Health Care Watch: March 28, 2026
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from March 22 – March 28 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 26, the Energy & Commerce Health Subcommittee held a legislative hearing titled Policies to Protect Our Communities from Illicit Drug Threats. Subcommittee members discussed multiple bills that would address illicit substances and substance use disorder, including legislation related to xylazine, nitazenes, pill presses, and opioid use disorder treatment policies.
On March 27, Energy & Commerce Committee Ranking Member Pallone and Health Subcommittee Ranking Member Diana DeGette (D-CO) sent a letter to Chairman Brett Guthrie (R-KY) and Health Subcommittee Chairman Morgan Griffith (R-VA) requesting oversight of confidential agreements between the Trump Administration and pharmaceutical manufacturers. The lawmakers requested that committee leadership seek disclosure of the agreements’ terms, emphasizing the need for congressional access to the agreements to support oversight of drug pricing policies
The House is in recess until April 14.
Senate
On March 25, Health, Education, Labor, & Pensions (HELP) Committee Chairman Bill Cassidy (R-LA), along with four other Republican Senators, announced an investigation into abortion drug manufacturers’ compliance with Food & Drug Administration (FDA) safety requirements. The lawmakers posed a series of questions to the manufacturers and urged FDA to take action against the online sale of unapproved and misbranded abortion drugs and requested information from manufacturers regarding adherence to Risk Evaluation and Mitigation Strategy (REMS) requirements. Responses are requested by April 8.
On March 25, HELP Committee Chairman Cassidy announced an expansion of his investigation into medical organizations’ roles in pediatric gender care guidelines. Chairman Cassidy requested information from the American Academy of Pediatrics (AAP) and the Endocrine Society regarding communications related to clinical recommendations and age considerations for gender-related medical interventions by April 7.
On March 25, Sen. Jeanne Shaheen (D-NH) led a bipartisan group of Senators in introducing the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act of 2026. The legislation would cap out-of-pocket insulin costs at $35 per month for individuals with private or employer-sponsored insurance and establish a pilot program for 10 states to provide insulin at the same cost for uninsured individuals. The bill also includes provisions related to pharmacy benefit manager (PBM) rebate pass-through and efforts to increase competition in the insulin market.
On March 26, Sens. Tammy Baldwin (D-WI), Minority Leader Chuck Schumer (D-NY), and Finance Committee Ranking Member Wyden led a group of lawmakers in sending a letter to Centers for Medicare & Medicaid Services (CMS) Administrator Dr. Mehmet Oz requesting the agency withdraw the proposed Notice of Benefit and Payment Parameters for 2027. The lawmakers raised concerns that the proposed rule’s provisions related to catastrophic plans, network requirements, and plan design flexibility could reduce enrollment and increase out-of-pocket costs. The letter requested that CMS instead issue a rule that lowers costs and maintains coverage for marketplace enrollees.
On March 27, Sens. Wyden and Jeff Merkley (D-OR) sent a letter to U.S. Department of Health & Human Services (HHS) Secretary Robert F. Kennedy, Jr., and HHS Office for Civil Rights Director Paula Stannard regarding the agency’s investigation into state laws requiring health insurance coverage of abortion services. The lawmakers raised concerns about the scope of the investigation affecting multiple states and requested that HHS discontinue its review of these state-level coverage requirements.
The Senate is in recess until April 14.
REGULATORY UPDATE
On March 20, the Centers for Disease Control and Prevention (CDC) reported 1,487 confirmed measles cases across 32 jurisdictions in 2026. CDC stated that 94% of cases are associated with outbreaks and that 92% of individuals infected are unvaccinated or have unknown vaccination status.
On March 24, the Administration for Strategic Preparedness and Response (ASPR) announced an $8.3 million award to the API Innovation Center (APIIC) to expand U.S. manufacturing capacity for active pharmaceutical ingredients used in essential hospital medicines. The funding will support domestic production of propofol and metoprolol and aims to establish an end-to-end U.S. based supply chain for metoprolol.
On March 24, CMS announced the Accelerating State Pediatric Innovation Readiness and Effectiveness (ASPIRE) Model to support children and youth with complex medical and behavioral needs through Medicaid and the Children’s Health Insurance Program (CHIP). The model will test whole-person care approaches, including coordinated physical and behavioral health services and caregiver support, with participating states accountable for quality and cost outcomes. CMS stated it will select up to five state Medicaid agencies to participate through a voluntary cooperative agreement.
On March 24, Dr. Robert Malone, an ally of HHS Secretary Kennedy confirmed that he is stepping away from the Advisory Committee on Immunization Practices (ACIP). Malone’s departure follows a ruling by Federal Judge Brian Murphy, who concluded the panel acted improperly and restored the initial pediatric vaccine schedule, placing the administration's reshaping of vaccine policies on hold. Malone earlier posted on social media that the decision wouldn’t be appealed, which was contradicted by HHS spokesman Andrew Nixon.
On March 25, FDA approved Avlayah (tividenofusp alfa-eknm) to treat neurologic manifestations of Hunter syndrome (Mucopolysaccharidosis type II) in certain pediatric patients. The approval was granted under the accelerated approval pathway based on reduction of cerebrospinal fluid heparan sulfate, a surrogate endpoint reasonably likely to predict clinical benefit.
On March 26, HHS and CMS announced the members of the Healthcare Advisory Committee, a federal advisory body that will provide nonbinding recommendations to HHS and CMS to improve and modernize Medicare, Medicaid, CHIP, and marketplace programs. The committee will focus on chronic disease prevention, reducing administrative burden, improving data use, strengthening care for vulnerable populations, and enhancing MA sustainability. Members will serve for two years and will publicly meet on a regular basis.
On March 26, FDA approved Kresladi (marnetegragene autotemcel), the first gene therapy for the treatment of severe leukocyte adhesion deficiency type I (LAD-I) in pediatric patients without a matched donor for stem cell transplant. The approval was granted under the accelerated approval pathway based on biomarker improvements observed in a clinical study, with post-marketing requirements to confirm clinical benefit.
On March 26, CMS announced an extension of the deadline for the Outpatient Prospective Payment System (OPPS) Drug Acquisition Cost Survey (ODACS) to April 7. Hospitals paid under OPPS and included on the ODACS provider table are required to submit drug acquisition cost data through CMS’s online system by the updated deadline.
WHITE HOUSE
On March 20, the White House announced the addition of three prescription drugs to the TrumpRx platform. The drugs are manufactured by Boehringer Ingelheim and include: Jentadueto and Jentadueto XR, for Type 2 diabetes, as well as the chronic obstructive pulmonary disease (COPD) drug Striverdi Respimat.
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
Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke; Established List Additions and Request for Comments; Notice; 03/19/2026
Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability; Notice; 03/23/2026
Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry; Availability; Notice; 03/23/2026
Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Notice; 03/23/2026
HEARINGS
House
Ways & Means Committee
Field Hearing on Health Care Affordability
April 14; time TBD; Sarasota, FL
Witnesses: Health care providers
REPORTS
Office of Inspector General (OIG)
On March 25, HHS OIG posted an audit titled Review of the Department of Health and Human Services’ Compliance With the Federal Information Security Modernization Act (FISMA) of 2014 for Fiscal Year 2025. The audit, conducted by Ernst & Young LLP, found that HHS’ information security program was rated “Not Effective” for FY 2025, marking the sixth consecutive year below the “Managed and Measurable” standard required under FISMA. OIG made 10 recommendations to improve oversight and implementation of federal information security requirements across HHS divisions, with HHS concurring with seven recommendations and not concurring with three.
On March 26, HHS OIG posted an evaluation titled Congressional Mandate: Part B Payment Amounts for One Drug Included Noncovered Self-Administered Versions in 2024. The evaluation found that Medicare Part B payment amounts for Omvoh included noncovered self-administered versions of the drug in 2024; and excluding those noncovered drugs would have reduced payment amounts, including a 15% decrease in the fourth quarter. OIG also reported that prior removals of noncovered self-administered versions for other drugs resulted in $1.3 billion in savings to Part B and beneficiaries from 2023 through 2024 and identified Omvoh for potential exclusion from future payment calculations.
On March 27, HHS OIG posted an audit titled Selected Diabetes and Weight Loss Drugs Were Dispensed to Michigan Medicaid Managed Care Enrollees in Accordance With Federal and State Requirements. The audit found that selected diabetes and weight loss drugs were dispensed in compliance with federal and state requirements, with Michigan ensuring managed care organizations adhered to applicable coverage and utilization controls, including prior authorization and quantity limits, for all sampled claims.
Government Accountability Office (GAO)
On March 24, GAO issued a report titled FDA Advisory Committees: More Transparency Needed on Policies for Making Conflict of Interest Determinations. The report found that FDA has not finalized or publicly shared guidance on how it determines financial conflicts of interest for advisory committee members or guest speakers, despite statutory requirements. GAO made three recommendations for FDA to establish a timeline for issuing guidance and to publicly disclose its processes for evaluating conflicts of interest, and HHS concurred with the recommendations.
On March 27, GAO issued a report titled CMS Innovation Center: Obligations and Model Testing Progress. The report found that the CMS Innovation Center obligated $11.4 billion from 2011 through 2024 to test 70 payment and delivery models, including 24 active models as of January 2025, and expanded four models nationwide that achieved net savings. GAO also reported that the Innovation Center established new performance goals in 2025 to guide future model development and assess outcomes.
ADDITIONAL POLICY NEWS
On March 20, the Informed Consent Action Network (ICAN) submitted a petition to HHS Secretary Kennedy requesting amendments to the Vaccine Injury Compensation Program (VICP) injury table. The petition requests that HHS initiate rulemaking to add additional vaccine-related injuries based on associations identified in federal reports and scientific literature.
On March 23, CVS Health’s Caremark and the Federal Trade Commission (FTC) filed court documents indicating they reached a proposed settlement to resolve claims related to insulin pricing practices. The parties requested withdrawal of the case to allow consideration of a consent agreement, which would resolve the claims if approved by the FTC.
On March 26, the Department of Justice (DOJ), through its Antitrust Division and the U.S. Attorney’s Office for the Southern District of New York, filed a civil antitrust lawsuit against New York-Presbyterian Hospital. The complaint alleges that the hospital system used contractual restrictions with payors that limited competition and prevented the development of lower-cost health plans, in violation of Section 1 of the Sherman Act.