Submitted Comments

HHS issued a Request for Information in May soliciting recommendations on specific regulations that should be eliminated "to lower healthcare costs, reduce burdens on physicians, and address the prevalence of chronic disease." The Alliance engaged its multiple workgroups to identify specific areas for inclusion and submitted to HHS a detailed chart of regulations with corresponding recommendations across specific guidance. These included recommendations to:

• Correct several problematic NCCI edits including Total Contact Cast (TCC)
• Revise Coverage w Evidence Development (CED) processes and the Transitional Coverage for Emerging Technologies (TCET) pathways – as they are cumbersome and do not achieve the desired results of bringing product to market faster.
• Remove burdens to the Medicare process for obtaining therapeutic shoes for patients with diabetes that currently creates unnecessary delays in care.
• Issue clear, enforceable guidance to Medicare Advantage Programs requiring that their coverage and documentation requirements align with, and are no more restrictive than, those established under Medicare Fee-for-Service (FFS) as is required in regulation.
• Update provisions for lymphedema compression treatment coverage to enable payment for clinicians to measure and fit lymphedema compression garments, and more...

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The Alliance submitted comments to the National Quality Forum (NQF) request for stakeholder input on its proposed updates to its Serious Reportable Events (SRE) List. The Alliance focused on a problematic update to SRE 15: "Patient Harm Associated With a Stage 3 Pressure Injury, Stage 4 Pressure Injury, or Deep Tissue Injury Acquired After Admission." The 2025 update identifies 27 areas as serious reportable events and expands all SREs to all healthcare settings. The Alliance recommended not only that SRE 15 “not be expanded to other healthcare settings since it is totally different and unique from others that are currently on the list” but also that it be removed from the list entirely. “Pressure ulcers/pressure injuries can be a normal physiologic response to the underlying co-morbid illnesses and acute hemodynamic factors and are not in the same category as operating on the wrong patient or wrong site, an overdose of radiotherapy, or insemination with the wrong sperm -- events that are clearly identifiable to a provider.” If NQF is not willing to delete SRE 15 from the 2025 list, the Alliance recommended that it limit the healthcare settings to only hospital/acute care and eliminate ambulatory/outpatient, post-hospital/subacute and home care. “Given the delay from event to presentation of a pressure ulcer/pressure injury, it will be impossible to reliably link them to an outpatient healthcare encounter,” the Alliance wrote.

• NQF

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The Alliance submitted comments in response to CMS' request for information (RFI) seeking input regarding the market of digital health products for Medicare beneficiaries as well as the state of data interoperability and broader health technology infrastructure. "The demand and dependencies on timely and high-quality electronic health information across the health care and technology innovation ecosystems have grown, and actors are not being held accountable for blocking or inhibiting the flow of patient data," the Alliance wrote in comments that highlighted the necessity to address specific gaps and challenges and submitted a number of detailed recommendations and suggestions for the Agency to consider. 

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.The Alliance submitted comments to the Office of Management and Budget responding to its request for feedback on opportunities for deregulation. The Alliance provided suggestions for deregulation as well as recommendations to streamline or correct current regulatory and sub-regulatory provisions. These suggestions included: 

• Withdrawal of FDA Proposed Rule re: Reclassification of Certain Antimicrobial Wound Dressings
• Changes to Prior Authorization processes
• Lessening of burdens within Medicare’s Therapeutic Shoe Program for Patients with Diabetes
• Fixes to problematic payment provisions for CTPs in the Hospital Outpatient Prospective Payment System
• Expanded adoption of real-world evidence (RWE) and updates to Coverage with Evidence Development
• National Correct Coding Initiative; Audit Reform; Data & Reporting Processes that are Duplicative or Overly Complex; plus additional opportunities for deregulation and reform...

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When the FDA last year released a proposed rule and companion amendments on classification of certain antimicrobial wound dressings, the Alliance flagged to the Agency the many gaps and ambiguities in the policy, the reduced availability of wound dressing products that could result if it is implemented, and the harm this could cause to patient care. Our submitted comments at that time urged FDA to withdraw the policy for further vetting. Following the late-March 2025 confirmation of a new FDA Commissioner, the Alliance opted to send a letter to the FDA Commissioner and to the Office of Management & Budget Director reiterating our concerns with the proposed reclassification and elevating our request for withdrawal. 

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The Alliance submitted comments to CMS' Proposed Guidance Document: Study Protocols That Use Real-world Data (RWD) urging that use of RWD for real-world evidence (RWE) be extended to all coverage determinations, not just to the national coverage determination (NCD) coverage with evidence development (CED) process as proposed. "Using RWE only for NCDs with CED is rather limiting as there are very few NCDs based on CED. If the Agency is permitting RWE to be used for coverage purposes, the use should be extended to all coverage determinations," the Alliance advocated to CMS, submitting the recommendation that "any coverage policy should consider RWE as an adjunct to Level 1/Level 2 evidence when determining product coverage since it aligns with the Congressional intent of the 21st Century Cures Act in 2016 encouraging the use and acceptance of RWE. Therefore any guidance offered in terms of appropriate evidentiary standards including the use of RWE should apply not only to NCDs based on CED or NCDs in general but also to Local Coverage Determinations (LCDs)."

• real-world evidence
• real-world data

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The Alliance signed on to a letter with the American Diabetes Association, American College of Cardiology, Society for Cardiovascular Angiography & Interventions and others, requesting that CMS create a national coverage determination (NCD) for peripheral artery disease (PAD) screening and recommended follow-up testing for at-risk Medicare beneficiaries as part of efforts to identify, prevent, and mitigate diabetes-related complications and amputations. 

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The Alliance joined with 100+ healthcare provider organizations urging Congress to take immediate action to reverse the current 2.8% Medicare Physician Fee Schedule Conversion Factor (CF) reduction now in effect and provide clinicians with a positive payment update in the upcoming March 2025 appropriations bill. "The ongoing downward reimbursement spiral is contributing to consolidation in the health care system as more clinicians are no longer able to sustain their practices," the coalition of provider groups told Congress, advocating for inclusion of the bipartisan Medicare Patient Access and Practice Stabilization Act (H.R. 879) in the March package. H.R. 879 is designed to safeguard the financial stability of physician practices with provisions that protect clinicians from the 2.8% Medicare payment cut and a 2% inflation update to help offset rising costs and strengthen the sustainability of practices across the country.

**Action opportunity: Clinicians - send your own letter of support for H.R. 879 via several Alliance members' "Voter Voice" Action Centers where you can adapt from their letter template and send to your state Congressional delegation at the touch of a button. See Action Centers from the American Physical Therapy Association, Academy of Nutrition and Dietetics and Society for Vascular Surgery. 

Read Co-Signed Letter to Congress

The Alliance submitted comments to CMS' Medicare Managed Care proposed rule supporting the Agency's provisions to improve Prior Authorization processes, while encouraging additional provisions to ensure MCO accountability are still needed. Only when payers are held accountable will the proposed changes to PA be a success for health care providers and the beneficiaries they are treating.

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The Alliance submitted comments to CMS and the Partnership for Quality Measurement’s Pre-Rulemaking Measure Review Committee reiterating that we do not support the Non-Pressure Ulcers Episode-Based Cost Measure as currently proposed. The letter again articulated our many concerns – which were previously raised in prior comment letters, in meetings with Acumen staff, and most recently as part of our oral statement at the December Pre-Rulemaking Measure Review (PRMR) Listening Session. The Alliance recommended that the measure be withdrawn until further refinements are made and additional testing can be conducted with results provided to the Clinical Expert Workgroup for further discussion.

• nonpressure ulcer cost measure

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