Skin Substitutes & Grafts Covered Under Medicare Advantage: What You Need to Know
Chronic wounds—especially diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs)—pose a serious burden to patients and the healthcare system. When standard care fails, skin substitutes and grafts (also called cellular and tissue-based products, CTPs) can offer a powerful healing adjunct. But an important question arises: which skin substitutes are approved under Medicare Advantage plans?
If you or your patients are navigating wound care under Medicare Advantage, understanding coverage, criteria, and your options for stability biologics is essential. In this post, we’ll walk through:
What skin substitutes and grafts are
How Medicare and Medicare Advantage approach coverage
Key criteria and documentation you’ll need
Examples of stability biologics we support
Tips for providers and patients navigating claims
Let’s dive in.
What Are Skin Substitutes / Grafts?
Skin substitutes, grafts, or cellular/tissue-based products (CTPs) are biologic or synthetic materials applied to a wound bed to encourage healing. They can act as scaffolds, deliver growth factors, or provide a biologic microenvironment to support tissue regeneration.
These products vary widely in:
Origin / composition: human (allografts), animal (xenografts), synthetic, or hybrid
Cellularity: acellular (matrix only) vs. cellular (live cells included)
Layers / structure: single-layer vs. multi-layer constructs
Intended permanence: some are temporary barriers, others more lasting grafts
Regulatory classification: some are regulated as HCT/Ps, others via FDA 510(k) or PMA
Because of this diversity, each product’s clinical data, cost, and risk profile differ.
Medicare & Medicare Advantage: How Coverage Works
Medicare Part B Treatment & Reimbursement
CMS treats skin substitutes like prescription biologics; in non-institutional settings they are reimbursed at 106% of average sales price (ASP). Office of Inspector General
Because of rising costs, scrutiny is growing around appropriate use and documentation to avoid fraud, waste, or abuse. Office of Inspector General+1
CMS has published Local Coverage Determinations (LCDs) specifically for skin substitute grafts / CTPs used to treat DFUs and VLUs. Centers for Medicare & Medicaid Services+1
As of November 2024, new LCDs are in place that will affect coverage from February 2025 onward (though some changes have been delayed) blog.picagroup.com+2Centers for Medicare & Medicaid Services+2
Medicare Advantage (MA) Plans
Medicare Advantage plans typically adopt the same LCDs and MAC policies that govern Original Medicare. UHC Provider+1
For example, UnitedHealthcare’s Medicare Advantage “Skin Substitutes Grafts / CTPs” policy follows the CMS LCDs. UHC Provider
Where no LCD exists in a jurisdiction, an MA plan may fall back on its commercial/individual medical policy to determine coverage. UHC Provider
Claims may be denied if criteria are not met or if required documentation is missing. UHC Provider
So in practice, patients using MA plans may have coverage for skin substitutes — provided the case and documentation fit within the policy framework.
Coverage Criteria & Documentation Requirements
To gain approval under Medicare / Medicare Advantage, the use of a skin substitute must generally satisfy the “reasonable and necessary” standard under an LCD; specifics include:
Failure of Standard of Care (SOC)
The wound must have been treated by standard methods (e.g. debridement, offloading for DFU, compression for VLU, infection management, moisture balance) for a minimum period—commonly 4 weeks / 28 days. Centers for Medicare & Medicaid Services+2Centers for Medicare & Medicaid Services+2
There must be documented lack of sufficient improvement (e.g. < 50% reduction in area) in that time period to justify escalation. Centers for Medicare & Medicaid Services+2Centers for Medicare & Medicaid Services+2
Chronic, Non-Infected Wounds
The ulcer should not show signs of active infection.
Adequate systemic disease management (e.g. diabetes control, vascular health) should be in place. Centers for Medicare & Medicaid Services+1
Physician / Provider Oversight
The procedure must be ordered and managed by a qualified provider (MD, DO, NP, etc.) with documentation of monitoring of systemic disease and wound progression. Centers for Medicare & Medicaid Services
Appropriate Wound Bed Preparation
Before applying the substitute, slough, necrotic tissue, debris must be removed; bed must be prepared per evidence-based wound care. Centers for Medicare & Medicaid Services+1
Product must be used “as intended”
The graft/substitute must be consistent with FDA labeling / intended wound healing purpose, not merely as a dressing or for off-label use. Centers for Medicare & Medicaid Services+1
Documentation & Coding
The medical record must explicitly support the necessity and use of the product, with wound measurements, images, progress notes.
Use the correct CPT / HCPCS codes and billing guidance in the related “Billing & Coding: Skin Substitute Grafts / CTPs” article. Centers for Medicare & Medicaid Services
If any criterion is missing or poorly documented, the risk of claim denial rises.
Stability Biologics & Products We Support
At VWC Solutions, we specialize in supplying stability biologics that align with policy requirements and deliver clinical value. Some of these include:
AmnioCore SL — a single-layer allogeneic amniotic membrane allograft (though studies remain limited) UHC Provider
Amnio Quad-Core — a 4-layer amniotic membrane allograft, processed under strict tissue bank standards UHC Provider
Amnio Tri-Core — a 3-layer version for more structural support UHC Provider
These products are listed in commercial and Medicare Advantage policy documents (e.g. UHC’s “Skin and Soft Tissue Substitutes” policy) as recognized wound covering / barrier options. UHC Provider
Because they are tissue-based, they require careful adherence to regulatory, sterilization, and banking standards—which we guarantee.
By working with us, clinicians can more confidently choose products already accepted in coverage policies, while reducing administrative hiccups.
Tips for Providers & Patients Navigating Claims
For Providers / Clinics:
Preauthorize when possible
Get prior authorization / pre-approval when allowed, especially for MA plans, to reduce denials.
Build detailed wound tracking
Use standardized wound measurement tools, photos (baseline + progress), journals of dressing changes, etc.
Document standard care trials thoroughly
Show the timeline, interventions, patient adherence, and why escalation is justified.
Use correct coding & attach physician notes
Attach operative or application notes, justification memos, and clinical history to claims.
Stay current on LCD updates
Policies evolve. For example, the 2025 LCD changes affect how certain products are reviewed. blog.picagroup.com+2Centers for Medicare & Medicaid Services+2
Know fallback plans
If a patient’s MA plan denies your request, consider appeals or alternate but policy-compliant products.
For Patients:
Confirm with your Medicare Advantage plan whether skin substitute / graft coverage is included and whether you’ll need doctor preauthorization.
Ask your wound care provider: “Which biologics / grafts are on your plan’s covered list?”
Keep copies / photos of your wound over time to support medical necessity.
Don’t hesitate to appeal denials—if your provider documents all criteria, many denials can be overturned.
Navigating skin substitute coverage under Medicare Advantage can feel daunting. But when you understand which products are accepted, what documentation is needed, and how to present your case, your patients can access advanced biologic tools without undue financial risk.
At VWC Solutions, we back you with stability biologics that align with policy standards, reliable quality, and support for claim success. If you’d like to assess which grafts best fit your patient population or need help preparing claims, reach out to our team — we’re ready to partner with you in advanced wound care.
