LCD ID Number: L39828 Status: A-Approved
LCD Title: Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
Geographic Jurisdiction: Connecticut Other Jurisdictions
Original Determination Effective Date:
04/13/2025
Original Determination Ending Date:
Revision Effective Date:
Revision End Date:
CMS National Coverage Policy:
This LCD supplements but does not replace, modify, or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for skin substitute grafts/CTP for the treatment of diabetic foot ulcers and venous leg ulcers. Federal Statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify, or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions, and scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations, and rules for Medicare payment for skin substitute grafts/CTP for the treatment of DFU and VLU and must properly submit only valid claims for service and products utilized. Please review, understand and apply the necessity provisions in the policy according to the Manual guidelines. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:
IOM Citations:
- CMS IOM Publication 100-02, Medicare Benefit Policy Manual
- Chapter 15, Section 50.4.1 Approved Use of Drug
- CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual,
- Chapter 1, Part 4 Section 270.3 Blood-Derived Products for Chronic Non-Healing Wounds, Section 270.4 Treatment of Decubitus Ulcers and Section 270.5 Porcine Skin and Gradient Pressure Dressings
- CMS IOM Publication 100-04, Medicare Claims Processing Manual,
- Chapter 17, Section 40 Discarded Drugs and Biologicals
- CMS IOM Publication 100-08, Medicare Program Integrity Manual,
- Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD
- CMS IOM Publication 100-04, Medicare Program Integrity Manual,
- Chapter 17, Section 10 Payment Rules for Drugs and Biologicals
Social Security Act (Title XVIII) Standard References:
- Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment may be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
- Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.
Code of Federal Regulations (CFR) References:
- CFR, Title 21, Volume 8, Chapter 1, Subchapter L, Part 1271.10 Human cells, tissues, and cellular and tissue- based products
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