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Coverage with Evidence Development

Autologous Platelet-rich Plasma (PRP)

CMS covers autologous platelet-rich plasma (PRP) only for patients who have chronic non-healing diabetic, pressure, and/or venous wounds and when all the following conditions are met:

  1. The patient is enrolled in a clinical research study that addresses the following questions using validated and reliable methods of evaluation.
  2. Clinical study applications for coverage pursuant to this National Coverage Determination (NCD) must be received 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:

  1. complete wound healing;
  2. ability to return to previous function and resumption of normal activities; or
  3. reduction of wound size or healing trajectory, which results in the patient's ability to return to previous function and resumption of normal activities?

CMS issued a Medicare National Coverage Determination on August 2, 2012 which allows coverage of autologous PRP under coverage with Evidence Development (CED) with certain conditions. The complete determination is available on our website.

http://www.cms.gov/medicare-coverage-database/details/nca-details.aspx?NCAId=260