CMS Posts Final Decision for Autologous PRP Coverage
In a final decision memo, the Centers for Medicare & Medicare Services (CMS) says there is insufficient evidence that autologous platelet-rich plasma (PRP) improves health outcomes in individuals with chronic diabetic, pressure, and/or venous wounds.
PRP used to treat chronic non-healing diabetic, pressure, and/or venous wounds may be covered under Medicare only when the beneficiary is enrolled in a clinical research study that addresses the following questions using validated and reliable methods of evaluation:
“Prospectively, do Medicare beneficiaries who have chronic non-healing diabetic, pressure, and/or venous wounds who receive well-defined optimal usual care along with PRP therapy, experience clinically significant health outcomes compared to patients who receive well-defined optimal usual care for chronic non-healing diabetic, pressure, and/or venous wounds as indicated by addressing at least one of the following:
a. complete wound healing;
b. ability to return to previous function and resumption of normal activities; or
c. reduction of wound size or healing trajectory, which results in the patient’s ability to return to previous function and resumption of normal activities?”
Clinical study applications for coverage must be received by CMS no later than Aug. 2, 2014; and the study of PRP must adhere to standards of scientific integrity and relevance to the Medicare population, as outlined in the decision memo.
CMS formally opened a third reconsideration of the national coverage analysis (NCA) on autologous blood-derived products for chronic non-healing wounds Nov. 9, 2011 and posted this final determination Aug. 2, 2012.