Upcoming Update to the Final Local Coverage Determinations (LCDs) for Certain Skin Substitutes
All seven CMS A/B Medicare Administrative Contractors (MACs) will issue updated Final Local Coverage Determinations (LCDs) effective January 1, 2026. These LCDs cover skin substitute grafts and cellular and tissue-based products (CTPs) for the treatment of diabetic foot ulcers and venous leg ulcers only — with frequency and utilization limits designed for patient safety.
Background
The Trump Administration delayed the original LCD effective date for review. A six-month window allowed stakeholders to submit supporting evidence. CMS received submissions for 66 products by November 1, 2025.
Products were sorted into three categories based on the evidence submitted:
Coverage: meets the evidence threshold; covered beginning January 1, 2026
Non-Covered: insufficient evidence submitted to support coverage
12-Month Status Quo: ongoing or interim research exists; MACs make individual claim determinations while studies conclude
At the end of the status quo period, MACs will reconsider the LCDs by reviewing evidence received by December 31, 2026, with reconsideration decisions scheduled for release in early 2027.
Of the 8 interventional randomized controlled trials (RCTs) reviewed, Grafix Prime (Smith & Nephew, Q4133) met the evidence threshold — its RCT was published April 16, 2025.
Covered Products (18 Codes)
The following products met the evidence threshold and are covered effective January 1, 2026:
Apligraft (Organogenesis): established wound care product with strong RCT support
Dermagraft: bioengineered skin substitute for diabetic foot ulcers
EpiFix (MiMedx): dehydrated human amnion/chorion membrane
Integra/Omnigraft: dermal regeneration template
Kerecis Omega3: fish-skin derived wound care product
TheraSkin: cryopreserved human skin allograft
GraftJacket: acellular dermal matrix
DermACELL: decellularized dermal allograft
Grafix Prime (Smith & Nephew, Q4133): newly meeting the RCT evidence threshold
This category includes 18 HCPCS codes in total.
MAC Discretion Products (154 Codes)
A total of 154 HCPCS codes fall into the 12-month status quo category. These products have ongoing or interim research and will be evaluated on a claim-by-claim basis by individual MACs during the review period. This category includes products from manufacturers such as Acell, BioTissue, Surgenex, Tides Medical, Vivex Biomedicals, and Smith & Nephew, among many others.
Non-Covered Products (158 Codes)
A total of 158 HCPCS codes were classified as non-covered due to insufficient evidence. This includes products such as AlloDerm (Abbvie), numerous Integra product lines, StimLab products, and certain Organogenesis entries. Practices billing these products for diabetic foot ulcers or venous leg ulcers will not receive Medicare reimbursement under the updated LCDs.
What This Means for Podiatry Practices
These LCD updates have significant implications for wound care billing and product selection. Practices should:
Review their current skin substitute inventory: verify which products fall under covered, MAC discretion, or non-covered categories
Update billing workflows: ensure claims reflect the correct coverage status for each product
Monitor MAC-specific guidance: individual MACs may differ in their handling of status quo products
Track the 2027 reconsideration timeline: product coverage may shift once the evidence review period concludes
Additional Resources
CMS LCD process page
CMS press release: "CMS Modernizes Payment Accuracy and Significantly Cuts Spending Waste"
CY 2026 Medicare Physician Fee Schedule Final Rule Fact Sheet (CMS-1832-F)