Submitted Comments

The Alliance signed on to a letter with 20+ other health/medial associations to the Centers for Medicare and Medicaid Innovation (CMMI) requesting an extension to comment on its Request for Information seeking stakeholder input regarding the design of future episode-based payment models. The RFI was published on July 18 - just days after the draft 2024 Medicare Physician Fee Schedule and Outpatient Prospective Payment System proposed rules were released for comment.
The RFI required comments within 30 days for this large and important payment issue – which we and others did not feel was sufficient time to vet within our various memberships to consolidate and provide substantive feedback. CMMI said it could not extend comment period but will provide additional opportunities to comment in rulemaking. In issuing the RFI, CMS is looking to address the inefficiencies in traditional Medicare fee-for-service, where providers are paid for each item or service, which may drive volume over value and fragment care. CMS indicated that the Innovation Center intends to design, implement, and evaluate future episode-based payment models with a focus on five strategic objectives, including advancing health equity and driving accountable care.

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The Alliance submitted comments to the FDA on its "Decentralized Clinical Trials for Drugs, Biological Products and Devices: Draft Guidance for Industry, Investigators and Other Stakeholders."  Overall supporting the guidance and its intent to expand access to diverse locations/populations, the Alliance raised several areas of concern surrounding whether the policy would have the impact that the Agency is striving to achieve. Our comments offer a series of recommendations, as well as highlight specific provisions that would benefit from additional clarity. 

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Together with 30+ clinical organizations in cardiology, podiatry and diabetology, the Alliance co-signed a letter to Congress supporting the Amputation Reduction and Compassion Act of 2023. Each year, more than 150,000 amputations are performed in the US to remove toes, legs or feet affected by advanced peripheral artery disease (PAD). This legislation would help reduce these preventable amputations by requiring Medicare, Medicaid, and plans sold on the federal healthcare exchanges to fully cover screening tests for beneficiaries who are at-risk of PAD. Early diagnosis and intervention can restore blood flow to affected limbs and reduce the risk of amputation. Originally introduced in 2021 (see full text) and reintroduced in June 2023, this legislation includes provisions to:

• Increase access to diagnostics aimed at identifying conditions that can lead to amputation by providing coverage for PAD screenings of at-risk beneficiaries in Medicare and Medicaid;
• Require the development of quality metrics among payers and facilities that can prevent amputations; and
• Provide access to amputation prevention services through the development of a voluntary pilot program, including through patient risk medication and management approaches, early screening and detection, ongoing surveillance, testing, and more.

See letter below. 

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Together with 150+ organizations spanning health, technology, aging and more, the Alliance voiced its support for the CONNECT for Health Act of 2023. Last introduced in 2021 and re-introduced in June 2023, the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act would expand coverage of telehealth services through Medicare, make permanent COVID-19 telehealth flexibilities, and make it easier for patients to connect with their doctors. Specifically, the legislation would:

• Remove geographic restrictions on telehealth services and expand originating sites to include the home and other sites;
• Allow health centers and rural health clinics to provide telehealth services;
• Allow more eligible health care professionals to utilize telehealth services;
• Remove unnecessary in-person visit requirement for telehealth services supporting mental health; and
• Require more published data to learn more about how telehealth is being used, impacts of quality of care, and how it can be improved to support patients and health care providers.

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Together with the Clinical Labor Coalition, the Alliance submitted a letter to Congress in support of the recently-introduced legislation, the “Providing Relief and Stability for Medicare Patients Act of 2023” (H.R. 3674). This legislation would help mitigate cuts to office-based specialists for a targeted group of services for two years, thereby helping to avoid significant disruptions in patient access to care. "As you are aware, the discrepancy between what it costs to run a physician practice and actual payment combined with the administrative and financial burden of participating in Medicare is incentivizing market consolidation. We are concerned that the ongoing severity of recent cuts, combined with additional anticipated payment adjustments, will result in a breaking point for many physicians. Absent additional Congressional intervention via passage of H.R. 3674, the result will be more providers leaving the field, more practices being closed or sold, and a significant number of patients losing access to a variety of healthcare service in their communities."

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The Alliance submitted a letter to CMS' Coverage and Analysis Group Director inquiring why the Agency has not addressed the reconsideration request submitted in July 2021 regarding Local Coverage Determination L33797 (Oxygen and Oxygen Equipment), which had established Medicare coverage criteria for topical oxygen therapy (TOT) in the treatment of diabetic foot ulcers (DFUs). The American Diabetes Association published a clinical compendia stating that the “evidence supporting TOT’s efficacy in healing chronic DFUs can no longer be disputed” and supported the inclusion of TOT in clinical practice guidelines for chronic DFUs, the Alliance reminded CMS. "The continued [18 month] delay of not moving forward with the reconsideration request for TOT increases the risk of negative health outcomes for some of the most at-risk Medicare patients."

• CMS
• Diabetic Foot Ulcer (DFU)
• topical oxygen

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The Alliance submitted a statement to the House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies public hearing (March 18) to be on the record regarding our concern about the approach CMS is taking with respect to proposed payment changes to skin substitutes (CTPs) in the Medicare Physician Fee Schedule that we believe will negatively impact patient access to care. The Alliance requested that Congress include language in the CMS Program Management Account appropriations bill to ensure that CMS adheres to the recommendations put forward in the March 2023 Office of Inspector General's report on Average Sales Price (ASP) for Skin Substitutes in order to maintain access to these products while saving valuable dollars to the Medicare Trust Fund.

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The Alliance submitted comments to CMS proposed rule on Advancing Interoperability and Improving Prior Authorization (PA) Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies. While the Alliance is supportive of the Agency’s proposal to streamline PA process, we expressed concern about the lack of provisions addressing payer accountability. "Payers need to be held accountable or the changes proposed will have little effect," the Alliance wrote. For example, in the proposal, CMS states that if a provider does not hear back from the payer in the timeframe proposed then the provider "should contact the payer." This certainly does not streamline the burden on providers, the Alliance noted, and does not hold payers accountable for their lack of response. The Alliance encouraged CMS to include payer accountability provisions as this proposal moves towards finalization. 

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The Alliance submitted comments to the director and deputy director of CMS' Hospital and Ambulatory Policy Group to augment oral comments shared at the Agency's January 2023 Skin Substitute Town Hall. "Any efforts by the Agency that will curtail access to CTPs will have a direct impact on infection and amputation rates," wrote the Alliance, noting that CMS "has failed to provide any assessment of this impact or details about its rationale for the change such as: an impact analysis, details on how CMS will implement bundling in the physician office setting, the criteria used for setting the rates, or the reasons for making this seismic change. Moreover, the Agency has not demonstrated that the bundling of these products will not impact access to these products, especially to our greatly underserved Medicare patient populations who suffer disproportionately." The Alliance included a list of detailed questions for the Agency to address and suggested that CMS develop a framework document where such questions could be answered - and vetted with stakeholders -  prior to any new rulemaking taking place.

• CMS
• CTPs/(skin substitutes)
• Physician Fee Schedules

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The Alliance, together with 100+ clinical and medical professional society organizations representing more than one million healthcare providers,  co-signed a letter to the new 118th Congress urging "comprehensive, transformative reforms" to the Medicare payment system over the next several years. The letter points to declining Medicare payments and the lack of an annual inflationary update in the Physician Fee Schedule, even though clinicians — many of whom are small business owners — contend with a wide range of shifting economic factors. "Year-over-year cuts, combined with a paucity of available alternative payment/value-based care models, clearly demonstrate that the Medicare payment system is broken...Reform is imperative to sustaining medical practices and ensuring a robust workforce to care for the growing number of America’s seniors. We again ask Congress to work with us on long-term, substantive payment reforms and urge Congressional hearings as soon as possible." 

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