Cytomedix Announces Medicare Coverage for Autologous PRP Gel in Chronic Wound Care
GAITHERSBURG, MD -- (Marketwire) -- 08/06/12 -- Cytomedix, Inc. (OTCBB: CMXI) (OTCQB: CMXI) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, today announced that the Centers for Medicare & Medicaid Services ("CMS") has issued a final National Coverage Determination ("NCD") for autologous blood-derived products for chronic non-healing wounds. As previously reported, on May 9, 2012 CMS posted its proposed NCD, which was followed by a 30-day public comment period that ended on June 8th. In the final decision memo released August 2nd, CMS responded to these comments, refined its decision and confirmed coverage for autologous platelet rich plasma ("PRP") in patients with diabetic, pressure and/or venous wounds via its Coverage with Evidence Development ("CED") program. CED is a process through which CMS provides reimbursement coverage for items and services while generating additional clinical data to demonstrate their impact on health outcomes.
In the final decision memo, CMS noted that it " ...has reviewed the medical literature on autologous PRP in patients with chronic wounds and believes that CED is appropriate for PRP treatment," and concluded that, "when reviewed as a body of evidence, it does indicate that PRP shows promise in the populations of interest to CMS."
"We are extremely pleased with the decision by CMS to provide coverage for autologous blood-derived products for chronic non-healing wounds through the CED program. This determination reverses a nearly 20 year non-coverage determination for PRP and provides for an appropriate research study with practical study designs we are confident will demonstrate that patients treated with our autologous PRP product, the AutoloGel System, experience clinically significant health outcomes," commented Martin P. Rosendale, Chief Executive Officer of Cytomedix.
"Importantly, we believe this decision by CMS bodes well for our ongoing discussions with a top 20 global pharmaceutical company for a favorable long-term arrangement in the U.S. wound care market, as clarity around the CED evidentiary requirements was a necessary element of the commercial market assessment," added Mr. Rosendale. "In the meantime, our discussions for a distribution agreement to be executed prior to month's end are progressing well."
Related to the evidentiary requirements, CMS outlined in the final decision memo that a research study that uses data collected by a registry can enhance its persuasiveness if it has the following attributes:
- It is a prospectively collected clinical research database for wound care that acquires certain standardized data elements.
- The information about the intervention is controlled and standardized, (i.e., the method of preparation of the PRP including the volume and concentration of platelets, lysate, anticoagulant or other additives, method and length of time of storage, centrifuge time, amount of blood taken for preparation, application schedule, etc.).
- There is longitudinal follow up whereby registry patients would have to be followed for pre-specified and well defined outcomes measured using standardized methods including:
- percentage of patients completely healed,
- time to healing,
- ulcer area reduction,
- durability of recovery,
- adverse events, and
- changes in functional status and mobility.
- There is a source of comparable patients who are treated with standard of care and for whom the data collection would have to be equivalent to that of the patients receiving PRP.
Mr. Rosendale added, "This decision appears to indicate that our recent interactions with CMS have been productive, as CMS has acknowledged the rationale we presented for a comprehensive research study that can appropriately encompass practical study designs to meet the evidentiary requirements of CMS. We look forward to continuing to work with CMS in the coming weeks in further defining the specifics of the protocols for the research studies and clinical questions to be answered through the CED program."
The complete final decision memo is available on the CMS website at: http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=260.
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