Health Care Watch: April 19, 2026
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from April 12 – April 19 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 13, Energy & Commerce Committee Ranking Member Frank Pallone (D-NJ), House Ways & Means Committee Ranking Member Richard Neal (D-MA), House Education & Workforce Committee Ranking Member Bobby Scott (D-VA), and Senate Finance Committee Ranking Member Ron Wyden (D-OR) sent letters to 11 pharmaceutical manufacturers requesting detailed information on their drug pricing agreements with the Trump Administration. The letters seek information on pricing structures, affected drugs, the role of direct-to-patient platforms, as well as potential implications for federal programs and patient costs. Lawmakers requested responses by April 27.
On April 14, Rep. Greg Murphy (R-NC) introduced the Every Dollar Counts Act to require that out-of-pocket spending on covered prescription drugs count toward a patient’s deductible and maximum out-of-pocket limit regardless of where the drugs are purchased. The legislation aims to address policies that exclude spending on drugs obtained through direct-to-patient platforms from insurance cost-sharing calculations.
On April 14, the Ways & Means Health Subcommittee held a field hearing titled Modernized Health Care in Practice: Empowering Americans to Live Healthier Lives, to discuss approaches to better prioritize wellness as part of chronic disease prevention and incentivize innovations in care delivery that improve patients’ outcomes. Please contact FHP Strategies for a summary of this hearing.
On April 15, the Energy & Commerce Health Subcommittee held a hearing on legislative proposals to improve public health, including bills related to disease research, treatment access, and therapeutic development.
On April 16, the Ways & Means Committee held a hearing with Department of Health & Human Services (HHS) Secretary Robert F. Kennedy, Jr.
On April 16, the Appropriations Subcommittee on Labor, HHS, Education, and Related Agencies held a hearing with HHS Secretary Kennedy. The hearing focused on funding considerations and resource allocation across HHS programs.
On April 17, the Education and Workforce Committee held a hearing with HHS Secretary Kennedy.
Senate
On April 15, Health, Education, Labor, and Pensions (HELP) Committee Chairman Bill Cassidy (R-LA) released the Money and Value for Patients (MVP) agenda outlining proposals to reduce health care costs and improve price transparency. The effort includes policies to provide direct financial support to patients for out-of-pocket costs, increase access to pricing information for medical services and prescription drugs, and promote competition. It also includes proposals related to nutrition and prevention as part of broader efforts to improve health outcomes. A fact sheet can be found here.
On April 16, the HELP Committee held a hearing to examine how competition can lower prescription drug prices and improve affordability. The hearing focused on policy approaches to increase market competition and reduce costs for patients. Please contact FHP Strategies for a summary of this hearing.
On April 16, HELP Committee Ranking Member Bernie Sanders (I-VT) released a minority staff report during a hearing titled Promises Made, Promises Broken: Prescription Drug Prices Continue to Skyrocket Under President Trump examining trends in prescription drug pricing. The report argued that drug prices increased following implementation of “most favored nation” (MFN) agreements, with companies raising prices on hundreds of drugs and launching new products at high price points. The report also outlines policy proposals, including the Prescription Drug Price Relief Act, aimed at aligning U.S. drug prices with those in peer countries.
REGULATORY UPDATE
On April 13, the Food & Drug Administration (FDA) announced that it reminded more than 2,200 medical product companies and researchers of requirements to submit certain clinical trial results information to ClinicalTrials.gov. The agency sent messages on March 30 to sponsors and investigators associated with more than 3,000 registered trials that do not appear to have reported required results or completed the National Library of Medicine’s quality control review process.
On April 13, the Centers for Medicare & Medicaid Services (CMS) announced it extended the application deadline for the Advancing Chronic Care with Effective Scalable Solutions (ACCESS) Model to May 15 and accepted more than 150 organizations to participate in the model’s initial cohort. The ACCESS Model tests an outcome-aligned payment approach in Original Medicare to expand access to new technology-supported care options that help people improve their health and prevent and manage chronic disease. CMS stated the model is scheduled to launch on July 5.
On April 15, HHS announced the 2026 KidneyX EMPOWER Prize Challenge, a $4 million competition to support innovation in living kidney donation and patient-centered care. The initiative seeks solutions to address barriers to living donation, including donor education, eligibility, and long-term outcomes. HHS also announced a related effort led by the Office of the National Coordinator for Health Information Technology to work with the nephrology community to explore opportunities to improve data standardization and interoperability across the kidney care ecosystem to support care coordination and research.
On April 15, FDA issued a notice titled Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing providing recommendations for evaluating the safety of genome editing therapies. The guidance outlines standardized approaches for assessing off-target editing risks, including sequencing strategies, sample selection, and reporting considerations for investigational new drug (IND) applications and Biologics License Applications (BLAs). Comments on the rule are due by July 14. The notice can be found here.
On April 16, FDA issued a notice requesting input from the Pharmacy Compounding Advisory Committee (PCAC) on whether seven peptide substances should be added to the list of drug ingredients that may be compounded. FDA announced the committee will meet on July 23 and 24 to evaluate the safety and regulatory status of these peptides, which are currently restricted from compounding.
On April 16, President Trump nominated Dr. Erica Schwartz, a former Deputy Surgeon General and retired Rear Admiral in the U.S. Public Health Service, to lead the Centers for Disease Control and Prevention (CDC). Schwartz is a board-certified physician in preventive medicine with a law degree. She spent most of her career in the U.S. Navy and Coast Guard, serving in a variety of positions, including as the Coast Guard’s preventive medicine chief. If confirmed, Schwartz would replace NIH Director Jay Bhattacharya, who has been serving as the de facto acting lead.
On April 16, HHS announced the appointment of Casey Mulligan as Chief Economist and Chief Regulatory Officer to advise agency leadership on health care affordability issues.
On April 16, FDA announced it is encouraging sponsors of approved testosterone replacement therapy (TRT) products to pursue a potential new indication for low libido in men with idiopathic hypogonadism. The announcement follows FDA review of emerging clinical evidence suggesting TRT may be safe and effective for certain patients without a known cause of low testosterone. FDA encourages holders of currently approved TRT new drug applications interested in seeking approval for the new indication contact FDA by April 30.
On April 17, CMS announced the agenda for the First Biannual 2026 Healthcare Common Procedure Coding System (HCPCS) Public Meeting, scheduled for June 1 and 2. The agenda provides background information and preliminary coding decisions for a wide array of medical products, including advanced wound dressings, lymphedema compression treatment items, and other Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS). Final coding determinations are expected to be published around August with an effective date of October 1.
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
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
Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke; Established List Additions and Request for Comments; Notice; 03/19/2026
HEARINGS
House
Ways and Means Committee
Protecting Patients and Taxpayers: Cracking Down on Medicare Fraud
April 21; 10:00 AM; 1100 Longworth
Witnesses: TBA
Hearing on Provider Consolidation and Health Care Costs
April 28; Time TBA; 1100 Longworth
Witnesses: Health system CEOs
Education & Workforce Health, Employment, Labor, and Pensions Subcommittee
Profits Over Patients: The PBM Business Model Under Scrutiny
April 22; 10:15 AM; 2175 Rayburn
Witnesses: TBA
Senate
Appropriations Labor, HHS, Education, and Related Agencies Subcommittee
April 21; 2:30 PM; 124 Dirksen
Witness: HHS Secretary Kennedy
Finance Committee
The President’s Fiscal Year 2027 Department of Health and Human Services Budget
April 22; 10:00 AM; 215 Dirksen
Witness: HHS Secretary Kennedy
HELP Committee
Hearing on Fiscal Year 2027 Department of Health and Human Services Budget
April 22; 2:00 PM; 430 Dirksen
Witness: HHS Secretary Kennedy
REPORTS
Office of Inspector General (OIG)
On April 14, the HHS OIG issued Advisory Opinion No. 26-07 evaluating a proposed arrangement between a Medicare Advantage (MA) organization’s subsidiaries that offer employer group waiver plans (EGWPs) and the employer and union group sponsors. Under the arrangement, the plan would share a percentage of savings with sponsors if a final calculated negotiated medical expense ratio was less than a negotiated target. Under the agreement, any gainsharing arrangement would be required to benefit enrollees. OIG issued a favorable opinion and concluded that, although the arrangement could generate remuneration under the Federal anti-kickback statute, it would not impose administrative sanctions under the Social Security Act.
Government Accountability Office (GAO)
On April 14, GAO released a report titled Veterans Community Care Program: Information on Behavioral Health Referrals, Fiscal Years 2021 Through 2024 examining referrals for behavioral health services through the Department of Veterans Affairs (VA) Veterans Community Care Program. The report found that veterans received over 600,000 referrals for behavioral health care from 2021 through 2024, with more than half for outpatient therapy. GAO also found that VA spent $4.29 billion on these services, with over two-thirds of spending associated with inpatient care, including residential treatment.
On April 16, GAO released a report titled VA Health Care: Efforts To Assess Mental Health Support For Veteran Caregiver Program Need Strengtheningexamining VA’s to evaluate mental health support for caregivers. The report found that the Veterans Health Administration (VHA) Caregiver Support Program served approximately 98,000 caregivers in fiscal year 2025 and obligated $2.6 billion but lacked comprehensive performance goals and data to assess outreach and service effectiveness. GAO recommended that VA establish quantitative targets, collect additional data, and use this information to better assess program performance and caregiver support outcomes.
ADDITIONAL POLICY NEWS
On April 13, the Peterson Health Technology Institute released a study examining the impact of artificial intelligence (AI) on prior authorization and medical coding processes. The study found that use of AI may increase administrative complexity, including more prior authorization interactions and more intensive medical coding practices.
On April 20, the Coalition to Strengthen America’s Healthcare, a group led by the American Hospital Association (AHA) and the Federation of American Hospitals, will announce the launch of a national advertising campaign focused on insurer practices. The campaign includes a television advertisement that highlights delays in patient care and customer service challenges and asserts that insurer practices contribute to higher medical costs. The announcement is part of a broader multi-million-dollar campaign by provider groups amid ongoing policy debates over drivers of health care costs.
Rudy S. Missmar | Principal | FHP Strategies
25 Mass. Ave. NW | Suite 500-H | Washington, D.C. 20001
(202) 448 1647 Tel | rudy.missmar@fhpstrategies.com