Health Care Watch: June 20, 2026
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from June 14 – June 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
The House will return to session on June 23.
Senate
On June 16, Finance Committee Ranking Member Ron Wyden (D-OR), joined by 10 Democrats, released a Request for Information (RFI) seeking input on more than two dozen proposals aimed at lowering prescription drug prices. The RFI focuses on three policy objectives: lowering the price manufacturers charge for prescription drugs, lowering out-of-pocket costs for patients, and fostering biopharmaceutical innovation in areas of unmet need (including bolstering domestic clinical trials and recruiting and maintaining scientific talent). The RFI follows listening sessions with more than 70 external organizations representing patients, consumers and their advocates, academic researchers, think tanks, health insurers, and pharmaceutical companies. Comments are due by August 17.
On June 17, the Health, Education, Labor, & Pensions (HELP) Committee held a markup to advance a series of health care bills, including legislation that would impact the pharmaceutical industry. The U.S. Food & Drug Administration (FDA)/United States Patent and Trademark Office patent transparency bill advanced by a 16-6 vote. The Ensuring Timely Access to Generics Act of 2025, which would clarify when FDA can reject citizen petitions used to delay approval of a generic competitor, did not receive a vote. Committee members voted 22-0 to advance bills reauthorizing programs to reduce infant mortality, connect patients with bone marrow transplant donors, increase breast health education, and continue research into neurodegenerative diseases, along with the Charlotte Woodward Organ Transplant Discrimination Protection Act and the Accelerating Access to Critical Therapies for ALS Act.
On June 17, Finance Committee Ranking Member Wyden and Health Subcommittee Ranking Member Maggie Hassan (D-NH) sent a letter to U.S. Department of Health & Human Services (HHS) Secretary Robert F. Kennedy, Jr., requesting records and information about the decision-making process behind the June 2025 dismissal of all 17 members of the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) and the subsequent rewriting of the ACIP charter. The letter cited Secretary Kennedy's testimony at an April 22 Senate Finance Committee hearing indicating that the White House Domestic Policy Council and President Donald Trump approved the firings and the charter rewrite. The senators requested by July 17 all records and communications between HHS and the White House regarding the firings; records identifying officials involved in approving the firings and selecting replacement members; analyses or briefing materials on potential public health consequences; records of the vetting of replacement appointees, including any role played by outside parties, and records related to compliance with the Federal Advisory Committee Act.
REGULATORY UPDATE
On June 12, HHS Secretary Kennedy announced that HHS filed a motion to expedite its appeal of a March 16 federal district court ruling that halted his overhaul of ACIP and blocked recent changes to the childhood immunization schedule. The decision, in a case brought by the American Academy of Pediatrics and other medical groups, stays the appointment and participation of 13 Kennedy‑selected ACIP members, freezes actions taken by the reconstituted committee, and pauses a January 2026 schedule that reduced the number of routinely recommended childhood vaccines from 17 to 11.
On June 12, FDA granted accelerated approval to Tzield (teplizumab) for a new indication to delay the decline of insulin production in pediatric patients ages 8 through 17 who have been recently diagnosed with Stage 3 type 1 diabetes (T1D). The approval marks the first FDA-approved treatment for this indication. Tzield was previously approved to delay the onset of Stage 3 T1D in adults and pediatric patients 1 year of age and older with Stage 2 T1D.
On June 15, FDA authorized Colorado's Section 804 Importation Program (SIP) for a period of two years, allowing the state to import certain prescription drugs from Canada under section 804 of the Federal Food, Drug, and Cosmetic Act. The FDA determined that the Colorado SIP, which was initially submitted on December 5, 2022 and revised on December 4, 2025, met the statutory requirement of significantly reducing the cost of covered products to American consumers without posing additional risk to public health and safety.
On June 16, FDA approved Rextovy, a 4 milligram naloxone hydrochloride nasal spray, as an additional OTC product for the emergency treatment of opioid overdose. Rextovy contains the same active ingredient as other naloxone nasal sprays and may be purchased directly by consumers without a prescription in pharmacies, convenience stores, and online.
On June 16, the Centers for Medicare & Medicaid Services (CMS) issued an RFI titled Pharmacy Benefit Manager Compensation and Data Collection. CMS notes that the RFI is narrowly focused on gathering information on current PBM business practices to inform two specific requirements added to the Social Security Act by section 6224 of the Consolidated Appropriations Act, 2026: (1) restrictions on the remuneration that PBMs and their affiliates may receive for services in connection with the utilization of covered Part D drugs and (2) data reporting requirements. Both requirements are effective beginning in CY 2028. Comments are due by July 20.
On June 16, FDA posted a briefing document ahead of the June 18 Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to vote on Moderna's MFLUSIVA mRNA influenza vaccine for adults ages 50 and older. FDA staff found that the vaccine did not pose serious safety risks in adults 50 and older but prompted more reactions compared to existing standard-dose flu shots and noted that the company's efficacy data reflects only one flu season and does not include immunocompromised adults. Moderna is seeking traditional FDA approval for adults ages 50 to 64 and accelerated approval for adults 65 and older with a post-marketing requirement to study the vaccine further in the older age group.
On June 17, FDA approved the first generic of Xofluza (baloxavir marboxil) tablets, a single-dose treatment for acute uncomplicated influenza and post-exposure prophylaxis in patients 5 years of age and older. The drug may be used for treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours and for post-exposure prophylaxis following contact with an individual who has influenza.
On June 17, press reports indicate that HHS elevated Rear Admiral Paul Jung to the role of Deputy Surgeon General, after he served in the role in an acting capacity for nearly four months.
On June 17, HHS Secretary Kennedy announced over $700 million in new funding opportunities for behavioral health programs under the Great American Recovery Initiative, including a $96 million funding opportunity for the new Safety Through Recovery, Engagement, and Evidence-based Treatment and Support (STREETS) program. The STREETS program, housed within the Substance Abuse and Mental Health Services Administration (SAMHSA), will award eight communities up to $3 million per year for four years to develop multisector care systems for people who are homeless and have substance use disorders, serious mental illness, or co-occurring disorders.
On June 17, CMS issued a memorandum to Medicare Advantage (MA) organizations announcing it is voluntarily recalculating 2027 Quality Bonus Payment (QBP) ratings for certain MA contracts following the court's May 27 decision in Clover Insurance Company v. HHS. The recalculation uses only select Part C measures and excludes Part D measures; contracts will receive the recalculated rating only if it is higher than their previously assigned rating. Affected contracts may resubmit their contract year 2027 bids by June 29, 2026, and CMS noted the recalculation does not reflect any policy position on the calculation of 2027 Star Ratings, scheduled for release in October 2026, nor the 2028 Quality Bonus Payment ratings.
On June 18, the Office of the U.S. Trade Representative (USTR) announced the initiation of a Section 301 investigation into whether Germany’s “persistent underpayment” for innovative pharmaceutical products is unreasonable or discriminatory and burdens or restricts U.S. commerce, following months of bilateral discussions that failed to resolve U.S. concerns. The investigation will examine Germany’s pricing and reimbursement policies for innovative medicines and will include a public comment process and hearing, after which the administration could consider appropriate responsive action under Section 301.
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
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
Short-Term, Limited-Duration Insurance (CMS-9881); Proposed Rule; 05/30/2026
Request for Information; Clinical Laboratory Improvement Amendments (CLIA) of 1988 Regulations (CMS-3485); Notice; 06/01/2026
Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model (CMS-5546); Final Rule; 06/15/2026
Prohibition on Federal Medicaid and Children's Health Insurance Program Funding for Specified Sex-Rejecting Procedures Furnished to Children and Youth (CMS-2451); Final Rule; 06/16/2026
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
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
Food Standards of Identity Modernization; Pasteurized Orange Juice; Final Rule; 05/08/2026
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
Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Notice; 06/01/2026
New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI: Guidance for Industry; Notice; 06/02/2026
Requirements For Additional Traceability Records For Certain Foods: Compliance Date Extension; Final Rule; 06/03/2026
Rulemaking to Provide by Regulation that an Ingredient Is Not Excluded From the Dietary Supplement Definition; Proposed Rule; 06/05/2026
HEARINGS
House
Energy & Commerce Committee
Health Subcommittee
June 25; time TBA
Markup of health policy legislation
Bills to be considered: TBA
Oversight & Investigations Subcommittee
State Medicaid Program Integrity: Examining Fraud Risks and Oversight Deficiencies
June 25; 10:15 AM EST; 2123 Rayburn
Witnesses: TBA
Ways & Means Committee
Week of June 29
Markup of health policy legislation
Bills to be considered: TBA
Senate
Appropriations Committee
June 25; 10:00 AM EST; 106 Dirksen
Markup of the FDA Appropriations bill
REPORTS
Congressional Budget Office
On June 15, the Congressional Budget Office (CBO) published a blog post examining whether the No Surprises Act (NSA) is producing the $17 billion in savings CBO originally projected from 2021 to 2030. Evidence suggests those savings may not materialize, as providers have filed 3.4 million independent dispute resolution (IDR) disputes since 2022, far exceeding initial projections of approximately 22,000 per year, and have prevailed in more than 80% of cases with awarded payments often exceeding 400 to 500% of Medicare's prices. CBO noted that while the NSA has reduced patient surprise billing and some inflation-adjusted prices have declined, arbitration outcomes could lead to higher health care prices and premiums over time, increasing federal deficits. CBO called for additional research on the law's effects on health care prices, network participation, and arbitration decision-making to inform future cost estimates.
Office of Inspector General (OIG)
On June 15, HHS OIG released an audit finding that a small hospital in the southeastern United States had implemented effective cybersecurity controls to prevent, detect, and respond to cyberattacks, including a custom system designed to block unusual or suspicious activity that successfully identified OIG's simulated cyberattack testing. No name appears anywhere in the report. The audit contained no recommendations.
On June 16, HHS OIG released two companion evaluations of the accuracy of Medicaid managed care provider directories and network lists related to maternal health care. The first evaluation found that online provider directories from Centene, Elevance, and UnitedHealthcare Medicaid managed care plans in five States contained inaccuracies that may limit enrollees' access to maternal health care. Nine percent of maternal health providers who appeared in the plans' directories reported to OIG that they were not in-network, 22% of confirmed in-network providers were not listed in the directories at all, and one-third of in-network providers listed in the directories had at least one inaccurate phone number or address. OIG recommended that CMS take steps to support States in holding Medicaid managed care plans accountable for the accuracy of their online provider directories, and CMS concurred.
The second evaluation found that network lists submitted by Centene, Elevance, and UnitedHealthcare Medicaid managed care plans to five States contained inaccuracies that may compromise State oversight of access to maternal health care. OIG found that approximately one-quarter of maternal health providers listed reported that they were not in-network, plans did not provide accurate phone numbers for more than one-quarter of providers, and nearly half of providers in the network lists did not appear in the plans' public-facing online provider directories. OIG recommended that CMS work with States to improve the accuracy of the provider data used to evaluate Medicaid managed care network adequacy and take steps to hold plans accountable for network list accuracy. CMS concurred with both recommendations.
On June 16, HHS OIG released an audit finding that Jefferson Regional Medical Center, an acute care hospital located in Pine Bluff, AR, received at least $4.7 million in estimated net Medicare overpayments for inpatient and outpatient claims that did not comply with Medicare requirements during a July 2019 through June 2021 audit period. The report stated that this was primarily because the hospital did not always follow its written policies and procedures to prevent incorrect billing. OIG made three recommendations, including that the hospital refund $4.7 million in estimated net overpayments to the federal government.
On June 17, HHS OIG released an audit finding that not all nursing homes' registered nurse (RN) staffing hours reported in the CMS Payroll-Based Journal for March 2024 were supported in accordance with Federal requirements. OIG estimated that nursing homes reported approximately 938,000 unsupported RN hours for approximately 53,000 RNs, representing 42% of RNs in the sampling frame. OIG made four recommendations, including that CMS educate nursing homes on updated guidance for submitting staffing information and communicate trends in Payroll-Based Journal audit findings.
On June 16, HHS OIG released an audit finding that North Dakota could improve its oversight of Home and Community-Based Services (HCBS) residential providers to better ensure health and safety standards for Medicaid waiver enrollees with intellectual and developmental disabilities. Among 16 providers and 51 residential settings reviewed, OIG identified 182 instances of noncompliance with administrative, health, safety, and residential records requirements, including 8 providers with administrative violations and 44 residential settings with health or safety deficiencies, as well as 1 provider without a written infection control and prevention policy. OIG made three recommendations, including that North Dakota follow up with noncompliant providers to ensure corrective actions have been taken and improve its oversight and monitoring of residential providers.
ADDITIONAL POLICY NEWS
On June 12, the U.S. District Court for the District of Maryland ruled that CMS lacks authority to implement certain provisions of the 2025 Affordable Care Act (ACA) Program Integrity Rule, in a case brought by the cities of Baltimore, Chicago, and Columbus, Ohio, along with Doctors for America and the Main Street Alliance. The Court struck down a provision that would have required people automatically reenrolled in marketplace coverage receiving ACA premium subsidies to pay a $5 monthly fee to reconfirm eligibility, finding that CMS lacks authority to alter the ACA subsidy formula established by Congress. The Court also blocked a provision imposing stricter income verification requirements, finding the administration could not support claims that the provision would address issues with fraudulent enrollments. The Court upheld a provision revising the agency's premium adjustment percentage methodology, which incorporates ACA plan pricing data into the calculation used to determine cost-sharing limits and subsidy amounts.
On June 16, the Justice Department's Antitrust Division filed a proposed settlement to resolve a civil antitrust lawsuit against OhioHealth Corporation, which owns or manages 16 hospitals and outpatient facilities in Ohio, alleging the company used contractual restrictions to prevent commercial health insurers from offering health care plan options that would increase competition for Ohio consumers and employers. If approved by the U.S. District Court for the Southern District of Ohio, the proposed consent judgment would void OhioHealth's existing contract provisions that prohibit, penalize, or prevent steering, steered plans, or transparency; prohibit the company from seeking similar provisions in future contracts; prevent it from penalizing insurers for offering lower-cost plan options; and subject the company to a five-year compliance monitor with regular reporting to the Antitrust Division.