Submitted Comments

The Alliance has continued our proactive wound care advocacy with CMS surrounding the waivers and flexibilities implemented in policies addressing medical care amid the COVID-19 crisis. In comments to CMS's Interim Final Rule, the Alliance supported the Agency’s implementation of many policies while also pursuing clarification on several specific provisions that we'd flagged in our April 6th letter to the Agency that still have not been addressed. These included advocacy on issues related to surgical dressing benefits, negative pressure wound therapy billing, CTP co-pays, reimbursement and increased access for alternative methods of debridement, documentation requirements,  and more. The Alliance provided specific policy recommendations and requested that CMS add to its series of upcoming "Office Hours" teleconferences a call specific to wound care as well as one for DME suppliers/providers and manufacturers of medical equipment.
Read Alliance comments

• CMS
• CTPs/(skin substitutes)
• LCDs
• Negative Pressure Wound Therapy (NPWT)
• Surgical Dressings
• COVID-19

In response to the COVID-19 crisis, the Alliance has continued our proactive wound care advocacy by sending our letter to Secretary Alex Azar, Administrator Seema Verma and their staff requesting temporary regulatory waivers to give flexibility to wound care clinicians to provide necessary procedures and products to treat their patients amid the evolving realities of the pandemic. The  Alliance identified specific regulatory provisions related to site of service, reimbursement, documentation, DME access and other issues that, with regulatory relief, could remove barriers to treat wound care patients efficiently and effectively during this pandemic while at the same time keeping them as safe as possible while they receive the necessary care.
READ ALLIANCE LETTER

• COVID-19

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.

• CMS
• CTPs/(skin substitutes)
• Prospective Payment System (PPS)

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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
READ FULL STATEMENT 

• COVID-19
• position statement

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. See additional Alliance recommendations in the full-text comments, below.

• Diabetic Foot Ulcer (DFU)
• DMEMACs
• LCDs
• Medicare Administrative Contractors (MACs)

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In written comments, the Alliance alerted Texas Medicaid 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.

• CTPs/(skin substitutes)
• Debridement
• Negative Pressure Wound Therapy (NPWT)
• Prior Authorization
• Surgical Dressings
• medicaid

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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.

• Capitol Hill
• DMEMACs
• HCPCS
• LCDs
• real-world evidence

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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.

• CMS
• Debridement
• DMEMACs
• Negative Pressure Wound Therapy (NPWT)

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