 0387), a substantive error was discovered in the June 2013 version of this electronically specified clinical quality measure. Therefore, the PQRS required the use of the prior, December 2012 version of this measure, which is CMS140v1 (78 FR 74489). Please note that, consistent with other EHR measures, since a more recent and corrected version of this measure has been developed, we will require the reporting of the most recent, updated versions of the measure Breast Cancer Hormonal Therapy for Stage IC-IIIC Estrogen Receptor/Progesterone Receptor (ER/PR) Positive Breast Cancer (NQF 0387)--currently version CMS140v3--for the year.

b. Proposed Cross-Cutting Measure Set for 2015 and Beyond

   In accordance with our proposed criteria for the satisfactory reporting of PQRS measures for the 2017 PQRS payment adjustment via claims and registry that requires an eligible professional or group practice to report on at least 2 cross-cutting measures, we are proposing the following 18 cross-cutting measure set specified in Table 21 for 2015 and beyond. Please note that our rationale for proposing each of these measures is found below the measure description. We have also indicated the PQRS reporting mechanism or mechanisms through which each proposed measure could be submitted. In addition to seeking comment on this proposed cross-cutting measure set specified in Table 21, we seek comment on other measures that commenters believe should be included in this proposed cross-cutting measure set for 2015 and beyond.

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c. Proposed New PQRS Measures Available for Reporting for 2015 and Beyond

   Table 22 contains the additional measures we are proposing to include in the PQRS measure set for CY 2015 and beyond. Please note that not all of the proposed cross-cutting measures may appear in Table 22, as some of the propose cross-cutting measures specified in Table 21 were finalized in the CY 2013 or CY 2014 PFS final rules with comment period. Please note that our rationale for proposing each of these measures is found below the measure description. We have also indicated the PQRS reporting mechanism or mechanisms through which each proposed measure could be submitted.

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   In Table 23, we specify the measures for which we are proposing a NQS domain change for reporting under the PQRS. Please note the rationale we have for each measure for which we are proposing a NQS domain change below.

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   In Table 24, we specify the measures we are proposing to remove from reporting under the PQRS. Please note that the rationale we have for each measure we are proposing to remove is specified after the measure title and description.

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   In Table 25 below, we specify our proposals to change the way in which previously established measures in the PQRS will be reported beginning in 2015. Please note that, in Table 25, we provide our explanation as to how we are proposing to change the way the measure is reported, as well as a corresponding rationale for this proposed change.

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   We seek comment on these proposals.

d. PQRS Measures Groups

   Section 414.90(b) defines a measures group as a subset of four or more Physician Quality Reporting System measures that have a particular clinical condition or focus in common. The denominator definition and coding of the measures group identifies the condition or focus that is shared across the measures within a particular measures group.

   In the CY 2014 PFS proposed rule, we proposed (78 FR 43448) to increase the number of measures that may be included in a measures group from a minimum of 4 measures to a minimum of 6. We proposed increasing the minimum number of measures that may be contained in a measures group in accordance with increasing the number of individual measures to be reported via claims and registry. However, we did not finalize this proposal, stating that, although we still plan to increase the minimum number of measures in a measures group in the future, we would work with the measure developers and owners of these measures groups to appropriately add measures to measures groups that only contain four measures within the measures group (78 FR 74730). We have worked with the measure owners and developers and are again proposing to increase the number of measures that may be included in a measures group from a minimum of 4 measures to a minimum of 6.

   Specifically, we are proposing to modify section 414.90(b) to define a measures group as a subset of six or more Physician Quality Reporting System measures that have a particular clinical condition or focus in common.

   In addition, we are proposing two new measures groups that will be available for reporting in the PQRS beginning in 2015:

    * The sinusitis measures group: We are proposing a new sinusitis measures group because this measures group represents a clinical gap within the measure group reporting option. The measures in the sinusitis measures group reflect a variety of measure types, and make up a clinically coherent and meaningful set of measures.

    * The Acute Otits Externa (AOE) measures group: We are proposing the addition of the AOE measures group, as it focuses on the quality of care of patients with AOE by combining existing disease-specific measures with relevant cross-cutting (generic) measures.

   Furthermore, we are proposing to remove the following measures groups for reporting beginning in 2015 for the following reasons:

    * Perioperative care measures group: We are proposing to remove the perioperative care measures group from reporting in the PQRS beginning in 2015 because this measures group does not add value to the PQRS and eligible professionals are consistently meeting performance on this measure with performance rates close to 100 percent.

    * Back pain measures group: We are proposing to remove the back pain measures group because the measure steward is not preparing these measures for re-endorsement by the National Quality Forum. We are also proposing to remove the measures group because it reflects clinical concepts that do not add clinical value to PQRS. Specifically, the measures in this group are entirely clinical process measures that do not meaningfully contribute to improved patient outcomes.

    * Cardiovascular prevention measures group: We are proposing to remove the cardiovascular prevention measures group because a number of individual measures contained in this measures group are proposed to be removed from all PQRS program reporting options with the exception of EHR reporting.

    * Ischemic Vascular Disease (IVD) measures group: We are proposing to remove the IVD measures group because a number of individual measures contained in this measures group are proposed to be removed from all PQRS program reporting options with the exception of EHR reporting.

    * Sleep Apnea measures group: We are proposing to remove the Sleep Apnea measures group from reporting in the PQRS beginning in 2015 because, for a number of measures included in this group, the measure steward has indicated they will no longer maintain those measures. Those measures and their associated measure groups are proposed for removal from the program. As a result, the measures group would have less than the 6 measures proposed to be required in a measures group. Please note that this proposal is contingent on the measure steward not being able to maintain ownership of certain measures. Should we learn that a measure owner/developer is able to maintain certain measures, or that another entity is able to maintain certain measures, such that the measure group maintains a sufficient number of measures for reporting under the PQRS for the CY 2017 PQRS payment adjustment, we propose to keep the measure group available for reporting under the PQRS and therefore not finalize our proposal to remove the measure group.

    * Chronic obstructive pulmonary disease (COPD) measures group: We are proposing to remove the COPD measures group from reporting in the PQRS beginning in 2015 because, for a number of measures included in this group, the measure steward has indicated they will no longer maintain those measures. Those measures and their associated measure groups are proposed for removal from the program. As a result, the measures group would have less than the 6 measures proposed to be required in a measures group. Please note that this proposal is contingent on the measure steward not being able to maintain ownership of certain measures. Should we learn that a measure owner/developer is able to maintain certain measures, or that another entity is able to maintain certain measures, such that the measure group maintains a sufficient number of measures for reporting under the PQRS for the CY 2017 PQRS payment adjustment, we propose to keep the measure group available for reporting under the PQRS and therefore not finalize our proposal to remove the measure group.

   Tables 26 through 48 specify our proposed measures groups in light of our proposal to increase the minimum number of measures in a measures group in previously established measures groups, so that each measures group contains at least 6 measures. We invite public comment on these proposals. GOES

Table 26--Proposed Asthma Measures Group for 2015 and Beyond NQF/ Measure title and Measure PQRS description developer 0047/053 Asthma: Pharmacologic AMA-PCPI/NCQA Therapy for Persistent Asthma--Ambulatory Care Setting: Percentage of patients aged 5 through 64 years with a diagnosis of persistent asthma who were prescribed long-term control medication 0041/110 Preventive Care and AMA-PCPI Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization 0419/130 Documentation of Current CMS/QIP Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route of administration 0028/226 Preventive Care and AMA-PCPI Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user N/A/N/A Tobacco Use and Help with NCQA/NCIQM Quitting Among Adolescents: Percentage of adolescents 13 to 20 years of age with a primary care visit during the measurement period for whom tobacco use status was documented and received help quitting if identified as a tobacco user 0421/128 Preventive Care and CMS/QIP Screening: Body Mass Index (BMI) Screening and Follow-Up: Percentage of patients aged 18 years and older with a documented BMI during the current encounter or during the previous 6 months AND when the BMI is outside of normal parameters, a follow-up plan is documented during the encounter or during the previous 6 months of the encounter Normal Parameters: Age 65 years and older BMI >/= 23 and < 30; Age 18-64 years BMI >/= 18.5 and < 25



GOES

Table 27--Proposed Acute Otitis Externa (AOE) Measures Group for 2015 and Beyond NQF/ Measure title and Measure PQRS description developer 0653/091 Acute Otitis Externa AMA-PCPI (AOE): Topical Therapy: Percentage of patients aged 2 years and older with a diagnosis of AOE who were prescribed topical preparations 0654/093 Acute Otitis Externa AMA-PCPI (AOE): Systemic Antimicrobial Therapy--Avoidance of Inappropriate Use: Percentage of patients aged 2 years and older with a diagnosis of AOE who were not prescribed systemic antimicrobial therapy 0419/130 Documentation of Current CMS/QIP Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route of administration 0420/131 Pain Assessment and CMS/QIP Follow-Up: Percentage of visits for patients aged 18 years and older with documentation of a pain assessment using a standardized tool(s) on each visit AND documentation of a follow-up plan when pain is present 0101/154 Falls: Risk Assessment: AMA-PCPI Percentage of patients aged 65 years and older with a history of falls who had a risk assessment for falls completed within 12 months 0101/155 Falls: Plan of Care: AMA-PCPI Percentage of patients aged 65 years and older with a history of falls who had a plan of care for falls documented within 12 months 0028/226 Preventive Care and AMA-PCPI Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user N/A/317 Preventive Care and CMS/QIP Screening: Screening for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 years and older seen during the reporting period who were screened for high blood pressure (BP) AND a recommended follow-up plan is documented based on the current blood pressure reading as indicated



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Table 28--Proposed Cataracts Measures Group for 2015 and Beyond NQF/ Measure title and Measure developer PQRS description 0419/130 Documentation of Current CMS/QIP Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route of administration 0565/191 Cataracts: 20/40 or AMA-PCPI/NCQA Better Visual Acuity within 90 Days Following Cataract Surgery: Percentage of patients aged 18 years and older with a diagnosis of uncomplicated cataract who had cataract surgery and no significant ocular conditions impacting the visual outcome of surgery and had best-corrected visual acuity of 20/40 or better (distance or near) achieved within 90 days following the cataract surgery 0564/192 Cataracts: Complications AMA-PCPI/NCQA within 30 Days Following Cataract Surgery Requiring Additional Surgical Procedures: Percentage of patients aged 18 years and older with a diagnosis of uncomplicated cataract who had cataract surgery and had any of a specified list of surgical procedures in the 30 days following cataract surgery which would indicate the occurrence of any of the following major complications: retained nuclear fragments, endophthalmitis, dislocated or wrong power IOL, retinal detachment, or wound dehiscence 0028/226 Preventive Care and AMA-PCPI Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user N/A/303 Cataracts: Improvement in AAO Patient's Visual Function within 90 Days Following Cataract Surgery: Percentage of patients aged 18 years and older in sample who had cataract surgery and had improvement in visual function achieved within 90 days following the cataract surgery, based on completing a pre-operative and post-operative visual function survey N/A/304 Cataracts: Patient AAO Satisfaction within 90 Days Following Cataract Surgery: Percentage of patients aged 18 years and older in sample who had cataract surgery and were satisfied with their care within 90 days following the cataract surgery, based on completion of the Consumer Assessment of Healthcare Providers and Systems Surgical Care Survey N/A/358 Patient-Centered Surgical ACS Risk Assessment and Communication: Percentage of patients who underwent a non-emergency surgery who had their personalized risks of postoperative complications assessed by their surgical team prior to surgery using a clinical data-based, patient-specific risk calculator and who received personal discussion of those risks with the surgeon N/A/N/A Cataract Surgery with AAEECE/ACHS Intra-Operative Complications (Unplanned Rupture of Posterior Capsule requiring unplanned vitrectomy): Rupture of the posterior capsule during anterior segment surgery requiring vitrectomy N/A/N/A Cataract Surgery: AAEECE/ACHS Difference Between Planned and Final Refraction: Percentage of patients who achieve planned refraction within +-1,0 D



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Table 29--Proposed Chronic Kidney Disease (CKD) Measures Group for 2015 and Beyond NQF/ Measure title and Measure developer PQRS description 0326/047 Care Plan: Percentage of AMA-PCPI/NCQA patients aged 65 years and older who have an care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or provide an care plan 0041/110 Preventive Care and AMA-PCPI Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization 1668/121 Adult Kidney Disease: AMA-PCPI Laboratory Testing (Lipid Profile): Percentage of patients aged 18 years and older with a diagnosis of chronic kidney disease (CKD) (stage 3, 4, or 5, not receiving Renal Replacement Therapy [RRT]) who had a fasting lipid profile performed at least once within a 12-month period N/A/122 Adult Kidney Disease: AMA-PCPI Blood Pressure Management: Percentage of patient visits for those patients aged 18 years and older with a diagnosis of chronic kidney disease (CKD) (stage 3, 4, or 5, not receiving Renal Replacement Therapy [RRT]) and proteinuria with a blood pressure /= 130/80 mmHg with a documented plan of care 0419/130 Documentation of Current CMS/QIP Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route of administration 0028/226 Preventive Care and AMA-PCPI Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user



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Table 30--Proposed Chronic Obstructive Pulmonary Disorder (COPD) Measures Group for 2015 and Beyond [Please note that we are proposing to remove this measure group contingent on the measure steward not being able to maintain certain measures contained in these measures group. If a measure steward is able to maintain ownership of these measures, we plan to keep this measures group in the PQRS measure set. This Table Q10 indicates the measures that we propose will be available in this measures group should we keep this measures group in the PQRS measure set.] NQF/ Measure title and Measure developer PQRS description 0326/047 Care Plan: Percentage of AMA-PCPI/NCQA patients aged 65 years and older who have an care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or provide an care plan 0091/051 Chronic Obstructive AMA-PCPI Pulmonary Disease (COPD): Spirometry Evaluation: Percentage of patients aged 18 years and older with a diagnosis of COPD who had spirometry evaluation results documented 0102/052 Chronic Obstructive AMA-PCPI Pulmonary Disease (COPD): Inhaled Bronchodilator Therapy: Percentage of patients aged 18 years and older with a diagnosis of COPD and who have an FEV1/FVC less than 60% and have symptoms who were prescribed an inhaled bronchodilator 0041/110 Preventive Care and AMA-PCPI Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization 0043/111 Pneumonia Vaccination NCQA Status for Older Adults: Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine 0419/130 Documentation of Current CMS/QIP Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route of administration 0028/226 Preventive Care and AMA-PCPI Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user



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Table 31--Proposed Coronary Artery Bypass Graft (CABG) Measures Group for 2015 and Beyond NQF/ Measure title and description Measure developer PQRS 0134/043 Coronary Artery Bypass Graft (CABG): Use of STS Internal Mammary Artery (IMA) in Patients with Isolated CABG Surgery: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who received an IMA graft 0236/044 Coronary Artery Bypass Graft (CABG): CMS/QIP Preoperative Beta-Blocker in Patients with Isolated CABG Surgery: Percentage of isolated Coronary Artery Bypass Graft (CABG) surgeries for patients aged 18 years and older who received a beta-blocker within 24 hours prior to surgical incision 0129/164 Coronary Artery Bypass Graft (CABG): STS Prolonged Intubation: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who require postoperative intubation > 24 hours 0130/165 Coronary Artery Bypass Graft (CABG): Deep STS Sternal Wound Infection Rate: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who, within 30 days postoperatively, develop deep sternal wound infection involving muscle, bone, and/or mediastinum requiring operative intervention 0131/166 Coronary Artery Bypass Graft (CABG): Stroke: STS Percentage of patients aged 18 years and older undergoing isolated CABG surgery who have a postoperative stroke (i.e., any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain) that did not resolve within 24 hours 0114/167 Coronary Artery Bypass Graft (CABG): STS Postoperative Renal Failure: Percentage of patients aged 18 years and older undergoing isolated CABG surgery (without pre-existing renal failure) who develop postoperative renal failure or require dialysis



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Table 32--Proposed Coronary Artery Disease (CAD) Measures Group for 2015 and Beyond NQF/ Measure title and Measure developer PQRS description 0067/006 Coronary Artery Disease AMA-PCPI/ACCF/AHA (CAD): Antiplatelet Therapy: Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12 month period who were prescribed aspirin or clopidogrel 0070/007 Coronary Artery Disease AMA-PCPI (CAD): Beta-Blocker Therapy--Prior Myocardial Infarction (MI) or Left Ventricular Systolic Dysfunction (LVEF < 40%: Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12 month period who also have prior MI OR a current or LVEF < 40% who were prescribed beta-blocker therapy 0421/128 Preventive Care and CMS/QIP Screening: Body Mass Index (BMI) Screening and Follow-Up: Percentage of patients aged 18 years and older with a documented BMI during the current encounter or during the previous 6 months AND when the BMI is outside of normal parameters, a follow-up plan is documented during the encounter or during the previous 6 months of the encounter Normal Parameters: Age 65 years and older BMI >/= 23 and < 30; Age 18-64 years BMI >/= 18.5 and < 25 0419/130 Documentation of Current CMS/QIP Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route of administration 0028/226 Preventive Care and AMA-PCPI Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user N/A/242 Coronary Artery Disease AMA-PCPI/ACCF/AHA (CAD): Symptom Management: Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12 month period with results of an evaluation of level of activity and an assessment of whether anginal symptoms are present or absent with appropriate management of anginal symptoms within a 12 month period



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Table 33--Proposed Dementia Measures Group for 2015 and Beyond NQF/ Measure title and description Measure developer PQRS 0326/047 Care Plan: Percentage of patients aged 65 AMA-PCPI/NCQA years and older who have an care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or provide an care plan N/A/280 Dementia: Staging of Dementia: Percentage of AMA-PCPI patients, regardless of age, with a diagnosis of dementia whose severity of dementia was classified as mild, moderate or severe at least once within a 12 month period N/A/281 Dementia: Cognitive Assessment: Percentage of AMA-PCPI patients, regardless of age, with a diagnosis of dementia for whom an assessment of cognition is performed and the results reviewed at least once within a 12 month period N/A/282 Dementia: Functional Status Assessment: AMA-PCPI Percentage of patients, regardless of age, with a diagnosis of dementia for whom an assessment of functional status is performed and the results reviewed at least once within a 12 month period N/A/283 Dementia: Neuropsychiatric Symptom AMA-PCPI Assessment: Percentage of patients, regardless of age, with a diagnosis of dementia and for whom an assessment of neuropsychiatric symptoms is performed and results reviewed at least once in a 12 month period N/A/284 Dementia: Management of Neuropsychiatric AMA-PCPI Symptoms: Percentage of patients, regardless of age, with a diagnosis of dementia who have one or more neuropsychiatric symptoms who received or were recommended to receive an intervention for neuropsychiatric symptoms within a 12 month period N/A/285 Dementia: Screening for Depressive Symptoms: AMA-PCPI Percentage of patients, regardless of age, with a diagnosis of dementia who were screened for depressive symptoms within a 12 month period N/A/286 Dementia: Counseling Regarding Safety AMA-PCPI Concerns: Percentage of patients, regardless of age, with a diagnosis of dementia or their caregiver(s) who were counseled or referred for counseling regarding safety concerns within a 12 month period N/A/287 Dementia: Counseling Regarding Risks of AMA-PCPI Driving: Percentage of patients, regardless of age, with a diagnosis of dementia or their caregiver(s) who were counseled regarding the risks of driving and the alternatives to driving at least once within a 12 month period N/A/288 Dementia: Caregiver Education and Support: AMA-PCPI Percentage of patients, regardless of age, with a diagnosis of dementia whose caregiver(s) were provided with education on dementia disease management and health behavior changes AND referred to additional sources for support within a 12 month period



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Table 34--Proposed Diabetes Measures Group for 2015 and Beyond NQF/ Measure title and description Measure developer PQRS 0059/001 Diabetes: Hemoglobin A1c Poor Control: NCQA Percentage of patients 18-75 years of age with diabetes who had hemoglobin A1c > 9.0% during the measurement period 0041/110 Preventive Care and Screening: Influenza AMA-PCPI Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization 0055/117 Diabetes: Eye Exam: Percentage of patients 18 NCQA through 75 years of age with a diagnosis of diabetes (type 1 and type 2) who had a retinal or dilated eye exam in the measurement period or a negative retinal or dilated eye exam (negative for retinopathy) in the year prior to the measurement period 0062/119 Diabetes: Medical Attention for Neuropathy: NCQA The percentage of patients 18-75 years of age with diabetes who had a nephropathy screening test or evidence of nephropathy during the measurement period 0056/163 Diabetes: Foot Exam: Percentage of patients NCQA aged 18-75 years of age with diabetes who had a foot exam during the measurement period 0028/226 Preventive Care and Screening: Tobacco Use: AMA-PCPI Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user



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Table 35--Proposed General Surgery Measures Group for 2015 and Beyond NQF/ Measure title and Measure developer PQRS description 0419/130 Documentation of Current CMS/QIP Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route of administration 0028/226 Preventive Care and AMA-PCPI Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user N/A/354 Anastomotic Leak ACS Intervention: Percentage of patients aged 18 years and older who required an anastomotic leak intervention following gastric bypass or colectomy surgery N/A/355 Unplanned Reoperation ACS within the 30 Day Postoperative Period: Percentage of patients aged 18 years and older who had any unplanned reoperation within the 30 day postoperative period N/A/356 Unplanned Hospital ACS Readmission within 30 Days of Principal Procedure: Percentage of patients aged 18 years and older who had an unplanned hospital readmission within 30 days of principal procedure N/A/357 Surgical Site Infection ACS (SSI): Percentage of patients aged 18 years and older who had a surgical site infection (SSI) N/A/358 Patient-Centered Surgical ACS Risk Assessment and Communication: Percentage of patients who underwent a non-emergency surgery who had their personalized risks of postoperative complications assessed by their surgical team prior to surgery using a clinical data-based, patient-specific risk calculator and who received personal discussion of those risks with the surgeon



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Table 36--Proposed Heart Failure (HF) Measures Group for 2015 and Beyond NQF/ Measure title and Measure developer PQRS description 0081/005 Heart Failure (HF): AMA-PCPI/ACCF/AHA Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy for Left Ventricular Systolic Dysfunction (LVSD): Percentage of patients aged 18 years and older with a diagnosis of heart failure (HF) with a current or prior left ventricular ejection fraction (LVEF) < 40% who were prescribed ACE inhibitor or ARB therapy either within a 12 month period when seen in the outpatient setting OR at each hospital discharge 0083/008 Heart Failure (HF): AMA-PCPI/ACCF/AHA Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD): Percentage of patients aged 18 years and older with a diagnosis of heart failure (HF) with a current or prior left ventricular ejection fraction (LVEF) < 40% who were prescribed beta-blocker therapy either within a 12 month period when seen in the outpatient setting OR at each hospital discharge 0326/047 Care Plan: Percentage of AMA-PCPI/NCQA patients aged 65 years and older who have an care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or provide an care plan 0041/110 Preventive Care and AMA-PCPI Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization 0419/130 Documentation of Current CMS/QIP Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route of administration 0028/226 Preventive Care and AMA-PCPI Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user



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Table 37--Proposed Hepatitis C Measures Group for 2015 and Beyond NQF/ Measure title and Measure developer PQRS description 0395/084 Hepatitis C: Ribonucleic AMA-PCPI Acid (RNA) Testing Before Initiating Treatment: Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C who started antiviral treatment within the 12 month reporting period for whom quantitative hepatitis C virus (HCV) RNA testing was performed within 12 months prior to initiation of antiviral treatment 0396/085 Hepatitis C: HCV Genotype AMA-PCPI Testing Prior to Treatment: Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C who started antiviral treatment within the 12 month reporting period for whom hepatitis C virus (HCV) genotype testing was performed within 12 months prior to initiation of antiviral treatment 0398/087 Hepatitis C: Hepatitis C AMA-PCPI Virus (HCV) Ribonucleic Acid (RNA) Testing Between 4-12 Weeks After Initiation of Treatment: Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C who are receiving antiviral treatment for whom quantitative hepatitis C virus (HCV) RNA testing was performed between 4-12 weeks after the initiation of antiviral treatment 0419/130 Documentation of Current CMS/QIP Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route of administration 0399/183 Hepatitis C: Hepatitis A AMA-PCPI Vaccination in Patients with Hepatitis C Virus (HCV): Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C who have received at least one injection of hepatitis A vaccine, or who have documented immunity to hepatitis A 0028/226 Preventive Care and AMA-PCPI Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user N/A/N/A Screening for AGA/AASLD/AMA-PCPI Hepatocellular Carcinoma (HCC) in patients with Hepatitis C Cirrhosis: Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C cirrhosis who were screened with either ultrasound, triple-contrast CT or triple-contrast MRI for hepatocellular carcinoma (HCC) at least once within the 12 month reporting period N/A/N/A Discussion and Shared AGA/AASLD/AMA-PCPI Decision Making Surrounding Treatment Options: Percentage of patients aged 18 years and older with a diagnosis of hepatitis C with whom a physician or other clinician reviewed the range of treatment options appropriate to their genotype and demonstrated a shared decision making approach with the patient. To meet the measure, there must be documentation in the patient record of a discussion between the physician/clinician and the patient that includes all of the following: . Treatment choices appropriate to genotype . Risks and benefits . Evidence of effectiveness . Patient preferences toward the outcome of the treatment



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Table 38--Proposed HIV/AIDS Measures Group for 2015 and Beyond NQF/ Measure title and description Measure developer PQRS 0326/047 Care Plan: Percentage of patients aged 65 AMA-PCPI/NCQA years and older who have an care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or provide an care plan 0418/134 Preventive Care and Screening: Screening for CMS/QIP Clinical Depression and Follow-Up Plan: Percentage of patients aged 12 years and older screened for clinical depression on the date of the encounter using an age appropriate standardized depression screening tool AND if positive, a follow-up plan is documented on the date of the positive screen 0405/160 HIV/AIDS: Pneumocystis Jiroveci Pneumonia NCQA (PCP) Prophylaxis: Percentage of patients aged 6 weeks and older with a diagnosis of HIV/AIDS who were prescribed Pneumocystis Jiroveci Pneumonia (PCP) prophylaxis 0409/205 HIV/AIDS: Sexually Transmitted Disease AMA-PCPI/NCQA Screening for Chlamydia, Gonorrhea, and Syphilis: Percentage of patients aged 13 years and older with a diagnosis of HIV/AIDS for whom chlamydia, gonorrhea and syphilis screenings were performed at least once since the diagnosis of HIV infection 0028/226 Preventive Care and Screening: Tobacco Use: AMA-PCPI Screening and Cessation Intervention: Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user 2082/338 HIV Viral Load Suppression: The percentage of HRSA patients, regardless of age, with a diagnosis of HIV with a HIV viral load less than 200 copies/mL at last HIV viral load test during the measurement year 2083/339 Prescription of HIV Antiretroviral Therapy: HRSA Percentage of patients, regardless of age, with a diagnosis of HIV prescribed antiretroviral therapy for the treatment of HIV infection during the measurement year 2079/340 HIV Medical Visit Frequency: Percentage of HRSA patients, regardless of age with a diagnosis of HIV who had at least one medical visit in each 6 month period of the 24 month measurement period, with a minimum of 60 days between medical visits



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Table 39--Proposed Inflammatory Bowel Disease (IBD) Measures Group for 2015 and Beyond NQF/ Measure title and description Measure developer PQRS 0028/226 Preventive Care and Screening: Tobacco Use: AMA-PCPI Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user N/A/270 Inflammatory Bowel Disease (IBD): Preventive AGA Care: Corticosteroid Sparing Therapy: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease who have been managed by corticosteroids greater than or equal to 10 mg/day for 60 or greater consecutive days that have been prescribed corticosteroid sparing therapy in the last reporting year N/A/271 Inflammatory Bowel Disease (IBD): Preventive AGA Care: Corticosteroid Related Iatrogenic Injury--Bone Loss Assessment: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease who have received dose of corticosteroids greater than or equal to 10 mg/day for 60 or greater consecutive days and were assessed for risk of bone loss once per the reporting year 0041/110 Preventive Care and Screening: Influenza AMA-PCPI Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization 0043/111 Pneumonia Vaccination Status for Older NCQA Adults: Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine N/A/274 Inflammatory Bowel Disease (IBD): Testing for AGA Latent Tuberculosis (TB) Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease for whom a tuberculosis (TB) screening was performed and results interpreted within 6 months prior to receiving a first course of anti-TNF (tumor necrosis factor) therapy N/A/275 Inflammatory Bowel Disease (IBD): Assessment AGA of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease (IBD) who had Hepatitis B Virus (HBV) status assessed and results interpreted within 1 year prior to receiving a first course of anti-TNF (tumor necrosis factor) therapy



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Table 40--Proposed Oncology Measures Group for 2015 and Beyond NQF/ Measure title and Measure developer PQRS description 0387/071 Breast Cancer: Hormonal AMA-PCPI/ASCO/NCCN Therapy for Stage IC-IIIC Estrogen Receptor/Progesterone Receptor (ER/PR) Positive Breast Cancer: Percentage of female patients aged 18 years and older with Stage IC through IIIC, ER or PR positive breast cancer who were prescribed tamoxifen or aromatase inhibitor (AI) during the 12-month reporting period 0385/072 Colon Cancer: AMA-PCPI/ASCO/NCCN Chemotherapy for AJCC Stage III Colon Cancer Patients: Percentage of patients aged 18 through 80 years with AJCC Stage III colon cancer who are referred for adjuvant chemotherapy, prescribed adjuvant chemotherapy, or have previously received adjuvant chemotherapy within the 12-month reporting period 0041/110 Preventive Care and AMA-PCPI Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization 0419/130 Documentation of Current CMS/QIP Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route of administration 0384/143 Oncology: Medical and AMA-PCPI Radiation--Pain Intensity Quantified: Percentage of patients, regardless of patient age, with a diagnosis of cancer currently receiving chemotherapy or radiation therapy in which pain intensity is quantified 0383/144 Oncology: Medical and AMA-PCPI Radiation--Plan of Care for Pain: Percentage of visits for patients, regardless of age, with a diagnosis of cancer currently receiving chemotherapy or radiation therapy who report having pain with a documented plan of care to address pain 0028/226 Preventive Care and AMA-PCPI Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user



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Table 41--Proposed Optimizing Patient Exposure to Ionizing Radiation Measures Group for 2015 and Beyond NQF/ Measure title and description Measure developer PQRS N/A/359 Optimizing Patient Exposure to AMA-PCPI Ionizing Radiation: Utilization of a Standardized Nomenclature for Computed Tomography (CT) Imaging Description: Percentage of computed tomography (CT) imaging reports for all patients, regardless of age, with the imaging study named according to a standardized nomenclature and the standardized nomenclature is used in institution's computer systems N/A/360 Optimizing Patient Exposure to AMA-PCPI Ionizing Radiation: Count of Potential High Dose Radiation Imaging Studies: Computed Tomography (CT) and Cardiac Nuclear Medicine Studies: Percentage of computed tomography (CT) and cardiac nuclear medicine (myocardial perfusion studies) imaging reports for all patients, regardless of age, that document a count of known previous CT (any type of CT) and cardiac nuclear medicine (myocardial perfusion) studies that the patient has received in the 12-month period prior to the current study N/A/361 Optimizing Patient Exposure to AMA-PCPI Ionizing Radiation: Reporting to a Radiation Dose Index Registry: Percentage of total computed tomography (CT) studies performed for all patients, regardless of age, that are reported to a radiation dose index registry AND that include at a minimum selected data elements N/A/362 Optimizing Patient Exposure to AMA-PCPI Ionizing Radiation: Computed Tomography (CT) Images Available for Patient Follow-up and Comparison Purposes: Percentage of final reports for computed tomography (CT) studies performed for all patients, regardless of age, which document that Digital Imaging and Communications in Medicine (DICOM) format image data are available to non-affiliated external entities on a secure, media free, reciprocally searchable basis with patient authorization for at least a 12-month period after the study N/A/363 Optimizing Patient Exposure to AMA-PCPI Ionizing Radiation: Search for Prior Computed Tomography (CT) Imaging Studies Through a Secure, Authorized, Media-Free, Shared Archive: Percentage of final reports of computed tomography (CT) studies performed for all patients, regardless of age, which document that a search for Digital Imaging and Communications in Medicine (DICOM) format images was conducted for prior patient CT imaging studies completed at non-affiliated external entities within the past 12 months and are available through a secure, authorized, media free, shared archive prior to an imaging study being performed N/A/364 Optimizing Patient Exposure to AMA-PCPI Ionizing Radiation: Appropriateness: Follow-up CT Imaging for Incidentally Detected Pulmonary Nodules According to Recommended Guidelines: Percentage of final reports for CT imaging studies of the thorax for patients aged 18 years and older with documented follow-up recommendations for incidentally detected pulmonary nodules (eg, follow-up CT imaging studies needed or that no follow-up is needed) based at a minimum on nodule size AND patient risk factors



GOES

Table 42--Proposed Parkinson's Disease Measures Group for 2015 and Beyond NQF/ Measure title and description Measure developer PQRS 0326/047 Care Plan: Percentage of AMA-PCPI/NCQA patients aged 65 years and older who have an care plan or surrogate decision maker documented in the medical record or documentation in the medical record that an care plan was discussed but the patient did not wish or was not able to name a surrogate decision maker or provide an care plan N/A/289 Parkinson's Disease: Annual AAN Parkinson's Disease Diagnosis Review: All patients with a diagnosis of Parkinson's disease who had an annual assessment including a review of current medications (e.g., medications that can produce Parkinson-like signs or symptoms) and a review for the presence of atypical features (e.g., falls at presentation and early in the disease course, poor response to levodopa, symmetry at onset, rapid progression [to Hoehn and Yahr stage 3 in 3 years], lack of tremor or dysautonomia) at least annually N/A/290 Parkinson's Disease: Psychiatric AAN Disorders or Disturbances Assessment: All patients with a diagnosis of Parkinson's disease who were assessed for psychiatric disorders or disturbances (e.g., psychosis, depression, anxiety disorder, apathy, or impulse control disorder) at least annually N/A/291 Parkinson's Disease: Cognitive AAN Impairment or Dysfunction Assessment: All patients with a diagnosis of Parkinson's disease who were assessed for cognitive impairment or dysfunction at least annually N/A/292 Parkinson's Disease: Querying AAN about Sleep Disturbances: All patients with a diagnosis of Parkinson's disease (or caregivers, as appropriate) who were queried about sleep disturbances at least annually N/A/293 Parkinson's Disease: AAN Rehabilitative Therapy Options: All patients with a diagnosis of Parkinson's disease (or caregiver(s), as appropriate) who had rehabilitative therapy options (e.g., physical, occupational, or speech therapy) discussed at least annually N/A/294 Parkinson's Disease: Parkinson's AAN Disease Medical and Surgical Treatment Options Reviewed: All patients with a diagnosis of Parkinson's disease (or caregiver(s), as appropriate) who had the Parkinson's disease treatment options (e.g., non-pharmacological treatment, pharmacological treatment, or surgical treatment) reviewed at least once annually



GOES

Table 43--Proposed Preventive Care Measures Group for 2015 and Beyond NQF/ Measure title and description Measure developer PQRS 0046/039 Screening or Therapy for AMA-PCPI/NCQA Osteoporosis for Women Aged 65 Years and Older: Percentage of female patients aged 65 years and older who have a central dual-energy X-ray absorptiometry (DXA) measurement ordered or performed at least once since age 60 or pharmacologic therapy prescribed within 12 months 0098/48 Urinary Incontinence: Assessment AMA-PCPI/NCQA of Presence or Absence of Urinary Incontinence in Women Aged 65 Years and Older: Percentage of female patients aged 65 years and older who were assessed for the presence or absence of urinary incontinence within 12 months 0041/110 Preventive Care and Screening: AMA-PCPI Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization 0043/111 Pneumonia Vaccination Status for NCQA Older Adults: Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine N/A/112 Breast Cancer Screening: NCQA Percentage of women 50 through 74 years of age who had a mammogram to screen for breast cancer within 27 months 0034/113 Colorectal Cancer Screening: NCQA Percentage of patients 50 through 75 years of age who had appropriate screening for colorectal cancer 0421/128 Preventive Care and Screening: CMS/QIP Body Mass Index (BMI) Screening and Follow-Up: Percentage of patients aged 18 years and older with a documented BMI during the current encounter or during the previous 6 months AND when the BMI is outside of normal parameters, a follow-up plan is documented during the encounter or during the previous 6 months of the encounter Normal Parameters: Age 65 years and older BMI >/= 23 and < 30; Age 18-64 years BMI >/= 18.5 and < 25 0418/134 Preventive Care and Screening: CMS/QIP Screening for Clinical Depression and Follow-Up Plan: Percentage of patients aged 12 years and older screened for clinical depression on the date of the encounter using an age appropriate standardized depression screening tool AND if positive, a follow-up plan is documented on the date of the positive screen 0028/226 Preventive Care and Screening: AMA-PCPI Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user



GOES

Table 44--Proposed Rheumatoid Arthritis (RA) Measures Group for 2015 and Beyond NQF/ Measure title and description Measure developer PQRS 0054/108 Rheumatoid Arthritis (RA): NCQA Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy: Percentage of patients aged 18 years and older who were diagnosed with RA and were prescribed, dispensed, or administered at least one ambulatory prescription for a DMARD 0041/110 Preventive Care and Screening: AMA-PCPI Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization N/A/176 Rheumatoid Arthritis (RA): AMA-PCPI Tuberculosis Screening: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who have documentation of a tuberculosis (TB) screening performed and results interpreted within 6 months prior to receiving a first course of therapy using a biologic disease-modifying anti-rheumatic drug (DMARD) N/A/177 Rheumatoid Arthritis (RA): AMA-PCPI Periodic Assessment of Disease Activity: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who have an assessment and classification of disease activity within 12 months N/A/178 Rheumatoid Arthritis (RA): AMA-PCPI Functional Status Assessment: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) for whom a functional status assessment was performed at least once within 12 months N/A/179 Rheumatoid Arthritis (RA): AMA-PCPI Assessment and Classification of Disease Prognosis: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who have an assessment and classification of disease prognosis at least once within 12 months N/A/180 Rheumatoid Arthritis (RA): AMA-PCPI Glucocorticoid Management: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who have been assessed for glucocorticoid use and, for those on prolonged doses of prednisone >/= 10 mg daily (or equivalent) with improvement or no change in disease activity, documentation of glucocorticoid management plan within 12 months 0028/226 Preventive Care and Screening: AMA-PCPI Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user



GOES

TAble 45--Proposed Sinusitis Measures Group for 2015 and Beyond NQF/PQRS Measure title and Measure developer description 0419/130 Documentation of Current CMS/QIP Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route of administration. 0420/131 Pain Assessment and CMS/QIP Follow-Up: Percentage of visits for patients aged 18 years and older with documentation of a pain assessment using a standardized tool(s) on each visit AND documentation of a follow-up plan when pain is present 0028/226 Preventive Care and AMA-PCPI Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user N/A/331 Adult Sinusitis: AMA-PCPI Antibiotic Prescribed for Acute Sinusitis (Appropriate Use): Percentage of patients, aged 18 years and older, with a diagnosis of acute sinusitis who were prescribed an antibiotic within 7 days of diagnosis or within 10 days after onset of symptoms N/A/332 Adult Sinusitis: AMA-PCPI Appropriate Choice of Antibiotic: Amoxicillin Prescribed for Patients with Acute Bacterial Sinusitis: Percentage of patients aged 18 years and older with a diagnosis of acute bacterial sinusitis that were prescribed amoxicillin, without clavulante, as a first line antibiotic at the time of diagnosis N/A/333 Adult Sinusitis: AMA-PCPI Computerized Tomography for Acute Sinusitis (Overuse): Percentage of patients aged 18 years and older with a diagnosis of acute sinusitis who had a computerized tomography (CT) scan of the paranasal sinuses ordered at the time of diagnosis or received within 28 days after date of diagnosis



GOES

Table 46--Proposed Sleep Apnea Measures Group for 2015 and Beyond [Please note that we are proposing to remove this measure group contingent on the measure steward not being able to maintain certain measures contained in these measures group. If a measure steward is able to maintain ownership of these measures, we plan to keep this measures group in the PQRS measure set. This Table Q26 indicates the measures that we propose will be available in this measures group should we keep this measures group in the PQRS measure set] NQF/PQRS Measure title and Measure developer description 0421/128 Preventive Care and CMS/QIP Screening: Body Mass Index (BMI) Screening and Follow-Up: Percentage of patients aged 18 years and older with a documented BMI during the current encounter or during the previous 6 months AND when the BMI is outside of normal parameters, a follow-up plan is documented during the encounter or during the previous 6 months of the encounter Normal Parameters: Age 65 years and older BMI >/= 23 and < 30; Age 18-64 years BMI >/= 18.5 and < 25 0419/130 Documentation of Current CMS/QIP Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route of administration 0028/226 Preventive Care and AMA-PCPI Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user N/A/276 Sleep Apnea: Assessment AMA-PCPI/NCQA of Sleep Symptoms: Percentage of visits for patients aged 18 years and older with a diagnosis of obstructive sleep apnea that includes documentation of an assessment of sleep symptoms, including presence or absence of snoring and daytime sleepiness N/A/277 Sleep Apnea: Severity AMA-PCPI/NCQA Assessment at Initial Diagnosis: Percentage of patients aged 18 years and older with a diagnosis of obstructive sleep apnea who had an apnea hypopnea index (AHI) or a respiratory disturbance index (RDI) measured at the time of initial diagnosis N/A/278 Sleep Apnea: Positive AMA-PCPI/NCQA Airway Pressure Therapy Prescribed: Percentage of patients aged 18 years and older with a diagnosis of moderate or severe obstructive sleep apnea who were prescribed positive airway pressure therapy N/A/279 Sleep Apnea: Assessment AMA-PCPI/NCQA of Adherence to Positive Airway Pressure Therapy: Percentage of visits for patients aged 18 years and older with a diagnosis of obstructive sleep apnea who were prescribed positive airway pressure therapy who had documentation that adherence to positive airway pressure therapy was objectively measured



GOES

Table 47--Proposed Total Knee Replacement (TKR) Measures Group for 2015 and Beyond NQF/PQRS Measure title and Measure developer description 0419/130 Documentation of Current CMS/QIP Medications in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list must include ALL known prescriptions, over-the-counters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications' name, dosage, frequency and route of administration 0028/226 Preventive Care and AMA-PCPI Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user N/A/350 Total Knee Replacement: AAHKS Shared Decision-Making: Trial of Conservative (Non-surgical) Therapy: Percentage of patients regardless of age or gender undergoing a total knee replacement with documented shared decision-making with discussion of conservative (non-surgical) therapy prior to the procedure N/A/351 Total Knee Replacement: AAHKS Venous Thromboembolic and Cardiovascular Risk Evaluation: Percentage of patients regardless of age or gender undergoing a total knee replacement who are evaluated for the presence or absence of venous thromboembolic and cardiovascular risk factors within 30 days prior to the procedure including history of Deep Vein Thrombosis, Pulmonary Embolism, Myocardial Infarction, Arrhythmia and Stroke N/A/352 Total Knee Replacement: AAHKS Preoperative Antibiotic Infusion with Proximal Tourniquet: Percentage of patients regardless of age undergoing a total knee replacement who had the prophylactic antibiotic completely infused prior to the inflation of the proximal tourniquet N/A/353 Total Knee Replacement: AAHKS Identification of Implanted Prosthesis in Operative Report: Percentage of patients regardless of age or gender undergoing total knee replacement whose operative report identifies the prosthetic implant specifications including the prosthetic implant manufacturer, the brand name of the prosthetic implant and the size of prosthetic implant



e. Proposals for Measures Available for Reporting in the GPRO Web Interface

   We finalized the measures that are available for reporting in the GPRO Web interface for 2014 and beyond in the CY 2013 PFS final rule (77 FR 69269). However, we are proposing to remove and add measures in the GPRO Web interface measure set as reflected in Tables 47 and 48 for 2015 and beyond. Specifically, Table 47 specifies the measures we are proposing to remove for reporting from the GPRO Web interface, and Table 48 specifies the measures we are proposing to add for reporting in the GPRO Web interface. CMS is proposing to adopt Depression Remission at Twelve Months (NQF #0710) in the 2015 GPRO Web Interface reporting option for ACOs and group practices. This measure is currently reportable in the PQRS program through the EHR reporting option only and has not been tested using claims level data or sampling methodology. Depression Remission at Twelve Months (NQF #0710) requires a look-back period and a look-forward period possibly spanning multiple calendar years. Additionally, this measure requires utilization of a PHQ-9 depression screening tool with a score greater than 9 and a diagnosis of depression/dysthymia to identify the beginning of the episode (initial patient population). Successful completion of the quality action for this measure looks for a PHQ-9 score of less than 5 at the twelve month mark (plus or minus 30 days) from the initial onset of the episode. CMS is soliciting comments regarding this proposal, including operational concerns and the technical feasibility for implementation in the 2015 GPRO Web Interface. We note that, in addition to addressing changes in evidence-based practices, we are modifying the GPRO Web interface in an effort to align with the proposed measure changes in the Medicare Shared Savings Program specified in section III.M.

BILLING CODE 4120-01-P

See Illustration in Original Document.

See Illustration in Original Document.

See Illustration in Original Document.

See Illustration in Original Document.

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   Please note that, if these proposals are finalized, the GPRO measure set will contain 21 measures available for reporting.

f. The Clinician Group (CG) Consumer Assessment of Healthcare Providers and Systems (CAHPS) Survey

   In the CY 2014 PFS final rule with comment period, we finalized the CG-CAHPS survey available for reporting under the PQRS for 2014 and beyond (78 FR 74750 through 74751), to which we are now referring as the CAHPS for PQRS. Please note that, in the CY 2014 PFS final rule with comment period, we classified the CAHPS for PQRS survey under the care coordination and communication NQS domain. We note that this was an error on our part, as the CAHPS for PQRS survey has typically been classified under the Person and Caregiver-Centered Experience and Outcomes domain as the CAHPS for PQRS survey assesses beneficiary experience of care and outcomes. Therefore, as we indicate in Table 21, we are proposing to reclassify the CAHPS for PQRS survey under the Person and Caregiver-Centered Experience and Outcomes domain. We invite public comment on this proposal.

6. Statutory Requirements and Other Considerations for the Selection of PQRS Quality Measures for Meeting the Criteria for Satisfactory Participation in a QCDR for 2014 and Beyond for Individual Eligible Professionals

   For the measures which eligible professionals participating in a QCDR must report, section 1848(m)(3)(D) of the Act, as amended and added by section 601(b) of the ATRA, provides that the Secretary shall treat eligible professionals as satisfactorily submitting data on quality measures if they satisfactorily participate in a QCDR. Section 1848(m)(3)(E) of the Act, as added by section 601(b) of the ATRA, provides some flexibility with regard to the types of measures applicable to satisfactory participation in a QCDR, by specifying that for measures used by a QCDR, sections 1890(b)(7) and 1890A(a) of the Act shall not apply, and measures endorsed by the entity with a contract with the Secretary under section 1890(a) of the Act may be used.

   In the CY 2014 PFS final rule with comment period, we finalized requirements related to the parameters for the measures that would have to be reported to CMS by a QCDR for the purpose of its individual eligible professionals meeting the criteria for satisfactory participation under the PQRS (78 FR 74751 through 74753). Although we are not proposing to remove any of the requirements we finalized related to these parameters, we are proposing to modify the following parameters we finalized in the CY 2014 PFS final rule with comment period related to measures that may be reported by a QCDR:

    * The QCDR must have at least 1 outcome measure available for reporting, which is a measure that assesses the results of health care that are experienced by patients (that is, patients' clinical events; patients' recovery and health status; patients' experiences in the health system; and efficiency/cost).

   As we are proposing that for an eligible professional to meet the criterion for satisfactory participation in a QCDR for the 2017 PQRS payment adjustment, the eligible professional must report on at least 3 outcome measures or, in lieu of 3 outcome measures, at least 2 outcome measures and 1 resource use, patient experience of care, or efficiency/appropriate use measure, we are modifying this requirement to conform to this proposed satisfactory participation criterion. Therefore, we are proposing that a QCDR must have at least 3 outcome measures available for reporting, which is a measure that assesses the results of health care that are experienced by patients (that is, patients' clinical events; patients' recovery and health status; patients' experiences in the health system; and efficiency/cost). In lieu of having 3 outcome measures available for reporting, the QCDR must have at least 2 outcome measures available for reporting and at least 1 resource use, patient experience of care, or efficiency/appropriate use measure.

   We are proposing to define resource use, patient experience of care, or efficiency/appropriate use measures in the following manner:

    * A resource use measure is a measure that is a comparable measure of actual dollars or standardized units of resources applied to the care given to a specific population or event, such as a specific diagnosis, procedure, or type of medical encounter.

    * A patient experience of care measure is a measure of person- or family-reported experiences (outcomes) of being engaged as active members of the health care team and in collaborative partnerships with providers and provider organizations.

    * An efficiency/appropriate use measure is a measure of the appropriate use of health care services (such as diagnostics or therapeutics) based upon evidence-based guidelines of care, or for which the potential for harm exceeds the possible benefits of care.

   Please note that, for purposes of meeting the criteria for satisfactory participation in a QCDR, we allow QCDRs to report on any measure provided that it meets the measure parameters we finalize. We note that we would allow and encourage the reporting of the Consumer Assessment of Healthcare Providers Surgical Care Survey (S-CAHPS) through a QCDR.

   Finally, in the CY 2014 PFS final rule with comment period, we stated that a QCDR must provide to CMS descriptions and narrative specifications for the measures for which it will report to CMS by no later than March 31, 2014. In keeping with this timeframe, we propose that a QCDR must provide to CMS descriptions for the measures for which it will report to CMS for a particular year by no later than March 31 of the applicable reporting period for which the QCDR wishes to submit quality measures data. For example, if a QCDR wishes to submit quality measures data for the 2017 PQRS payment adjustment (the 12-month reporting period of which occurs in 2015), the QCDR must provide to CMS descriptions for the measures for which it will report to CMS by no later than March 31, 2015. The descriptions must include: name/title of measures, NQF # (if NQF endorsed), descriptions of the denominator, numerator, and when applicable, denominator exceptions and denominator exclusions of the measure. The narrative specifications provided must be similar to the narrative specifications we provide in our measures list, available at http://www.cms.gov/apps/ama/license.asp?file=/PQRS/downloads/2014_PQRS_IndClaimsRegistry_MeasureSpecs_SupportingDocs_12132013.zip.

   Related to this proposal, we propose that, 15 days following CMS approval of these measure specifications, the QCDR must publicly post the measures specifications for the measures it intends to report for the PQRS using any public format it prefers. Immediately following posting of the measures specification information, the QCDR must provide CMS with the link to where this information is posted. CMS will then post this information when it provides its list of QCDRs for the year. We believe providing this information will further aide in creating transparency of reporting.

   We invite public comment on these proposals.

7. Informal Review

   In the CY 2013 PFS final rule with comment period (77 FR 69289), we established that "an eligible professional electing to utilize the informal review process must request an informal review by February 28 of the year in which the payment adjustment is being applied. For example, if an eligible professional requests an informal review related to the 2015 payment adjustment, the eligible professional would be required to submit his/her request for an informal review by February 28, 2015." As stated in the CY 2013 PFS final rule with comment period, we believed this deadline provided ample time for eligible professionals and group practices after their respective claims begin to be adjusted due to the payment adjustment. However, because PQRS data is used to establish the quality composite of the VM, we believe it is necessary to expand the informal review process to allow for some limited corrections of the PQRS data to be made. Therefore, we propose to modify the payment adjustment informal review deadline to within 30 days of the release of the feedback reports. For example, if the feedback reports for the 2016 payment adjustment (based on data collected for 2014 reporting periods) are released on August 31, 2015, an eligible professional or group practice would be required to submit a request for an informal review by September 30, 2015. We believe that by being able to notify eligible professionals and group practices of CMS' decision on the informal review request much earlier than we would have been able to do with the previous informal review request deadline we can provide a brief period for an eligible or group practice to make some limited corrections to its PQRS data. This resubmitted data could then be used to make corrections to the VM calculations, when appropriate.

   The PQRS regulations at SEC 414.90(m)(1) currently require an eligible professional or group practice to submit an informal review request to CMS within 90 days of the release of the feedback reports. Therefore, we propose to revise SEC 414.90(m)(1).

   Regarding the eligible professional's or group practice's ability to provide additional information to assist in the informal review process, we propose to provide the following limitations as to what information may be taken into consideration:

    * CMS would only allow resubmission of data that was submitted using a third-party vendor using either the qualified registry, EHR data submission vendor, or QCDR reporting mechanisms. Therefore, CMS would not allow resubmission of data submitted via claims, direct EHR, or the GPRO web interface reporting mechanisms. We are limiting resubmission to third-party vendors, because we believe that third-party vendors are more easily able to detect errors than direct users.

   CMS would only allow resubmission of data that was already previously submitted to CMS. Submission of new data--such as new measures data not previously submitted or new data for eligible professionals for which data was not submitted during the original submission period--would not be accepted.

    * For any given resubmission period, CMS would only accept data that was previously submitted for the reporting periods for which the corresponding informal review period applies. For example, the resubmission period immediately following the informal review period for the 2017 PQRS payment adjustment would only allow resubmission for data previously submitted for the 2017 PQRS payment adjustment reporting periods occurring in 2015.

   As such, we are proposing to add SEC 414.90(m)(3) to reflect this proposal as follows: (3) If, during the informal review process, CMS finds errors in data that was submitted using a third-party vendor using either the qualified registry, EHR data submission vendor, or QCDR reporting mechanisms, CMS may allow for the resubmission of data to correct these errors. (i) CMS will not allow resubmission of data submitted via claims, direct EHR, and the GPRO web interface reporting mechanisms. (ii) CMS will only allow resubmission of data that was already previously submitted to CMS. (iii) CMS will only accept data that was previously submitted for the reporting periods for which the corresponding informal review period applies.

   We invite public comment on these proposals.

L. Electronic Health Record (EHR) Incentive Program

   The HITECH Act (Title IV of Division B of the ARRA, together with Title XIII of Division A of the ARRA) authorizes incentive payments under Medicare and Medicaid for the adoption and meaningful use of certified EHR technology (CEHRT). Section 1848(o)(2)(B)(iii) of the Act requires that in selecting CQMs for eligible professionals (EPs) to report under the EHR Incentive Program, and in establishing the form and manner of reporting, the Secretary shall seek to avoid redundant or duplicative reporting otherwise required. As such, we have taken steps to establish alignments among various quality reporting and payment programs that include the submission of CQMs.

   For CY 2012 and subsequent years, SEC 495.8(a)(2)(ii) requires an EP to successfully report the clinical quality measures selected by CMS to CMS or the states, as applicable, in the form and manner specified by CMS or the states, as applicable.

   In the CY 2014 PFS final rule with comment period (78 FR 74756), we finalized our proposal to require EPs who seek to report CQMs electronically under the Medicare EHR Incentive Program to use the most recent version of the electronic specifications for the CQMs and have CEHRT that is tested and certified to the most recent version of the electronic specifications for the CQMs. We noted it is important for EPs to electronically report the most recent versions of the electronic specifications for the CQMs as updated measure versions correct minor inaccuracies found in prior measure versions. We stated that to ensure that CEHRT products can successfully transmit CQM data using the most recent version of the electronic specifications for the CQMs, it is important that the product be tested and certified to the most recent version of the electronic specifications for the CQMs.

   Since finalizing this proposal, we have received feedback from stakeholders regarding the difficulty and expense of having to test and recertify CEHRT products to the most recent version of the electronic specifications for the CQMs. While we still believe EPs should test and certify their products to the most recent version of the electronic specifications for the CQMs when feasible, we understand the burdens associated with this requirement. Therefore, to eliminate this added burden, we are proposing that, beginning in CY 2015, EPs would not be required to ensure that their CEHRT products are recertified to the most recent version of the electronic specifications for the CQMs. Please note that, although we are not requiring recertification, EPs must still report the most recent version of the electronic specifications for the CQMs.

   In the CY 2014 PFS final rule with comment period, we established the requirement that EPs who seek to report CQMs electronically under the Medicare EHR Incentive Program must use the most recent version of the electronic specifications for the CQMs (78 FR 74756). When establishing this requirement, we did not account for instances where errors are discovered in the updated electronic measure specifications. To account for these instances and consistent with the proposal set forth in the PQRS in section III.K, we propose that, beginning in CY 2015, if we discover errors in the most recently updated electronic measure specifications for a certain measure, we would use the version of electronic measure specifications that immediately precedes the most recently updated electronic measure specifications.

   Additionally, we noted that, with respect to the following measure CMS140v2, Breast Cancer Hormonal Therapy for Stage IC-IIIC Estrogen Receptor/Progesterone Receptor (ER/PR) Positive Breast Cancer (NQF 0387), a substantive error was discovered in the June 2013 version of this electronically specified clinical quality measure (78 FR 74757). If an EP chooses to report this measure electronically under the EHR Incentive Program in CY 2014, the prior, December 2012 version of the measure, which is CMS140v1, must be used (78 FR 74757). Since a more recent and corrected version of this measure has been developed, we will require the reporting of the most recent, updated version of the measure Breast Cancer Hormonal Therapy for Stage IC-IIIC Estrogen Receptor/Progesterone Receptor (ER/PR) Positive Breast Cancer (NQF 0387), if an EP chooses to report the measure electronically in CY 2015.

   In the EHR Incentive Program Stage 2 final rule, we established CQM reporting options for the Medicare EHR Incentive Program for CY 2014 and subsequent years that include one individual reporting option that aligns with the PQRS's EHR reporting option (77 FR 54058) and two group reporting options that align with the PQRS GPRO and Medicare Shared Savings Program (MSSP) and Pioneer ACOs (77 FR 54076 to 54078). In the CY 2014 PFS final rule with comment period, we finalized two additional aligned options for EPs to report CQMs for the Medicare EHR Incentive Program for CY 2014 and subsequent years with the intention of minimizing the reporting burden on EPs (78 FR 74753 through 74757). One of the aligned options finalized in the CY 2014 PFS final rule with comment period (78 FR 74754 through 74755) is a reporting option for CQMs for the Medicare EHR Incentive Program under which EPs can submit CQM information using qualified clinical data registries, according the definition and requirements for qualified clinical data registries established under the PQRS.

   The second aligned option finalized in the CY 2014 PFS final rule with comment period (78 FR 74755 through 74756) is a group reporting option for CQMs for the Medicare EHR Incentive Program beginning in CY 2014 under which EPs who are part of a Comprehensive Primary Care (CPC) initiative practice site that successfully reports at least nine electronically specified CQMs across three domains for the relevant reporting period in accordance with the requirements established for the CPC initiative and using CEHRT would satisfy the CQM reporting component of meaningful use for the Medicare EHR Incentive Program. If a CPC practice site is not successful in reporting, EPs who are part of the site would still have the opportunity to report CQMs in accordance with the requirements established for the Medicare EHR Incentive Program in the Stage 2 final rule. Additionally, only those EPs who are beyond their first year of demonstrating meaningful use may use this CPC group reporting option. The CPC practice sites must submit the CQM data in the form and manner required by the CPC initiative. Therefore, whether CPC required electronic submission or attestation of CQMs, the CPC practice site must submit the CQM data in the form and manner required by the CPC initiative.

   The CPC initiative, under the authority of section 3021 of the Affordable Care Act, is a multi-payer initiative fostering collaboration between public and private health care payers to strengthen primary care. Under this initiative, we will pay participating primary care practices a care management fee to support enhanced, coordinated services. Simultaneously, participating commercial, state, and other federal insurance plans are also offering enhanced support to primary care practices that provide high-quality primary care. There are approximately 483 CPC practice sites across 7 health care markets in the U.S. More details on the CPC initiative can be found at http://innovation.cms.gov/initiatives/Comprehensive-Primary-Care-Initiative/index.html.

   Under the CPC initiative, CPC practice sites are required to report to CMS a subset of the CQMs that were selected in the EHR Incentive Program Stage 2 final rule for EPs to report under the EHR Incentive Program beginning in CY 2014 (for a list of CQMs that were selected in the EHR Incentive Program Stage 2 final rule for EPs to report under the EHR Incentive Program beginning in CY 2014, see 77 FR 54069 through 54075). We propose to retain the group reporting option for CPC practice sites as finalized in the CY 2014 PFS final rule, but to relax the requirement for the CQMs to cover three domains. Instead, we propose that, for CY 2015 only, under this group reporting option, the CPC practice site must report a minimum of nine CQMs from the CPC subset, and the nine CQMs reported must cover at least 2 domains, although we strongly encourage practice sites to report across more domains if feasible. Although the requirement to report across three domains is important because the domains are linked to the National Quality Strategy and used throughout CMS quality programs, the CPC practice sites are required to report from a limited number of CQMs that were selected for the EHR Incentive Program and are focused on a primary care population. Therefore, these CPC practice sites may not have measures to select from that cover three domains. Additionally, CPC practice sites are assessed for quality performance on measures other than electronically specified CQMs which do cover other National Quality Strategy domains. We invite public comment on this proposal.

M. Medicare Shared Savings Program

   Under section 1899 of the Act, CMS has established the Medicare Shared Savings program (Shared Savings Program) to facilitate coordination and cooperation among providers to improve the quality of care for Medicare Fee-For-Service (FFS) beneficiaries and reduce the rate of growth in health care costs. Eligible groups of providers and suppliers, including physicians, hospitals, and other health care providers, may participate in the Shared Savings Program by forming or participating in an Accountable Care Organization (ACO). The final rule implementing the Shared Savings Program appeared in the November 2, 2011Federal Register (Medicare Shared Savings Program: Accountable Care Organizations Final Rule (76 FR 67802)).

   Section 1899(b)(3)(A) of the Act requires the Secretary to determine appropriate measures to assess the quality of care furnished by ACOs, such as measures of clinical processes and outcomes; patient, and, wherever practicable, caregiver experience of care; and utilization such as rates of hospital admission for ambulatory sensitive conditions. Section 1899(b)(3)(B) of the Act requires ACOs to submit data in a form and manner specified by the Secretary on measures that the Secretary determines necessary for ACOs to report to evaluate the quality of care furnished by ACOs. Section 1899(b)(3)(C) of the Act requires the Secretary to establish quality performance standards to assess the quality of care furnished by ACOs, and to seek to improve the quality of care furnished by ACOs over time by specifying higher standards, new measures, or both for the purposes of assessing the quality of care. Additionally, section 1899(b)(3)(D) of the Act gives the Secretary authority to incorporate reporting requirements and incentive payments related to the PQRS, EHR Incentive Program and other similar initiatives under section 1848 of the Act. Finally, section 1899(d)(1)(A) of the Act states that an ACO is eligible to receive payment for shared savings, if they are generated, only after meeting the quality performance standards established by the Secretary.

   In the November 2011 final rule establishing the Shared Savings Program, we established the quality performance standards that ACOs must meet to be eligible to share in savings that are generated (76 FR 67870 through 67904). Quality performance measures are submitted by ACOs through a CMS web interface, currently the group practice reporting (GPRO) web interface, calculated by CMS from internal and claims data, and collected through a patient and caregiver experience of care survey.

   Consistent with the directive under section 1899(b)(3)(C) of the Act, we believe the existing Shared Savings Program regulations incorporate a built in mechanism for encouraging ACOs to improve care over the course of their 3-year agreement period, and to reward quality improvement over time. During the first year of the agreement period, ACOs can qualify for the maximum sharing rate by completely and accurately reporting all quality measures. After that, ACOs must meet certain thresholds of performance, which are currently phased in, and are rewarded for improved performance on a sliding scale in which higher levels of quality performance translate to higher rates of shared savings (or, for ACOs subject to performance-based risk that demonstrate losses, lower rates of shared losses). In this way, the quality performance standard increases over the course of the ACO's agreement period.

   Additionally, we have made an effort to align quality performance measures, submission methods, and incentives under the Shared Savings Program with the PQRS. Eligible professionals participating in an ACO may qualify for the PQRS incentive payment under the Shared Savings Program or avoid the downward PQRS payment adjustment when the ACO satisfactorily reports the ACO GPRO measures on their behalf using the GPRO web interface.

   Since the November 2011 final rule establishing the Shared Savings Program was issued, we have revisited certain aspects of the quality performance standard in the annual PFS rulemaking out of a desire to ensure thoughtful alignment with the agency's other quality incentive programs that are addressed in that rule. Specifically, we have updated our rules to align with PQRS and the EHR Incentive Program, and addressed issues related to benchmarking and scoring ACO quality performance (77 FR 69301 through 69304; 78 FR 74757 through 74764). We have identified several policies related to the quality performance standard that we would like to address in this rule at this time. Specifically, we are revisiting the current quality performance standard, proposing changes to the quality measures, and seeking comment on future quality performance measures. We are also proposing to modify the timeframe between updates to the quality performance benchmarks, to establish an additional incentive to reward ACO quality improvement, and to make several technical corrections to the regulations in subpart F of Part 425.

1. Existing Quality Measures and Performance Standard

   As discussed previously, section1899(b)(3) of the Act states that the Secretary may establish quality performance standards to assess the quality of care furnished by ACOs and "seek to improve the quality of care furnished by ACOs over time by specifying higher standards, new measures, or both. . . ." In the November 2011 Shared Savings Program final rule, we established a quality performance standard that consists of 33 measures. These measures are submitted by the ACO through the GPRO web interface, calculated by CMS from administrative and claims data, and collected via a patient experience of care survey based on the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) survey. Although the patient experience of care survey used for the Shared Savings Program includes the core CG-CAHPS modules, this patient experience of care survey also includes some additional modules. Therefore, we will refer to the patient experience of care survey that is used under the Shared Savings Program as CAHPS for ACOs. The measures span four domains, including patient experience of care, care coordination/patient safety, preventive health, and at-risk population. The measures collected through the GPRO web interface are also used to determine whether eligible professionals participating in an ACO qualify for the 2013 and 2014 PQRS incentive payment or avoid the PQRS payment adjustment for 2015 and subsequent years. Eligible professionals in an ACO may qualify for the PQRS incentive payment or avoid the downward PQRS payment adjustment when the ACO satisfactorily reports all of the ACO GPRO measures on their behalf using the GPRO web interface.

   In selecting the 33 measure set, we balanced a wide variety of important considerations. Given that many ACOs were expected to be newly formed organizations, in the November 2011 Shared Savings Program final rule (76 FR 67886), we concluded that ACO quality measures should focus on discrete processes and short-term measurable outcomes derived from administrative claims and limited medical record review facilitated by a CMS-provided web interface to lessen the burden of reporting. Because of the focus on Medicare FFS beneficiaries, our measure selection emphasized prevention and management of chronic diseases that have high impact on these beneficiaries such as heart disease, diabetes mellitus, and chronic obstructive pulmonary disease. We believed that the quality measures used in the Shared Savings Program should be tested, evidence-based, target conditions of high cost and high prevalence in the Medicare FFS population, reflect priorities of the National Quality Strategy, address the continuum of care to reflect the requirement that ACOs accept accountability for their patient populations, and align with existing quality programs and value-based purchasing initiatives.

   At this time, we continue to believe it is most appropriate to focus on quality measures that directly assess the overall quality of care furnished to FFS beneficiaries. The set of 33 measures that we adopted in the November 2011 Shared Savings Program final rule includes measures addressing patient experience, outcomes, and evidence-based care processes. Thus far, we have not included any specific measures addressing high cost services or utilization since we believe that the potential to earn shared savings offers an important and direct incentive for ACOs to address utilization issues in a way that is most appropriate for their organization, patient population, and local healthcare environment. We note that while the quality performance standard is limited to these 33 measures, the performance of ACOs is measured on many more metrics and ACOs are informed of their performance in these areas. For example, an assessment of an ACO's utilization of certain resources is provided to the ACO via quarterly reports that contain information such as the utilization of emergency services or the utilization of CTs and MRIs.

   As we have stated previously (76 FR 67872), our principal goal in selecting quality measures for ACOs was to identify measures of success in the delivery of high-quality health care at the individual and population levels. We believe endorsed measures have been tested, validated, and clinically accepted, and therefore, selected the 33 measures with a preference for NQF-endorsed measures. However, the statute does not limit us to using endorsed measures in the Shared Savings Program. As a result we also exercised our discretion to include certain measures that we believe to be high impact but that are not currently endorsed, for example, ACO#11, Percent of PCPs Who Successfully Qualify for an EHR Incentive Program Payment.

   In selecting the final set of 33 measures, we sought to include both process and outcome measures, including patient experience of care (76 FR 67873). Because ACOs are charged with improving and coordinating care and delivering high quality care, but also need time to form, acquire infrastructure and develop clinical care processes, we continue to believe it is important to have a combination of both process and outcomes measures. We note, however, that as other CMS quality reporting programs, such as PQRS, move to more outcomes-based measures and fewer process measures over time, we may also revise the quality performance standard for the Shared Savings Program to incorporate more outcomes-based measures over time.

   Therefore, we viewed the 33 measures adopted in the November 2011 Shared Savings Program final rule as a starting point for ACO quality measurement. As we stated in that rule (67 FR 67891), we plan to modify the measures in future reporting cycles to reflect changes in practice and improvements in quality of care and to continue aligning with other quality reporting programs and will add and/or retire measures as appropriate through the rulemaking process. In addition, we are working with the measures community to ensure that the specifications for the measures used under the Shared Savings Program are up-to-date. We note that we must balance the timing of the release of specifications so they are as up-to-date as possible, while also giving ACOs sufficient time to review specifications. Our intention is to issue the specifications annually, prior to the start of the reporting period for which they will apply. For example, we issued the specifications for the 2014 reporting period in late 2013, prior to the start of the 2014 reporting period.

   In the November 2011 Shared Savings Program final rule (76 FR 67873), we combined care coordination and patient safety into a single domain to better align with the National Quality Strategy and to emphasize the importance of ambulatory patient safety and care coordination. We also intended to continue exploring ways to best capture ACO care coordination metrics and noted that we would consider adding new care coordination measures for future years (67 FR 67877).

2. Proposed Changes to the Quality Measures Used in Establishing Quality Performance Standards That ACOs Must Meet To Be Eligible for Shared Savings

   Since the November 2011 Shared Savings Program final rule, we have continued to review the quality measures used for the Shared Savings Program to ensure that they are up to date with current clinical practice and are aligned with the GPRO web interface reporting for PQRS. Based on the reviews, we have identified a number of proposed measure additions, deletions and other revisions that we believe would be appropriate for the Shared Savings Program. Under the following proposed measure revisions, ACOs would be assessed on 37 measures annually, an increase of 4 measures. However, as explained in more detail below, we believe the measures chosen are more outcome-oriented and would ultimately reduce the reporting burden on ACOs.

   The following is a description of the proposed changes that would be effective for the 2015 reporting period and would be reported by ACOs to us in early 2016. Table 50 offers an overview of the proposed changes and is provided as a reference. (We note that the deletion and insertion of certain measures affects the composite measures, and we are proposing corresponding revisions to both the diabetes and coronary artery disease composite measures.)

    * CAHPS Stewardship of Patient Resources. This measure is one of the unscored survey measures currently collected in addition to the seven that are already part of the current set of 33 scored measures under the Shared Savings Program. Information on the unscored survey measure modules is currently shared with the ACOs for informational purposes only. The Stewardship of Patient Resources measure asks the patient whether the care team talked with the patient about prescription medicine costs. The measure exhibited high reliability during the first two administrations of the CAHPS survey, and during testing, the beneficiaries that participated in cognitive testing said that prescription drug costs was important to them. We are proposing to add Stewardship of Patient Resources as a scored measure in the patient experience domain because we believe, based on testing, that this is an important factor for measuring a beneficiary's experience with healthcare providers. We are also proposing that the measure would be phased into pay for performance as we plan to do for other new measures, using a similar process to the phase in that was used for the measure modules in the survey that are currently used to assess ACO quality performance. We seek comment on this proposal and on any other patient experience of care measures that might be considered in future rulemaking.

    * Skilled Nursing Facility 30-Day All-Cause Readmission Measure (SNFRM). We propose to add a 30-day all cause SNF readmission measure. CMS is the measure steward for this claims based measure which is under review at NQF under NQF #2510. This measure estimates the risk-standardized rate of all-cause, unplanned, hospital readmissions for patients who have been admitted to a Skilled Nursing Facility within 30 days of discharge from a prior inpatient admission to a hospital, CAH, or a psychiatric hospital. The measure is based on data for 12 months of SNF admissions. We believe this measure would help fill a gap in the current Shared Savings Program measure set and would provide a focus on an area where ACOs are targeting care redesign. ACOs and their ACO providers/suppliers often include post-acute care (PAC) settings and the addition of this measure would enhance the participation and alignment with these facilities. Even when the ACO does not include post-acute facilities formally as part of its organization, ACO providers/suppliers furnish other services that have the potential to affect PAC outcomes. Thus, this measure would emphasize the importance of coordinating the care of beneficiaries across these sites of care. Additionally, because this measure is calculated from claims, there would not be a burden on ACOs to collect this information.

    * All-Cause Unplanned Admissions for Patients with Diabetes Mellitus (DM), Heart Failure (HF) and Multiple Chronic Conditions. We propose to add three new measures to the Care Coordination/Patient Safety domain. The three proposed new measures are for: all-cause unplanned Admissions for Patients with Diabetes Mellitus (DM), all-cause unplanned Admissions for Patients with Heart Failure (HF) and all-cause unplanned Admissions for Patients with Multiple Chronic Conditions. These three measures are under development though a CMS contract with Yale New Haven Health Services Corporation/Center for Outcomes Research and Evaluation (CORE) to develop quality measures specifically for ACO patients with heart failure, diabetes, and multiple chronic conditions. We believe that these measures are important to promote and assess ACO quality as it relates to chronic condition inpatient admission because they are major causes for unplanned admissions and will support the ACOs' efforts to improve care coordination for these chronic conditions. These measures are claims based, and therefore, we do not expect that they would impose any additional burden on ACOs.

    * Depression Remission at Twelve Months. We propose to add Depression Remission at Twelve Months (NQF #0710) to the Preventive Health domain. Depression is a serious health condition for the Medicare population and can decrease patient adherence to treatment for chronic conditions. This measure would enhance our measurement of health outcomes and depression is an important health condition that we believe is appropriate to be addressed by ACOs. The measure would be submitted through the GPRO web interface, and would be aligned with PQRS. We also seek comments on the inclusion of additional behavioral health measures, such as substance abuse or mental health measures, in future rulemaking cycles.

    * Diabetes Measures for Foot Exam and Eye Exam. Diabetes is one of the most serious, chronic health conditions for Medicare beneficiaries. It is critical that Medicare beneficiaries that have diabetes receive foot and eye exams to help prevent diabetes-related foot amputations and blindness. Both of the two new measures would be added to the Clinical Care for at Risk Population-Diabetes domain. They are endorsed by NQF (NQF #0055 and #0056). We also propose to include these two new measures as part of a new Diabetes Mellitus composite measure. These measures would also align with PQRS and the EHR Incentive Program. We believe these measures would be appropriate additional measures for assessing quality of care furnished in ACOs to help prevent diabetes-related foot amputations and blindness.

    * Coronary Artery Disease (CAD): Symptom Management. This new measure would be added to the Clinical Care for At Risk Population-Coronary Artery Disease domain and included in the CAD Composite Measure. The measure helps assess symptom management for CAD patients based on the percentage of adults with a diagnosis of coronary artery disease seen within a 12-month period with results of an evaluation of level of activity and an assessment of whether anginal symptoms are present or absent with appropriate management of anginal symptoms within a 12-month period. This new measure would be added to further enhance the CAD composite measure by adding an assessment of patient activity level and management of angina, which are important clinical factors for beneficiaries with CAD. The measure would align with PQRS (PQRS #0242) and the EHR Incentive Program.

    * Coronary Artery Disease (CAD): Beta Blocker Therapy--Prior Myocardial Infarction (MI) or Left Ventricular Systolic Dysfunction (LVEF

    * Coronary Artery Disease (CAD): Antiplatelet Therapy. This new measure would be added to the Clinical Care for At Risk Population-Coronary Artery Disease domain and included in the CAD Composite Measure. The measure is defined as the percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12-month period that were prescribed aspirin or clopidogrel. This new measure is endorsed by NQF as NQF #0067 and would be added to update the CAD composite measure to reflect updated clinical guidelines for lipid control. This new measure would replace the existing measure at ACO #30, Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic, which we are proposing to remove because it no longer reflects current clinical guidelines.

    * Documentation of Current Medications in the Medical Record (NQF #0419). This new measure would replace ACO #12 (NQF #0097) Medication Reconciliation measure. The current measure is designed to determine whether medication reconciliation was done immediately following a hospital discharge whereas the medical community has indicated to us that it is better clinical practice to perform medication reconciliation at every office visit, which NQF #0419 is designed to measure. In addition, this new replacement measure aligns with both PQRS and the EHR Incentive Program.

    * Percent of PCPs who Successfully Meet Meaningful Use Requirements. Because the EHR Incentive Program begins its transition to a payment adjustment effective in 2015, we propose to modify the name and specifications for ACO #11 Percent of PCPs who Successfully Qualify for an EHR Incentive Program Payment so that it more accurately depicts successful use and adoption of EHR technology in the coming years. We note this measure would continue to be doubly weighted.

   We seek comment on these proposed new measures.

   Additionally, we have identified a number of the existing measures that have not kept up with clinical best practice, are redundant with other measures that make up the quality reporting standard, or that could be replaced by similar measures that are more appropriate for ACO quality reporting. We propose to no longer collect data on the following measures, and these measures would no longer be used for establishing the quality performance standards that ACOs must meet to qualify to share in savings:

    * ACO #12, Medication Reconciliation after Discharge from an Inpatient Facility: As explained above, we would replace this measure with a new measure for documentation of current medications in the medical record since the medical community has indicated the importance of medication reconciliation at each office visit rather than only after an inpatient discharge.

    * ACO #22, Diabetes Composite measure: Hemoglobin A1c control (

    * ACO #24, Diabetes Composite: Blood Pressure (

    * ACO #25, Diabetes Composite: Tobacco Non-use (NQF #0729). We believe this measure is somewhat duplicative of the separate measure ACO #17, Tobacco Use Assessment and Tobacco Cessation Intervention (NQF #0028) and that the diabetes measure may capture a subpopulation of the broader measure. We prefer to use NQF #0028 as a measure of tobacco use for the Shared Savings Program because this measure has been identified as a cross-cutting measure as it represents a screening assessment that most eligible professionals may perform and is applicable to most adult patients. This measure is applicable in various outpatient settings.

    * ACO #23, Diabetes Composite: Low Density Lipoprotein (American College of Cardiology and American Heart Association (see https://circ.ahajournals.org/content/early/2013/11/11/01.cir.0000437738.63853.7a.full.pdf). The new guidelines recommend treating individuals with moderate-to-high dose statin therapy based on cardiac risk rather than only treating high cholesterol to specific targets.

    * ACO #29, Ischemic Vascular Disease: Complete Lipid Profile and LDL Control (

    * ACO #30, Ischemic Vascular Disease: Use of Aspirin or another Antithrombotic (NQF #0068). This measure would be replaced by the proposed new CAD measure for antiplatelet therapy (NQF #67), which reflects current clinical guidelines.

    * ACO #32, Coronary Artery Disease (CAD) Composite: Drug Therapy for Lowering LDL Cholesterol (NQF #74). We propose to retire this lipid control related measure because of the new clinical guidelines for statin treatment as noted above.

   We seek comment on our proposal to remove these measures from the quality performance standards.

   Finally, given these proposed changes, we propose updates and revisions to the Diabetes and CAD Composites. We propose that the Diabetes Composite would include the following measures:

    * ACO #26: Diabetes Mellitus: Daily Aspirin or Antiplatelet Medication Use for Patients with Diabetes Mellitus and Ischemic Vascular Disease.

    * ACO #27: Diabetes: Hemoglobin A1c Poor Control.

    * ACO #41: Diabetes: Foot Exam.

    * ACO #42: Diabetes: Eye Exam.

   We further propose that the CAD Composite would include the following measures:

    * ACO #33: Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy--Diabetes or Left Ventricular Systolic Dysfunction (LVEF

    * ACO #43: Antiplatelet Therapy.

    * ACO #44: Symptom Management.

    * ACO #45: Beta-Blocker Therapy--Prior Myocardial Infarction (MI) or Left Ventricular Systolic Dysfunction (LVEF

   We seek comment on these proposed composites and whether there are any concerns regarding calculation of a composite score. There has been increased interest in the use of composite performance measures over the past few years and stakeholders have raised general concerns regarding composite measures and their purpose for quality improvement. CMS worked with the National Quality Forum (NQF) and their technical expert panel in 2013 to update NQF's composite measure evaluation guidance, which in turn may also be used by developers for composite measure development. Given the general concerns around composite measures and their use, we seek comment on how we combine and incorporate component measure scoring for the composite. In particular, we are interested in whether stakeholders have any concerns about including ACO #27, reverse-scored measure, in the Diabetes Composite, and whether there are any methodological considerations we should consider when including a reverse-scored measures in composites.

   To summarize, under these proposed changes, we would add 12 new measures and retire eight measures. We are also proposing to rename the EHR measure in order to reflect the transition from an incentive payment to a payment adjustment under the EHR Incentive Program and to revise the component measures within the Diabetes and CAD composites. In total, we propose to use 37 measures for establishing the quality performance standards that ACOs must meet to achieve shared savings. Although the total number of measures would increase from the current 33 measures to 37 measures, we do not anticipate that this would increase the reporting burden on ACOs. The increased number of measures is accounted for by measures that would be calculated by CMS using administrative claims data or from a patient survey. The total number of measures that the ACO would need to directly report through the CMS Web site interface would actually decrease by one, in addition to removing redundancy in measures reported.

   As part of these proposed changes, we would replace the current five component diabetes composite measure with a new four component diabetes composite measure. In addition, we would replace the current two component coronary artery disease composite measure with a new four component coronary artery disease composite measure. Twenty-one of the measures would be reported by ACOs through the GPRO web interface and scored as 15 measures.

   An overview of the proposed changes is provided in Table 50 which demonstrates what measures would be used to assess ACO quality under the Shared Savings Program if our proposals are finalized.

Table 50--Measures for Use in Establishing Quality Performance Standards That ACOs Must Meet for Shared Savings Domain ACO Measure title Proposed new NQF No./ Measure No. measure Measure steward AIM: Better Care for Individuals Patient/Caregiver ACO-1 CAHPS: Getting NQF #0005, Experience Timely Care, AHRQ Appointments, and Information ACO-2 CAHPS: How NQF #0005 AHRQ Well Your Doctors Communicate ACO-3 CAHPS: NQF #0005 AHRQ Patients' Rating of Doctor ACO-4 CAHPS: Access NQF #N/A to Specialists CMS/AHRQ ACO-5 CAHPS: Health NQF #N/A Promotion and CMS/AHRQ Education ACO-6 CAHPS: Shared NQF #N/A Decision CMS/AHRQ Making ACO-7 CAHPS: Health NQF #N/A Status/Functio CMS/AHRQ nal Status ACO-34 CAHPS: X NQF #N/A Stewardship of CMS/AHRQ Patient Resources Care ACO-8 Risk- Adapted NQF Coordination/ Standardized, #1789 CMS Safety All Condition Readmission ACO-35 Skilled X NQF #TBD CMS Nursing Facility 30- Day All-Cause Readmission Measure (SNFRM) ACO-36 All-Cause X NQF #TBD CMS Unplanned Admissions for Patients with Diabetes ACO-37 All-Cause X NQF #TBD CMS Unplanned Admissions for Patients with Heart Failure ACO-38 All-Cause X NQF #TBD CMS Unplanned Admissions for Patients with Multiple Chronic Conditions ACO-9 Ambulatory Adapted NQF Sensitive #0275 AHRQ Conditions Admissions: Chronic Obstructive Pulmonary Disease or Asthma in Older Adults (AHRQ Prevention Quality Indicator (PQI) #5) ACO-10 Ambulatory Adapted NQF Sensitive #0277 AHRQ Conditions Admissions: Heart Failure (AHRQ Prevention Quality Indicator (PQI) #8) ACO-11 Percent of NQF #N/A CMS PCPs who Successfully Meet Meaningful Use Requirements ACO-39 Documentation X NQF #0419 CMS of Current Medications in the Medical Record ACO-13 Falls: NQF #0101 NCQA Screening for Future Fall Risk AIM: Better Health for Populations Preventive Health ACO-14 Preventive NQF #0041 AMA- Care and PCPI Screening: Influenza Immunization ACO-15 Pneumonia NQF #0043 NCQA Vaccination Status for Older Adults ACO-16 Preventive NQF #0421 CMS Care and Screening: Body Mass Index (BMI) Screening and Follow Up ACO-17 Preventive NQF #0028 AMA- Care and PCPI Screening: Tobacco Use: Screening and Cessation Intervention ACO-18 Preventive NQF #0418 CMS Care and Screening: Screening for Clinical Depression and Follow-up Plan ACO-19 Colorectal NQF #0034 NCQA Cancer Screening ACO-20 Breast Cancer NQF #NA NCQA Screening ACO-21 Preventive CMS Care and Screening: Screening for High Blood Pressure and Follow-up Documented Clinical Care for ACO-40 Depression X NQF #0710 MNCM At Risk Remission at Population-- Twelve Months Depression Clinical Care for Diabetes CMS composite At Risk Composite (All Population-- or Nothing Diabetes Scoring) ACO-26 ACO-26: NQF #0729 MNCN Diabetes (individual Mellitus: measure) Daily Aspirin or Antiplatelet Medication Use for Patients with Diabetes Mellitus and Ischemic Vascular Disease ACO-27 ACO-27: NQF #0059 NCQA Diabetes (individual Mellitus: component) Hemoglobin A1c Poor Control ACO-41: ACO-41: X NQF #0056 NCQA Diabetes: Foot (individual Exam component) ACO-42 ACO-42: X NQF #0055 NCQA Diabetes: Eye (individual Exam component) Clinical Care for ACO-28 Hypertension NQF #0018 NCQA At Risk (HTN): Population-- Controlling Hypertension High Blood Pressure Clinical Care for ACO-31 Heart Failure NQF #0083 AMA- At Risk (HF): Beta- PCPI Population--Heart Blocker Failure Therapy for Left Ventricular Systolic Dysfunction (LVSD) Clinical Care for Coronary CMS composite At Risk Artery Disease Population-- (CAD) Coronary Artery Composite (All Disease or Nothing Scoring) ACO-33 ACO-33; NQF #0066 ACC Angiotensin- (individual Converting component) Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy--for patients with CAD and Diabetes or Left Ventricular Systolic Dysfunction (LVEF <40%) ACO-43 ACO-43: X NQF #0067 ACC Antiplatelet (individual Therapy component) ACO-44 ACO-44 X NQF #N/A AMA- :Symptom PCPI Management (individual component) ACO-45 ACO-45: Beta- X NQF #0070 ACC Blocker (individual Therapy--Prior component) Myocardial Infarction (MI) or Left Ventricular Systolic Dysfunction (LVEF <40%)

Table 50--Measures for Use in Establishing Quality Performance Standards That ACOs Must Meet for Shared Savings Domain Method of data Pay for perfor mance phase in submission R--Reporting P--Performance PY1 PY2 PY3 AIM: Better Care for Individuals Patient/Caregiver Survey R P P Experience Survey R P P Survey R P P Survey R P P Survey R P P Survey R P P Survey R R R Survey R P P Care Claims R R P Coordination/ Safety Claims R R P Claims R R P Claims R R P Claims R R P Claims R P P Claims R P P EHR Incentive R P P Program Reporting CMS Web R P P Interface CMS Web R P P Interface AIM: Better Health for Populations Preventive Health CMS Web R P P Interface CMS Web R P P Interface CMS Web R P P Interface CMS Web R P P Interface CMS Web R P P Interface CMS Web R R P Interface CMS Web R R P Interface CMS Web R R P Interface Clinical Care for CMS Web R P P At Risk Interface Population-- Depression Clinical Care for CMS Web R P P At Risk Interface Population-- Diabetes R P P CMS Web R P P Interface CMS Web R P P Interface CMS Web R P P Interface Clinical Care for CMS Web R P P At Risk Interface Population-- Hypertension Clinical Care for CMS Web R R P At Risk Interface Population--Heart Failure Clinical Care for CMS Web R R P At Risk Interface Population-- Coronary Artery Disease CMS Web R P P Interface CMS Web R R P Interface CMS Web R R P Interface CMS Web R R P Interface



   Table 51 provides the current number of measures by domain and displays the total points and domain weights used for scoring purposes. The current scoring methodology is explained in the regulations at SEC 425.502 and in the preamble to the November 2011 final rule (76 FR 67895 through 67900). Table 52 provides a summary of the proposed number of measures by domain and the resulting total points and domain weights that would be used for scoring purposes under these proposed changes. Otherwise, the current quality scoring points methodology for calculating an ACO's overall quality performance score would continue to apply. Table 53 provides the measures that are retired/replaced.

Table 51--Current Number of Measures and Total Points for Each Domain Within the Quality Performance Standard Domain Number of Total measures Total possible Domain weight individual for scoring points (percent) measures purposes Patient/ 7 7 individual 14 25 Caregiver survey module Experience measures Care 6 6 measures, 14 25 Coordination/ including the EHR Patient Safety measure double- weighted (4 points) Preventive 8 8 measures 16 25 Health At-Risk 12 7 measures, 14 25 Population including 5- component diabetes composite measure and 2-component coronary artery disease composite measure Total in all 33 28 58 100 Domains

Table 52--Proposed Number of Measures and Total Points for Each Domain within the Quality Performance Standard Domain Number of Total measures Total possible Domain weight individual for scoring points (percent) measures purposes Patient/Caregi 8 8 individual 16 25 ver Experience survey module measures Care 10 9 measures, plus 22 25 Coordination/P the EHR measure atient Safety double-weighted (4 points) Preventive 8 8 measures 16 25 Health At-Risk 11 5 measures, 10 25 Population including 3 individual measures plus a 4-component diabetes composite measure and a 4-component coronary artery disease composite measure Total in all 37 31 64 100 Domains

Table 53--Shared Savings Program Measures Retired/Replaced Notes Domain Measure title NQF measure #/ Method of data measure submission steward ACO #12 Replaced Care Medication NQF #97 AMA- GPRO Web Coordination/ Reconcilia- PCPI/NCQA Interface Patient Safety tion: Reconciliation After Discharge from an Inpatient Facility ACO #22 Retired At Risk Diabetes NQF #0729 MN GPRO Web Population-- Composite (All Community Interface Diabetes or Nothing Measurement Scoring): Hemoglobin A1c Control (<8 percent) ACO #23 Retired At Risk Diabetes NQF #0729 MN GPRO Web Population-- Composite (All Community Interface Diabetes or Nothing Measurement Scoring): Low Density Lipoprotein (<100) ACO #24 Retired - At Risk Diabetes NQF #0729 MN GPRO Web Redundant Measure Population-- Composite (All Community Interface Diabetes or Nothing Measurement Scoring): Blood Pressure <140/90 ACO #25 Retired-- At Risk Diabetes NQF #0729 MN GPRO Web Redundant measure Population-- Composite (All Community Interface Diabetes or Nothing Measurement Scoring): Tobacco Non Use ACO #29 Retired At Risk Ischemic NQF #75 NCQA GPRO Web Population-- Vascular Interface Ischemic Disease (IVD): Vascular Complete Lipid Disease Profile and LDL Control <100 mg/dl ACO #30 Replaced At Risk Ischemic NQF #68 NCQA GPRO Web Population-- Vascular Interface Ischemic Disease (IVD): Vascular Use of Aspirin Disease or Another Antithrombotic ACO #32 Retired At Risk Coronary NQF #74 CMS GPRO Web Population-- Artery Disease (composite)/ Interface Coronary (CAD) AMA-PCPI Artery Disease Composite: All (individual or Nothing component) Scoring: Drug Therapy for Lowering LDL- Cholesterol

Table 53--Shared Savings Program Measures Retired/Replaced Notes Pay for Performance Phase In R = Reporting P=Performance Performance Performance Performance Year 1 Year 2 Year 3 ACO #12 Replaced R P P ACO #22 Retired R P P ACO #23 Retired R P P ACO #24 Retired - R P P Redundant Measure ACO #25 Retired-- R P P Redundant measure ACO #29 Retired R P P ACO #30 Replaced R P P ACO #32 Retired R R P



   We believe that these modifications will enhance ACO quality reporting, better reflect clinical practice guidelines, streamline measures reporting, and enhance alignment with PQRS and the EHR Incentive Program. Finally, we are proposing that these measures would become effective beginning with the 2015 reporting period, and 2015 performance year (PY). All 37 measures would be phased in for ACOs with 2015 start dates according to the phase-in schedule in Table 50. ACOs with start dates before 2015 would be responsible only for complete and accurate reporting of the new measures for the 2015 performance year, and then responsible for either reporting or performance on the measures according to the phase in schedule. For example, assume a new measure is scheduled to phase in with reporting in PY1, reporting in PY2, and performance in PY3. Further assume that an ACO with a 2014 start date will be in its second performance year (PY2) when the measure becomes effective. In this example, the ACO would be responsible for complete and accurate reporting of the new measure in PY2 and for performance on the measure in PY3. If we change the assumptions in the example to say that the new measure is scheduled to phase in with reporting in PY1, performance in PY2, and performance in PY3, then the ACO would be responsible for complete and accurate reporting of the new measure in PY2 and for performance on the measure in PY3. Finally, we note that consistent with our proposed revisions to SEC 425.502(a) regarding quality reporting in a second and subsequent agreement period, an ACO that transitions to a new agreement period would continue to be assessed on the quality performance standard that would otherwise apply to an ACO in the third performance year of its first agreement period. Take the example of an ACO with a 2013 start date that will be responsible for reporting the new measure in the 2015 reporting period, its third performance year. Assume the measure is scheduled to phase in from reporting in PY1, reporting in PY2, and performance in PY3. In this case, the ACO would be responsible for complete and accurate reporting of the new measure in 2015 (PY3 of its first agreement period). If the ACO renews its participation agreement for another 3 years, the ACO would be responsible for performance on that measure for each year of its new agreement period because the measure is designated as a pay for performance measure in PY3 of the preceding agreement period.

   Additionally, as noted in the November 2011 Shared Savings Program final rule (76 FR 67900), the Shared Savings Program uses the same sampling method used by PQRS GPRO. Specifically, the sample for the ACO GPRO must consist of at least 411 assigned beneficiaries per measure set/domain. If the pool of eligible, assigned beneficiaries is less than 411, the ACO must report on 100 percent, or all, of the assigned beneficiaries sampled. To the extent that PQRS modifies and finalizes changes in the reporting requirements for group practices reporting via the GPRO web interface, we propose to make similar modifications to ACO reporting through the GPRO web interface. Specifically, as discussed in section III.K.4.a. of this proposed rule, we are proposing to reduce the GPRO web interface minimum reporting requirements for PQRS reporting from 411 to 248 consecutively ranked and assigned patients for each measure or 100 percent of the sample for each measure if there are less than 248 patients in a given sample. We propose that the reduced sample for each measure for reporting through the GPRO web interface would also apply to ACOs. We believe that a reduction in the number of sampled beneficiaries would reduce reporting burden for ACOs while maintaining high statistical validity and reliability in results.

3. Request for Comments for Future Quality Measures

   In addition to the proposed changes to the current set of 33 quality measures for the Shared Savings Program discussed above, we are interested in public comment on additional measures that we may consider in future rulemaking. We particularly welcome comments regarding the following issues:

    * Gaps in measures and additional specific measures: We recognize that there may be gaps in the ACO quality performance standard. For example, ACOs are charged with improving care coordination for FFS beneficiaries. While above we propose to add a measure for SNF 30-day all-cause readmission to address current gaps in SNF settings, we seek comment on whether there are additional measures that might be used to assess the ACO's performance with respect to care coordination in post-acute care and other settings. We also recognize the need to balance filling gaps in the quality performance standard with the reporting burden on ACOs. To the extent possible, we wish to identify measures for filling any gaps in the quality performance standard that would not increase the reporting burden on ACOs unduly. We welcome comments on specific measures or measure groups that may be considered in future rulemaking to fill in gaps that may exist for assessing ACO quality performance. For example, we seek input on measures that address the quality of care in the various different settings that may be part of an ACO, such as post-acute care settings including SNF or home health. We note that any suggestions for new measures would be more thoroughly discussed in a future rulemaking cycle prior to being adopted as part of the quality performance standard under the Shared Savings Program and if we deem it appropriate we would also submit them to the NQF Measures Application Partnership (MAP) via the list of Measures Under Consideration that the Secretary annually makes available to the public as part of the pre-rulemaking process under section 1890A(a)(2) of the Act for the purpose of seeking multi-stakeholder group input, consistent with the requirements of section 3014 of the Affordable Care Act, if the measures have not already been reviewed by the MAP.

    * Caregiver experience of care: While we recognize there is a concern about patient subjectivity to surveys, we include measures based on data collected via the patient experience of care survey in the quality performance standard because we believe patients' perception of their care experience reflects important aspects of the quality of the care they receive, such as communication and patient engagement in decision-making, that are not adequately captured by other measures. As such, patient surveys are important complements to the other process of care and outcomes measures. For this reason, we stated in November 2011 Shared Savings Program final rule (76 FR 67874) that we intended to expand the quality measures over time to include more caregiver experience measures. Therefore, we seek comment on additional specific caregiver experience of care measures that might be considered in future rulemaking.

    * Alignment with Value-Based Payment Modifier (VM) measures: We desire to continue to align with other Medicare quality initiatives in order to reduce ACO burden and streamline quality reporting and indicators. In the CY 2013 PFS final rule with comment period (77 FR 69313) we established a policy not to apply the VM in CY 2015 and CY 2016 to groups of physicians that participate in ACOs under the Shared Savings Program. Although section 1848(p)(4)(B)(iii)(I) of the Act gives the Secretary discretion to apply the VM to specific physicians and groups of physicians as the Secretary determines appropriate for 2015 and 2016, consistent with section 1848(p)(4)(B)(iii)(II), which requires application of the VM to all physicians and groups of physicians beginning not later than January 1, 2017, we are proposing to start applying the VM to physicians participating in ACOs beginning in 2017. In addition, in section III.K.4.b of this proposed rule, we discuss our proposal to also apply the VM to all nonphysician eligible professionals in groups with 2 or more eligible professionals and to solo practitioners who are nonphysician eligible professionals, including eligible professionals participating in ACOs, starting in CY 2017. To that end, we are seeking comment on whether there are synergies that can be created by aligning the ACO quality measures set with the measures used under the VM. For example, in the Value-based Modifier program, there are two claims-based composite outcomes measures, namely, the Composite of Acute Prevention Quality Indicators (PQIs) comprised by 3 measures (NQF #279 Bacterial Pneumonia Admission Rate, NQF #280 Dehydration Admission Rate, and NQF #281 Urinary Tract Infection Admission Rate) and the Composite of Chronic Prevention Quality Indicators (PQIs) comprised by 6 measures (NQF #638 Uncontrolled Diabetes, NQF #272 Short Term Diabetes complications, NQF #274 Long Term Diabetes Complications, NQF #285 Lower Extremity Amputation for Diabetes, NQF #275 COPD, and NQF #277 Congestive Heart Failure). (See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/Downloads/2012-ACSC-Outcomes-Msrs.pdf). Because these VM measures are claims based measures, no additional reporting burden would be added to ACOs. In addition, we note that two of these measures are currently a part of the ACO quality measures set, specifically, NQF #275, "Ambulatory Sensitive Conditions Admissions: Chronic Obstructive Pulmonary Disease," and NQF #277: "Ambulatory Sensitive Conditions Admissions: Congestive Heart Failure." Although we are not proposing changes at this time to align with the measures used under the VM, we are seeking comment on whether the VM composites should be considered in the future as a replacement for the two ACO claims based ambulatory sensitive conditions admissions (ASCA) measures.

    * Specific measures to assess care in the frail elderly population: We recognize providers face challenges in caring for the health needs of the frail elderly. There are, however, many challenges in defining and measuring the quality of care for this population. In the November 2011 Shared Savings Program final rule, we incorporated a measure focused on the frail elderly population--ACO#13 Screening for Fall Risk, which rewards ACOs for incorporating fall risk assessments in the redesign of their care processes. Our expectation was that practitioners would use the results of the fall risk assessments to promote meaningful conversations with their frail elderly patients about fall risks and ways to prevent or reduce these events. We also stated that as ACOs gain more experience integrating the fall risk screening into their day-to-day practices, we planned to revisit the frail elderly measures in future rulemaking to build upon these achievements and to address additional issues for the frail elderly (76 FR 67886). We welcome comments with suggestions of new measures of the quality of care furnished to the frail elderly population that we may consider adopting in future rulemaking.

    * Utilization: We did not include utilization measures in the quality performance standards adopted in the November 2011 final rule establishing the Shared Savings Program because we believed that ACOs have an intrinsic motivation to reduce inappropriate utilization of services in order to achieve shared savings. However, in recognition of the value of feedback on utilization, we include utilization data as part of the quarterly aggregate reports provided to ACOs. We welcome comments on whether it is sufficient for such utilization information to be included in the aggregate quarterly reports to ACOs or whether utilization measures should also be used to assess the ACO's quality performance as an added incentive to provide more efficient care. If commenters are interested in having such utilization measures included in the quality performance standard, we welcome specific comments on what measures would be most appropriate and suggestions for how to risk adjust these measures.

    * Health outcomes: Currently, the quality performance standard includes a self-reported health and functional status measure as part of the patient experience of care survey. We finalized this measure as pay for reporting for all 3-years of the agreement period to allow ACOs to gain experience with the measure (which had not previously been used for accountability purposes in any pay-for-performance initiative) and to provide important information to them on improving the health outcomes of the population they serve (76 FR 67876). Patient-reported outcomes, although subjective, provide valuable information not captured by other means. We continue to believe that it is appropriate to require ACOs to report this measure and to maintain the performance standard at full and accurate reporting in order to allow ACOs to gain experience with the measure. We welcome suggestions as to whether and when it would be appropriate to include a self-reported health and functional status measure in the quality performance standard. We specifically welcome comments on the appropriateness of using a tool such the Health Outcomes Survey for health plans which assesses changes in the physical and mental health of individual beneficiaries over time. This survey would require at least 2 years of reporting by the same beneficiary and assesses function over time rather than function at a particular point in time. We also welcome suggestions for alternatives to self-reported measures that may be considered in the future.

    * Measures for retirement: Some measures may not provide sufficiently useful information for assessing ACO quality performance since they are "topped out", meaning that all but a very few of organizations achieve near perfect performance on the measure. As a result, such measures may no longer provide meaningful information regarding an ACO's quality performance. Other examples of candidates for retirement could be measures that do not drive quality improvement. We seek input from commenters on any measures that should be considered for retirement in future rulemaking. We welcome comments on whether to continue to require "topped out" measures be included as pay for reporting measures. For example, it could be important to require ACOs to continue to report such measures so that we can assess performance to ensure quality of care does not decline or for other reasons. In addition, we note that as discussed below we are proposing changes to the benchmarking methodology for topped out measures.

    * Additional public health measures: We may propose to include an additional preventive health measure in the quality measure set under the Shared Savings Program in future rulemaking. Specifically, we are considering adding "Preventive Care and Screening: Unhealthy Alcohol Use: Screening and Brief Counseling" (NQF #2152). This measure would reflect screening of Medicare beneficiaries covered under the existing Medicare benefit referred to as the "Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol Misuse" benefit. We welcome comments on the potential addition of this measure and would consider any comments received in developing any future proposal with respect to this measure.

4. Accelerating Health Information Technology

a. Overview

   HHS believes all patients, their families, and their healthcare providers should have consistent and timely access to their health information in a standardized format that can be securely exchanged between the patient, providers, and others involved in the patient's care. (HHS August 2013 Statement, "Principles and Strategies for Accelerating Health Information Exchange." http://www.healthit.gov/policy-researchers-implementers/accelerating-health-information-exchange-hie). The Department is committed to accelerating health information exchange (HIE) through the use of electronic health records (EHRs) and other types of health information technology (HIT) across the broader care continuum through a number of initiatives including: (1) alignment of incentives and payment adjustments to encourage provider adoption and optimization of HIT and HIE services through Medicare and Medicaid payment policies; (2) adoption of common standards and certification requirements for interoperable HIT; (3) support for privacy and security of patient information across all HIE-focused initiatives; and (4) governance of health information networks. These initiatives are designed to encourage HIE among health care providers, including professionals and hospitals eligible for the Medicare and Medicaid EHR Incentive Programs and those who are not eligible for the EHR Incentive Programs, as well as those providers that are participating in the Medicare Shared Savings Program in an ACO and those that are not, and are designed to improve care delivery and coordination across the entire care continuum. For example, the Transition of Care Measure #2 in Stage 2 of the Medicare and Medicaid EHR Incentive Programs requires HIE to share summary records for more than 10 percent of care transitions. In addition, to increase flexibility in the Office of the National Coordinator for Health IT's (ONC's) HIT Certification Program and expand HIT certification, ONC has issued a proposed rule concerning a voluntary 2015 Edition of EHR certification criteria, which would more easily accommodate certification of HIT for technology used in health care settings where health care providers are not typically eligible for incentive payments under the EHR Incentive Programs, to facilitate greater HIE across the entire care continuum.

   We believe that HIE and the use of certified EHRs can effectively and efficiently help ACOs and participating providers improve internal care delivery practices, support management of patient care across the continuum, and support the reporting of eCQMs. More information on the Voluntary 2015 Edition EHR Certification Criteria Proposed Rule is available at http://healthit.gov/policy-researchers-implementers/standards-and-certification-regulations.

   b. Electronic Reporting of Quality Measure Data

   We believe that certified EHR technology used in a meaningful way is one piece of a broader health information technology infrastructure needed to reform the health care system and improve health care quality, efficiency, and patient safety. Through our programs such as the Medicare and Medicaid EHR Incentive Programs and the Stage 2 meaningful use (MU) requirements we seek to expand the meaningful use of certified EHR technology. Adoption of certified EHR technology (CEHRT) by ACO participants and ACO providers/suppliers may help support efforts to achieve improvements in patient care and quality, including reductions in medical errors, increased access to and availability of records and data, improved clinical decision support, and the convenience of electronic prescribing. Additionally, we believe that the potential for the Shared Savings Program to achieve its goals could be further advanced by direct EHR-based quality data reporting by ACOs and their ACO participants and ACO providers/suppliers. This could help reinforce the use of CEHRT, reduce errors in quality measure submission, and achieve data submission efficiencies. We believe ACOs and their providers should be leaders in encouraging EHR adoption and should be using CEHRT to improve quality of care and patient safety and to reduce errors.

   Furthermore, beginning in 2015, eligible professionals that do not successfully demonstrate meaningful use of certified EHR technology will be subject to a downward payment adjustment under Medicare that starts at -1 percent and increases each year that an eligible professional does not demonstrate meaningful use, to a maximum of -5 percent. A final rule establishing the requirements of Stage 2 of the Medicare EHR Incentive Program appeared in the September 4, 2012Federal Register (Medicare and Medicaid Programs; Electronic Health Record Incentive Program--Stage 2 Final Rule) (77 FR 53968). Included in this final rule are the meaningful use and other requirements that apply for the payment adjustments under Medicare for covered professional services provided by eligible professionals failing to demonstrate meaningful use of CEHRT, including the CQM reporting component of meaningful use. As previously discussed in section III.M.2, we are proposing to revise the name and the specifications for the quality measure regarding EHR adoption to take the changing incentives into account. Specifically, we are proposing to change the name of ACO #11 from "Percent of PCPs Who Successfully Qualify for an EHR Incentive Program Payment" to "Percent of PCPs Who Successfully Meet Meaningful Use Requirements" to more accurately reflect what is being measured.

   Additionally, under a group reporting option established for the Medicare EHR Incentive Program (77 FR 54076 through 54078), EPs participating in an ACO under the Shared Savings Program who extract the data necessary for the ACO to satisfy the quality reporting requirements of the Shared Savings Program from CEHRT would satisfy the CQM reporting component of meaningful use as a group for the Medicare EHR Incentive Program. In addition to submitting CQMs as part of an ACO, EPs have to individually satisfy the other objectives and associated measures for their respective stage of meaningful use.

   However, we clarify that if an EP intends to use this group reporting option to meet the CQM reporting component of meaningful use, then the EP would have to extract all its CQM data from a CEHRT and report it to the ACO (in a form and manner specified by the ACO) in order for the EP to potentially qualify for the Medicare EHR Incentive Program. The ACO must also report the GPRO web interface measures and satisfy the reporting requirements under the Shared Savings Program in order for its EPs to satisfy the CQM reporting component of meaningful use for the Medicare EHR Incentive Program.

   Although these group reporting requirements were established under the Medicare EHR Incentive Program, the Shared Savings Program regulations were not amended to reflect these reporting requirements. Therefore, we propose to amend the regulations governing the Shared Savings Program to align with the requirements previously adopted under the Medicare EHR Incentive Program in order to provide that EPs participating in an ACO under the Shared Savings Program can satisfy the CQM reporting component of meaningful use for the Medicare EHR Incentive Program when the ACO reports GPRO web interface measures by adding new paragraph (d) to SEC 425.506. This new paragraph will provide that EPs participating in an ACO under the Shared Savings Program satisfy the CQM reporting component of meaningful use for the Medicare EHR Incentive Program when: (1) The eligible professional extracts data necessary for the ACO to satisfy its GPRO quality reporting requirements from CEHRT; and (2) the ACO satisfactorily reports the ACO GPRO measures through a CMS Web interface. Although this proposal will align the Medicare Shared Savings Program regulations with the existing requirements under the Medicare EHR Incentive Program, we intend to take steps in the future to better align and integrate EHR use into quality reporting under the Shared Savings Program.

   We recognize there are operational constraints that must be considered when developing policies related to electronic reporting of quality measures under the Shared Savings Program. First, many ACO legal entities are conveners of Medicare enrolled entities, but are not Medicare-enrolled themselves, that is, many ACO legal entities do not provide direct health care services, and therefore, may not thus far have had a need for an EHR. Further, ACO participants and ACO providers/suppliers may be at different levels of EHR adoption. For example, an ACO may have ACO participants that do not own an EHR. Other ACOs may have ACO participants that have and use EHR platforms, but have chosen different platforms, each requiring different modifications to make them uniformly extract required quality data. In addition, ACOs have told us that different EHR platforms may not yet be seamlessly interoperable. Finally, within each ACO participant, there may be differing levels of EHR use among the ACO providers/suppliers that are EPs. Operationally, a few options could be considered for implementing the eCQM portion of the meaningful use requirements in the future. For example, we could consider whether it would be preferable for the EPs within each ACO participant to individually submit EHR data to CMS, whether each ACO participant should report as a group; whether the ACO itself should aggregate EHR data from its ACO participants and then submit the quality measures to CMS; or whether the ACO could submit quality measure data via a data submission vendor that would be responsible for aggregating and submitting the data on the ACO's behalf.

   Although we are not proposing any new requirements regarding EHR based reporting under the Shared Savings Program at this time, we welcome suggestions and comments about these issues which we would consider in developing any future proposals. We especially seek comment on the feasibility of an ACO to be a convener and submitter of quality measures through an EHR or alternative method of electronically reporting quality measures to us. We are interested in the opportunities and barriers to ACO EHR quality measure reporting, as well as ways to overcome any barriers. We also welcome suggestions on alternative ways that we might implement EHR-based reporting of quality measures in the Shared Savings Program, such as directly from EHRs or via data submission vendors. We seek comment on whether EHR reporting should be a requirement for all Shared Savings Program ACOs or if the requirement for EHR reporting should be phased in gradually, for instance through a separate risk track or by the establishment of a "core and menu" quality measure set approach in which we would establish a core set of required quality measures and then supplement these required measures with a menu of additional measures (such as EHR-based reporting) from which an ACO could choose. This approach could provide ACOs with additional flexibility and allow them to report on quality measures that better reflect any special services they provide. As an alternative, we also seek comment on whether ACO providers/suppliers could use a local registry-like version of the GPRO Web interface to capture relevant clinical information and to monitor performance on all Medicare patients throughout the year and to more easily report quality data to CMS annually.

3. Quality Performance Benchmarks

a. Overview of Current Requirements

   Section 1899(b)(3)(C) of the Act directs the Secretary to "establish quality performance standards to assess the quality of care furnished by ACOs" and to "seek to improve the quality of care furnished by ACOs over time by specifying higher standards, new measures, or both for purposes of assessing such quality of care." Under the current Shared Savings Program regulations at SEC 425.502, the following requirements with regard to establishing a quality performance benchmark for measures apply: (1) During the first performance year of an ACO's agreement period, the quality performance standard is set at the level of complete and accurate reporting; (2) during subsequent performance years, the quality performance standard will be phased in such that ACOs will be assessed on their performance on certain measures (see Table 1 of the November 2011 Shared Savings Program final rule (76 FR 67889 through 67890), for details of the transition for each of the 33 measures); (3) we designate a quality performance benchmark and minimum attainment level for each measure, and establish a point scale for the level of achievement on each measure; and (4) we define quality performance benchmarks using FFS Medicare data or using flat percentages when the 60th percentile is equal to or greater than 80.00 percent.

   Section 425.502(b)(2) governs the data that CMS uses to establish the quality performance benchmarks for quality performance measures under the Shared Savings Program. Consistent with section 1899(b)(3)(C) of the Act, which requires CMS to seek to improve the quality of care furnished by ACOs participating in the Shared Savings Program over time, SEC 425.500(b)(3) states that in establishing the measures to assess the quality of care furnished by an ACO, CMS seeks to improve the quality of care furnished by ACOs over time by specifying higher standards, new measures, or both.

   Subsequently, we discussed several issues related to the establishment of quality performance benchmarks in the CY 2014 PFS final rule with comment period (78 FR 74759 through 74764). In that rule (78 FR 74760), we finalized a proposal to combine all available Medicare FFS quality data, including data gathered under PQRS (through both the GPRO web interface tool and other quality reporting mechanisms) and other relevant FFS quality data reported to CMS (including data submitted by Shared Savings Program and Pioneer ACOs) to set the quality performance benchmarks for 2014 and subsequent reporting periods. In establishing this policy, we determined that it was appropriate to use all FFS data rather than only ACO data, at least in the early years of the program, to avoid the possibility of punishing high performers where performance is generally high among all ACOs. We did not finalize a proposal to use Medicare Advantage (MA) data alone or in combination with FFS data in the short-term. Instead, we stated in the CY 2014 PFS final rule with comment period (78 FR 74760) that we intended to revisit the policy of using MA data in future rulemaking when we have more experience setting benchmarks for ACOs.

   Additionally, in the CY 2014 PFS final rule with comment period, we retained the ability to use flat percentages to set benchmarks when many reporters demonstrate high achievement on a measure, so that ACOs with high performance on a measure are not penalized (78 FR 74760). More specifically, we will now use all available FFS data to calculate benchmarks, including ACO data, except where performance at the 60th percentile is equal to or greater than 80 percent for individual measures. In these cases, a flat percentage will be used to set the benchmark for the measure. This policy allows ACOs with high scores to earn maximum or near maximum quality points while still allowing room for improvement and rewarding that improvement in subsequent years.

   As previously discussed, the first year of an ACO's agreement period is pay for reporting only, so ACOs earn their maximum sharing rate for completely and accurately reporting all 33 quality measures. Quality performance benchmarks are released in subregulatory guidance prior to the start of the quality reporting period for which they apply so that as we phase in measures to pay for performance ACOs are aware of the actual performance rates they will need to achieve to earn the maximum quality points under each domain. In the November 2011 Shared Savings Program final rule, we indicated our intent to gradually raise the minimum attainment level to continue to incentivize quality improvement over time and noted that we would do so through future rulemaking after providing sufficient advance notice with a comment period to allow for industry input (76 FR 67898). In the CY 2014 PFS final rule with comment period, we reiterated our policy of setting quality performance benchmarks prior to the reporting year for which they would apply (78 FR 74759). Specifically, we use data submitted in 2013 for the 2012 reporting period to set the quality performance benchmarks for the 2014 reporting period. However, we recognize that in the first few years of the Shared Savings Program, we will only have a limited amount of data for some measures, which may cause the benchmarks for these measures to fluctuate, possibly making it difficult for ACOs to improve upon their previous year's performance. Stakeholders have also told us that they prefer to have a stable benchmark target so that they can be rewarded for quality improvement from one year to the next. Therefore, instead of modifying quality performance benchmarks annually, in the CY 2014 PFS final rule with comment period (78 FR 74761) we stated that we would set the benchmarks for the 2014 reporting year in advance using data submitted during 2013 for the 2012 reporting year, and continue to use that benchmark for 2 reporting years (specifically, the 2014 and 2015 reporting years). We further indicated our intention to revisit this issue in future rulemaking to allow for public comment on the appropriate number of years that a benchmark should apply before it is updated.

b. Proposed Revisions for Benchmarking Measures That Are "Topped Out"

   In the discussion of measures above, we indicated that some measures may be topped out, meaning that all but a very few of organizations achieve near perfect performance on the measure. Since publication of the quality performance benchmarks for the 2014 and 2015 quality reporting years, a number of ACOs have noted that using available national FFS data has resulted in some benchmarks where the 80th or 90th percentiles approach 100 percent performance on the measure. Stakeholders have suggested it is unreasonable to hold organizations, especially very large organizations such as ACOs to this high standard and that it may be easier for smaller and medium size physician practices to achieve higher levels of performance given their smaller patient populations. We believe these concerns have merit because we have looked at the FFS data submitted to CMS and agree it is possible that smaller practices or practices with smaller populations may be able to achieve these higher levels of performance more easily than larger practices or organizations with larger patient populations. Therefore, we are proposing certain modifications to our benchmarking methodology to address the way that such "topped out" measures are treated for purposes of evaluating an ACO's performance. Specifically, when the national FFS data results in the 90th percentile for a measure are greater than or equal to 95 percent, we would use flat percentages for the measure, similar to our policy under SEC 425.502(b)(2)(ii) of using flat percentages when the 60th percentile is greater than 80 percent to address clustered measures. We believe this approach would address concerns about how topped out measures affect the quality performance standard while continuing to reward high performance, and being readily understandable to all. We propose to revise SEC 425.502(b)(2)(ii) to reflect this proposed policy. We invite comments on this proposal. We also invite comments on other potential approaches for addressing topped out measures. We would use any comments received to help develop any future proposals regarding topped out measures. For example, we welcome comments on whether we should drop topped out measures from the measures set, fold them into composites, or retain them but make them pay for reporting only.

c. Proposed Quality Performance Standard for Measures That Apply to ACOs That Enter a Second or Subsequent Participation Agreement

   As discussed previously, during an ACO's first participation agreement period, the quality performance standard during the first performance year is initially set at the level of complete and accurate reporting, and then, during performance years 2 and 3 within the ACO's first agreement period, the quality performance standard is phased in such that the ACO is assessed on its performance on selected measures. We did not directly indicate the quality performance standard that would apply if an ACO were to subsequently enter into a second or subsequent participation agreement. However, SEC 425.502(a)(1) provides that during the first performance year of an ACO's agreement period, CMS will define the quality performance standard at the level of complete and accurate reporting of all quality measures. As drafted, this regulation could be read to imply that the quality performance standard for ACOs in the first performance year of a subsequent agreement period would also be set at the standard of full and accurate reporting. We do not believe it is appropriate for an ACO in a second or subsequent agreement period to report quality measures on a pay-for-reporting basis if they have previously reported these measures in a prior agreement period. The ACO would have gained experience reporting the quality measures during the earlier agreement period, and as a result, we do not believe it would be necessary to provide any further transition period. Rather, we believe it would be appropriate to assess the ACO's actual performance on measures that have been designated as pay for performance during all 3 years of the second or subsequent participation agreement period.

   Accordingly, we propose to revise our regulations to expressly provide that during a second or subsequent participation agreement period, the ACO would continue to be assessed on its performance on each measure that has been designated as pay for performance. That is, the ACO would continue to be assessed on the quality performance standard that would otherwise apply to an ACO if it were in the third performance year of the first agreement period. We will do this by modifying SEC 425.502(a)(1) and (a)(2) to indicate that the performance standard will be set at the level of complete and accurate reporting of all quality measures only for the first performance year of an ACO's first agreement period, and that during subsequent agreement periods, pay for performance will apply for all three performance years. As proposed earlier in this section, new measures that are added to the quality performance standard would be phased in along the timeline indicated when the measure is added and in operational documents.

d. Proposed Timing for Updating Benchmarks

   As discussed in the CY 2014 PFS final rule with comment (78 FR 74761), we have further considered suggestions from ACOs regarding the appropriate number of years that a benchmark should apply before it is updated. ACOs suggested that there be a longer period of time to gain experience with the performance measure, before benchmarks are further updated. ACOs also indicated that it would be desirable to set and leave benchmarks static for additional performance years so that they have a quality improvement target to strive for that does not change frequently. ACOs believe that a stable benchmark would enhance their ability to be rewarded for quality improvement, as well as quality achievement, from one year to the next. We recognize, however, that there could be some concerns about lengthening the period between updates to the quality performance benchmarks. The current benchmarks as discussed previously, for example, are based on a combination of all available Medicare FFS quality data, including data gathered under PQRS, the Shared Savings Program and Pioneer ACO Model, but not MA quality data. To the extent that the benchmarks are based on quality data reported by a large number of ACOs and other FFS entities, we believe it is reasonable to use them to assess the quality performance of ACOs. Furthermore, as discussed in the 2014 PFS final rule with comment period (78 FR 74761), we are also persuaded that we should establish a longer period between updates to the benchmarks in order to provide ACOs with a more stable target for measuring quality improvement. In the absence of this stability, it could be very difficult to assess quality improvement from year to year.

   In the 2014 PFS final rule with comment period, we noted that we intended to address the number of years between updates to the benchmarks again in future rulemaking in order to allow for public comment. Therefore, we considered how long benchmarks should be in place before they are updated. We considered a range of options, from setting benchmarks every 2 years to setting benchmarks every 5 years. For example, we considered the option of setting benchmarks every 3 years. However, we note that ACO agreement periods are 3 years long and a new cohort of ACOs enters the program each year. As a result, setting benchmarks every 3 years might advantage some ACOs over others, particularly ACOs that have an agreement period during which benchmarks are not updated. Therefore, we propose to update benchmarks every 2 years. We believe 2 years is an appropriate amount of time because the Shared Savings Program is relatively new and we do not have extensive experience in setting benchmarks under the Shared Savings Program. Updating the benchmarks every 2 years would enable us to be more flexible and give us the ability to make adjustments more frequently if appropriate. We note, however, that we may revisit this policy as more ACOs enter the program, more FFS data is collected which could help us better understand to what extent benchmarks should vary from year to year, or if we make any future proposals regarding the use of MA quality data for setting benchmarks.

   Accordingly, we propose to revise SEC 425.502(b) to add a new paragraph (b)(4)(i), which will provide that CMS will update benchmarks every 2 years. To illustrate this proposed policy, the existing quality performance benchmarks, which are based on data submitted in 2013 for the 2012 reporting period would apply for a total of 2 performance years (the 2014 and 2015 performance years) after which we would reset the benchmarks for all ACOs based on data for the 2014 reporting period that is reported during 2015. These updated benchmarks would apply for the 2016 and 2017 performance years. This timeline is summarized in Table 54. Under this proposal, ACOs would have a stable target for quality achievement for 2 years, which should improve the opportunity for ACOs to be rewarded for improvement from year to year compared to that benchmark. We also propose to revise SEC 425.502(b) to add a new paragraph (b)(4)(ii), which will provide that for measures introduced in the first year of the 2-year benchmarking cycle, the benchmark will be established in the second year and updated along with the other measures at the start of the next 2-year benchmarking cycle.

   We seek comment on this proposal. We specifically seek comment on the appropriate number of years that a benchmark should remain stable before it is updated. We also welcome comments about when annual updates might be appropriate such as when there is a substantive specification change to a measure between years. For instance, the age range used for the breast cancer screening measure is different in 2014 than in 2013, or when the measure owner modifies or retires a measure. Additionally, although we are proposing to retain our current policy of using the most recent available data to set the quality performance benchmarks, we also seek comment on whether data from other reporting periods should also be considered in establishing benchmarks that will apply for 2 performance years. Specifically, we seek input on whether data from multiple years should be used to help provide more stable benchmarks. For example, should data submitted for the 2013 and 2014 reporting periods be combined to set benchmarks for the 2016 and 2017 performance years? GOES

Table 54--Proposed Timeline for Setting and Updating Quality Performance Benchmarks Reporting period for data used to set benchmark Year data is Performance collected, year and analyzed, reporting and period to benchmark is which published benchmark applies 2012 2013 2014 & 2015 2014 2015 2016 & 2017 2016 2017 2018 & 2019



4. Rewarding Quality Improvement

a. Current Approach To Rewarding ACOs for Both Quality Attainment and Quality Improvement

   ACOs must meet a CMS-specified quality performance standard in order to be eligible to share in savings. The Shared Savings Program quality performance standard currently consists of a set of quality measures spanning four domains that are collected via the patient and caregiver experience of care survey, calculated by CMS from internal administrative and claims data, and submitted by the ACO through the CMS web interface. The four domains include patient/caregiver experience of care, care coordination/patient safety, preventive health, and at-risk populations. The measures collected through the CMS web interface are also used to determine whether eligible professionals that bill through the TIN of an ACO participant qualify for the PQRS incentive payment or avoid the downward PQRS payment adjustment. Eligible professionals that bill through the TIN of an ACO participant may qualify for the PQRS incentive payment or avoid the downward PQRS payment adjustment when the ACO satisfactorily reports the ACO GPRO quality measures on their behalf.

   Under current policy, the quality performance standard is defined at the level of full and complete reporting for the first performance year of an ACO's agreement period. After that, an ACO must meet certain thresholds of performance and is rewarded on a sliding scale in which higher levels of quality performance translate to higher rates of shared savings. This scale, therefore, rewards improvement over time, since higher performance translates to higher shared savings. For example, an ACO that performs at the 80th percentile one year and then at the 90th percentile the next year would receive a higher level of shared savings in its second year than its first year, based on its improved quality performance. In this way, ACOs are rewarded for both attainment and improvement. This is particularly true when benchmarks are stable for more than one year, as proposed previously.

   We recognize that rewards for both quality attainment, as well as quality improvement are not always built in to pay-for-performance initiatives. For example, in HVBP (Hospital Value-Based Purchasing) hospitals are scored based on the higher of their achievement or improvement on specified quality measures, with some hospitals receiving incentive payments if their overall performance is high enough relative to their peers. In the November 2011 final rule establishing the Shared Savings Program (76 FR 67897), we indicated in response to comments that we believe the approach of offering more points for better quality performance also offers an implicit incentive for continuous quality improvements, since it incorporates a sliding scale in which higher levels of quality performance translate to higher sharing rates. We believed that high performing ACOs should do well under this approach since it recognizes and provides incentives for ACOs to maintain high quality performance in order to maximize their share of savings and minimize their share of losses.

b. Additional Rewards for Quality Improvement

   ACOs and other stakeholders have suggested that the current quality points scale described above does not adequately reward ACOs for both quality attainment and improvement. They request that we further strengthen the incentives for quality improvement by including an additional explicit reward for those ACOs that improve from one year to the next.

   As discussed previously, the existing quality performance standard includes a sliding point scale that rewards ACOs for certain levels of attainment. In addition, we note that under the proposal discussed above in which we propose to establish a stable quality performance benchmark for a period of 2 years, there should be an even greater opportunity for every ACO to demonstrate improvement and be rewarded for that improvement from year to year. However, we are persuaded by suggestions from stakeholders that an additional, more explicit reward should be included for ACOs that improve their quality scores from year to year. The success of the Shared Savings Program is partially dependent on ACOs further improving the quality of the care they provide, not merely maintaining current levels of quality. Therefore, we are proposing to revise our existing quality scoring strategy to explicitly recognize and reward ACOs that make year-to-year improvements in their quality performance scores on individual measures. We believe that offering an additional and explicit reward for improving quality performance would complement and reinforce our current quality performance scoring system that implicitly takes into account improvements over prior performance and rewards ACOs with a greater share in savings for greater quality performance. We believe that adding an explicit incentive places even greater emphasis on quality improvement, encouraging all ACOs to continue to improve quality for their patient populations over time, in addition to maintaining existing high quality levels.

   To develop such an approach, we looked to the MA program, which has already successfully developed and implemented a formula for measuring quality improvement. The MA five star rating program computes an improvement change score which is defined as the score for a measure in performance year minus the score in previous performance year. The MA five star rating program then measures each plan's net quality improvement by calculating the total number of significantly improved quality measures and subtracting the total number of significantly declined quality measures. This is an approach that we believe is also appropriate for measuring quality improvement for ACOs. (For more details on the formula for calculating the MA quality improvement measure, see the discussion in "Medicare 2014 Part C & D Star Rating Technical Notes", Attachment I, page 80, which can be downloaded from the CMS Web site at http://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn/PerformanceData.html.)

   We continue to believe it is important to recognize that the Shared Savings Program is not a managed care program. Unlike MA, this program's design retains FFS flexibility and the freedom of choice available to beneficiaries under Medicare Parts A and B which generally necessitates different program requirements. However, in this case we believe there would be significant advantages for the Shared Savings Program to adopt the formula for a quality improvement measure that MA has already developed and implemented rather than attempt to develop a new formula for a quality improvement measure. In particular, the MA measure formula has already been fully developed and vetted with stakeholders, in the context of the MA program, with detailed operational specifications and previously shared with the public.

   In addition, we believe it is important to add a quality improvement measure to the Shared Savings Program in a manner that would minimize disruption for ACOs. We believe it would be undesirable for both ACOs and the program if the quality improvement measure were added in a way that required extensive revisions to the current quality measurement methodology, for example, reweighting of the four quality measure domains. Therefore, we propose to add a quality improvement measure to award bonus points for quality improvement to each of the existing four quality measure domains. For each quality measure domain, we would award an ACO up to two additional bonus points for quality performance improvement on the quality measures within the domain. These bonus points would be added to the total points that the ACO achieved within each of the four domains. Under this proposal, the total possible points that can be achieved in a domain, including up to 2 bonus points, could not exceed the current maximum total points achievable within the domain. For example, as shown in Table 51, currently the total possible points for the patient/caregiver experience domain, which has seven individual measures, is 14 total possible points. Under this proposal to provide for quality improvement bonus points, the maximum possible points within this domain would continue to be 14. If an ACO scored 12 points and was awarded two additional bonus points for quality improvement then the ACO's total points for this domain would be 14. However, if instead this same ACO had scored 13 points, then this ACO's total points after adding the bonus points could still not exceed 14.

   ACOs would achieve bonus points for this quality improvement measure in a domain if they achieve statistically significant levels of quality improvement for measures within the domain, as discussed below. Otherwise, the current methodology for calculating the ACO's overall quality performance score would continue to apply (see SEC 425.502(e) and 76 FR 67895 through 67900). Additional details about the proposal to incorporate bonus points into the quality performance scoring methodology follow:

   Table 51 shows the maximum possible points that currently may be earned by an ACO in each domain and for all domains. Table 52 shows the maximum possible points that may be earned under the proposed quality measures changes. The data in Tables 51 and 52 are not affected by this proposal to provide for bonus points for quality improvement and do not include the proposed maximum of two bonus points in each domain. The quality improvement measure scoring for a domain would be based on the ACO's net improvement in quality for the other measures in the domain. The calculation of the quality improvement measure for each domain would generally be based on the formula used for the MA five star rating program, as follows:

Improvement Change Score = score for a measure in performance year minus score in previous performance year.

   In general, for a measure to be eligible to be included for purposes of determining quality improvement and awarding bonus points in a domain for a performance year, the measure must be a measure for which an ACO was scored in both the performance year and the immediately preceding performance year. Measures that were not scored in both the performance year and the immediately preceding performance year, for example, new measures, would not be included in the assessment of improvement. Otherwise, for purposes of determining quality improvement and awarding bonus points, we would include all of the individual measures within the domain, including both pay-for-reporting measures and pay-for-performance measures. We believe it would be appropriate to include pay-for-reporting measures for purposes of determining quality improvement and awarding bonus points since under SEC 425.500(f) ACOs that fail to report all quality measures, including pay-for-reporting measures completely, accurately, and timely may be subject to termination or other corrective action. As an example, pay for reporting applies to the CAHPS health status/functional status measure for all three performance years. However, the ACO's performance on the health status/functional status measure would still be considered in performance years two and three when we evaluate whether an ACO should be awarded bonus points.

   In determining improvement, the actual performance score achieved by the ACO on the measure would be used, not the score used to determine shared savings. In other words, we calculate a performance score for each measure, regardless of whether it is pay for reporting or pay for performance, and include the score in the report we provide to the ACO. For example, all measures are pay for reporting in the first year of an ACO's first agreement period, but even though the ACO will receive full credit for all reported measures, its actual performance on those measures will also be scored and provided to the ACO for informational purposes. We believe it is appropriate to use these actual performance scores to assess improvement on a measure from year to year, regardless of whether the measure is designated as a pay for reporting or a pay for performance measure in that performance year because the performance scores achieved by the ACO provide the best indication of the actual change in quality performance by the ACO.

   If the ACO is in its first performance year of its first agreement period, then it would not be possible, of course, to measure quality improvement. Therefore, for these ACOs the existing scoring methodology would continue to apply and no bonus points would be awarded. If an ACO in its second or subsequent performance year does not experience an improvement nor a decline in quality performance for any of the selected measures compared to its previous reporting period, or it experiences an improvement for some measures but has an equal or greater number of measures where quality performance has declined, then the ACO would likewise not be awarded any bonus points. If an ACO renews a participation agreement, then the measurement of quality improvement would be based on a comparison between performance in the first year of the new agreement period and performance in the 3rd year of the previous agreement period.

   For each qualifying measure, we would determine whether there was a significant improvement or decline between the two performance years by applying a common standard statistical test. (See the discussion of the t-test for calculating the MA quality improvement measure in "Medicare 2014 Part C & D Star Rating Technical Notes", Attachment I, page 80, which can be downloaded from the CMS Web site at http://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn/PerformanceData.html). Statistical significance testing in this case assesses how unlikely it is that differences as big as those observed would be due to chance when the performance is actually the same. Under this methodology, we can be reasonably certain, at a 95 percent level of confidence, that statistically significant differences in an ACO's quality measure performance for a year compared to the previous year are real and not simply due to random variation in measure sampling.

   The awarding of bonus points would be based on an ACO's net improvement within a domain, and would be calculated by determining the total number of significantly improved measures and subtracting the total number of significantly declined measures. Up to two bonus points would be awarded on a sliding scale based on the ACO's net improvement for the domain to the total number of individual measures in the domain. Specifically, the bonus points, up to a maximum of 2 points, would be awarded in direct proportion to the ACO's net improvement for the domain to the total number of individual measures in the domain. For example, there are seven individual measures for the patient/caregiver experience of care domain. If the ACO achieved a significant quality increase in all seven measures then the ACO would be awarded the maximum of two bonus points for this domain. However, if the ACO achieved a significant quality increase in only one of the seven measures in this domain and no significant quality decline on any of the measures then the ACO would be awarded 0.29 bonus points for quality improvement in the domain that is 1/7 times 2 = 0.29. The total points that the ACO could achieve in this domain could still not exceed the current maximum of 14 points shown in Table 51.

   Tables 51 and 52 reflect the current quality measure scoring methodology which would continue under this proposal. These tables show the number of points available per domain under both the current quality performance standard and the proposed revisions to the quality performance standard.

   Consistent with our current quality scoring methodology, the total points earned for measures in each domain, including any quality improvement bonus points up to the total possible points, would be summed and divided by the total points available for that domain to produce an overall domain score of the percentage of points earned versus points available. The percentage score for each domain will be averaged together to generate a final overall quality performance score and sharing rate for each ACO that will be used to determine the amount of savings it shares or, if applicable, the amount of losses it owes, consistent with the requirements under SEC 425.502(e).

   In developing this proposal to award bonus points for quality improvement, we considered several alternative options. Specifically, we considered whether it would be more appropriate not to award bonus points but instead to include a computed quality improvement measure that would be incorporated into the current scoring methodology just as any other measure would be added. Under this alternative approach, we would increase the total possible points that could be awarded in a domain. However, we did not propose that approach because we believe that awarding bonus points would provide the desired incentive, would be more understandable and less disruptive, and would not require extensive changes to the quality performance standard. By awarding bonus points we also avoid the need to develop ways to avoid unfairly penalizing new ACOs. Similarly, ACOs that have already achieved a very high level of quality for an individual measure may not be able to achieve further statistically significant improvement for the measure. Such ACOs could otherwise be disadvantaged if they were not able to earn performance points for a new quality improvement measure added to the total measures in the domain. We believe our quality improvement proposal mitigates these concerns because the measure recognizes incremental improvement at higher levels of performance and does not impose any penalty on ACOs that have already achieved a high level of performance.

   We also considered whether we should provide an even greater additional incentive by increasing the total possible bonus points, perhaps up to 4 points to provide a higher incentive for greater levels of quality improvement. However, we are not proposing that option because we are concerned that awarding 4 points for the quality improvement measure could overweight the additional incentive for quality improvement given that the program already rewards higher performance with a greater share of any savings.

   In addition, we have some concerns about whether it would be appropriate to use the "pay for reporting" data reported to us, given that the accuracy does not affect an ACO's quality performance score in the first performance year. Therefore, we considered whether the proposed quality improvement score should apply only to those ACOs that have completed at least two performance years. Under this alternative approach, ACOs would have an opportunity to be assessed based on their actual quality measure performance before being assessed on their quality improvement scores. We did not select this approach because we wanted to provide an incentive that would apply as soon as possible in the agreement period. Furthermore, as noted earlier, we believe it would be appropriate to include pay-for-reporting measures for purposes of awarding bonus points since under SEC 425.500(f) ACOs are required to report pay-for-reporting measures completely, accurately, and timely.

   We are proposing to add a new paragraph (e)(4) to SEC 425.502 to incorporate this proposed process for calculating bonus points for quality improvement into the quality performance scoring methodology. We seek comments on this proposal and welcome comments on the alternative approaches discussed above. We also seek comments on whether there are other alternative approaches to explicitly rewarding quality improvement for ACOs, and whether the implicit reward for quality improvement provided under the current regulations is sufficient.

   We also welcome any suggestions on how the Shared Savings Program might integrate elements of other quality improvement methodologies such as those employed by HVBP or MA. Such comments would be considered in developing possible future proposals to further align with other Medicare quality improvement programs.

5. Technical Corrections

   Currently SEC 425.502(d)(2)(ii) states that ACOs must score above the minimum attainment level determined by CMS on 70 percent of the measures in each domain. If an ACO fails to achieve the minimum attainment level on at least 70 percent of the measures in a domain, CMS will take the actions described in SEC 425.216(c). We note that SEC 425.216, which addresses the actions we may take prior to termination of an ACO from the Shared Savings Program does not include a paragraph (c). To encompass all of the actions we may take prior to termination, we believe the correct reference should be to SEC 425.216 generally, and therefore, propose to make a technical correction to SEC 425.502(d)(2)(ii) to eliminate the specific reference to paragraph (c) of SEC 425.216. We also propose to correct a typographical error in this provision by revising "actions describe" to read "actions described."

   In addition, we are also proposing to make a technical correction to SEC 425.502(a)(2). This provision currently states that ACOs will be assessed on performance based on the minimum attainment level for certain measures. However, as explained above and in the November 2011 Shared Savings Program final rule (76 FR 67895 through 67896), ACO performance on a measure is assessed not only based on the minimum attainment level for the measure but also based upon the quality performance benchmark that has been established for that measure. This methodology for calculating the performance score for a measure is codified in the regulations at SEC 425.502(c). Accordingly, we propose to amend SEC 425.502(a)(2) to state that ACO performance will be assessed based on the quality performance benchmark and minimum attainment level for certain measures.

   We request comments on these proposed technical corrections.

N. Value-Based Payment Modifier and Physician Feedback Program

1. Overview

   Section 1848(p) of the Act requires that we establish a value-based payment modifier (VM) and apply it to specific physicians and groups of physicians the Secretary determines appropriate starting January 1, 2015, and to all physicians and groups of physicians by January 1, 2017. On or after January 1, 2017, section 1848(p)(7) of the Act provides the Secretary discretion to apply the VM to eligible professionals as defined in section 1848(k)(3)(B) of the Act. Section 1848(p)(4)(C) of the Act requires the VM to be budget neutral.

   In this rule, we are proposing policies to apply the VM to all physicians and groups of physicians and also nonphysician eligible professionals and to increase the amount of payment at risk. We also are proposing to refine the methodologies used to determine our quality and cost composites and also to establish a corrections process for 2015.

2. Governing Principles for VM Implementation

   In the CY 2013 PFS final rule with comment period, we discussed the goals of the VM and also established that specific principles should govern the implementation of the VM (77 FR 69307). We refer readers to that rule for a detailed discussion and list those principles here for reference.

    * A focus on measurement and alignment. Measures for the VM should consistently reflect differences in performance among groups or solo practitioners, reflect the diversity of services furnished, and be consistent with the National Quality Strategy and other CMS quality initiatives, including the PQRS, the Shared Savings Program, and the Medicare EHR Incentive Program.

    * A focus on physician and eligible professional choice. Physicians and other nonphysician eligible professionals should be able to choose the level (individual or group) at which their quality performance will be assessed, reflecting eligible professionals' choice over their practice configurations. The choice of level should align with the requirements of other physician quality reporting programs.

    * A focus on shared accountability. The VM can facilitate shared accountability by assessing performance at the group level and by focusing on the total costs of care, not just the costs of care furnished by an individual professional.

    * A focus on actionable information. The Quality and Resource Use Reports (QRURs) should provide meaningful and actionable information to help groups and solo practitioners identify clinical areas where they are doing well, as well as areas in which performance could be improved by providing groups and solo practitioners with QRURs on the quality and cost of care they furnish to their patients.

    * A focus on a gradual implementation. The VM should focus initially on identifying high and low performing groups and solo practitioners. As we gain more experience with physician measurement tools and methodologies, we can broaden the scope of measures assessed, refine physician peer groups, create finer payment distinctions, and provide greater payment incentives for high performance.

3. Overview of Existing Policies for the Physician VM

   In the CY 2013 PFS final rule with comment period (77 FR 69310), we finalized policies to phase-in the VM by applying it starting January 1, 2015, to payments under the Medicare PFS for physicians in groups of 100 or more eligible professionals. A summary of the existing policies that we finalized for the CY 2015 VM can be found in the CY 2013 PFS proposed rule (77 FR 44991 through 45021). Similarly, in the CY 2014 PFS final rule with comment period, we finalized policies to phase-in the VM by applying it starting January 1, 2016 to payments under the Medicare PFS for physicians in groups of 10 or more eligible professionals. The policies that we finalized for the CY 2016 VM can be found in the CY 2014 final rule with comment period (78 FR 74765 through 74787).

4. Provisions of This Proposed Rule

   We are making the following proposals regarding the VM policies:

    * To apply the VM to all physicians and nonphysician eligible professionals in groups with 2 or more eligible professionals and to solo practitioners starting in CY 2017.

    * To make quality-tiering mandatory for groups and solo practitioners within Category 1 for the CY 2017 VM. Category 1 includes: (1) Groups that meet the criteria for satisfactory reporting of data on PQRS quality measures via the group practice reporting option (GPRO) for the CY 2017 PQRS payment adjustment; (2) groups that do not register to participate in the PQRS as a group practice participating in the PQRS GPRO in CY 2015 and that have at least 50 percent of the group's eligible professionals meet the criteria for satisfactory reporting of data on PQRS quality measures as individuals for the CY 2017 PQRS payment adjustment, or in lieu of satisfactory reporting, satisfactorily participate in a PQRS-qualified clinical data registry for the CY 2017 PQRS payment adjustment; and (3) solo practitioners that meet the criteria for satisfactory reporting of data on PQRS quality measures as individuals for the CY 2017 PQRS payment adjustment, or in lieu of satisfactory reporting, satisfactorily participate in a PQRS-qualified clinical data registry for the CY 2017 PQRS payment adjustment. However, groups with between 2 and 9 eligible professionals and solo practitioners would be subject only to any upward or neutral adjustment determined under the quality-tiering methodology, and groups with 10 or more eligible professionals would be subject to upward, neutral, or downward adjustments determined under the quality-tiering methodology.

    * To apply the VM to physicians and nonphysician eligible professionals participating in the Shared Savings Program, the Pioneer ACO Model, the CPC Initiative, or other similar Innovation Center models or CMS initiatives starting in CY 2017.

    * To clarify the exclusion of non-assigned claims for non-participating providers from the VM.

    * To increase the amount of payment at risk under the VM from 2.0 percent in CY 2016 to 4.0 percent in CY 2017.

    * To align the quality measures and quality reporting mechanisms for the VM with those available to groups and individuals under the PQRS during the CY 2015 performance period.

    * To expand the current informal inquiry process to allow additional corrections for the CY 2015 payment adjustment period.

    * To address the concerns raised by NQF regarding the per capita cost measures in the cost composite.

   We also seek comment on, but make no proposals regarding the treatment of hospital-based physicians with regard to the VM.

a. Group Size

   Section 1848(p)(4)(B)(iii) of the Act requires the Secretary to apply the VM to items and services furnished under the PFS beginning on January 1, 2015, for specific physicians and groups of physicians the Secretary determines appropriate, and beginning not later than January 1, 2017, for all physicians and groups of physicians.

   In the CY 2013 PFS final rule with comment period, we stated that we would gradually phase in the VM in CY 2015 by first applying it to large groups (77 FR 69308), which we defined as groups of physicians with 100 or more eligible professionals. In the CY 2014 PFS final rule with comment period, we continued our phase-in of the VM and adopted a policy to apply the VM in CY 2016 to groups of physicians with 10 or more eligible professionals (78 FR 74765-74767).

   As mentioned above, section 1848(p)(4)(B)(iii)(II) of the Act requires the Secretary to apply the VM to items and services furnished under the PFS beginning not later than January 1, 2017, for all physicians and groups of physicians. Therefore, we propose to apply the VM in CY 2017 and each subsequent calendar year payment adjustment period to physicians in groups of physicians with 2 or more eligible professionals and to physicians who are solo practitioners. For purposes of the VM, we defined a physician, a group of physicians, and an eligible professional in the CY 2013 PFS final rule with comment period (77 FR 69307-69310). We propose to define a "solo practitioner" at SEC 414.1205 as a single Tax Identification Number (TIN) with 1 eligible professional who is identified by an individual National Provider Identifier (NPI) billing under the TIN. This proposal completes our phase in of the VM as required by the Act. Please note that in section III.N.4.b of this proposed rule, we discuss our proposal to also apply the VM to nonphysician eligible professionals in groups subject to the VM and to nonphysician eligible professionals who are solo practitioners in CY 2017 and subsequent CY payment adjustment periods. Additionally, we note that in section III.N.4.g of this proposed rule, we state that performance on quality and cost measures in CY 2015 will be used to calculate the VM that is applied to items and services for which payment is made under the PFS during CY 2017.

   Table 55 shows the number of groups, eligible professionals, physicians, and nonphysician eligible professionals in groups of various sizes based on an analysis of CY 2012 claims with a 90-day run-out period. We note that the number of eligible professionals includes other practitioners, such as physician assistants and nurse practitioners, in addition to physicians. We estimate that our proposals to apply the VM to all groups with 2 or more eligible professionals and to all solo practitioners in CY 2017 would affect approximately 83,500 groups and 210,000 solo practitioners (as identified by their TINs) that consist of approximately 815,000 physicians and 315,000 nonphysician eligible professionals.

Table 55--Eligible Professional/Physician Group Size Distribution (2012 claims) Group size Number of Eligible Number of Number of Percent of Percent of groups profes- physicians non- physicians non- (TINs) * sionals physician physician (EPs) EPs EPs 100+ EPs 1,044 303,009 223,917 79,092 27 25 50-99 EPs 1,526 103,998 71,089 32,909 9 10 25-49 EPs 3,675 125,314 85,127 40,187 10 13 20-24 EPs 1,831 39,887 27,115 12,772 3 4 10-19 EPs 8,356 112,553 76,905 35,648 9 11 2-9 EPs 67,065 235,756 166807 68,949 20 22 1 EP 209,950 209,950 164,334 45,616 20 14 Total 293,447 1,130,467 815,294 315,173 100 100 * The number of groups (TINs) does not include TINs that have one or more EPs participating in the Shared Savings Program, the Pioneer ACO Model, or the Comprehensive Primary Care Initiative.



   As discussed in the CY 2014 PFS proposed rule with comment period (78 FR 43500 through 43502), we conducted statistical reliability analysis on the PQRS quality measures contained in the 2010 and 2011 group and individual Quality and Resource Use Reports (QRURs). These reports contained the PQRS quality measures used in these years, and these PQRS measures are similar to the PQRS measures that will be used in the VM starting in CY 2015. The quality measures in the group reports were statistically reliable at a high level. Moreover, at that time, the average reliability score was high for 98 percent of the individually reported PQRS measures included in the individual feedback reports; therefore, with the exceptions discussed in section III.N.4.h of this proposed rule regarding the all cause hospital readmission measure, we believe that the PQRS quality measures for groups with 2 or more eligible professionals and solo practitioners will also be reliable since they are chosen by the physicians and reflect their patients' conditions and practices' clinical priorities.

   We believe that we can validly and reliably apply a VM to groups with 2 or more eligible professionals and to solo practitioners because we would be basing the quality of care composite on the PQRS measures selected, and reported on, by the groups (or the eligible professionals in the groups) and the solo practitioners. We believe that the VM should recognize the diversity of medical practices and the various measures used to assess quality of care furnished by these practices and provide flexibility on the data they report for quality measures under the PQRS. Therefore, beginning in the CY 2014 performance period for the groups of physicians subject to the CY 2016 VM, we have permitted these groups for purposes of the VM to participate in the PQRS as a group under the GPRO or to have at least 50 percent of the eligible professionals in the group participate in the PQRS as individuals (78 FR 74767 through 74768). As a result, physicians and other eligible professionals in the group are able to report data on quality measures that reflect their own clinical practice. In the latter case, as proposed in section III.N.4.c of this proposed rule, a group would be included in Category 1 (as described in section III.N.4.c of this proposed rule) if at least 50 percent of the eligible professionals in the group meet the criteria to avoid the CY 2017 PQRS payment adjustment by using any of the reporting options available to them under the PQRS in CY 2015.

   We also conducted statistical reliability analyses on the cost measures contained in the 2010 and 2011 group and individual QRURs. These reports contained the same 5 per capita cost measures that will be used for the VM. The cost measures in the group reports were statistically reliable at a high level, and the average reliability score was high for all of the cost measures included in the individual feedback reports. In addition, as discussed in the CY 2014 PFS final rule with comment period (78 FR 74774-74784), we are including the Medicare Spending per Beneficiary (MSPB) measure in the cost composite of the VM and are adjusting the cost comparison approach to consider the medical specialty composition of the group of physicians. Based on an analysis of CY 2012 claims, we estimate that approximately 48 percent of all eligible professionals are in a group (as identified by a TIN) that would have the total per capita cost measure, as identified in SEC 414.1235(a)(1), in its cost composite score; approximately 41 percent of all eligible professionals are in a TIN that would have the MSPB measure in its cost composite score; and approximately 34 percent of all eligible professionals are in a TIN that would have both measures in its cost composite score. Therefore, we believe that we will be able to calculate a cost composite score for a significant number of groups and solo practitioners. In the CY 2014 PFS final rule with comment period, we finalized the proposal that if we are unable to attribute a sufficient number of beneficiaries to a group of physicians subject to the VM, and thus, are unable to calculate any of the cost measures with at least 20 cases, then the group's cost composite score would be classified as "average" under the quality-tiering methodology (78 FR 74780 through 74781). However, we note this policy was codified in SEC 414.1270(b)(5) as a group of physicians subject to the value-based payment modifier will receive a cost composite score that is classified as "average" under SEC 414.1275(b)(2) if such group does not have at least one cost measure with at least 20 cases. We believe the regulation text at SEC 414.1270(b)(5) better reflects the intent of this policy, and accordingly, we propose to clarify that the description of this policy in the preamble of the CY 2014 PFS final rule with comment period (78 FR 74780 through 74781) should be the same as the regulation text at SEC 414.1270(b)(5). We propose to apply the same policy to groups and solo practitioners beginning in CY 2017. That is, a group or solo practitioner would receive a cost composite score that is classified as "average" under the quality-tiering methodology if the group or solo practitioner does not have at least one cost measure with at least 20 cases. We propose to revise SEC 414.1270 accordingly.

   We believe we have provided smaller groups and solo practitioners sufficient lead time to understand how the VM works and how to participate in the PQRS. In the late summer of 2014, we plan to disseminate QRURs based on CY 2013 data to all groups of physicians and physicians who are solo practitioners. These QRURs will contain performance information on the quality and cost measures used to calculate the quality and cost composites of the VM and will show how all TINs would fare under the policies established for the VM. The QRURs will also include additional information about the TINs' performance on the MSPB measure, individually-reported PQRS measures, and the specialty-adjusted cost measures. Then, during the summer of 2015, we intend to disseminate QRURs based on CY 2014 data to all groups of physicians and physicians who are solo practitioners and the reports would show how all TINs would fare under the policies established for the VM for the CY 2016 payment adjustment period. Thus, we believe all groups and solo practitioners will have adequate data to improve performance on the quality and cost measures that will be used to calculate the VM in CY 2017. Although we are sensitive to providing groups and solo practitioners with adequate lead time to understand the impact of the beneficiary attribution method used for the VM, we believe our proposal to hold harmless groups with between 2 and 9 eligible professionals and solo practitioners from any downward payment adjustments under quality-tiering in CY 2017 would likely mitigate unintended consequences that could occur (see section III.N.4.c of this proposed rule).

   Accordingly, we propose to revise the regulations at SEC 414.1210 to reflect that beginning in the CY 2017 payment adjustment period, the VM would be applied to physician and nonphysician eligible professionals in groups with 2 or more eligible professionals and to solo practitioners based on the performance period described at SEC 414.1215. As established in the CY 2014 PFS final rule with comment period (78 FR 74772) and stated in section III.N.4.g of this proposed rule, CY 2015 is the performance period for the CY 2017 VM. Since the VM policies established for the CY 2017 payment adjustment period and each subsequent calendar year payment adjustment period would apply to groups and solo practitioners, we propose to amend the regulations under subpart N to add references to solo practitioners accordingly. We seek comments on all of these proposals.

b. Application of the VM to Nonphysician EPs

   Section 1848(p) of the Act requires that we establish a VM and apply it to items and services furnished under the PFS beginning on January 1, 2015, for specific physicians and groups of physicians the Secretary determines appropriate, and beginning not later than January 1, 2017, for all physicians and groups of physicians. Section 1848(p)(7) of the Act provides the Secretary discretion to apply the VM on or after January 1, 2017 to eligible professionals as defined in section 1848(k)(3)(B) of the Act. In CY 2015 and CY 2016, we apply the VM to the items and services billed under the PFS by physicians in groups (as identified by their Medicare-enrolled TIN) subject to the VM, but not to the other eligible professionals that also may bill under the TIN. We finalized in the CY 2013 PFS final rule with comment period (77 FR 69307 through 69310) that physicians, as defined in section 1861(r) of the Act, include doctors of medicine or osteopathy, doctors of dental surgery or dental medicine, doctors of podiatric medicine, doctors of optometry, and chiropractors.

   In section III.N.4.a. of this proposed rule, we discussed our proposal to apply the VM in the CY 2017 payment adjustment period and each subsequent calendar year payment adjustment period to physicians in groups of physicians with 2 or more eligible professionals and to physicians who are solo practitioners as required by section 1848(p)(4)(B)(iii)(II) of the Act.

   Under the discretion afforded the Secretary in section 1848(p)(7) of the Act, we propose to apply the VM beginning in the CY 2017 payment adjustment period to all of the eligible professionals in groups with 2 or more eligible professionals and to eligible professionals who are solo practitioners. That is, we propose to apply the VM beginning in CY 2017 to the items and services billed under the PFS by all of the physicians and nonphysician eligible professionals who bill under a group's TIN. We propose to apply the VM beginning in CY 2017 to groups that consist only of nonphysician eligible professionals (for example, groups with only nurse practitioners or physician assistants). We propose to modify the definition of "group of physicians" under SEC 414.1205 to also include the term "group" to reflect these proposals. We also propose to apply the VM beginning in CY 2017 to nonphysician eligible professionals who are solo practitioners. Additionally, we propose that physicians and nonphysician eligible professionals would be subject to the same VM policies established in earlier rulemakings and under 42 CFR part 414, subpart N. For example, nonphysician eligible professionals would be subject to the same amount of payment at risk and quality-tiering policies as physicians. We propose to modify the regulations under 42 CFR part 414, subpart N accordingly.

   We finalized in the CY 2013 PFS final rule with comment period (77 FR 69307 through 69310) that, for purposes of establishing group size, we will use the definition of an eligible professional as specified in section 1848(k)(3)(B) of the Act. This section defines an eligible professional as any of the following: (1) A physician; (2) a practitioner described in section 1842(b)(18)(C) of the Act: physician assistant, nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse-midwife, clinical social worker, clinical psychologist, registered dietician, or nutrition professional; (3) a physical or occupational therapist or a qualified speech-language pathologist; or (4) a qualified audiologist. Beginning CY 2017, under our proposal, the VM would apply to all of the eligible professionals, as specified in section 1848(k)(3)(B) of the Act, that bill under a group's TIN based on the TIN's performance during the applicable performance period. During the payment adjustment period, all of the nonphysician eligible professionals who bill under a group's TIN would be subject to the same VM that would apply to the physicians who bill under that TIN.

   We stated in the CY 2013 PFS final rule with comment period (77 FR 69307) that one of the principles that govern the implementation of the VM is our focus on shared accountability and that we have a role in fostering high value care for individual patients, but also focusing on how that patient interacts with the health care system generally. We stated our belief that the VM can facilitate shared accountability by assessing performance at the group practice level and by focusing on the total costs of care, not just the costs of care furnished by an individual physician. We believe that our proposal to apply the VM to the physicians and nonphysician eligible professionals in a group will foster shared accountability among all of the eligible professionals in the group and encourage them to seek innovative ways to furnish high-quality, patient-centered, and efficient care to the Medicare FFS patients they treat.

   Moreover, section 1848(p)(5) of the Act requires us to, as appropriate, apply the VM "in a manner that promotes systems-based care." We stated in the CY 2013 PFS proposed rule that, in this context, systems-based care is the processes and workflows that (1) make effective use of information technologies, (2) develop effective teams, (3) coordinate care across patient conditions, services, and settings over time, and (4) incorporate performance and outcome measurements for improvement and accountability. /10/ (77 FR 44996) We believe that applying the VM to all of the eligible professionals in a group, rather than only the physicians in the group, would enhance their ability and the resources to redesign such processes and workflows to achieve these objectives and furnish high-quality and cost-effective clinical care with greater care coordination.

   FOOTNOTE 10 Johnson JK, Miller SH, Horowitz SD. Systems-based practice: Improving the safety and quality of patient care by recognizing and improving the systems in which we work. In: Henriksen K, Battles JB, Keyes MA, Grady ML, editors. Advances in Patient Safety: New Directions and Alternative Approaches, Vol 2: Culture and Redesign. AHRQ Publication No. 08-0034-2. Rockville, MD: Agency for Healthcare Research and Quality; August 2008. p. 321-330. END FOOTNOTE

   As mentioned above, we are also proposing to apply the VM to groups that consist only of nonphysician eligible professionals, as well as solo practitioners who are nonphysician eligible professionals beginning in CY 2017. The quality of care composite for these groups and solo practitioners would be based on the quality data submitted under the PQRS at the group or individual level in accordance with our policy. To the extent we are able to attribute beneficiaries to these groups and solo practitioners under the attribution methodology proposed in section III.N.4.j of this proposed rule to calculate cost measures, we propose to calculate the cost composite using those cost measures. If a cost composite cannot be calculated for a group or solo practitioner, then we propose to classify the group or solo practitioner's cost composite as "average" as specified in SEC 414.1270. We seek comments on all of our proposed policies for applying the VM to nonphysician eligible professionals beginning in CY 2017.

c. Approach To Setting the VM Adjustment Based on PQRS Participation

   In the CY 2014 PFS final rule with comment period (78 FR 74767-74768), we adopted a policy to categorize groups of physicians subject to the VM in CY 2016 based on a group's participation in the PQRS. Specifically, we categorize groups of physicians eligible for the CY 2016 VM into two categories. Category 1 includes groups of physicians that (a) meet the criteria for satisfactory reporting of data on PQRS quality measures through the GPRO for the CY 2016 PQRS payment adjustment or (b) do not register to participate in the PQRS as a group practice in CY 2014 and that have at least 50 percent of the group's eligible professionals meet the criteria for satisfactory reporting of data on PQRS quality measures as individuals for the CY 2016 PQRS payment adjustment, or in lieu of satisfactory reporting, satisfactorily participate in a PQRS-qualified clinical data registry for the CY 2016 PQRS payment adjustment. For a group of physicians that is subject to the CY 2016 VM to be included in Category 1, the criteria for satisfactory reporting (or the criteria for satisfactory participation, if the PQRS-qualified clinical data registry reporting mechanism is selected) must be met during the CY 2014 reporting period for the PQRS CY 2016 payment adjustment. For the CY 2016 VM, Category 2 includes those groups of physicians that are subject to the CY 2016 VM and do not fall within Category 1. For those groups of physicians in Category 2, the VM for CY 2016 is -2.0 percent.

   We propose to use a similar two-category approach for the CY 2017 VM based on participation in the PQRS by groups and solo practitioners. To continue to align the VM with the PQRS and accommodate the various ways in which EPs can participate in the PQRS, for purposes of the CY 2017 VM, we propose that Category 1 would include those groups that meet the criteria for satisfactory reporting of data on PQRS quality measures via the GPRO (through use of the web-interface, EHR, or registry reporting mechanism, as proposed in section III.K of this proposed rule) for the CY 2017 PQRS payment adjustment. Our proposed criteria for satisfactory reporting of data on PQRS quality measures via the GPRO for the PQRS payment adjustment for CY 2017 are described in section III.K of this proposed rule. We also propose to include in Category 1 groups that do not register to participate in the PQRS as a group practice participating in the PQRS group practice reporting option (GPRO) in CY 2015 and that have at least 50 percent of the group's eligible professionals meet the criteria for satisfactory reporting of data on PQRS quality measures as individuals (through the use of claims, EHR, or registry reporting mechanism) for the CY 2017 PQRS payment adjustment, or in lieu of satisfactory reporting, satisfactorily participate in a PQRS-qualified clinical data registry for the CY 2017 PQRS payment adjustment, all as proposed in section III.K of this proposed rule. We note that these proposals are consistent with the policies for inclusion in Category 1 as established for the CY 2016 VM (78 FR 74767 through 74768). We would maintain the 50 percent threshold for the CY 2017 VM as we expand the application of the VM to all groups and solo practitioners in CY 2017. Our proposed criteria for satisfactory reporting by individual eligible professionals for the claims, EHR, and registry reporting mechanisms and for satisfactory participation in a qualified clinical data registry for the CY 2017 PQRS payment adjustment are described in section III.K of this proposed rule. Lastly, we propose to include in Category 1 those solo practitioners that meet the criteria for satisfactory reporting of data on PQRS quality measures as individuals (through the use of claims, registry, or EHR reporting mechanism) for the CY 2017 PQRS payment adjustment, or in lieu of satisfactory reporting, satisfactorily participate in a PQRS-qualified clinical data registry for the CY 2017 PQRS payment adjustment, all as proposed in section III.K of this proposed rule. Category 2 would include those groups and solo practitioners that are subject to the CY 2017 VM and do not fall within Category 1. As discussed in section III.N.4.f of this proposed rule, for CY 2017, we are proposing to apply a -4.0 percent VM to groups with two or more eligible professionals and solo practitioners that fall in Category 2. We seek comment on these proposals.

   For a group and a solo practitioner that would be subject to the CY 2017 VM to be included in Category 1, the criteria for satisfactory reporting (or the criteria for satisfactory participation, in the case of solo practitioners and the 50 percent option described above for groups) would need to be met during the reporting periods occurring in CY 2015 for the CY 2017 PQRS payment adjustment. As noted earlier, CY 2015 is the performance period for the CY 2017 payment adjustment period for the VM. In the event that the criteria that are finalized for the CY 2017 PQRS payment adjustment differ from what is proposed for the PQRS in this proposed rule, our intention is to align the criteria for inclusion in Category 1 to the extent possible with the criteria that are ultimately established for the CY 2017 PQRS payment adjustment.

   In the CY 2014 PFS final rule with comment period (78 FR 74768-74770), we finalized that the quality-tiering methodology will apply to all groups in Category 1 for the VM for CY 2016, except that groups of physicians with between 10 and 99 eligible professionals would be subject only to upward or neutral adjustments derived under the quality-tiering methodology, while groups of physicians with 100 or more eligible professionals would be subject to upward, neutral, or downward adjustments derived under the quality- tiering methodology. In other words, we finalized that groups of physicians in Category 1 with between 10 and 99 eligible professionals would be held harmless from any downward adjustments derived from the quality-tiering methodology for the CY 2016 VM.

   For the CY 2017 VM, we propose to continue a similar phase-in of the quality-tiering based on the number of eligible professionals in the group. We propose to apply the quality-tiering methodology to all groups and solo practitioners in Category 1 for the VM for CY 2017, except that groups with between 2 and 9 eligible professionals and solo practitioners would be subject only to upward or neutral adjustments derived under the quality-tiering methodology, while groups with 10 or more eligible professionals would be subject to upward, neutral, or downward adjustments derived under the quality-tiering methodology. In other words, we propose that solo practitioners and groups with between 2 and 9 eligible professionals in Category 1 would be held harmless from any downward adjustments derived from the quality-tiering methodology for the CY 2017 VM. Accordingly, we propose to revise SEC 414.1270 to reflect these proposals. We believe this proposed approach would reward groups and solo practitioners that provide high-quality/low-cost care, reduce program complexity, and would also fully engage groups and solo practitioners into the VM as we complete the phase-in of the VM in CY 2017. We seek comments on these proposals.

   We believe it is appropriate to hold groups with between 2 and 9 eligible professionals and solo practitioners in Category 1 harmless from any downward adjustments under the quality-tiering methodology, which is similar to the policy we apply to groups with between 10 and 99 eligible professionals during the first year the VM applies to them (CY 2016). We note that we anticipate applying the CY 2018 VM with both upward and downward adjustments based on a performance period of CY 2016 to all groups and solo practitioners, and therefore, we would make proposals in future rulemaking accordingly.

   For groups with between 10 and 99 eligible professionals, we believe it is appropriate to begin both the upward and the downward payment adjustments under the quality-tiering methodology for the CY 2017 VM. As stated in the CY 2014 PFS final rule with comment period (78 FR 74769), on September 16, 2013, we made available to all groups of 25 or more eligible professionals an annual QRUR based on 2012 data to help groups estimate their quality and cost composites. As discussed in section III.N.4.a. of this proposed rule, in the late summer of 2014, we plan to disseminate QRURs based on CY 2013 data to all groups of physicians and physicians who are solo practitioners. These QRURs will contain performance information on the quality and cost measures used to calculate the quality and cost composites of the VM and will show how all TINs would fare under the policies established for the VM for the CY 2015 payment adjustment period. Then, during the summer of 2015, we intend to disseminate QRURs based on CY 2014 data to all groups and solo practitioners, and the reports would show how all TINs would fare under the policies established for the VM for the CY 2016 payment adjustment period. The QRURs will also include additional information about the TINs' performance on the MSPB measure, individually-reported PQRS measures, and the specialty-adjusted cost measures. Thus, we believe groups with between 10 and 99 eligible professionals will have adequate data to improve performance on the quality and cost measures that will be used to calculate the VM in CY 2017. As a result, we believe it is appropriate to apply both upward and downward adjustments under the quality-tiering methodology to groups with 10 or more eligible professionals in 2017.

   Based on an analysis of CY 2012 claims, we estimate that approximately 6 percent of all eligible professionals are in a Category 1 TIN that would be classified in tiers that would earn an upward adjustment, approximately 11 percent of all eligible professionals are in a Category 1 TIN that would be classified in tiers that would receive a downward adjustment, and approximately 83 percent of all eligible professionals are in a Category 1 TIN that would receive no payment adjustment in CY 2017. These results suggest that our quality-tiering methodology identifies a small number of groups and solo practitioners that are outliers--both high and low performers--in terms of whose payments would be affected by the VM, thus limiting any widespread unintended consequences.

   We will continue to monitor the VM program and continue to examine the characteristics of those groups that could be subject to an upward or downward payment adjustment under our quality-tiering methodology to determine whether our policies create anomalous effects in ways that do not reflect consistent differences in performance among physicians and physician groups.

d. Application of the VM to Physicians and Nonphysician Eligible Professionals that Participate in the Shared Savings Program, the Pioneer ACO Model, the CPC Initiative, or Other Similar Innovation Center Models or CMS Initiatives

   We established a policy in the CY 2013 PFS final rule with comment period (77 FR 69313) to not apply the VM in CY 2015 and CY 2016 to groups of physicians that participate in the Shared Savings Program Accountable Care Organizations (ACOs), the Pioneer ACO Model, the Comprehensive Primary Care (CPC) Initiative, or other similar Innovation Center or CMS initiatives. We stated in the CY 2014 PFS final rule with comment period (78 FR 74766) that from an operational perspective, we will apply this policy to any group of physicians that otherwise would be subject to the VM, if one or more physician(s) in the group participate(s) in one of these programs or initiatives during the relevant performance period (CY 2013 for the CY 2015 VM, and CY 2014 for the CY 2016 VM).

   Although section 1848(p)(4)(B)(iii)(I) of the Act gives the Secretary discretion to apply the VM beginning on January 1, 2015 to specific physicians and groups of physicians the Secretary determines appropriate, section 1848(p)(4)(B)(iii)(II) of the Act requires application of the VM beginning not later than January 1, 2017 to all physicians and groups of physicians. Therefore, as discussed in section III.N.4.a. of this proposed rule, we are proposing to apply the VM to all physicians in groups with 2 or more eligible professionals and to solo practitioners who are physicians starting in CY 2017. In section III.N.4.b of this proposed rule, we discussed our proposal to also apply the VM starting in CY 2017 to all nonphysician eligible professionals in groups with 2 or more eligible professionals and to solo practitioners who are nonphysician eligible professionals. We describe in this section how we propose to apply the VM beginning in the CY 2017 payment adjustment period to the physicians and nonphysician eligible professionals in groups, as well as those who are solo practitioners, participating in the Shared Savings Program, Pioneer ACO Model, the CPC Initiative, or other similar Innovation Center models or CMS initiatives.

(1) Physicians and Nonphysician Eligible Professionals That Participate in ACOs Under the Shared Savings Program

   Beginning with the CY 2017 payment adjustment period, we propose to apply the VM to physicians and nonphysician eligible professionals in groups with 2 or more eligible professionals and to physicians and nonphysician eligible professionals who are solo practitioners that participate in the Shared Savings Program. Groups and solo practitioners participate in the Shared Savings Program as part of an ACO as provided in section 1899 of the Act. Under the Shared Savings Program, an ACO may consist of multiple participating groups and solo practitioners (as identified by the ACO participants' TINs). As of April 1, 2014, there are 338 ACOs participating in the Shared Savings Program. This number includes 31 ACOs that consist of only one ACO participant TIN. The ACO submits quality data on behalf of all the ACO participant TINs in that ACO under the Shared Savings Program.

   Beginning with the CY 2017 payment adjustment period, we propose to classify the cost composite for the VM as "average cost" for groups and solo practitioners (as identified by the ACO's participant TINs) that participate in the Shared Savings Program during the payment adjustment period (for example, CY 2017). We propose to apply "average cost" to these groups and solo practitioners regardless of whether they participated in the Shared Savings Program during the performance period (for example, in CY 2015 for the CY 2017 VM). We believe that it would not be appropriate to apply the quality-tiering methodology to calculate the cost composite for these groups and solo practitioners because of the differences in the methodology used to calculate the cost benchmarks under the Shared Savings Program and the VM. Under the Shared Savings Program, cost benchmarks are based on the actual historical Medicare fee-for-service expenditures for beneficiaries that would have been assigned to the ACO during the historical benchmark period, and are updated to reflect changes in national FFS spending; however, the cost benchmarks under the VM are based on national averages. We believe that these are significant differences in the methodology for calculating the cost benchmarks under the two programs. Consequently, we believe that any attempt to calculate the cost composite for groups and solo practitioners participating in the Shared Savings Program using the quality-tiering methodology would create two sets of standards for ACOs for their cost performance. We believe that having two sets of standards for ACOs for cost performance would be inappropriate and confusing. We seek comments on our proposals to classify the cost composite as "average cost" for groups and solo practitioners that participate in the Shared Savings Program during the payment adjustment period.

   For groups and solo practitioners that participate in the Shared Savings Program during the performance period (for example, CY 2015), but no longer participate in the Shared Savings Program during the payment adjustment period (for example, CY 2017), we propose to apply the quality-tiering methodology to calculate the cost composite for the VM for the payment adjustment period based on the groups' and solo practitioners' performance on the cost measures, as identified under SEC 414.1235, during the performance period. We believe that it would be appropriate to apply the quality-tiering methodology to calculate the cost composite because these groups and solo practitioners are no longer part of the Shared Savings Program during the payment adjustment period and their cost benchmarks would be calculated only under the VM during the payment adjustment period.

   Beginning with the CY 2017 payment adjustment period, we propose to calculate the quality of care composite score for the VM for groups and solo practitioners that participate in an ACO under the Shared Savings Program in accordance with the following policies:

   (a) We propose to calculate the quality of care composite score based on the quality-tiering methodology using quality data submitted by the ACO, as discussed in section III.N.4.h of this proposed rule, from the performance period and apply the same score to all of the groups and solo practitioners under the ACO during the payment adjustment period. In other words, using CY 2017 as an example, we propose to calculate the quality of care composite score for the CY 2017 VM for all of the groups and solo practitioners participating in the ACO in CY 2017 based on the ACO's CY 2015 quality data. We note that in section III.N.4.h of this proposed rule, we are proposing to exclude the claims-based outcome measures identified under SEC 414.1230 from the calculation of the quality of care composite score for groups and solo practitioners that participate in the Shared Savings Program during the payment adjustment period.

   (b) For groups and solo practitioners that participate in the ACO during the payment adjustment period (for example, CY 2017) and either did not participate in the Shared Savings Program or were part of a different ACO during the performance period (for example, CY 2015), we propose to calculate the quality of care composite score based on the quality-tiering methodology using the quality data submitted by the ACO from the performance period. For example, if a group or solo practitioner is in ACO 1 during CY 2017, and either was not in the Shared Savings Program or was part of ACO 2 during CY 2015, we would use ACO 1's quality data from CY 2015 to calculate the quality of care composite. We believe this approach is consistent with our policy not to "track" or "carry" an individual professional's performance from one TIN to another TIN (see 77 FR 69308 through 69310). In other words, if a professional changes groups from TIN A in the performance period to TIN B in the payment adjustment period, we would apply TIN B's VM to the professional's payments for items and services billed under TIN B during the payment adjustment period.

   (c) If the ACO did not exist during the performance period (for example, CY 2015), then we would not have the ACO's quality data to use in the calculation of the quality of care composite score for the payment adjustment period (for example, CY 2017). Therefore, if the ACO exists during the payment adjustment period but did not exist during the performance period, we propose to classify the quality of care composite for all groups and solo practitioners that participate in the ACO during the payment adjustment period as "average quality" for the payment adjustment period. We propose to apply this policy to groups and solo practitioners regardless of their status during the performance period--in other words, regardless of whether they participated in the Shared Savings Program as part of a different ACO, or did not exist during the performance period (for example, a TIN forms or newly enrolls in Medicare after the end of the performance period). We believe this proposal is appropriate since we would not have the ACO's quality data from the performance period to calculate a quality of care composite for all of the groups and solo practitioners participating in the ACO during the payment adjustment period. We note that some of these groups and solo practitioners may have participated in the PQRS during the performance period; therefore, we would have quality data for those groups and solo practitioners. If they were part of a different ACO during the performance period, then we would also have that ACO's quality data. However, we do not believe that it would be appropriate to use the groups' and solo practitioners' PQRS or other ACO quality data from the performance period to calculate a quality of care composite because the groups and solo practitioners are part of a new ACO during the payment adjustment period. We believe this approach is consistent with our policy not to "track" or "carry" an individual professional's performance from one TIN to another TIN (see 77 FR 69308 through 69310). In this case, if a TIN's status changes from the performance period to the payment adjustment period (that is, participating in ACO 2 or not participating in the Shared Savings Program in the performance period, to participating in ACO 1 in the payment adjustment period), then we would not "track" or "carry" ACO 2's quality data or the TIN's PQRS quality data to determine the quality of care composite for groups and solo practitioners that participate in ACO 1.

   (d) For groups and solo practitioners that participate in the Shared Savings Program during the performance period (for example, CY 2015) but no longer participate in the Shared Savings Program during the payment adjustment period (for example, CY 2017), we propose to classify the quality of care composite as "average quality" for the VM for the payment adjustment period. Since these groups and solo practitioners were part of an ACO during the performance period, we would have the ACO's quality data from that period. However, we do not believe that it would be appropriate to use the ACO's quality data from the performance period to calculate a quality of care composite because the groups and solo practitioners are no longer part of the ACO during the payment adjustment period. We believe this approach is also consistent with our policy not to "track" or "carry" an individual professional's performance from one TIN to another TIN (see 77 FR 69308 through 69310). Even though we are proposing to classify the quality of care composite for these groups and solo practitioners as "average quality," we seek comments on whether we should use the ACO's quality data from the performance period to calculate the quality composite for these groups and solo practitioners for the payment adjustment period.

   We seek comments on all of our proposals to calculate the quality composite for groups and solo practitioners participating in the Shared Savings Program as described above. A summary of these proposals is shown in Table 56 using TIN A and ACO 1 and ACO 2 as examples.

Table 56--Summary of Proposed Policies for Groups and Solo Practitioners With Shared Savings Program Participation Changes Scenario TIN's Status TIN's Status TIN's Quality TIN's Cost during the during the composite for composite for performance payment the payment the payment period (for adjustment adjustment adjustment example, CY period (for period (for period (for 2015) example, CY example, CY example, CY 2017) 2017) 2017) a. Continued ACO TIN A is part TIN A is part Based on ACO Average cost. participation --TIN A of ACO 1 of ACO 1 1's quality participates in ACO 1 data from the during both the performance performance and period (for payment adjustment example, CY periods 2015 b. Joining an TIN A is not TIN A is part Based on ACO Average cost. existing ACO and not part of any of ACO 1 1's quality from another ACO--TIN ACO and ACO 1 data from the A was not part of any exists performance ACO during the OR period (for performance period, TIN A is not example, CY but participates in part of ACO 2 2015 ACO 1 during the and ACO 1 payment adjustment exists period (ACO 1 existed in the performance period) OR Joining an existing ACO from another ACO--TIN A participated in ACO 2 during the performance period, but is part of ACO 1 during the payment adjustment period (ACO 1 existed in the performance period) c. Joining a new ACO TIN A and ACO TIN A is part Average Average cost. as a new TIN--TIN A 1 did not of ACO 1 quality participates in ACO 1 exist during the payment OR adjustment period TIN A is not (ACO 1 and TIN A did part of any not exist in the ACO and ACO 1 performance period) did not exist OR OR Joining a new ACO and TIN A is part not from another of ACO 2 and ACO--TIN A was not ACO 1 did not part of any ACO exist. during the performance period, but participates in ACO 1 during the payment adjustment period (ACO 1 did not exist in the performance period) OR Joining a new ACO from another ACO--TIN A participated in ACO 2 during the performance period, but is part of ACO 1 during the payment adjustment period (ACO 1 did not exist in the performance period) d. Dropping out of an TIN A is part TIN A is not Average Based on TIN ACO--TIN A of ACO 1. part of any quality A's cost data participated in ACO 1 ACO for the during the performance performance period, period using but is not part of the quality- any ACO during the tiering payment adjustment methodology. period



   We believe that our proposal to apply the VM to groups and solo practitioners that participate in ACOs under the Shared Savings Program is appropriate in light of the statutory requirement under section 1848(p)(4)(B)(iii)(II) of the Act to apply the VM to all physicians and groups of physicians beginning not later than January 1, 2017. We believe our proposals, as described above, would further encourage groups and solo practitioners that participate in ACOs under the Shared Savings Program to furnish high quality care to Medicare beneficiaries by providing them with an opportunity to earn upward payment adjustments. We propose to apply the same VM, which would be calculated based on the policies proposed above, to all groups and solo practitioners, as identified by their TINs, that participate in an ACO under the Shared Savings Program during the payment adjustment period. Consequently, the same VM would also apply to the physicians and nonphysician eligible professionals in those groups and to the physicians and nonphysician eligible professionals who are solo practitioners that participate in the ACO during the payment adjustment period.

   In section III.N.4.c of this proposed rule, we discussed our proposal to hold groups with between 2 and 9 eligible professionals and solo practitioners who are in Category 1 harmless from any downward adjustments under the quality-tiering methodology for the CY 2017 payment adjustment period. We propose to also hold harmless from any downward adjustments groups with between 2 and 9 eligible professionals and solo practitioners that participate in ACOs under the Shared Savings Program during the CY 2017 payment adjustment period based on their size during the performance period. We would follow our established process for determining group size, which is described at SEC 414.1210(c). Therefore, to the extent that a quality of care composite can be calculated for an ACO, and the cost composite would be classified as "average cost," groups with 10 or more eligible professionals participating in the Shared Savings Program would be subject to an upward, downward, or no payment adjustment in CY 2017, and groups with between 2 and 9 eligible professionals and solo practitioners would be subject to an upward or no payment adjustment in CY 2017. We also propose that groups and solo practitioners participating in ACOs under the Shared Savings Program would be eligible for the additional upward payment adjustment of +1.0x for caring for high-risk beneficiaries, as proposed in section III.N.4.f. We propose to modify SEC 414.1210 to reflect these proposals.

(2) Physicians and Nonphysician Eligible Professionals that Participate in the Pioneer ACO Model, the Comprehensive Primary Care (CPC) Initiative, or Other Similar Innovation Center Models or CMS Initiatives

   Section 1115A of the Act authorizes the Innovation Center to test innovative payment and service delivery models to reduce Medicare, Medicaid, or Children's Health Insurance Program (CHIP) expenditures, while preserving or enhancing the quality of care furnished to beneficiaries under those programs. Therefore, all models tested by the Innovation Center would be expected to assess participating entities (for example, providers, ACOs, states) based on quality and cost performance. As noted above, we established a policy in the CY 2013 PFS final rule with comment period (77 FR 69313) to not apply the VM in CY 2015 and CY 2016 to groups of physicians that are participating in the Pioneer ACO Model, the CPC Initiative, or in other Innovation Center initiatives or other CMS programs which also involve shared savings and where participants make substantial investments to report quality measures and to furnish higher quality, more efficient and effective healthcare.

   In section III.N.4.a. of this proposed rule, we discussed our proposal to apply the VM to all physicians in groups with 2 or more eligible professionals and to solo practitioners who are physicians starting in CY 2017, as required under section 1848(p)(4)(B)(iii)(II) of the Act. In section III.N.4.b, we discussed our proposal to also apply the VM starting in CY 2017 to all nonphysician eligible professionals in groups with 2 or more eligible professionals and to solo practitioners who are nonphysician eligible professionals.

   The Pioneer ACO Model and the CPC Initiative are scheduled to end on December 31, 2016. Therefore, the relevant performance periods for consideration for participants in these initiatives are CY 2015 for the CY 2017 VM payment adjustment period and potentially CY 2016 for the CY 2018 VM payment adjustment period. Under the Pioneer ACO Model, an ACO may consist of practitioners from multiple participating groups and solo practitioners (as identified by their individual TIN/NPI combination). Thus, a group practice may consist of one or more eligible professionals who participate in the Pioneer ACO Model and other eligible professionals who do not participate in the Pioneer ACO Model. In the case of the CPC Initiative, a practice site may participate in the model even if one or more other practice sites that use the same TIN does not participate. Beginning with the CY 2017 payment adjustment period, we propose to apply the VM to physicians and nonphysician eligible professionals in groups with 2 or more eligible professionals and to physicians and nonphysician eligible professionals who are solo practitioners that participate in the Pioneer ACO Model or the CPC Initiative during the relevant performance period in accordance with the policies described below.

   (a) For groups and solo practitioners that participate in the Pioneer ACO Model or the CPC Initiative during the performance period (for example, CY 2015) and do not participate in the Shared Savings Program or other similar Innovation Center models or CMS initiatives during the payment adjustment period (for example, CY 2017), we propose to calculate the quality of care composite score for the VM for the payment adjustment period based on the following three scenarios:

   Scenario 1: If a group participates in the PQRS as a group practice under the PQRS GPRO during the performance period and meets the criteria for satisfactory reporting of data on PQRS quality measures via one of the GPRO reporting mechanisms, as proposed in section III.K of this proposed rule, for the respective PQRS payment adjustment, then we propose to use the PQRS GPRO data to calculate the group's quality of care composite for the VM for the payment adjustment period. We propose to apply the same quality of care composite to all eligible professionals that bill under the group's TIN during the payment adjustment period. We also propose that if the group registers for GPRO for the performance period and does not meet the criteria for satisfactory reporting of data on PQRS quality measures via one of the GPRO reporting mechanisms for the respective PQRS payment adjustment, then the group would fall in Category 2. As discussed in section III.N.4.f of this proposed rule, for CY 2017, we are proposing to apply a -4.0 percent VM to groups with two or more eligible professionals and solo practitioners that fall in Category 2. In this case, all eligible professionals that bill under the group's TIN during the payment adjustment period would be subject to the -4.0% VM payment adjustment. We seek comment on this proposal.

   Scenario 2: In the case of a group that does not report under the PQRS GPRO during the performance period and includes one or more eligible professionals that participate in a Pioneer ACO under the Pioneer ACO Model or in the CPC Initiative during the performance period, as well as other eligible professionals that do not participate in these models, we propose that if at least 50 percent of all eligible professionals in the group satisfactorily report quality data to CMS for the performance period, then we would calculate a quality of care composite using the quality-tiering methodology and the satisfactorily reported data on the PQRS quality measures submitted by the eligible professionals in the group as individuals under PQRS. For purposes of this scenario, by "satisfactorily report quality data to CMS," we mean that at least 50 percent of the group's eligible professionals meet the criteria for satisfactory reporting of data on PQRS quality measures as individuals for the PQRS payment adjustment during the performance period, or in lieu of satisfactory reporting, satisfactorily participate in a PQRS-qualified clinical data registry for the PQRS payment adjustment during the performance period, or successfully report quality data to the Pioneer ACO Model or the CPC Initiative during the performance period. The quality of care composite would be calculated using satisfactorily reported data on the PQRS quality measures submitted by the eligible professionals in the group as individuals under PQRS regardless of whether or not the eligible professionals who report the data participate in the Pioneer ACO Model or the CPC Initiative. We propose to assign the group a quality of care composite that is the higher of "average quality" or the group's actual classification as determined under the quality-tiering methodology. We propose to apply the same quality of care composite to all eligible professionals that bill under the group's TIN during the payment adjustment period, regardless of whether they participated in the model during the performance period.

   We propose that if less than 50 percent of all eligible professionals in the group satisfactorily report quality data to CMS for the performance period, then this group would fall in Category 2. In other words, less than 50 percent of the group's eligible professionals meet the criteria for satisfactory reporting of data on PQRS quality measures as individuals for the PQRS payment adjustment during the performance period, or in lieu of satisfactory reporting, satisfactorily participate in a PQRS-qualified clinical data registry for the PQRS payment adjustment during the performance period, or successfully report quality data to the Pioneer ACO Model or the CPC Initiative during the performance period. As discussed in section III.N.4.f of this proposed rule, for CY 2017, we are proposing to apply a -4.0 percent VM to groups with two or more eligible professionals and solo practitioners that fall in Category 2. In this case, all eligible professionals that bill under the group's TIN during the payment adjustment period would be subject to the -4.0 percent VM payment adjustment, regardless of whether they participated in the model during the performance period.

   We note the eligible professionals in these groups that participate in the Pioneer ACO Model or the CPC Initiative submit quality data under their respective model. However, we do not believe that we can reasonably use the quality data submitted under these models in the calculation of the quality of care composite for these groups. At this time, we are unable to operationally integrate the data from these models with the value modifier program due to systems constraints and the unique nature of reporting for participants in these models. We also do not believe that we are able to predict how the quality data submitted under these models would affect the group's quality composite. We note that because these models are at the forefront of innovation, we believe that the eligible professionals participating in these models would have higher quality performance. For example, results from the first performance year of the Pioneer ACO Model demonstrated that Pioneer ACOs performed better than published rates in fee-for-service for 15 clinical quality measures for which comparable data are available. On readmissions, 25 of 32 Pioneer ACOs generated lower risk-adjusted readmission rates for their aligned beneficiaries than the benchmark rate for all Medicare fee-for-service beneficiaries. On clinical quality measures that assess hypertension control for Medicare beneficiaries, the median rate among Pioneer ACOs with diabetes was 68 percent compared to 55 percent as measured in adult diabetic population in 10 managed care plans across 7 states from 2000 to 2001. Also, on clinical quality measures that assess low density lipoprotein (LDL) control for patients with diabetes, the median rate among Pioneer ACOs for low density lipoprotein control among beneficiaries with diabetes was 57 percent compared to 48 percent in an adult diabetic population in 10 managed care plans across 7 states from 2000 to 2001. For these reasons, we seek to ensure that these groups are at least considered to have "average" quality, as reflected in our proposal above.

   We also considered two alternatives to our proposal above for Scenario 2. First, we considered assigning these groups a quality composite of "average quality" without consideration of any PQRS quality data that may be available to calculate quality measure scores and a quality composite. We did not believe it would be appropriate to make such a proposal because we believe it is important to use data on quality, to the extent practicable, to determine a group's quality composite. Consequently, we believe it is appropriate to use the data that is reported under PQRS to calculate a quality composite for these groups. We recognize that some eligible professionals in these groups may not submit quality data under PQRS and that these professionals are likely to participate in a model and submit quality data through that model. Since we believe that participants in these models tend to perform better than average with regard to quality as described above, we believe that it is possible that we would underestimate a group's quality performance if we consider PQRS data only. Accordingly, to the extent that the data reported under PQRS by individual eligible professionals in the group results in a quality composite that is one standard deviation above average (that is, "high quality"), we believe it is likely that this composite would increase by including data (were it available) from the eligible professionals who report quality data through the model. Therefore, we believe that it would be inappropriate to reduce a quality composite from "high quality" to "average quality." Second, we considered assigning a quality composite of "average quality" to groups where less than 50 percent of all eligible professionals in the group meet the criteria for satisfactory reporting of data on PQRS quality measures as individuals for the PQRS payment adjustment during the performance period, or in lieu of satisfactory reporting, satisfactorily participate in a PQRS-qualified clinical data registry for the PQRS payment adjustment during the performance period, because we would not have quality data for more than half of the group that we could use to calculate a quality composite. Similarly, if at least 50 percent of all eligible professionals in a group satisfactorily report or participate under PQRS as individuals, we considered using their PQRS quality data to calculate a quality composite for the group and applying the quality-tiering methodology to classify the group as high, average, or low quality. We did not believe it would be appropriate to make such a proposal. We do not believe that it is appropriate to classify a group as "low quality" when more than half of the eligible professionals in the group successfully report quality data (whether it be under PQRS or a model), even though we do not believe at this time we can reasonably use quality data reported through a model for the VM, because we believe that participants in these models would likely increase the group's quality performance were their data included. In other words, to the extent that the data reported under PQRS by individual eligible professionals in the group results in a quality composite that is "low quality" (that is, one standard deviation below average), we believe that this could be in part because the quality data of higher performing eligible professionals reported through the model would not be included in the calculation of the quality composite. Therefore, we believe it would be inappropriate to classify such a group as lower than "average quality."

   We note that it may be possible for a group to have a disproportionately large number of eligible professionals participating in the Pioneer ACO Model or the CPC Initiative. In this instance, our proposal would result in the use of the PQRS data reported by a relatively small number of eligible professionals who are not participating in the model to determine the quality of care composite that would apply to all eligible professionals in the group. We seek comment on the degree to which this situation occurs and the appropriateness of our proposal in this instance, as well as alternatives to our proposal.

   Scenario 3: If a group does not report under the PQRS GPRO during the performance period, consists entirely of eligible professionals that participate in the Pioneer ACO Model or the CPC Initiative, and successfully reports quality data to CMS under the model for the performance period, then we propose to classify the group's quality of care composite as "average quality." We also propose to classify as "average quality" the quality of care composite of solo practitioners that participate in the Pioneer ACO Model or the CPC Initiative and successfully report quality data to CMS under the model for the performance period. We propose to apply the same quality of care composite to all eligible professionals that bill under the group's TIN during the payment adjustment period. These eligible professionals submit quality data to the Pioneer ACO Model or the CPC Initiative; however, as discussed above, we do not believe that we can reasonably use the model quality data in the calculation of the quality of care composite for these groups and solo practitioners. Additionally, we propose that if the group or the solo practitioner does not successfully report quality data to CMS under the model for the performance period, then the group or solo practitioner would fall in Category 2. As discussed in section III.N.4.f of this proposed rule, for CY 2017, we are proposing to apply a -4.0 percent VM to groups with two or more eligible professionals and solo practitioners that fall in Category 2. In this case, all eligible professionals that bill under the group's TIN during the payment adjustment period would be subject to the -4.0% VM payment adjustment.

   As an alternative to this proposal, we considered assigning "average quality" to groups and solo practitioners that do not successfully report quality data to CMS under the model for the performance period. We believe that this policy would not have been consistent with our proposal to consider groups and solo practitioners that do not satisfactorily report or participate for PQRS as Category 2 as described in section III.N.4.c of this proposed rule. We also believe that assigning "average quality" may inadvertently create incentives for groups and solo practitioners to not report quality data to CMS under these models.

   For groups and solo practitioners that participate in the Pioneer ACO Model or the CPC Initiative during the performance period (for example, CY 2015) and do not participate in the Shared Savings Program or other similar Innovation Center models or CMS initiatives during the payment adjustment period (for example, CY 2017) (Scenarios 1 through 3 above), we propose to apply the quality-tiering methodology to calculate the cost composite for the VM for the payment adjustment period based on a group's and solo practitioner's performance on the cost measures, as identified under SEC 414.1235, during the performance period. We believe that it would be appropriate to apply the quality-tiering methodology to calculate the cost composite because these groups and solo practitioners are no longer part of the Pioneer ACO Model or the CPC during the payment adjustment period, and their cost benchmarks would be calculated only under the VM during the payment adjustment period.

   (b) For groups and solo practitioners that participate in the Pioneer ACO Model or the CPC Initiative during the performance period (for example, CY 2015) and participate in other similar Innovation Center models or CMS initiatives during the payment adjustment period (for example, CY 2017) (but not the Shared Savings Program), we propose to calculate the quality of care composite based on the three scenarios described above to the extent we are able. We recognize that these three scenarios might not be applicable to all of the various models and initiatives that may be developed in future years. We also propose to classify the cost composite for these groups and solo practitioners for the payment adjustment period as "average cost." We believe that, for groups and solo practitioners participating in other similar models or initiatives during the payment adjustment period, calculating a cost composite based on the quality-tiering methodology may create two sets of standards for evaluating their cost performance; therefore, we believe it would be appropriate to assign "average cost" to these groups and solo practitioners. If we believe a different approach to applying the VM would be appropriate for a new model or initiative, we intend to address it in future rulemaking.

   (c) For groups and solo practitioners that participate in the Pioneer ACO Model or the CPC Initiative during the performance period (for example, CY 2015) and participate in an ACO under the Shared Savings Program during the payment adjustment period (for example, CY 2017), we propose to calculate the quality of care composite score based on the quality-tiering methodology using quality data submitted by the Shared Savings Program ACO from the performance period. For groups and solo practitioners that participate in a Shared Savings Program ACO during the payment adjustment period that did not exist during the performance period, we propose to classify the quality of care composite as "average quality" for the payment adjustment period because we would not have quality data from the performance period for that ACO. We also propose to classify the cost composite for the VM as "average cost" for groups and solo practitioners that participate in a Shared Savings Program ACO during the payment adjustment period. As we stated in section III.N.4.d.1 of this proposed rule, we believe that there are significant differences in the methodology for calculating the cost benchmarks under the VM and the Shared Savings Program. Consequently, we believe that any attempt to calculate the cost composite for groups and solo practitioners participating in the Shared Savings Program using the quality-tiering methodology would create two sets of standards for ACOs for their cost performance, which would be inappropriate and confusing. These proposals are consistent with the proposals for participants in the Shared Savings Program described above.

   (d) In section III.N.4.c of this proposed rule, we discussed our proposal to hold groups with between 2 and 9 eligible professionals and solo practitioners who are in Category 1 harmless from any downward adjustments under the quality-tiering methodology for the CY 2017 payment adjustment period. We propose to also hold harmless from any downward adjustments for CY 2017 groups with between 2 and 9 eligible professionals, where one or more eligible professionals participate in the Pioneer ACO Model or the CPC, and solo practitioners that participate in the Pioneer ACO Model or the CPC during the CY 2015 performance period based on their size during the performance period. We would follow our established process for determining group size, which is described at SEC 414.1210(c). We also propose that groups where one or more eligible professionals participate in the Pioneer Model or the CPC during the performance period, and solo practitioners participating in the Pioneer ACO Model or the CPC during the performance period would be eligible for the additional upward payment adjustment of +1.0x for caring for high-risk beneficiaries, as proposed in section III.N.4.f below.

   (e) In addition, beginning with the CY 2017 payment adjustment period, we propose to apply the VM to physicians and nonphysician eligible professionals in groups with 2 or more eligible professionals and to physicians and nonphysician eligible professionals who are solo practitioners that participate in other similar Innovation Center models or CMS initiatives during the relevant performance period for the VM in accordance with the proposed policies described above for the Pioneer ACO Model and the CPC Initiative. We are unable to propose an exhaustive list of the models and initiatives that would fall under this category because many of them have not yet been developed. In addition, it is possible that the timeline for implementing some of these new models and initiatives may not coincide with the timeline for rulemaking for the VM. To address these issues, we propose to rely on the following general criteria to determine whether a model or initiative would fall in this "other similar" category and thus would be subject to the policies described above for the Pioneer ACO Model and the CPC Initiative: (1) The model or initiative evaluates the quality of care and/or requires reporting on quality measures; (2) the model or initiative evaluates the cost of care and/or requires reporting on cost measures; (3) participants in the model or initiative receive payment based at least in part on their performance on quality measures and/or cost measures; (4) potential for conflict between the methodologies used for the VM and the methodologies used for the model or initiative; or (5) other relevant factors specific to a model or initiative. We note that a model or initiative would not have to satisfy or address all of these criteria to be included in this "other similar" category. Rather, the criteria are intended to serve as a general framework for evaluating models and initiatives with regard to the application of the VM to groups and solo practitioners that participate. We are seeking public comment on these or other appropriate criteria for determining which models or initiatives we should classify as "other similar" models, for the purposes of applying the policies for the Pioneer ACO Model and the CPC Initiative described above.

   As noted above, we recognize that the policies we finalize for the Pioneer ACO Model and the CPC Initiative after consideration of public comments might not be applicable to all of the various models and initiatives that could be developed in future years. If we believe a different approach to applying the VM would be appropriate for a model or initiative, we intend to address it in future rulemaking. In addition, if we were to determine that a model or initiative falls under this "other similar" category based on the general criteria that we finalize after consideration of public comments, we propose to provide notice to participants in the model or initiative through the methods of communication that are typically used for the model or initiative.

   We propose to modify SEC 414.1210 to reflect all of these proposals.

   A summary of these proposals is shown in Table 57 using TIN A as an example.

Table 57--Summary of Proposed Policies for Groups and Solo Practitioners With Pioneer ACO Model, CPC Initiative, or Other Similar Innovation Center Model or CMS Initiative Participation Changes Scenario TIN's status TIN's status TIN's quality TIN's cost during the during the composite for composite for performance payment the payment the payment period (for adjustment adjustment adjustment example, CY period period (for period (for 2015) (for example, example, CY example, CY CY 2017) 2017) 2017) a. Scenario 1: TIN A is part TIN A is not If TIN A If TIN A TIN A of the Pioneer part of the satisfactorily satisfactorily participates in ACO Model or Shared Savings reports under reports under the Pioneer ACO CPC Initiative Program or PQRS GPRO for PQRS GPRO for Model or the CPC other similar the the Initiative during Innovation performance performance the performance Center models period: Based period: period, but does or CMS on TIN A's Based on TIN not participate initiatives PQRS GPRO data A's cost data in the Shared If TIN A does for the Savings Program not performance or other similar satisfactorily period using Innovation Center report under the quality- models or CMS PQRS GPRO for tiering initiatives the methodology. during the performance payment period: TIN A adjustment period falls in (some or all of Category 2 and the eligible a -4.0 percent professionals in VM is applied TIN A participate to the TIN in in the Pioneer the payment ACO Model or CPC adjustment Initiative) period AND TIN A registers for PQRS GPRO for the performance period a. Scenario 2: TIN A is part TIN A is not If at least 50 If at least 50 TIN A of the Pioneer part of the percent of all percent of all participates in ACO Model or Shared Savings eligible eligible the Pioneer ACO CPC Initiative Program or professionals professionals Model or the CPC other similar in TIN A in TIN A Initiative during Innovation satisfactorily satisfactorily the performance Center models report quality report quality period, but does or CMS data to CMS data to CMS not participate initiatives for the for the in the Shared performance performance Savings Program period: Higher period: Based or other similar of "average on TIN A's Innovation Center quality" or cost data for models or CMS the actual the initiatives classification performance during the under the period using payment quality- the quality- adjustment period tiering tiering (TIN A has one or methodology methodology more eligible based on PQRS professionals quality data that participate submitted by in the Pioneer the eligible ACO Model or CPC professionals Initiative and as individuals other non- If less than participating 50 percent of eligible all eligible professionals) professionals AND in TIN A For the satisfactorily performance report quality period: TIN A data to CMS does not report for the under PQRS GPRO; performance some eligible period: TIN A professionals falls in report quality Category 2 and data to the a -4.0 percent Pioneer ACO Model VM is applied or the CPC to the TIN in Initiative and the payment others report adjustment under PQRS as period individuals a. Scenario 3: TIN A is part TIN A is not If TIN A If TIN A TIN A of the Pioneer part of the successfully successfully participates in ACO Model or Shared Savings reports reports the Pioneer ACO CPC Initiative Program or quality data quality data Model or the CPC other similar to the Pioneer to the Pioneer Initiative during Innovation ACO Model or ACO Model or the performance Center models CPC Initiative CPC Initiative period, but does or CMS for the for the not participate initiatives performance performance in the Shared period: period: Based Savings Program Average on TIN A's or other similar quality cost data for Innovation Center If TIN A does the models or CMS not performance initiatives successfully period using during the report quality the quality- payment data to the tiering adjustment period Pioneer ACO methodology. (all eligible Model or CPC professionals in Initiative for TIN A participate the in the Pioneer performance ACO Model or CPC period: TIN A Initiative) falls in AND Category 2 and For the a -4.0 percent performance VM is applied period: TIN A to the TIN in does not report the payment under PQRS GPRO; adjustment TIN A reports period quality data to the Pioneer ACO Model or the CPC Initiative b. TIN A TIN A is part TIN A is part Based on Average cost. participates in of the Pioneer of other Scenarios 1-3 the Pioneer ACO ACO Model or similar Model or the CPC CPC Initiative Innovation Initiative during Center models the performance or CMS period and initiatives participates in (but not the other similar Shared Savings Innovation Center Program) models or CMS initiatives during the payment adjustment period (but not the Shared Savings Program) c. TIN A TIN A is part TIN A is part Based on the Average cost. participates in of the Pioneer of an ACO Shared Savings the Pioneer ACO ACO Model or under the Program ACO's Model or the CPC CPC Initiative Shared Savings quality data Initiative during Program for the the performance performance period and period participates in If the ACO did an ACO under the not exist in Shared Savings the Program during performance the payment period: adjustment period Average quality



e. Clarification Regarding Treatment of Non-Assigned Claims for Non-Participating Physicians

   As indicated earlier, section 1848(p) of the Act requires the Secretary to establish a payment modifier that provides for differential payment to a physician or a group of physicians under the PFS based upon the quality of care furnished compared to cost during a performance period. In the CY 2013 PFS final rule with comment period in which we established a number of key policies for the VM, we stated that we had received few comments on our proposal to apply the VM to the Medicare paid amounts for the items and services billed under the PFS so that beneficiary cost-sharing or coinsurance would not be affected (77 FR 69309). These commenters generally agreed with the proposal to apply the VM to the Medicare paid amounts for the items and services billed under the PFS at the TIN level so that beneficiary cost-sharing would not be affected. Therefore, we finalized this policy and accordingly established a definition of the VM at SEC 414.1205 that was consistent with the proposal and the statutory requirement to provide for differential payment to a physician or a group of physicians under the fee schedule based upon the quality of care furnished compared to cost during a performance period.

   We continue to believe it is important that beneficiary cost-sharing not be affected by the VM and that the VM should be applied to the amount that Medicare pays to physicians. However, in previous rulemaking, we did not directly address whether the VM would be applied to both assigned services for which Medicare makes payment to the physician, and to non-assigned services for which Medicare makes payment to the beneficiary. Participating physicians are those who have signed an agreement in accordance with section 1842(h)(1) of the Act to accept payment on an assignment-related basis for all items and services furnished to Medicare beneficiaries. In other words, participating physicians agree to accept the Medicare approved amount as payment in full and to charge the beneficiary only the Medicare deductible and coinsurance amount. In contrast, non-participating physicians have not signed an agreement to accept assignment for all services furnished to beneficiaries, but they can still choose to accept assignment for individual services. If they choose not to accept assignment for particular services non-participating physicians can charge the beneficiary more than the Medicare-approved amount, up to a limit called the "limiting charge." The limiting charge is defined at section 1848(g)(2)(C) of the Act as 115 percent of the recognized payment amount for nonparticipating physicians. In contrast, if a non-participating physician chooses to accept assignment for a service, they receive payment from Medicare at the approved amount for non-participating physicians, which is 95 percent of the fee schedule amount. Over 99 percent of Medicare physician services are billed on an assignment related basis by both participating and non-participating physicians and other suppliers, with the remainder billed as non-assigned services by non-participating physicians and other suppliers.

   For assigned claims, Medicare makes payment directly to the physician. In accordance with section 1848(p)(1) of the Act and the regulations at SEC 414.1205 and SEC 414.1210(a), the VM should be applied to assigned claims. However, for non-assigned claims, the limiting charge (the amount that the physician can bill a beneficiary for a non-assigned service) would not be affected if the VM were applied to the claim. This is so, because for non-assigned claims, application of the VM would not affect the limiting charge. Rather, Medicare makes payment for the non-assigned services directly to the beneficiary and the physician receives all payment for a non-assigned service directly from the beneficiary. If the VM were to be applied to non-assigned services, then the Medicare payment to a beneficiary would be increased when the VM is positive and decreased when the VM is negative. The application of the VM to non-assigned claims would therefore directly affect beneficiaries and not physicians, contrary to our intent as discussed in previous rulemaking (77 FR 69309). On that basis, we are proposing to clarify that we would apply the VM only to assigned services and not to non-assigned services starting in CY 2015. We do not expect this proposed clarification, to not apply the VM to non-assigned claims, would be likely to affect a physician's decision to participate in Medicare or to otherwise accept assignment for a particular claim. This is because the amount that a provider is entitled to receive from the beneficiary for non-assigned claims is not affected by whether or not the VM is applicable to non-assigned claims. Additionally, to the extent our proposal to expand application of the VM to nonphysician eligible professionals is finalized, we would likewise apply the VM only to services billed on an assignment-related basis and not to non-assigned services. We invite comments on this proposed clarification.

f. Payment Adjustment Amount

   Section 1848(p) of the Act does not specify the amount of payment that should be subject to the adjustment for the VM; however, section 1848(p)(4)(C) of the Act requires the VM be implemented in a budget neutral manner. Budget neutrality means that payments will increase for some groups and solo practitioners based on high performance and decrease for others based on low performance, but the aggregate expected amount of Medicare spending in any given year for physician and nonphysician eligible professional services paid under the Medicare PFS will not change as a result of application of the VM.

   In the CY 2014 PFS final rule with comment period (78 FR 74770-74771), we adopted a policy to apply a maximum downward adjustment of 2.0 percent for the CY 2016 VM for those groups of physicians with 10 or more eligible professionals that are in Category 2 and for groups of physicians with 100 or more eligible professionals that are in Category 1 and are classified as low quality/high cost groups.

   Although we received comments suggesting that larger payment adjustments (both upward and downward) would be necessary to more strongly encourage quality improvements, we finalized our proposed adjustments as we believed they better aligned with our goal to gradually phase in the VM. However, we noted that as we gained experience with our VM methodologies, we would likely consider ways to increase the amount of payment at risk (77 FR 69324).

   We received comments on the CY 2014 proposed rule suggesting that the payment adjustment under the VM must be of significant weight to drive physician behavior toward achieving high quality and low cost care and that the VM should represent a larger percentage of physician payments under the PFS that should be increased incrementally from 2.0 percent and subject to annual review. In our response to these comments, we agreed that the amount of payment at risk should be higher to incentivize physicians to provide high quality and low cost care. We also stated that our experience under PQRS has shown us that a 1.0 or 2.0 percent incentive payment has not produced widespread participation in the PQRS. Thus, we believed that we needed to increase the amount of payment at risk for the CY 2016 VM to incentivize physicians and groups of physicians to report PQRS data, which will be used to calculate the VM. We continue to believe this is the appropriate strategy.

   We believe that we can increase the amount of payment at risk because we can reliably apply a VM to groups with 2 or more eligible professionals and to solo practitioners in CY 2017 as discussed in section III.N.4.a. of this proposed rule. Therefore, we propose to increase the downward adjustment under the VM by doubling the amount of payment at risk from 2.0 percent in CY 2016 to 4.0 percent in CY 2017. That is, for CY 2017, we propose to apply a -4.0 percent VM to groups with two or more eligible professionals and solo practitioners that fall in Category 2. In addition, we propose to increase the maximum downward adjustment under the quality-tiering methodology in CY 2017 to -4.0 percent for groups and solo practitioners classified as low quality/high cost and to set the adjustment to -2.0 percent for groups and solo practitioners classified as either low quality/average cost or average quality/high cost. However, as discussed in section III.N.4.c of this proposed rule, we are proposing to hold solo practitioners and groups with between 2 and 9 eligible professionals that are in Category 1 harmless from any downward adjustments under the quality-tiering methodology in CY 2017. Consistent with our previous policy, we note that the estimated funds derived from the application of the downward adjustments to groups and solo practitioners in Category 1 and Category 2 would be available to all groups and solo practitioners eligible for VM upward payment adjustments. Based on an estimate of these funds, we also propose to increase the maximum upward adjustment under the quality-tiering methodology in CY 2017 to +4.0x for groups and solo practitioners classified as high quality/low cost and to set the adjustment to +2.0x for groups and solo practitioners classified as either average quality/low cost or high quality/average cost. We also propose to continue to provide an additional upward payment adjustment of +1.0x to groups and solo practitioners that care for high-risk beneficiaries (as evidenced by the average HCC risk score of the attributed beneficiary population). Lastly, we propose to revise SEC 414.1270 and SEC 414.1275(c) and (d) to reflect the proposed changes to the payment adjustments under the VM for the CY 2017 payment adjustment period. Table 58 shows the proposed quality-tiering payment adjustment amounts for CY 2017 (based on CY 2015 performance). We believe that the proposed VM amount differentiates between cost and quality tiers in a more meaningful way. We seek comments on all of these proposals. GOES

Table 58--CY 2017 Value-Based Payment Modifier Amounts Cost/quality Low Average High quality quality quality Low Cost +0.0% +2.0x* +4.0x* Average Cost -2.0% +0.0% +2.0x* High Cost -4.0% -2.0% +0.0% * Groups and solo practitioners eligible for an additional +1.0x if reporting Physician Quality Reporting System quality measures and average beneficiary risk score is in the top 25 percent of all beneficiary risk scores.



   Consistent with the policy adopted in the CY 2013 PFS final rule with comment period (77 FR 69324 through 69325), the upward payment adjustment factor ("x" in Table 58) would be determined after the performance period has ended based on the aggregate amount of downward payment adjustments.

   In section III.N.4.d of this proposed rule, we discussed our proposal to apply the VM to physicians and nonphysician eligible professionals in groups with 2 or more eligible professionals and to physicians and nonphysician eligible professionals who are solo practitioners that participate in the Shared Savings Program during the payment adjustment period beginning with the CY 2017 payment adjustment period. We will have the final list of ACOs that will participate in the Shared Savings Program during the payment adjustment period and their participant TINs during the late fall prior to the beginning of the payment adjustment period (for example, the late fall of CY 2016 prior to the CY 2017 payment adjustment period). We note that this final list may not be available until after the beginning of the payment adjustment period. Therefore, we propose to calculate preliminary payment adjustment factors ("x" in Table 58) prior to the beginning of the payment adjustment period, and subsequently finalize the payment adjustment factors after the final ACO participation list is completed. We note that the final payment adjustment factors may be updated depending on the outcome of the informal inquiry process described later at section III.N.4.i of this proposed rule.

g. Performance Period

   In the CY 2014 PFS final rule with comment period (78 FR 74771 through 74772), we adopted a policy that performance on quality and cost measures in CY 2015 will be used to calculate the VM that is applied to items and services for which payment is made under the PFS during CY 2017. Accordingly, we added a new paragraph (c) to SEC 414.1215 to indicate that the performance period is CY 2015 for VM adjustments made in the CY 2017 payment adjustment period.

h. Quality Measures

   In the CY 2014 PFS final rule with comment period (78 FR 74773), we aligned our policies for the VM for CY 2016 with the PQRS group reporting mechanisms available to groups in CY 2014 and the PQRS reporting mechanisms available to individual eligible professionals in CY 2014, such that data that groups submit for quality reporting purposes through any of the PQRS group reporting mechanisms in CY 2014 and the data that individual eligible professionals submit through any of the individual PQRS reporting mechanisms in CY 2014 will be used for calculating the quality composite under the quality-tiering approach for the VM for CY 2016. Moreover, all of the quality measures for which groups and individual eligible professionals are eligible to report under the PQRS in CY 2014 would be used to calculate the VM for a group for CY 2016 to the extent the group or individual eligible professionals in the group submits data on such measure in accordance with our 50 percent threshold policy (78 FR 74768). We also noted that, in accordance with 42 CFR 414.1230, three additional quality measures (outcome measures) for groups subject to the VM will continue to be included in the quality measures used for the VM in CY 2016. These measures are: (1) A composite of rates of potentially preventable hospital admissions for heart failure, chronic obstructive pulmonary disease, and diabetes; (2) a composite rate of potentially preventable hospital admissions for dehydration, urinary tract infections, and bacterial pneumonia; and (3) rates of an all-cause hospital readmissions measure (77 FR 69315).

   PQRS Reporting Mechanisms: We believe it is important to continue to align the VM for CY 2017 with the requirements of the PQRS, because quality reporting is a necessary component of quality improvement. We also seek not to place an undue burden on eligible professionals to report such data. Accordingly, for purposes of the VM for CY 2017, we propose to include all of the PQRS GPRO reporting mechanisms available to groups for the PQRS reporting periods in CY 2015 and all of the PQRS reporting mechanisms available to individual eligible professionals for the PQRS reporting periods in CY 2015. These reporting mechanisms are described in Tables 21 through 49 of this proposed rule.

   PQRS Quality Measures: We propose to use all of the quality measures that are available to be reported under these various PQRS reporting mechanisms to calculate a group or solo practitioner's VM in CY 2017 to the extent that a group (or individual eligible professionals in the group, in the case of the "50 percent option") or solo practitioner submits data on these measures. These PQRS quality measures are described in Tables 21 through 49 of this proposed rule. We propose that groups with 2 or more eligible professionals would be able to elect to include the patient experience of care measures collected through the PQRS CAHPS survey for CY 2015 in their VM for CY 2017. We propose to continue to include the three outcome measures in SEC 414.1230 in the quality measures used for the VM in CY 2017. For groups that are assessed under the "50 percent option" for the CY 2017 VM, we propose to calculate the group's performance rate for each measure reported by at least one eligible professional in the group by combining the weighted average of the performance rates of those eligible professionals reporting the measure. We also propose for groups that are assessed under the "50 percent option" for the CY 2017 VM to classify a group's quality composite score as "average" under the quality-tiering methodology, if all of the eligible professionals in the group satisfactorily participate in a PQRS qualified clinical data registry in CY 2015 and we are unable to receive quality performance data for those eligible professionals. If some EPs in the group report data using a qualified clinical data registry and we are unable to obtain the data, but other EPs in the group report data using the other PQRS reporting mechanisms for individuals, we would calculate the group's score based on the reported performance data that we obtain through those other mechanisms.

   While we finalized policies in the CY 2014 final rule with comment period that would allow groups assessed under the "50 percent option" to have data reported through a PQRS qualified clinical data registry in CY 2014 used for the purposes of their CY 2016 VM to the extent performance data are available, we note that we did not directly address the issue of how we would compute the national benchmarks for these measures. Under SEC 414.1250, benchmarks for the quality of care measures for the VM are the national mean of a measure's performance rate during the year prior to the performance period. In the CY 2013 PFS final rule with comment period (77 FR 69322), we finalized a policy that if a measure is new to the PQRS, we will be unable to calculate a benchmark, and hence, performance on that measure will not be included in the quality composite. Therefore, we propose to apply that policy to measures reported through a PQRS qualified clinical data registry that are new to PQRS (in other words, measures that were not previously reported in PQRS). Performance on these measures would not be included in the quality composite for the VM because we would not be able to calculate benchmarks for them. This proposal would apply beginning with the measures reported through a PQRS qualified clinical data registry in the CY 2014 performance period for the CY 2016 payment adjustment period. We welcome public comment on this proposal.

   In addition, we note that the PQRS administrative claims option, which included the outcome measures described in SEC 414.1230, is no longer available through PQRS. We propose to clarify that we calculate benchmarks for those outcome measures described in SEC 414.1230 using the national mean for a measure's performance rate during the year prior to the performance period in accordance with our regulation at SEC 414.1250(b). We welcome public comment on this proposal.

   Quality Measures for the Shared Savings Program: Starting with the CY 2017 payment adjustment period, as described in section III.M. of this proposed rule, we are proposing to apply the value modifier to groups and solo practitioners participating in ACOs under the Shared Savings Program. To do so, we are proposing quality measures and benchmarks for use with these groups and solo practitioners and seek public comment on these proposals. We describe these proposals more fully below.

   With regard to quality measures, we note that there is substantial overlap between those used to evaluate the ACOs under the Shared Savings Program and those used in the PQRS program and for the value modifier payment adjustment. For the CY 2017 payment adjustment period and subsequent payment adjustment periods, to determine a quality composite for the VM for groups and solo practitioners that participate in an ACO under the Shared Savings Program, we propose to use the quality measures that are identical for the two programs. Specifically, for the CY 2017 payment adjustment period, we propose to use the PQRS GPRO Web Interface measures and the outcome measure described at SEC 414.1230(c) to determine a quality composite for groups and solo practitioners that participate in an ACO under the Shared Savings Program. Because the ACO GPRO measures and PQRS GPRO Web Interface measures will be the same in CY 2015, we propose to use the GPRO Web Interface measures reported by ACOs in determining the quality composite for groups and solo practitioners participating in ACOs under the Shared Savings Program in CY 2017. Utilizing these GPRO Web Interface measures in this regard further encourages successful quality reporting for Shared Savings Program ACOs. Additionally, we believe that the all-cause hospital readmissions measure as calculated for ACOs under the Shared Savings Program is equivalent to the all-cause hospital readmissions measure we have adopted for the VM at SEC 414.1230(c) and therefore propose use of that measure as calculated for ACOs in the Shared Savings Program for inclusion in the VM for the CY 2017 payment adjustment period. We note that the outcome measures described at SEC 414.1230(a) and SEC 414.1230(b) are not currently calculated for ACOs in the Shared Savings Program. These measures are: (1) A composite of rates of potentially preventable hospital admissions for heart failure, chronic obstructive pulmonary disease, and diabetes; and (2) a composite rate of potentially preventable hospital admissions for dehydration, urinary tract infections, and bacterial pneumonia. Because we have no experience with these measures in the Shared Savings Program, at this time, we do not propose to include these measures for groups and solo practitioners that participate in ACOs under that program. We propose to modify the regulations at SEC 412.1230 accordingly.

   To determine the standardized scores for these quality measures proposed for use with those participating in ACOs under the Shared Savings Program, we propose to apply the benchmark policy for quality measures for the VM as described under SEC 414.1250. Under this policy, the VM benchmarks are the national mean for a measure's performance rate based on data from one year prior to the performance period. We believe these are the appropriate benchmarks to use when determining the value modifier payment adjustment because they are the same benchmarks used to determine the value modifier payment adjustment for other groups and solo practitioners. In other words, we believe that use of the VM benchmarks creates a fair comparison among groups and solo practitioners because we believe it is appropriate to evaluate those that participate in Shared Savings Program ACOs on the same basis as those that do not participate in the Shared Savings Program for the purpose of the value modifier. We believe the VM benchmarks are appropriate because they include all PQRS data available (77 FR 69322), including quality data used for the Shared Savings Program. On the other hand, while the Shared Savings Program develops benchmarks using all available Medicare fee-for-service data, we do not believe it is appropriate to use the benchmarks from the Shared Savings Program to determine standardized scores for the quality composite of the value modifier payment adjustment. We do not think this enables a fair comparison among groups and solo practitioners subject to the value modifier because the Shared Savings Program benchmarks are calculated using a different methodology, providing gradients by decile (including the median) of national performance based on data two years prior to the performance period (78 FR 74759 through 74760).

   All-Cause Hospital Readmissions Measure: In addition, since finalizing the all-cause hospital readmissions measure described at SEC 414.1230(c) in the CY 2013 PFS final rule with comment (77 FR 69285), we have investigated the reliability of this measure. According to SEC 414.1265, to calculate a composite score for a quality or cost measure based on claims, a group subject to the VM must have 20 or more cases for that measure. Furthermore, according to SEC 414.1265(a), if a group has fewer than 20 cases for a measure in a performance period, that measure is excluded from its domain and the remaining measures in the domain are given equal weight.

   Based on 2012 data, we found that the average reliability for the all-cause hospital readmissions measure was below 0.4 when we examined groups with fewer than 200 cases but exceeded 0.4 for groups with 200 or more cases. Although we do not believe there is a universal consensus concerning a minimum reliability threshold, reliability scores in the 0.4 to 0.7 range are often considered moderate, and scores greater than 0.7 are considered high. In general, we found that the groups with at least 10 eligible professionals were more likely to have 200 or more cases as compared to groups with fewer eligible professionals. Thirty percent of groups with 10 or more eligible professionals had 200 or more cases, as compared to 3 percent of groups with 1-9 eligible professionals. Nonetheless, the finding that the average reliability exceeded 0.4 for groups with 200 or more cases included all group sizes (1 or more eligible professionals).

   After examining the reliability of the all-cause hospital readmissions measure data for 2012 across all group sizes and considering its impacts on the cost composite of the VM as discussed below, we propose to change the reliability policy (minimum number of cases) with respect to this measure. Specifically, beginning with the CY 2017 payment adjustment period, we propose to change the reliability policy (minimum number of cases) with respect to the all-cause hospital readmissions measure as described in SEC 414.1230(c) from a minimum of 20 cases to a minimum of 200 cases for this measure to be included in the quality composite for the VM. For this measure only, we propose to exclude the measure from the quality domain for a group or solo practitioner if the group or solo practitioner has fewer than 200 cases for the measure during the relevant performance period. In implementing this proposal, we note that we would only apply it to the all-cause hospital readmissions measure as it is calculated for groups or solo practitioners that are not part of a Shared Savings Program ACO. In instances where we are including Shared Savings Program data for groups or solo practitioners that are part of a Shared Savings Program ACO, we would include their all-cause hospital readmissions measure as it is calculated for the