Health Care Week in Review | White House Issues Childhood Vaccine Executive Order; CMS Ends Federal Medicaid and CHIP Funding for Gender-Affirming Care for Minors

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 August 10, 2026, the Health Resources and Services Administration (HRSA) released a notice entitled, Final Health Center Program Scope of Project Policy Manual. The Health Center Program Scope of Project Policy Manual (Scope Manual) assists health centers in understanding what constitutes the Health Center Program scope of project under section 330 of the Public Health Service Act (PHS Act).

• On August 11, 2026, the Food and Drug Administration (FDA) released final guidance entitled, Guide to Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce. The guidance is intended to help manufacturers or processors of ready-to-eat fresh-cut produce that is not a low-moisture food comply with applicable requirements in our regulations on current good manufacturing practices for hazard analysis and risk-based preventive controls for human food.

• On August 11, 2026, the Centers for Medicare & Medicaid Services (CMS) released a final rule entitled, Prohibition on Federal Medicaid and Children's Health Insurance Program Funding for Sex-Rejecting Procedures Furnished to Children. This final rule requires that a State Medicaid plan must provide that the Medicaid agency will not make payment under the plan for sex-rejecting procedures for children under 18, and prohibits the use of federal Medicaid dollars to fund sex-rejecting procedures for individuals under the age of 18. In addition, this final rule requires that a separate State Children’s Health Insurance Program (CHIP) plan must provide that the CHIP agency will not make payment under the plan for sex-rejecting procedures for children under 19, and prohibits the use of Federal CHIP dollars to fund sex-rejecting procedures for individuals under the age of 19. For Medicaid and CHIP beneficiaries who are actively receiving cross-sex hormone therapy, State Medicaid and CHIP agencies may continue to claim Federal Financial Participation for those hormone therapy medications for a period of up to six months from the effective date of this final rule (April 13, 2027, as the effective date of the final rule is October 13, 2026).

• On August 11, 2026, HRSA released a notice of supplemental funding entitled, National Newborn Screening Stakeholder Workgroup. HRSA provides funding to support a national center for newborn screening systems known as the National Center for Newborn Screening Systems Excellence (NBS Excel). Supplemental funding is being provided to NBS Excel to establish a national newborn screening stakeholder workgroup in fiscal year (FY) 2026. This workgroup will be a pathway for conditions to be considered and recommended for inclusion in the Recommended Uniform Screening Panel (RUSP) and to discuss national-level issues related to newborn screening. Membership will include representatives from a wide range of newborn screening experts and stakeholders. The award recipient will convene the workgroup and develop findings, reports, and recommendations for HRSA’s review and consideration. HRSA will then make recommendations to the Secretary of the Department of Health and Human Services (HHS), who has final decision-making authority on updates to the RUSP.

• On August 12, 2026, CMS released a payment advisory entitled, Medicare Program: Alternative Payment Model Incentive Payment Advisory for Clinicians - Request for Current Billing Information for Qualifying Alternative Payment Model Participants. This advisory is intended to alert certain clinicians who are Qualifying Alternative Payment Model (APM) participants (QPs) and eligible to receive an APM Incentive Payment that CMS does not have the current billing information needed to disburse the payment. This advisory provides information to these clinicians on how to update their billing information to receive this payment for the 2026 payment year (PY).

• On August 12, 2026, FDA released final guidance entitled, Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products. This guidance provides recommendations for formal meetings between FDA and companies developing prescription drugs and biologics regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidance outlines procedures and best practices for requesting, preparing for, conducting, and documenting meetings intended to support product development and regulatory review. According to FDA, the final guidance incorporates feedback received on a draft version issued in September 2023 and includes clarifications on meeting types, meeting formats, and other aspects of the agency’s formal meeting process. The agency notes that the guidance reflects FDA’s current thinking but does not create legally binding requirements.

• On August 13, 2026, HHS released a notice entitled, Semiannual Regulatory Agenda. This semiannual regulatory agenda provides an overview of rulemakings HHS expects to pursue, finalize, or complete in the near future, as required under the Regulatory Flexibility Act and executive order (EO) 12866. The agenda highlights a range of planned actions across HHS agencies, including CMS, FDA, the HHS Office for Civil Rights (OCR), the Substance Abuse and Mental Health Services Administration (SAMHSA), and the Administration for Children and Families (ACF). Among the items listed are forthcoming Medicare payment rules for 2027, implementation of the Medicare Drug Price Negotiation Program, updates to independent dispute resolution (IDR) procedures under the No Surprises Act, FDA initiatives related to drug safety, labeling, and manufacturing standards, and civil rights and accessibility regulations.

• On August 13, 2026, FDA released a notice entitled, Container Closure Systems for Human Drugs and Biological Products. This document provides guiding principles for evaluating the quality of container closure systems (CCSs) used to package drugs and biological products, for human use. This includes CCSs that are also device constituent parts of combination products and CCSs used to package the drug or biological product constituent parts of combination products.

• On August 14, 2026, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Order Continuing the Suspension of the Right to Introduce Certain Persons from Countries Where a Quarantinable Communicable Disease Exists. This notice announces CDC is issuing an order under Section 362 and 365 of the PHS Act, and associated implementing regulations, continuing the suspension of the right to introduce certain persons from countries where an outbreak of a quarantinable communicable disease exists. This action took effect on August 12, 2026, and will remain in effect through September 11, 2026.

• On August 14, 2026, FDA released a final order entitled, Hematology and Pathology Devices: Reclassification of In Situ Hybridization Test Systems for Use with a Corresponding Approved Oncology Therapeutic Product. FDA issued this final order reclassifying in situ hybridization (ISH) test systems used with corresponding FDA-approved oncology therapeutic products from Class III devices requiring premarket approval (PMA) to Class II devices subject to special controls and the 510(k) premarket notification pathway. FDA determined that the risks associated with these companion diagnostic tests, including false positive and false negative results that could affect cancer treatment decisions, can be adequately mitigated through special controls governing analytical validation, clinical performance, labeling, and quality requirements. FDA stated that the reclassification is intended to reduce regulatory burden, accelerate review timelines, encourage additional test development, and expand patient access to oncology diagnostics while maintaining reasonable assurance of safety and effectiveness. Devices already approved through the PMA pathway may remain on the market without additional authorization, while new devices and significant modifications will generally require FDA clearance through the 510(k) process.

• On August 14, 2026, FDA released a proposed rule entitled, Gastroenterology-Urology Devices: Reclassification of Diagnostic Endoscopic Light Source Systems to Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer. FDA has proposed reclassifying diagnostic endoscopic light source systems, which would be renamed “cystoscopic systems intended as an aid for detection of bladder cancer,” from Class III devices requiring PMA to Class II devices subject to special controls and the 510(k) premarket notification pathway. FDA concluded that more than a decade of clinical, postmarket, and published evidence demonstrates that these devices, when used with an approved optical imaging agent as an adjunct to white light cystoscopy, can improve detection of bladder cancer lesions, including carcinoma in situ, while their risks can be adequately mitigated through special controls addressing clinical performance, optical and electrical safety, software validation, biocompatibility, sterility, reprocessing, and labeling requirements.

• On August 14, 2026, FDA released a proposed rule entitled,  Medical Devices: Classification of Accessories Distinct from Other Devices; Proposed List of Accessories Suitable for Class I. As required by the FDA Reauthorization Act of 2017 (FDARA), FDA has identified a list of accessories for which it believes general controls alone are sufficient to provide reasonable assurance of safety and effectiveness, making them appropriate for class I classification. FDA proposes to classify these accessories into Class I and seeks public comment in accordance with procedures established by FDARA.  

Event Notices

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

• August 24, 2026: The National Institutes of Health (NIH) announced a meeting of the Advisory Council on Parkinson's Research, Care, and Services (ACPRCS). This is a virtual meeting open to the public.

• August 24, 2026: CMS announced a meeting of the Advisory Panel on Hospital Outpatient Payment. This is a virtual meeting open to the public.
• August 25, 2026: FDA announced a meeting entitled, Patient-Focused Drug Development for Nonhealing Chronic Wounds. This is a hybrid meeting open to the public.
• August 26, 2026: CDC announced a meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This is a hybrid meeting open to the public.
• August 26, 2026: NIH announced a meeting of the Muscular Dystrophy Coordinating Committee (MDCC). This is a virtual meeting open to the public.
• August 31, 2026: NIH announced a meeting of the National Institute on Minority Health and Health Disparities. This is a virtual meeting with some sessions open to the public.
• September 2, 2026: NIH announced a meeting of the National Cancer Institute (NCI). This is a virtual meeting with some sessions open to the public.
• September 4, 2026: NIH announced a meeting of the National Deafness and Other Communication Disorders Advisory Council. This is a hybrid meeting 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 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 meeting 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 15, 2026: 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: 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: FDA announced a meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for 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 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 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.
• November 5, 2026: ONC announced a meeting of the Health Information Technology Advisory Committee (HITAC). This is a virtual meeting open to the public.
• December 1, 2026: NIH announced a meeting of 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.
• January 16, 2027: HHS announced a meeting of PACCARB. This is a virtual meeting open to the public.

Reports, Studies & Analyses

• On August 12, 2026, the HHS Administration for Planning and Evaluation (ASPE) released a report entitled, An Overview of State-Directed Payments and Medicaid Provider Taxes: History and Potential Effects of the Working Families and Tax Cut Legislation on Health Care Costs. The report examines the role of Medicaid provider taxes and state-directed payments (SDPs) in financing Medicaid and analyzes the potential effects of reforms enacted in the Working Families Tax Cut (WFTC) legislation (also referred to as the One Bill Beautiful Bill Act). The report describes how states have increasingly used provider taxes and SDPs to draw additional federal Medicaid funding and raises concerns that these financing arrangements may contribute to higher commercial health care prices and increased federal spending. Using an economic model, ASPE estimates that the WFTC provisions limiting provider taxes and reducing permissible SDP payment levels could lower non-Medicaid provider prices by up to 3.5 percent and generate savings for commercial payers, Medicare, and the federal government over time. The report projects reductions in overall health care spending relative to a baseline without the legislation, while noting that its findings are based on modeled assumptions regarding provider behavior, Medicaid financing, and health care market responses.

• On August 13, 2026, HHS published a report entitled, Wolves in White Coats: How Doctors and Hospitals Pushed and Profited from the Fraud of “Gender Medicine”, examining insurance coding practices and the provision of gender-affirming care for minors. The report analyzed the more than 225 hospitals and health systems nationwide with “established pediatric gender programs” alongside claims data from 2015 through 2025, highlighting the nearly $50 million in insurance claims for puberty blockers billed using endocrine disorder diagnostic code E34.9 (Endocrine Disorder, Unspecified). HHS also reported that nearly $11 million in claims for patients 13 to 17 were billed using diagnosis code E30.1 (precocious puberty), a condition for which puberty blockers are typically indicated, but argued that the volume and coding patterns of these claims warrant additional review to determine whether the codes were used to obtain reimbursement for gender-related care. Pursuant to that information, HHS recommended that federal and state agencies assess coding and billing practices, enhance oversight of claims submitted to public health programs, and refer potentially fraudulent billing activity for investigation when appropriate.

Other Health Policy News

• On August 10, 2026, the White House issued an EO entitled, Gold Standard Childhood Vaccine Recommendations, which is intended to align federal childhood immunization recommendations with what the Administration described as practices used in peer developed countries. The EO creates three categories of vaccine recommendations: vaccines recommended for all children, vaccines recommended for certain high-risk populations, and vaccines recommended through shared clinical decision-making. It also directs federal agencies to review and advance the recommendations where permitted by law and encourages states to review school immunization requirements in light of the new framework. The EO further directs HHS to evaluate alternative vaccine schedules, expand vaccine safety research and monitoring activities, assess alternatives to aluminum-containing adjuvants, and explore options for offering certain vaccines, including measles, mumps, and rubella (MMR), as separate single-disease products while maintaining access to currently available combination vaccines. In addition, the EO instructs the Department of Justice (DOJ), the Department of Education (ED), and HHS to take actions related to parental choice, religious liberty, disability accommodations, and state immunization exemption policies.

  The full text of the EO is available here. A fact sheet is available here.

• On August 11, 2026, CMS released a final rule entitled, Prohibition on Federal Medicaid and Children's Health Insurance Program Funding for Sex-Rejecting Procedures Furnished to Children. This final rule prohibits the use of federal Medicaid and CHIP funding to pay for medical gender-affirming care for minors. This includes puberty blockers, cross-sex hormones, and surgical operations, but does not impact coverage of mental health. Under the final rule, federal Medicaid and CHIP funding will be available for a tapering-off period of up to six months from the effective date of the final rule, October 13, 2026, for children currently on hormone therapy.

  The text of the final rule as published in the Federal Register can be found here.

  The CMS press release can be found here. The HHS press release can be found here.

• On August 13, 2026, HRSA announced $102 million in New Access Points funding to expand the Health Center Program, marking the program’s first major expansion since 2019. The awards will support 158 new and existing health centers in establishing 415 new service sites nationwide, with the goal of extending access to comprehensive primary care services to nearly one million additional people. According to HHS, the investment is intended to strengthen preventive care, nutrition services, behavioral health care, and substance use disorder treatment, particularly in medically underserved communities. HRSA also stated that it is exploring ways to help health centers identify and purchase American-made medical supplies and equipment. HHS noted that HRSA-funded health centers currently serve more than 32 million people through over 16,000 sites nationwide, including large shares of children, rural residents, and older adults.

A press release is available here.

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