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National Coverage Determination

Effective April 13, 2021, Medicare covers the 3C Patch for the treatment ofchronic non-healing diabetic wounds for 20 weeks.

A large (n=269), multicenter, randomized controlled trial was designed withinput from CMS and approved under the CMS CED program. The study was published in the Lancet Diabetes & Endocrinology, 2018, and served as the basis for the CMS National Coverage Determination. The evidence shows that 3C Patch “is associated with significant enhancement of healing of hard-to-heal foot ulcers in people with diabetes”.

3C Patch is recommended by IWGDF

The International Working Group of the Diabetic Foot recommends the use of 3C Patch - an autologous combined leukocyte, platelet and fibrin patch as an adjunctive treatment in diabetic foot ulcers that are difficult to heal.

3C Patch is the first product of its kind utilizing the patient’s own blood, without adding any reagents or additives, to produce a three-layer patch containing leukocyte cells, platelets, and fibrin. 3C Patch is clinically proven to significantly increase the chances of healing chronic diabetic wounds.

Site of care
The service is covered when performed in:
  • POS 11 (office),

  • 19 (outpatient hospital – off campus),

  • 22 (outpatient hospital – on campus),

  • 49 (independent clinic).

Autologous platelet rich plasma (prp) for diabetic chronic wounds/ulcers using an FDA-cleared device (includes administration, dressings, phlebotomy, centrifugation, and all other preparatory procedures, per treatment).
ICD 10
Two diagnosis codes are required -
  • Diabetes Melitus

  • Chronic Ulcer

National Average Payment
Coding information derived from Pub 100-04 Medicare Claims Processing, CMS Transmittal 11171, January 12, 2022 and CMS Transmittal11460, June 17, 2022 National Coverage Determination (NCD) 270.3 Blood-Derived Products for Chronic, Non-Healing Wounds, April 13, 2021.Current Procedural Terminology (CPT®) copyright 2023 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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