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National Coverage Analysis (NCA) Tracking Sheet for Autologous Blood-Derived Products for Chronic Non-Healing Wounds (CAG-00190R3)

CMS has defined a chronic wound as one in which the healing process has failed to progress properly and the wound persists for longer than 30 days. Chronic wounds are common in the face of many disease processes, including diabetes and vascular insufficiency as well as in those individuals with mobility impairments.

Platelet rich concentrates, gels and releasates have been used as topical treatments for many years. Platelets contain a large number of growth factors and cytokines, which when released, are thought to stimulate the process of wound healing.

CMS has made previous pertinent decisions regarding plasma products used for wound healing, the last being in March 2008, in a National Coverage Decision (NCD) for Blood-Derived Products for Chronic Non-Healing Wounds (270.3). At that time, we determined that the evidence was not adequate to conclude that autologous platelet-rich plasma (PRP) is reasonable and necessary for the treatment of chronic non-healing, cutaneous wounds. Additionally, we determined the evidence was not adequate to conclude that autologous PRP is reasonable and necessary for the treatment of acute surgical wounds when the autologous PRP is applied directly to the closed incision or for dehiscent wounds.

However, interested parties have asked for reconsideration of NCD 270.3 in order to examine new evidence surrounding the use of autologous platelet rich gel used to improve the health outcomes in patients with chronic non-healing pressure ulcers, venous ulcers and diabetic foot ulcers. Specifically, they are asking that we cover PRP gel produced by systems that have received clearance or approval by the Food and Drug Administration for the treatment of pressure ulcers, venous ulcers or diabetic foot ulcers may be covered for those indications following a period of at least 30 days during which alternative covered treatments have been unsuccessful in reducing wound area or depth. The request includes a proposal to prospectively collect outcomes data to furnish additional evidence.

CMS is reconsidering NCD 270.3 to complete a thorough review of the evidence to determine if the use of autologous platelet rich gel in patients with chronic non-healing pressure ulcers, venous ulcers and diabetic foot ulcers is reasonable and necessary under the Medicare program. As we are considering coverage under Section 1862(a)(1)(A) and Section 1862(a)(1)(E) of the Social Security Act, we also encourage the submission of comments that would pertain to clinical studies falling under the Coverage with Evidence Development (CED) paradigm.

Incident to a physician's professional Service
Requestor Name(s)Jean M. de Leon, MD; Vickie R. Driver, MS DPM FACFAS; Caroline E. Fife, MD; Robert G. Frykberg, DPM MPH; William W. Li, MD; Martin P. Rosendale, Thomas E. Serena, MD, FACS, FAPWCA
Requestor Letter(s)View Letter
Formal Request Accepted and Review Initiated11/09/2011
Expected NCA Completion Date08/07/2012
Public Comment Period11/09/2011 - 12/09/2011
Proposed Decision Memo Released05/09/2012
Proposed Decision Memo Public Comment Period: 05/09/2012 - 06/08/2012 
Decision Memo Released08/02/2012
Comments for this NCA:View Public Comments
Lead Analyst(s)
Lead Medical Officer(s)
  • James Rollins, MD, PhD

November 9, 2011

CMS opens this reconsideration of the NCD for Blood-Derived products for Chronic Non-Healing Wounds (270.3), in order to reevaluate the use of PRP products in the treatment of chronic non-healing pressure ulcers, venous ulcers and diabetic foot ulcers. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies falling under the coverage with evidence development (CED) paradigm. Instructions on submitting comments can be found at http://www.cms.hhs.gov/InfoExchange/02_publiccomments.asp#TopOfPage

You can also submit a public comment by clicking on the highlighted word COMMENT in the title bar at the top of this page. We strongly urge that all public comments be submitted through this website. Please do not submit personal health information in public comments. Comments with personal health information may not be posted to the website.

May 9, 2012

August 2, 2012

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