Submitted Comments
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The Alliance submitted recommendations regarding payment methodologies for cellular and/or tissue based products for skin wounds (CTPs) for the Agency to consider prior issuing proposed rulemaking for Calendar Year 2021. The Alliance highlighted that there are many differing interpretations of the three payment methodologies that CMS has been considering: Episodic Payment, Single APC, and Comprehensive APC. The Alliance outlined its understanding of each methodology, and sought to clarify if its definitions and interpretations were correct. "Once we come to an understanding of the definitions, we can better offer our specific recommendation," the Alliance informed CMS.
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As hospitals and health systems are directed to halt all elective and “non essential” services as part of COVID-19 response, a concerning number have categorized wound care services and procedures as “non essential” – leaving a fragile cohort of chronic wound patients at risk. The Alliance developed a position statement to help health systems and providers avoid unintended consequences for wound patients amid the realities of the COVID-19 pandemic: “Wound Care is an Essential, Not Elective, Service that Prevents Hospital Admissions and ED Visits Among a Fragile Cohort of Patients at High-Risk of Mortality from COVID-19.”
See Alliance COVID-19 Resources for Wound Care
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The Alliance submitted comments to the DME MACs' preliminary determination to not cover Topical Oxygen Therapy (TOT) for would healing. The Alliance outlined why the current analysis of evidence on which the LCD was based is "incomplete" and urged the DME MACs to consider the available evidence on a per wound-type basis (i.e., for diabetic food ulcers) and make wound type-specific coverage determinations.
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In written comments, the Alliance alerted Texas Medicare to the many provisions within its Draft Policy on Wound Care Management Services that are out of date with current standards of good wound care practice. Comments addressed policy provisions surrounding CTPs, negative pressure wound therapy (NPWT and dNPWT), surgical dressings, debridement, documentation, prior authorization and more, and included specific recommendations to update the policy as it moves from draft to final.
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In response to Rep. Diana DeGette's (D-CO) and Rep. Fred Upton's (R-MI) request for stakeholder input on how to modernize how new cures and medical products are covered by health insurance, including Medicare and Medicaid, the Alliance submitted a letter offering our recommendations on how reform of Medicare coding, coverage and payment could better support patients’ access to innovative therapies. The letter focused on three main topics: (1) contractor coverage issues that need revising from 21st Century Cures, (2) transparency issues in coverage and coding processes, and (3) the importance of real-world evidence and the need for reporting of more wound-relevant quality measures.
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As part of comments submitted to Wisconsin Physicians Service Insurance Corporation’s Draft Local Coverage Determination for Wound Care, the Alliance flagged eight key concerns and flaws within the policy that negatively impact patient care. Comments focused on WPS’ limiting coverage of debridement while not providing adequate scientific evidence to support its coverage policy. The Alliance questioned the policy’s elimination of a significant number of CPT codes related to debridement and the inclusion of only a limited number of conditions which must be present in order to provide a debridement. The Alliance also flagged many areas where the policy conflicted with other existing DMEMAC policies or violated processes in CMS’s Program Integrity Manual. These comments follow similar comments submitted to WPS in 2017, 2018 and early-2019 raising the same issues. A series of recommendations from the Alliance, addressing each of the eight key concerns, were submitted for WPS consideration as part of comments.
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The Alliance submitted comments to the United States Pharmacopeia's (USP) draft Medicare Model Guidelines advocating for creation of a new subcategory for wound care products. Under the current policy, wound care products are in the “Dermatological, Other” category that includes a long list of products for a variety of conditions with varying severity, such as acne and lice treatments. The Alliance requested that the USP add a subcategory titled “wound care” under Dermatology to distinguish the chronic wound products from other subcategories in Dermatology, which would also better protect coverage of wound care products under Medicare Part D.
- The broad sweep to move all therapeutic services from direct to general supervision
- The implementation of prior authorization for procedures that are often utilized to treat chronic wounds that threaten both life and limb
- Payment methodologies for CTPs
- Lump-sum episode based payment for a wound care episode
- The single Ambulatory Payment Classification (APC) proposal and C-APC methodologies
- Inaccurate APC Group assignments for CTPs due to facilities' incorrect coding/billing, which for years has resulted in APC Group assignments that fail to reflect the true costs of the CTPs.
