Health Care Week in Review | Senate Holds Hearings for NIH and FDA Nominees; CMS, HRSA, and SAMHSA Advise Against Forms of Gender-Affirming Care

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, the Senate held hearings for the Trump Administration’s nominees to lead the NIH and FDA and several HHS agencies released notices that they will review policies, grants, and programs involving certain forms of gender-affirming care.

I. Regulations, Notices & Guidance

• On March 1, 2025, EOP released an executive order (EO) entitled, Designating English as the Official Language of The United States. This EO designates English as the official language of the United States. It revokes Executive Order 13166, which directed agencies to take actions to improve access to services for persons with limited English proficiency, but does not mandate any changes to existing services provided in other languages. The EO also clarifies that agency heads retain discretion to continue offering multilingual services as necessary to fulfill their missions.
• On March 4, 2025, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Advisory Committee on Immunization Practices; Cancellation of Meeting. This notice was released to notify the public that the February 26-28, 2025 meeting of the Advisory Committee on Immunization Practices (ACIP) was cancelled, will be rescheduled, and will accommodate a new public comment period in advance of the rescheduled meeting.
• On March 4, 2025, the Centers for Medicare & Medicaid Services (CMS) released a Center Information Bulletin (CIB) entitled, Rescission of Guidance on Health-Related Social Needs. To evaluate policy options consistent with Medicaid and Children’s Health Insurance Program (CHIP) requirements and objectives, CMS is rescinding the November 16, 2023 and December 10, 2024 CIBs both entitled “Coverage of Services and Supports to Address Health-Related Social Needs in Medicaid and the Children’s Health Insurance Program.” CMS will consider states’ applications to cover these services and supports on a case-by-case basis to determine whether they satisfy federal requirements for approval under the applicable provisions of the Social Security Act and implementing federal regulations, without reference to the November 2023 and December 2024 CIBs or the “health-related social needs” framework.
• On March 6, 2025, the Food and Drug Administration (FDA) released a notice entitled, Notice of the Denial of a Hearing Request Regarding a Proposal to Refuse to Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon). FDA is announcing the decision to deny a request for a hearing regarding the proposal of the Center for Drug Evaluation and Research (CDER) to refuse to approve the supplemental new drug application (sNDA) 205677-012, submitted by Vanda Pharmaceuticals, Inc., for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), for the treatment of insomnia characterized by difficulties with sleep initiation. The decision, which also refuses approval of sNDA 205677-012, is available in docket number FDA-2022-N-2390.
• On March 6, 2025, the Health Resources and Services Administration (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 Act, as amended. While the Secretary of Health and Human Services (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.
• On March 6, 2025, EOP released notice of an EO entitled, Further Amendment to Duties Addressing the Synthetic Opioid Supply Chain in the People’s Republic of China. This EO amends the duties imposed on products of the People’s Republic of China identified in EO 14195 from ten percent to twenty percent.
• On March 7, 2025, the Agency for Healthcare Research and Quality (AHRQ) released a notice entitled, Request for Information Regarding Diagnostic Excellence Measurement; Reopening of Comment Period. AHRQ invites public comment on the development of measures of diagnostic excellence that may be calculated using administrative data or electronic health record (EHR) data. The purpose of diagnostic excellence measurement is to identify potential opportunities to improve the diagnostic process at a health system or geographic level. AHRQ welcomes comments on the importance and usability of existing measures and those that may be under development. Comments must be received by March 10, 2025.

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

• 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 2, 2025: 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 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 NACNEP. This is a hybrid meeting open to the public.
• August 8, 2025: HRSA announced a meeting of ACTPCMD. 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.

II. Hearings & Markups

• On March 5, 2025, the House Science, Space, and Technology Committee, Investigations and Oversight Subcommittee held a hearing entitled, Assessing the Threat to U.S. Funded Research. Witnesses included: Mr. Jeffrey Stoff, President, Center for Research Security & Integrity; Mr. John F. Sargent Jr., Retired, Specialist in Science and Technology Policy, Congressional Research Service; and Dr. Maria Zuber, E.A. Griswold Professor of Geophysics and Presidential Advisor for Science and Technology Policy, Massachusetts Institute of Technology.
• On March 5, 2025, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a hearing entitled, Hearing to Examine the Nomination of Jayanta Bhattacharya, of California, to be Director of the National Institutes of Health. Dr. Jayanta Bhattacharya was the only witness.
• On March 6, 2025, the Senate HELP Committee held a hearing entitled, Hearing to Examine the Nomination of Martin Makary, of Virginia, to be Commissioner of Food and Drugs. Dr. Martin Makary was the only witness.

III. Reports, Studies, & Analyses

• On March 5, 2025, the Congressional Budget Office (CBO) released a letter addressed to Rep. Brendan Boyle (D-PA-02) and Rep. Frank Pallone (D-NJ-06), the Ranking Members of the House Committee on the Budget and House Committee on Energy and Commerce, respectively, regarding “Mandatory Spending Under the Jurisdiction of the House Committee on Energy and Commerce (E&C).” In its letter, CBO notes that, over the next ten years, mandatory spending outlays for programs under E&C jurisdiction total $8.8 trillion, and that 93 percent of these funds are attributable to Medicaid. With Medicaid removed, the total outlays are $581 billion. If the Children’s Health Insurance Program is also removed, mandatory spending outlays total $381 billion. Rep. Boyle and Rep. Pallone requested this information in an effort to demonstrate that the budget resolution passed by the House on February 25, 2025, which calls for E&C to reduce the deficit of programs under its jurisdiction by $880 billion, is impossible to meet without some reductions in Medicaid spending. The full letter from CBO can be found here.

IV. Other Health Policy News

• On March 5, 2025, the Senate HELP Committee held a confirmation hearing for Dr. Jay Bhattacharya to be Director of the NIH. Dr. Bhattacharya, a health economist and professor of medicine at Stanford University, emphasized during the hearing that he would support efforts to increase funding on chronic disease research, create a culture of dissent and free speech within the agency, advance reforms that would ensure scientific studies are more robust, fund innovative research, and to ensure that NIH properly regulates research that has the potential to cause a pandemic. Democrats on the Committee repeatedly asked Dr. Bhattacharya about his position on the agency’s recent proposal to cap indirect cost rates for NIH grants and the Trump Administration’s announcement that it stopped $65 million in funding for Alzheimer’s disease research. Democrats on the Committee also voiced concern for cuts and layoffs that have recently occurred at the agency. Some Republicans echoed these concerns, especially regarding the cap on indirect cost rates and Alzheimer’s disease research. On the other hand, Republicans on the Committee emphasized about the need for NIH to be more streamlined; to improve the public trust in scientific research, especially following the COVID-19 pandemic; and to promote funding research on chronic diseases. Next Thursday, March 13, 2025, the HELP committee is scheduled to hold a vote on advancing Dr. Bhattacharya’s nomination to the full Senate. More information on the hearing can be found here.
• On March 6, 2025, the Senate HELP Committee held a confirmation hearing for Dr. Marty Makary to be the Commissioner of Food and Drugs. Members of both parties voiced concern regarding the transparency of the drug approval process and the recent cancelation of an upcoming meeting of a FDA vaccine advisory board. Democrats on the Committee noted their concern about potential conflicts of interest regarding Dr. Makary’s business relationships/investments, about maintaining access to mifepristone, and about recent cuts to the FDA led by the Department of Government Efficiency (DOGE). Republicans on the Committee asked Dr. Makary questions on a variety of topics and were generally supportive of Dr. Makary’s nomination. Dr. Makary emphasized repeatedly his alignment with Secretary Kennedy’s vision to reduce the burden of chronic disease but often did not commit to take any specific action when prompted to by Senators, including to maintain access to mifepristone and to reschedule a meeting of the FDA vaccine advisory board. Next Thursday, March 13, 2025, the HELP committee is scheduled to hold a vote on advancing Dr. Bhattacharya’s nomination to the full Senate. More information on the hearing can be found here.
• On March 5, 2025, the Centers for Medicare & Medicaid Services (CMS) issued an alert with the subject "Protecting Children from Chemical and Surgical Mutilation," advising hospital providers about the potential risks associated with certain medical interventions for gender dysphoria in children. In the alert, CMS states that there is a lack of robust evidence supporting these interventions and raises concerns about possible long-term harm, including sterilization, emphasizing the importance of adhering to the highest standards of care and scientific integrity. The agency also notes that other developed nations, such as the United Kingdom, Sweden, and Finland, have already taken steps to limit such practices. CMS also provides notice that the agency may begin taking steps to align agency policy, including CMS-regulated provider requirements and agreements, with “the highest-quality medical evidence in the treatment of the nation’s children.”
• Following the CMS alert, the Health Resources & Services Administration (HRSA) and Substance Abuse and Mental Health Services Administration (SAMHSA) issued similar alerts to stakeholders that they will review their policies, grants, and programs in light of the aforementioned CMS alert. HRSA specifically referenced that the agency will review its Children’s Hospitals Graduate Medical Education (CHGME) program for consistency with the CMS alert described above. Based on this review, HRSA explains that it may “re-scope, delay, or potentially cancel new grants in the future depending on the nature of the work and any future policy change(s) HRSA may make.” The alert from SAMHSA was more vague regarding specific programs, but did state that “SAMHSA…may begin taking steps in the future to appropriately update its policies to protect children from chemical and surgical mutilation…[including] re-scoping, delaying, or potentially cancelling new grants in the future depending on the nature of the work and any future policy change(s) SAMHSA may make.” The CMS alert can be viewed here.
• On March 3, 2025, HHS Secretary Robert F. Kennedy Jr. published an opinion piece with Fox News voicing his support for the measles, mumps, and rubella (MMR) vaccine in response to a measles outbreak in Texas. At the time of the op-ed’s release, the Texas outbreak had resulted in 146 confirmed cases and one fatality. In response, Secretary Kennedy stated that he has directed the CDC and the Administration for Strategic Preparedness and Response (ASPR) to collaborate closely with Texas health authorities and provide vaccines, therapeutic medications, and technical assistance in containing the outbreak. He also emphasized the importance of having healthcare providers, community leaders, and policymakers disseminate accurate information about vaccine safety and efficacy. The full op-ed can be viewed here.
• On March 3, 2025, HHS issued a policy statement entitled “Policy on Adhering to the Text of the Administrative Procedure Act (APA).” According to the statement, HHS will no longer follow the “Richardson Waiver,” which imposed additional procedural requirements, such as those around public notice and comment periods, on rules that were not included in the scope of the APA. Specifically, matters related to agency management, personnel, public property, loans, grants, benefits, or contracts, are exempt from the APA’s notice and comment procedures, unless otherwise required by law. However, since 1971 the Richardson Waiver had been HHS’ policy to follow notice and comment procedures for these matters regardless. By removing the Richardson Waiver, HHS says that it aims to enhance efficiency and reduce unnecessary burdens, while also adhering more closely to the APA’s provisions. By definition, Medicare and Medicaid payment rules qualify as those related to “benefits.” While the Medicare statute contains a requirement for full notice and comment procedures, the Medicaid statute does not, so there could be the potential for a lack of public comment periods for future Medicaid regulations. The full policy statement published to the Federal Register can be viewed here.

V. Additional Alston & Bird Publications

• On March 4, 2025, we released an advisory on the potential ramifications of HHS rescinding the Richardson Waiver, which can be found here.
• Also on March 4, 2025, we released an advisory on how the Trump Administration’s indirect cost guidance could impact NIH and other grant recipients, which can be found here.
• Finally, we maintain an online tracker for all executive orders issued by the Trump Administration, which is updated daily and can be found here.

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