Submitted Comments

Wound Care Advocacy Wins: Separate, Site Neutral Payments for CTPs/Skin Substitutes Remove Access Barriers in Hospital Outpatient Setting; Combat Waste/Fraud/Abuse that has Led to Unsustainable Medicare Spend in Physicians’ Office Setting.

November 2025 – The Alliance of Wound Care Stakeholders commends CMS on its initiatives in the final CY 2026 Medicare Physician Fee Schedule and Hospital Outpatient Prospective Payment System (HOPPS) to reform the payment system for cellular and tissue-based products for wounds (CTPs, or “skin substitutes”) in its efforts to combat fraud, waste and abuse of these products and address the excessive spending that has made the current payment methodology unsustainable. Following years of persistent advocacy with CMS policymakers, the Alliance believes the establishment of separate, site neutral payment in 2026 enables clinically appropriate site-of-service decisions – with particular impact in the hospital outpatient setting, where the current bundled payment methodology has challenged access and driven care to other sites of service. The Alliance has repeatedly addressed this issue to the Centers for Medicare and Medicaid Services in our comments which had already gained the endorsement of the Agency’s Advisory Panel on Hospital Outpatient Payment on policy fix recommendations. CMS had not acted on those recommendations until now. In an advocacy “win” for patients and providers alike, HOPDs will now be more able to provide CTPs to patients with larger wounds rather than shifting them to alternate sites of care.

Separate, Site Neutral Payment & “Win” for Access in the Hospital Outpatient Setting...

1/25/25 - All of the Medicare Administrative Contractors (MACs) have delayed the effective date of the final local coverage determinations for cellular and tissue-based products for wounds (CTPs, or "skin substitutes") in diabetic foot ulcers and venous leg ulcers by 60 days, moving the implementation date across all MAC jurisdictions from 2/12/25 to 4/13/25. (NOTE: on 12/24/25 CMS announced withdrawal of the LCDs.)

Statement from the Alliance of Wound Care Stakeholders

Nov. 19, 2024 – The Alliance of Wound Care Stakeholders is pleased that CMS’ Medicare Administrative Contractors (MACs) carefully considered stakeholder recommendations and made substantive changes following input from the wound care community in the recently released final Local Coverage Determinations (LCDs) and accompanying Coding and Billing Articles, “Skin Substitute Grafts/Cellular and Tissue-Based Products (CTPs) for the Treatment of Diabetic Foot Ulcers & Venous Leg Ulcers.” With publication of the final policy by each MAC, the wound care community now has clearer understanding of Medicare coverage for the application of CTP/skin substitute products in treating diabetic foot ulcers (DFU) and venous leg ulcers (VLU). The Alliance and the larger wound care clinical community mobilized together, illustrating the power of tenacious advocacy and a unified voice to positively influence policies so that they reflect quality wound care practice. In a noted change that was in direct alignment with Alliance recommendations, the MACs increased the covered application limit from 4 to 8 in the final policy, now consistent with the supportive clinical evidence, treatment guidelines and current standard of care to promote wound healing. Similarly the "episode of care" treatment duration increased from 12 to 16 weeks.

The Alliance believes these are considerable improvements to the concerning limitations that had been included in the proposed policies issued for comment this past April. Under the finalized LCDs, providers have the application flexibility (supported by sufficient documentation) needed for wound healing and, importantly, Medicare beneficiaries with hard-to-heal DFUs/VLUs can benefit from improved outcomes. Still, additional clarity is needed...

October 2020 – In comments submitted to the Center for Medicare and Medicaid Services (CMS), the Alliance of Wound Care Stakeholders voiced its opposition to payment cuts from five to nine percent for surgical procedures and nine percent for physical therapy services as CMS proposes in its CY2021 Physician Fee Schedule. The Alliance also called on CMS to (1) Adopt all of the American Medical Association’s RUC recommendations including updated E/M values in procedure codes with 10- and 90-day global periods; (2) Maintain a patient’s home as an originating site even when the public health emergency expires; (3) Include additional telehealth codes for physical therapy services, and more.

Additionally, in comments submitted to CMS' CY2021 Hospital Outpatient Prospective Payment System proposed updates, the Alliance flagged concerns with provisions dealing with coding and payment for Cellular and/or Tissue based Products for skin wounds (CTPs, also known as skin substitutes). The Alliance supported inclusion of synthetic CTPs in the definition of “skin substitutes” but expressed significant concerns with the Agency’s proposed establishment of a unique C code to define an entire class of non-branded products and the placement of these products in the OPPS high cost payment package.
See Alliance News Update Summarizing Comments