CMS Announces Updated LCDs for Skin Substitutes: What Wound Care Providers Need to Know

The Centers for Medicare & Medicaid Services has announced that all seven Medicare Administrative Contractors (MACs) will issue updated Final Local Coverage Determinations (LCDs) for skin substitute grafts and cellular and tissue-based products (CTPs) used in the treatment of diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). These updated LCDs will take effect January 1, 2026 and will significantly impact product coverage, utilization, and reimbursement in wound care.

Below is a breakdown of what’s changing and what it means for clinics and providers.

What the Updated LCDs Do

The updated LCDs define which skin substitute products Medicare will cover for DFUs and VLUs only. They do not affect coverage for other indications. The LCDs also reinforce frequency and utilization limits designed to promote patient safety and appropriate use.

In short, CMS is tightening its focus on evidence-based wound care, while still allowing flexibility for products actively undergoing clinical evaluation.

Why CMS Updated These Policies

Under the Trump Administration, the original LCD implementation was delayed to allow CMS additional time to review coverage policies. Manufacturers were given an extra six-month window to submit high-quality clinical evidence demonstrating product effectiveness.

By the November 1, 2025 deadline, CMS received 66 evidence submissions for skin substitute products. These submissions were reviewed and categorized into three distinct groups.

The Three Coverage Categories Explained

✅ 1. Covered Products

Products that met the LCDs’ evidence threshold will be covered by Medicare beginning January 1, 2026. These products demonstrated sufficient clinical effectiveness and safety.

• 18 products were identified as covered

• Only 8 submissions included randomized controlled trials (RCTs)
  
  

❌ 2. Non-Covered Products

These products did not submit adequate evidence to meet Medicare’s “reasonable and necessary” standard and currently have no qualifying clinical research underway.

Manufacturers in this category may still seek reconsideration if additional evidence is submitted.

⏳ 3. 12-Month Status Quo Products

Products in this group submitted interim data, clinical trial protocols, assigned trial numbers, or peer-reviewed investigational research between the proposed LCD posting and November 1, 2025.

Key points:

• No positive or negative coverage determination yet

• MACs may pay claims at their discretion on a case-by-case basis

• Sponsors have until December 31, 2026 to submit additional evidence

• CMS will reconsider these products in early 2027
  
  

This approach minimizes market disruption while maintaining evidence-based standards.

What This Means for Wound Care Providers

For clinics, hospitals, and wound care specialists, these updates reinforce several realities:

• Clinical evidence matters more than ever

• Product selection directly impacts reimbursement stability

• Documentation, utilization limits, and product choice must align with LCD criteria

• Working with products that have strong evidence, or clear reimbursement pathways, is essential
  
  

Providers should proactively review which products fall into each category and ensure their wound care protocols are aligned with the new LCDs.

Our Commitment to Maximizing Healing & Reimbursement

At Wound Care Portal, we work with advanced wound care products designed to support both clinical outcomes and reimbursement success in an increasingly evidence-driven environment.

If you want to:

• Navigate the new LCD landscape with confidence

• Optimize healing outcomes for DFU and VLU patients

• Protect your clinic from reimbursement disruptions
  
  

We’d be happy to help.

📞 Schedule a 15-minute discovery call to discuss wound care solutions that align with CMS coverage standards and support long-term practice sustainability.

👉 Contact us today to get started by going to our Contact page, emailing us at admin@regenedgesummit.com, or calling us at (203) 715-8390.