Submitted Comments
June 21, 2023
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.
June 20, 2023
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.
May 26, 2023
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."
May 26, 2023
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."
March 23, 2023
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.
March 6, 2023
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.
February 10, 2023
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.
January 23, 2023
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."
January 18, 2023
The Alliance informed CMS that it does not support the packaging of skin substitutes in the physician office, as recent experience shows that packing has not worked well for patients or for hospital outpatient departments. In addition to significant flaws in the current payment methodology, there have been issues with patient access to care as well as limiting clinician’s choice of product. "We really need to have more information from the Agency on CMS’s intent, goals or criteria for packaging skin substitutes in the physician office," the Alliance said as part of oral testimony offered at CMS' Skin Substitutes Town Hall convened to collect stakeholder feedback related to changes in payment and terminology of skin substitute products being considered under the Physician Fee Schedule. The Alliance recommended that CMS develop and put forward a policy "Framework Document" for stakeholder input prior to initiating rulemaking. In the meantime, the Alliance urged CMS to continue its longstanding policy of recognizing and providing separate payment for CTPs products under the ASP methodology. Savings could be realized, the Alliance told CMS, if all skin substitute companies to submit ASP pricing to the Agency and all companies’ ASP data are published in the ASP data file.
January 3, 2023
The Alliance submitted comments to the final 2023 Medicare Hospital Outpatient PPS rule, questioning why CMS again failed to adopt the recommendations of its Hospital Outpatient Payment Panel related to skin substitutes (CTPs) and emphasizing flaws in the Agency's rationales. In 2021 and 2022, the HOPPs panel endorsed the Alliance’s policy update recommendations to enable provider-based departments to (1) be reimbursed for an adequate amount of CTP products for larger wounds so that they do not need to absorb the cost themselves or refer patients out, and (2) to equalize the payment for CTP application for wounds/ulcers of the same size no matter the anatomic location. Yet these have not been included in the HOPPS rule. "Over the nine plus years that CMS has proposed and implemented packaging for skin substitutes, the Alliance has submitted substantive data to CMS showing that the data used and the conclusions that CMS has made as it relates to the rate setting for CTPs is flawed...CMS erroneously believes that facilities are making significant profit on skin substitutes which is perpetuating the flawed logic. As a result of this flawed logic, CMS is making decisions not in the best interest in Medicare beneficiaries who are patients with wounds/ulcers," the Alliance wrote, urging the Agency to adopt the Panel recommendations related to skin substitutes in the next round of rulemaking. See full comments below.
