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Autologous Platelet-rich Plasma

Guidance for coverage for 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: 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.

Issued by: Centers for Medicare & Medicaid Services (CMS)

Issue Date: January 30, 2020

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 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:

  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.

Decision Memo

 

How to apply for CMS approval of CED study for Autologous Platelet-rich Plasma (PDF)

Approved Studies:

Study Title: Reapplix 3C Patch® System for the Treatment of Diabetic Foot Ulcers: A Medicare Claims Study
Sponsor: Reapplix
ClinicalTrials.gov Number: NCT03997526
CMS Approval Date: 06/20/19

Study Title: Randomized, Placebo-Controlled, Blind-Assessor Study to Evaluate the Safety and Efficacy of Autologous Platelet Rich Plasma Gel Prepared with the RegenKit-BCT Plus Family of Kits for the Treatment of Diabetic Foot Ulcer
Sponsor: RegenLab SA
ClinicalTrials.gov Number: NCT02402374
CMS Approval Date: 01/15/2015

Study Title: Effectiveness of Autologous Platelet Rich Plasma in the Treatment of Chronic Non-Healing Wounds
Sponsor: ACR Biologics, LLC
ClinicalTrials.gov Number: NCT02307448
CMS Approval Date: 10/31/2014

Study Title: A Prospective, Randomized Clinical Trial of ECLIPSE PRP™ Wound Biomatrix in Non-Healing Diabetic Foot Ulcers
Sponsor: PRP Concepts, LLC
ClinicalTrials.gov Number: NCT02312596
CMS Approval Date: 09/25/2014

Study Title: Clinical Trial of ECLIPSE PRP™ Wound Biomatrix in Chronic Non-Healing Venous Leg Ulcers
Sponsor: PRP Concepts, LLC
ClinicalTrials.gov Number: NCT02312518
CMS Approval Date: 09/25/2014

Study Title: Clinical Trial of ECLIPSE PRP™ Wound Biomatrix in Chronic Non-Healing Pressure Ulcers
Sponsor: PRP Concepts, LLC
ClinicalTrials.gov Number: NCT02312570
CMS Approval Date: 09/25/2014

Study Title: Leucopatch® System in the Management of Hard-To-Heal Diabetic Foot Ulcers
Sponsor: Nottingham University Hospitals NHS Trust (Reapplix Aps)
ClinicalTrials.gov Number: NCT02224742
CMS Approval Date: 08/14/2014

Study Title: A Multi-Center, Randomized Trial Comparing the Effectiveness of APIC-PRP to Control, when added to Standard of Care in the Treatment of Non-healing Diabetic Foot Ulcers
Sponsor: Cytonics Corporation
ClinicalTrials.gov Number: NCT02209662
CMS Approval Date: 07/30/2014

Study Title: Effectiveness of Autologous Platelet Rich Plasma in the Treatment of Chronic Skin Wounds
Sponsor: Arteriocyte, Inc.
ClinicalTrials.gov Number: NCT02071979
CMS Approval Date: 08/21/2013

Study Title: A Multi-Center, Prospective, Clinical Trial Comparing the Efficacy of AutoloGel Therapy to Usual and Customary Care in Wagner 1 and 2 Diabetic Foot Ulcers
Sponsor: Cytomedix (Nuo Therapeutics) Inc.
ClinicalTrials.gov Number: NCT01816672
CMS Approval Date: 02/21/2013

Study Title: A Multi-Center, Prospective, Randomized Trial Comparing the Effectiveness of Aurix Therapy to Usual and Customary Care in All Wagner Grades of Diabetic Foot Ulcers
Sponsor: Nuo Therapeutics (Cytomedix) Inc.
ClinicalTrials.gov Number: : NCT02352480 (previously NCT01816633)
CMS Approval Date: 01/16/2015 (previously 02/21/2013)

Study Title: A Multi-Center, Prospective, Randomized Trial Comparing the Effectiveness of Aurix Therapy to Usual and Customary Care in Venous Leg Ulcers
Sponsor: Nuo Therapeutics (Cytomedix) Inc.
ClinicalTrials.gov Number: NCT02352454 (previously NCT01817543)
CMS Approval Date: 01/16/2015 (previously 02/21/2013)

Study Title: A Multi-Center, Prospective, Randomized Trial Comparing the Effectiveness of Aurix Therapy to Usual and Customary Care in Stage II-IV Pressure Ulcers
Sponsor: Nuo Therapeutics (Cytomedix) Inc.
ClinicalTrials.gov Number: NCT02352467 (previously NCT01819142)
CMS Approval Date: 01/16/2015 (previously 02/21/2013)

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