CMXI shares are soaring in today’s trading after the company announced that the Centers for Medicare & Medicaid Services (CMS) issued a final National Coverage Determination (NCD) for autologous blood-derived products for chronic non-healing wounds.
Back in May this year, CMS posted its proposed NCD, which was followed by a 30-day public comment period. In the final decision memo, which was released last week, CMS responded to the comments, refined its decision and confirmed coverage for autologous platelet rich plasma (PRP) in patients with diabetic, pressure and/or venous wounds through its Coverage with Evidence Development program (CED) program.
Through the CED program, CMS offers conditional payment for items and services while generating additional clinical data to show their impact on health outcomes.
CMS noted in its final decision memo that it reviewed the medical literature on autologous PRP in patients with chronic wounds and believes that CED is appropriate for PRP treatment.CMS concluded in its memo that when reviewed as a body of evidence, it does indicate that PRP shows promise in the populations of interest to CMS.
Martin P. Rosedale, CEO of Cytomedix, said that CMXI is extremely pleased with the decision by CMS to provide coverage for autologous blood-derived products for chronic non-healing wounds through the CED program. Rosendale said that the determination reverses a nearly 20 year non-coverage determination for PRP and provides for an appropriate research study with practical study designs that will show that patients treated with autologous PRP product, the AutoGel™ system, experience clinically significant health outcomes.
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