News Column

HHS and Centers for Medicare & Medicaid Services Issuse Final Rule on Medicare and Medicaid Electronic Health Record Program

September 4, 2014



Targeted News Service

WASHINGTON, Sept. 4 -- The U.S. Department of Health & Human Services and Centers for Medicare & Medicaid Services published the following rule in the Federal Register:

Medicare and Medicaid Programs; Modifications to the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program for 2014 and Other Changes to the EHR Incentive Program; and Health Information Technology: Revisions to the Certified EHR Technology Definition and EHR Certification Changes Related to Standards

A Rule by the Health and Human Services Department and the Centers for Medicare & Medicaid Services on 09/04/2014

Publication Date: Thursday, September 04, 2014

Agencies: Office of the Secretary

Department of Health and Human Services

Centers for Medicare & Medicaid Services

Dates: These regulations are effective on October 1, 2014.

Effective Date: 10/01/2014

Entry Type: Rule

Action: Final rule.

Document Citation: 79 FR 52909

Page: 52909 -52933 (25 pages)

CFR: 42 CFR 495

45 CFR 170

Agency/Docket Number: CMS-0046-F and CMS-0052-F

Document Number: 2014-21021

Shorter URL: https://federalregister.gov/a/2014-21021

Action

Final Rule.

Summary

This final rule changes the meaningful use stage timeline and the definition of certified electronic health record technology (CEHRT) to allow options in the use of CEHRT for the EHR reporting period in 2014. It also sets the requirements for reporting on meaningful use objectives and measures as well as clinical quality measure (CQM) reporting in 2014 for providers who use one of the CEHRT options finalized in this rule for their EHR reporting period in 2014. In addition, it finalizes revisions to the Medicare and Medicaid EHR Incentive Programs to adopt an alternate measure for the Stage 2 meaningful use objective for hospitals to provide structured electronic laboratory results to ambulatory providers; to correct the regulation text for the measures associated with the objective for hospitals to provide patients the ability to view online, download, and transmit information about a hospital admission; and to set a case number threshold exemption for CQM reporting applicable for eligible hospitals and critical access hospitals (CAHs) beginning with FY 2013. Finally, this rule finalizes the provisionally adopted replacement of the Data Element Catalog (DEC) and the Quality Reporting Document Architecture (QRDA) Category III standards with updated versions of these standards.

DATES:

These regulations are effective on October 1, 2014.

FOR FURTHER INFORMATION CONTACT:

Elizabeth Holland, (410) 786-1309.

Elisabeth Myers, (410) 786-4751.

Elise Sweeney Anthony, (202) 475-2485.

SUPPLEMENTARY INFORMATION:

I. Background

A. Statutory Basis

1. Standards, Implementation Specifications, and Certification Criteria

The Health Information Technology for Economic and Clinical Health (HITECH) Act, Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5) was enacted on February 17, 2009. The HITECH Act amended the Public Health Service Act (PHSA) and created "Title XXX--Health Information Technology and Quality" to improve health care quality, safety, and efficiency through the promotion of health IT and electronic health information exchange.

Section 3004(b)(3) of the PHSA titled "Subsequent Standards Activity" provides that the "Secretary shall adopt additional standards, implementation specifications, and certification criteria as necessary and consistent" with the schedule published by the HIT Standards Committee. We consider this provision in the broader context of the HITECH Act to grant the Secretary the authority and discretion to adopt standards, implementation specifications, and certification criteria that have been recommended by the HIT Standards Committee and endorsed by the National Coordinator, as well as other appropriate and necessary health IT standards, implementation specifications, and certification criteria.

In the September 4, 2012Federal Register (77 FR 54163), the Secretary issued a final rule (the "2014 Edition EHR certification criteria final rule") that adopted the 2014 Edition EHR certification criteria and a revised Certified EHR Technology (CEHRT) definition. The standards, implementation specifications, and certification criteria adopted by the Secretary in the final rule established the capabilities that CEHRT must include in order to, at a minimum, support the achievement of meaningful use by eligible professionals (EPs), eligible hospitals, and CAHs under the Medicare and Medicaid EHR Incentive Programs beginning with the EHR reporting periods in FY/CY 2014.

2. Health IT Certification Programs

Section 3001(c)(5) of the PHSA provides the National Coordinator with the authority to establish a certification program or programs for the voluntary certification of health IT. Specifically, section 3001(c)(5)(A) specifies that the "National Coordinator, in consultation with the Director of the National Institute of Standards and Technology, shall keep or recognize a program or programs for the voluntary certification of health information technology as being in compliance with applicable certification criteria adopted under this subtitle" (that is, certification criteria adopted by the Secretary under section 3004 of the PHSA). The certification program(s) must also "include, as appropriate, testing of the technology in accordance with section 13201(b) of the [HITECH] Act."

Section 13201(b) of the HITECH Act requires that with respect to the development of standards and implementation specifications, the Director of the National Institute of Standards and Technology (NIST), in coordination with the HIT Standards Committee, "shall support the establishment of a conformance testing infrastructure, including the development of technical test beds." The HITECH Act also indicates that "[t]he development of this conformance testing infrastructure may include a program to accredit independent, non-Federal laboratories to perform testing." ONC has established the ONC HIT Certification Program for the purpose of testing and certifying health information technology, related to the compliance of health IT with adopted standards, implementation, and certification criteria. (see 76 FR 1262 and 77 FR 54268). EHR technology capabilities certified through the ONC HIT Certification Program are required for use with the EHR Incentive Programs (see 76 FR 1262).

3. Medicare and Medicaid EHR Incentive Programs

The American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5) amended Titles XVIII and XIX of the Social Security Act (the Act) to authorize incentive payments to EPs, eligible hospitals, CAHs, and Medicare Advantage (MA) organizations to promote the adoption and meaningful use of certified electronic health record (EHR) technology. Sections 1848(o), 1853(l) and (m), 1886(n), and 1814(l) of the Act provide the statutory basis for the Medicare incentive payments made to meaningful EHR users. These statutory provisions govern EPs, MA organizations (for certain qualifying EPs and hospitals that meaningfully use CEHRT, subsection (d) hospitals, and CAHs, respectively. Sections 1848(a)(7), 1853(l) and (m), 1886(b)(3)(B), and 1814(l) of the Act also establish downward payment adjustments, beginning with calendar or fiscal year 2015, for EPs, MA organizations, subsection (d) hospitals, and CAHs that are not meaningful users of CEHRT for certain associated reporting periods. Sections 1903(a)(3)(F) and 1903(t) of the Act provide the statutory basis for Medicaid incentive payments.

[*Federal RegisterVJ 2014-09-04]

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