09 December 2024 This Week in Health Policy for December 9 Lawmakers are expected to continue negotiations on their must-pass year-end legislative items, including a government funding bill, likely to be addressed through a continuing resolution; hurricane and disaster relief; the FARM bill; and the National Defense Authorization Act (NDAA). Discussions are ongoing to determine which health care policies and extenders, including Medicare telehealth flexibilities, will be included and the duration of the extensions. House Committee on Veterans' Affairs Subcommittee on Technology Modernization Oversight will hold a hearing on "Modernizing VA: Lessons Learned in the 118th Congress."
Congress activities in lame duck. Last week, lawmakers made little progress in their year-end negotiations and continue to work through how to handle year-end funding, the National Defense Authorization Act, and more. Leadership is still determining whether and how to address expiring Medicare telehealth flexibilities, other health care extenders, including funding for community health centers, and mitigation for looming Medicare physician pay cuts. The Biosecure Act also remains part of the NDAA negotiations as lawmakers work to address member concerns over the scope of the bill and the entities named in the legislation. FDA issued draft guidance on accelerated approval pathway. On Thursday (December 5), the Food and Drug Administration (FDA) published draft guidance on accelerated approval drugs that details procedures and criteria for the agency's accelerated approval pathway for serious conditions, including guidelines for how confirmatory trials should be conducted and how surrogate endpoints should be considered. FDA in the document said it intends to use authority provided by the Consolidated Appropriations Act of 2023 to require confirmatory trials be underway prior to accelerated approval or within a specified time period after approval but will address this in separate guidance. The document will be open for a 60-day comment window once published in the Federal Register. CMS moves forward with Cell and Gene Therapy Access Model. On Wednesday (December 4), the Centers for Medicare and Medicaid Services' (CMS) Center for Medicare and Medicaid Innovation announced that bluebird bio, Inc. and Vertex Pharmaceuticals have entered intro agreements to participate in the Cell and Gene Therapy Access Model. The voluntary model aims to test whether outcomes-based agreements for cell and gene therapies can increase access to the treatments and improve health outcomes, while lowering costs. The model is set to launch in January 2025 and states have one year to decide if they would like to participate in the model. CMS issues ACA enrollment update. On Wednesday (December 4), CMS announced that nearly 988,000 people who do not currently have coverage through the Affordable Care Act's individual market exchanges have signed up for plan year 2025 coverage. CMS said 4.4 million existing enrollees have also selected a plan for the 2025 coverage year. Open enrollment will continue through January 15. The reported numbers highlight those who have selected plans, not those who have effectively enrolled in coverage by paying their first month's premium. Click here for a fact sheet. FDA guidance on AI-enabled device marketing submissions. On Wednesday (December 4), the FDA published guidance on marketing submissions for AI-enabled devices, which recommends that companies include planned modifications to AI-enabled device software functions, the methodology to implement those modifications, and the potential impact when completing a device's Predetermined Change Control Plan. CMS publishes final rule removing barrier for HIV-to-HIV transplants. On November 26, HHS published a final rule that removes requirements that individuals with HIV must participate in clinical research and receive institutional review board approvals to receive a kidney or liver transplant from an HIV-positive donor. Click here for the final rule. CMS issues MA, Part D Policy and Technical Changes proposed rule. On November 26, CMS published its Contract Year (CY) 2026 Policy and Technical Changes for Medicare Advantage (MA) and Part D Proposed Rule, which includes proposed policy updates to the MA and Medicare Part D prescription drug programs and codifies existing MA and Part D guidance, including guidance implementing the Inflation Reduction Act's Medicare Prescription Payment Plan and Part D cost-sharing caps on vaccine and insulin products. The proposed rule includes several provisions aimed at ensuring MA and Part D enrollees can make informed enrollment decisions, such as updates to the Medicare Plan Finder, new discussion requirements for agents and brokers, and expanding CMS' review of marketing and communications materials. In addition, the proposed rule includes provisions aimed at expanding enrollees' access to anti-obesity medications and behavioral health services and clarify existing rules around prior authorization and utilization management tools, as well as the use of artificial intelligence (AI) in coverage determinations. Click here for the press release. Click here for the fact sheet. Click here for the proposed rule. CMS finalizes organ transplant model. On November 26, CMS issued a final rule implementing the Increasing Organ Transplant Access (IOTA) model. CMS in the rule delayed the start of the model from January 2025 to July 1, 2025, to give transplant hospitals more time to prepare for the mandatory payment model. The model, which is set to run through 2031, aims to test whether performance-based payments can improve access to kidney transplants for patients with end-stage renal disease and improve accountability in the U.S. organ transplantation system. CMS said it will select participating kidney transplant hospitals by randomly selecting about 50% of all donation service areas; all eligible kidney transplant hospitals within selected DSAs will be required to participate in the model. CMS will measure performance of participating hospitals against non-participants across three domains: achievement, efficiency, and quality. Click here for the press release. Click here for the fact sheet. Click here for the final rule. CMS issues new guidance on Medicaid Ex Parte renewals. On November 26, CMS sent states guidance outlining current requirements and expectations for conducting Ex Parte coverage renewals for Medicaid and Children's Health Insurance Program (CHIP) beneficiaries, which occurs when the state determines eligibility renewals without contacting the beneficiary. Senate Health, Education, Labor & Pensions Committee held a hearing on What Is the FDA Doing to Reduce the Diabetes and Obesity Epidemics in America and Take on the Greed of the Food and Beverage Industry? On Thursday (December 5), the Committee heard testimony from FDA Commissioner Robert Califf and FDA Deputy Commissioner of the Human Foods Program on FDA's work to regulate the food and beverage industry as a way to address diabetes and obesity. During the hearing, the officials spoke about the need for increased funding, while lawmakers from both sides of aisle said the FDA needs to do more, particularly to increase transparency in food ingredients and labelling.
House Committee on Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic held a business meeting. On Wednesday (December 4), the Select Subcommittee adopted by voice vote an amended version of the Republican members' final report summarizing its investigation in the federal government's handling of the COVID-19 pandemic. The Select Subcommittee also released recommendations for federal agencies to improve public health and pandemic response. During the meeting, Ranking member Raul Ruiz (D-CA) spoke critically about the lack of bipartisan work on the report and highlighted Democrats' separate report, which outlines areas of disagreement regarding the committee's work.
House and Senate Democrats publish CBO impact estimates on not extending the enhanced ACA subsidies. On Thursday (December 5), Senate Finance Committee Chair Ron Wyden (D-OR), House Ways and Means Ranking Member Richard Neal (D-MA), Sen. Jeanne Shaheen (D-NH), and Rep. Lauren Underwood (D-IL) released data from the Congressional Budget Office that showed not extending the enhanced subsidies would increase the number of people without health insurance by 2.2 million in 2026 and raise the average gross benchmark premiums for plans purchased through the marketplaces by an average of 4.3% in 2026.
Government Accountability Office: Private Health Plans: Comparison of Employer-Sponsored Plans to Healthcare.gov Marketplace Plans. The report estimates that people with employer-sponsored coverage have lower premiums than those enrolled in exchange plans, but their average contributions to the premiums were higher than those in the exchange market. CMS: Fiscal Year 2024 Improper Payment Data for All Programs. The report details improper payment data, including overpayments and underpayments, for fee-for-service Medicare, Medicare Advantage, Medicare Part D, Medicaid, Children's Health Insurance Program, and the Advance Payment of Premium Tax Credits for the Federally Facilitated Health Insurance Exchange. CMS: Prematurity and severe maternal morbidity among Medicaid- and CHIP-covered live births in 2021. The report provides demographic information on individuals who had a birth covered by Medicaid or CHIP and experienced a pre-term birth or severe maternal morbidity condition.
Document ID: 2024-2231 | |||
