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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 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.

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

 

HOW TO APPLY FOR CMS APPROVAL OF CED STUDY

CMS will maintain a list of all approved studies:

Study Title: Leucopatch® System in the Management of Hard-To-Heal Diabetic Foot Ulcers
Sponsor: Reapplix Aps
ClinicalTrials.gov Number: NCT02224742 - http://clinicaltrials.gov/ct2/show/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 - http://clinicaltrials.gov/ct2/show/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 - http://clinicaltrials.gov/ct2/show/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, Inc.
ClinicalTrials.gov Number: NCT01816672 - http://clinicaltrials.gov/ct2/show/NCT01816672
CMS Approval Date: 02/21/2013

Study Title: A Multi-Center, Prospective, Cohort Trial Comparing the Effectiveness of AutoloGel Therapy to Usual and Customary Care in All Wagner Grades of Diabetic Foot Ulcers
Sponsor: Cytomedix, Inc.
ClinicalTrials.gov Number: NCT01816633 - http://clinicaltrials.gov/ct2/show/NCT01816633
CMS Approval Date: 02/21/2013

Study Title: A Multi-Center, Prospective, Cohort Trial Comparing the Effectiveness of AutoloGel Therapy to Usual and Customary Care in Venous Leg Ulcers
Sponsor: Cytomedix, Inc.
ClinicalTrials.gov Number: NCT01817543 - http://clinicaltrials.gov/ct2/show/NCT01817543
CMS Approval Date: 02/21/2013

Study Title: A Multi-Center, Prospective, Cohort Trial Comparing the Effectiveness of AutoloGel Therapy to Usual and Customary Care in Stage II-IV Pressure Ulcers
Sponsor: Cytomedix, Inc.
ClinicalTrials.gov Number: NCT01819142 - http://clinicaltrials.gov/ct2/show/NCT01819142
CMS Approval Date: 02/21/2013