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."
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