Health Care Week in Review | Supreme Court Strikes Down Trump Administration Tariffs; NIH Director Named Acting 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. 

Regulations, Notices & Guidance

• On February 18, 2026, the Food and Drug Administration (FDA) released a final rule entitled, Revocation of Methods of Analysis Regulation. FDA is issuing a final rule to revoke the methods of analysis regulation, which describes an FDA policy to use certain methods of analysis for FDA enforcement programs when the method of analysis is not prescribed in a regulation. FDA is issuing this action because the existing regulation is no longer necessary.
• On February 18, 2026, FDA released a final rule entitled, Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community. FDA is issuing a final rule revoking the regulations entitled, Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community. FDA is taking this action because the regulations at 21 CFR part 26 have been superseded in part by the United States-European Union Amended Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs) that entered into force in 2017, are outdated, do not reflect current FDA practice, and are unnecessary.
• On February 18, 2026, FDA released a notice entitled, Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 065. FDA is announcing a publication containing modifications it is making to the list of standards recognized for use in premarket reviews. This publication will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
• On February 19, 2026, FDA released draft guidance entitled, Questions and Answers About Requirements for Additional Traceability Records for Certain Foods. The draft guidance answers questions about the final rule entitled, Requirements for Additional Traceability Records for Certain Foods, issued on November 21, 2022. The final rule established additional recordkeeping requirements for individuals who manufacture, process, pack, or hold foods FDA has designated for inclusion on the Food Traceability List (FTL). The draft guidance is intended to answer questions to facilitate industry’s understanding of the final rule.
• On February 20, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—October through December 2025. This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published in the three-month period, relating to the Medicare and Medicaid programs and other programs administered by CMS.

Event Notices

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

• February 23-24, 2026: The Department of Health and Human Services (HHS) announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.
• March 6, 2026: The National Institutes of Health (NIH) announced a meeting of the National Advisory Mental Health Council. This is a virtual meeting with some sessions open to the public.
• March 11-13, 2026: HHS announced the 2026 National Conference on Women’s Health. This conference is free and open to the public.
• March 12, 2026: FDA announced a meeting of the Vaccines and Related Biological Products Advisory Committee. This is a virtual meeting open to the public.
• March 19, 2026: NIH announced a meeting of the Board of Scientific Counselors of the National Cancer Institute. This is a hybrid meeting with some sessions open to the public.
• March 16, 2026: NIH announced a meeting of the National Cancer Advisory Board. This is a hybrid meeting with some sessions open to the public.
• March 18, 2026: NIH announced a meeting of the National Institute of Environmental Health Sciences. This is a hybrid meeting with some sessions open to the public.
• March 18, 2026: NIH announced a meeting of the National Advisory Mental Health Council. This is a virtual meeting open to the public.
• March 18, 2026: NIH announced a meeting of the National Cancer Institute Clinical Trials and Translational Research Advisory Committee.  This is a hybrid meeting open to the public.
• March 24, 2026: The Department of Veterans’ Affairs (VA) announced a meeting of its National Research Advisory Council. This is a hybrid meeting open to the public.
• March 25, 2026: NIH announced a meeting of the National Heart, Lung, and Blood Advisory Council. This is a hybrid meeting with some sessions open to the public.
• March 30-31, 2026: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting with some sessions open to the public.
• March 30-31, 2026: NIH announced a meeting of the National Institute on Aging. This is a hybrid meeting with some sessions open to the public.
• April 6, 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.
• April 7, 2026: NIH announced a meeting of the Advisory Committee on Research on Women’s Health. This is a hybrid meeting open to the public.
• April 9-10, 2026: NIH announced a meeting of the Sleep Disorders Research Advisory Board. This is a hybrid meeting open to the public.
• April 17, 2026: NIH announced a meeting of the National Center for Complementary & Integrative Health. This is a hybrid meeting with some sessions open to the public.
• April 23, 2026: 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 4-5, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting open to the public.
• May 5, 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.
• May 7, 2026: ASTP announced a meeting of the Health Information Technology Advisory Committee. This is a hybrid meeting open to the public.
• May 12, 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.
• May 13, 2026: NIH announced a meeting of the National Institute on Aging. This is an in-person meeting with some sessions open to the public.
• May 13, 2026: NIH announced a meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council. This is a hybrid meeting with some sessions open to the public.
• May 19, 2026: NIH announced a meeting of the National Advisory Council for Nursing Research. This is a hybrid meeting open to the public.
• June 1-2, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• June 2, 2026: NIH announced a meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. This is a hybrid meeting with some sessions open to the public.
• June 5, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting with some sessions open to the public.
• June 15-16, 2026: HHS announced a meeting of PTAC. This is a hybrid meeting open to the public.
• June 29, 2026: NIH announced a meeting of the National Cancer Advisory Board. This is a hybrid meeting with some sessions open to the public.
• July 8, 2026: 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 10-11, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• September 14-15, 2026: HHS announced a meeting of PTAC. This is a hybrid 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 24, 2026: The Assistant Secretary for Technology Policy (ASTP) announced a meeting of the Health Information Technology Advisory Committee. This is a virtual meeting open to the public.
• November 5, 2026: ASTP announced a meeting of the Health Information Technology Advisory Committee. This is a virtual meeting open to the public.
• December 8-9, 2026: HHS announced a meeting of PTAC. This is a hybrid meeting open to the public.

Reports, Studies & Analyses

• On February 19, 2026, the Government Accountability Office (GAO) released a report entitled, High Risk Research: HHS Should Publicly Share More Information on How Risk Is Assessed and Mitigated. The report examined the outcomes of gain-of-function research of concern and related risk mitigation strategies, as recently introduced legislation and executive actions have aimed to restrict or ban federal departments and agencies from conducting or funding such research. GAO reviewed literature and other sources published between 2019 and 2024; assessed HHS procedures for reviewing risks and risk mitigation strategies; examined federal policies and guidance for the oversight of higher-risk pathogen research; interviewed HHS officials; and interviewed biosafety and biosecurity experts who authored relevant articles and have experience with gain-of-function research of concern.
  
  The report found that gain-of-function research of concern has advanced scientific knowledge of how pathogens infect humans and transmit and cause disease. However, GAO noted that there is no broad consensus on the extent to which this research has led to the development of vaccines and therapeutics. Notably, there was broad consensus that this research can pose biosafety and biosecurity risks, as it can involve enhancing the transmissibility or virulence of pathogens that have the potential to cause widespread and uncontrollable disease, resulting in significant morbidity and mortality if they were to be accidentally or deliberately released. GAO recommended that HHS ensure that key information on its risk reviews of research involving pathogens is publicly shared, including steps taken to mitigate risk. HHS neither agreed nor disagreed with the recommendation, but noted it will work in the future to ensure public transparency about the scope of research involving higher-risk pathogens and actions taken to mitigate risks.

• On February 19, 2026, GAO released a report entitled, Private Health Insurance: Provider Participation and Payments for Selected Services Before and After the No Surprises Act. The report analyzed health insurance claims, focusing on four specialties most likely to be affected by the prohibition on balance billing enacted in the No Surprises Act . GAO examined trends in in-network claims and payments between 2019 and 2023 and interviewed representatives from 20 stakeholder groups, including specialty provider associations, issuers, and state insurance departments. Among specialties likely to be affected by the No Suprises Act, including emergency medicine, radiology, anesthesiology, and air ambulance, the percentage of in-network claims increased for three of the four specialties after the law took effect. Changes in payment rates for the selected services largely continued trends that existed prior to implementation of the law. For example, inflation-adjusted payments for in-network emergency medicine services billed by facilities increased in 2022 and 2023, consistent with trends since 2019. Moreover, inflation-adjusted payments for in-network emergency services billed by physicians or their practices decreased in 2022 and 2023, continuing previous trends. 

Other Health Policy News

• Federal funding for the Department of Homeland Security (DHS) expired on February 13, 2026, triggering a shutdown isolated solely to DHS activities. Most notably, this affects the Federal Emergency Management Agency (FEMA), the Transportation Security Administration (TSA), and the Coast Guard, all of which will continue operating essential functions without pay. The shutdown occurs as Democrats are engaged with ongoing negotiations with the White House and Republicans over reforms to the Trump Administration’s immigration enforcement practices. Democrats have asked for a prohibition on immigration raids at sensitive areas, including hospitals, as well as judicial warrants for all other raids. DHS operations will continue to operate under a shutdown until an agreement between the two parties is reached.

• On February 17, 2026, Senator Bill Cassidy (R-LA) released a report entitled, Patients and Families First: Building the FDA of the Future. The report argues that FDA’s current regulatory framework is unpredictable, fragmented, and poorly aligned with the pace of biomedical digital innovation. A central theme of the report is the need for more modern and flexible clinical evidence models. While FDA has recognized innovative trial designs, the report notes that the traditional clinical trial is evolving and that FDA “could do more to expand the use of novel trail designs and technologies to garner better data…and reduce costs.” This includes expanding digital health technologies and ensuring validation requirements are tailored to their actual risk.
  
  The report also highlights growing concerns around FDA’s approach to artificial intelligence (AI). It calls for a clear, risk-based framework, emphasizing that the agency should take a risk-based approach to regulating AI and provide broadly applicable guidance on AI use to avoid delays and provide FDA reviewers with the tools and expertise needed to oversee the deployment of AI-enabled technologies. Moreover, the report argues that outdated pathways for biologics and biosimilars hinder competition, noting the need for a new middle regulatory option. Additionally, the report calls for clearer premarket guidance and greater adoption of tools for medical device oversight. It cites that manufacturers report “delays, inconsistent review practices, and limited opportunities for real-time engagement with FDA reviewers,” which contributes to the “Valley of Death,” in which fewer than 10 percent of breakthrough-designated products reach market. The report calls for clearer premarket guidance and greater adoption of tools such as predetermined change control plans to keep pace with technologies that evolve rapidly.
  
  The full report can be found here. A press release can be found here.  

• On February 18, 2026, Democratic leaders of the House Energy & Commerce Committee sent a letter to HHS Secretary Robert F. Kennedy, Jr. regarding the cancelation of millions of dollars in health care funding in four Democratic-led states. The four affected states, including California, Colorado, Illinois, and Minnesota, sued HHS last week over the terminated grants. In the letter, Members stated that the decision to terminate the funding “threatens each of these states’ ability to respond to and prepare for public health emergencies.” When notifying Congress of the termination, HHS stated that the grants were inconsistent with agency priorities.
  
  The letter can be found here.

• On February 18, 2026, President Trump issued an Executive Order (EO) entitled, Promoting the National Defense by Ensuring an Adequate Supply of Elemental Phosphorus and Glyphosate-Based Herbicides. The EO promotes the domestic production of elemental phosphorus and glyphosate-based herbicides, citing that the materials are essential to military readiness and agricultural strength, respectively. The EO authorizes the Secretary of Agriculture, in consultation with the Secretary of War, to require the “performance of contracts or orders related to these materials to promote the national defense,” and to determine the “proper allocation of materials, services, and facilities to ensure adequate supply.” Supporters of the Make America Healthy Again (MAHA) agenda have criticized the EO, emphasizing that it promotes the production of harmful pesticides.
  
  The EO can be found here.

• On February 18, 2026, NIH Director Dr. Jay Bhattacharya was appointed as Acting CDC Director, while maintaining his current role. The announcement follows the departure of HHS Deputy Secretary Jim O’Neill, who was also serving as Acting CDC Director. Additionally, Secretary Kennedy announced that he was elevating the CMS Director for Medicare Chris Klomp to Chief Counselor for HHS, and CMS Chief Policy and Regulatory Officer John Brooks to Senior Counselor for CMS. Secretary Kennedy is also elevating Kyle Diamantas, Deputy Commissioner for Human Foods at FDA, and Grace Graham, Deputy Commissioner for Policy at FDA, to Senior FDA Counselor positions in his staff. Each of these individuals will also retain their current roles within CMS and FDA.
  
  
• In February 2026, the HHS Office of Inspector General (OIG) issued new Medicare Advantage Industry Segment-Specific Compliance Program Guidance (MA ICPG). The MA ICPG is OIG’s first update in 27 years to its 1999 Medicare+ Choice Compliance Program (1999 CPG). The new MA ICPG outlines seven compliance risk areas and provides corresponding recommendations for mitigation. While the MA ICPG carries forward many of the risk areas identified in the 1999 CPG, the updated guidance focuses even more on practices that support data accuracy. Medicare Advantage Organization (MAOs)—and what OIG more broadly defines as the “MA Parties,” meaning “the wide range of entities and individuals participating in or engaged with the [Medicare Advantage (MA)] program”—should use OIG’s roadmap to evaluate and update their compliance infrastructure to mitigate these risk areas. Companies may find that enforcement agencies are less forgiving about issues OIG explicitly highlights in the updated guidance.

  Additional information can be found in the Alston & Bird Health Care Advisory here.
  
  

• On February 20, 2026, the U.S. Supreme Court ruled in a 6-3 decision that the International Emergency Economic Powers Act (IEEPA) does not authorize the President to impose tariffs. The ruling effectively invalidates current tariff rates on countries like China, Canada, and Mexico, while also endangering the stability of trade deals that the Trump Administration negotiated with others, including the United Kingdom, the European Union, South Korea, and Japan. The Supreme Court did not address refunds of tariffs that have already been collected, which total approximately $170 billion, leaving that decision to be further deliberated by the lower court. When asked, President Trump expressed frustration that the Supreme Court did not address the refund issue, stating, “We’ll end up being in court for the next five years”.
  
  The Supreme Court’s decision only affects global tariffs established under IEEPA and does not address tariffs established on specific products under Section 232 of the Trade Expansion Act of 1962, which includes steel, aluminum, and automobiles. Pharmaceuticals, copper, semiconductors, critical minerals, and polysilicon are also being investigated by the Administration for a potential Section 232 tariff. President Trump has stated that he intends to pursue other authorities that permit him to establish tariffs on trading partners who threaten domestic industry, discriminate against U.S. businesses or commerce, or violate U.S. rights under a trade agreement. Using the authority granted to the President under Section 122 of the Trade Act of 1974, for example, he has stated he will impose a 10 percent global tariff rate, although this can only last for 150 days without Congressional approval. The President said the Section 122 tariffs would be effective starting Monday.  

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