CMS Withdraws Local Coverage Policy That Dramatically Restricted Access to CTPs (Skin Substitutes)

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Following tenacious, collaborative advocacy across the wound care community, Medicare Administrative Contractors (MACs) Novitas, First Coast Service Options (FCSO) and CGS Administrators (CGS) withdrew local coverage determination (LCD) and local coverage article (LCA) policies that that would have dramatically restricted Medicare patients’ access to cellular and tissue-based products for wounds (CTPs/“skin substitutes”). The policies were scheduled to go into effect on Oct. 1, but were withdrawn on Sept. 28.
 
“The LCD entitled, Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers, will not become effective on 10/01/2023. A new Proposed LCD will be published for comment and presented at an Open Meeting in the near future,” reads a message at the top of the LCD page on Novitas’ website, with similar messages posted Sept. 28 on the policy pages of FCSO and CGS. All clarify that with the withdrawal of the 2023 coverage policy revision, the MACs’ previously existing LCDs guiding use of CTPs for diabetic foot ulcers/venous leg ulcers (DFU/VLU)—which the 2023 update was supposed to supersede—will now remain in place.

Problematic Policies

Released in early August, the policies had placed 130 CTPs on the non-covered list, which removed Medicare coverage from a large number commonly used products that previously have been covered and reimbursed by Medicare. The coverage policies also capped the number of CTP applications to 4, halving the applications allowed over a treatment episode without regard for wound healing progression, product labeling or supportive clinical evidence.

Problematic Implementation Timeframe

Also problematic was the implementation timeframe of the policies. Less than 8 weeks was provided from the policies’ Aug. 3 issuance date to effective date (initially Sept. 17, then extended to Oct. 1 to accommodate a technical "system update"). CTPs are a category of products with standard 12-week instructions for use, so it was anticipated that the short transition period would result in concerning disruptions to care for DFU/VLU patients in the middle of a CTP treatment plan. If their care plan involved a CTP that was moved to the non-covered list, or included more than four applications of a covered product, their care plan would be disrupted come Oct. 1 due to the coverage changes.

Problematic Impacts on Patient Care

With limitations in the number of applications permitted under the LCD/LCA policies, as well as the constraints accessing the CTPs no longer covered, it was going to become harder for wound care providers in the 15 states under FCSO, CGS and Novitas A/B MAC jurisdictions to provide appropriate wound care and avoid a decline in a patient’s chronic wound condition that includes potentially having to amputate the patient’s leg. The states in the MACs jurisdictions include: Arkansas, Colorado, Delaware, Florida, Kentucky, Louisiana, Maryland (Montgomery and Prince George’s counties), Mississippi, New Jersey, New Mexico, Ohio, Oklahoma, Pennsylvania, Texas, Virginia (Arlington and Fairfax counties, Alexandria), Washington DC, and Puerto Rico. These access challenges would adversely impact all Medicare beneficiaries in these jurisdictions receiving wound care, and in particular, vulnerable populations such as African Americans, Latinos, and other minorities who are at higher risk for amputations from diabetes complications.

Advocacy: Clinician Call to Action—Share Real World Impacts with Policymakers

The Alliance of Wound Care Stakeholders, a leading voice of wound care advocacy for the past 20 years, had initially elevated concerns with the coverage policies when they issued as drafts in early 2022. In the months that followed, the Alliance submitted a series of written comments and oral testimonies that again and again flagged clinically incorrect information in the policies, arbitrary utilization parameters, and the lack of scientific evidence to support the changes proposed. When the LCDs/LCAs issued as “final” in August 2023 with few of these concerns addressed, the Alliance launched an Advocacy Action Center initiative to ensure that policymakers at the MACs, at the Centers for Medicare and Medicaid Services (CMS) and on Capitol Hill understood the real-world impact of these policies.
 
The “Call to Action” mobilized not just the Alliance’s 20+ medical specialty society/clinical association members, but also mobilized wound care provider groups, individual wound care providers and wound care patients to email MAC medical directors and CMS policymakers.

Advocacy: Capitol Hill

At the same time, several Alliance member organizations also engaged with members of Congress, educated them on the issues and encouraged Congressional representatives to submit letters voicing concerns to CMS. Ultimately, multiple letters were sent to CMS, including a letter from a bipartisan group of seven members of Congress to CMS Administrator Chiquita Brooks-LaSure, saying:
 
“We are advised that the overall process lacked transparency and adequate public notice. The final LCDs depart substantially from the draft LCDs that proceeded them. For example, the final LCDs introduce critical terms and coverage conditions that were not in the draft and are not the outcome of public comment. Moreover, they entail major changes for beneficiaries and other stakeholders. In view of these concerns, we are hopeful [CMS] can ensure that Medicare beneficiaries in these 15 states will continue to have access to medically necessary skin substitutes and that CMS will work with the three MACs to rescind the LCDs and restore coverage for such products or to delay the effective date of the LCD until these issues can be addressed.”

The Biggest Winners: Medicare Beneficiaries

While it is unknown exactly how many emails were sent to the MACs and CMS from patients, providers, or members of Congress, the advocacy clearly had impact and the policies were withdrawn. This advocacy success is the result of a collaborative effort across the wound care community, with providers and patients proactively elevating their voices and perspectives to policymakers. In its note pulling the policies, CMS stated that new, revised proposed LCDs/LCAs will be released for comment at some point in the near future, so advocacy will continue. But ultimately, the real winners of this current “advocacy victory” are Medicare beneficiaries with chronic wounds who now won’t face disruptions to care or unnecessary restrictions to treatments that can support wound healing.
 
Marcia Nusgart, RPh, is founder and CEO of the Alliance of Wound Care Stakeholders, the leading voice of wound care advocacy for the past 20 years. The Alliance unites leading wound care organizations and experts through advocacy and educational outreach in the regulatory, legislative and public arenas to advocate on public policy issues that may create barriers to patient access to treatments or care. With a key focus on coding, coverage and reimbursement, quality measures and wound care research, the Alliance elevates the visibility and united voice of wound care providers to regulators and policymakers. Learn more here.