Health Care Week in Review | House Appropriations Labor-HHS Subcommittee Releases FY 2026 Funding Bill; HHS Issues Enforcement Notice on Health Information Blocking

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 2, 2025, the Food and Drug Administration (FDA) released a notice entitled, Secondary Direct Food Additives Permitted in Food for Human Consumption; Hydrogen Peroxide. FDA is amending the food additive regulation to provide for the safe use of hydrogen peroxide in food as an antimicrobial agent, oxidizing and reducing agent, and bleaching agent, and to remove sulfur dioxide.
• On September 3, 2025, FDA released a notice entitled, Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 in Yogurt and Other Cultured Dairy Products Fermented with Lactobacillus delbrueckii, subspecies bulgaricus, and Streptococcus thermophilus. FDA is amending the food additive regulations to provide for the safe use of vitamin D3 as a nutrient supplement in yogurt and other cultured dairy products fermented with Lactobacillus delbrueckii, subspecies bulgaricus (L. delbrueckii, subspecies bulgaricus), and Streptococcus thermophilus (S. thermophilus) at a level higher than is currently permitted. FDA is also updating the reference for the vitamin D3 specifications.
• On September 4, 2025, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Medicare Program; Approved Renewal of Deeming Authority of the Utilization Review Accreditation Commission (URAC) for Medicare Advantage Health Maintenance Organizations and Local Preferred Provider Organizations. This final notice announces CMS’s decision to renew URAC’s application for Medicare Advantage (MA) deeming authority of Health Maintenance Organizations and Preferred Provider Organizations for a term of six years.
• On September 4, 2025, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a notice entitled, Fiscal Year 2025 Notice of Supplemental Funding Opportunity. SAMHSA is supporting administrative supplements in scope of the parent award for the 56 eligible grant recipients funded in Fiscal Year (FY) 2025 Projects for Assistance in Transition from Homelessness Grant (PATH). Each PATH recipient may receive up to $9,083. These awards have a project end date of September 29, 2026.
• On September 5, 2025, the Health Resources and Services Administration (HRSA) released a notice entitled, Sickle Cell Disease Newborn Screening Follow-up Program. HRSA will provide $65,500 in supplemental award funds to each of the 25 Sickle Cell Disease (SCD) Newborn Screening Follow-Up Program (NBS FP) grantees under HRSA-21-036 in FY 2025, totaling $1,637,500. The FY 2025 supplemental funds will support grant activities that are in scope of program goals and objectives. The supplemental funding can support activities related to: (1) increasing access to medical and support services, particularly during the pediatric to adult transition period; (2) improving data systems; (3) increasing workforce training and knowledge; (4) expanding quality improvement projects; or (5) conducting outreach to help identify individuals living with SCD who have been lost to follow-up. The notice states that these activities will strengthen the linkage of individuals with SCD to appropriate and ongoing care to improve health outcomes.
• On September 5, 2025, the Centers for Disease Control and Prevention (CDC) released a notice entitled, CAUTI events among patients with Spinal Cord Injury-associated Neurogenic Bladder (SCI-NB); Request for Information. CDC is seeking information regarding Catheter-associated Urinary Tract Infections (CAUTIs) among patients with Spinal Cord Injury-associated Neurogenic Bladder (SCI-NB). CDC seeks to understand the burden of CAUTIs among this patient population and any implications related to reporting within the CDC National Healthcare Safety Network (NHSN) device-associated urinary tract infection (UTI) event module. This notice provides an opportunity for professionals who work with this patient population, as well as those who conduct NHSN UTI surveillance, to offer feedback related to CDC’s approach.

Event Notices

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

• September 3-4, 2025: The National Institutes of Health(NIH) announced a meeting of the National Advisory Neurological Disorders and Stroke Council. This is a hybrid meeting with some sessions open to the public.
• September 4, 2025: NIH announced a meeting of the National Institute on Alcohol Abuse and Alcoholism. This is a hybrid meeting with some sessions open to the public.
• September 4, 2025: NIH announced a meeting of the National Cancer Advisory Board. This is a hybrid meeting with some sessions open to the public.
• September 4, 2025: NIH announced a meeting of the National Deafness and Other Communication Disorders Advisory Council. This is an in-person meeting with some sessions open to the public.
• September 4-5, 2025: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• September 5, 2025: NIH announced a meeting of the National Advisory Council on Minority Health and Health Disparities. This is a hybrid meeting with some sessions open to the public.
• September 9, 2025: NIH announced a meeting of the National Advisory Council for Nursing Research. This is a hybrid meeting with some sessions open to the public.
• September 9, 2025: NIH announced a meeting of the National Council on Drug Abuse. This is a hybrid meeting with some sessions open to the public.
• September 9-10, 2025: NIH announced a meeting of the National Advisory Child Health and Human Development Council. This is a hybrid meeting with some sessions open to the public.
• September 9-10, 2025: CDC announced a meeting of the National Center for Health Statistics ICD-10 Coordination and Maintenance Committee. This is a virtual meeting open to the public.
• September 10, 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.
• September 10, 2025: FDA announced a meeting of the National Advisory Dental and Craniofacial Research Council. This is a hybrid meeting with some sessions open to the public.
• September 10, 2025: FDA announced a workshop entitled, Lessons Learned From the Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Public Workshop. This is a virtual workshop open to the public.
• September 11, 2025: NIH announced a meeting of the National Advisory General Medical Sciences Council. This is a virtual meeting with some sessions open to the public.
• September 11, 2025: NIH announced a meeting of the National Institute of Mental Health. This is a virtual meeting with some sessions open to the public.
• September 11-12, 2025: HRSA announced a meeting of the Council on Graduate Medical Education. This is a hybrid meeting open to the public.
• September 11-12, 2025: NIH announced a meeting of the Council of Councils. This is a hybrid meeting with some sessions open to the public.
• September 11-12, 2025: NIH announced a meeting of the National Institute of Environmental Health Sciences. This is a hybrid meeting open to the public.
• 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: NIH announced a meeting of the National Human Genome Research Institute. This is a hybrid meeting open to the public.
• September 16-17, 2025: 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 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 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 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.
• 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: 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.
• 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 3, 2025, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report entitled, National Government Services, Inc., Reopened and Corrected Cost Report Final Settlements for Desk Reviews Only With Obvious Errors To Correct Payments Made to Medicare Providers. OIG audited cost reports that National Government Services, Inc. (NGS), a Medicare administrative contractor, had reopened to correct final settlements previously completed through desk reviews. OIG found that all 60 cost reports reviewed contained errors or inconsistencies, leading to $5.6 million in corrected settlements. NGS acknowledged that auditors and supervisors lacked sufficient training and that supervisors failed to catch incorrect audit adjustments. OIG concluded that these errors create risks of inefficiency in Medicare spending and recommended additional education for staff and stronger supervisory procedures. NGS concurred with OIG recommendations.
• On September 3, 2025, OIG released a report entitled, Some Medicaid Managed Care Plans Made Few or No Referrals of Potential Provider Fraud. OIG reviewed Medicaid managed care plans’ efforts to refer potential provider fraud, waste, or abuse. In 2022, 10 percent of plans made no referrals, despite covering 1.6 million enrollees and receiving $8 billion from 13 states. Among plans that made referrals, over half reported two or fewer per 10,000 enrollees. OIG found that plans with dedicated fraud staff and those that received state or Medicaid Fraud Control Unit training were more likely to make referrals. However, only half of plans had received such training and 78 percent of fraud referral staff had responsibilities across multiple programs. OIG recommended that CMS follow up with states where plans failed to make referrals and encourage states to expand fraud referral training. CMS stated that it has undertaken such follow-up and agreed with the recommendation to expand training.
• On September 4, 2025, the Government Accountability Office (GAO) released a report entitled, Behavioral Health: Federal Activities to Support Crisis Response Services. GAO reviewed how SAMHSA has supported states in strengthening behavioral health crisis response services between 2020 and 2025. GAO found that SAMHSA provided over $1.3 billion across ten programs, along with guidance and technical assistance, to expand services such as crisis hotlines, mobile crisis teams, and crisis stabilization centers. States used these resources to hire staff, enhance infrastructure, and improve coordination of care. GAO also reviewed SAMHSA’s evaluation plans for its 988 Lifeline and Certified Community Behavioral Health Clinic (CCBHC) grant programs and found that the agency’s evaluations of its behavioral health crisis response efforts were largely in the planning stages. As of May 2025, SAMHSA officials planned to continue this evaluation and noted that a contractor had started collecting data.

Hearings & Markups

• On September 2, 2025, the House Appropriations Committee Departments of Labor, Health and Human Services, Education, and Related Agencies Subcommittee held a markup of the FY 2026 Labor, Health and Human Services, Education, and Related Agencies Appropriations Act. The bill was favorably reported to the full House Appropriations Committee by a vote of 11-7.
• On September 3, 2025, the House Energy and Commerce Committee Health Subcommittee held a hearing entitled, Examining Opportunities to Advance American Health Care through the Use of Artificial Intelligence Technologies. Witnesses included: TJ Parker, Lead Investor, General Medicine; Andrew Toy, Chief Executive Officer, Clover Health; Dr. Andrew Ibrahim, MD, MSc, Chief Clinical Officer, Viz.ai; Dr. Michelle Mello, JD, PhD, MPhil, Professor of Law and Professor of Health Policy, Stanford University; and Dr. C. Vaile Wright, PhD, Senior Director, Health Care Innovation, American Psychological Association.
• On September 4, 2025, the Senate Finance Committee held an executive session to consider nominations. Among the nominees were Gustav Chiarello III, to be Assistant Secretary of HHS, and The Honorable Michael Stuart, to be General Counsel of HHS. Both nominations were advanced by a vote of 14-13.
• On September 4, 2025, the Senate Finance Committee held a hearing entitled, The President’s 2026 Health Care Agenda. The Honorable Robert F. Kennedy, Jr., Secretary of HHS, served as the sole witness.

Other Health Policy News

House Appropriations Labor-HHS Subcommittee and Related Agencies Release Draft Funding Bill for FY 2026.

On September 2, 2025, the House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies released its draft funding bill for FY 2026. The bill would reduce discretionary funding for HHS to $108 billion, a reduction of approximately six percent from the previous year. While this is lower than the $116 billion proposed by the Senate, it is higher than the $94.7 billion in the Trump Administration’s budget request. Specifically, the House proposes a 19 percent cut to CDC and the elimination of funding for the Agency for Healthcare Research and Quality (AHRQ). However, the bill does not include cuts to NIH proposed by the Trump Administration, instead proposing a similar funding level for NIH as the Senate of $48 billion. The bill also includes $515 million for rural health programs, as well as funding for telehealth and chronic care management services, as a part of Secretary Kennedy’s Make America Healthy Again (MAHA) initiative. The House and Senate bills do not include specific language for the establishment of an Administration for a Healthy America (AHA), a central component of Secretary Kennedy’s reorganization plan.

The appropriations bill was passed out of the Subcommittee on September 2, 2025. The full House Appropriations Committee is expected to consider the legislation in the near future.

The full bill text can be found here. A summary of the bill released by the Republican members of the Committee can be found here.

Hearing on Advancing American Health Care & Use of AI

On September 3, 2025, the Energy & Commerce Committee Subcommittee on Health held a hearing entitled, Examining Opportunities to Advance American Health Care through the Use of Artificial Intelligence Technologies, during which members and witnesses highlighted both the promise and the risks of artificial intelligence (AI) in health care. Members agreed that AI could reduce administrative burden, improve access to care in rural and underserved areas, accelerate drug discovery, and support clinicians. Concerns centered on patient safety, trust, and accountability, specifically regarding prior authorization, reimbursement policy, and outdated regulatory frameworks. Witnesses stressed the need to update reimbursement to encourage adoption, particularly in rural hospitals, while also acknowledging the costs of training staff and ensuring algorithms serve diverse populations. Witnesses highlighted the risks associated with the use of unsafe or deceptive mental health chatbots, especially for children and adolescents. They urged the implementation of safeguards, including age limits and greater independent research before products reach the market. Overall, the hearing highlighted the need for Congress to modernize oversight, strengthen guardrails, and ensure sustainable reimbursement to ensure the responsible deployment of AI.

A recording of the hearing can be found here.

HHS Targets Information Blocking by Health Care Entities

On September 3, 2025, HHS announced it is increasing resources to investigate and enforce rules against information blocking by health care entities. The Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC), in coordination with HHS OIG, is taking enforcement actions through authorities granted under the 21st Century Cures Act. These efforts build on the ONC Cures Act Final Rule published in May 2020. Entities found to be engaging in prohibited practices could face penalties, including: (1) a civil monetary penalty of up to $1 million per violation for health IT developers, health information networks, or health information exchanges; (2) termination of product certifications for developers with products certified under the ONC Health IT Certification Program; and (3) disincentives for providers participating in certain CMS programs. HHS encouraged patients, providers, and innovators to report suspected information blocking through designated reporting channels.

An HHS press release announcing the enforcement notice can be found here.

Act Introduced to Extend Enhanced Premium Tax Credits (EPTCs)

On September 4, 2025, Representatives Jen Kiggans (R-VA-02) and Tom Suozzi (D-NY-03) introduced the Bipartisan Premium Tax Credit Extension Act, which would extend enhanced premium tax credits (EPTCs) until January 1, 2027. EPTCs are currently set to expire on January 1, 2026. Premium tax credits were first enacted under the Affordable Care Act (ACA) to help individuals pay for health insurance purchased through the ACA marketplace. During the COVID-19 pandemic, Congress expanded the credits through the American Rescue Plan Act for 2021-2022. In 2022, Congress extended these enhanced credits through 2025 in the Inflation Reduction Act.

The full bill text can be found here. A press release announcing the introduction of the bill can be found here.

Senate Finance Committee Discusses Trump Administration's Approach to Health System Reforms

On September 4, 2025, the Senate Finance Committee held a hearing entitled, The President's 2026 Health Care Agenda. The hearing covered the Trump Administration’s approach to health system reforms, including efforts to address chronic disease prevention and expand investments in rural health infrastructure. Members expressed concern regarding Secretary Kennedy’s approach to vaccine policy and his dismissal of Dr. Susan Monarez from her role as CDC Director. Members also highlighted provisions of the One Big Beautiful Bill Act (H.R. 1), including the Rural Health Transformation Program, the exemption of certain cancer drugs from Medicare price negotiations, and efforts to reduce improper payments in the Medicaid program. Throughout the contentious hearing, Secretary Kennedy emphasized the need to restore credibility at federal health agencies. He said that CDC’s pandemic response justified the replacement of its leadership and members of ACIP. Members raised concerns about the politicization of vaccine policy and its potential impact on public trust, child health, and vaccine access.

A recording of the hearing can be found here.

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