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.
Alston & Bird's multidisciplinary Executive Order, Action & Proclamation Task Force advises clients on the business and legal implications of President Trump's Executive Orders.
Week in Review Highlight of the Week:
This week, HHS announced plans for an additional reduction in 10,000 full-time employees and consolidation of departmental divisions, and the nominees to head the FDA and the NIH were confirmed by the Senate.
1. Regulations, Notices & Guidance
- On March 25, 2025, the Health Resources and Services Administration (HRSA) released a notice entitled, Charter Renewal for Advisory Council on Blood Stem Cell Transplantation. The Advisory Council on Blood Stem Cell Transplantation (ACBSCT) advises, assists, consult withs, and makes recommendations to the Secretary of Health and Human Services (HHS) on matters related to the C.W. Bill Young Cell Transplantation Program and National Cord Blood Inventory. In accordance with the Federal Advisory Committee Act (FACA), HHS is hereby giving notice that ACBSCT has been renewed.
- On March 27, 2025, the Food and Drug Administration (FDA) released guidance entitled, Study Data Technical Conformance Guide - Technical Specifications Document. This guidance provides technical recommendations to sponsors for the submission of animal and human study data and related information in a standardized electronic format in investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs). The guidance is intended to complement and promote interactions between sponsors and FDA review divisions. However, it is not intended to replace the need for sponsors to communicate directly with review divisions regarding implementation approaches or issues relating to data standards.
- On March 28, 2025, HRSA released a notice entitled, National Vaccine Injury Compensation Program: List of Petitions Received. HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions
Event Notices—NOTE: Due to an HHS communications freeze, many of these meetings may be cancelled or postponed. We are continuing to monitor.
** - New addition
- April 2, 2025: The Centers for Medicare & Medicaid Services (CMS) announced a hearing to reconsider its decision to disapprove Idaho’s Medicaid State Plan Amendment, numbered 24-0015. This is a hybrid hearing open to the public.
- April 3, 2025: The National Institutes of Health (NIH) announced a meeting of the Board of Scientific Counselors for the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting open to the public.
- April 10-11, 2025: HRSA announced a meeting of the Council on Graduate Medical Education (COGME). This is a hybrid meeting open to the public.
- April 15-16, 2025: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Committee on Immunization Practices (ACIP). This is a virtual meeting open to the public.
- **April 17, 2025: 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.
- **April 21, 2025: NIH announced a meeting of the Council of Councils. This is a hybrid meeting with some sessions open to the public.
- **April 21, 2025: 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.
- **April 22, 2025: NIH announced a meeting of the National Advisory Council on Aging. This is a virtual meeting with some sessions open to the public.
- **April 23, 2025: NIH announced a meeting of the National Heart, Lung, and Blood Advisory Council. This is a virtual meeting open to the public.
- **April 23, 2025: NIH announced a meeting of the National Advisory Council for Nursing Research. This is a virtual meeting with some sessions open to the public.
- April 24, 2025: NIH announced a meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council. This is a virtual meeting with one session open to the public.
- **April 30, 2025: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
- April 30, 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.
- May 5-6, 2025: NIH announced a meeting of the Board of Scientific Counselors, National Institute Environmental Health. This is a hybrid meeting with some sessions open to the public.
- **May 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.
- **May 5, 2025: NIH announced a meeting of the National Advisory Board on Medical Rehabilitation Research. This is a hybrid meeting open to the public.
- **May 6, 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.
- **May 8, 2025: NIH announced a meeting of the National Deafness and Other Communication Disorders Advisory Council. This is a virtual meeting open to the public.
- **May 13, 2025: NIH announced a meeting of the National Advisory Council on Drug Abuse. This is a virtual meeting with some sessions open to the public.
- May 14, 2025: HRSA announced a meeting of the National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
- May 14, 2025: NIH announced a meeting of the National Advisory Council on Aging. This is an in-person meeting with one session open to the public.
- **May 22, 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.
- **May 28, 2025: 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.
- June 3-4, 2025: FDA announced a public workshop entitled, Fiscal Year (FY) 2025 Generic Drug Science and Research Initiatives Workshop. This is a hybrid workshop open to the public.
- **June 5, 2025: NIH announced a meeting of the National Advisory Environmental Health Sciences Council. This is a hybrid meeting with some sessions open to the public.
- **June 6, 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 virtual meeting with some sessions open to the public.
- **July 7, 2025: NIH announced a meeting of the Board of Scientific Counselors, National Cancer Institute. This is a virtual meeting with some sessions open to the public.
- **June 9, 2025: NIH announced a meeting of the National Advisory Child Health and Human Development Council. This is a virtual meeting with some sessions open to the public.
- **June 13, 2025: NIH announced a meeting of the National Advisory Eye Council. This is a hybrid meeting with some sessions open to the public.
- August 6-7, 2025: HRSA announced a meeting of NACNEP. 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.
- September 11-12, 2025: HRSA announced a meeting of the COGME. 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.
2. Reports, Studies, & Analyses
- On March 27, 2025, the Congressional Budget Office (CBO) published a report entitled, The Long-Term Budget Outlook: 2025 to 2055. In the report, CBO projects that public debt as a percentage of gross domestic product (GDP) will rise from 100 percent in 2025 to 156 percent by 2055. CBO attributes this increase to sustained annual deficits and growing interest payments on the debt. CBO also projects that annual deficits will widen from 6.2 percent of the GDP in 2025 to 7.3 percent by 2055. Additionally, the report states that the Social Security trust fund is expected to be depleted by 2033, which is consistent with CBO’s previous projections and would reduce the program's ability to pay full benefits. CBO also expects a significant increase in interest costs, which may surpass the overall rate of economic growth by 2045.
- On March 24, 2025, the Kaiser Family Foundation (KFF) released a report entitled, Putting $880 Billion in Potential Federal Medicaid Cuts in Context of State Budgets and Coverage. This report examines the implications of proposed reductions in federal Medicaid spending totaling $880 billion over the next decade. These reductions, outlined in the House budget resolution, would represent 29 percent of state-financed Medicaid spending per resident, equivalent to 6 percent of state tax revenues per resident. The report states that, following the reduced federal Medicaid payments, states may raise taxes, cut other programs like education, or reduce Medicaid coverage, benefits, or provider payments in an effort to offset lost revenue. The report also states that, in total, the reduced payments are equivalent in value to Medicaid spending on 18 percent of senior and disabled enrollees, 38 percent of other adult enrollees, or 76 percent of child enrollees.
3. Hearings & Markups
- On March 24, 2025, the House Veterans’ Affairs Committee, Subcommittee on Technology Modernization, held a hearing entitled, Closing the Data Gap: Improving Interoperability Between VA and Community Providers. Witnesses included: Dr. Jonathan Nebeker, M.D., Chief Medical Informatics Officer & Executive Director of Clinical Informatics, Veterans Health Administration, U.S. Department of Veterans Affairs; Dr. Laura Prietula, Ed.D., Deputy Chief Information Officer, Electronic Health Record Modernization Integration Office, U.S. Department of Veterans Affairs; Mr. Rick McGraw, Chief Growth Officer, Michigan Health Information Network Shared Services; Dr. Andrew Rosenberg, M.D., Chief Information Officer, Michigan Medicine; and Dr. Leo Greenstone, M.D., Chief Medical Officer, Signature Performance.
- On March 25, 2025, the Senate Finance Committee held a hearing entitled, Hearing to consider the nomination of Frank Bisignano, of New Jersey, to be Commissioner of the Social Security Administration. Frank Bisignano, Chairman and Chief Executive Officer (CEO) of Fiserv, was the only witness.
- On March 25, 2025, the House Veterans’ Affairs Committee, Subcommittee on Health, held a mark-up session to discuss the following bills:
- H.R. 217, CHIP IN for Veterans Act;
- H.R. 1969, No Wrong Door for Veterans Act;
- H.R. 1971, Veterans Supporting Prosthetics Opportunities and Recreational Therapy (SPORT) Act;
- H.R. 1823, The VA Budget Accountability Act;
- H.R. 1107, The Protecting Veteran Access to Telemedicine Services Act;
- H.R. 1336, The Veterans National Traumatic Brain Injury Act;
- H.R. 658, To amend title 38, United States Code, to establish qualifications for the appointment of a person as a marriage and family therapist, qualified to provide clinical supervision, in the Veterans Health Administration;
- H.R. 1644, Copay Fairness for Veterans Act; and
- H.R. 1860, The Women Veterans Cancer Care Coordination Act.
- On March 25, 2025, at 2:30 PM, the House of Representatives' Veterans’ Affairs Committee, Subcommittee on Health, held a hearing entitled, Breaking Down Barriers: Getting Veterans ACCESS to Lifesaving Care. Witnesses included: Ms. Missy Jarrott, Mother of Navy Veteran Landon Holcomb; Mr. Michael Urban, LCSW, Army Veteran and Mental Health Advocate; Dr. Shankar Yalamanchili, CEO, River Region Psychiatry Associates; Ms. Maria D. Llorente, Acting Undersecretary for Health, Office of Integrated Veterans Care, Veterans Health Administration, U.S. Department of Veterans Affairs; and Dr. Ilse Wiechers, Deputy Director, Office of Mental Health, Veterans Health Administration, U.S. Department of Veterans Affairs.
- On March 26, 2025, the House of Representatives' Energy and Commerce Committee, Subcommittee on Commerce, Manufacturing, and Trade, held a hearing entitled, The World Wild Web: Examining Harms Online. Witnesses included: Ms. Dawn Hawkins, Senior Advisor, National Center on Sexual Exploitation; Ms. Yiota Souras, Chief Legal Officer, National Center for Missing and Exploited Children; Ms. Clare Morell, Fellow, Ethics and Public Policy Center; and the Honorable Kelly Slaughter, Former Commissioner, Federal Trade Commission.
4. Other Health Policy News
- On March 27, 2025, HHS announced that it would be undergoing a significant workforce reduction alongside a number of additional administrative and organizational changes. HHS plans to terminate an additional 10,000 full-time employees, which would ultimately reduce HHS to 62,000 full-time employees from a pre-Administration level of 82,000. Of the 10,000 employees, 3,500 will come from FDA, 1,400 will come from the current CDC, 1,200 will come from NIH, and 300 will come from CMS. According to HHS, this reduction will lower costs by $1.8 billion per year.
- HHS also announced plans to consolidate its 28 divisions into 15 divisions and reduce the number of regional offices from 10 to 5. Notably, the Office of the Assistant Secretary for Health (OASH), HRSA, the Substance Abuse and Mental Health Services Administration (SAMHSA), the Agency for Toxic Substances and Disease Registry (ATSDR), and the National Institute for Occupational Safety and Health (NIOSH) will all be consolidated into a new division, the Administration for a Healthy America (AHA). Additionally, the Administration for Strategic Preparedness and Response (ASPR) will be moved into CDC, and programs from the Administration for Community Living (ACL) will be moved under the Administration for Children and Families, the Assistant Secretary for Planning and Evaluation (ASPE), and CMS. The press release from HHS announcing these changes can be found here, and a fact sheet on the proposed changes can be found here.
- On Tuesday, March 25, 2025 the Senate confirmed Marty Makary, M.D., to be the next FDA Commissioner by a vote of 56-44, and Jay Bhattacharya, M.D., Ph.D., to be the next NIH by a party-line vote of 53-47.Also on March 25, 2025 Mehmet Oz, M.D., the nominee to be CMS Administrator was reported favorably by the Senate Committee on Finance by a party-line vote of 14-13. Finally, the Trump Administration announced that it was nominating Susan Monarez, Ph.D., to be the next CDC Director. Dr. Monarez is replacing Dave Weldon, M.D., whose nomination suddenly collapsed after reported pushback from some Republican senators due to Dr. Weldon’s past comments on vaccine safety and in light of an ongoing measles outbreak that has resulted in at least two deaths. Dr. Monarez is the current acting director of CDC, a role she has been in since President Trump’s inauguration. Prior to this, Dr. Monarez was the Deputy Director of the Advanced Research Projects Agency for Health (ARPA-H) at NIH and had also held a number of roles with HRSA, the Department of Homeland Security, the National Security Council, and the Office of Science and Technology Policy. Dr. Monarez is notable for being the first non-physician to be tapped to lead the CDC in over 50 years – instead she has a Ph.D. in microbiology and a background in biosecurity. Her hearing before the Senate Committee on Health, Education, Labor, and Pensions has yet to be announced.
- On March 27, 2025, Representatives Mark Green (R-TN-07), Kim Schrier (D-WA-08), and Greg Murphy (R-NC-03) re-introduced H.R.2433, the Reducing Medically Unnecessary Delays in Care Act of 2025. This bill aims to improve the prior authorization process in the Medicare and Medicare Advantage (MA) programs by clarifying rules around “medically necessary” care. The bill would require that all prior authorization decisions are reviewed by a board-certified physician in the relevant specialty and that MA and Medicare Part D plans disclose their standards for medical necessity, which must be based upon written clinical guidelines and published on their website. The bill also would require that MA and Medicare Part D plans disclose statistics on prior authorization denials, including the medical specialty, medication or procedure requested, and reasons for denial. The full bill can be viewed here.
5. Additional Alston & Bird Publications
- We maintain an online tracker for all executive orders issued by the Trump Administration, which is updated daily and can be found here.
View our Health Care Legislative & Public Policy team.
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