Health Care Watch: July 28, 2025
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from July 20 – July 26. 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 July 22, the Ways & Means Health and Oversight Subcommittees held a joint hearing entitled Medicare Advantage: Past Lessons, Present Insights, Future Opportunities. The hearing discussed various aspects of the MA program including prior authorization, upcoding, chronic disease, increasing spending in the MA program, supplemental benefits, and transparency. Many Democratic members of the subcommittee discussed the recently passed reconciliation bill and its impacts on the larger health care ecosystem and uninsured populations. Broadly, committee members agreed on the need for general reform to the MA program, primarily around prior authorization and increased plan transparency
On July 22, Ways & Means Health Subcommittee Ranking Member Lloyd Doggett (D-TX) and Greg Murphy (R-NC) introduced the Prompt and Fair Pay Act. The legislation would establish a floor requiring MA plans to reimburse for all covered health care items and services at least what would have been paid under Medicare Parts A and B. The legislation also establishes prompt payment rules for clean in-network claims, which are requirements that would mirror those under Medicare Part D.
On July 22, the Energy & Commerce Subcommittee on Oversight and Investigations held a hearing entitled Ensuring Patient Safety: Oversight of the U.S. Organ Procurement and Transplant System. The hearing came after the release of a Health Resources & Services Administration (HRSA) investigation into a Kentucky-based organ procurement organization where reports found organs were procured from patients showing signs of life.
On July 23, Centers for Medicare & Medicaid Services (CMS) Administrator Dr. Mehmet Oz met with members of the Ways & Means Committee. Dr. Oz defended the One Big Beautiful Bill Act’s Medicaid cuts, stating they were targeted efforts to curb waste, fraud and abuse. Democratic members of the Committee criticized the format, suggesting it should have been a public hearing.
On July 23, Ways and Means Committee Chairman Jason Smith (R-MO) and Oversight Subcommittee Chairman David Schweikert (R-AZ) requested that three Organ Procurement Organizations (OPOs) provide the Committee with financial records, information related to the use of private jets, and other documents following allegations of potential Medicare reimbursement fraud and abuse. The letters to the OPOs follow a public call for information as part of the Committee’s examination into whether these tax-exempt organizations are abiding by the existing laws and regulations that govern them.
On July 23, the Energy and Commerce Committee voted unanimously to advance H.R. 4273, Over-the-Counter Monograph Drug User Fee Amendments.
The House is in recess until September 2.
Senate
On July 21, Finance Committee Ranking Member Ron Wyden (D-OR) and Sen. Mark Warner (D-VA) sent a letter to Department of Health & Human Services (HHS) Secretary Robert F. Kennedy, Jr., and CMS Administrator Oz asking the Administration to share its plans to help small and rural hospitals meet federal cybersecurity standards, as well as its plan to use the rural health transformation program to fund cybersecurity improvements.
On July 22, the Senate voted 50-47 to confirm Terry Cole as Administrator of the Drug Enforcement Administration (DEA).
On July 22, Finance Committee Ranking Member Wyden (D-OR) and Minority Leader Chuck Schumer (D-NY) launched a caucus effort to repeal the health provisions of the reconciliation bill. The Senators introduced legislation to repeal all health provisions included in the health title of the One Big Beautiful Bill Act
On July 22, Finance Committee Chairman Mike Crapo (R-ID) told reporters that he is looking to reform to pharmaceutical benefit manager (PBM) practices and address provider upcoding via legislation later this year.
On July 23, Majority Leader John Thune (R-SD) stated that Congress will need to pass a short-term funding bill to avoid a shutdown in October. Leader Thune stated that the goal is to pass many of the 12 appropriations bills into law and use the temporary funding to fund the remainder of the government.
On July 23, Health, Education, Labor & Pensions (HELP) Committee Chairman Bill Cassidy (R-LA) called on major health care provider and insurer organizations to comply with President Trump’s executive order (EO) on gender affirming care for minors. He requested information from these entities on whether they use taxpayer dollars to provide care or coverage for gender transition services for minors.
On July 24, the HELP Committee voted to recommend Dr. Brian Christine to serve as HHS Assistant Secretary for Health.
REGULATORY UPDATE
On July 21, the Food & Drug Administration announced that Dr. George Tidmarsh will serve as Director of the Center for Drug Evaluation and Research (CDER). Dr. Tidmarsh will take over for Dr. Jacqueline Corrigan-Curay who has been serving in an acting capacity.
On July 21, CMS’ Innovation Center announced that it is hiring for dozens of new positions. According to former and current CMS employees, the Center is looking to hire roughly 100 positions. These postings come after 300 CMS employees were let go due to Trump Administration reductions in force and agency reorganization.
On July 21, HHS announced an initiative to begin reforming the organ transplant system following a HRSA investigation. HHS stated that HRSA’s independent investigation of a federally-funded OPO serving Kentucky, southwest Ohio, and part of West Virginia revealed clear negligence – even though the previous Organ Procurement and Transplantation Network (OPTN) Board of Directors claimed to find no major concerns in their internal review. HHS has stated that the OPO must conduct a full root cause analysis of its failure to follow internal protocols and develop clear, enforceable policies to define donor eligibility criteria and must adopt a formal procedure allowing any staff member to halt a donation process if patient safety concerns arise. Secretary Kennedy has stated that he will decertify the OPO if it fails to comply with these corrective action requirements.
On July 22, FDA released additional information on the Commissioner’s National Priority Voucher (CNPV) pilot program – including eligibility criteria, statement of interest requirements, and selection criteria. The new voucher may be redeemed by manufacturers to participate in a novel priority program by the FDA that shortens its review time from 10-12 months to 1-2 months following a sponsor’s final drug application submission. To apply, manufacturers must submit a brief “statement of interest” on the FDA website that includes a description of how the drug development program aligns with the identified national health priority. National priorities include: addressing a U.S. public health crisis; delivering more innovative cures for the American people; addressing a large unmet medical need; onshoring drug development and manufacturing to advance the health interests of Americans and strengthen U.S. supply chain resiliency; and increasing affordability.
On July 23, HHS Secretary Kennedy signed the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommendations to remove the mercury-based preservative thimerosal from all influenza vaccines distributed in the United States. This move follows a 5-1-1 vote at the ACIP’s June 25-26 meeting where committee members voted that all children 18 years and younger, pregnant women, and adults receive only single-dose influenza vaccines free of mercury.
On July 24, FDA launched its Regulatory Accelerator, an initiative featuring specific FDA resources that have been curated and presented to meet the information needs of digital health innovators. The goal of the Accelerator is to help innovators create higher quality and complete submissions, facilitate review, help speed up time to market, and ultimately increase patients’ access to safe and effective devices.
On July 24, FDA Commissioner Marty Makary stated that roughly a quarter of the 3,500 FDA employees who received reduction-in-force notices earlier this year have been reinstated. Commissioner Makary indicated that he does not plan for more layoffs at FDA. Commissioner Makary also stated that FDA is still on track to meet its user fee targets despite a high vacancy rate among scientific reviewers.
On July 24, the Federal Trade Commission (FTC) held a second listening session on lowering drug prices, as directed by President Trump’s Executive Order (EO) on Lowering Drug Prices by Once Again Putting Americans First. The event focused on formulary and benefit practices used by drug manufacturers and PBMs. The agenda can be found here.
WHITE HOUSE
On July 24, President Trump issued an EO entitled Ending Crime and Disorder on American Streets. The EO directs the Attorney General, HHS Secretary, the Secretary of Housing and Urban Development, and the Secretary of Transportation to assess their discretionary grant programs and determine whether priority for those grants may be given to grantees in States and municipalities to: 1) enforce prohibitions on open illicit drug use; 2) enforce prohibitions on urban camping and loitering; and 3) enforce prohibitions on urban camping and loitering. Among other provisions it also directs the HHS Secretary to ensure that discretionary grants issued by the Substance Abuse and Mental Health Services Administration (SAMHSA) for substance use disorder prevention, treatment, and recovery fund evidence-based programs do not fund programs that fail to achieve adequate outcomes, including harm reduction or safe consumption programs.
A list of all administrative and health care-related EOs can be found here. FHP Strategies will update this document, as needed.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Medicaid Eligibility Changes Under the Affordable Care Act of 2010; Giving States Freedom to Use Immigration Information to Determine State Residency for Medicaid Eligibility (CMS-2349); Final Rule; 5/27/25
Medicaid Managed Care-State Directed Payments (CMS-2449); Proposed Rule; 6/9/25
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2026 Rates (CMS-1833); Final rule; 6/20/25
Contract Year 2026 Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, and Medicare Cost Plan Programs, and PACE (CMS-4208); Final Rule; 7/9/25
FY 2026 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1835); Final Rule; 7/10/25
FY 2026 Skilled Nursing Facility (SNFs) Prospective Payment System and Consolidated Billing and Updates to the Value-Based Purchasing and Quality Reporting Programs (CMS-1827); Final Rule; 7/10/25
FY 2026 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Program (CMS-1829); Final Rule; 7/10/25
FY 2026 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1831); Final Rule; 7/10/25
Medicaid Program; Prohibition on Federal Medicaid Funding for Sex Trait Modification Procedures Furnished to Children and Youth (CMS-2451); Proposed Rule; 7/18/25
FDA
Requirements for Additional Traceability Records for Certain Foods: Compliance Date Extension; Proposed Rule; 5/27/25
Approaches to Assessment of Overall Survival in Oncology Clinical Trials; Draft Guidance; Notice; 6/17/25
Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency; Guidance for Industry and Food and Drug Administration Staff; Availability; Notice; 6/30/25
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
Safety Labeling Changes--Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability; Notice; 7/21/25
Development of Non-Opioid Analgesics for Chronic Pain, Draft Guidance for Industry; Availability; Notice; 7/21/25
Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Guidance for Industry; Availability; Notice; 7/21/25
HRSA
340B Rebate Guidance; Notice; 6/1/25
REPORTS
Congressional Budget Office (CBO)
On July 21, CBO released its final estimated budgetary effects of the One Big Beautiful Bill Act. CBO estimates that the legislation will result in a net increase in the unified budget deficit totaling $3.4 trillion over the 2025-2034 period. That increase in the deficit is estimated to result from a decrease in direct spending of $1.1 trillion and a decrease in revenues of $4.5 trillion. CBO also updated its uninsured figure, estimating that 10 million people over the next 10 years will lose health insurance, down from its earlier estimate of 11.8 million.
Government Accountability Office (GAO)
On July 23, GAO released a report finding that HHS violated the Impoundment Control Act (ICA) by withholding funds for the Head Start Program. GAO found that between January 20, 2025, and April 15, 2025, HHS significantly reduced the rate of disbursement of funds for Head Start grant programs, as compared to amounts disbursed in the same time period in FY 2024. GAO stated that HHS has not provided requested information on the potential impoundment of appropriated funds, yet publicly available evidence, including data recorded by HHS on its Tracking Accountability in Government Grants System, indicates that between January 20, 2025, and April 15, 2025, HHS withheld from disbursement funds appropriated for Head Start. Based on this evidence, GAO concluded that HHS violated the ICA.
HEARINGS
Senate
HELP Committee
July 30; 10:00 AM; 430 Dirksen
HELP Committee to Vote on Bills to Strengthen Americans’ Health Care, Retirement
Legislation to be considered:
S. 2292, Over-the-Counter Monograph Drug User Fee Amendments
S. 1440, Uniformed Services Leave Parity Act
S.___, Kay Hagan Tick Reauthorization Act
S. 2301, Improving Care in Rural America Reauthorization Act of 2025
S. 1727, Employee Ownership Fairness Act of 2025
S. 1728, Employee Ownership Representation Act of 2025
S.___, Retire Through Ownership Act
July 31; 10:00 AM; 430 Dirksen
Making Health Care Affordable: Solutions to Lower Costs and Empower Patients
ADDITIONAL POLICY NEWS
On July 21, Humana announced accelerated efforts to approve care requests as quickly as possible and reduce the administrative burden for physicians associated with prior authorization. The company stated that these actions will reduce the number of prior authorization requirements and make the process faster. Humana stated that by January 1, 2026, it will provide a decision within one business day on at least 95% of all complete electronic prior authorization requests.
On July 23, UnitedHealth Group announced that the Department of Justice (DOJ) has launched criminal and civil investigations into aspects of the company’s Medicare business lines. UnitedHealth Group stated that it is complying with formal criminal and civil requests from the Department.