Health Care Watch: May 10, 2026
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from May 4 – May 10. 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 May 5, over 250 congressional Democrats filed an amicus brief with the U.S. Supreme Court in litigation involving the abortion medication, mifepristone. The brief urged the Court to overturn a Fifth Circuit decision that would reinstate certain dispensing restrictions for mifepristone and argued that the Food & Drug Administration (FDA) approval and regulation of the drug followed the agency’s established scientific and regulatory review processes. The lawmakers also stated that changes to the current regulatory framework for mifepristone could affect patient access and broader FDA authority related to drug approval decisions.
On May 6, Energy & Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Ranking Member Diana DeGette (D-CO), and Oversight & Investigations Subcommittee Ranking Member Yvette Clarke (D-NY) sent a letter to the U.S. Department of Health & Human Services (HHS) Secretary Robert F. Kennedy, Jr., requesting information regarding reports that CDC leadership delayed or declined publication of a study examining the effectiveness of 2025-2026 COVID-19 vaccines. The lawmakers referenced reporting that the study found that COVID-19 vaccination reduced emergency department visits, urgent care visits, and hospitalizations during the 2025-2026 winter season. The letter also requested information regarding HHS review processes for scientific publications, including whether political appointees directed delays, edits, or suppression of Morbidity and Mortality Weekly Report (MMWR) manuscripts since January 2025.
On May 7, over 110 Republican lawmakers filed an amicus brief in the U.S. Supreme Court supporting Louisiana’s lawsuit challenging FDA policies related to the dispensing of the abortion medication, mifepristone. The brief urged the Court to reinstate the in-person dispensing requirement for mifepristone while litigation proceeds, arguing that FDA exceeded its authority in removing the requirement.
On May 7, Rep. Suzanne Bonamici (D-OR), Sen. Jeff Merkley (D-OR), Rep. John Mannion (D-NY), Rep. Lauren Underwood (D-IL), and Sen. Angela Alsobrooks (D-MD) announcedplans to introduce a Congressional Review Act (CRA) resolution to overturn the Department of Education’s finalized student loan rule that caps federal borrowing for certain graduate and professional degree programs. The lawmakers stated that the rule would limit borrowing eligibility for programs including nursing, social work, and physical and occupational therapy, while also eliminating the Grad PLUS program and modifying repayment options. The announcement noted that the CRA resolution would be introduced once the rule is formally received by Congress.
Senate
On May 5, the Health, Education, Labor, & Pensions (HELP) Committee held a field hearing in Baton Rouge, LA, examining policies to reduce health care costs for patients and families. During the hearing, Chairman Bill Cassidy, M.D. (R-LA) highlighted his Money and Value for Patients (MVP) agenda, and the hearing focused on price transparency, patient-directed spending, prescription drug affordability, pharmacy benefit manager (PBM) reform, TrumpRx, and reducing regulatory barriers to lower-cost generics and biosimilars.
On May 6, the HELP Committee held a field hearing in Jefferson Parish, LA, examining treatment access and policy approaches related to mental health and substance use disorders. The hearing focused on the need for coordinated mental health and substance use disorder care.
REGULATORY UPDATE
On May 1, FDA announced that it issued a “safe to proceed” letter to Revolution Medicines permitting an expanded access treatment protocol (EAP) for the investigational pancreatic cancer drug daraxonrasib. FDA signed the protocol on April 30, allowing physicians licensed in the U.S. to request access on behalf of eligible patients under EAP requirements. Daraxonrasib previously received Breakthrough Therapy and Orphan Drug designations and is expected to be submitted under the Commissioner’s National Priority Voucher (CNPV) pilot program.
On May 4, FDA updated its organizational leadership information to reflect the appointment of R. Angelo de Claro, M.D., as Director of the Oncology Center of Excellence (OCE) from the role of Acting Director of OCE. FDA stated that de Claro will oversee OCE efforts to coordinate oncology product review activities across drugs, biologics, and devices, including programs such as Project Orbis and the Real-Time Oncology Review (RTOR) initiative.
On May 4, FDA issued a letter requesting that companies review and confirm contact information and Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee-eligible product lists in advance of fiscal year (FY) 2027 program fee invoices. FDA stated that companies must submit updates related to contact information, product eligibility, and marketing status changes by June 1, while additional deadlines apply for notifying the agency about discontinued or withdrawn products before FY 2027 fees are assessed. FDA stated that FY 2027 PDUFA program fee invoices are expected to be issued in August 2026.
On May 4, HHS announced a new action plan focused on reducing psychiatric overprescribing and supporting deprescribing efforts when clinically indicated. During a MAHA Institute summit on mental health and overmedicalization, HHS Secretary Kennedy outlined planned agency activities, including provider education, prescribing trend analysis, clinical guidance development, and expanded access to nonmedication mental health treatments. HHS also released a Dear Colleague Letter encouraging informed consent and shared decision-making, while the Centers for Medicare & Medicaid Services (CMS) issued guidance clarifying Medicare payment policies related to deprescribing services and tapering support. The letter can be found here.
On May 5, FDA authorized the marketing of four Glas electronic nicotine delivery system (ENDS) products through the premarket tobacco product application (PMTA) pathway. The authorized products represent the first FDA authorization of non-tobacco and non-menthol ENDS products. FDA stated that the authorization was supported by device access restriction technology intended to limit youth use, including age and identity verification through government-issued identification, smartphone pairing, and biometric verification features, along with FDA-required marketing restrictions.
On May 5, the Advanced Research Projects Agency for Health (ARPA-H) announced the launch of the Intelligent Generator of Research (IGoR) program, an initiative intended to accelerate biomedical research through an AI-enabled research ecosystem. The five-year program seeks to improve reproducibility and speed discovery related to complex and chronic diseases through advanced disease modeling, standardized experimental protocols, and coordinated laboratory networks.
On May 5, CMS Administrator Dr. Mehmet Oz published a blog outlining the Agency’s effort to modernize prior authorization (PA) through expanded electronic PA initiatives and interoperability standards. The blog highlighted implementation timelines under the CMS Interoperability and PA Final Rule. Starting January 1, 2026, Medicare Advantage, Medicaid and Children’s Health Insurance Program (CHIP), and Marketplace plans were required to meet standardized PA decision timelines. Electronic PA interfaces are scheduled to go live on January 1, 2027. CMS stated that the policies are projected to reduce administrative burden and generate approximately $15 billion in savings over 10 years. Dr. Oz also noted that CMS is currently pursuing a companion proposal to extend electronic PA requirements to drugs.
On May 6, CMS previewed the Medicare GLP-1 Bridge, a demonstration program that will provide eligible Medicare Part D beneficiaries access to certain GLP-1 medications for $50 per month from July 1 through December 31, 2027. CMS confirmed that the Bridge demonstration operates under the HHS Secretary’s authority to test new approaches to care delivery under Medicare and is supported by CMS, including centralized processes for claims adjudication and payment to pharmacies.
On May 6, FDA announced a pilot program for one-day inspectional assessments intended to complement standard FDA inspections through shorter, targeted facility reviews. FDA reported that approximately 46 one-day assessments have been completed as of late April 2026, with most resulting in No Action Indicated (NAI) outcomes. The pilot will continue through FY 2026 as the agency evaluates metrics related to inspection duration, escalation rates, and risk-based oversight activities.
On May 6, FDA announced the launch of Elsa 4.0, an upgraded version of the agency’s internal artificial intelligence (AI) platform, alongside the consolidation of more than 40 FDA application and submission data systems into a new platform called Harmonized AI & Lifecycle Operations for Data (HALO). FDA stated that the integration of HALO and Elsa is intended to allow agency staff to query data and build workflows without manually uploading documents, while supporting broader deployment of AI capabilities across agency operations.
On May 6, FDA issued a proposed rule titled Modification of Certain Terminology in Title 21 to revise terminology used throughout Title 21 of the Code of Federal Regulations. The proposed rule would remove the term “gender” and replace it with “sex” or remove references to gender, as applicable, across multiple FDA regulations to align with Executive Order 14168, “Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.” Comments are due by July 6.
On May 8, FDA issued final guidance for industry titled Postapproval Pregnancy Safety Studies, which provides recommendations on methodologies for studying the safety of drugs and biological products used during pregnancy after approval. The guidance outlines approaches for collecting pregnancy safety data, including pregnancy registries, real-world data studies, and descriptive analyses based on individual case reports. FDA stated that the guidance is intended to support the collection of clearer safety information for clinicians and patients making treatment decisions during pregnancy and should be used alongside existing scientific standards and FDA guidance related to observational research, pharmacovigilance, and postmarket study requirements.
On May 8, CMS announced the availability of a new comment guide to assist stakeholders in preparing comments on the 2026 CMS Interoperability Standards and Prior Authorization for Drugs Proposed Rule (CMS-0062-P). Comments on the proposed rule are due by June 15.
On May 8, CMS announced that Preliminary April 2026 Interim Performance Reports (IPRs) for the expanded Home Health Value-Based Purchasing (HHVBP) Model are available through the Internet Quality Improvement and Evaluation System (iQIES). CMS also announced that the April 2026 IPRs reflect a correction to risk adjustment processing for certain home health episodes in calendar year 2025 and stated that recalculation requests for Preliminary April 2026 IPRs are due by May 15.
On May 8, FDA granted approval for Bizengri to treat adults with an ultra-rare and aggressive cancer of the bile ducts. The approval marked the seventh approval under the CNPV pilot program.
WHITE HOUSE
On May 5, the White House released a report outlining the Trump Administration’s Most-Favored-Nation (MFN) drug pricing policy framework and projected savings associated with the initiative. The report estimates nearly $600 billion in total savings over the next 10 years, including $529 billion from prospective MFN pricing for new drugs and $64.3 billion in federal and state spending from applying MFN prices to existing drugs in Medicaid. In addition, the report projects $4.6 billion in savings for patients using fertility medications purchased through TrumpRx.gov over 10 years and substantial per‑patient savings for GLP‑1 users, who are expected to save up to $3,000 annually as MFN prices are fully implemented.
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
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
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Revised Draft Guidance for Industry; Availability; Notice; 04/24/2026
Statistical Approaches to Establishing Bioequivalence; Guidance for Industry; Availability; Notice; 04/28/2026
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Guidance for Industry; Availability; Notice; 04/28/2026
HEARINGS
House
Energy & Commerce Health Subcommittee
Markup of legislation, including public health extenders
May 13, 2026; 2:00 PM ET
Senate
Appropriations Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies
A Review of the President’s Fiscal Year 2027 Budget Request for the FDA
May 13, 2026; 10:30 AM ET; 138 Dirksen
Witness: The Honorable Martin Makary, M.D., Commissioner, FDA
REPORTS
Office of Inspector General (OIG)
On May 8, HHS OIG released a report examining Medicare Part B billing and utilization trends for office-based peripheral vascular procedures, including angioplasty, stenting, and atherectomy. The report found that, from 2019 through 2023, physicians increasingly shifted these procedures from hospital outpatient departments to office-based laboratories (OBLs), where Medicare payments are higher. OIG estimated that $105 million in Part B payments for procedures performed in OBLs in 2023 may indicate billing for medically unnecessary services, with 26 physicians accounting for 61% of the concerning payments identified. OIG recommended that CMS monitor billing patterns for potentially medically unnecessary peripheral vascular procedures and follow up on physicians identified with concerning billing practices, and CMS concurred with both recommendations.
On May 8, HHS OIG released a report comparing average sales prices (ASPs) and average manufacturer prices (AMPs) for Part B drugs for the fourth quarter of 2025. The report found that 10 drug codes met CMS’ price-substitution criteria by exceeding the statutory 5% threshold for two consecutive quarters or three of the previous four quarters. Under the Social Security Act, CMS may substitute the ASP-based payment amount with a lower calculated rate when pricing thresholds are exceeded to limit potentially excessive Part B drug payments.
Government Accountability Office (GAO)
On May 5, GAO released a report examining federal programs that provide services to pregnant women, children through age 5, and their families. The report identified 242 federal programs serving this population, including 15 programs that provide direct services solely to these groups, and found that 3 programs had not fully established federal performance management processes to assess program goals and outcomes. GAO recommended that HHS establish a federal performance management process for the Preschool Development Grants Birth Through Five Program, USDA establish a similar process for the WIC Farmers Market Nutrition Program, and the Department of Veterans Affairs finalize its process for the Veterans Health Administration Maternity Care Coordinator Program.
ADDITIONAL POLICY NEWS
On May 1, Sensible Medicine announced that former FDA senior leader Dr. Vinay Prasad would rejoin the publication’s editorial team. The editors stated that Sensible Medicine plans to continue its focus on discussions related to biomedical evidence, medical literature, and health policy, while now also expanding content related to federal drug and biologics regulation and editor debates on medical topics.
On May 5, various news outlets reported that FDA officials blocked publication of several studies supporting the safety of widely used vaccines against COVID-19 and shingles. According to these reports, an HHS spokesperson stated that the studies were withdrawn because their conclusions were not supported by the underlying data.
On May 6, Oscar Health and Aetna reported better-than-expected 2026 Q1 financial results, which included medical cost management efforts, pricing adjustments, and benefit changes. Oscar Health reported a more than 50% increase in revenue compared with Q1 in 2025, with medical costs in line with expectations. CVS Health raised its full year outlook following strong performance across its insurance operations. However, insurers tend to report stronger first quarter results as many enrollees have yet to hit their deductibles, at which point insurers start paying claims.
On May 7, Families USA released an analysis examining the relationship between hospital system consolidation, pricing, and hospital profits across U.S. markets. The report found that a small number of large corporate health systems dominate most of the hospital market and large health systems operating in highly consolidated markets charged commercial insurers rates that exceeded Medicare payment rates by more than 300%, on average. The report also found that system-owned hospitals report substantially higher annual net income than independent hospitals. Families USA argued that Congress should adopt policies that strengthen price transparency, ban anti-competitive practices, adopt site neutral payment policies, improve oversight over non-profit hospitals to ensure they are providing a community benefit, and limit prices and price growth to a Medicare benchmark.