Health Care Watch: May 18, 2026

The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from May 11 – May 17 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 11, Reps. Diana Harshbarger (R-TN) and Jake Auchincloss (D-MA) and Sens. Josh Hawley (R-MO) and Elizabeth Warren (D-MA) reintroduced the Patients before Monopolies (PBM) Act.  The bill would prohibit a parent company of a pharmacy benefit manager (PBM) from owning a pharmacy, require parent companies to divest pharmacy business, and create authorities for the Federal Trade Commission, U.S. Department of Health & Human Services (HHS), and U.S. Department of Justice Antitrust Division to enforce the law.

• On May 12, Ways & Means Committee Democrat leaders sent a letter to HHS Secretary Kennedy and CMS Administrator Dr. Mehmet Oz requesting answers on the exposure of Medicare provider Social Security numbers (SSNs) on a CMS provider directory website.  The lawmakers cited a Washington Post article reporting that the CMS website linked SSNs to provider names and other identifying information for dozens of providers, and stated that the exposure raises concerns about identity theft and the Administration's handling of sensitive information.

• On May 13, the Energy & Commerce Health Subcommittee held a markup of public health reauthorization bills, as well as bills that strengthen the U.S. Food & Drug Administration (FDA) oversight and improve Medicare outcomes for both patients and providers.  All bills were reported to the full committee by a voice vote.  

Senate 

• On May 16, Health, Education, Labor, and Pensions (HELP) Committee Chairman Bill Cassidy (R-LA) failed to advance in the Louisiana U.S. Senate GOP primary.  Rep. Julia Letlow (R-LA) finished just short of exceeding the 50% threshold needed to become the GOP nominee and will face former Rep. John Flemming (R-LA) in the runoff.

REGULATORY UPDATE

• On May 10, the Administration for Strategic Preparedness & Response (ASPR) and the Centers for Disease Control and Prevention (CDC), announced its support for the U.S. Department of State in repatriating American citizens from the MV Hondius cruise ship affected by the Andes variant of hantavirus.  Passengers will be transported by Department of State airlift to ASPR Regional Emerging Special Pathogen Treatment Centers (RESPCTs), beginning with the facility at the University of Nebraska Medical Center/Nebraska Medicine where each individual will undergo clinical assessment and receive care.  

• On May 11, a CMS spokesperson confirmed to STAT News that Medicare is not forecasting significant spending on the recently approved Alzheimer's medications Leqembi and Kisunla in 2026 or 2027, compared to earlier projections of billions of dollars in annual spending on Leqembi.  STAT News attributed lower-than-expected uptake to challenges such as the intravenous administration of the drugs, required imaging, a limited eligible population, and concerns about modest benefits alongside risks of severe side effects including brain bleeding.  

• On May 11, HHS announced that HHS Secretary Kennedy conducted his "Take Back Your Health" tour across Ohio, with stops in Toledo, Huron, Medina, Cleveland, and Akron.  The Secretary visited a Head Start program, a regenerative farm, an addiction recovery facility, the Cleveland Clinic, and Summa Health, and met with the CEOs of the Cleveland Clinic, University Hospitals, MetroHealth, and Summa Health to discuss a prevention-first approach to health care.  

• On May 11, Substance Abuse and Mental Health Services Administration (SAMHSA) sent an email to mental health and addiction groups indicating that the agency will remove the Buprenorphine Provider Locator and the Pharmacist Verification of Buprenorphine Provider databases from SAMHSA.gov beginning June 1.  SAMHSA cited the 2023 Mainstreaming Addiction Treatment Act, which eliminated the federal requirement that practitioners apply for a special waiver before prescribing buprenorphine, and stated that "it was not possible to add new practitioners" to the existing tools.  SAMHSA indicated that they plan to develop a new locator, with voluntary inclusion for practitioners.  

• On May 12, HHS Office on Women's Health (OWH) announced a Memorandum of Understanding (MOU) with Heartland Forward to advance maternal health outcomes and improve care for women and families.  Under the partnership, HHS and Heartland Forward will exchange information, align strategies, and collaborate on evidence-based initiatives to reduce maternal morbidity and mortality, including expanding the HHS Perinatal Improvement Collaborative (HHS PIC), a nationwide network currently spanning more than 220 hospitals.  

• On May 12, HHS and CMS announced that the Healthcare Advisory Committee will hold its first meeting on May 18 at 2 p.m. via virtual webinar.  The public meeting will focus on introducing committee members, outlining the committee's vision, and establishing bylaws.  

• On May 12, FDA published a Request for Information (RFI) titled Drug Repurposing for Unmet Medical Needs, opening a public docket to solicit input on priority disease areas and potential candidates for repurposing FDA-approved drugs.  Comments are due by June 11.  

• On May 13, CMS announced a six-month, nationwide moratoria on new Medicare enrollment for hospices and home health agencies (HHAs), in coordination with Vice President JD Vance's Anti-Fraud Task Force.  CMS stated it will use the period to intensify targeted investigations, deploy data analytics, and accelerate the removal of hospice and HHA providers suspected of fraud, building on a similar moratorium issued earlier this year for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) companies.  

• On May 13, CMS announced 30 health care organizations as early adopters of its Electronic Prior Authorization (PA) Acceleration initiative, part of the agency's Health Tech Ecosystem effort to address implementation challenges ahead of 2027 PA requirements.  The initiative complements the CMS Interoperability and PA final rule, which requires certain impacted payers to support API-enabled data exchange using FHIR-based standards, defined timeframes for PA decisions, and public reporting of PA metrics by the January 1, 2027 deadline.  

• On May 13, the U.S. Department of Commerce's Bureau of Industry and Security (BIS) published a notice establishing procedures for pharmaceutical companies to apply for company-specific onshoring agreements to obtain tariff adjustments under Presidential Proclamation 11020.  Proclamation 11020 imposed a 100% ad valorem tariff on certain imports of patented pharmaceuticals and associated ingredients effective September 29; companies with approved onshoring plans would receive a reduced 20% duty rate, and the rate would be zero through January 20, 2029, for companies that also enter into Most Favored Nation (MFN) pricing agreements with the HHS.  Applications are requested by June 12.  

• On May 13, Rich Danker, Assistant Secretary for Public Affairs at HHS and chief spokesman for HHS Secretary Kennedy, resigned in protest of administration efforts to allow major tobacco companies to sell flavored e-cigarettes.

• On May 15, it was reported that Dr. Donald Prater was selected as FDA’s Deputy Commissioner for Food, replacing Kyle Diamantas, who will become FDA’s Acting Commissioner. 

• On May 15, it was reported that Tracy Beth Høeg, Acting Director of FDA’s Center for Drug Evaluation and a close ally of former FDA Commissioner Makary, is departing the agency immediately.  Michael Davis, the center’s current Deputy Director, is expected to step in as Acting Director.

• On May 15, CMS issued the Notice of Benefit and Payment Parameters for 2027 final rule that sets standards for Health Insurance Exchanges, health insurance issuers, and the agents and brokers who connect consumers to Affordable Care Act coverage.  The rule finalized provisions including removing standardized plan requirements, letting non-network plans participate in the exchanges, and expanding catastrophic plans, among many other changes.  A fact sheet can be found here. 

WHITE HOUSE

• On May 11, President Trump announced a set of initiatives focused on family support, fertility care, and childcare.  The actions include new federal guidance encouraging employers to provide fertility benefits, the launch of Moms.gov as a digital resource hub for new and expectant mothers, and childcare reforms aimed at expanding access, affordability, and provider choice.  President Trump also announced the launch of Mom.gov, a website providing information for new and expecting mothers.  The platform features resources on pregnancy centers, FQHCs, nutrition, TrumpRx, preconception health, breastfeeding, mental health, and adoption.  

• On May 12, President Trump announced the resignation of FDA Commissioner Dr. Marty Makary.  He named Kyle Diamantas, who previously served as the FDA's Deputy Commissioner for Food, as acting commissioner.  

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

• 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 

• 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

• Food Standards of Identity Modernization; Pasteurized Orange Juice; Final Rule; 05/08/2026 

• Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities--Questions and Answers; Revised Draft Guidance for Industry; Availability; Notice; 05/11/2026 

• Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Notice; 05/12/2026 

• Forms FDA 3542 and 3542a: Questions and Answers; Draft Guidance for Industry; Availability; Notice; 05/12/2026

HEARINGS

House

• Ways & Means Committee

Potential markup of health policy legislation

May 20; time TBD; 1100 Longworth

Legislation may include the Ensuring Community Access to Pharmacist Services Act (HR 3164), the Provider Reimbursement Stability Act (HR 8163), the Chiropractic Medicare Coverage Modernization Act (HR 539), and legislation to improve home dialysis; reduce fraud in home health, hospice and durable medical equipment; and non-profit hospital reporting.

• Energy & Commerce Health Subcommittee

Examining the Medicare Physician Fee Schedule, MACRA, and Opportunities for Payment Reforms

May 20; 2:00 PM EST; 2123 Rayburn

Witnesses: TBD

• Education & Workforce Subcommittee on Health, Employment, Labor, and Pensions

Bad Medicine: Politics Unions and Antisemitism in Health Care

May 20; 10:15 AM EST; 2175 Rayburn

REPORTS 

Office of Inspector General (OIG) 

• On May 12, HHS OIG released an audit report finding that unclear Medicare requirements led to differing interpretations among OIG, CMS, and inpatient rehabilitation facility (IRF) stakeholders regarding documentation, coverage, and billing requirements.  OIG made four recommendations to CMS, including revising or clarifying IRF documentation, coverage, and billing requirements and offering training to IRFs; CMS concurred with just one recommendation.

ADDITIONAL POLICY NEWS

• On May 11, UnitedHealth Group’s pharmacy benefits business, Optum Rx, announced a new pharmacy care model that replaces traditional pricing structures tied to manufacturer drug prices or prescription volume with a transparent, fee-based structure for all PBM customers.  Optum Rx also launched two consumer-facing tools: Shop MyScript, which notifies patients of pricing and pharmacy options after a prescription is written; and Price Wise, which displays a full cost breakdown including drug price and service fee for medications purchased without benefits.  

• On May 11, the Journal of the American Medical Association (JAMA) published a perspective by Jacob Shiff, MBA, and Abe Sutton, JD, of the CMS Innovation Center, detailing the recently announced Advancing Chronic Care With Effective, Scalable Solutions (ACCESS) model, a 10-year payment model launching in July 2026.  

• On May 13, CVS announced that it received court approval to sell its long-term care pharmacy, Omnicare, to GenieRx Holdings LLC. 

• On May 14, the Supreme Court issued an order that continues to block the 5th Circuit Court of Appeals decision that would invalidate FDA regulations expanding telehealth and mail access to mifepristone.  The order maintains online and mail-order access to mifepristone, without in-person dispensing, while lawsuits proceed in the lower courts.