Health Care Watch: April 26, 2026
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from April 20 – April 26. 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 April 21, the Ways & Means Committee held a hearing titled “Protecting Patients and Taxpayers: Cracking Down on Medicare Fraud.” A primary focus of this hearing was fraud within the Medicare home health benefit. Members emphasized the importance of strong program oversight, raising concerns about Medicare fraud prevention, and called for modernizing CMS fraud detection through advanced data analytics and artificial intelligence and strengthening eligibility verification prior to payment.
On April 21, the Energy & Commerce Committee held a hearing with the U.S. Department of Health & Human Services (HHS) Secretary Kennedy on President Donald Trump’s FY27 Budget Proposal. Members raised concerns about vaccine policy, health care pricing, transparency, and cost drivers, including noncompliance with price transparency requirements, variation in service pricing, and the role of programs such as 340B and supply chain factors in driving costs. Members also discussed Medicare, Medicaid, and coverage policy, as well as providers, rural hospitals and workforce, and program integrity and oversight.
On April 21, the House passed several bipartisan health care bills, including H.R. 2493, the Improving Care in Rural America Reauthorization Act of 2025, which would extend the Rural Health Services Outreach programs through 2030, passed by a vote of 406-4. The House also passed H.R. 3419, to reauthorize the telehealth network and telehealth resource centers grant programs and H.R. 2319, the Women and Lung Cancer Research and Preventive Services Act of 2025, by voice vote.
On April 21, a bipartisan group of 82 Members of Congress led by Rep. Rudy Yakym (R-IN) sent a letter to HHS and the Centers for Medicare & Medicaid Services (CMS) requesting expanded Medicare coverage for breakthrough medical devices. The lawmakers urged CMS to use the Ensuring Patient Access to Critical Breakthrough Products Act as a model for establishing via regulation a temporary Medicare coverage pathway for breakthrough devices following Food & Drug Administration (FDA) approval and highlighted the negative impact of delays in Medicare coverage for novel technologies. The letter also requested that CMS incorporate safeguards related to clinical evidence, appropriate use, and fraud, waste, and abuse in any future policy.
On April 22, the Education & Workforce Health, Employment, Labor, and Pensions Subcommittee held a hearing titled “Profits Over Patients: The PBM Business Model Under Scrutiny.” The hearing examined the role of pharmacy benefit managers (PBMs) in employer-sponsored coverage, their financial relationships with brokers and consultants, and the impact of these practices on drug pricing, transparency, and patient access. Members discussed PBM brokers and consultants, market consolidation, transparency, drug pricing reform, utilization management, formulary design, business models and incentives, and potential PBM reform options.
Senate
On April 21, Finance Committee Ranking Member Ron Wyden (D-OR) and 17 Senate Democrats introduced the Drug Deal Disclosure Act which would require HHS to disclose the terms of agreements between the Trump Administration and pharmaceutical manufacturers. The legislation would also direct the Congressional Budget Office (CBO) and the Government Accountability Office (GAO) to conduct an independent analysis of the agreements’ economic and budgetary impacts. The announcement accompanied the release of a report examining agreements with more than a dozen drug companies and their potential effects on prescription drug pricing and federal health care programs.
On April 21, the Appropriations Labor, HHS, Education, and Related Agencies Subcommittee held a hearing with HHS Secretary Kennedy on President Trump’s FY27 Budget Proposal.
On April 22, the Finance Committee held a hearing with HHS Secretary Kennedy on President Trump’s FY27 Budget Proposal. Members raised concerns about vaccine policy, drug pricing, transparency, PBM practices, FDA decision-making, and U.S. competitiveness in pharmaceutical innovation and global markets. Members also discussed rural health and hospital sustainability, hospital policy and delivery models, and Medicare policy and program administration.
On April 22, the Health, Education, Labor, & Pensions (HELP) Committee held a hearing with HHS Secretary Kennedy on President Trump’s FY27 Budget Proposal. Members raised concerns about vaccine policy, drug regulation, pricing, innovation, and global competitiveness, including oversight of medication abortion, consumer cost sensitivity, use of artificial intelligence in drug development, and the shift of clinical trials overseas. Members also discussed rural health and hospital sustainability, as well as hospitals and federal oversight.
REGULATORY UPDATE
On April 20, FDA issued draft guidance entitled Establishing Impurity Specifications for Antibiotics to provide recommendations on setting standards for organic impurities in antibiotic products. The guidance applies to drugs approved under new drug applications (NDAs), abbreviated NDAs, and over-the-counter antibiotic products, and is intended to support consistent quality and manufacturing controls. Comments on the draft guidance are due by June 22.
On April 21, the Advanced Research Projects Agency for Health (ARPA-H) announced the first set of research teams for its Evidence-Based Validation & Innovation for Rapid Therapeutics in Behavioral Health (EVIDENT) initiative. The initiative will provide up to $139.4 million in funding to support the development of objective, data-driven measures to evaluate rapid-acting behavioral health treatments, including digital interventions, neuromodulation, and neuroplastogens. ARPA-H stated that the selected teams will contribute clinical trial and real-world data to support the development of FDA-ready endpoints and improve the precision of treatment selection for conditions such as depression, anxiety, and substance use disorders.
On April 21, CMS announced it will extend the Medicare GLP-1 Bridge demonstration through December 31, 2027, while pausing implementation of the Medicare Part D component of the Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth (BALANCE) Model for CY 2027 to allow for additional data collection and evaluation. The GLP-1 Bridge, set to launch July 1, will provide certain beneficiaries access to GLP-1 medications outside of the Part D benefit and is intended to inform future coverage and payment policy. CMS indicated that the agency plans to issue further guidance on the BALANCE Model’s future. CMS will continue accepting applications for the BALANCE Model from state Medicaid agencies through July 31 with participation beginning as early as May 1.
On April 21, CMS Administrator Mehmet Oz announced a nationwide initiative requiring all states to submit plans within 30 days outlining how they will revalidate Medicaid providers to address program integrity concerns. CMS indicated that states that do not comply may face additional federal audits and oversight.
On April 22, CMS issued a transmittal updating the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP) files for July 2026. The transmittal provides instructions for quarterly updates to Healthcare Common Procedure Coding System (HCPCS), ZIP code, and single payment amount files used in claims processing, with an effective date of July 1 and an implementation date of July 6. CMS stated the updates are part of routine program maintenance to support payment accuracy and administration of the DMEPOS CBP.
On April 23, the Agency for Healthcare Research and Quality (AHRQ) solicitednominations from a wide range of clinical disciplines to serve on the United States Preventive Services Task Force (USPSTF). Nominations are due by May 23, with new member terms expected to begin in June 2026.
On April 23, CMS and FDA announcedthe Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, to accelerate Medicare coverage for certain FDA-designated Breakthrough Devices by aligning regulatory and reimbursement processes earlier in development with the goal of issuing a proposed National Coverage Determination (NCD) on the same day as FDA market authorization. CMS indicated the pathway applies to eligible Class II and Class III Breakthrough Devices and will pause new entrants into the Transitional Coverage for Emerging Technologies (TCET) pathway while RAPID implementation proceeds. CMS indicated that it will issue a proposed procedural notice on the new pathway with a 60-day comment period.
On April 24, FDA announced the issuance of national priority vouchers to three sponsors studying psilocybin for treatment‑resistant depression, psilocybin for major depressive disorder, and methylone for post‑traumatic stress disorder. FDA is also allowing an early‑phase clinical trial of noribogaine hydrochloride for alcohol use disorder to proceed under a new IND. FDA noted that final guidance for sponsors on designing and conducting clinical trials of serotonin‑2A agonists and similar products will be released imminently.
WHITE HOUSE
On April 18, the White House issued an EO directing HHS and FDA to accelerate research, development, and regulatory review of treatments for serious mental illness, including psychedelic drugs. The EO directs ARPA-H to allocate at least $50 million to support state-level initiatives and instructs FDA and the Drug Enforcement Administration (DEA) to facilitate patient access through pathways such as the Right to Try Act. The EO also calls for enhanced federal coordination, data sharing, and expedited review processes for therapies that have received Breakthrough Therapy designation.
On April 23, the White House announced that President Trump reached an agreement with Regeneron to implement most-favored-nation (MFN) pricing for certain prescription drugs, marking the 17th MFN agreement made with manufacturers. The agreement includes similar provisions as previous MFN deals (e.g., MFN pricing for Medicaid, price reductions for select drugs sold through TrumpRx, domestic manufacturing). Notably, the deal also includes a provision for providing Regeneron’s new gene therapy (Otarmeni) for a rare type of genetic deafness at no cost to U.S. patients. As part of the MFN deal, on the same day, the FDA approvedOtarmeni under a national priority voucher.
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
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
Medicare Drug Price Negotiation Program (CMS-4215); 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
Establishing State Community Engagement Requirements for Certain Individuals Under Section 1902(xx) of the Social Security Act (CMS-2454); Interim Final Rule; 03/31/2026
Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program (CMS-9883); Final Rule; 4/01/2026
Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model (CMS-5544); Final Rule; 04/11/2026
CY 2027 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1850); Proposed Rule; 04/13/2026
CY 2027 Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1848); Proposed Rule; 04/14/2026
Exchange Pre-Enrollment Eligibility Verification (CMS-9873); Proposed Rule; 04/22/2026
CY 2027 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program (CMS-1846); Proposed Rule; 04/22/2026
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
Postapproval 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
Serotonin-2A Agonists and Related Products: Considerations for Clinical Investigations; Guidance for Industry; Availability; Notice; 04/17/2026
Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods; Final Rule; 04/20/2026
HEARINGS
House
Ways & Means Committee
Full Committee Hearing with Health System CEOs
April 28; 10 AM ET; 1100 Longworth
Energy & Commerce Health Subcommittee
Legislative Proposals on the Regulation and Oversight of Food
April 29; 2 PM ET; 2123 Rayburn
Bills to be discussed:
H.R. 4958, Grocery Reform and Safety (GRAS) Act;
H.R. 7291, GRAS Oversight and Transparency Act;
H.R. ____, [FDA Review and Evaluation for Safe, Healthy and Affordable Foods Act of 2026];
H.R. 4306, Food Chemical Reassessment Act of 2025;
H.R. 8385, Food Labeling Modernization Act of 2026;
H.R. 8429, Baby Food Safety Act of 2026;
H.R. 7867, Infant Formula Safety Modernization Act of 2026;
H.R. 4725, Transparency, Readability, Understandability, Truth, and Helpfulness (TRUTH) in Labeling Act;
H.R. 2472, Improving Newborns’ Food and Nutrition Testing Safety (INFANTS) Act of 2025;
H.R. 2511, Sarah Katz Caffeine Safety Act;
H.R. 5882, No Tricks on Treat Act of 2025;
H.R. 8370, Dietary Supplement Listing Act of 2026;
H.R. 8430, Federal and State Food Safety Information Sharing Act;
H.R. 3722, Do or Dye Act;
H.R. 5027, Ban Harmful Food Dyes Act;
H.R. 1394, Codifying Useful Regulatory Definitions (CURD) Act;
H.R. 1178, Alpha-gal Allergen Inclusion Act;
H.R. 2162, Honey Integrity Act;
H.R. 4987, Food Date Labeling Act of 2025;
H.R. 5832, Requiring Ethical and Accurate Labeling of Lab-grown (REAL) Meats Act;
H.R. 7366, Dietary Supplement Regulatory Uniformity Act;
H.R. 2615, Stephen Hacala Poppy Seed Safety Act;
H.R. 3324, Safer Shrimp Imports Act;
H.R. 933, Defending Domestic Orange Juice Production Act of 2025;
H.R. 8414, Defending Against Imitations and Replacements of Yogurt, Milk, and Cheese to Promote Regular Intake of Dairy Everyday (DAIRY PRIDE);
H.R. 8431, Third-Party Certification and Inspection Modernization Act of 2026;
H.R. 8412, No False Formula Act;
H.R. 8432, To provide the Food and Drug Administration needed authorities to carry out its regulatory mission with respect to human foods, to provide additional resources and authorities with respect to human foods research, and for other purposes.
Senate
Homeland Security & Governmental Affairs; Subcommittee on Investigations
April 29; 2:30 PM ET; 342 Dirksen
Witnesses: Karl Jablonski, Director of Science and Research, Children’s Defense Fund; David Wiseman, President, Synechion, Inc.; and Maria Young, COVID-19 Survivor.
REPORTS
Office of Inspector General (OIG)
On April 17, HHS OIG issued a report finding that CMS has limited oversight of selected compounded drugs prescribed to Medicare Part D enrollees due to incomplete data on drug ingredients. The report identified cases where compounded drugs included substances not reflected in Prescription Drug Event (PDE) records, as well as instances involving drugs associated with misuse, such as gabapentin and ketamine, including concurrent opioid use. OIG recommended that CMS work with Part D sponsors to improve the accuracy of reporting and oversight of compounded drug claims, and CMS concurred with all recommendations.
Government Accountability Office (GAO)
On April 21, GAO released a report examining CMS’ use of data analytics to identify and prevent fraud in Medicare. The report found that CMS uses claims data to detect anomalous billing patterns and inform administrative actions, including payment suspensions and provider enrollment revocations, and estimated that these efforts prevented $11.9 billion in potentially fraudulent payments from fiscal years 2022 through 2024. GAO also noted that CMS began sharing information on payment suspensions with supplemental payers in December 2025 to reduce improper cost-sharing payments on fraudulent claims.
ADDITIONAL POLICY NEWS
On April 23, the Paragon Health Institute released a paper examining the role of federal and state policies in driving hospital prices, consolidation, and spending growth in the U.S. health care system. The paper found that hospitals account for approximately one-third of total health care spending and that hospital prices have increased three times faster than inflation since 2000, with operating margins averaging 6.4% and total margins reaching 6.5% in 2024. The report also noted that more than 55% of physicians are now employed by hospitals and outlined policy recommendations, including site-neutral payments, enhanced price transparency, and reforms to Medicaid financing and hospital subsidy programs to improve efficiency and competition.