National Coverage Analysis (NCA) Tracking Sheet

Autologous Blood-Derived Products for Chronic Non-Healing Wounds

CAG-00190R4

Issue

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.

Since 2012, CMS has covered autologous platelet-rich plasma (PRP) for patients with chronic non-healing diabetic wounds, pressure wounds and venous wounds under Coverage with Evidence Development (CED).

CMS received a complete, formal request from Nuo Therapeutics to reconsider the NCD. CMS will complete a thorough review of published evidence to determine if the use of autologous platelet rich plasma in patients with chronic non-healing pressure ulcers, venous ulcers and diabetic foot ulcers is reasonable and necessary under the Medicare program.

CMS is soliciting public comment relevant to the reconsideration. We are particularly interested in comments that include scientific evidence and that address the breadth of the request.

Benefit Category

Incident to a physician's professional Service
Physicians' Services

Requestor Information

Requestor NameRequestor Letter
Nuo Therapeutics, Inc. View Letter

Important Dates

Formal Request Accepted and Review Initiated
04/03/2020
Expected NCA Completion Date
03/21/2021
Public Comment Period
04/03/2020 - 05/03/2020
Proposed Decision Memo Released
12/21/2020
Proposed Decision Memo Public Comment Period
12/21/2020 - 01/20/2021
Decision Memo Released
04/13/2021
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
David Dolan
david.dolan@cms.hhs.gov
410-786-3365
Lead Medical Officers
James Rollins, MD, PhD

Actions Taken

April 3, 2020

CMS initiates this national coverage analysis for Autologous Blood-Derived Products for Chronic Non-Healing Wounds. 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 and other scientific information relevant to the topic under review.

Instructions on submitting comments can be found at: http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html.

To submit a comment, please use the orange "Comment" button at the top of the page. Enter comments directly into the "Submit A Public Comment" webpage.

December 21, 2020

April 13, 2021