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Article
CMS to cover plasma gel in clinical trials
Author(s):
The Centers for Medicare and Medicaid Services will cover autologous platelet-rich plasma (PRP) gel for patients suffering chronic wounds only in approved clinical trials.
Washington - The Centers for Medicare and Medicaid Services will cover autologous platelet-rich plasma (PRP) gel for patients suffering chronic wounds only in approved clinical trials.
The decision allows PRP gel to be used to treat pressure wounds, venous ulcers and chronic diabetes and reverses a nearly 20-year precedent of non-coverage for platelet-derived wound healing formulas, MedPageToday reports.
Cytomedix, a Maryland-based firm, had petitioned CMS to cover its PRP product, AutoloGel. PRP gel, an extract derived from a patient’s blood, contains platelets, growth factors, chemokines and cytokines, which may help repair damaged tissue.
In September 2007, the Food and Drug Administration approved the AutoloGel System as a medical device for manufacturing and delivering autologous platelet-rich plasma.
By obtaining CMS coverage, Cytomedix will be able to study the product on a Medicare population. After the study, CMS will rule whether the product will be given full coverage.
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