Policy and the Power of Wound Care Advocacy
Key Takeaways
1. CTP payment reform will significantly alter site-of-care dynamics and reimbursement. CMS finalized site-neutral payment in 2026, improving HOPD access but introducing new complexities—particularly geographic adjustments that may disadvantage rural providers.
2. Several major policy actions were delayed or revised due to methodological and clinical concerns. CMS refined a flawed non-pressure ulcer cost measure that would impact payment, and FDA did not finalize its reclassification of antimicrobial dressing into more restrictive device categories – so access to these products remains unchanged.
3. Gaps in reimbursement and coverage remain a central challenge across emerging and existing technologies. Ongoing efforts to improve reimbursement for blood-derived products, point-of-care imaging, topical oxygen therapy, lymphedema compression garments, and other wound care product categories address misalignments between clinical practice, innovation and payment policy that continue into 2026.
Substantial Medicare payment reforms, deregulation efforts and increasing federal scrutiny of select wound care products created a fast-moving policy landscape in 2025. From consequential changes to payment for cellular and tissue-based products for wounds (CTPs or skin substitutes) to halting flawed episode-based cost measures and pausing restrictive FDA proposals, the Alliance of Wound Care Stakeholders advocated for the field and saw policies impacting multiple facets of wound care. Below is a look at the issues, actions, and impacts that defined wound care advocacy in 2025, and a preview of what may lie ahead in 2026 and beyond.
Examining a Non-Pressure Ulcer Cost Measure
CMS has been developing an episode-based cost measure for non-pressure ulcers that will impact payment under the Merit-based Incentive Payment System (MIPS).1 Initial testing revealed serious methodological flaws, including inaccurate cost attribution and insufficient clinical data capture. The Alliance escalated concerns to CMS, its contractor and advisory panels, documenting how the measure could unfairly penalize clinicians and distort wound care delivery costs. In January 2025, CMS’ Pre-Rulemaking Measure Review Clinician Recommendation Workgroup did not advance the measure.2 The measure will undergo refinement and additional testing before reconsideration, with stronger wound care clinician participation in its development.
Why this matters: For providers who treat Medicare beneficiaries, this mattered enormously. Cost measures tied to performance programs directly impact reimbursement. Ensuring they are clinically sound and methodologically fair is essential – as a flawed cost measure can unfairly penalize providers and distort wound care delivery metrics.
Pausing a Proposed Reclassification of Antimicrobial Dressings
The Food and Drug Administration’s (FDA) 2023 proposal3 to reclassifying certain wound dressings and liquid wound washes containing antimicrobials into more restrictive device categories was an outgrowth of FDA panel meetings held in 1998, 2005 and 2016. When the 2023 proposed rule published, the Alliance continued a years-long effort and again met with FDA staff and submitted comments flagging potential unintended consequences. With the early-2025 changes in federal agency leadership, the Alliance elevated concerns directly to the new FDA Commissioner and White House Office of Management and Budget (OMB) Director. Although FDA had scheduled publication of the final rule for October 2025, the proposed rule did not move forward and was not finalized in 2025.
Why this matters: The new classification would result in the unnecessary withdrawal of many antimicrobial wound care products from the market – and a likely secondary effect would be that clinicians turn to antibiotic pharmaceuticals, exacerbating the very resistance problems that FDA is trying to address through the proposed regulation. For clinicians, the pause means continued access to products currently used in practice, and more time for dialogue regarding regulatory classification standards.
Strengthening Payment for Blood-Derived Products
In 2025, the Alliance advocated for CMS to increase the national payment rate autologous blood-derived products to better account for clinician time, procedural complexity, and supply costs.4 They also gathered actual real-world pre-, intra-, and post-procedure time data to establish realistic clinical work estimates to incorporate in their efforts, aimed at the CY 2027 rulemaking cycle.
Why this matters: The current reimbursement rate does not reflect clinician time and costs, which in turn challenges access as providers often lose money when using autologous blood derived products to treat their patients.
Expanding Point-of-Care Imaging Reimbursement
As wound imaging technologies advance, payment pathways have lagged behind. To address this issue, in 2025, the Alliance launched a Point-of-Care Imaging (POCI) workgroup5 to coordinate advocacy focused on establishing CMS coverage pathways and billing codes for image capture, interpretation, and care planning for wound care imaging tools. Initial efforts included conducting a clinician survey to capture current POCI technology usage and codes being billed to serve as groundwork for discussions with CMS and its contractors, as well as consolidating evidence to challenge a noncoverage decision for select wound imaging products from Medicare Administrative Contractor Palmetto GBA.6
Why this matters: POCI technologies that support wound healing are often underutilized by clinicians due to lack of explicit reimbursement. Establishing coverage and reimbursement for technologies that enhance documentation, measurement accuracy, and care planning aims for policy to keep pace with innovation.
Addressing Ongoing Surgical Dressing Claims Issues
Claims processing errors and coding inconsistencies continue to create administrative burden and access barriers. The Alliance has worked directly with the Durable Medical Equipment Medicare Administrative Contractor medical directors to resolve issues in the surgical dressing space such as:
• denial of full orders when only one component is noncovered;
• modifier A1-A9 processing errors;
• frequency of change discrepancies between clinical need and LCD allowables; and more.
Why this matters: Resolving the underlying issues that generate these inconsistent surgical dressings claims denials has immediate impact. Inconsistent claims denials create financial and operational challenges for providers by causing delayed or lost reimbursement. Providers often must devote significant time to reviewing denials, and addressing audits, gathering documentation, and filing appeals, increasing administrative burden and diverting resources away from patient care.
CTP Payment Reform
One of the most consequential developments of 2025 was CMS’ overhaul of CTP payment across all sites of care. These “new” provisions finalized are in fact an outcome of several years of CMS attempts to reform CTP payment. The Agency has proposed payment overhauls and/or solicited feedback on payment methodologies for the physician office setting each year since 2022. Stakeholders such as the Alliance have provided input at each opportunity, as well as flagged payment issues in the hospital outpatient department (HOPD) setting, where the bundled payment system implemented more than a decade ago have created financial disincentives and access challenges to use CTPs, particularly for larger wounds.7
Most recently, federal investigations on CTP overuse and fraud resulting in skyrocketing Medicare spend on this product category in physicians’ offices and mobile clinics put CTPs under intense scrutiny from policymakers, prompting CMS to finalize reforms that have been under consideration for years.8
In calendar year (CY) 2026 payment rules, CMS finalized a site neutral methodology that restores separate payment for CTPs across all settings and establishes a single national 2026 payment rate, with plans to introduce differentiated payment based on FDA regulatory status of products (PMA-approved, 510(k)-cleared, 361 HCT/Ps and BLA-approved) in proposed CY 2027 rulemaking.9
Why does this matter? For hospital outpatient departments, the return to separate payment removes long-standing access barriers created by bundled payments, where add-on codes failed to cover the cost of treating larger wounds and use of CTPs was reimbursed inconsistently depending on the wound’s anatomic location – even though the identical amount of product must be purchased for wounds of the same size regardless of location. These forced HOPDs to either absorb the cost of the products or refer patients out, ultimately shifting treatment with CTPs to physician offices and mobile clinics.10 Now, with separate payments for the product and the application service, HOPDs again will have the financial flexibility to treat patients with CTPs, especially those with with larger wounds.
For office-based clinicians, payment methodology is shifting to an “incident-to supplies” framework, with what CMS has termed a “single payment” put in place in 2026 and plans for differentiated payments based on products’ FDA status in 2027 and beyond. While there are many differing opinions on the impact of the payment rate, the Alliance believes that in concept these reforms balance CMS’ goals of curbing fraud and reducing inappropriate spending, while still protecting legitimate patient care and innovation of evidence-based products. However, CMS’ inclusion of a geographic adjustment in the final payment rule will create discrepancies: reimbursement will be higher for CTPs when provided in physician offices in urban areas and lower in rural areas – although product cost doesn’t differ by geographic location. The geographic adjustment is inconsistent with the single payment that CMS aimed to achieve and will negatively impact patient access in rural areas. The Alliance is in ongoing dialogue with CMS on this issue, seeking clarity or a technical correction from the Agency to apply a geographic adjustment only to the application service (in keeping with how geographic adjustments are typically applied) rather than to the product reimbursement amount that doesn’t differ regionally.
Supporting Evidence-Based CTP Coverage Policies
While payment reform dominated headlines, coverage policy remained equally critical. Throughout 2025, the Alliance supported implementation of clinically flexible, evidence-based CTP Local Coverage Determinations (LCDs) that reflected years of stakeholder input. Although these LCDs were ultimately withdrawn in late December just prior to implementation, the policies had evolved substantially from earlier, more restrictive drafts due to sustained wound care community engagement. This remains an area of advocacy attention, as the Alliance and others monitor the impact of the new payment reforms and whether the upcoming move to differentiated payments based on the level of supporting evidence will, as the LCDs had intended, focus use on products with the highest levels of evidence.
Wound Care Perspectives on Broader Policy Issues
Beyond product-specific advocacy, 2025 included engagement on broader federal initiatives that influence practice:
• Supported legislation for expanded peripheral artery disease screening to reduce preventable amputations.
• Worked to secure coverage for topical oxygen therapy in diabetic foot ulcers in the Oxygen and Oxygen Equipment LCDs.
• Requested that CMS eliminate burdensome cosigning requirements in Medicare’s Therapeutic Shoe Program for Patients with Diabetes that delay timely access.
• Urged expanded reimbursement for tools that improve efficiency, such as remote patient monitoring, point-of-care imaging, automated coding, and voice-enabled documentation.
• Opposed CMS’ proposed reintroduction of the Competitive Bidding Program (CBP) in its home health payment update for CY 2026.
• Flagged areas in wound care where Medicare Advantage plans need to better align with fee-for-service coverage standards.
• Leveraged the Presidential Administration’s deregulation priorities to reduce burdens in wound care.
• Supported for expanded use of real-world evidence in coverage decisions.
Looking Ahead
Many 2025 issues will carry into 2026. Key areas where the Alliance will be monitoring and advocating include:
• Implementation and impact of CTP payment reforms, with specific attention to the problematic geographic adjustments.
• Development of differentiated payment levels for CTPs based on FDA status.
• Refinement and field testing of the non-pressure ulcer episode-based cost measure.
• FDA regulatory decisions regarding classification of antimicrobial dressings.
• Reimbursement pathways for point-of-care imaging
• Increased reimbursement for autologous blood derived products
Change takes time, and policy reform is often incremental. Successful advocacy requires sustained engagement across multiple rulemaking cycles, ongoing data collection, and consistent on-the-record input via submitted comments and testimony at public meetings.
For wound care providers, participation matters. Policymakers rely on clinical insight when shaping coverage and payment decisions. Advocacy engagement helps ensure that policy reflects the realities of wound care practice. This is particularly important for wound care, which represents only a small sector within a vast federal health policy landscape. Without coordinated and consistent advocacy as well as proactive engagement, policy decisions affecting our space risk being shaped without real-world clinical expertise. When we can identify shared issues, build consensus across a diversity of perspectives, and advocate together, policymakers are more likely to listen.
Marcia Nusgart, RPh, is Founder and CEO of the Alliance of Wound Care Stakeholders. Since 2002, the Alliance has served as the unified advocacy voice for the wound care community, working collaboratively with CMS, FDA, Congress, and other federal agencies to shape policy, educate policymakers, and protect patient access to wound care products and services. Learn more at www.woundcarestakeholders.org.
References
1. Centers for Medicare & Medicaid Services. CMFT EBCM process document. Published February 2024. Accessed April 17, 2026. https://www.cms.gov/files/document/2024-02-cmft-ebcm-process.pdf
2. Partnership for Quality Measurement. PRMR Clinician Recommendations Group meeting summary. Published February 2025. Accessed April 17, 2026. https://p4qm.org/sites/default/files/2025-02/PRMR-Clinician-Recommendations-Group-Meeting-Summary.pdf
3. US Food and Drug Administration. Skin substitute guidance document. Accessed April 17, 2026. https://www.fda.gov/media/174547/download
4. Alliance of Wound Care Stakeholders. Comments to proposed 2026 Medicare physician fee schedule update. Accessed April 17, 2026. https://www.woundcarestakeholders.org/advocacy/submitted-comments/comments-to-proposed-2026-medicare-physician-fee-schedule-pfs-update
5. Alliance of Wound Care Stakeholders. Areas of focus. Accessed April 17, 2026. https://www.woundcarestakeholders.org/advocacy/areas-of-focus
6. Centers for Medicare & Medicaid Services. Local coverage determination (LCD): wound care (LCD ID 39385). Accessed April 17, 2026. https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39385&ver=6
7. Alliance of Wound Care Stakeholders. Alliance statement on final 2026 Medicare physician fee schedule and hospital outpatient PPS. Accessed April 17, 2026. https://www.woundcarestakeholders.org/news/news-releases/alliance-statement-on-final-2026-medicare-physician-fee-schedule-hospital-outpatient-pps
8. Office of Inspector General, US Department of Health and Human Services. Medicare Part B payment trends for skin substitutes raise major concerns about fraud, waste, and abuse. Published 2025. Accessed April 17, 2026. https://oig.hhs.gov/reports/all/2025/medicare-part-b-payment-trends-for-skin-substitutes-raise-major-concerns-about-fraud-waste-and-abuse/
9. Centers for Medicare & Medicaid Services. Calendar year 2026 Medicare physician fee schedule final rule (CMS-1832-F). Accessed April 17, 2026. https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2026-medicare-physician-fee-schedule-final-rule-cms-1832-f
10. Carter MJ, DaVanzo J, Haught R, Nusgart M, Cartwright D, Fife CE. Chronic wound prevalence and the associated cost of treatment in Medicare beneficiaries: changes between 2014 and 2019. J Med Econ. 2023;26(1):894-901.
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