A Closer Look at the CMS MACs’ Recent Proposed Coverage Policies for CTPs

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The editors of Today’s Wound Clinic had the chance to touch base with Alliance of Wound Care Stakeholders policy advisor Karen Ravitz, JD, at SAWC Spring to discuss policy issues impacting wound care. Below find some highlights of this discussion.
 
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 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 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 were recently 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 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. 

Stakeholder Submission Is Ongoing Through June 8

The good news is this: these LCDs and LCAs are open for public comment through the submission deadline of June 8. Over the month of May, each MAC hosted an open public comment webinar for stakeholders to provide oral testimony and, at these virtual meetings, encouraged submission of written comments. MACs are obligated by regulation to review and consider submitted comments, so stakeholders should take advantage of opportunities to weigh in, share concerns, and offer up specific recommendations. 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.
 
From the perspective of the Alliance of Wound Care Stakeholders and the thousands of wound care clinicians that our member organizations represent, we will be submitting comments and encourage other aligned organizations—as well as individual clinicians and patients—to also make their voices heard by submitting comments.
 
While our association’s written comments are still being shaped by our members, at the May MAC public meetings, or oral remarks voiced support for the proposed LCD language permitting additional applications or an extension of the 12-week treatment period based on medical necessity with documentation provided in the patients’ medical record. 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 will no doubt be the focus of many submitted comments to the MACs. We are finalizing our own organizational comments but take reassurance that there is now at least a clearer process to extend coverage for patients whose wound healing is progressing.
 
Many conversations among wound care advocates are currently focused on the policies’ elimination of coverage for a significant majority of products currently in the market. At the May public meetings the Alliance and others went on the record in our oral testimony asking for the MACs to be more transparent regarding the evidentiary bar being applied to determine if coverage will be provided. 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.

Make Your Voice Heard

Will the changes in these draft LCDs and LCAs impact your practice and your patient care for patients with diabetic foot ulcers and venous leg ulcers? The Alliance of Wound Care Stakeholders encourages aligned organizations, wound clinics and wound care providers to email their respective MAC, share the clinical impact that the proposed policies will have, and voice the changes you’d like to see. Health care policymakers 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.
 
Want to weigh in? Not sure which MAC covers your state? See this map.

LCD title: Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
 

• CGS Administrators: LCD #DL39756 / LCA #A59618
  Submit comments online or email comments to cmd.inquiry@cgsadmin.com
• First Coast Service Options: LCD #DL36377 / LCA #A57680
  Submit comments online or email comments to ProposedLCDComments@fcso.com
• National Government Services: LCD #DL39828 / LCA #A59712
  Submit comments online or email comments to NGSDraftLCDComments@anthem.com
• Noridian (JE district): LCD #DL39760/ LCA #A59626
  Submit comments online or email comments to policydraft@noridian.com
• Noridian (JF district): LCD #DL39764 / LCA #A59628
  Submit comments online or email comments to policydraft@noridian.com
• Novitas Solutions: LCD #DL35041 / LCA #A54117
  Submit comments online or email comments to ProposedLCDComments@novitas-solutions.com
• Palmetto GBA: LCD #DL39806 / LCA #A59691
  Submit comments online or email comments to A.Policy@PalmettoGBA.com
• WPS Insurance Corporation: LCD #DL39865 / LCA #A59740
  Submit comments online or email comments to policycomments@wpsic.com

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.