Submitted Comments
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alerted Texas Medicare to the many provisions within its Draft Policy on Wound Care Management Services that are out of date with current standards of good wound care practice.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.
The Alliance submitted detailed comments to CMS on a range of provisions in the proposed Physician Fee Schedule that impact wound care providers. Comments focused on:
- Evaluation and Management Codes
- The conclusions of three RAND Corporation reports utilized in the report to support certain provisions (CMS had contracted RAND to collect data on the number and level of post-operative visits for surgical global codes provided to Medicare beneficiaries)
- Relative Value Units (RVUs) for Physical Therapy
- Practice Expense (PE) RVUs for Disposable Negative Pressure Wound Therapy (CPT Codes 97607 & 97608)
- Open Wound Debridement (CPT Codes 97597 and 97598)
- Ultrasonic Wound Assessment (CPT Code 97610)
- The process of removing measures from the MIPs for being “topped out”
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The Alliance submitted comments to CMS in response to the proposed updates in the CY 2020 Home Health Prospective Payment System. The Alliance noted concern with CMS’ proposal to reduce the Requests for Anticipated Payment (RAP), asking that CMS consider the cash flow requirements of new home health agencies who also have capitalization needs and smaller agencies and those in rural areas have a significant need for cash flow support. The Alliance also strongly opposed the removal of pain measures from the Home Health Quality Reporting Program (HH QRP) and the Home Health Consumer Assessment of Healthcare Providers and Systems (HHCAHPS surveys). While CMS reports that elimination of the measure is in line with the agency’s broader efforts to address the opioid epidemic, the Alliance flagged that pain remains an issue that is important to patients served in the home health setting and there is no evidence to suggest that the use of these measure is linked to opioid misuse.
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The Alliance submitted comments to CMS in response to its Request for Information regarding Patients Over Paperwork related to reporting and documentation requirements, coding and documentation requirements for Medicare or Medicaid payments, and prior authorization procedures. Our comments focused on several key issues, including:
- NCCI edits
- HCPCS coding reform
- Local coverage decisions (LCDs) versus coverage articles (LCAs)
- Prior authorization
- Billing for disposable negative pressure wound therapy in home health care setting
- Implementation timing of rules issued by CMS
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The Alliance submitted comments to AHRQ regarding its draft Technical Brief (TB) and Supplemental Evidence and Data for Systematic Reviews (SEADS) report on “Skin Substitutes for Treating Chronic Wounds.” Comments summarized the problematic procedural issues surrounding the report and raised concern that only 3 of the 83 studies submitted were accepted for consideration - excluding of most of the evidence submitted from the expanded evidence search that had deliberately been re-opened. "Stakeholders have the right to review the next version of the draft to ensure that the corrections were made, the evidence was utilized correctly and read whether any conclusions were altered as a result," emphasized the Alliance. "We urge AHRQ to release the next draft of the technical review with an additional public comment period prior to final publication."
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