Health Care Week in Review | HHS Blocks Access to Select Federal Health Programs for Undocumented Individuals; Senate HELP Committee Advances Nominee for CDC Director

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.

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 Regulations, Notices & Guidance

• On July 10, 2025, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Solicitation of Nominations for Appointment to the Advisory Council for the Elimination of Tuberculosis. In accordance with the Federal Advisory Committee Act, CDC is seeking nominations for membership on the Advisory Council for the Elimination of Tuberculosis (ACET). ACET consists of ten members in fields associated with public health, epidemiology, immunology, infectious disease, pulmonary disease, pediatrics, tuberculosis, microbiology, and preventive health care delivery.
• On July 10, 2025, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Privacy Act of 1974; System of Records. In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is modifying an existing system of records maintained by CMS, entitled Home Health Agency (HHA) Outcome and Assessment Information Set (OASIS), System No. 09-70-0522. This system of records covers information about patients receiving home health services from a Medicare or Medicaid-approved HHA. Home health agencies required to comply with Medicare Conditions of Participation (CoP) are now mandated to collect OASIS on patients with any payer source, rather than only those with Medicare or Medicaid pay sources.
• On July 11, 2025, HHS released a notice entitled, Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA); Interpretation of Federal Public Benefit. This notice sets forth the interpretation that HHS uses for the term “Federal public benefit” as used in Title IV of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA), Pub. L. 104–193, 8 U.S.C. § 1611. This notice revises the interpretation of the term set forth in a prior notice, 63 FR 41658 (Aug. 4, 1998) (the 1998 HHS PRWORA Notice or 1998 Notice). This notice also describes and preliminarily identifies the HHS programs that provide “Federal public benefits” within the scope of PRWORA, including HHS programs that were not listed in the 1998 HHS PRWORA Notice.

Event Notices

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

• July 14, 2025: the Food and Drug Administration (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.
• July 14, 2025: 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.
• July 15, 2025: FDA announced a meeting entitled, Second Annual Animal Drug User Fee Educational Conference. This is a hybrid meeting open to the public.
• July 17, 2025: FDA announced a meeting of the Oncologic Drugs Advisory Committee. This is an in-person meeting open to the public.
• July 18, 2025: FDA announced a meeting of the Psychopharmacologic Drugs Advisory Committee. This is an in-person meeting open to the public.
• July 23, 2025: FDA announced a meeting entitled, Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population. This is a hybrid meeting open to the public.
• July 23-24, 2025: CMS announced a meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. This is a hybrid meeting open to the public.
• August 4, 2025: FDA announced a meeting entitled, Medical Device User Fee Amendments. This is a hybrid meeting open to the public.
• ** August 5, 2025: The Department of Veterans Affairs (VA) announced a meeting of the Special Medical Advisory Group. This is a virtual meeting open to the public.
• August 6-7, 2025: The Health Resources and Services Administration (HRSA) announced a meeting of National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
• August 7, 2025: The National Institutes of Health (NIH) announced a meeting of the National Institute of Neurological Disorders and Stroke. This is a hybrid meeting open to the public.
• August 7-8, 2025: NIH announced a meeting of the National Heart, Lung, And Blood Institute. This is a hybrid meeting open to the public.
• August 8, 2025: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry. This is a hybrid meeting open to the public.
• August 13, 2025: FDA announced a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This is a virtual meeting open to the public.
• ** August 20, 2025: VA announced a meeting of the Rehabilitation Research and Development Service Scientific Merit Review Board. This is a virtual 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 9, 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 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 11-12, 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 National Institute of Environmental Health Sciences. This is a hybrid meeting 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.
• October 8-9, 2025: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases. This is a virtual 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 (NICHD). This is a hybrid meeting open to the public.
• December 4-5, 2025: HRSA announced a meeting of NACNEP. This is a hybrid meeting open to the public.
• December 5, 2025: NIH announced a meeting of the Board of Scientific Counselors Eunice Kennedy Shriver NICHD. This is a hybrid meeting with some sessions open to the public.
  

Reports, Studies & Analyses

• On July 10, 2025, the Government Accountability Office (GAO) released a report entitled, Serious Mental Illness: HHS Assessments of Assisted Outpatient Treatment Have Yielded Inconclusive Results. The report reviewed HHS efforts to evaluate the effectiveness of assisted outpatient treatment (AOT) programs, which are court-ordered and designed to help adults with serious mental illnesses who may not be able to live safely in the community without supervision. Through the Substance Abuse and Mental Health Services Administration (SAMHSA), HHS has awarded approximately $146 million in AOT grants since 2016. However, GAO found that assessments by both SAMHSA and the Office of the Assistant Secretary for Planning and Evaluation (ASPE) were inconclusive due to methodological challenges, including reliance on self-reported data and significant variation in how programs were implemented across states. The report states that these limitations hindered the ability to draw clear conclusions about the program’s impact on outcomes such as treatment adherence, hospitalizations, and arrests.
• On July 11, 2025, the Kaiser Family Foundation (KFF) released a report entitled, Americans’ Challenges with Health Care Costs. The report outlines the financial burdens tied to health care across the U.S. population. Nearly half of adults report difficulty affording health care, with disproportionate impacts among Black and Hispanic adults, those with lower incomes, and the uninsured. One in four adults say they or a family member had problems paying for care in the past year, and over a third delayed or skipped needed care due to cost. The report also notes that prescription drug costs led many to forgo medications or adopt cost-saving behaviors like skipping doses. Health care debt remains widespread, affecting 41 percent of adults, and concerns about affording premiums, out-of-pocket costs, and unexpected bills are common even among the insured. The report highlights that affordability challenges extend across income levels and insurance types.

Hearings & Markups

• On July 9, 2025, the Senate Appropriations Committee held a markup entitled, Full Committee Markup of Commerce, Justice, Science; Agriculture, Rural Development, FDA; and Legislative Branch Appropriations Acts. The bills discussed included:
  • FY 2026 Commerce, Justice, Science, and Related Agencies Appropriations Act
  • FY 2026 Agriculture, Rural Development, Food and Drug Administration (FDA), and Related Agencies Appropriations Act
  • FY 2026 Legislative Branch Appropriations Act
• On July 9, 2025, the Senate Appropriations Committee held a hearing entitled, A Future Without Type 1 Diabetes: Accelerating Breakthroughs and Creating Hope. Witnesses included: Ms. Ruby Whitmore, Children’s Congress Delegate; Ms. Rachel White, Children’s Congress Delegate; Ms. Katie Bone, USA Climbing Speed National Champion; and Dr. Griffin P. Rodgers, Director, National Institute of Diabetes and Digestive and Kidney Diseases.
• On July 9, 2025, Senate Health, Education, Labor and Pensions (HELP) Committee held an executive session entitled, Nomination of Susan Monarez to be Director of the Centers for Disease Control and Prevention, Department of Health and Human Services. Dr. Susan Monarez, Nominee for Director, CDC, served as the sole witness.
• On July 9, 2025, the Senate HELP Committee held a hearing entitled, Securing the Future of Health Care: Enhancing Cybersecurity and Protecting Americans' Privacy. Witnesses included: Mr. Greg Garcia, Executive Director, Healthcare and Public Health Sector Coordinating Council; Mr. René Quashie, Vice President, Digital Health, Consumer Technology Association; Ms. Linda Stevenson, Chief Information Officer, Fisher-Titus; Mr. Robert Weissman, President, Public Citizen; and Dr. Alison Galvani, Professor, Yale School of Public Health.

Other Health Policy News

Lawsuit Challenges Directive Removing COVID-19 Vaccine Recommendations

On July 7, 2025, a coalition of medical and public health organizations filed a lawsuit against HHS Secretary Robert F. Kennedy Jr. over his May directive removing COVID-19 vaccine recommendations for healthy children and pregnant people. The plaintiffs, which include the American Academy of Pediatrics, American College of Physicians, and American Public Health Association, argue the decision was “arbitrary and capricious,” bypassed established federal procedures, and undermines public trust in vaccines. The lawsuit, filed in federal court in Massachusetts, seeks to reverse the policy change and block its enforcement. 

Plaintiffs assert the directive has already caused confusion among providers and patients, disrupted insurance coverage expectations, and weakened the physician-patient relationship. One anonymous plaintiff, a pregnant physician, says she has been unable to access a COVID booster recommended by her doctor. The complaint also highlights broader concerns about Secretary Kennedy’s overhaul of federal vaccine policy, including his removal of all 17 members of the CDC Advisory Committee on Immunization Practices (ACIP) and replacement with new appointees. A preliminary injunction hearing is expected in the coming weeks.

The complaint can be viewed here.

Senate HELP Committee Advances CDC Director Nominee

On July 9, 2025, the Senate HELP Committee advanced President Donald Trump’s nominee for CDC Director, Dr. Susan Monarez. Chair Senator Bill Cassidy (R-LA) praised Dr. Monarez’s commitment to transparency and effective public health communication, particularly amid growing concerns over vaccine misinformation and reemerging diseases like measles. Public health experts have expressed cautious optimism about Dr. Monarez’s qualifications, noting the challenges she may face under Secretary Kennedy, whose vaccine policy changes have drawn criticism. Senator Bernie Sanders (I-VT) raised concerns about Dr. Monarez’s response to Secretary Kennedy’s controversial statements on vaccines. If confirmed by the full Senate, Dr. Monarez would oversee ACIP, which has already recommended changes to flu vaccine guidelines.

HHS Announces Cessation of Certain Federal Health Programs for Undocumented Individuals

On July 10, 2025, the HHS announced that undocumented individuals will no longer be able to access certain federal health programs, including Head Start, community health centers, and certain behavioral health and workforce initiatives. In a notice, HHS stated that it is rescinding its 1998 interpretation of PRWORA, which had previously extended access to some federal public benefits for immigrants without legal status. The updated interpretation applies PRWORA’s original definition of “Federal public benefit” and affirms that programs serving individuals, households, or families are subject to eligibility restrictions. HHS clarified that no programs under its authority have been formally exempted under PRWORA’s limited exceptions. The policy takes effect immediately upon publication in the Federal Register and includes a 30-day public comment period. 

The HHS notice can be found here. 

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