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Updated on September 19, 2023

Questions about the Medicare Administrative Contractors' (MACs) local coverage determinations (LCDs) for Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. These LCDs provide updated guidance on which products are covered/not covered, as well as their utilization. Now limited to 4 applications per 12-week episodes. Learn more about these new LCDs here.

Links to Local Coverage Determination Changes:

Links to Billing Articles for Covered and Non-Covered Products:  

Reimbursement FAQs about LCD Changes

What is the Medicare Administrative Contractor (MAC) local coverage determination (LCD) update?  

On August 3, 2023, Novitas, First Coast Service Options (FCSO), and CGS, three of the seven regional MACs, released final LCDs titled “Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers." 

What is the application frequency for skin substitutes?  

Novitas, FCSO, and CGS all established a limit of four applications per wound in their final LCD, which will be allowed for the episode of skin replacement surgery for wound care. Currently, an episode is defined as 12-weeks from the first application of a skin substitute graft per wound. 

What is the effective date? 

The effective date of the three new final LCDs is October 1, 2023. The original effective date published by the MACs was September 17th. However, on September 14, 2023, all three MACs announced a postponement of the effective date to October 1, 2023.

What Smith+Nephew products are covered?

The MAC LCDs provide coverage for GRAFIX PL PRIME (Q4133), GRAFIX PRIME (Q4133), GRAFIX CORE (Q4132), OASIS WOUND MATRIX (Q4102), and OASIS ULTRA (Q4124).

Lookup coverage for GRAFIX & OASIS in your state.

OASIS BURN was not listed on the final LCDs. The LCD Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (L36690) applies to diabetic foot ulcers and venous leg ulcers and use other than DFU/VLU is not addressed in the LCD. Oasis Burn Matrix is a porcine derived skin substitute. Its Medicare coverage is determined by the CMS NCD Porcine Skin and Gradient Pressure Dressings 270.5, medical necessity, and the product’s FDA Indications for Use. OASIS BURN Matrix is indicated for the management of wounds including: Partial and full-thickness wounds, Second-degree burns, Donor sites/grafts, Trauma wounds (abrasions, lacerations, skin tears), Surgical wounds (post-Mohs’ surgery, post-laser surgery, podiatric, wound dehiscence), Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Tunnelled, undermined wounds, and Draining wounds. The Medicare MACs may require additional documentation to support medical necessity for products used beyond the scope of DFU/VLU. *

*As of September 15, 2023, the intent of the Medicare Administrative Contractors (CGS, First Coast Service Options, and Novitas) to apply the published application limit for the DFU/VLU LCDs has not been fully documented; therefore, providers need to contact their local MAC for further medical necessity considerations for treatment of wounds outside of DFU/VLU.

What products are not covered?  

A full list of the non-covered products can be found by following the links below:   

What specific criteria were considered by the MACs in arriving at their coverage decision for skin substitutes, including factors like TRG, evidence, etc.?

“If a determination cannot be made as to whether the skin substitute/CTP graft meets the definition of skin scaffolding solely based on the FDA documentation (e.g., TRG letter or product label), peer-reviewed, published evidence would be needed to support the medically reasonable and necessary criteria for the product(s). To meet the medically reasonable and necessary threshold for coverage, the skin substitute grafts/CTPs must be FDA approved for use as an ulcer treatment, not as a wound covering. Products without evidence of FDA regulatory compliance, products with FDA designation or approval as a dressing or wound covering, and products lacking some evidence of improved health outcomes in the Medicare population or benefits relative to established alternatives/standard of care when used as an ulcer treatment, will be non-covered1.”

Are other wound types and or upper extremity ulcers covered?

According to the LCDs, “Application of skin substitute grafts/CTPs for wound/ulcer care indications other than for DFU or VLU are not addressed by this LCD. Use of skin substitute grafts/CTPs must meet the medically reasonable and necessary threshold for coverage and must be used in accordance with their intended use as approved/regulated by the United States (U.S.) Food and Drug Administration (FDA)2.”

NOVITAS/FCSO:

CGS:

  • The LCD addresses requirements for the treatment of Diabetic Foot Ulcers and Venous Leg Ulcers, and therefore the LCDs outline coverage criteria for skin substitutes used for DFUs and VLUs. The MAC also published an associated Billing and Coding Article which defines the ICD-10 diagnosis codes that support medical necessity, as well as covered and non-covered CPT/HCPCS codes. While the ICD-10 code list that supports medical necessity includes the most common ICD-10 codes associated with DFU/VLU; providers should become familiar with the list. The Billing and Coding Article does not specifically exclude other diagnosis codes from coverage, but it is not clear if additional review will be triggered if billing ICD-10 codes not included on the MAC’s list of ICD-10 codes supporting medical necessity. See link - Article - Billing and Coding: Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (A56696)

It is not clear how these MACs may implement these LCDs outside of DFU and VLU; along with how the MACs will handle products on the non-covered list for other wound types and or upper extremities. We will be in touch on this once we have further guidance*. In the interim, as a provider, you may request further clarification on coverage, by contacting your local MAC.

*As of August 16, 2023, LCD Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (L36690) applies to diabetic foot ulcers and venous leg ulcers and use other than DFU/VLU is not addressed in the LCD. 

The use of products outside of these areas are handled the same as other services not specifically addressed in policy. 

  • A product should be used:
    • on a case-by-case basis if outside of the LCD 
    • within its FDA Regulatory approved indications 
    • in accordance with the product’s Indications for Use per FDA
    • based on medical necessity 
    • may require additional documentation

What happens when a patient is already being treated, and their care overlaps the October 1, 2023, effective date of the new LCD?

The LCDs do not provide clear guidance on overlapping treatments after October 1, 2023. The LCDs specify the following:

  • “Greater than four applications of a skin substitute graft or CTP within the episode of skin replacement surgery (defined as 12 weeks from the first application of a skin substitute graft or CTP)” is “considered not medically reasonable and necessary."

Since the “first application” determines the start of the episode of skin replacement surgery, and the LCDs do not address patients who began treatment before October 1, 2023; it is expected that the number of allowed applications or treatments will still not exceed four. Providers may request further clarification on coverage by contacting the local MAC.

What states are impacted by the LCDs?

The following states are impacted by the recent release of the LCDs for Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers

  • NOVITAS

  • MAC Jurisdictions STATES
    H Arkansas, Colorado, New Mexico, Oklahoma, Texas, Louisiana, Mississippi
    L Delaware, District of Columbia, Maryland, New Jersey, Pennsylvania (includes Part B for counties of Arlington and Fairfax in Virginia and the city of Alexandria in Virginia)

  • FIRST COAST SERVICE OPTION (FCSO)

  • Florida, as well as US Territory Puerto Rico, and the U.S Virgin Islands

  • CGS

  • MAC Jurisdiction STATES
    15 Ohio, Kentucky

What is direction regarding excessive wastage / discarded amount? 

FCSO/NOVITAS:

“The instruction for the ‘limitation’ regarding ‘excessive wastage (discarded amount)’ has been re-worded to: The skin substitute graft/CTP must be used in an efficient manner utilizing the most appropriate size product available at the time of treatment. It is expected that where multiple sizes of a specific product are available, the size that best fits the ulcer with the least amount of wastage will be utilized.”

CGS:

“The language for the ‘limitation’ regarding ‘excessive wastage (discarded amount)’ has been re-worded to: The skin substitute graft or CTP must be used in an efficient manner utilizing the most appropriate size product available at the time of treatment. It is expected that where multiple sizes of a specific product are available, the size that best fits the ulcer with the least amount of wastage will be utilized.”

How do I access the final LCDs for more information?  

You may access the final LCDs at the following links:  

NOVITAS 

FCSO  

CGS 

Whom do I contact if there are any questions? 

If you have any questions, please notify your Smith+Nephew account manager that you would like to speak with your local Patient Access and Reimbursement Manager (PARM) to answer any questions regarding the recent policy change or click the "Request more info" button for further information.

1Medicare Administrative Contractors’ (MACs) local coverage determinations (LCDs) for Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers -  Novitas, FCSO, and CGS 

2Ibid.

Reimbursement Disclaimer: Due to the rapidly changing nature of the law and the Medicare payment policy, and reliance on information provided by outside sources, the information provided herein does not constitute a guarantee or warranty that reimbursement will be received or that the codes identified herein are or will remain applicable. This information is provided “AS IS” and without any other warranty or guarantee, expressed or implied, as to completeness or accuracy, or otherwise. This information has been compiled based on data gathered from many primary and secondary sources, including the American Medical Association, and certain Medicare Administrative Contractors. Providers must confirm or clarify coding and coverage from their respective payers, as each payer may have differing formal or informal coding and coverage policies or decisions. Providers are responsible for accurate documentation of patient conditions and for reporting of products in accordance with payer requirements.