Health Care Week in Review | Senate Blocks House-Passed Continuing Resolution; CMS Launches Rural Health Transformation Program

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• On September 16, 2025, the Food and Drug Administration (FDA) released draft guidance for industry entitled, Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment; Draft Guidance for Industry. The draft guidance details FDA’s recommendations on the clinical trials for drugs being developed for the treatment of symptomatic nonerosive gastroesophageal reflux disease (sGERD) in adults, including considerations for eligibility criteria, trial design features, efficacy evaluations, and safety assessments.
• On September 16, 2025, FDA released draft guidance for industry entitled, Erosive Esophagitis: Developing Drugs for Treatment; Draft Guidance for Industry. The draft guidance details recommendations on clinical trials for drugs being developed for the healing of erosive esophagitis (EE) and maintenance of healed EE in adults, including considerations for eligibility criteria, trial design features, efficacy evaluations, and safety assessments.
• On September 16, 2025, FDA released draft guidance for industry entitled, Disseminated Coccidioidomycosis: Developing Drugs for Treatment; Draft Guidance for Industry. The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of disseminated coccidioidomycosis caused by Coccidioides species (i.e., C. immitis and C. posadasii).
• On September 17, 2025, FDA released a final order entitled, Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices. FDA is issuing a final order reclassifying qualitative hepatitis B virus (HBV) antigen assays (product code LOM), HBV antibody assays (product code LOM), and quantitative HBV nucleic acid-based assays (product code MKT), all of which are postamendments class III devices, into class II (special controls), subject to premarket notification. FDA is also establishing the special controls that are necessary to provide a reasonable assurance of safety and effectiveness of these device types.
• On September 17, 2025, FDA released a notice entitled, Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026. FDA is announcing the fee rate for using a priority review voucher for fiscal year (FY) 2026. The Federal Food, Drug, and Cosmetic (FD&C) Act, as amended, authorizes FDA to determine and collect priority review user fees for certain applications for review of human drug or biological products when those applications use a tropical disease, rare pediatric disease, or material threat medical countermeasure (MCM) priority review voucher. These vouchers are awarded to the sponsors of tropical disease, rare pediatric disease, or material threat MCM product applications, respectively, that meet the requirements of the FD&C Act, upon FDA approval of such applications. This notice establishes the FY 2026 priority review fee rate applicable to submission of eligible applications for review of human drug or biological products using a rare pediatric disease, material threat MCM, or tropical disease priority review voucher and outlines the payment procedures for such fees.
• On September 17, 2025, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a notice entitled, Fiscal Year (FY) 2025 Notice of Supplemental Funding Opportunity. This notice is to inform the public that SAMHSA is supporting administrative supplements in scope of the parent award for the eleven eligible grant recipients funded in FY 2024 under the Prevention Technology Transfer Centers (PTTCs) Cooperative Agreements. Recipients may receive up to $227,272 each for a total funding amount of approximately $2.5 million. These recipients have a project end date of September 29, 2029. The supplemental funding will be used to expand the efforts of the PTTCs to develop and deliver resources to the prevention field, allowing for a focused effort to SAMHSA prevention grant recipients.
• On September 17, 2025, SAMHSA released a notice entitled, Fiscal Year (FY) 2025 Notice of Supplemental Funding Opportunity. This notice is to inform the public that SAMHSA is supporting an administrative supplement in scope of the parent award for one eligible grant recipients funded in FY 2024 under the National Anti-Drug Coalitions Training and Workforce Development Cooperative Agreement. The recipient may receive up to $300,000. This recipient has a project end date of September 29, 2029. The supplemental funding will be used to leverage existing resources to expand SAMHSA’s youth-focused substance use prevention capacity. It will provide training and technical assistance to youth leaders who are members of anti-drug community coalitions and who are committed to addressing the evolving needs of the behavioral health field, thereby promoting youth engagement in substance use prevention workforce development opportunities. The recipient will use the funds to support development and implementation of a Substance Use Prevention Youth Summit in 2025-2026.
• On September 17, 2025, SAMHSA released a notice entitled, Fiscal Year (FY) 2025 Notice of Supplemental Funding Opportunity. This notice is to inform the public that SAMHSA is supporting an administrative supplement in scope of the parent award for one eligible grant recipient funded in FY 2023 under the Historically Black Colleges and Universities Center for Excellence (HBCU-CFE) grant. The recipient may receive up to $350,000 total funding. This recipient has a project end date of September 29, 2026. The supplement expands SAMHSA’s engagement with Historically Black Colleges and Universities (HBCUs) by supporting a series of strategic initiatives that promote behavioral health career exploration and student wellness. These efforts are aligned with Executive Order (EO) 14283, The White House Initiative to Promote Excellence and Innovation at Historically Black Colleges and Universities, and focus on building active public-private sector and philanthropic partnerships to advance shared goals related to student success and retention and creating professional development opportunities for HBCU students to expand the behavioral health workforce. The initiative will include the formation of a planning committee and a national convening of HBCU educators and behavioral health professionals to co-develop a shared vision and strategy. A key deliverable will be the creation of a behavioral health career exploration curriculum tailored to high school, community college, and early college students, with plans for national dissemination through local educational agencies. To further support student wellness and crisis prevention, the program will co-develop peer-led, campus-based interventions focused on suicide and crisis prevention and launch a culturally responsive 988 education and public awareness campaign tailored to HBCU communities.
• On September 18, 2025, FDA released draft guidance for industry entitled, Safety Labeling Changes--Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act. This draft guidance provides information on the implementation of the statutory provision that authorizes FDA to require application holders for certain drug and biological products to make labeling changes based on new safety information that becomes available after approval of the drug that FDA determines should be included in the labeling of the drug. This guidance is being updated and reissued in draft to, among other things, include the addition of information related to Congress’ 2018 changes to the definition of adverse drug experience regarding reduced effectiveness and make other changes to reflect current FDA processes and procedures regarding safety labeling changes. This draft guidance revises and, when finalized, will replace the guidance for industry entitled, Safety Labeling Changes--Implementation of Section 505(o)(4) of the FD&C Act, issued in July 2013.
• On September 18, 2025, SAMHSA released a notice entitled, Fiscal Year (FY) 2025 Notice of Supplemental Funding Opportunity. This notice is to inform the public that SAMHSA is supporting administrative supplements in scope of the parent award for one eligible grant recipient funded under the FY 2020 Homeless and Housing Resource Center. The total available funding is $563,703. This supplemental funding will be used to continue to provide technical assistance to the general public and persons working with individuals who are at risk for, or are experiencing, homelessness and have serious mental illness (SMI), serious emotional disturbance (SED), substance use disorders (SUDs), and/or co-occurring substance use and mental disorders (CODs). The project period end date will be August 30, 2026.
• On September 19, 2025, the Department of Health and Human Services (HHS) released a notice entitled, Semiannual Regulatory Agenda. The Semiannual Regulatory Agenda presents the regulatory activities that HHS expects to undertake in the foreseeable future to advance this mission. The forecasted regulatory actions reflect the priorities of HHS Secretary Robert F. Kennedy, Jr. and the Trump Administration and include rulemakings aimed at Making America Healthy Again. To achieve this goal, HHS shows a commitment to Administration priorities, including: (1) managing chronic disease; (2) eliminating unnecessary administrative expenses and rent-seeking practices that increase health care costs; (3) battling obesity; (4) ensuring the safety and efficacy of vaccines; (5) protecting the religious liberty of the medical workforce; and (5) standing up for the health and well-being of biological women, children, and families.

Event Notices

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

• September 24, 2025: FDA announced a meeting entitled, Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment. This is a hybrid meeting open to the public.
• September 25, 2025: The National Institutes of Health (NIH) announced a meeting of the National Institute of Allergy and Infectious Diseases. This is a virtual meeting open to the public.
• September 29, 2025: NIH announced a meeting of the Novel and Exceptional Technology and Research Advisory Committee. This is a virtual meeting open to the public.
• September 30, 2025: NIH announced a meeting of the Diabetes Mellitus Interagency Coordinating Committee. This is a virtual meeting open to the public.
• September 30, 2025: FDA announced a meeting entitled, Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments. This is a hybrid meeting open to the public.
• October 3, 2025: NIH announced a meeting of the National Eye Institute. This is a virtual meeting with some sessions open to the public.
• October 7, 2025: NIH announced a meeting of the Office of the Director. This is a virtual meeting open to the public.
• October 8, 2025: FDA announced a meeting of the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee. This is a virtual meeting open to the public.
• October 8-9, 2025: 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.
• **October 9, 2025: FDA announced a meeting of the Vaccines and Related Biological Products Advisory Committee. This is a virtual meeting open to the public.
• October 14, 2025: NIH announced a meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. This is a hybrid meeting with some sessions open to the public.
• **October 15, 2025: NIH announced a meeting of the National Cancer Advisory Board Ad hoc Working Group on Extramural Research Concepts and Programs. This is a virtual meeting open to the public.
• October 15-16, 2025: NIH announced a meeting of the National Library of Medicine Board of Scientific Counselors. This is a hybrid meeting with some sessions open to the public.
• October 17, 2025: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.
• October 27-28, 2025: NIH announced a meeting of the Board of Regents of the National Library of Medicine. This is a virtual meeting with some sessions open to the public.
• October 27-29, 2025: NIH announced a meeting of the Board of Scientific Counselors of the National Institute on Aging. This is a hybrid meeting with some sessions open to the public.
• October 29, 2025: NIH announced a meeting of the National Heart, Lung, and Blood Advisory Council. This is a hybrid meeting with some sessions open to the public.
• November 6, 2025: FDA announced a meeting of the Digital Health 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 1-2, 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 4, 2025: NIH announced a meeting of the Board of Scientific Counselors 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: The Health Resources and Services Administration (HRSA) announced a meeting of 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 Board of Scientific 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: The Centers for Medicare & Medicaid Services (CMS) announced a town hall meeting on 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.
• 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.
• 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.

Reports, Studies & Analyses

• On September 16, 2025, the Government Accountability Office (GAO) released a report entitled, Medicaid Demonstrations: Action Needed to Address New Cost Concerns. The report examined how changes in CMS budget neutrality policies for Medicaid Section 1115 demonstrations have affected federal spending. GAO found that federal expenditures under Medicaid demonstrations nearly doubled between 2013 and 2023. CMS sets spending limits for each demonstration based on projections of what Medicaid would have spent without the demonstration. In 2021, CMS required states to use recent spending data when setting limits, which reduced potential federal costs by an estimated $123 billion in two selected demonstrations. In 2022, CMS reversed part of this policy, allowing some reliance on historical projections, raising potential spending by $17 billion in three selected demonstrations. CMS also permitted limits to include certain health-related social needs, adding nearly $4 billion in spending across five selected demonstrations. GAO recommended that CMS fully implement GAO’s 2002 recommendation to use valid methods for budget neutrality and that the CMS should no longer allow costs that Medicaid would not otherwise cover in demonstration spending limits. CMS said it will consider these recommendations as it implements new budget neutrality requirements.
• On September 18, 2025, GAO released a report entitled, Urban Hospitals: Factors Contributing to Selected Hospital Closures and Related Changes in Available Health Care Services. The report examined five urban hospitals that closed in 2022 and 2023 and found that all experienced prolonged financial decline due to factors such as decreased inpatient volumes, aging infrastructure, poor management practices, and conflicting ownership interests. In some cases, hospitals faced repeated bankruptcies prior to closure. After closure, two hospitals transitioned to offering outpatient services, while three closed operations entirely. GAO found that this reduction in services strained nearby hospitals and worsened access to care for residents, particularly for those facing transportation barriers and limited access to primary care. GAO emphasized that while rural closures have been widely studied, urban hospital closures also present significant consequences for community health care access and warrant closer attention.
• On September 18, 2025, the Congressional Budget Office (CBO) released a report entitled, The Estimated Effects of Enacting Selected Health Coverage Policies on the Federal Budget and on the Number of People With Health Insurance. The report found that a permanent extension of enhanced premium tax credits (EPTCs), originally enacted temporarily under the American Rescue Plan Act of 2021, would cost about $350 billion from 2026 to 2035 and increase the number of people with health insurance by 3.8 million in 2035. In addition, CBO estimated that nullifying a June 2025 HHS final rule related to Affordable Care Act (ACA) Marketplaces would raise the federal deficit by about $40 billion and expand coverage to 300,000 more people by 2035. Moreover, repealing sections of the One Big Beautiful Bill Act restricting Marketplace eligibility and enrollment, such as those affecting certain immigrants and low-income individuals, would cost approximately $272 billion and increase the insured population by 2.9 million in 2035.

Hearings & Markups

• On September 16, 2025, the House Ways and Means Committee Oversight Subcommittee held a hearing entitled, Virtue Signaling vs. Vital Services: Where Tax-Exempt Hospitals are Spending Your Tax Dollars. Witnesses included: Dr. Ge Bai, PhD, Professor of Health, Policy, and Management, Johns Hopkins Bloomberg School of Public Health; Mr. William Hild, Executive Director, Consumers’ Research; Dr. Christopher Whaley, PhD, Associate Director, The Center of Advancing Health Policy through Research, Brown University; Dr. Stanley Goldfarb, Chairman of the Board, Do No Harm; and Dr. Jill R. Horwitz, Trobman Family Innovation Professor, Northwestern University Pritzker School of Law and Professor of Emergency Medicine, Northwestern Feinberg School of Medicine.
• On September 17, 2025, the Senate Health, Education, Labor & Pensions (HELP) Committee held a hearing entitled, Restoring Trust Through Radical Transparency: Reviewing Recent Events at the Centers for Disease Control and Prevention and Implications for Children’s Health. Witnesses included: Dr. Susan Monarez, Ph.D., former Centers for Disease Control and Prevention (CDC) Director; and Dr. Debra Houry, M.D., M.P.H., former CDC Chief Medical Officer.
• On September 17, 2025, the House Energy & Commerce Committee held a markup of seven bills, including: H.R. 2493, Improving Care in Rural America Reauthorization Act of 2025; H.R. 3419, To amend the Public Health Service Act to reauthorize the telehealth network and telehealth resource centers grant programs; H.R. 2846, To amend title II of the Public Health Service Act to include as an additional right or privilege of commissioned officers of the Public Health Service (and their beneficiaries) certain leave provided under title 10, United States Code to commissioned officers of the Army (or their beneficiaries); H.R. 1262, Give Kids a Chance Act of 2025; H.R.1843, To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications; H.R. 3302, Healthy Start Reauthorization Act of 2025; and H.R. 979, AM Radio for Every Vehicle Act of 2025. All bills, excluding H.R.1843, To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications, were approved by the Committee.
• On September 17, 2025, the House Committee on Ways and Means held a markup of ten bills including: H.R. 842, Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act; H.R. 4313, Hospital Inpatient Services Modernization Act; H.R. 5347, Health Care Efficiency Through Flexibility Act; and H.R. 5343, Ensuring Patient Access to Critical Breakthrough Products Act. The bills were approved by the Committee.
• On September 17, 2025, the Senate Special Committee on Aging held a hearing entitled, Prescription for Trouble: Drug Safety, Supply Chains, and the Risk to Aging Americans. Witnesses included: Mr. Peter Baker, Former FDA Inspector, President, Live Oak Quality Assurance; Dr. George Ball, PhD, Associate Professor and Weimer Faculty Fellow, Kelley School of Business, Indiana University; Mr. Brandon Daniels, CEO, Exiger; and Dr. Ronald Piervincenzi, PhD, CEO, U.S. Pharmacopeia, Washington, DC. 
• On September 18, 2025, the House Energy & Commerce Committee Health Subcommittee held a hearing entitled, Examining Policies to Enhance Seniors’ Access to Breakthrough Medical Technologies. Witnesses included: Dr. Todd Brinton, MD, Corporate Vice President, Advanced Technology, and Chief Scientific Officer, Edwards Lifesciences; Mr. Stephen Ezell, Vice President, Global Innovation Policy, and Director, Center for Life Sciences Innovation, Information Technology and Innovation Foundation; Mr. Roger Royse, Patient Advocate and Partner, Haynes and Boone, LLP; Dr. Diana Zuckerman, PhD, President, National Center for Health Research; and Mr. David Lipschutz, JD, Co-Director of Law and Policy, Center for Medicare Advocacy.

Other Health Policy News

• On September 15, 2025, CMS published the Notice of Funding Opportunity (NOFO) for the Rural Health Transformation Program (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 FY 2026, with $10 billion allocated annually. Half of the funds will be evenly distributed among approved states, while the remainder will be awarded based on state-specific metrics and applications demonstrating potential for impact. In its announcement, CMS outlined five strategic goals for the program, including: (1) supporting rural health innovation to promote preventative health and address the root causes of disease; (2) supporting long-term sustainability of rural health care providers; (3) improving the recruitment and retention of health care professionals in rural areas; (4) promoting innovative care models to improve health outcomes, coordinate care, and promote flexible care arrangements; and (5) supporting the adoption of innovative technologies that promote efficient care delivery, data security, and access to digital health tools by rural facilities, providers, and patients. A press release can be found here. Additional information on RHTP can be found here.
• On September 17, 2025, former CDC Director Dr. Susan Monarez testified before the Senate HELP Committee. During the hearing, Dr. Monarez stated that her dismissal by Secretary Kennedy resulted from her refusal to pre-approve changes to the childhood immunization schedule without scientific evidence. Dr. Monarez also stated that Secretary Kennedy pressured her to endorse all recommendations from ACIP and to fire career vaccine policy officials without cause. Former CDC Chief Medical Officer Dr. Debra Houry, who stepped down following Dr. Monarez’s removal, highlighted concerns that Secretary Kennedy’s leadership has politicized CDC processes and jeopardized public health. Some Republican committee members challenged Dr. Monarez’s testimony and questioned the scientific basis of current vaccine recommendations, while other members expressed concern about the implications of Secretary Kennedy’s leadership. A recording of the hearing can be found here.
• On September 17, 2025, the House Committee on Ways and Means advanced a series of bipartisan bills aimed at addressing a range of issues affecting seniors, patients, families, and taxpayers. The legislative package includes health-care related bills to expand access to early cancer detection, extend home-based hospital care, and modernize health care reporting.Members unanimously approved the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 842), which would establish Medicare coverage for multi-cancer early detection blood tests. Some Members highlighted the potential for early diagnosis to improve survival rates and lower long-term costs, while other Members noted the need for continued oversight to ensure test accuracy and prevent unnecessary harms. The Committee also advanced the Hospital Inpatient Services Modernization Act (H.R. 4313), which would extend the Medicare Hospital at Home program for five years, and the Healthcare Efficiency Through Flexibility Act (H.R. 5347), which would ease reporting requirements for providers lacking digital infrastructure. In addition, members approved the Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 5343), intended to speed Medicare coverage of FDA-approved breakthrough medical devices by providing four years of immediate coverage. Some Members voiced concerns that health policy changes, including the expiration of EPTCs and reductions in NIH and FDA funding, could offset the benefits of these targeted reforms. More information on this hearing and the full bill texts can be found here.
• On September 17, 2025, the House Energy & Commerce held a markup of seven bills, with all of the bills advancing with bipartisan support. Chairman Brett Guthrie (R-KY) opened the hearing by emphasizing the importance of extending vital public health programs, including rural health services, telehealth access, rare pediatric disease research, and generic drug transparency. Ranking Member Frank Pallone (D-NJ) expressed concerns about health equity and workforce diversity, noting the absence of professional development programs and the Newborn Screening Reauthorization Act from the Committee’s consideration. Despite some policy disagreements and the withdrawal of several proposed amendments, the Committee successfully passed legislation to support rural health, expand telehealth, enhance benefits for the Public Health Service Corps, promote research into rare pediatric diseases, and reauthorize the Healthy Start program. More information on this markup can be found here.
• On September 19, 2025, the Senate rejected the Continuing Resolution (CR) entitled, the Continuing Appropriations and Extensions Act of 2026, by a vote of 48-44. The CR was passed by the House of Representatives earlier in the day by a vote of 217-212. The CR would extend current funding levels through November 21 and includes an extension of several public health provisions that are set to expire on the government funding deadline of September 30 without congressional action. These provisions include an extension of Medicare telehealth flexibilities and funding for community health centers, the National Health Service Corps, and Teaching Health Center Graduate Medical Education (THCGME) programs. The CR passed by the House of Representatives can be found here. A summary of the bill can be found here.
  
  The Senate also rejected an alternative CR released by Democratic leadership of the Senate and House Appropriations Committees on September 17, 2025, by a vote of 47-45. The CR would extend funding through October 31. While the Democratic version includes an extension of the same public health provisions as the CR released by the House Appropriations Committee, it also includes a permanent extension of EPTCs, which are set to expire on December 31. The bill would also repeal the health care provisions of the One Big Beautiful Bill Act. The CR released by the Democratic leadership of the Senate and House Appropriations Committees can be found here. A summary of the bill can be found here

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