Health Care Watch: May 31, 2026
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from May 25 – May 30. 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
The House is expected to begin consideration of H.R. 8646, the Agriculture, Rural Development, Food & Drug Administration, and Related Agency Appropriations Act, 2027, on June 4.
The House will return to session on June 2.
Senate
On May 21, Health, Education, Labor, & Pensions (HELP) Chair Bill Cassidy (R-LA) sent a letter to Hims & Hers asking how the company responded to a recent data leak and what the company is doing to protect consumers’ private health information. A response is requested by June 8.
On May 27, Aging Committee Chairman Rick Scott (R-FL) hosted a roundtable discussion in Tampa, Florida on domestic pharmaceutical manufacturing, federal procurement policy, and patient safety. Participants included representatives from B. Braun Medical, Belcher Pharmaceuticals, Bravado Pharmaceuticals, BayCare Health System, Moffitt Cancer Center, the University of South Florida, and AARP Florida.
Finance Committee Democrats are preparing to release a prescription drug pricing Request for Information (RFI) to stakeholders as part of an ongoing policy development process that began in early February. Committee Democrats plan to draft a white paper following their review of stakeholder responses.
The Senate will return to session on June 1.
REGULATORY UPDATE
On May 22, the U.S. Food & Drug Administration (FDA) updated its website to announce that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on June 18 to discuss and make recommendations on the safety and effectiveness of MFLUSIVA (Influenza Vaccine, mRNA), manufactured by Moderna.
On May 22, the U.S. Department of Health & Human Services (HHS) issued a declaration under the Public Readiness and Emergency Preparedness (PREP) Act, extending liability protections for favipiravir, an oral antiviral by Fujifilm that is approved in Japan as an emergency influenza treatment, for use related to hantavirus. The declaration is effective through July 18 and follows the recent Andes variant hantavirus outbreak linked to the MV Hondius cruise ship.
On May 23, a Centers for Medicare & Medicaid Services (CMS) spokesperson reported that Rebekah Armstrong, who was running CMS’ Office of Legislation, has been named the Agency’s Chief of Staff. Ms. Armstrong will replace Stephanie Carlton, who will now focus on her Deputy Administrator role.
On May 26, Outlook Therapeutics, Inc. announced that FDA granted its appeal through the Formal Dispute Resolution (FDR) process, concluding that substantial evidence of effectiveness has been established for LYTENAVA (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD). This determination follows completion of the FDR process with the Office of New Drugs (OND).
On May 27, AstraZeneca announced that FDA extended the Prescription Drug User Fee Act (PDUFA) date for the New Drug Application (NDA) for camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) for first-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumors have an emergent ESR1 mutation.
On May 28, FDA’s VRBPAC met to discuss and make recommendations on the selection of the 2026-2027 Formula for COVID-19 vaccines for use in the U.S. The agenda included a vote on whether to recommend the XFG variant as the preferred strain and a discussion of situations that may warrant a vaccine targeting a variant other than the currently favored JN.1 family.
On May 28, HHS, along with the Departments of Labor and Treasury, and the Office of Personnel Management, finalized the Federal Independent Dispute Resolution (IDR) Operations rule, aiming to reduce backlogs and improve transparency in the No Surprises Act’s payment dispute process. The final rule improves the process used to resolve out-of-network payment disputes between providers and payers by cutting administrative costs and improving how disputes are handled. Specifically, the rule cuts the non-refundable administrative fee for each party by more than 85%, from $115 to $15 per dispute, allows more claims to be resolved together in “batched” disputes, and requires payers to use standardized claim codes when communicating about out-of-network services. The rule also lays the groundwork for a new Federal IDR Gateway, a centralized platform that will let users initiate disputes, track status, and manage activity in one place beginning later this year. A fact sheet on the final rule can be found here.
On May 28, CMS released a final rule updating the Increasing Organ Transplant Access (IOTA) Model for Performance Year (PY) 2 and subsequent years. The IOTA Model is a 6‑year mandatory kidney transplant payment model that runs from July 1, 2025, through June 30, 2031. The rule includes provisions that refine participant eligibility, update performance assessment through risk‑adjusted graft survival metrics, and modify payment rules by incorporating Medicare Advantage transplants, among other provision. A fact sheet can be found here.
WHITE HOUSE
On May 25, U.S. District Judge Vince Chhabria ordered the Trump administration to temporarily pause sharing Medicaid patient data with Immigration and Customs Enforcement (ICE) amid an ongoing lawsuit brought by California and 21 other states. The pause will remain in effect while the court considers whether to revise a preliminary injunction issued in December 2025, which permitted ICE to access the names, addresses, and immigration status of undocumented immigrants receiving Medicaid but prohibited access to health history data and information about individuals lawfully present in the U.S.
On May 26, the White House released a summary of recent actions by the White House Task Force to Eliminate Fraud, including a series of measures targeting health care fraud. The update outlines the expansion of its Health Care Fraud Strike Force program by adding 15 new trial attorney positions dedicated to combatting Medicaid fraud.
On May 26, a coalition of 22 Attorneys General sent a letter to Vice President JD Vance declining an invitation to attend a roundtable meeting of the Vice President's Task Force on Fraud, citing less than one business days’ notice and the absence of an agenda. The letter affirmed the states' commitment to Medicaid fraud prevention and raised concerns that recent HHS staffing and programmatic cuts risk undermining federal-state fraud enforcement efforts.
On May 29, President Trump issued an Executive Order directing the Centers for Disease Control and Prevention and its Advisory Committee on Immunization Practices (ACIP) to review a January 2026 HHS report recommending a slimmer childhood vaccine schedule, and to “take any appropriate steps to update” U.S. core childhood vaccine recommendations in line with practices in peer developed countries. The order follows a March federal court injunction in American Academy of Pediatrics (AAP) v. Kennedy that blocked earlier HHS actions to remove several routinely recommended childhood vaccines and stayed controversial changes to ACIP’s membership.
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
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
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
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
CY 2027 Home Health Prospective Payment System Rate Update and Home Infusion Therapy Services Payment Update (CMS-1844); Proposed Rule; 05/11/2026
Strengthening the Integrity of Medicaid and CHIP Managed Care, Financing, and Access to Care (CMS-2450); Proposed Rule; 05/12/2026
Request for Information: Comprehensive Review of the Essential Health Benefits Framework and Typical Employer Standard (CMS-9874); Notice; 05/14/2026
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
Food Standards of Identity Modernization; Pasteurized Orange Juice; Final Rule; 05/08/2026
Forms FDA 3542 and 3542a: Questions and Answers; Draft Guidance for Industry; Availability; Notice; 05/12/2026
Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry; Notice; 05/22/2026
Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry; Availability; Notice; 05/27/2026
HEARINGS
House
Oversight and Government Reform Committee
Universal Basic Fraud: Vulnerabilities in Medicaid Waiver Programs
June 3; 10:00 AM EST; Rayburn 2154
Appropriations Subcommittee on Labor, HHS, Education, and Related Agencies
June 5; 8:00 AM EST; H-140 the Capitol
Senate
Health, Education, Labor & Pensions (HELP)
Protecting Our Children: Exposing the Dangers of Irreversible Gender Transition Procedures on Minors
June 3; 10:00 AM EST; Dirksen 430
Witnesses: Dr. Kurt Miceli, Chief Medical Officer, Do No Harm; Chloe Cole, De-stransitioner and Advocate; Shannon Minter, National Center for LGBTQ Rights.
Homeland Security and Governmental Affairs Subcommittee on Investigations
Plausible Mechanisms of COVID-19 Injections Causing Cancer and Attacks on Scientific Publications
June 3; 2:30 PM EST; Dirksen 342
Witnesses: TBD
REPORTS
Congressional Budget Office (CBO)
On May 28, CBO released a cost estimate for H.R. 2528, the Association Health Plans Act, which would revise the definition of "employer" under the Employee Retirement Income Security Act of 1974 (ERISA) to allow self-employed individuals and groups of employers without a common interest to form association health plans (AHPs). CBO estimates the bill would increase the federal deficit by $4.4 billion over the 2026-2036 period, which is driven primarily by increased federal subsidies for health insurance and larger tax deductions for self-employed people, and projects AHP enrollment would increase by approximately 725,000 people per year on average over 2027-2036.
ADDITIONAL POLICY NEWS
On May 22, the U.S. Government Accountability Office (GAO), announced the appointment of Dr. Amol Navathe, as Chair of the Medicare Payment Advisory Commission (MedPAC), and Gregory Poulsen, as Vice Chair. Benedic Ippolito and Danielle Pierotti were appointed to the commission for the first time. Current Commissioners Dr. Tamara Konetzka and Dr. Brian Miller were reappointed.
On May 26, Lilly announced agreements to acquire three infectious disease vaccine companies for combined potential payments of up to $3.83 billion. The acquisitions would include:
Curevo Inc., for up to $1.5 billion, to obtain amezosvatein, an adjuvanted subunit shingles vaccine in Phase 2 development;
LimmaTech Biologics AG, for up to $780 million, to obtain a platform targeting bacterial pathogens, with the lead program LTB-SA7 in Phase 1 for Staphylococcus aureus; and
Vaccine Company, Inc., for up to $1.55 billion, to obtain In Vivo Nanoparticle (IVN) technologies, including a Phase 1-ready Epstein-Barr Virus (EBV) candidate.
On May 27, the Kaiser Family Foundation (KFF) announced that Drew Altman, Founding President and CEO, will retire from his role on December 31 after nearly 40 years of leadership. The Board of Trustees has appointed Larry Levitt as incoming CEO and Dr. Mollyann Brodie as incoming President, effective January 2027.
On May 29, the Massachusetts Attorney General's Office filed a lawsuit in Suffolk Superior Court against UnitedHealthcare Insurance Company, alleging the company manipulated the health status of MassHealth members enrolled in its Senior Care Options (SCO) plan to secure higher reimbursement payments from the state's Medicaid program. The complaint alleges United improperly classified members at higher levels of care through falsely identifying behavioral health diagnoses, improperly assigning the highest care designation to ineligible members, and misrepresenting the need for daily skilled nursing services.