This piece is adapted in part, with permission from Today’s Wound Clinic, and has been updated since its publication. The original piece can be found here. 

The “hot button” issues right now for wound care providers and wound patients are focused on access to cellular and/or tissue-based products (CTPs or “skin substitutes”). Just prior to the 2024 Spring SAWC meeting, the Medicare Administrative Contractors (MACs) released draft Local Coverage Determinations (LCDs) and accompanying Local Coverage Billing & Coding Articles (LCAs) that will dramatically affect Medicare coverage of these products, which in turn impacts what clinicians can provide to patients as part of their care plan.

Coverage of CTPs (Skin Substitutes) for DFU/VLU

Last year, three Medicare Administrative Contractors issued final LCDs and LCAs that would have dramatically limit access to CTPs for treatment of diabetic foot ulcers (DFU)/venous leg ulcers (VLU) with an implementation timeframe that, we and many other wound care experts, believe would have significantly jeopardized patient care. As a response to advocacy from the wound care community led by the Alliance of Wound Care Stakeholders, the MACs withdrew the policies days before their implementation date. With the announcement of withdrawal was a statement from the MACs that the policies would be redeveloped and reissued following additional vetting with stakeholders.
 
That brings us to today—as these “redeveloped” coverage policies Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers were published on April 25, and not just by three MACs (which had combined coverage-setting jurisdiction over 15 states), but by all the MACs—which essentially means that this is no longer a regional coverage issue but a national one. There are several revisions in the policies  that we at the Alliance of Wound Care Stakeholders regard as improvements to the policies, as well as provisions that may likely jeopardize patient care and outcomes due to the access barriers being put in place. While the policies span a range of issues, several of the key takeaways that clinicians should be aware of and, if they choose, weigh in on, are:

• Number of applications: The newly issued draft policies continue to permit only 4 applications of CTPs in a 12-week treatment period. This is the same limitation as had been included in the policies issued (then withdrawn) last year. The key improvement is this: policy provisions now allow for additional applications or an extension of the 12-week period when medically necessary and documented in the patient medical record. This is an important point: a clinician’s documentation is the key to success. Every part of the patient’s care as well as justification for the use of a particular CTP must be documented in the patient file.
• Covered products: Just as with the 2023 policies, these new policies place significantly restrictions on the number of CTPs covered for the treatment of DFU/VLU. Only 15 product HCPCS codes are accepted for coverage under these newly issued policies, based on what the MACs deem sufficient peer-reviewed evidence. Approximately 130 CTPs are on the non-covered list. In short, these policies remove coverage from a significant number commonly used products that are currently covered and reimbursed by Medicare. 

The good news is this: these LCDs and LCAs were open for public comment, and many clinical associations, medical specialty societies, patient groups, wound researchers, manufacturers, and individual clinicians submitted feedback and recommendations via oral remarks at open public meetings convened by the MACs in May, and via submission of written comments.  MACs are obligated by regulation to review and consider submitted comments, so stakeholder participation in comment and feedback opportunities is essential to help the MACs medical directors and policymakers understand the realities and complexities of real-world wound care as they develop and finalize policies.

 As an Alliance representing wound care practitioners, we take reassurance that there is included in these drafts a clearer process to extend coverage for patients whose wound healing is progressing. Whether or not the 4 applications are sufficient and supported by evidence—or whether more than 4 should allowed—is one of the debated issues that was the focus of many submitted comments to the MACs. 

 Similarly, many conversations among wound care advocates focused on the policies’ elimination of coverage for a significant majority of products currently in the market. While the Alliance absolutely supports coverage based on published evidence, the MACs were not clear and consistent in what evidence they will consider for coverage. For example, our members have noted that there are studies supporting products that were eliminated from coverage and there are published, peer-reviewed studies that for unknown reasons, were not included on the MACs’ list of evidence reviewed. We and other stakeholders will be seeking more clarity on this front so that products with available published evidence today that was not considered—and those initiating new studies in the future—have a clear path to submit, and have timely review of, evidence that can support coverage. Comments submitted to the MACs on behalf of the Alliance and our members ultimately focused on:  

Evidence and the need for a consistent, equally applied methodology to determine sufficient evidentiary support for coverage.

Reconsideration processes and the imperative for a predictable process under which new evidence can be submitted for review to gain coverage.

Number of applications and treatment duration, with recommendations to more accurately reflect current peer-reviewed evidence.

Implementation, with a request for an extended implementation period to avoid interruptions to care.

Payment for CTPs – CMS Proposed 2025 Payment Policies

In mid-July CMS released its draft 2025 proposed rules guiding payment. Below is a summary of provisions impacting CTP payment. 

Proposed 2025 Physician Fee Schedule:

• There are no substantive proposals regarding CTP payment policy contained in the proposed 2025 Medicare Physician Fee Schedule (PFS) update. However, there are valuable insights in the language of this rule in terms of future intentions of CMS. For example, in the absence of policy changes this year the Agency wrote in this proposed rule that state that it is continuing to look at ways to treat CTPs as "incident-to supplies" under the PFS methodology, with the ultimate goal of establishing a consistent coding and payment approach across care settings. This move to bundle CTP payment in the physician office setting had been a big issue in the 2023 PFS Proposed Rule that the Alliance had flagged substantive concerns with and aggressively advocated against. With CMS confirming that an overhaul of CTP payment is still in deliberation at the Agency, this remains an  area where advocacy, outreach to policymakers and education will continue.  

Proposed 2025 Hospital Outpatient Prospective Payment System update: 

•  Although the Alliance and other aligned advocates have long urged CMS to remove patient access barriers by correcting CTP payment Inadequacies in the HOPPs rule, there were no significant changes for 2025. The Agency has not proposed any changes to the pricing methodology and will continue to place CTP products in to the existing high/low category. 

Make Your Voice Heard on Policies that Impact Your Patients and Your Practice

The Alliance of Wound Care Stakeholders encourages aligned organizations, wound clinics and wound care providers to keep abreast of coverage and payment policies that will impact your practice and your patients. There are opportunities to weigh in and submit comments to  share the clinical impact that proposed policies will have and voice the changes you’d like to see. Health care policymakers at CMS, FDA and in Congress are particularly interested in the voice of healthcare providers. Individual clinicians, clinical associations, specialty societies, wound clinics, and health systems all have valuable perspectives to share. Articulating the realities and complexities of wound care helps policymakers and payers forge clinically sound policies. And that makes wound care better.
 
Karen Ravitz, JD, is the health care policy advisor to the Alliance of Wound Care Stakeholders—an association of medical specialty societies, clinical and patient associations whose mission is to promote quality care and access to products and services for people with wounds. Through advocacy and educational outreach in the regulatory, legislative, and public arenas, the Alliance unites leading wound care organizations and experts to advocate on public policy issues that may create barriers to patient access to treatments or care.