Health Care Week in Review: President Trump Issues a Series of Executive Orders; Senate Committees Announce Hearing Dates for HHS Secretary Nominee Robert F. Kennedy, Jr.

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.

Week in Review Highlight of the Week:

This week, President Donald Trump issued a series of executive orders following his inauguration and the Senate Committees overseeing HHS Nominee Robert F. Kennedy, Jr.’s nomination announced the dates of his hearings.

I. Regulations, Notices & Guidance

• On January 20, 2025, the White House issued an executive order entitled, Regulatory Freeze Pending Review. This executive order directs all executive departments and agencies to: 1) not propose or issue any rule in any manner, including by sending a rule to the Office of the Federal Register (the “OFR”), until a department or agency head appointed or designated by the President after noon on January 20, 2025, reviews and approves the rule. 2) Immediately withdraw any rules that have been sent to the OFR but not published in the Federal Register, so that they can be reviewed and approved as described above. 3) Consistent with applicable law and subject to the exceptions described above, consider postponing for 60 days from January 20, 2025, the effective date for any rules that have been published in the Federal Register, or any rules that have been issued in any manner but have not taken effect, for the purpose of reviewing any questions of fact, law, and policy that the rules may raise. As a result, a number of notices, regulations, and guidance that were publicly noticed on January 21, 2025, have been withdrawn.
• On January 21, 2025, the Food and Drug Administration (FDA) released guidance entitled, Bioanalytical Method Validation for Biomarkers: Guidance for Industry. This guidance helps sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications (BLAs), and NDA and BLA supplements as well as abbreviated new drug applications (ANDAs), as applicable, to validate bioanalytical methods used to evaluate biomarker concentrations.  This guidance can also inform the development of bioanalytical methods used for the analysis of biomarker concentrations in nonclinical study samples.
• On January 24, 2025, FDA released a notice entitled, Nonprescription Drug Product with an Additional Condition for Nonprescription Use. This notice indicates that, in accordance with the memorandum of January 20, 2025, from the President, entitled Regulatory Freeze Pending Review, the effective date of the final rule, entitled “Nonprescription Drug Product With an Additional Condition for Nonprescription Use,” (ACNU) is delayed until March 21, 2025.
• On January 24, 2025, the Occupational Safety and Health Review Commission (OSHRC) released a notice entitled, Senior Executive Service Performance Review Board Membership; Withdrawal. This notice indicates that, in compliance with the Presidential Action of January 20, 2025, Restoring Accountability for Career Senior Executives, OSHRC is withdrawing its notice published in the Federal Register on January 21, 2025, concerning the appointment of members to the agency’s Performance Review Board (PRB): Cynthia L. Attwood, Chairman.

Event Notices—NOTE: Due to an HHS communications freeze, many of these meetings have been cancelled or postponed. We are continuing to monitor.

January 27, 2025: The National Institutes of Health (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.

January 28, 2025: NIH announced a meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. This is an in-person meeting open the public.

January 28, 2025: NIH announced a meeting of the National Advisory Council for Nursing Research. This is an in-person meeting open to the public.

January 29-30, 2025: The Health Resources and Services Administration (HRSA) announced a meeting of the Advisory Commission on Childhood Vaccines. This is a virtual meeting open to the public.

February 5, 2025: FDA announced a joint public meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. This is a hybrid meeting open to the public.

February 6, 2025: The Centers for Medicare & Medicaid Services (CMS) announced a meeting of the Advisory Panel on Outreach and Education (APOE). This is a virtual meeting open to the public.

February 10, 2025: NIH announced a meeting of the National Advisory Council for Human Genome Research. This is a virtual meeting open to the public.

February 11-12, 2025: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Association of Public Health Laboratories (APHL) entitled, Establishing a Road Map for Accelerated Diagnosis and Treatment of HCV Infection in the United States. This is a virtual meeting open to the public.

February 13-14, 2025: HRSA announced a meeting of the Advisory Committee on Heritable Disorders in Newborns and Children. This is a virtual meeting open to the public.

February 25, 2025: CDC announced a meeting of the Advisory Board on Radiation and Worker Health. This is a hybrid meeting open to the public.

February 25, 2025: FDA announced a public workshop entitled, Cell Therapies and Tissue-Based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development. This is a virtual workshop open to the public.

February 26-28, 2025: CDC announced a meeting of the Advisory Committee on Immunization Practices (ACIP). This is a virtual meeting open to the public.

March 5-6, 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.

March 27-28, 2025: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD). This is a hybrid meeting open to the public.

March 27-28, 2025: FDA announced a public workshop entitled, Optimizing Pregnancy Registries. This is an in-person workshop open to the public.

April 3, 2025: 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 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 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.

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.

August 6-7, 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.

August 8, 2025: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD). This is a hybrid meeting open to the public.

September 11-12, 2025: HRSA announced a meeting of the Council on Graduate Medical Education (COGME). This is a hybrid meeting open to the public.

December 4-5, 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.

II. Hearings & Markups

• On January 20, 2025, the Senate Homeland Security and Governmental Affairs Committee held a hearing entitled, Nomination of Kristi Noem. Governor Kristi Noem was the only witness.
• On January 21, 2025, the Senate Veteran’s Affairs Committee held a hearing entitled, Nomination of the Honorable Douglas A. Collins to be Secretary of Veterans Affairs. Mr. Douglas Collins was the only witness.
• On January 21, 2025, the Senate Health, Education, Labor, & Pensions (HELP) Committee held an executive session entitled, Starting the 119th Congress.
• On January 22, 2025, the Senate Budget Committee held a hearing entitled, The Nomination of the Honorable Russell T. Vought, of Virginia, to be Director of the Office of Management and Budget. The Mr. Russell Vought was the only witness.
• On January 22, 2025, the House Veterans’ Affairs Committee held an oversight hearing entitled, Restoring Focus: Putting Veterans First in Community Care.

III. Reports, Studies, & Analyses

• On January 16 through 17, 2025, the Medicare Payment Advisory Commission (MedPAC) held its January 2025 Public Meeting. The first session of the meeting was entitled Assessing payment adequacy and updating payments: Physician and other health professional services. The Commission summarized previously presented data on whether Medicare payments to physicians and other health professionals were adequate to maintain beneficiary access to care. In light of this review, MedPAC staff brought forth a draft recommendation that Congress should, for calendar year (CY) 2026, update the 2025 Medicare base payment rate for physician and other health professional services by the projected increase in the Medicare Economic Index (MEI) minus one percentage point, and enact the Commission’s March 2023 recommendation to establish safety-net add-on payments under the Physician Fee Schedule (PFS) for services delivered for low-income Medicare beneficiaries. The draft recommendation received unanimous support with Commissioners specifically praising the safety-net add-on payments aspect of the recommendation. A transcript of the meeting is available here. Slides from the session are available here.
• On January 16, 2025, MedPAC held its second session of the meeting entitled, Assessing payment adequacy and updating payments: Hospital inpatient and outpatient services. The Commission summarized previously presented data on whether Medicare’s fee-for-service (FFS) payment policies for hospitals were adequate to maintain beneficiaries’ access to care, maintain high quality of care, and have adequate access to capital.  In light of this review, MedPAC staff brought forth a recommendation that Congress should, for fiscal year (FY) 2026, update the 2025 Medicare base payment rates for general acute care hospitals by the amount specified in current law plus one percent, distribute existing disproportionate share hospital (DSH) and uncompensated care payments through the Medicare Safety-Net Index (MSNI), and add $4 billion to the MSNI pool. The draft recommendation received broad support, especially the MSNI aspect of the draft recommendation. Additionally, some Commissioners voiced concern about the lack of site neutral payments and the growth of the 340B Drug Pricing Program (340B Program) and expressed support for future work in these areas. Two Commissioners opposed the recommendation primarily because of the blended nature of the draft recommendation, which uniformly covers both the Inpatient Prospective Payment System (IPPS) and the Outpatient Prospective Payment System (OPPS). The Commission voted 15 to 2 to adopt the draft recommendation. A transcript of the meeting is available here. Slides from the session are available here.
• On January 16, 2025, MedPAC held its third session of the meeting entitled, Assessing payment adequacy and updating payments: Skilled nursing facility services; home health agency services; inpatient rehabilitation facility services; outpatient dialysis services; and hospice services. The Commissioners reviewed previous assessments on the payment adequacy of post-acute care services, including those provided by skilled nursing facilities (SNFs), home health agencies, inpatient rehabilitation facilities (IRFs), outpatient dialysis providers, and hospice care providers. In light of this review, MedPAC staff brought forth a recommendation that Congress should, for FY 2026, reduce the base payment rate for SNFs by 3 percent, the base payment rate for IRFs by 7 percent, and eliminate the update for base payment rates for hospice services, as well as, for CY 2026, reduce the base payment rate for home health agencies by 7 percent and update the base payment rate for outpatient dialysis services by the amount determined under current law. The Commissioners provided brief remarks and voted on each recommendation. All recommendations were supported unanimously except for the recommendation on outpatient dialysis services, during which two Commissioners abstained. A transcript of the meeting is available here. Slides from the session are available here.
• On January 16, 2025, MedPAC held its fourth session of the meeting entitled, Eliminating Medicare’s coverage limits on stays in freestanding inpatient psychiatric facilities. MedPAC staff presented on their recent analyses that found that a large majority of the 50,000 Medicare beneficiaries near the 190-day lifetime coverage limit for stays at freestanding inpatient psychiatric facilities (IPFs) had a disability or were low-income, and that about half lacked alternative means for paying for IPF stays beyond FFS. Staff found that this led to considerable difficulty for both freestanding and hospital-based IPFs to manage patients who required long-term care, and that, based upon unadjusted data, nearly 29 percent of beneficiaries discharged to their communities had an emergency department visit within 30 days. In light of this review, MedPAC staff brought forth a recommendation that Congress should eliminate the 190-day limit on freestanding IPF days, as well as the reduction in the number of available IPF days during the initial benefit period if a new beneficiary used a freestanding IPF in the 150 days before enrollment. Staff said they projected this recommendation, if implemented, to increase the amount of FFS spending by about $40 million in the first year. The Commissioners enthusiastically endorsed these recommendations, citing the vulnerability of the beneficiaries affected and the outdated nature of the policy, and unanimously voted to approve them. A transcript of the meeting is available here. Slides from the session are available here.
• On January 16, 2025, MedPAC held its fifth session of the meeting entitled, Medicare prescription drug program (Part D): Status report. The Commissioners reviewed the annual status report on Medicare’s Part D program, which included the latest data on enrollment, plan offerings, premiums, and utilization. The discussion highlighted significant upcoming changes to the program in 2025 and beyond. Commissioners discussed the decline in freestanding Prescription Drug Plans (PDPs), the role of rebates in market destabilization, and the challenges of maintaining competition against $0 premium Medicare Advantage (MA) plans. Commissioners emphasized the need to monitor the implementation of the Inflation Reduction Act of 2022 (IRA) and its effects on drug markets, benefit design, and risk adjustments. Chair Michael Chernew highlighted the session's purpose as a status update, encouraging a holistic view of the system's design and thoughtful prioritization of future efforts. A transcript of the meeting is available here. Slides from the session are available here.
• On January 17, 2025, MedPAC held its seventh session during its January 2025 Public Meeting entitled, The Medicare Advantage program: Status report. During this session, staff presented on changes to enrollment, vertical integration, rebate value, and spending in the MA program. In particular, staff presented an analysis of discrepancies in spending between the MA program and FFS. Staff identified differences in coding intensity and favorable selection between the two programs as the primary drivers of increased spending in MA relative to FFS. They noted that, given these discrepancies and increasing MA enrollment, MA payments are projected to be $84 billion higher than FFS payments for enrolled beneficiaries in 2025. The majority of Commissioners expressed concern about this increase in relative spending, suggesting that FFS beneficiaries were subsidizing the supplemental benefits in MA plans and asking whether there were more effective ways to spend this money. Some Commissioners questioned the accuracy of these projections, noting that MA plans have a higher enrollment of beneficiaries who are low-income, have a chronic disease, or are a member of a racial or ethnic minority group, factors traditionally associated with poor health outcomes and higher costs. The Commissioners also discussed the differences between plan spending and plan value. A transcript of the meeting is available here. Slides from the session are available here.

IV. Other Health Policy News

• On January 20, 2025, Donald Trump was sworn in as the 47th President of the United States, beginning his second term. Shortly after taking office, President Trump issued a series of executive orders, the most notable of which was the recission of 78 executive orders from the Biden Administration, as well as a regulatory freeze on proposed and final regulations not posted to the Federal Register.
• Among the rescinded executive orders was the Biden Administration’s order outlining the federal government’s approach to “responsible” artificial intelligence (AI), an order for three new drug pricing model pilot programs under the Center for Medicare and Medicaid Innovation (CMMI), and a set of orders addressing the COVID-19 pandemic, some of which still called for the support of organizations treating individuals affected by COVID-19 and research into new therapeutics and long-term COVID-19 patient health.
• Other executive orders issued by President Trump include providing notice of the United States’ intent to withdraw from the World Health Organization (WHO), ending the use of Diversity, Equity, and Inclusion (DEI) practices in federal hiring processes as well as eliminating federal rules and advisories which include DEI. Also, the President’s border security executive order revokes a Biden Administration executive order that listed hospitals among the ‘sensitive’ areas protected from Immigration and Customs Enforcement (ICE) and Customs and Border Protection (CBP) enforcement actions. A full list of the Trump Administration’s executive orders can be found here.
• The Senate Finance Committee and Senate HELP Committee have announced confirmation hearings for Robert F. Kennedy Jr., President Trump’s nominee for Secretary of the Department of Health and Human Services (HHS). The Finance Committee, chaired by Senator Mike Crapo (R-ID), will hold its hearing on January 29, 2025. The HELP Committee, led by Senator Bill Cassidy (R-LA), is scheduled to follow on January 30, 2025.
• Kennedy, an environmental attorney and advocate for holistic health, has outlined priorities that include addressing the nation’s chronic disease burden through preventive care and integrating alternative and holistic health approaches into federal health programs. He has expressed a desire to reduce reliance on pharmaceuticals, instead focusing on diet, exercise, and other non-traditional therapies to improve public health outcomes. Supporters of Kennedy’s nomination have praised his commitment to preventive care and environmental health, while critics have raised concerns about his past anti-vaccine activism and its implications for public health.
• The Committees will review Kennedy’s qualifications to oversee programs such as Medicare and Medicaid, as well as examine his broader vision for public health and healthcare reform. Both hearings are expected to include rigorous questioning from lawmakers, with Committee members scrutinizing Kennedy’s views and priorities. A media advisory released by Senate Finance Committee is available here.

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