Health Care Week in Review | President Trump Signs FY 2027 Continuing Resolution Into Law; House Members Introduce Bipartisan AI Health Insurance Legislation

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 1, 2026, the Department of Health and Human Services (HHS) released a notice entitled, Privacy Act of 1974; Matching Program. In accordance with the Privacy Act of 1974, as amended, and Office of Management and Budget (OMB) guidance on computer matching, HHS is providing notice of the establishment of a new matching program. Pursuant to the Payment Integrity Information Act of 2019, HHS, including its component divisions and program offices, is establishing a new matching program consisting of the computerized comparison of an HHS system of records with the Do Not Pay (DNP) Working System, which is administered by Treasury’s Bureau of the Fiscal Service. This matching program will enable HHS to compare records maintained in an HHS system of records covering HHS grantees and grant payments with records maintained in the DNP Working System for the purposes of identifying and preventing improper payments and conducting any related recovery activities.
• On September 1, 2026, the Food and Drug Administration (FDA) released a notice entitled, Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage; Draft Guidance for Industry; Availability. FDA is announcing the availability of a draft guidance for industry entitled, Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage. This guidance assists sponsors in the design and analysis of studies that assess the influence of hepatic impairment on the pharmacokinetics and, where appropriate, the pharmacodynamics of a drug, including therapeutic biological products. FDA is also withdrawing the May 2003 guidance for industry entitled, Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling, which formerly provided FDA’s thinking relating to studies to assess the effect of hepatic impairment on the pharmacokinetics or pharmacodynamics of a drug and recommendations to include hepatic impairment information in labeling.
• On September 1, 2026, FDA released a notice entitled, Dental Composite Resin Devices and Dental Curing Lights--Premarket Notification (510(k)) Submissions Guidances; Guidances for Industry and Food and Drug Administration Staff; Availability. FDA is announcing the availability of two final guidances entitled, Dental Composite Resin Devices--Premarket Notification (510(k)) Submissions and Dental Curing Lights--Premarket Notification (510(k)) Submissions. These guidance documents provide recommendations for device description, performance testing, and labeling to include in 510(k) submissions for dental composite resin devices and dental curing lights. The recommendations in these guidances are intended to promote consistency and facilitate efficient review of these submissions.
• On September 1, 2026, FDA released a notice entitled, International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1); Guidance for Industry; Availability. FDA is announcing the availability of a final guidance for industry entitled, Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The objective of this guidance is to ensure international harmonization of reproduction testing that is appropriate for the evaluation of effects on reproduction from long-term, low-dose exposures, which may be encountered from the presence of veterinary drug residues in food.
• On September 1, 2026, FDA released a notice entitled, International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2); Guidance for Industry; Availability. FDA is announcing the availability of a final guidance for industry entitled, Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2). This guidance has been developed for veterinary use by the VICH. The objective of this guidance is to ensure international harmonization of genotoxicity testing of veterinary drug residues.
• On September 2, 2026, HHS released a notice entitled, Emergency Use Authorization Declaration. On July 15, 2026, the Secretary of War determined under the Federal Food, Drug, and Cosmetic (FD&C) Act that there is a military emergency, or a significant potential for a military emergency involving biological, chemical, radiological, or nuclear agent or agents, or agents of military combat, including firearms, projectiles, and explosive devices, that may cause, or may otherwise be associated with, an imminently life-threatening and specific risk to U.S. military forces. On the basis of this determination, HHS Secretary Kennedy declared on August 31, 2026, pursuant to the FD&C Act, that circumstances exist justifying the authorization of emergency use of drugs identified and supported by the Department of War (DOW) as addressing an unmet military operations-related medical need for use to manage moderate to severe acute pain in casualties caused by, or associated with, such an emergency.
• On September 3, 2026, the Administration for Children and Families (ACF) released a proposed rule entitled, Reducing Bureaucracy and Burden for the Repatriation of Mentally Ill Nationals. ACF proposes to remove the Care and Treatment of Mentally Ill Nationals of the United States, Returned from Foreign Countries regulations, originally published on July 19, 1974, to streamline regulations and to renumber it under Part 1390. This would consolidate two sections into one concise section while not changing any of the operational practice or protections for mentally ill American nationals. Comments on this proposed rule must be received by October 5, 2026, for consideration.
• On September 3, 2026, FDA released a request for information entitled, Advancing Development of Botanical Drug Products. FDA is opening a public docket to solicit comments on FDA’s efforts to advance development of botanical drug products (BDPs). FDA is publishing this request for information to better understand stakeholders’ perspectives on the state of BDP development in the United States, challenges encountered, and potential solutions to gathering the information required by the FD&C Act. Comments must be received by November 3, 2026, for consideration.
• On September 4, 2026, FDA released a notice entitled, Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availability. FDA is announcing the availability of a final guidance for industry entitled, Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates. This final guidance describes FDA’s regulatory and enforcement priorities regarding the compounding of certain starter parenteral nutrition drug products for neonates by outsourcing facilities and by state-licensed pharmacies and federal facilities that are not registered with FDA as outsourcing facilities. This final guidance is being published for immediate implementation due to the expected market exit of the predominant source of certain starter parenteral nutrition drug products for neonates in the United States.

Event Notices

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

• **September 8, 2026: The National Institutes of Health (NIH) announced a meeting of the National Advisory Council on Drug Abuse. This is a virtual meeting with some sessions open to the public.
• September 9, 2026: NIH announced a meeting of the National Advisory Dental and Craniofacial Research Council. This is a virtual meeting with some sessions open to the public.
• September 9-10, 2026: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). This is a hybrid meeting open to the public.
• September 9-10, 2026: NIH announced a meeting of the National Advisory Neurological Disorders and Stroke Council. This is a virtual meeting with some sessions open to the public.
• September 10, 2026: NIH announced a meeting of the National Advisory Environmental Health Sciences Council (NAEHSC). This is a virtual 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 virtual meeting with some sessions open to the public.
• September 10-11, 2026: NIH announced a meeting of the Council of Councils. This is a hybrid meeting with some sessions open to the public.
• September 11, 2026: NIH announced a meeting of the National Advisory Council for Complementary and Integrative Health (NCCIH). This is a hybrid meeting with some sessions open to the public.
• September 14, 2026: FDA announced a hearing on the potential future therapeutic use of psychedelic drugs. This is a hybrid hearing open to the public.
• September 14-15, 2026: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.
• **September 14-15, 2026: NIH announced a meeting of the National Advisory Mental Health Council. This is a hybrid meeting with some sessions open to the public.
• September 15, 2026: The Centers for Disease Control and Prevention (CDC) announced a meeting of the ICD-10 Coordination and Maintenance Committee. This is a virtual meeting open to the public.
• September 15, 2026: NIH announced a meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. This is a virtual meeting with some sessions open to the public.
• September 15, 2026: NIH announced a meeting of the National Advisory Council for Nursing Research. This is a virtual meeting with some sessions open to the public.
• September 15-16, 2026: The Centers for Medicare & Medicaid Services (CMS) announced a meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (CDLTs). This is a virtual meeting open to the public.
• September 15-16, 2026: NIH announced a meeting of the National Advisory Council on Aging. This is a hybrid meeting with some sessions open to the public.
• September 15-16, 2026: 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.
• September 16, 2026: NIH announced a meeting of the National Institute of Biomedical Imaging and Bioengineering. This is an in-person meeting with some sessions open to the public.
• September 16, 2026: ACF announced a meeting between HHS/ACF Office of Head Start (OHS) leadership and Tribal government leadership. This is a virtual meeting with some sessions open to the public.

• September 16, 2026: FDA announced a meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2028 through 2032. This is a hybrid meeting open to the public.

• September 17, 2026: FDA announced a meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for FYs 2028 to 2032. This is a hybrid meeting open to the public.
• September 17, 2026: NIH announced a meeting of the National Advisory Council on Alcohol Abuse and Alcoholism. This is a hybrid meeting with some sessions open to the public.
• September 17, 2026: FDA announced a meeting of the Office of Women’s Health and the Center for Drug Evaluation and Research. This is a hybrid meeting open to the public.
• September 18, 2026: NIH announced a meeting of the Diabetes Mellitus Interagency Coordinating Committee (DMICC). This is a hybrid meeting open to the public.
• September 18, 2026: NIH announced a meeting of the National Center for Advancing Translational Sciences Advisory Council. This is a virtual meeting with some sessions open to the public.
• September 23, 2026: NIH announced a meeting of the National Advisory Allergy and Infectious Diseases Council. This is a virtual meeting with some sessions open to the public.
• September 23, 2026: NIH announced a meeting of the AIDS Research Advisory Committee. This is a virtual meeting open to the public.
• September 24, 2026: The Office of the National Coordinator for Health IT (ONC) announced a meeting of the Health Information Technology Advisory Committee (HITAC). This is a virtual meeting open to the public.
• September 25, 2026: NIH announced a meeting of the National Advisory Eye Council. This is a hybrid meeting with some sessions open to the public.
• September 28-29, 2026: NIH announced a meeting of the National Advisory Council for Human Genome Research. This is a hybrid meeting with some sessions open to the public.
• October 8, 2026: CDC announced a meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This is a virtual meeting open to the public.
• October 14, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD) National Advisory Child Health and Human Development Council. This is an in-person meeting with some sessions open to the public.
• October 16, 2026: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.
• October 20, 2026: NIH announced a meeting of the Advisory Committee on Research on Women’s Health. This is a virtual meeting open to the public.
• October 20, 2026: NIH announced a meeting of the Office of AIDS Research Advisory Council. This is a hybrid meeting open to the public. 
• October 28, 2026: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). This is a virtual meeting with some sessions open to the public.
• October 28, 2026: CDC announced a meeting of the Subcommittee on Procedures Reviews (SPR) of the ABRWH. This is a virtual meeting open to the public.
• October 28, 2026: NIH announced a meeting of the National Heart, Lung, and Blood Advisory Council. This is a hybrid meeting open to the public.
• November 5, 2026: ONC announced a meeting of HITAC. This is a virtual meeting open to the public.
• November 20, 2026: NIH announced a meeting of the Board of Scientific Counselors, National Institute of Diabetes and Digestive and Kidney Diseases. This is a virtual meeting with some sessions open to the public.
• December 1, 2026: NIH announced a meeting of the National Cancer Institute (NCI). This is an in-person meeting with some sessions open to the public.
• December 7-8, 2026: NIH announced a meeting of NICHD. This is a hybrid meeting open to the public.
• December 8-9, 2026: HHS announced a meeting of PTAC. This is a hybrid meeting open to the public.
• December 9-10, 2026: CMS announced a town hall meeting to discuss FY 2028 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). This is a virtual meeting open to the public.
• January 16, 2027: HHS announced a meeting of PACCARB. This is a virtual meeting open to the public.

Reports, Studies & Analyses

• On September 2, 2026, the HHS Office of Inspector General (OIG) released a report entitled, CMS Oversight Did Not Prevent Medicare Part D Sponsors From Making $587.7 Million in Ineligible Payments to Pharmacies for Drugs Available Over the Counter but Labeled as Prescription-Only. OIG conducted a nationwide audit to determine whether CMS oversight of Medicare Part D sponsors ensured compliance with federal requirements for preventing payment for over the counter (OTC) drugs sold under obsolete Rx-only labeling. Through the audit, OIG found that Part D sponsors made $587.7 million in ineligible payments for five drugs associated with obsolete Rx-only labeling more than one year after the brand-name drugs were switched to OTC use. OIG recommended that CMS issue guidance on timeframes for Part D sponsors to reject payments for OTC drugs sold under obsolete Rx-only labeling after an Rx-to-OTC switch. CMS concurred with the OIG recommendation. 

Other Health Policy News

• On September 2, 2026, President Trump signed H.R.6500, the Continuing Appropriations and Extensions Act, 2027, into law. This follows the vote by the House of Representatives on September 1, 2026, on a continuing resolution (CR) to fund the government through December 11, 2026. The measure passed on a vote of 370-48, with 19 Republicans and 29 Democrats voting in opposition. The Senate advanced this measure by a vote of 90-6 on August 8, 2026. 

In addition to preventing a government shutdown, the CR delays OMB from finalizing its May 29. 2026 proposed rule entitled, Regulation for Federal Financial Assistance. Under the proposed rule, OMB would transform the existing framework for grants in subtitle A of Title 2 from nonbinding guidance into formally binding OMB regulation. As a result, any future revisions made by OMB would apply uniformly across all agencies as of OMB’s specified effective date, without requiring or allowing separate rulemaking by individual agencies. Further, OMB would require senior political appointments to review awards prior to issuance to ensure that all discretionary awards adhere to administration priorities and are compliant and permissible under applicable law. The CR prohibits any similar action from being issued or finalized prior to December 11.

The text of the CR may be found here. The White House press release may be found here.

• On September 1, 2026, HHS hosted the Live Real Life Symposium to examine the harms of screen use in children and discuss actionable approaches to supporting healthier childhood development. The symposium is part of the HHS Live Real Life campaign, a national effort to help families, schools, and communities reduce harmful screen use and create more opportunities for children to engage in the experiences essential to healthy development. This event builds on the Surgeon General’s Warning on the Harms of Screen Use: An Advisory and Toolkit on How to Protect Children and Adolescents issued earlier this year, which outlines how factors such as age, content, design, purpose, and duration influence when screen engagement may be beneficial and when it becomes harmful.

  At the event, HHS announced that health care providers can now earn free accredited continuing education (CE) credits through the Office of the Surgeon General’s partnership with the American College of Preventive Medicine (ACPM). Providers can earn 1.5 AMA Category 1 Credits for completing the Advisory on the Harms of Screen Use and 1 AMA Category 1 Credit for the accompanying toolkit.

  The HHS press release on the event may be found here.

• On September 1, 2026, Representatives Greg Landsman (D-OH-01), Buddy Carter (R-GA-01), Kim Schrier (D-WA-08), and Tom Barrett (R-MI-07) introduced H.R.10210, the Doctors Not AI Act of 2026 to limit the role of artificial intelligence (AI) in medical decision making. This bipartisan legislation would prohibit AI systems from issuing or dictating adverse benefit determinations involving clinical judgment, requiring instead that a licensed professional with relevant expertise make these decisions independently. The bill also would mandate disclosure of AI usage in notices and treat AI-driven utilization review as a treatment limitation under mental health parity laws. Additionally, the bill aims to protect access to mental health care by preventing AI from unfairly denying or limiting mental health and substance use disorder care, instead requiring health professionals to independently review each patient’s individual medical circumstances.

The bill text may be found here. The associated press release from Representative Landsman’s office may be found here.

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