THIS WEEK’S DOSE

• Senate HELP Committee advances legislation, examines healthcare affordability. The legislation would reauthorize expiring programs, including the Over-the-Counter Monograph Drug User Fee Program.
• Senate Appropriations Committee advances HHS funding. The Labor, Health and Human Services (HHS), and Education appropriations bill advanced by a wide bipartisan margin.
• Senate Finance Committee considers HHS nominations. The committee advanced the nominee for assistant secretary for family support at HHS, and nominees for assistant secretary of financial services at HHS and general counsel of HHS testified.
• Senate Democrats introduce legislation to repeal reconciliation health provisions. The entire Democratic caucus cosponsored the bill.
• White House announces health IT interoperability pledge. More than 60 healthcare and information technology (IT) firms pledged to work collaboratively on a patient-centered health technology ecosystem.
• HRSA announces 340B rebate model pilot program. The Health Resources and Services Administration (HRSA) outlined a voluntary program to test a rebate model on a select group of drugs.
• CMS releases FY 2026 Medicare Hospital IPPS final rule. The Centers for Medicare and Medicaid Services (CMS) fiscal year (FY) 2026 Medicare Hospital Inpatient Prospective Payment System (IPPS) final rule updates Medicare payment policies and quality reporting programs relevant for inpatient hospital services.
• White House takes steps on MFN drug pricing. The president sent letters to 17 pharmaceutical manufacturers about implementing most-favored nation (MFN) pricing.

CONGRESS

Senate HELP Committee advances legislation, examines healthcare affordability. The Senate Health, Education, Labor, and Pensions (HELP) Committee unanimously passed:

• S. 2292, the Over-the-Counter Monograph Drug User Fee Amendments (OMUFA), would revise and extend the expiring program through fiscal year (FY) 2030. The House Energy and Commerce Committee advanced its version of OMUFA last week, which notably did not include the Senate’s provisions related to sunscreen or prescription to non-prescription switches.
• S. 2301, the Improving Care in Rural America Reauthorization Act of 2025, would reauthorize several rural health grant programs through FY 2030.
• S. 2398, the Kay Hagan Tick Reauthorization Act, would reauthorize the Kay Hagan Tick Act through FY 2030.

The committee also held a hearing on healthcare affordability where witnesses highlighted transparency and oversight of vertically integrated entities as possible solutions to affordability issues. Republicans raised concerns about the lack of clarity in programs such as 340B and the role of pharmacy benefit managers in drug pricing. They advocated for market-based reforms. Democrats were more focused on systemic reform, with several members advocating for stronger federal oversight, expanded public options, and Medicare for All.

Senate Appropriations Committee advances HHS funding. The FY 2026 Labor-HHS funding bill advanced in a 26 – 3 vote and, notably, includes a $400 million increase to the National Institutes of Health. The report language can be found here, and a summary of the bill, as prepared by the committee, can be found here. Additionally, the committee released its 79-page list of congressional directed spending (otherwise known as earmarks) for the Labor-HHS bill.

Senate Finance Committee considers HHS nominations. Gustav Chiarello III, nominee for assistant secretary of financial services at HHS, and Michael Stuart, nominee for general counsel of HHS, testified in front of the committee. Republicans agreed that both candidates were qualified for their positions, bringing a range of experience to their respective role; their discussion focused on conscience rights of providers, Title X funding, Medicaid fraud, and rural healthcare. Democrats expressed concerns about the Emergency Medical Treatment and Labor Act, HHS reorganization, Head Start, canceled grants, and hospital payment discrepancies.

Additionally, the committee advanced the nomination of Alex Adams to be assistant secretary for family support at HHS in a 14 – 13 party-line vote.

Senate Democrats introduce legislation to repeal reconciliation health provisions. Senate Democrats, led by Minority Leader Schumer (D-NY), introduced S. 2556, the Protecting Health Care and Lowering Costs Act, which would repeal the healthcare provisions of the recently passed Republican reconciliation package, H.R. 1, the One Big Beautiful Bill Act. The entire Democratic caucus cosponsored S. 2556.

ADMINISTRATION

White House announces health IT interoperability pledge. During a White House event hosted in partnership with CMS, the administration announced that, in addition to the 60 firms that pledged to work collaboratively on a patient-centered health technology ecosystem, 21 data networks pledged to meet the administration’s newly unveiled interoperability framework. The framework outlines data-sharing criteria and participant categories. The criteria include:

• Patient access and empowerment. Patients can access their full health and insurance data, including clinical records, claims, and prior authorizations, through any app of their choice, without needing provider-specific logins, as long as they use a CMS-verified digital identity.
• Provider access and delegation. Providers with verified credentials and authorization are granted access to patient data (unless restricted by law) for treatment purposes. The framework supports delegated access through trusted vendors, allows payers to query for quality metrics, and permits claims-based data access for recent encounters.
• Data availability and standards compliance. Clinical documents and chart notes are returned in machine- and human-readable formats with timely queries. By July 4, 2026, networks provide or facilitate data access using Fast Healthcare Interoperability Resources (FHIR) application programming interfaces.
• Network connectivity and transparency. Participants agree to be displayed as a CMS aligned network and to update the CMS national provider directory.
• Identity, security, and trust. All queries must include the purpose of the request to ensure lawful disclosures, and to ensure that digital credentials for patients and providers using a CMS-approved service are accepted and that networks maintain verifiable audit logs.

Participants include data networks, electronic health records (EHRs), health systems and providers, payers, and patient-facing apps. In related news, HHS released an open data plan that seeks to improve quality data availability through a unified, department-wide approach. HHS also published three new HHS assets for public use.

HRSA announces 340B rebate model pilot program. The voluntary program, set to begin in January 2026, will last a minimum of one year and will test a rebate model (rather than the direct discount, which is how the program has always operated) on a select group of drugs. Under the rebate model, a covered entity would pay for the drug at a higher price up front, then later receive a post-purchase rebate that reflects the difference between the higher initial price and the 340B price. The model is limited to the initial 10 drugs selected for Medicare drug price negotiation, but HRSA notes that it may expand the model based on the pilot program’s effectiveness.

Manufacturers must submit plans for participation by September 15, 2025. Approvals will be made by October 15, 2025, for a January 1, 2026, effective date. HRSA seeks public comments, which will be due 30 days following the notice’s publication in the Federal Register.

CMS releases FY 2026 Medicare Hospital IPPS final rule. CMS updates Medicare fee-for-service payment rates and policies for inpatient hospitals and long-term care hospitals for FY 2026. Key highlights include:

• Standardized amount: CMS finalized an increase of 2.6% in operating payment rates for general acute care hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality Reporting Program and are meaningful EHR users.
• Transforming Episode Accountability Model (TEAM): Although CMS largely finalized the proposed TEAM policies without change, the agency added a new low-volume hospital policy in response to extensive stakeholder feedback, which would remove downside risk for any episode category in which a hospital had fewer than 31 episodes during the three-year baseline.
• Quality reporting programs: CMS signaled future quality measure concepts related to the Make America Healthy Again priorities of well-being and nutrition, and finalized proposals to remove quality measures on health equity and social determinants of health.
• Wage index: CMS will discontinue the low wage index policy, but implement a temporary transitional policy to phase out the low wage index adjustment for affected hospitals.

The rule also includes the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC) HTI-4 final rule, which finalizes policies related to enabling the use of certified EHRs to submit prior authorizations, select drugs consistent with a patient’s insurance coverage, and exchange electronic prescription information with pharmacies and insurance plans.

White House takes steps on MFN drug pricing. In letters to pharmaceutical manufacturers, President Trump outlined steps the White House is taking to implement MFN drug pricing, including:

• Calling on manufacturers to provide MFN prices to Medicaid patients.
• Requiring manufacturers to stipulate that they will not offer other developed nations better new drug prices than offered to the United States.
• Facilitating direct-to-consumer sales as long as manufacturers offer the MFN price.
• Supporting manufacturers in raising international prices as long as the increased revenues are used to lower drug prices for Americans.

BIPARTISAN LEGISLATION SPOTLIGHT

QUICK HITS

• Senate confirms CDC director. Susan Monarez was confirmed as Centers for Disease Control and Prevention (CDC) director in a 51 – 47 party line vote.
• Medicare Part D premiums to increase. CMS announced that the average base premium will increase by $2.21 in 2026 and released updated parameters for the voluntary Part D Premium Stabilization Demonstration.
• FTC issues RFI on gender-affirming care for minors. The Federal Trade Commission (FTC) seeks to evaluate whether gender-affirming care providers failed to disclose material risks or made unsubstantiated claims about the care’s benefits or effectiveness. Comments are due by September 26, 2025.
• HHS announces hepatitis C pilot. The pilot program will provide $100 million in grants for states and community-based organizations to prevent, test for, treat, and cure hepatitis C in individuals with substance use disorder or serious mental illness.
• States sue administration over access to gender-affirming care.  In Massachusetts District Court, 16 states and DC argue that the administration is unlawfully seeking to impose a nationwide ban on the treatments.

NEXT WEEK’S DIAGNOSIS

Barring any surprises or delays as the Senate continues to work on confirming President Trump’s nominees, the Senate is scheduled to head home and join the House next week, officially kicking off four weeks of August recess. Following suit, the Check-Up will be on hiatus until August 22, 2025, when we will provide you with a mid-recess roundup.