Recent Policy and Regulatory Insights from the Alliance of Wound Care Stakeholders

Throughout 2024 the wound care community made significant strides in its advocacy to advance and shape policies that support fair reimbursement, appropriate coverage and equitable patient access to wound care products and services. With the collaborative action and collective voice of multiple organizations, last year held many successes.

National Payment Rate Set for Blood-Derived Products

Although there is a National Coverage Determination for use of autologous platelet rich plasma (PRP) and other blood-derived products for diabetic chronic wounds/ulcers, there was no equitable reimbursement rate across Medicare Administrative Contractor (MAC) jurisdictions. Each MAC set pricing separately. The result was inconsistent pricing that failed to account for the complexity and costs of these unique products prepared from a patient’s own blood. Inequitable reimbursement in turn caused issues with access in the physician office setting as providers lost money when using autologous blood derived products to treat their patients. Throughout 2024, the Alliance and its members elevated this issue to MAC medical directors and CMS leadership, documented the real-world costs, and proposed solutions.

As a result of this advocacy, in the CY 2025 Medicare Physician Fee Schedule, the Centers for Medicare and Medicaid Services (CMS) established a national payment rate for PRP or other blood-derived product for use in treating chronic diabetic wounds (HCPCS code G0465).¹ These products are now no longer contractor priced as of January 2025 and have a nationally published, consistent, and predictable payment rate under the Fee Schedule. The Alliance was also responsible for the nationally published rate being increased from the proposed to the final rule issuance.

Clinical Care Improvements in the Final Local Coverage Determinations (LCDs) on Cellular and Tissue-based Products for Wounds

At time of posting, this LCD was due to go into effect on April 13, 2025.

When CMS Medicare Administrative Contractors re-issued the draft LCDs guiding coverage of CTPs in diabetic foot ulcer/venous leg ulcer in April 2024, the proposed policies contained problematic limitations. The advocacy of a multitude of voices from the wound care community successfully swayed the MACs to remove arbitrary application limitations and incorporate substantive stakeholder input in the final policies. The final LCDs² now enable clinicians to have application flexibility and an extended episode of care to help heal the chronic wounds of their patients. The improvements made to the policy on the clinical care front illustrate the power of a unified wound care voice to impact change. Implementation pushed from February 2025 to April 2025 based on the Presidential Administration’s Executive Orders. In the meantime, the Alliance and others are pursuing  clarity from CMS on the process and timeline by which new evidence can be submitted and reviewed for coverage so that  the number of covered products available for use treating DFU/VLU can be expanded moving forward.  

Surgical Dressings Claims Processing Issues Fixed

The Alliance escalated shared claim processing issues and compiled specific examples of inconsistent/inaccurate denials related to the maximum allowed quantities per patient/per month with multiple wounds to MAC medical directors. The collection of denied claims provided impetus to the Medicare administrators to review and adjust their claims processing to fix the issue that was resulting in denials. Additionally, the MACs updated their surgical dressings policy article to clarify modifier quantity limitations facilitating coverage and payment for surgical dressing application to a second wound.³

Episode-Based Cost Measure for Non-Pressure Ulcers to be Refined

CMS is in the process of developing  additional episode-based cost measures for use in the Merit-based Incentive Payment System (MIPS).⁴ This work includes a measure for non-pressure ulcers, with a goal to inform clinicians of the cost of their beneficiary’s care for which they are responsible and enable CMS to identify doctors whose spending on wound care patients is far outside the norm. As the measure will be considered for use in the MIPS cost performance category, it is important for it to be based on fair and correct criteria. However, initial field testing⁵ for the measure demonstrated concerning problems and cost attribution inaccuracies including: clinicians are being held accountable for the work of other clinicians, tests are being performed outside of a clinician tax identification number (TIN), yet being attributed to them, and costs being attributed to a clinician for care provided in hospitals or facilities not associated with the clinician’s TIN.  Following tenacious Alliance advocacy elevating these concerns, CMS’ Pre-Rulemaking Measure Review Clinician Recommendation Group ultimately did not reach consensus to move the measure forward at its January 2025 meeting.⁶ As a result, the measure will not be considered for adoption until further work, testing and refinement is undertaken.

The Alliance also focused its efforts on several other coverage and payment policy issues that impact wound care practices:  

• Lymphedema: Urged CMS to enable payment for clinicians to measure and fit lymphedema compression garments via an ongoing advocacy initiative of letters, comments and meetings to keep focus on this issue.
• Topical oxygen therapy: Pursued update to oxygen and oxygen equipment LCD  to establish coverage of topical oxygen therapy for diabetic foot ulcers.
• Total contact casting: Sought fix to flawed TCC payment with a separately payable APC code for TCC when performed on the same date of service as a debridement and/or the application of CTP. This would remove a barrier that inconveniences patients and providers by preventing these treatments from being performed on the same date.
• Anti-microbial wound products: Led advocacy urging FDA to withdraw its proposal to reclassify hundreds of antimicrobial wound products to class III, a policy shift that would result in the unnecessary removal of many important products from the market and challenge quality care.

Marcia Nusgart, RPh, is founder and CEO of the Alliance of Wound Care Stakeholders. Learn more at www.woundcarestakeholders.org.

References

1. Federal Register. Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments. Available at: https://www.federalregister.gov/documents/2024/12/09/2024-25382/medicare-and-medicaid-programs-cy-2025-payment-policies-under-the-physician-fee-schedule-and-other. Published December 9, 2024. Accessed March 24, 2025.
2. Alliance of Wound Care Stakeholders. Delayed Implementation: “Effective Date” for CTP (skin substitutes) LCDs is now 4/13/25. Available at: https://www.woundcarestakeholders.org/news/news-releases/delayed-implementation-new-future-effective-date-for-lcds-for-ctps-skin-substitutes-in-dfu-vlu-is-4-13-25. Published January 25, 2025. Accessed March 24, 2025.
3. Noridian Healthcare Solutions.  Policy Article Revisions Summary for February 29, 2024. Available at: https://med.noridianmedicare.com/web/jddme/policies/dmd-articles/2024/policy-article-revisions-summary-for-022924. Published February 29, 2024. Accessed March 24, 2025.
4. Partnership for Quality Measurement. 2024-2025 Pre-Rulemaking Measure Review Recommendation Group Final Meeting Summary. Available at: https://p4qm.org/sites/default/files/2025-02/PRMR-Clinician-Recommendations-Group-Meeting-Summary.pdf. Published January 2025. Accessed March 24, 2025.
5. Fife C. The Non-Pressure Ulcer Episode-Based Cost Measure “Field Test” Began February 1. Today’s Wound Clinic. Available at: https://www.hmpgloballearningnetwork.com/site/twc/non-pressure-ulcer-episode-based-cost-measure-field-test-began-feb-1. Published February 2024. Accessed March 24, 2025.
6. Centers for Medicare and Medicaid Services. PRMR Clinician Recommendation Group Meeting. Available at: https://mmshub.cms.gov/2024/2024-11/prmr-clinician-recommendation-group-meeting. Published January 21, 2025. Accessed March 24, 2025.

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