Health Care Week in Review | CMS Announces New Drug Payment Model; Negotiations to End Government Shutdown Continue

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news. 

 Regulations, Notices & Guidance

• On November 6, 2025, the Food and Drug Administration (FDA) released guidance entitled, How to Prepare a Pre-Request for Designation (Pre-RFD). The guidance is intended to help sponsors obtain a preliminary assessment from FDA through the Pre-RFD process. It explains the process managed by the Office of Combination Products (OCP) and outlines the type of information sponsors should include in a Pre-RFD submission. This document replaces the final guidance for industry with the same title issued in February 2018.
• On November 7, 2025, the Health Resources and Services Administration (HRSA) released a notice entitled, Improving Ryan White HIV/AIDS Program Part A and B Formula Awards Using Most Recent Address Data. The Ryan White HIV/AIDS Program (RWHAP) Part A and B funding formulas are defined by the Public Health Service Act (PHS) and rely on the living HIV/AIDS cases reported to and confirmed by the Centers for Disease Control and Prevention (CDC). Advancements in HIV surveillance have improved the mapping of the epidemic, leading to better care strategies. Since 2017, CDC has shifted to using the most recent addresses of people with HIV for reporting, raising questions about whether RWHAP funds follow clients or remain in the jurisdiction of diagnosis. HRSA has analyzed the effects of this updated methodology on formula funding and is now seeking public feedback on proposed changes to better direct resources to where clients currently live and receive care.
• On November 7, 2025, the Centers for Medicare & Medicaid Services (CMS) released guidance entitled, Ensuring Medicaid Eligibility Integrity by Addressing Concurrent Medicaid and Children’s Health Insurance Program (CHIP) Enrollment Across States. CMS aims to ensure that individuals who are otherwise eligible for Medicaid or the Children’s Health Insurance Program (CHIP) are enrolled only in the Medicaid program or CHIP of their state of residence, rather than in multiple states’ programs. CMS will soon provide each state with a one-time file on Medicaid and CHIP beneficiaries identified as potentially enrolled in multiple states. States should review the information provided and, as appropriate, promptly redetermine eligibility for the identified beneficiaries and take necessary action to terminate coverage for those whom the state determines are no longer eligible based on residency. CMS expects all states to comply with federal requirements intended to maximize retention for eligible individuals and minimize inappropriate coverage loss, including providing advance notice of termination that includes the right to a Medicaid fair hearing or a CHIP review.

Event Notices

Please note that two asterisks (**) preceding the item indicate a new event. 

• November 10, 2025: The National Institutes of Health (NIH) announced a meeting of the Council of Councils. This is a virtual meeting open to the public.
• November 13, 2025: FDA announced a meeting of the Pediatric Advisory Committee. This is a virtual meeting open to the public.
• November 16-18, 2025: NIH announced a meeting of the National Institute of Environmental Health Sciences. This is a hybrid meeting with some sessions open to the public.
• December 1, 2025: NIH announced a peer review meeting of the draft National Toxicology Program (NTP) Developmental and Reproductive Toxicity Technical Report on 2-Hydroxy-4-methoxybenzophenone. This is a hybrid meeting open to the public.
• December 1, 2025: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting open to the public.
• **December 3, 2025: FDA announced a meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. This is a virtual meeting open to the public.
• December 4, 2025: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. This is a hybrid meeting with some sessions open to the public.
• December 4-5, 2025: HRSA announced a meeting of the National Advisory Council on Nurse Education and Practice. This is a hybrid meeting open to the public.
• December 5, 2025: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting with some sessions open to the public.
• December 10, 2025: CMS announced a town hall meeting on fiscal year (FY) 2027 applications for new technology add-on payments. This is a virtual meeting open to the public.
• December 10, 2025: FDA announced a workshop entitled, Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development – Leveraging Rare Disease Frameworks. This is a hybrid meeting open to the public.
• January 23, 2026: NIH announced a meeting of the National Center for Complementary & Integrative Health. This is a virtual meeting open to the public.
• January 26-27, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a virtual meeting with some sessions open to the public.
• February 9-10, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• March 30-31, 2026: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting with some sessions open to the public.
• May 4, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting open to the public.
• June 1-2, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• June 5, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting with some sessions open to the public.
• September 10-11, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.

Reports, Studies & Analyses

• On November 5, 2025, RAND published a study entitled, Clinic Price Reductions in a Tiered Total Cost Benefit Design. The study analyzed administrative data on consumer primary care clinic choice, clinic tier placement, and clinic actions, along with interviews with informants from clinics, health plans, and program administrators. The study aimed to understand how primary care clinics respond to inclusion in a tiered total cost of care insurance benefit design. The findings show that clinics respond to tiered cost-sharing incentives due to concerns about being perceived as high-cost and the potential loss of patients facing higher cost sharing. Informants noted that price reductions alone are not scalable and emphasized the need for greater transparency in tier assignment and increased data sharing to help reduce costly or unnecessary utilization. Some clinics agreed to price reductions or risk-sharing arrangements to move to, or remain in, a tier with lower cost sharing. Overall, managers of primary care clinics respond to tiered benefit designs that hold them accountable for the total cost of care by offering price discounts and expressing interest in reducing costly referrals and unnecessary service use.

Hearings & Markups

• On November 5, 2025, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing entitled, Registered Apprenticeship: Scaling the Workforce for the Future. Witnesses included: Josh Laney, Vice President of Apprenticeship and Work-Embedded Learning, Competency-Based Education Network (C-BEN); Latitia McCane, Ph.D., Director of Education, The Apprentice School, Newport News Shipbuilding; Gardner Carrick, Chief Program Officer, The Manufacturing Institute; John Downey, General President, International Union of Operating Engineers; and Brent Booker, General President, Laborers' International Union of North America. 
• On November 5, 2025, at 3:30 PM, the Senate Special Committee on Aging held a hearing entitled, Renewing Our Commitment: How the Older Americans Act Uplifts Families Living with Aging-Related Diseases.  Witnesses included: Erick Montealegre, Family Caregiver; Stephen Sappington, Patient Advocate; and Duana Patton, President, USAging, and CEO, Ohio District 5 Area Agency on Aging (AAA).
• On November 6, 2025, the Senate HELP Committee held a hearing entitled, Reforming Financial Transparency in Higher Education. Witnesses included: Justin Draeger, MBA, Senior Vice President for Affordability, Strada Education Foundation; Brenda Hicks, MA, Director of Financial Aid, Southwestern College; Preston Cooper, Ph.D., Senior Fellow, American Enterprise Institute; Onjila Odeneal, M.Ed., Chief Executive Officer, Detroit Promise; and Mark Huelsman, M.Ed., Director of Policy and Advocacy, The Hope Center for Student Basic Needs.
• On November 6, 2025, the Senate Committee on Homeland Security and Governmental Affairs (HSGAC) Permanent Subcommittee on Investigations held a hearing entitled, Assessing the Damage Done by Obamacare. Witnesses included: Joel White, President, Council for Affordable Health Coverage; Tarren Bragdon, President and Chief Executive Officer, Foundation for Government Accountability; Brian Blase, Ph.D., President, Paragon Health Institute; and Shana Verstegen, Small Business Employee and Affordable Care Act (ACA) Marketplace Enrollee.

Other Health Policy News

• The government shutdown has entered its second month after the Senate, on November 4, 2025, failed for the fourteenth time to pass the Republican-backed continuing resolution (CR), which would extend current government funding levels through November 21. The bill was rejected by a vote of 54-44, again falling short of the 60 votes required to proceed, with only three members of the Democratic caucus joining Republicans in support.
  
  On November 3, 2025, a bipartisan group of House members — Representatives Don Bacon (R-NE), Tom Suozzi (D-NY), Jeff Hurd (R-CO), and Josh Gottheimer (D-NJ) — released a statement of principles proposing a temporary extension and reform of the ACA enhanced premium tax credits (EPTCs). The plan represents the first major health policy initiative introduced since the federal government shutdown began more than a month ago. The framework calls for a two-year extension of the EPTCs with a phased income cap between $200,000 and $400,000. It also proposes several reforms, including stronger guardrails against improper payments, enhanced eligibility verification to prevent “ghost beneficiaries,” new fraud prevention standards, and transparency measures to improve oversight and reduce waste within ACA Marketplaces. The proposal comes amid a broader political impasse, as Democrats continue to push for inclusion of an extension of EPTCs in any deal to reopen the government, while Republican leaders and the Trump Administration have resisted addressing this issue until after the shutdown ends. Representative Bacon described the plan as a potential “starting point” for Senate appropriators working on long-term funding measures, stating that he supports efforts to “break the logjam.”
  
  On November 6, 2025, a federal judge ordered the Trump Administration to fully fund Supplemental Nutrition Assistance Program (SNAP) benefits for the month of November, rejecting the Administration’s previous plan to provide partial payments without tapping additional funds. On November 7, following a federal court’s order, the Trump Administration announced that it would immediately begin fully funding SNAP benefits while the Administration’s appeals the court’s order. SNAP benefits were set to expire on November 1, potentially impacting nearly 40 million Americans. Meanwhile, the Federal Aviation Administration (FAA) announced that it would reduce flight capacity by 10 percent at 40 high-traffic airports beginning November 7 to reduce strain on air traffic controllers, who are set to miss their second paycheck on November 11.
• On November 5, 2025, CMS announced that all 50 states have submitted applications for the Rural Health Transformation Fund (RHTP), a $50 billion initiative established under the One Big Beautiful Bill Act, also referred to as the Working Families Tax Cuts Act. The program is intended to support states in strengthening rural health care infrastructure and access. Funding will be distributed over five years beginning in fiscal year 2026, with $10 billion allocated annually. Half of the funds will be evenly distributed among states with applications that meet baseline criteria, following review by CMS. The remainder will be awarded based on state-specific metrics and applications demonstrating potential for impact. CMS will announce the awardees by December 31, 2025.
  
  A press release can be found here.
• On November 6, 2025, the Trump Administration announced new agreements with pharmaceutical manufacturers Eli Lilly & Co. and Novo Nordisk to reduce the price of obesity drugs. Under the agreement, weight loss drugs such as Wegovy and Ozempic will be sold at discounted rates for Medicare and Medicaid beneficiaries and when purchased through TrumpRx, a new federal direct-to-consumer platform. Eli Lilly & Co. and Novo Nordisk have also agreed to provide Most Favored Nation (MFN) pricing on new products they bring to market, provide state Medicaid programs with MFN pricing, and repatriate increased foreign revenue on existing products. The Trump Administration further announced that Novo Nordisk has agreed to invest $10 billion to “strengthen its domestic footprint,” and Eli Lilly & Co. plans a $27 billion investment in domestic manufacturing.
  
  FDA also announced that both companies will each receive a priority review voucher for a weight loss drug to accelerate product review under the Commissioner’s National Priority Voucher (CNPV) pilot program. A total of six new drugs were selected for the CNPV program, including Zongertinib, Bedaquiline, Dostarlimab, Casgevy, Orforglipron, and Wegovy, bringing the total to 15 drugs so far.
  
  A White House fact sheet can be found here.
• On November 6, 2025, Senate Budget Chair Lindsey Graham (R-SC) indicated that he is meeting with Senate Republicans to discuss potentially pursuing a second reconciliation bill, which may include policies related to health care, though details remain unclear. Using the reconciliation process would allow Republicans to bypass the 60-vote threshold required in the Senate to consider legislation.
• On November 6, 2025, CMS announced that it will launch the GENErating cost Reductions fOr U.S. (GENEROUS) Medicaid Model, a new drug payment model set to begin in January 2026. The GENEROUS model is designed to promote fair and reasonable drug prices for Medicaid by enabling CMS-led negotiations with drug manufacturers. Under the model, participating manufacturers will provide supplemental rebates to states based on prices paid by select countries for prescription drugs covered under Medicaid. Under the model, manufacturers with approved applications will enter agreements with CMS to establish set pricing for their portfolio of covered outpatient drugs, calculated based upon select international pricing data. These agreements will also include standardized coverage criteria for state Medicaid programs, negotiated between CMS and the manufacturer. CMS will release a Request for Applications (RFA) later this fall for manufacturers interested in participating in the model and will seek letters of intent from interested state Medicaid agencies. States that express interest will subsequently have the opportunity to formally apply and potentially opt in to the negotiated terms and pricing.
  
  A press release can be found here. Additional information can be found here.

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