THIS WEEK’S DOSE
- Congress Negotiates Healthcare Extenders, Continues to Plan for 2025. Congress is discussing healthcare extenders to be added to a year-end funding package.
- House Select Subcommittee on the Coronavirus Pandemic Concludes Investigation. The two-year investigation resulted in a Republican-led final report, “After Action Review of the COVID-19 Pandemic: The Lessons Learned and a Path Forward,” that was approved by the subcommittee.
- Senate HELP Committee Holds Hearing on Obesity and Diabetes with FDA Commissioner Califf. The hearing focused primarily on food labeling.
- CMS Finalizes Mandatory Kidney Transplant Model. The model is set to begin in July 2025 and includes kidney transplant hospitals in a random selection of half of all donation service areas.
- CMS Releases Plan Year 2026 MA, Part D Proposed Rule. Key proposals include requiring Medicare and Medicaid to cover anti-obesity medications for treatment of obesity and regulating plan use of utilization management and artificial intelligence.
- CMS Announces Sickle Cell Drug Manufacturer Participation in Access Model. The manufacturers’ participation is essential for the functioning of the model, which initially will focus on access to treatments for people with sickle cell disease.
CONGRESS
Congress Negotiates Healthcare Extenders, Continues to Plan for 2025. Lawmakers continue negotiations to wrap up the 118th Congress and pass remaining must-do policies, including government funding, likely through a continuing resolution (CR). Discussions are occurring to determine whether and for what duration Congress might include healthcare extenders and additional health policies as part of the CR. Whether Republicans and Democrats can reach an agreement on so-called “pay fors” for longer-term healthcare extenders, along with other key policies for inclusion, remains a significant complicating factor.
Meanwhile, the 119th Congress continues to take shape with the release of the 2025 House and Senate calendars.
House Select Subcommittee on the Coronavirus Pandemic Concludes Investigation. During a business meeting, subcommittee members adopted by voice vote an amended version of the Republican-led final report, titled “After Action Review of the COVID-19 Pandemic: The Lessons Learned and a Path Forward. Subcommittee Chairman Wenstrup (R-OH) and Subcommittee Ranking Member Ruiz (D-CA) provided brief comments. Chair Wenstrup emphasized that the work of the subcommittee held bad actors accountable, drove change in public health agencies, and supported the lab leak origin theory. Ranking Member Ruiz stated that policymakers have not done enough to work together to tackle challenges from the COVID-19 pandemic and prepare for future pandemics, but said that he believes they will still be able to do so in the future. He noted how the separate, Democrat-led final report highlights the parties’ differing perspectives on the subcommittee’s work. The subcommittee also developed final recommendations for federal agencies to improve public health and pandemic response.
Senate HELP Committee Holds Hearing on Obesity and Diabetes with FDA Commissioner Califf. The hearing’s purpose was to question top Food and Drug Administration (FDA) officials on what the agency is doing to address the impact that the food and beverage industry is having on the diabetes and obesity epidemics. Most members of the committee agreed that the food and beverage industry, coupled with insufficient FDA regulation, is to blame for the prevalence of chronic disease nationwide. FDA Commissioner Califf emphasized the need for increased funding from Congress for the FDA. The hearing mainly focused on transparency in food labeling and did not focus on health outcomes.
ADMINISTRATION
CMS Finalizes Mandatory Kidney Transplant Model. The finalized Increasing Organ Transplant Access (IOTA) model is set to start July 2025, a delay from the proposed January 2025 start date, and is designed to last for six years through June 2031. The mandatory IOTA model aims to test whether performance-based incentive payments paid to or owed by participating kidney transplant hospitals increase access to kidney transplants for patients with end-stage renal disease, while preserving or enhancing the quality of care and reducing Medicare expenditures. The Centers for Medicare and Medicaid Services (CMS) intends to randomly select approximately half of the donation service areas (DSAs), and all eligible kidney transplant hospitals within the chosen DSAs will be required to participate. The other half of the DSAs will serve as the comparison group. CMS will then measure and assess the participating hospitals’ performance during each performance year across three domains: achievement, efficiency, and quality. While the model is finalized, it is unclear if the incoming administration will support mandatory models or if it will seek to adjust the IOTA model before its start date. Read the press release here and the fact sheet here.
CMS Releases Plan Year 2026 MA, Part D Proposed Rule. If finalized by the new administration, the proposed rule would institute changes to the Medicare Advantage (MA) and the Medicare Prescription Drug (Part D) Programs, most of which would be effective in plan year 2026. Key proposals include:
- Anti-Obesity Medications (AOMs): CMS proposes to permit Medicare coverage of AOMs for the treatment of obesity, and proposes that AOMs cannot be excluded from Medicaid coverage and must be considered covered outpatient drugs.
- Utilization Management: CMS proposes to define “internal coverage criteria” to clarify when MA plans can apply utilization management. CMS also proposes to ensure that plan internal coverage policies are transparent and readily available to the public and that plans make enrollees aware of appeals rights.
- AI guardrails: If an MA plan uses artificial intelligence (AI), CMS proposes that it must comply with applicable regulations to provide equitable access to services and cannot discriminate on the basis of health status.
- MA Plan Provider Directories: CMS proposes to require MA plans to make provider directory data available to CMS, attest to their accuracy, and provide defined updates in order for CMS to populate Medicare Plan Finder with searchable provider information for all MA organizations to improve shopping experiences for Medicare beneficiaries.
Comments are due January 27, 2025. CMS will not have the opportunity to finalize the rule under the Biden Administration, so the incoming Trump Administration could make changes. Read the fact sheet here and the press release here.
CMS Announces Sickle Cell Drug Manufacturer Participation in Access Model. Two manufacturers of FDA-approved gene therapies for sickle cell disease will participate in the Cell and Gene Therapy Access Model beginning January 2025. Their participation is essential to meet the model’s goal of expanding access to these costly therapies because the model requires outcome-based agreements between manufacturers and state Medicaid agencies. Read more about the model, which has been subject to Republican criticism, here.
QUICK HITS
- CMS Releases Marketplace 2025 Open Enrollment Period Report. As of December 4, 2024, more than 988,000 individuals have newly enrolled in Marketplace coverage since open enrollment began on November 1, 2024. Open enrollment ends on January 15, 2025, and CMS is hopeful that enrollment will break the 2024 open enrollment record of 21.4 million enrollees. Read the fact sheet here.
- Democrats Release CBO Findings Urging for Extension of Expiring Enhanced APTCs. The Congressional Budget Office (CBO) data released by top House and Senate Democrats detailed that if Congress doesn’t extend the enhanced advance premium tax credits (APTCs) before they expire in 2025, premiums will increase by 7.9 percent and 3.8 million individual will go uninsured.
- GAO Releases Report Comparing Employer and Marketplace Consumer Costs. The US Government Accountability Office (GAO) report highlights how individuals enrolled in employer coverage contribute more to their premiums than individuals in the Marketplace, despite Marketplace premiums being higher overall.
- CMS Releases Guidance on Ex Parte Medicaid and CHIP Renewals. The guidance reminds states about current requirements and expectations for conducting renewals for Medicaid and Children’s Health Insurance Program (CHIP) beneficiaries based on reliable information available to the state without contacting the beneficiary, also known as ex parte Medicaid and CHIP eligibility renewals. The report includes strategies to increase uptake of ex parte.
- FDA Releases Guidance on Marketing Submissions for AI-Enabled Devices. The FDA recommends that companies describe planned modifications to AI-enabled device software functions and the methodology to implement those modifications when completing a device’s marketing submission. Read the guidance here, and register for an FDA webinar on the guidance here.
- HHS Finalizes Rule to Expand Access to Organ Transplants for People with HIV. The US Department of Health and Human Services (HHS) rule further implements the 2013 HIV Organ Policy Equity Act and removes previous requirements that individuals with HIV must participate in clinical research in order to receive a kidney or liver transplant from another HIV-positive individual. Read the press release here.
- CMS Releases Data Brief on Maternal Health Outcomes in Medicaid. The report highlights demographic information for individuals who had a birth covered by Medicaid or CHIP and experienced a preterm birth or severe maternal morbidity (SMM) condition. Non-Hispanic Black and non-Hispanic American Indian and Alaska Native enrollees had the highest rates of preterm birth and SMM compared to other racial and ethnic groups.
- OCR Reminds HHS-Funded Entities of Nondiscrimination Requirements. An HHS Office for Civil Rights (OCR) letter reiterates existing federal civil rights laws that prohibit entities that receive HHS federal funding from discriminating on the basis of religion, ethnicity, and national origin. This includes discrimination based on antisemitism and islamophobia.
NEXT WEEK’S DIAGNOSIS
Both chambers are in session next week and have only two weeks remaining to wrap up the work of the 118th Congress. Lawmakers are working on another stop-gap CR in advance of the current CR’s December 20 expiration date. This package is expected to include healthcare extenders. As noted above, however, the duration and breadth of the health package is still being negotiated. At a minimum, expiring healthcare provisions likely will be extended for the same duration as the short-term CR, potentially into March 2025.
For more information, contact Debra Curtis, Kristen O’Brien, Erica Stocker, Julia Grabo, or Maddie News.
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