I am writing to share my perspective on an urgent issue impacting patients with hard-to-heal wounds. We, the undersigned clinicians, patients, stakeholders, and advocates, respectfully urge Congress to take immediate bipartisan action to protect Medicare beneficiaries’ access to advanced wound-care therapies that prevent amputation, infection, and premature death in Medicare beneficiaries.
Two concurrent federal actions by the Centers for Medicare & Medicaid Services (CMS) will soon reshape the healthcare economic landscape and clinical availability of life-saving wound-care products:
1. The CY 2026 Physician Fee Schedule (PFS) Final Rule (CMS-1784-F), which finalizes a flat national average payment rate of $127.20 per cm² for skin substitutes, and
2. The future-effective Local Coverage Determinations (LCDs), scheduled to take effect January 1, 2026, impose restrictive limits on skin substitutes.
Individually, each policy poses a threat to access and innovation. Together, they create a dual barrier that will limit treatment for patients with diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), pressure injuries, and other complex wounds, conditions that, if undertreated, lead directly to avoidable emergency department visits, hospitalization admissions, limb loss, and higher mortality.
Why Congressional Action Is Urgent
The flat-rate PFS payment and restrictive LCD coverage criteria are interconnected. The finalized $127.20 per cm² rate fails to reflect acquisition costs or care-delivery complexity, while the LCDs restrict coverage to eight applications within 16 weeks and does not take into account treatment course complications like cellulitis or required hospital admissions.
Together, these policies will:
- Reduce the availability of evidence-based skin substitute therapies in the facility and non-facility settings,
- Disproportionately harm rural, minority, and mobility-limited Medicare beneficiaries, and
- Increase total Medicare costs by driving higher rates of infections, hospitalization admissions, and amputations.
We respectfully ask Congress to:
1. Support and enact the bipartisan Skin Substitute Patient Access and Payment Reform Act (H.R. 5768 / S. 2561) to establish an equitable, outcomes-based reimbursement framework tied to clinical performance and real-world data.
2. Delay or rescind both the future-effective LCDs and the $127.20 per cm² PFS rate until CMS completes an independent analysis of product costs, clinical outcomes, and access disparities.
3. Direct CMS to align reimbursement and coverage limits with peer-reviewed evidence and FDA-cleared indications.
4. Target oversight toward the small proportion of outlier providers responsible for disproportionate spending, rather than penalizing the 95 % of clinicians who deliver appropriate, evidence-based care.
5. Preserve access for all medically appropriate wound types, including diabetic, venous, arterial, pressure, and dehisced surgical wounds, to ensure equitable treatment for all Medicare beneficiaries.
Without swift congressional intervention, these dual CMS policies will reverse decades of progress in limb preservation, innovation, and equitable access to care. A short legislative delay, paired with stakeholder collaboration, will safeguard patients, sustain responsible innovation, and protect the Medicare Trust Fund through a transparent, data-driven reimbursement model.
Sincerely,