Health Care Watch: March 21, 2026
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from March 15 – March 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 March 17, the Energy & Commerce Oversight & Investigations Subcommittee held a hearing titled Protecting Patients and Safeguarding Taxpayer Dollars: The Role of the Centers for Medicare & Medicaid Services (CMS) in Combatting Medicare and Medicaid Fraud. The hearing covered the Trump Administration’s efforts to address fraud in Medicare and Medicaid, as well as common fraud schemes and program vulnerabilities. A summary of the hearing can be found here.
On March 17, the Appropriations Labor, Health & Human Services, Education, and Related Agencies Subcommittee held an oversight hearing on the National Institutes of Health (NIH). The hearing examined NIH activities and priorities, with testimony from NIH Director Dr. Jay Bhattacharya.
On March 17, Rep. Mike Lawler (R-NY), Sanford Bishop Jr. (D-GA), Maria Elvira Salazar (R-FL), and Yvette Clarke (D-NY) introduced the H–1Bs for Physicians and the Healthcare Workforce Act, a bipartisan bill to exempt physicians and other health care workers from a $100,000 H-1B visa petition fee established under a recent Executive Order (EO). The legislation would also prohibit additional fees on health care workers beyond those outlined in existing immigration law.
On March 18, the Ways & Means Health Subcommittee held a hearing titled Improving Kidney Health Through Better Prevention and Innovative Treatment. The hearing examined systemic challenges in kidney disease care and how improvements to reimbursements and advances in prevention and innovative treatments could improve patient outcomes and reduce costs. A summary of the hearing can be found here.
On March 18, the Energy & Commerce Health Subcommittee held its third hearing on health care affordability titled Lowering Health Care Costs for All Americans: An Examination of the U.S. Provider Landscape. The hearing covered the role that provider payment policies, competition, transparency, the 340B program, and other incentives shape patient access and the cost of care. A summary of the hearing can be found here.
Senate
On March 19, the Health, Education, Labor, and Pensions (HELP) Committee held a Member Day hearing. The hearing provided an opportunity for Senators to present legislative priorities and policy proposals within the Committee’s jurisdiction, including FDA-related policy. Members outlined a range of bipartisan legislative proposals focused on maternal health access, prescription drug affordability, workforce development, opioid overdose prevention, and patient access to care. Specifically, proposals included efforts to support rural maternal care, address patent practices affecting generic drug entry, expand naloxone access, strengthen the nursing workforce, and revise policies related to experimental and off-label treatments.
On March 19, Finance Committee Ranking Member Ron Wyden (D-OR), and several Senate Democrats sent a Dear Colleague letter outlining policy priorities to address health insurance affordability and coverage challenges. The letter described concerns related to rising premiums, out-of-pocket costs, and barriers to accessing care, and announced plans to develop policies focused on expanding coverage, simplifying plan selection, and increasing oversight of insurance practices.
REGULATORY UPDATE
On March 12, the Food & Drug Administration (FDA) approved a supplemental biologics license application to expand the indication for GlaxoSmithKline’s (GSK) respiratory syncytial virus (RSV) vaccine, Arexvy, to include adults ages 18 to 49 at increased risk of RSV-related lower respiratory tract disease. The approval includes updated labeling and new postmarketing study requirements to evaluate safety outcomes, including Guillain-Barré syndrome and atrial fibrillation, in a broader population. FDA outlined timelines for required postmarketing studies, with completion expected by June 30, 2030, and final reports due by December 31, 2031.
On March 13, CMS’ Innovation Center released a notice of funding opportunity for the MAHA ELEVATE model, which will select up to 30 cooperative agreement recipients, including three focused on dementia and cognitive decline. The model will provide up to $3.3 million per recipient over a three-year period, with total funding of up to $100 million, and will condition payments on meeting operational and enrollment milestones. Letters of intent are due by April 10, and applications for the first cohort are due by May 15, with a second cohort to be announced at a later date.
On March 13, the Trump administration added seven drugs from GSK and Amgen to TrumpRx, bringing the total number of listed medicines to 54. These newly listed treatments include Amgen’s Amjevita, Aimovig, and Repatha, alongside GSK’s Anoro Ellipta, Arnuity Ellipta, Incruse Ellipta, and Relenza.
March 13, FDA announced it accepted recommendations from FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) on the influenza strains to be included in vaccines for the 2026-2027 U.S. flu season. The advisory committee unanimously supported formulations for both egg-based and non-egg-based vaccines, which manufacturers will use to produce doses ahead of the upcoming respiratory virus season. FDA stated it anticipates an adequate and diverse supply of approved seasonal influenza vaccines.
On March 13, CMS announced that drug manufacturers for all 15 selected drugs, as well as one renegotiated drug, have agreed to participate in the Medicare Drug Price Negotiation Program for Initial Price Applicability Year (IPAY) 2028.
On March 17, CMS released a second public dataset on the Acute Hospital Care at Home (AHCAH) initiative through the Research and Data Assistance Center (ResDAC). The dataset includes information from April 1, 2023, through September 30, 2025, and expands previously released data to provide nearly five years of information on hospital-at-home care delivery, including patient admissions, care escalations, and outcomes. CMS stated the data will support research and analysis of the AHCAH model, which has been extended through September 30, 2030.
On March 18, FDA issued draft guidance outlining validation considerations for new approach methodologies (NAMs) as alternatives to animal testing in drug development. The guidance provides recommendations from the Center for Drug Evaluation and Research (CDER) on demonstrating reliability, human biological relevance, and fitness for regulatory use when submitting NAMs data in drug applications. FDA stated the guidance is intended to support the use of human-relevant methods in nonclinical testing and encouraged stakeholders to submit comments on the draft guidance.
On March 19, the U.S. Department of Health & Human Services (HHS) confirmed the postponement of a scheduled Advisory Committee on Immunization Practices (ACIP) meeting following a federal judge’s temporary stay, issued on March 16, on newly appointed members’ authority to serve and vote. The delay follows actions by HHS Secretary Robert F. Kennedy, Jr., to replace prior ACIP members, which have been challenged by public health organizations. A draft report prepared for the meeting indicated potential expansion of ACIP’s role to include recommendations on vaccine injury policy related to COVID-19 vaccination.
On March 19, HHS’ Office for Civil Rights (OCR) announced investigations into thirteen states regarding alleged noncompliance with the Weldon Amendment, a federal conscience protection law. OCR stated that the investigations are based on information that states may be requiring health care entities to provide or cover abortion services contrary to conscience protections and clarified its interpretation of the law to include employers and plan sponsors as protected entities. OCR indicated that the investigations are part of broader efforts to enforce federal conscience laws and review state compliance with nondiscrimination requirements tied to federal funding.
On March 19, CMS released a readout of its first Rural Health Transformation Summit, which convened leaders from all 50 states on March 18 to support implementation of the Rural Health Transformation Program. The summit focused on state-led strategies to expand access to care, strengthen the rural health workforce, advance value-based care models, and modernize health infrastructure under the $50 billion initiative. CMS indicated that the meeting marked the launch of an ongoing learning collaborative to support coordination, technical assistance, and best practice sharing across states.
On March 19, FDA approved a 7.2 mg higher-dose formulation of semaglutide injection (Wegovy) for chronic weight management in certain adults with obesity or overweight with at least one weight-related condition. The approval was granted under the Commissioner’s National Priority Voucher (CNPV) pilot program and was supported by clinical data showing additional weight reduction compared to previously approved doses.
On March 20, FDA issued a notice seeking public comment on the CNPV pilot program and announced a public meeting scheduled for June 12 to gather stakeholder input. The notice requests feedback on program eligibility, voucher selection, sponsor responsibilities, and review processes for the pilot program. Requests to speak at the meeting are due by May 1, and written comments are due by June 27.
On March 20, FDA withdrew a proposed rule that would have restricted minors from using indoor tanning beds and required adult users to acknowledge associated health risks. FDA indicated it will reconsider regulatory approaches, citing factors including compliance burdens on small businesses and considerations related to personal choice and parental decision-making.
On March 20, CMS issued a final rule titled Administrative Simplification; Adoption of Standards for Health Care Claims Attachments Transactions and Electronic Signatures. The rule establishes national standards for the electronic exchange of clinical documentation supporting health care claims and for electronic signatures, replacing manual processes such as fax and mail. CMS estimates the rule will save approximately $781.98 million annually. Compliance with the new requirements is required by May 26, 2028. A fact sheet can be found here.
WHITE HOUSE
On March 16, the White House issued an EO titled Establishing the Task Force to Eliminate Fraud. The order establishes a Task Force within the Executive Office of the President, chaired by the Vice President, to coordinate a national strategy to address fraud, waste, and abuse across Federal benefit programs. The Task Force will work with federal agencies including HHS to strengthen eligibility verification, improve data sharing, and identify high-risk fraud schemes.
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
Interoperability Standards and Prior Authorization for Drugs (CMS-0062); Proposed Rule; 01/16/2026
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital 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
FY 2027 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1847); Proposed Rule; 02/25/2026
FY 2027 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1851); Proposed Rule; 02/26/2026
Medicare Drug Price Negotiation Program (CMS-4215); Proposed Rule; 02/26/2026
FY 2027 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Program (CMS-1845); Proposed Rule; 02/26/2026
Medicaid Managed Care State Directed Payments and Medicaid Fee-For-Service Targeted Medicaid Practitioner Payments (CMS-2449); Proposed Rule; 02/27/2026
FY 2027 Skilled Nursing Facility (SNFs) Prospective Payment System and Consolidated Billing and Updates to the Value-Based Purchasing and Quality Reporting Programs (CMS-1843); Proposed Rule; 02/27/2026
Announcement of Calendar Year 2027 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies (the "CY 2027 Rate Announcement"); Notice; 03/19/2026
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
Substances Generally Recognized as Safe; Proposed Rule; 12/01/25
Establishment Registration and Product Listing for Tobacco Products; Proposed Rule; 02/19/2026
Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments; Rule; 03/04/2026
Cannabidiol (CBD) Products Compliance and Enforcement Policy; Notice; 03/13/2026
Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle; Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties; Availability; Notice; 03/16/2026
Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke; Established List Additions and Request for Comments; Notice; 03/19/2026
HEARINGS
House
Energy & Commerce
Policies to Protect Our Communities from Illicit Drug Threats
March 26; 2:00 PM; 2123 Rayburn
Bills to be considered:
o H.R. 1266, Combatting Illicit Xylazine Act (Reps. Panetta and Pfluger)
o H.R. 5630, To amend the Public Health Service Act to require additional information in State plans for Substance Use Prevention, Treatment, and Recovery Services block grants (Rep. Houchin)
o H.R. 5629, To provide that the final rule of the Department of Health and Human Services titled “Medications for the Treatment of Opioid Use Disorder”, except for the portion of the final rule relating to accreditation of opioid treatment programs, shall have no force or effect. (Rep. Houchin)
o H.R. 2004, Tyler’s Law (Reps. Lieu and Latta)
o H.R. 7970, STOP Nitazenes Act (Rep. Latta)
o H.R. 8000, END 7-OH Act (Rep. Bilirakis)
o H.R. 7184, PRESS Act (Rep. McDowell)
o H.R. 8005, Stop Pills That Kill Act (Rep. Evans)
o H.R. 5880, Fight Illicit Pill Presses Act (Reps. Hageman and Stansbury)
o H.R. 1227, Alternatives to Pain Act (Reps. Miller-Meeks and Barragan)
o H.R. 2715, Destruction of Hazardous Imports Act (Reps. Higgins and Carter)
o H.R. 1561, ALERT Communities Act (Reps. Crockett and Gooden)
o H.R. 7994, HERO Act (Rep. Ruiz)
o H.R. 7407, Prohibiting Tianeptine and Other Dangerous Products Act of 2026 (Rep. Pallone)
REPORTS
Office of Inspector General (OIG)
On March 12, HHS OIG issued an audit report examining diagnosis codes submitted by Gateway Health Plan, Inc. to CMS for use in the Medicare Advantage risk adjustment program. OIG found that most sampled diagnosis codes did not comply with Federal requirements, with medical records failing to support codes in 232 of 286 enrollee-years. OIG recommended that Gateway Health Plan, Inc. refund $4.3 million in estimated overpayments, identify and return additional overpayments from similar noncompliance, and strengthen internal compliance procedures to ensure accurate diagnosis coding, while the company disagreed with some findings and all recommendations.
On March 16, HHS OIG issued an evaluation examining whether Indiana ensured that selected nursing homes complied with Federal background check requirements. OIG found that Indiana generally complied. Of the eight selected nursing homes, 812 of 825 reviewed employees had completed background checks and there were no identified disqualifying offenses among those with completed checks. OIG recommended that Indiana advise nursing homes to verify completion of employee background checks and maintain documentation, and the State indicated it would continue actions to address the recommendation.
On March 16, the HHS OIG released two evaluations examining antipsychotic drug use in nursing homes. The first evaluation focused on the use of schizophrenia diagnoses related to antipsychotic drug prescribing. Based on a review of 40 CMS nursing home inspections, the OIG found that some nursing homes inappropriately diagnosed residents with schizophrenia to mask the misuse of antipsychotic drugs and influence quality reporting measures, including facility star ratings. The OIG recommended that CMS strengthen oversight by expanding data monitoring, targeting inappropriate diagnoses, and ensuring residents and families are informed when antipsychotic drugs are administered. The second evaluation examined the use of antipsychotic drugs in nursing homes and associated risks to residents. Based on the same 40 CMS nursing home inspections, the OIG found instances of inappropriate prescribing, inadequate facility policies and procedures, and failures to prevent inappropriate use of drugs, protect residents given those drugs, and in pharmacist oversight in identifying medical concerns or recommending dosing reductions. The OIG recommended that CMS enhance oversight, improve transparency, and strengthen the roles of medical directors and pharmacists in reducing inappropriate use.
On March 18, HHS OIG issued an evaluation report summarizing activities and outcomes of State Medicaid Fraud Control Units (MFCUs) for fiscal year 2025. The report found that MFCUs recovered $4.64 for every dollar spent, with nearly $2 billion in total recoveries, including $1.3 billion from criminal cases and $706 million from civil cases, along with 1,185 convictions and 674 civil settlements and judgments. The report also highlighted that MFCU convictions led to 900 exclusions from Federal health care programs and that managed care entities referred 5,991 fraud cases to MFCUs.
ADDITIONAL POLICY NEWS
On March 12, Microsoft announced the launch of Copilot Health, a health-focused artificial intelligence tool designed to help users interpret personal health data and generate personalized insights. The platform integrates electronic health records, wearable device data, and other health information sources to support users in understanding their health and preparing clinical visits.
On March 13, major hospital and health insurance trade groups, including America’s Essential Hospitals and AHIP, submitted a joint comment letter to CMS opposing a proposed rule that would allow non-network health plans to be sold on the Affordable Care Act (ACA) marketplaces. The groups stated that the proposal could create consumer confusion, complicate oversight of provider access, and shift risk pools by attracting healthier enrollees to lower-premium plans. The letter also raised concerns about potential increases in uncompensated care and impacts on ACA marketplace stability as CMS continues rulemaking on the proposal.
On March 16, Structure Therapeutics announced positive topline results from its Phase 2 ACCESS II trial evaluating aleniglipron, an investigational oral GLP-1 receptor agonist, for the treatment of obesity and overweight. The study reported placebo-adjusted mean weight loss of approximately 16% at 44 weeks, with additional data suggesting continued weight reduction and a safety profile consistent with the GLP-1 class.
On March 10, NEJM Evidence published a study on newly analyzed data from the Centers for Disease Control and Prevention (CDC) National Health Interview Survey showing that the U.S. adult cigarette smoking rate declined to 9.9% in 2024, the first time it has fallen below 10%. CDC Analyses are typically responsible for interpreting and disseminating national tobacco use data, however, reductions in capacity within CDC’s Office of Smoking and Health have coincided with increased reliance on external researchers and institutions to analyze and publish federal survey data.
On March 19, former Rep. Brad Wenstrup (R-OH) announced the launch of Americans for Health Excellence (AFHE), a health policy advocacy coalition focused on patient affordability, access, and innovation. The organization stated it will engage policymakers and stakeholders through research and policy development across areas including expanding access and choice, supporting U.S. medical innovation, and promoting market-based approaches to health care. AFHE will serve as a policy and advocacy hub aimed at advancing proposals related to health care costs, coverage, and system transparency.