Submitted Comments

The Alliance submitted a letter informing Acumen that we cannot support the Non-Pressure Ulcers Episode-Based Cost Measure as currently written and articulating the many reasons the current version does not accurately capture the data necessary for a fair, reliable, accurate measure. The Alliance provided specific recommendations and refinements while emphasizing several key areas of concern, including:

• Costs being attributed to clinicians inappropriately: clinicians being held accountable for the work of other clinicians.
• Costs being attributed to a clinician for care provided in hospitals or facilities not associated with the clinician’s TIN.
• Tests being performed outside of a clinician TIN which they have no control over, yet which are being attributed to them.

As the measure will be considered for potential use in the cost performance category of the Merit-based Incentive Payment System (MIPS), it is important for it to be based on fair, meaningful and correct criteria. The Alliance offered to conduct an educational session on wound care to better inform Acumen’s work on the measure.

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In a co-signed letter with the American Physical Therapy Association, American Occupational Therapy Association, and Lymphedema Advocacy Group, the Alliance urged CMS to modify its lymphedema compression garments payment structure to ensure that clinicians are compensated for the measuring, fitting, and training services they provide. This would ensure that beneficiaries have flexibility to receive these services from either their lymphedema therapist or their DME supplier, the letter advocated, noting that the current policy doesn’t assure payment to the therapists who render these services.

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As CMS embarks on CY 2025 rulemaking, the Alliance submitted a letter urging the Agency to support patient access to CTPs (skin substitutes), level the playing field for manufacturers, and reduce Medicare Part B costs by adopting a universal average sales price (ASP) reimbursement methodology for all CTP products. The Alliance voiced concern, again, about  the Agency's past bundling proposals, which would be detrimental to patients—particularly among patients with large and/or more complex wounds. 

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In comments submitted to the FDA's proposed rule on classification of certain wound dressings and companion amendments, the Alliance requested that the Agency withdraw the policy for further vetting. Alliance comments flagged the many "gaps and ambiguities" in the current policy, the reduced availability of wound dressing products that could result if the policy is implemented and the harm this could cause to patient care. "Though we agree with FDA that creating a classification regulation may provide added benefits regarding regulatory expectations, we believe the current proposal will create much greater confusion about requirements for wound dressings, and result in the unnecessary withdrawal of many important products from the market to the detriment of clinicians and their patients. These regulatory actions may result in clinicians using more antibiotic products, exacerbating the very resistance problems that FDA is trying to address through regulations on antiseptic-based wound dressings and washes. Therefore, the Alliance respectfully requests that FDA withdraw its current proposal, and if it desires to proceed, we ask that it publish a more detailed proposed rule, with companion guidance, addressing the points raised stakeholder comments," the Alliance wrote.

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The Alliance submitted comments supporting the intentions of FDA's draft guidance Use of Real-World Evidence (RWE) to Support Regulatory Decision-Making for Medical Devices, which would make use of real-world data and RWE for clinical trials and in expanding indications for use on already approved or cleared devices. We reminded the FDA that CMS and private payers do not accept this type of data for most products - including medical devices - for coverage purposes. As such, even if the FDA adopts/permits real world data/evidence for regulatory decision making, unless CMS and commercial payers also accept real world data/evidence, manufacturers would need to provide one type of evidence for the FDA and another for payers for coverage and payment purposes. The Alliance encouraged the FDA to dialogue with CMS and offered to serve as a resource and convener so that dialogue focused on  realistic and workable solutions can move forward.

• FDA
• real-world evidence
• real-world data

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The Alliance co-signed a letter with aligned vascular and cardiology groups (American Venous Forum, Outpatient Endovascular and Interventional Society & others) to address Aetna's medical policy revision to Policy 0382 Intravascular Ultrasound, Policy 0295 Peripheral Atherectomy and Thrombectomy Devices, and Peripheral Vascular Intervention Clinical Guidelines. The letter flagged inconsistencies with medical society guidelines and current evidence and requested that the "experimental" designation for Intravascular Ultrasound (IVUS) for select interventions be removed.

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The Alliance submitted a letter to the Congressional Joint Committee on Public Health supporting “An Act Relative to the Definition of Podiatry” (H.R.2150/S.1453) – legislation that would modernize the podiatric scope of practice law in Massachusetts to allow podiatrists to treat the foot, ankle, and lower leg.

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The Alliance submitted comments to the Partnership for Quality Measurement supporting expansion of the Global Malnutrition Composite Score in the Hospital Inpatient Quality Reporting (IQR) program from 65 years of age and older to 18 years of age and older. Inclusion of MUC2023-114 will ultimately improve patient care outcomes through standardized identification and treatment of malnutrition.

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As part of its advocacy collaboration with a large group of wound care/HBO stakeholders, the Alliance, submitted comments to CMS requesting an immediate correction to the payment rate for hyperbaric oxygen (“HBO”) therapy included in the 2024 Hospital Outpatient Prospective Payment System rule. In the final rule published in November, "CMS unexpectedly, and without explanation, implemented a reduction of over 40% to the CY 2024 OPPS payment rate for HBO therapy, compared to the CY 2023 OPPS payment rate. We believe that an error was made in the calculation and publication of this payment rate in the 2024 OPPS Final Rule, and we respectfully request that CMS take immediate action to issue a correction," the Alliance wrote, reminding the Agency that implementing this level of payment reduction through the final rule without the opportunity for public comment clearly violates the notice-and-comment rulemaking requirements of the Administrative Procedure Act. HBO has fixed costs "which cannot absorb the cut in the CY 2024 OPPS Final Rule," wrote the Alliance, emphasizing the negative patient care impacts as well as HBO site closures that could result. As part of its collaboration with a range of organizations in this space, the Alliance engaged independent reviewers to analyze the root cause of the drastic decrease in payment rate. The independent review analyzed outpatient claims and concluded that the final cost estimate that CMS provided with the final rule was most likely an error. The review was submitted with Alliance comments urging CMS to review its calculations of the cost, and thus the payment, for HBOT.

• CMS
• Hyperbaric Oxygen Therapy (HBOT)
• Prospective Payment System (PPS)
• HOPPS

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The Alliance played a role in activating CGS Administratos to hold a formal “listening session” to collect stakeholder input, following the MAC's receipt of many communiques from many different stakeholders that Alliance outreach and advocacy had prompted. The Alliance testified at the Sept 13th “listening session” as well as helped mobilize a broad range of other voices from the wound care community to present and make their voices heard. 

• CTPs/(skin substitutes)
• LCDs
• Medicare Administrative Contractors (MACs)
• Novitas FCSO CGS LCD

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