Health Care Week in Review | House Appropriations Committee Approves FY 2026 Labor-HHS Spending Bill; CMS Issues Guidance Implementing New Federal Payment Limits on SDPs

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 8, 2025, the Food and Drug Administration (FDA) released guidance entitled, Classification Categories for Certain Supplements under Biosimilar User Fee Amendments III. This guidance provides recommendations for applicants on classification categories A, B, C, D, E, and F for original and resubmitted prior approval supplements submitted to approved applications for biosimilar and interchangeable biosimilar products under the Public Health Service Act (PHS Act). The commitment letter associated with the Biosimilar User Fee Amendments of 2022 (BsUFA III) sets forth these supplement classification categories and their associated review performance goals. This guidance is intended to help applicants identify the appropriate classification category and review goal date of the supplement being submitted. This guidance finalizes and replaces the draft guidance of the same title issued on August 11, 2023.
• On September 8, 2025, FDA released guidance entitled, Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations. This guidance describes FDA’s recommendations on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product licensed under the PHS Act. Additionally, this guidance is intended to provide recommendations to sponsors on the scientific and technical information for the chemistry, manufacturing, and controls (CMC) portion of a marketing application for a proposed product submitted under the PHS Act. This guidance finalizes and replaces the draft guidance of the same title issued on May 22, 2019, and replaces the final guidance entitled, Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product issued on April 30, 2015.
• On September 8, 2025, FDA released guidance entitled, E6(R3) Good Clinical Practice; International Council for Harmonisation. The guidance is intended to outline flexible and modern good clinical practices for conducting clinical trials. Notably, the guidance highlights the importance of quality-by-design, proportionality, and risk-based approaches in conducting clinical trials to ensure safety and reliability of results. The guidance also encourages use of innovative design elements and technology in clinical trials, while avoiding unnecessary complexities. The guidance finalizes the draft guidance of the same title issued on June 7, 2023.
• On September 8, 2025, FDA released a notice entitled, M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver. FDA is reopening the comment period for the draft guidance announced in the notice entitled, M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver; International Council for Harmonisation; Draft Guidance for Industry, published in the Federal Register of June 2, 2025. FDA is taking this action to allow interested persons additional time to submit comments.
• On September 10, 2025, FDA released guidance entitled, Development of Non-Opioid Analgesics for Chronic Pain. This guidance is intended to assist sponsors in the development of non-opioid analgesics for the treatment of chronic pain. It describes FDA’s current recommendations regarding phase 3 trials for prescription non-opioid analgesic products being developed to treat chronic pain. This guidance also responds to the statutory requirements of the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), which directs FDA to issue or update existing guidance to help address challenges to developing non-opioid medical products to treat pain.
• On September 11, 2025, FDA released guidance entitled, Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications. This guidance provides information to applicants on how FDA intends to use alternative tools to assess drug manufacturing facilities identified in a marketing application. As part of the negotiations relating to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA), FDA agreed to issue guidance on the use of alternative tools to assess manufacturing facilities named in pending applications and to incorporate best practices from the use of such tools during the COVID-19 pandemic. This guidance finalizes the draft guidance of the same title issued on September 22, 2023.

Event Notices

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

• September 15, 2025: The Department of Veterans Affairs (VA) announced a meeting of the National Research Advisory Council. This is a hybrid meeting open to the public. 
• September 16, 2025: The National Institutes of Health (NIH) announced a meeting of the National Human Genome Research Institute. This is a hybrid meeting open to the public.
• September 16-17, 2025: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Association of Public Health Laboratories (APHL). This is a virtual meeting open to the public.
• September 17-18, 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.
• September 17-18, 2025: NIH announced a meeting of the National Institute on Aging. This is a virtual meeting with some sessions open to the public.
• September 18, 2025: NIH announced a meeting of the National Center for Advancing Translational Sciences. This is a hybrid meeting with some sessions open to the public.
• September 18, 2025: FDA announced a meeting entitled, Biosimilar User Fee Act (BsUFA) III Regulatory Science Program Interim Public Meeting.  This is a hybrid meeting open to the public.
• September 18, 2025: CDC announced a meeting of the Advisory Committee on Immunization Practices (ACIP). This is a virtual meeting open to the public.
• September 18-19, 2025: FDA announced a public workshop entitled, Patient-Focused Drug Development: Workshop #2 to Discuss Methodologic and Other Challenges Related to Patient Experience Data. This is a virtual meeting open to the public.
• **September 19, 2025: NIH announced a meeting of the National Advisory Council for Complementary and Integrative Health. This is a hybrid meeting with some sessions open to the public.
• September 19, 2025: FDA announced a public workshop entitled, Advancing the Development of Interchangeable Products: Identifying Future Needs. This is a hybrid workshop open to the public.
• 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: 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 14, 2025: NIH announced a meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. This a hybrid meeting with some sessions 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 the fiscal year (FY) 2027 applications for new technology add-on payments. This is a virtual 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 8, 2025, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report entitled, By Requiring Emergency Preparedness Plans for Independent Labs, CMS Could Better Ensure That Medicare Enrollees Have Access to Infectious-Disease Diagnostic Testing During a Public Health Emergency. OIG found that by requiring emergency preparedness plans for independent labs, CMS could better ensure that enrollees have access to diagnostic testing related to an emerging infectious disease or a biological toxin that is the cause of a public health emergency (PHE). OIG reported that CMS does not have an emergency preparedness plan requirement for independent labs but has such a requirement for certain provider types that participate in Medicare. OIG recommends that CMS implements such requirements for labs that participate in Medicare to ensure that Medicare enrollees have access to diagnostic testing related to an emerging infectious disease or a biological toxin in the event of a future PHE. 
• On September 9, 2025, the Government Accountability Office (GAO) released a report entitled, Medicare: National Coverage Determinations Are Generally Timely, but Improvements Are Needed. GAO reviewed CMS’s Medicare coverage process and other documentation, compiled coverage analyses data, and interviewed CMS officials to find that CMS did not systematically identify the causes of coverage determination delays when it did not meet specified time frames. GAO made two recommendations: (1) identify the causes of national coverage determination delays to better ensure that analyses are finalized within specified time frames, and (2) make available to the public the criteria it uses to prioritize its coverage analyses. GAO reported that HHS concurred with their recommendations.
• On September 9, 2025, the Congressional Budget Office (CBO) released a report entitled, Growth in the 340B Drug Pricing Program. The 340B Drug Pricing Program requires drug manufacturers to offer discounted prices to eligible health care facilities, including hospitals, clinics, and government-affiliated organizations. In 2021, approximately 50,000 facilities participated in the program, with about 90 percent also enrolled in the Prime Vendor Program (PVP), which negotiates additional discounts and provides support services. CBO analyzed drug purchases made through the PVP in 2021 and tracked growth from 2010 to 2021. They found that participating facilities spent $43.9 billion on discounted drugs in 2021—up from $6.6 billion in 2010 (adjusted to 2021 dollars). CBO also examined factors driving this growth and assessed the program’s impact on the federal budget.
• On September 12, 2025, CBO released a presentation entitled, Medicaid State-Directed Payments: An Update on CBO's Modeling. The presentation highlighted projected federal savings of $149 billion from 2025 to 2034 due to new limits imposed by the One Big Beautiful Bill Act (Public Law 119-21), which caps state directed payment (SDP) rates for hospitals, nursing facilities, and academic medical center-affiliated physicians at Medicare rates (100 percent for expansion states and 110 percent for non-expansion states). Existing arrangements above these limits will be phased down starting in 2028. Additionally, provider tax thresholds—a key funding source for SDPs—will be reduced, especially for expansion states. The presentation also underscored the rapid growth of SDPs, which rose from $26 billion in FY 2020 to $102 billion in FY 2024, and now account for over 20 percent of managed care spending.

Hearings & Markups

• On September 9, 2025, the House Committee on Agriculture held a hearing entitled, Exploring State Options in SNAP. Witnesses included: Ms. Chloe Green, Manager, Food and Nutrition Services, American Public Human Services Association; Mrs. Joy L. Bivens, Deputy County Administrator, Health and Human Services, on behalf of the National Association of Counties; and Ms. Korin Schmidt, Director, Wyoming Department of Family Services.
• On September 9, 2025, the House Appropriations Committee held a markup of the FY 2026 Labor, Health and Human Services, Education, and Related Agencies Appropriations Act. The bill was approved by the Committee with a vote of 35-28.
• On September 9, 2025, the House Committee on Oversight and Government Reform held a hearing entitled, Better Meals, Fewer Pills: Making Our Children Healthy Again. Witnesses included: Dr. Dorothy Fink, M.D., Acting Assistant Secretary for Health and Head of the U.S. Public Health Service Commissioned Corps, HHS; and Dr. Eve Stoody, Ph.D., Director, Nutrition Guidance and Analysis Division, Center for Nutrition Policy and Promotion U.S. Department of Agriculture (USDA).
• On September 9, 2025, the Senate Homeland Security & Governmental Affairs Committee held a hearing entitled, How the Corruption of Science has Impacted Public Perception and Policies Regarding Vaccines. Witnesses included: Mr. Aaron Siri, Managing Partner, Siri & Glimstad LLP; Mr. Toby Rogers, Ph.D., Fellow, Brownstone Institute; and Dr. Jake Scott, M.D., Infectious Disease Specialist, Stanford University School of Medicine.
• On September 10, 2025, the House Energy and Commerce Subcommittee on Health held a markup of several public health reauthorization bills including: H.R. 4262, To reauthorize programs related to health professions education, and for other purposes; H.R. 3593, Title VIII Nursing Workforce Reauthorization Act of 2025; H.R. 2493, Improving Care in Rural America Reauthorization Act of 2025; H.R. 3419, To amend the PHS Act to reauthorize the telehealth network and telehealth resource centers grant programs; H.R. 3302, Healthy Start Reauthorization Act of 2025; H.R. 2846, To amend title II of the PHS 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); and H.R. 4709, Newborn Screening Saves Lives Reauthorization Act of 2025. The bills were reported favorably to the full Energy and Commerce Committee.

Other Health Policy News

• On September 9, 2025, the House Appropriations Committee held a markup of the FY 2026 Labor, Health and Human Services, Education, and Related Agencies Appropriations Act. Republican Members expressed support for the bill, emphasizing that it includes investments in biomedical research, rural hospitals, and public health programs, while also enacting restrictions on diversity, equity, and inclusion initiatives, abortion-related services, and gender affirming care. On the other hand, Democratic Members expressed concern that the bill cuts funding for the CDC, NIH, and HIV prevention programs. The bill provides a total discretionary allocation of $108 billion for HHS which is approximately $7 billion, or six percent, below the enacted FY 2025 level. The bill was approved by the Committee with a vote of 35 to 28, following the approval of eight amendments. Notably, an amendment prohibiting CMS from implementing a new prior authorization pilot model, the Wasteful and Inappropriate Service Reduction (WISeR) Model, along with another amendment modifying the PHS Act to support continuing medical education programs, were both adopted by voice vote. The bill text can be found here. The bill report can be found here. A complete list of amendments can be found here.
• On September 9, 2025, CMS issued preliminary guidance for states regarding the implementation of new federal payment limits for SDPs in Medicaid managed care, as required by Public Law 119-21. The guidance establishes caps on payments for inpatient and outpatient hospital services, nursing facilities, and certain academic medical center practitioners, limiting them to 100 percent of Medicare rates in Affordable Care Act (ACA) Medicaid expansion states and 110 percent in non-expansion states beginning July 4, 2025. It also outlines criteria for a temporary grandfathering period that allows certain SDPs submitted or approved before the cutoff dates to be maintained until phased reductions begin in January 2028. CMS clarified that grandfathered SDPs cannot be increased and that renewals must comply with Medicare-based caps and aggregate payment limits. CMS emphasized that renewals will require evaluation plans explicitly tied to state quality strategies, measurable benchmarks, and reporting of outcomes for SDPs that have been in place for at least two rating periods. The guidance can be found here.
• On September 9, 2025, HHS released its Make Our Children Health Again Strategy, outlining over 120 initiatives aimed at addressing the root causes of childhood chronic diseases. The report highlights findings from the Make America Healthy Again (MAHA) Commission, which identified poor diet, exposure to environmental chemicals, lack of physical activity, chronic stress, and overmedicalization as the key drivers behind the rise in childhood chronic disease. The strategy calls for new executive actions and deregulation efforts, while emphasizing the importance of restoring scientific transparency and strengthening food and health systems. The strategy also calls for expanding research into areas such as nutrition, mental health, autism, and vaccine safety. It further proposes reforms to tie Medicaid quality measures to nutrition and physical fitness and supports provider-led discussions on nutrition and lifestyle interventions. The strategy report can be found here.
• On September 10, 2025, Representatives Buddy Carter (R-GA-01) and Diana Harshbarger (R-TN-01) reintroduced the 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act (340B ACCESS Act), which aims to increase oversight and tighten restrictions on the 340B program. The bill would restrict the ability for hospital outpatient departments to offer 340B drugs and require hospitals to regularly report on how they utilize the savings generated by the 340B program. Of note, the bill places restrictions on pharmacy benefit managers (PBMs), contract pharmacies, and third-party administrators on imposing conditions on 340B covered entities that differ from those that are not covered entities. For example, a PBM acting on behalf of an insurer is prohibited from reimbursing a covered entity in an amount less than they would pay to any other similar entity that is not a covered entity. The bill’s reintroduction comes shortly after the release of a report by CBO which found that federal drug spending increased as a result of growth of the 340B program.  Following the release of the CBO report, House Energy and Commerce Committee Chairman Brett Guthrie issued a statement noting that the report confirms the 340B program encourages behaviors that increase federal spending and raise prices for American taxpayers. The full bill text can be found here and a press release on the bill’s introduction can be found here. The CBO report can be found here. The statement by Chairman Brett Guthrie can be found here.
• On September 10, 2025, the Federal Trade Commission (FTC) sent letters to health care employers and staffing agencies urging them to review and potentially eliminate noncompete agreements that may restrict worker mobility and reduce patient access to care. The increased oversight follows FTC’s withdrawal of its legal defense of the nationwide noncompete ban issued during the Biden Administration. The letter highlights FTC’s authority to investigate unfair methods of competition under Section 5 of the FTC Act. The agency emphasized that unjustified or overly broad noncompete agreements can harm competition and limit patient access to care, especially in underserved areas. An FTC press release can be found here and the letter can be found here. Alston & Bird’s Antitrust / Labor & Employment Advisory, FTC Targets Noncompete Agreements in Health Care Industry After Abandoning Defense of Blanket Noncompete Ban, can be found here.

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