GAITHERSBURG, MD -- (Marketwired) -- 07/10/13 -- Cytomedix, Inc. (OTCQX: CMXI)
•Covers AutoloGel in Physicians' Offices and Outpatient Settings •Use in Physician's Offices Expected to Add Incremental Sales in 2H-2013
Cytomedix, Inc. (OTCQX: CMXI), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today that the Centers for Medicare and Medicaid Services (CMS) has issued proposed payment regulations under the Physician Fee Schedule (PFS) and the Hospital Outpatient Prospective Payment System (HOPPS) that include proposed guidelines covering Medicare reimbursement for AutoloGel. Following review and revision based on public comments, the final regulations will take effect on January 1, 2014.
CMS has proposed that Medicare Administrative Contractors (MACs) determine the payment amount for AutoloGel for claims submitted from physician offices. Historically, Medicare contractors have paid these types of claims based on product invoices presented by the healthcare provider. Cytomedix expects that providers will be paid based on the product invoice they use to substantiate the charges they submit to their respective MACs. For claims submitted by physician offices from July 1, 2013, through December 31, 2013, CMS has instructed MACs to follow the same payment process as outlined in the proposed rule. As a result, Cytomedix expects to charge a price for AutoloGel in this large market segment that is economically viable, leading to additional sales opportunities for the Company in the second half of this year.
Under the proposed HOPPS regulations, CMS has placed the reimbursement code for AutoloGel in an Ambulatory Payment Classification that provides limited reimbursement for use of the product in the outpatient setting. For claims submitted from July 1, 2013, through December 31, 2013, CMS has instructed MACs to use the same payment category as outlined in the proposed regulation.
As part of government transparency initiatives, CMS allows for a public comment period during which interested parties may submit formal written comments on any aspect of these proposed rules. CMS will review and consider those public submissions while deliberating on the final rule, which will be issued in November. Cytomedix will continue to work with CMS and will submit comments in support of adequate payment for AutoloGel in the hospital outpatient setting.
"By allowing individual contractors to determine the reimbursement amounts for services furnished in a physician's office, CMS has established an opportunity for reasonable payment and a path for implementing Medicare's National Coverage Decision (NCD)," said Martin Rosendale, Chief Executive Officer of Cytomedix. "We are excited about initiating AutoloGel treatments for patients receiving services in physicians' offices, and providing access to Medicare beneficiaries suffering with chronic wounds."
Mr. Rosendale continued, "While the hospital outpatient reimbursement decision will, in the short term, limit access for some Medicare beneficiaries, we look forward to working with CMS through a well established public process to have this addressed. We remain optimistic that CMS wants the NCD to be implemented successfully in all sites of care, and will agree to a reasonable APC assignment following the public comment period. In the meantime, we will begin treating Medicare beneficiaries in the physician's office market, and prepare to launch AutoloGel in the hospital outpatient market."
Background on Ambulatory Payment Classifications
The Hospital Outpatient Prospective Payment System (HOPPS) is used by CMS to determine payment for services provided in hospital outpatient settings and covered by Medicare. All services paid under HOPPS are classified into groups called Ambulatory Payment Classifications or APCs. Services in each APC are similar clinically and use comparable resources. A single payment rate is established for each APC. Within each APC, payment for dependent, ancillary, supportive, and adjunctive items and services is packaged into payment for the primary independent service. HOPPS was defined in the Balanced Budget Act of 1997 and was implemented on August 1, 2000.
About The AutoloGel System
The AutoloGel System utilizes a unique proprietary technology that enables the rapid isolation and activation of PRP from a patient's own blood. The PRP is subsequently processed to produce a bioactive gel for application to the wound bed, re-establishing a balance needed for natural healing to occur. In normal healing, platelets migrate from the blood into the wound site where they serve as the primary source of growth factors for effective wound healing. In chronic wounds, blood supply may be impaired and the delivery of platelets is impeded, disallowing adequate concentrations of growth factors. The AutoloGel System is used at the point-of-care and is the only PRP system cleared by the U.S. Food and Drug Administration for use on exuding wounds, such as leg ulcers, pressure ulcers and diabetic ulcers, and for the management of mechanically or surgically-debrided wounds. Cytomedix's clinical studies have shown that AutoloGel rapidly and more effectively improved healing compared with control-treated wounds. This has been demonstrated in a variety of clinical studies including a systematic review of 21 comparison studies and a number of other observational and case series publications as well.
Cytomedix, Inc. is an autologous regenerative therapies company commercializing innovative platelet technologies for orthopedics and wound care with a pipeline of adult stem cell therapies for tissue repair. The Company markets the AutoloGel System, a device for the production of autologous platelet rich plasma ("PRP") gel for use on a variety of exuding wounds and the Angel® Concentrated Platelet Rich Plasma System, a blood processing device and disposable products used for the separation of whole blood or a mixture of blood and bone marrow, into red cells, platelet poor plasma ("PPP") and PRP in surgical settings On February 8, 2012 Cytomedix closed the acquisition of Aldagen, a biopharmaceutical company developing regenerative cell therapies based on its proprietary ALDH bright cell technology, currently in a Phase 2 trial for the treatment of ischemic stroke. For additional information please visit cytomedix.com.
Safe Harbor Statement - Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including among many others, risks and uncertainties related to the Company's ability to successfully execute its Angel and AutoloGel sales strategies, to achieve AutoloGel expected reimbursement rates in 2013, to successfully negotiate with physician offices as anticipated and to realize the anticipated sales growth from such treatments; to meet its stroke trial enrollment rates, the Company's ability to successfully integrate the Aldagen acquisition, the Company's ability to expand patient populations as contemplated, its ability to provide Medicare patients with access as expected, the Company's expectations of favorable future dialogue with potential strategic partners, and its ability to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes", "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2012, as amended to date, and other subsequent filings. These filings are available at www.sec.gov.
Chief Executive Officer
Steven A. Shallcross
EVP/Chief Financial Officer
LifeSci Advisors, LLC
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