On August 2, 2012, the Centers for Medicare and Medicaid Services (CMS) issued a Medicare National Coverage Determination which allows coverage of autologous PRP (platelet-rich plasma) under coverage with Evidence Development (CED) with certain conditions.
On December 15, 2014, the agency updated its coverage page for meeting the conditions for applying for approval of a CED study.
CMS covers autologous PRP only for patients who have chronic non-healing diabetic, pressure, and/or venous wounds and when all the following conditions are met:
- The patient is enrolled in a clinical research study that addresses the following questions using validated and reliable methods of evaluation.
- Clinical study applications for coverage pursuant to this National Coverage Determination (NCD) must be approved by August 2, 2014.
The clinical research study must meet the requirements specified below to assess the effect of PRP for the treatment of chronic non-healing diabetic, pressure, and/or venous wounds. The clinical study must address:
“Prospectively, do Medicare beneficiaries that 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:”
- complete wound healing;
- ability to return to previous function and resumption of normal activities; or
- reduction of wound size or healing trajectory, which results in the patient’s ability to return to previous function and resumption of normal activities?
The complete determination is available here.
Instructions for submission of applications is available here.
