Health Care Watch: February 21, 2026
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from February 15 – February 21. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
LEGISLATIVE UPDATE
House
On February 18, Energy & Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Ranking Member Diana DeGette (D-CO), and Oversight and Investigations Subcommittee Ranking Member Yvette Clarke (D-NY) sent a letter to U.S. Department of Health& Human Services (HHS) Secretary Robert F. Kennedy, Jr., requesting documentation and information regarding the termination of hundreds of millions of dollars in health care grants to recipients in California, Colorado, Illinois, and Minnesota. The lawmakers raised questions about the geographic concentration of the terminated grants and requested responses and records by March 4.
Senate
On February 17, Health, Education, Labor, and Pensions (HELP) Committee Chairman Bill Cassidy (R-LA) released a report titled Patients and Families: Building the FDA of the Future, outlining proposals to modernize the Food & Drug Administration (FDA). The report calls for eliminating red-tape and increasing predictability within FDA’s review processes, strengthening FDA’s Human Food Program to promote nutrition, encouraging U.S.-based clinical trials through improved Agency collaboration with developers, and establishing incentives to attract American scientists to work at the FDA.
On February 17, Sen. Rand Paul (R-KY) introduced legislation to amend the National Vaccine Injury Compensation Program (VICP) framework to allow individuals alleging vaccine injury to file civil lawsuits against vaccine manufacturers and administrators without first petitioning the federal vaccine court. The bill would modify the 1986 law establishing the VICP, which currently requires petitioners to exhaust remedies through the program before pursuing claims in state or federal court. The legislation would also remove COVID-19 vaccines from liability protections under the Public Readiness and Emergency Preparedness Act, allowing related injury claims to proceed in court.
REGULATORY UPDATE
On February 12, FDA published revised draft guidance describing the certification process for designated medical gases. The draft guidance outlines requirements for manufacturers seeking certification under provisions established by recent statutory changes. FDA is accepting public comments on the draft guidance.
On February 13, it was reported that staff at the National Institute of Allergy and Infectious Diseases (NIAID) were directed to remove references to “biodefense” and “pandemic preparedness” from the institute’s website.
On February 15, HHS Secretary Kennedy stated that he will respond to a citizen petition requesting that FDA reconsider the “Generally Recognized as Safe” status of certain ultra-processed food ingredients. Secretary Kennedy indicated that potential actions could include public education efforts regarding health risks associated with ultra-processed foods.
On February 17, Centers for Medicare & Medicaid Services (CMS) Administrator Dr. Mehmet Oz spoke at the Pharmaceutical Research and Manufacturers of America’s (PhRMA) annual forum. Dr. Oz stated that CMS will continue to provide insurance coverage for all vaccines recommended under the federal schedule and encouraged individuals to receive the measles vaccine amid rising infections. Dr. Oz also discussed ongoing drug pricing negotiations and encouraged industry participation in legislative efforts related to most-favored-nation pricing policies.
On February 18, HHS Secretary Kennedy appointed National Institutes of Health (NIH) Director Dr. Jay Bhattacharya as Acting Director of the Centers for Disease Control and Prevention (CDC) following the dismissal of Jim O’Neill. Administration officials stated that O’Neill will be nominated to lead the National Science Foundation. The leadership changes are part of a broader restructuring within HHS.
On February 18, FDA reversed its earlier decision on Moderna’s flu vaccine and has agreed to review it for possible approval. Moderna announced that FDA will review Moderna’s biologics license application for its mRNA seasonal influenza vaccine after declining to evaluate the submission earlier on February 10. Moderna amended its application to seek full approval for adults ages 50 to 64 and accelerated approval for adults 65 and older, with a post-marketing study requirement for the older population.
On February 18, ProPublica reported that FDA removed a webpage warning consumers about products marketed as treatments or cures for autism, including chelation therapies, hyperbaric oxygen treatments, chlorine dioxide, and raw camel milk.
On February 18, FDA Commissioner Dr. Marty Makary and Principal Deputy Commissioner Dr. Vinay Prasad indicated, via a New England Journal of Medicine column, that the FDA plans to adopt a “default requirement” of one pivotal study plus confirmatory evidence, rather than two, to support approval of new drugs and certain novel health products.
On February 18, FDA Commissioner Dr. Makary stated that he believes “everything should be over the counter” unless a drug is unsafe, addictive or requires monitoring. He indicated that FDA is updating OTC monographs through existing regulatory processes and reviewing certain prescription products for potential transition.
On February 19, Bloomberg reported that the Advisory Committee on Immunization Practices (ACIP) will delay its upcoming meeting, originally scheduled for next week, to mid-March. HHS spokesperson Andrew Nixon confirmed the delay, which occurs as a lawsuit challenging the committee’s validity is ongoing.
On February 19, FDA announced the appointment of Rick Abramson, a former health artificial intelligence executive, to lead its Digital Health Center. The agency stated that the leadership change is intended to support oversight of digital health technologies, including software and artificial intelligence-enabled medical products.
WHITE HOUSE
On February 13, Department of Government Efficiency (DOGE) publicly released a dataset containing nearly seven years of Medicaid spending data extracted from HHS systems. Specifically, the dataset contains provider-level Medicaid spending data aggregated from outpatient and professional claims with valid Healthcare Common Procedure Coding System (HCPCS) codes, covering January 2018 through December 2024.
On February 19, it was reported that the Trump administration is considering proposing developing a U.S.-led global disease surveillance and outbreak response system following the United States’ withdrawal from the World Health Organization (WHO). Administration officials indicated that the proposal would allocate approximately $2 billion annually to replicate laboratory networks, data-sharing systems, and rapid-response infrastructure previously accessed through WHO participation.
On February 20, the Supreme Court in a 6 to 3 decision invalidated Trump administration tariffs implemented using the International Emergency Economic Powers Act (IEEPA). The ruling blocks the Trump administration’s reciprocal tariffs and the tariffs imposed on Canada, China, and Mexico. The ruling does not impact sector-specific tariffs under Section 232 of the Trade Expansion Act of 1962, including potential Section 232 pharmaceutical tariffs that the Department of Commerce is considering.
On February 24, President Donald Trump will deliver the 2026 State of the Union Address to a joint session of Congress at 9:00 PM EST.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Amending the Indirect Hold Harmless Threshold of Health Care-Related Taxes (CMS-2452); Proposed Rule, 12/31/2025
Administrative Simplification: Adoption of Standards for Health Care Attachment Transactions and Electronic Signatures (CMS-0053); Final Rule, 01/09/26
Interoperability Standards and Prior Authorization for Drugs (CMS-0062); Proposed Rule; 01/16/2026
Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH) (CMS-6098); Notice; 01/16/2026
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term CareHospital Prospective Payment System; and FY 2027 Rates (CMS-1849); Proposed Rule; 01/22/2026
Independent Dispute Resolution Operations (CMS-9897); Final Rule; 01/29/2026
Strengthening Oversight of Accrediting Organizations (AO), Burden Reduction, and Related Provisions (CMS-3367); Final Rule; 02/04/2026
Contract Year 2027 Policy and Technical Changes to Medicare Advantage, Medicare Prescription Drug Benefit, Medicare Cost Plan, and Programs of All-Inclusive Care for the Elderly Programs (CMS-4212); Final Rule; 02/18/2026
FDA
Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern; Guidance for Industry; Notice; 7/10/25
Post approval Pregnancy Safety Studies; Guidance for Industry; Availability; Notice; 8/21/25
New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers; Draft Guidance for Industry; Availability; Notice; 12/01/25
Substances Generally Recognized as Safe; Proposed Rule; 12/01/25
Medical Devices with Indications Associated with Weight Loss--Premarket Considerations; Guidance for Industry and Food and Drug Administration Staff; Availability; Notice; 12/18/25
General Considerations for the Use of New Approach Methodologies; Draft Guidance for Industry; Availability; Notice; 01/09/25
Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry; Availability; Notice; 01/27/2026
E2D(R1) Postapproval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports; International Council for Harmonisation; Guidance for Industry; Availability; Notice; 02/11/2026
Developing Individualized Therapies Using a Plausible Mechanism Framework; Draft Guidance for Industry; Availability; Notice; 02/12/2026
Statement of Policy – Considerations for Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications; Draft Guidance for Industry; Notice; 02/18/2026
Establishment Registration and Product Listing for Tobacco Products; Proposed Rule; 02/19/2026
HEARINGS
House
Ways & Means Health Subcommittee
Advancing the Next Generation of America’s Health Care Workforce
February 24; 10:00 AM; 1100 Longworth
Witnesses: TBD
Budget Committee
The Congressional Budget Office’s Budget and Economic Outlook
February 24; 10:15 AM; 210 Cannon
Witness: Phillip Swagel, Director, Congressional Budget Office
Senate
HELP Committee
February 25; 10:00 AM; 430 Dirksen
Witness: Casey Means, MD
February 26; 10:00 AM; 430 Dirksen
Health care bills to be considered:
S. 1782, the Charlotte Woodward Organ Transplant Discrimination Prevention Act, which would prohibit discrimination on the basis of mental or physical disability in cases of organ transplants;
S. 1552, the Living Donor Protection Act of 2025, which would promote and protect living organ donors from discrimination; and
S. 3315, the Health Care Cybersecurity and Resiliency Act of 2025, which would improve cybersecurity in the health care and public health sectors, and for other purposes.
REPORTS
Office of Inspector General (OIG)
On February 17, HHS OIG released a memorandum titled Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the Third Quarter of 2025. OIG identified 11 drug codes that met CMS criteria for price substitution after exceeding the 5% threshold between average sales price (ASP) and average manufacturer price (AMP) for the required quarters and identified one additional drug code that met the threshold but was in short supply as determined by FDA.
On February 20, HHS OIG released an audit report titled Medicare Home Health Agency Provider Compliance Audit: Alternate Solutions Homecare of Dayton. OIG found that Alternate Solutions Homecare of Dayton complied with Medicare billing requirements for 96 of 100 sampled claims for calendar years 2022 and 2023 but received $940 in overpayments for four claims that did not meet billing and comprehensive assessment reporting requirements. OIG recommended that the provider refund the $940 and conduct additional internal reviews to identify and return any similar overpayments, and the provider concurred with the recommendations.
Government Accountability Office (GAO)
On February 19, GAO released a report titled Private Health Insurance: Provider Participation and Payments for Selected Services Before and After the No Surprises Act. GAO found that the percentage of in-network claims increased for emergency medicine, radiology, and anesthesiology after the No Surprises Act took effect on January 1, 2022, which may indicate increased in-network participation since the law’s enactment, following declines prior to implementation. GAO also found that inflation-adjusted health plan payments to hospitals for emergency services increased in 2022 and 2023, while plan payments to physicians decreased, reflecting trends that began before the law’s protections against balance billing took effect.
On January 20, GAO released a report titled High Risk Research: HHS Should Publicly Share More Information on How Risk Is Assessed and Mitigated. GAO found that HHS has procedures to assess and mitigate risks associated with research involving higher-risk pathogens, including “gain-of-function” research of concern but does not consistently publicly disclose key information about those reviews. GAO recommended that HHS ensure that key information on its risk assessments and mitigation steps is publicly shared with researchers, Congress, and the public.
ADDITIONAL POLICY NEWS
On February 17, California Attorney General Rob Bonta announced that the state is preparing a lawsuit challenging recent federal changes to childhood vaccine recommendations issued by HHS and CDC. The updated immunization schedule removed universal recommendations for certain vaccines and shifted to shared clinical decision-making for others.
On February 17, the American College of Obstetricians and Gynecologists (ACOG) releasedupdated clinical guidance on maternal immunizations. ACOG stated that the updated recommendations address vaccination during pregnancy and are intended to inform obstetric care providers on current immunization practices.
On February 18, Children’s Health Defense (CHD) filed a motion in the U.S. District Court for the District of Massachusetts to intervene in the American Academy of Pediatrics’ (AAP) lawsuit challenging HHS actions related to the childhood vaccine schedule and changes to ACIP. CHD and associated parties seek to participate in the case as counterclaim plaintiffs and argue against halting ACIP meetings while litigation proceeds. The Department of Justice also filed a response addressing plaintiffs’ claims regarding ACIP’s authority over the Vaccines for Children program, stating that ACIP resolutions are not required to align with the CDC immunization schedule.
On February 18, Modern Healthcare reported CMS data showing 35.5 million beneficiaries enrolled in a Medicare Advantage (MA) plan as of February 1, reflecting a 3.2% increase from the prior year. The growth rate is lower than the 4% increase reported in 2025. Several major carriers, including UnitedHealthcare, Elevance Health, Aetna, and Centene, reported enrollment declines as they adjusted plan offerings.
On February 18, the National Specialty Care Access Coalition announced its launch, with more than 20 health systems participating to expand specialty care access in rural and underserved communities. The coalition stated that it will focus on standardizing care models, advancing policy reforms, and implementing pilot programs to improve access through technology-enabled approaches.
On February 19, the Wisconsin State Assembly passed legislation to extend Medicaid coverage for postpartum women from 60 days to 12 months after childbirth. The measure received near-unanimous support and follows years of debate over expanding postpartum benefits under the State’s Medicaid program. If enacted, Arkansas would be the only state that does not extend Medicaid postpartum coverage for one year.
On February 19, JAMA Network published a study projecting that approximately 10% of MA enrollees will lose their MA plan in the 2026 plan year due to plan withdrawal from their market. Researchers from Johns Hopkins University and Georgetown University found that the mean “forced disenrollment” rate increased from 1% between 2018 and 2024 to 6.9% in 2025. The study reported that beneficiaries enrolled in preferred provider organization plans, those covered by smaller insurers, and individuals in rural areas are more likely to be affected.
On February 19, GRAIL announced that its multi-cancer early detection (MCED) blood test, Galleri, failed to meet its primary endpoint in a three-year, 142,000-participant trial conducted with England’s National Health Service. The study aimed to demonstrate that the test could shift cancer detection to earlier stages, thereby reducing stage 4 diagnoses. While the main result was not statistically significant, GRAIL noted a “favorable trend” toward reducing stage 4 diagnoses in a pre-specified group of 12 deadly cancers.