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.
Highlight of the Week
This week, President Trump delivered the first State of the Union address of his second term and Vice President Vance and CMS Administrator Oz announced actions to address fraud, waste, and abuse in Medicare and Medicaid.
Regulations, Notices & Guidance
- On February 23, 2026, the Food and Drug Administration (FDA) released a notice entitled, Advisory Committee; Gastrointestinal Drugs Advisory Committee; Renewal. FDA is announcing the renewal of the Gastrointestinal Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Gastrointestinal Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until the March 3, 2028, expiration date.
- On February 23, 2026, the Health Resources and Services Administration (HRSA) released a notice entitled, Medical Student Education Program Non-Competitive Supplement; Correction. HRSA published a document in the Federal Register of December 2, 2025, concerning the Medical Student Education Program Non-Competitive Supplement. The document contained an incorrect project period. The project period in the notice stated July 1, 2026, to June 30, 2027, but should instead state July 1, 2025, to June 30, 2026.
- On February 23, 2026, the Department of Health and Human Services (HHS) released a notice entitled, Private Health Insurance; Transparency in Coverage; Extension of Comment Period. This document extends the comment period for the proposed rule that appeared in the Federal Register on December 23, 2025, entitled Transparency in Coverage. The comment period for the proposed rule, which would end on February 23, 2026, is extended until March 2, 2026.
- On February 23, 2026, FDA released guidance entitled, Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause. The draft guidance document describes considerations for generating substantial evidence of effectiveness and evidence of safety of individualized therapies based on a plausible mechanism framework.
- On February 25, 2026, HRSA released a notice entitled, Request for Information: 340B Rebate Model Pilot Program; Extension of Comment Period. HRSA is extending the comment period for Request for Information: 340B Rebate Model Pilot Program from 30 days to 60 days. The change will provide stakeholders additional time to submit meaningful comments for HRSA’s review in evaluating operational, financial, and potential impacts on access to drugs for patients under a rebate model.
- On February 25, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Request for Information: Comprehensive Regulations to Uncover Suspicious Healthcare. This request for information (RFI) solicits stakeholder feedback on potential regulatory changes that might be included in a potential upcoming Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH) proposed rule, as well as other programmatic changes that could be implemented to make CMS more effective in crushing fraud to protect taxpayer dollars and the Americans we serve.
- On February 25, CMS released a notice entitled, Medicare, Medicaid, and Children's Health Insurance Programs: Nationwide Temporary Moratoria on Enrollment of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Supplier Medical Supply Companies. This notice announces the imposition of a six-month nationwide moratorium on the Medicare enrollment of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) supplier medical supply companies.
- On February 26, 2026, FDA released a notice entitled, Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability. FDA is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled, Bioequivalence Recommendations for Specific Products, that explained the process that would be used to make product-specific guidances available to the public on FDA’s website. The draft guidances identified in this notice were developed using the process described in that guidance.
- On February 26, 2026, FDA released a notice entitled, International Drug Scheduling: Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Scheduling Recommendations; N-Pyrrolidino Isotonitazene; N-Desethyl Etonitazene; Coca Leaf; MDMB-FUBINACA. FDA is providing interested persons with the opportunity to submit written comments concerning recommendations to impose international manufacturing and distributing restrictions on certain drug substances, under international drug control treaties. The comments received in response to this notice will be considered in preparing the United States’ position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 9-13, 2026. This notice is issued under the Controlled Substances Act (CSA).
- On February 26, 2026, FDA released a notice entitled, Priority Review Voucher: Rare Pediatric Disease Product; Zycubo (Copper Histidinate). FDA is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that ZYCUBO (copper histidinate), approved January 12, 2026, manufactured by Sentynl Therapeutics Inc., meets the criteria for a priority review voucher.
Event Notices
Please note that two asterisks (**) preceding the item indicate a new event.
- 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: the Assistant Secretary for Technology Policy (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.
- **March 17, 2026: the Centers for Disease Control and Prevention (CDC) announced a meeting of the ICD-10 Coordination and Maintenance Committee. This is a virtual meeting open to the public.
- **March 18, 2026: CDC announced a meeting of the Advisory Committee on Immunization Practices (ACIP). This is a virtual meeting open to the public.
- **March 23, 2026: VA announced a meeting of the Veterans’ Rural Health Advisory Committee. This is a virtual meeting 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.
- **May 19, 2026: NIH announced a meeting of the Interagency Autism Coordinating Committee. 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 8-9, 2026: FDA announced a public workshop entitled, Fiscal Year 2026 Generic Drug Science and Research Initiatives Workshop. This is a hybrid meeting 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: 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 26, 2026, the RAND Corporation released a report entitled, State-Level Impacts of Key Medicaid Provisions in the One Big Beautiful Bill Act. The analysis examines how key Medicaid provisions in the One Big Beautiful Bill Act (OBBBA) are expected to affect state budgets and coverage between 2025 and 2034. The report states that most states will experience substantial Medicaid budget reductions—totaling an estimated $664 billion—while Medicaid enrollment is projected to decline by 7.6 million, primarily due to new work requirements, more frequent eligibility redeterminations, and restrictions on immigrant eligibility. States that rely heavily on provider taxes and state-directed payments, particularly large expansion states such as California and New York, face the largest fiscal losses, whereas several smaller or non-expansion states may see neutral or even positive effects due in part to the $50 billion Rural Health Transformation Program. Provisions limiting federal financing tools, such as constraints on provider taxes, state-directed payments, and emergency Federal Medical Assistance Percentage (FMAP), shift fiscal pressure to states and may prompt reductions in eligibility, services, or provider payment rates.
- On February 23, 2026, the Congressional Budget Office (CBO) released a report entitled, CBO's Updated Projections of the Hospital Insurance Trust Fund's Finances. The report includes updated projections on the financial outlook of Medicare’s Hospital Insurance (HI) Trust Fund. According to the report, the HI Trust Fund’s balance is expected to be exhausted in 2040, 12 years earlier than previously expected, with spending beginning to exceed income starting in 2032. CBO attributes the earlier date of exhaustion to decreased revenue from taxes on Social Security benefits, as implemented by the OBBBA. The analysis notes that, under current law, benefits would continue to be paid as scheduled even after depletion, though total payments would be limited to incoming revenue. CBO estimates that benefits may need to be reduced by eight percent in 2040, rising to 10 percent by 2056, and reports an actuarial deficit of 0.30 percent of taxable payroll over the next 25 years.
- On February 27, 2026, the Government Accountability Office (GAO) released a report entitled, Medicare Part D: Implementation of Beneficiary Premium Stabilization Demonstration. The report examines CMS’s implementation of the Medicare Part D Premium Stabilization Demonstration, a temporary initiative launched in 2025 to prevent premium increases for beneficiaries enrolled in standalone prescription drug plans. Without the demonstration, GAO found that average monthly premiums for enrollees remaining in their 2024 plans would have nearly doubled in 2025, with 37 percent of beneficiaries facing increases of more than $40—changes CMS expected would significantly disrupt enrollment and continuity of medication access. To avoid such disruption, CMS reduced 2025 premiums by up to $15 per enrollee and capped plan‑level premium increases at $35, while also offering financial protections for participating plan sponsors. The demonstration is expected to cost $9.8 billion across 2025 and 2026, and early data show average premiums rose only slightly—from $42 to $43—while enrollment in standalone plans increased by 2 percent. GAO notes that a formal evaluation will be needed to determine how much of these observed changes can be attributed to the demonstration itself versus other policy shifts, including those triggered by the Inflation Reduction Act’s redesign of the Part D benefit.
Hearings & Markups
- On February 24, 2026, the House Committee on Ways and Means held a hearing entitled, Health Subcommittee Hearing on Advancing the Next Generation of America’s Health Care Workforce. Witnesses present: Dr. Emily Hawes, Professor, University of North Carolina at Chapel Hill, and
Director, Sheps Graduate Medical Education Technical Assistance Center; Mr. Jason Shenefield, Chief Executive Officer, Phelps Health; Dr. Thomas Mohr, D.O., Dean, Sam Houston State University College of Osteopathic Medicine; Dr. Jennifer Trilk, Ph.D., Director, Lifestyle Medicine, University of South Carolina School of Medicine Greenville, and Co-founder and Director of Lifestyle Medicine Education; and Dr. Andrew Racine, President, American Academy of Pediatrics. - On February 25, 2026, the Senate Committee on Health, Education, Labor and Pensions (HELP) held a hearing entitled, Nomination of Casey Means to be Medical Director in the Regular Corps of the Public Health Service and Surgeon General of the Public Health Service. Dr. Casey Means was the sole witness.
- On February 26, 2026, the Senate Special Committee on Aging held a hearing entitled, From Regulator to Roadblock: How FDA Bureaucracy Stifles Innovation. Witnesses present: Ms. Annie Kennedy, Chief Mission Officer, EveryLife Foundation for Rare Diseases; Dr. Jeremy Schmahmann M.D., Director, Massachusetts General Hospital Ataxia Center; Mr. Bradley Campbell, President and CEO, Amicus Therapeutics; and Dr. Cara O'Neill M.D., F.A.A.P., Chief Science Officer and Co-Founder, Cure Sanfilippo Foundation.
- On February 26, 2026, the Senate HELP Committee held an executive session of the following legislation: S. 1602, Mathematical and Statistical Modeling Education Act (agreed to by roll call vote, 22-1); S. 3747, A bill to amend the Higher Education Act of 1965 to recognize students who have completed secondary school education in a home school setting as high school graduates, and for other purposes (agreed to by roll call vote, 23-0); S. 1552, Living Donor Protection Act of 2025 (agreed to by roll call vote, 22-1); and S. 3315, Health Care Cybersecurity and Resiliency Act of 2025 (agreed to by roll call vote, 22-1).
Other Health Policy News
- On February 24, 2026, President Trump delivered the State of the Union address. Of note, President Trump highlighted that insurance company stocks have soared in recent years and that he strongly prefers sending money directly to the public to purchase their own health care, possibly at a lower cost. President Trump embraced his “Great Healthcare Plan”, announced in January 2026, which calls on Congress to enact legislation to lower drug prices, lower insurance premiums, hold large insurance companies accountable, and maximize price transparency. President Trump also called on Congress to codify the Most Favored Nation (MFN) drug pricing agreements that the Administration made with certain pharmaceutical companies. He also touted TrumpRx, a recently launched website that helps individuals buy discounted drugs without using their insurance. Further, President Trump announced that Vice President JD Vance would lead an effort to combat fraud in taxpayer-funded programs, including Medicare and Medicaid.
The “Great Healthcare Plan” can be found here. A TrumpRx fact sheet can be found here. - On February 24, 2026, the House Ways & Means Committee Health Subcommittee held a hearing entitled, Advancing the Next Generation of America’s Health Care Workforce. The hearing focused on physician shortages, particularly in rural and underserved areas, and the role of Medicare graduate medical education (GME) in addressing these gaps. Members raised concerns that current GME financing and slot distribution favor large urban hospitals, limiting rural training capacity. Witnesses broadly agreed that physicians are more likely to practice where they train and urged Congress to better target Medicare-supported residency slots to rural settings and modernize outdated GME caps and payment structures. Witnesses also highlighted the importance of primary care, pediatrics, osteopathic and community-based training models, prevention- and lifestyle-focused education, and the use of telehealth and technology to support rural training. Some Members underscored the potential workforce impacts of Medicaid cuts, student loan caps, and H-1B visa policy changes, while other Members emphasized the redistribution of training slots and domestic workforce development. Overall, the hearing reflected recognition that reexamining how, where, and what physicians are trained is central to strengthening the health care workforce and improving access to care.
- On February 25, 2026, the Senate HELP Committee held a hearing entitled, Nomination of Casey Means to be Medical Director in the Regular Corps of the Public Health Service and Surgeon General of the Public Health Service. Senators examined Dr. Means’ views on chronic disease, vaccine policy, maternal and reproductive health, pediatric care, medical transparency, nutrition, environmental exposures, and digital and social media harms. Senators argued along party lines on matters including vaccines, Dr. Means’ alleged conflicts of interest, and federal health policy generally, while agreeing on certain areas of interest such as chronic disease prevention, nutrition, and youth mental health. Throughout her testimony, Dr. Means promoted a platform centered on addressing the “root causes” of chronic illness, improving metabolic health, expanding research into environmental and dietary contributors to disease, and rebuilding public trust in health care institutions.
More information on this hearing can be found here. Dr. Means’ testimony can be found here. - On February 25, 2026, Vice President Vance and CMS Administrator Mehmet Oz announced several actions to address Medicare and Medicaid fraud. These actions include: (1) deferring $259.5 million of quarterly federal Medicaid funding to Minnesota; (2) imposing a six-month moratorium on Medicare enrollment for certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers; and (3) implementation of the Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH) initiative.
During a press conference, Vice President Vance stated that the deferral of federal Medicaid funding to Minnesota will remain in effect until the state develops a new corrective action plan to address fraud in its Medicaid program. Administrator Oz later added that similar funding freezes may be announced for other states.
As part of the CRUSH initiative, CMS released a request for information (RFI) seeking stakeholder feedback on regulatory changes that could be included in a potential CRUSH proposed rule. The RFI also solicits input on additional programmatic changes that could be implemented to make CMS more effective in addressing fraud. Comments on the RFI are due by March 30, 2026.
The CMS press release can be found here. The CMS CRUSH webpage can be found here. The RFI can be found here.
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