News Releases
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 department (HOPD) 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
The provisions of the CY 2026 Physician Fee Schedule and HOPPS Final Rules bring consistency and stability to CTP payment. Currently, CTPs are packaged into the payment for the application procedure under a bundled payment methodology in the hospital outpatient setting, while in the physicians’ office and mobile clinic setting are reimbursed separately based on their cost under the Average Sales Price (ASP) + 6% methodology for biologics and drugs. The final CY 2026 Fee Schedule and OPPS establish a separate “incident-to supplies” payment for CTPs at a standardized rate of approximately $127 per cm2 in 2026 across physician offices/mobile clinics ($127.28 per cm2) and hospital outpatient department ($127.14 per cm2) regardless of the specific product used. Moving forward, the Agency has said it will set three differentiated reimbursement categories for CTPs along FDA regulatory status: PMA-approved, 510(k)-cleared, and 361 HCT/Ps. Payment rates for these new categories will be proposed in future CMS rulemaking. (BLA-approved CTPs will remain reimbursed as a biological under CMS’ existing ASP +6% methodology.) While the Alliance does not agree with CMS’ designation of CTPs as “supplies,” we do ultimately support CMS’ approach to pay for CTPs separately - without bundling or packaging. The move to a consistent, predictable and site neutral separate payment is a positive evolution and improvement to CMS’ past payment proposals.
A “Win” for Access in the Hospital Outpatient Setting
The switch to a site neutral separate payment will have a particularly positive impact in the HOPD setting, where in 2014 CMS put in place a bundled payment system (to the Alliance’s dissent ever since) containing several methodology flaws that have challenged access to CTPs. The Alliance has long advocated for policy fixes, bringing recommendations to – and receiving the endorsement of – CMS’ Advisory Panel for Hospital Outpatient Payment multiple times. In the CY 2026 rules, CMS finally addresses many of the issues elevated by the Alliance. With this win, the new payment methodology will:
Originally finalized in November 2024 with a February 2026 implementation date, the LCDs were delayed until April by President Trump's January executive orders directing a 60-day review period and a regulatory freeze on broad categories of government policies, then delayed again until January 2026 with the opportunity for manufacturers to submit new evidence.
Webinar series highlights key 2025 changes to payment and coverage policies that impact wound care, providing actionable insights to help health professionals navigate complex policies and ensure they are prepared for changes that affect clinical practice.
(February 4, 2025) — An educational partnership between HMP Global and the Alliance of Wound Care Stakeholders will give health care professionals the critical information they need to understand the impact of 2025 Medicare policy updates on wound care. The new webinar series will address key changes to payment and coverage policies and their impacts, ensuring that wound care providers are equipped with the knowledge needed to implement these changes effectively in their practices. The seminar series in February and March will specifically focus on new provisions within the 2025 Medicare Physician Fee Schedule (MPFS), the Hospital Outpatient Prospective Payment System (OPPS), and the Home Health Prospective Payment System (HH PPS), plus the Local Coverage Determinations (LCDs) on Cellular and Tissue-Based Products (CTPs/skin substitutes) for Diabetic Foot Ulcers and Venous Leg Ulcers and their accompanying Billing and Coding Articles.
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.
As there were seismic changes to the number of covered products, allowable applications, and required documentation in the final LCDs published in November 2024, wound care providers across the country who treat DFU/VLU in Medicare beneficiaries have been preparing for the original February 12, 2025 implementation date. This 60 day postponement to April 13th has the upside of providing additional preparation time. See the "Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers & Venous Leg Ulcers" LCDs from each MAC below.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...
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