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Senate HELP Committee Hearing on the 340B Program

On October 23, 2025, the Senate HELP Committee held a hearing to examine the 340B Program’s growth and impact on patients. The members heard testimony on how the program functions as well as some current challenges that have been identified. There was strong bipartisan support for the continuation of the program, but there were also calls from both sides of the aisle for careful regulations to ensure the program’s continuing success.

Opening Statements

Witness Testimony

  • Michelle Rosenberg, Director, Health Care, U.S. Government Accountability Office (GAO)– Testimony
  • Dr. Aditi Sen, Chief, Health Policy Studies Unit, Congressional Budget Office (CBO) – Testimony
  • William B. Feldman, Physician and Health Policy Researcher, University of California, Los Angeles – Testimony

Member Discussion

The most common line of questioning from members, including Sen. Tuberville (R-AL), Sen. Murkowski (R-AK), Sen. Kim (D-NJ), Sen. Collins (R-ME), and Sen. Banks (R-IN), was regarding how 340B Program facilities use the savings from the program in their operating budgets. Ms. Rosenberg responded each time that there are no specific requirements in the program on how to use the funds, and Dr. Sen elaborated that the CBO does not have the data required to have a full understanding of how different entities are using the funds. Sen. Hassan (D-NH) suggested that reporting requirements for revenue generated by the program could increase transparency and guide future regulations on its use.

Sen. Baldwin (D-WI), who is a member of a bipartisan 340B working group, raised concerns about the new 340B Rebate Model Pilot Program, which requires program participants to purchase pharmaceuticals at market price and receive a rebate later, creating greater upfront costs. Dr. Feldman shared these concerns and suggested a 3rd party clearing house could be a solution to ensure that pharmaceutical companies and health care providers are able to reach equitable agreements.

Sen. Marshall (R-KS) suggested that creating a definition of a patient under the program, considering factors such as recency or frequency of visits, could aid in regulating eligibility requirements. Dr. Sen agreed but cautioned that any narrowing of the definition would have implications that would need to be understood.

When asked by Sen. Kaine (D-VA) and Sen. Baldwin about recommendations for 340B program reforms, Ms. Rosenberg suggested the 15 recommendations GAO previously made to HRSA, through reports on June, 28 2018, January 10, 2020, and January 27, 2020, that have not been implemented. These include addressing duplicate discount policies, more auditing of contracts and hospital systems, and more data collection on cost savings and use. Sen Hickenlooper (D-CO) continued this line of questioning with the need for more HRSA oversight, which requires authorization to impose regulations and staffing levels to uphold them.

Sen. Kim, Sen. Murray (D-CT), Sen. Markey (D-MA), and Sen. Alsobrooks (D-MD) all discussed how stretched 340B hospital systems’ budgets are, and they raised concerns about how policy decisions such as not renewing advance premium tax credits (APTCs) could make things worse. Dr. Feldman agreed and stressed that any increase in the uninsured population would lead to providing more uncompensated care and a larger burden on the providers in those systems. Sen. Collins and Sen. Murkowski were concerned that regulations limiting 340B hospitals would have a disproportionate impact on rural hospitals that rely more heavily on the 340B program to provide care to their patients.

Senate Aging Committee Hearing on How Shoppable Services Improve Outcomes and Lower Costs

On October 22, 2025, the Senate Special Committee on Aging held a hearing on how shoppable health services can improve outcomes and lower costs. Committee members heard testimony on different ways to reduce costs, especially for older Americans.

Witness Testimony 

  • Mark Cuban, Co-Founder, Cost Plus Drugs – Testimony
  • G. Keith Smith, Co-Founder, Surgery Center of Oklahoma and the Free Market Medical Association – Testimony
  • Don Moulds, Chief Health Director, CalPERS – TestimonyJeanne Lambrew, Director of Health Care Reform and Senior Fellow, The Century Foundation – Testimony

Member Discussion

Prescription Drugs and Pharmacy Benefit Managers (PBMs)

One major topic of discussion was ways to address the high cost of prescription drugs. Sen. Tuberville (R-AL) asked how direct-to-patient programs, like Cost Plus Drugs save patients money. Mr. Cuban responded by saying that these companies build trust with patients through transparent pricing and can charge less as there are no intermediaries.

There was bipartisan interest in addressing concerns about PBMs. Sen Husted (R-OH) mentioned his concerns about a lack of competition if insurance companies are able to create monopolies by owning PBMs and pharmacies. He also noted his concerns that this would further increase price and push smaller independent providers out of business. Sen. Warren (D-MA) expanded on this line of questioning through the discussion of the Department of Defense TRICARE provider, Cigna, who also owns PBM Express Scripts, as well as specialty pharmacy Accredo. She noted her concern that this enables Express Scripts to highly encourage patients to use Accredo and reimburse other pharmacies at lower rates causing independent practices to go out of business.

Sen. Justice (R-WV) mentioned mimicking state legislation that passes the PBM cost savings onto patients as a way to respond to large profits by PBMs.

Pricing Transparency

Multiple senators, including Sen. Tuberville, Sen. Marshall (R-KS), and Sen. Moody (R-FL), questioned whether publishing prices encouraged patients to shop for care. Dr. Smith testified that his clinic often serves out-of-state and out-of-country patients due to their low prices. Patients were also able to use his clinic’s publicly posted prices to negotiate with their local hospital systems and price match.

Chairman Scott (R-FL) and Ranking Member Gillibrand (D-NY) were curious about the logistics of reference-based pricing in the CalPERS system and how competition between hospital systems can be beneficial. Dr. Moulds emphasized that due to CalPERS’ size, they had more power than smaller systems but still faced price differentials between geographic areas that had greater amounts of providers and smaller amounts of providers. Dr. Moulds was also frank that not all health services can be referenced-based, and that CalPERS makes decisions on how to balance encouraging members to receive care with the potential cost of care.

Advance Premium Tax Credits (APTC)

Sen. Gillibrand was the first of many members, including Sen. Warnock (D-GA) and Sen. Kelly (D-AZ), to highlight the increased premium costs due to the expiration of APTCs. Concerns were raised about the affordability of health insurance and how the 55-65 aged community will respond to the increased price. Dr. Lambrew emphasized that adults aged 55-65 will be the most affected by the rise in premium costs due to their reliance on the health care marketplace and their greater need to receive care. Dr. Lambrew and Mr. Cuban agreed that many will forgo health insurance to pay for other expenses.

Sen. Johnson (R-WI) pressed Dr. Lambrew on the design of the Affordable Care Act and the continued growth in health care costs. Dr. Lambrew maintained the position that although the tax credits were not part of the original design of the ACA, they were an improvement that should be continued.

Summary of House Energy and Commerce Markup of Health Care Bills

On September 17, 2025, the House Energy and Commerce Committee (E&C) marked up five bills related to various health care issues, including legislation to reauthorize rural health, telehealth, and pediatric rare disease drug development programs. Although the bills marked up enjoyed bipartisan support, Democratic members expressed disappointment that the markup did not include legislation passed out of the E&C Health Subcommittee on September 11 related to reauthorization of health care workforce and newborn screening programs. Democratic members also criticized the One Big Beautiful Bill Act’s provisions related to Medicaid and urged the Committee to pass a permanent extension of the Affordable Care Act (ACA) expanded tax credits. Democratic members called for the committee to conduct oversight on several Department of Health and Human Services (HHS) actions, including the firing of the director of the Centers for Disease Control and Prevention (CDC), the cutting of federal research funding, the reductions in force at HHS, and changes to the Advisory Committee on Immunization Practices. Committee Chair Brett Guthrie (R-KY-2) stated that he was willing to consider such requests but did not commit to a specific timeline for future hearings.

Opening Statements

Health Care Legislation Marked Up

  • H.R. 2493, Improving Care in Rural America Reauthorization Act of 2025 (Rep. Buddy Carter, R-GA-1), a bill to reauthorize grant programs for rural health care services outreach, rural health network development, and small health care provider improvement through Fiscal Year 2030.
    • Reps. Buddy Carter (R-GA-1), Kim Schrier (D-WA-8), and Troy Carter (D-LA-2) expressed support for the bill. However, Rep. Schrier criticized the One Big Beautiful Bill Act for Medicaid cuts and criticized the Rural Health Transformation Fund as being overly focused on the “Make America Healthy Again agenda. Rep. Troy Carter also brought up his disappointment that legislation related to health workforce program reauthorization was not included in the markup.
    • Rep. Kathy Castor (D-FL-14) offered an amendment to insert a permanent extension of ACA tax credits into H.R. 2493, which numerous Democratic members voiced support for. Republicans countered that it was the Inflation Reduction Act that set the ACA expanded tax credit expiration date and that this issue is not within E&C’s jurisdiction. Rep. Guthrie noted that conversations are underway regarding possible next steps related to the tax credits, but that H.R. 2493 is not the bill to extend the tax credits. This amendment was withdrawn.
    • Final vote tally for H.R. 2493: Passed 49-0.
  • H.R. 3419 (Rep. David Valadao, R-CA-22), a bill to reauthorize the telehealth network and telehealth resource centers grant programs through Fiscal Year 2030.
    • Final vote tally for H.R. 3419: Passed 48-0.
  • H.R. 2846, (Rep. Chrissy Houlahan, D-PA-6), a bill to amend title II of the Public Health Service Act to include as an additional right or privilege of commissioned officers of the Public Health Service (and their beneficiaries) certain leave provided under title 10, United States Code to commissioned officers of the Army (or their beneficiaries).
    • Final vote tally for H.R. 2846: Passed 46-0.
  • H.R. 1262, Give Kids a Chance Act of 2025 (Rep. Michael McCaul, R-TX-10), a bill to expand the FDA’s authority with respect to research on rare pediatric diseases, including by permitting the FDA to take enforcement action against drug sponsors that fail to satisfy pediatric study requirements and by reauthorizing programs that support pediatric research.
    • Rep. Neal Dunn (R-FL-2) offered an amendment to add H.R. 1843, a bill to increase transparency in generic drug applications, to H.R. 1262. This amendment was agreed to by voice vote.
    • Rep. Castor offered an amendment to add language to H.R. 1262 that would prevent any modifications from being made to the CDC’s Adult and Child and Adolescent Immunization Schedules in effect on May 26, 2025, that would result in a reduction to no-cost coverage of vaccines. Other Democratic members expressed support for the amendment, but Republican members questioned the amendment’s germaneness. This amendment was withdrawn.
    • Rep. Diana DeGette (D-CO-1) offered an amendment to add the health care extenders from the December 2024 year-end agreement in H.R. 1262. Rep. Morgan Griffith (R-VA-9) noted that even though he is willing to work on these extenders, he did not support this amendment because of concerns about germaneness and that some of the extenders have moved separately. This amendment was withdrawn.
    • Final vote tally for H.R. 1262: Passed 47-0 as amended.
  • H.R. 3302, Healthy Start Reauthorization Act of 2025 (Rep. Alexandria Ocasio-Cortez, D-NY-14), a bill to reauthorize the Healthy Start Initiative through Fiscal Year 2030.
    • Final vote tally for H.R. 3302: Passed 49-0.

House Energy and Commerce Health Subcommittee Markup of 7 Health Care Bills

On September 10, 2025, the House Energy and Commerce Health Subcommittee held a markup of 7 public health reauthorization bills. Many of these bills were discussed at the Subcommittee in a legislative hearing on July 9, 2025.  It is expected that most if not all these rather non-controversial bills will be voted on at the full committee in the next week or so.

Opening Statements

  • Health Subcommittee Chairman Morgan Griffith (R-VA) emphasized that the markup represents a pivotal step toward securing reauthorization of essential public health programs before they expire at the end of the fiscal year. Expert testimony from the July hearing helped inform the subcommittee’s understanding of their impact on communities and health systems. Among the measures under review, Chairman Griffith highlighted the importance of reauthorizing Title VII and Title VIII programs, which play critical roles in bolstering the nation’s health care workforce.
  • In his opening remarks, Ranking Member Frank Pallone (D-NJ) highlighted seven bills to strengthen key public health programs. He emphasized reauthorizing HRSA’s Title VII and VIII workforce programs to address provider shortages and boost diversity. He also underscored the Healthy Start Program to improve maternal and infant health, and newborn screening programs that save thousands of lives annually. Ranking Member Pallone also called for restoring expert guidance on newborn screening and ensuring parental leave parity for U.S. Public Health Service officers to support recruitment and retention.

Legislation Included in the Markup

H.R. 4262. This legislation would reauthorize through FY 2030 health care workforce education and training programs in Title VII of the Public Health Service Act (PHSA). Passed by voice vote with amendment.

H.R. 3593.  This legislation would reauthorize through FY 2030 nursing workforce development programs from Title VIII of the PHSA. Passed by voice vote.

H.R. 2493, Improving Care in Rural America Reauthorization Act of 2025.  This legislation would reauthorize through FY 2030 grant programs for rural health care services outreach, rural health network development, and small health care provider improvement. Passed by voice vote.

H.R. 3419.  This legislation would reauthorize the telehealth network and telehealth resource centers grant programs through FY 2030. Passed by voice vote.

H.R. 3302, the Healthy Start Reauthorization Act of 2025.  This legislation would reauthorize the Healthy Start program through FY 2030.  Passed by voice vote.

H.R. 2846, to allow commissioned Public Health Service offices to access leave as commissioned officers of the Army do. Passed by voice vote.

H.R. 4709, the Newborn Screening Saves Lives Reauthorization Act of 2025.  This legislation would reauthorize through FY 2030 certain programs and activities related to newborn screening of heritable disorders. Passed by voice vote.

House Ways and Means Oversight Subcommittee Hearing on Tax-Exempt Hospitals

On September 16, 2025, the House Ways and Means Oversight Subcommittee held a hearing on examining the role of tax-exempt hospitals, the sustainability of rural health care, and the future of Affordable Care Act premium tax credits (APTCs). Members debated whether current policies enable hospitals to fulfill their charitable missions, the impact of Medicaid expansion and proposed Medicaid cuts, and the need to extend premium tax credits set to expire at the end of this year.

WITNESS TESTIMONY

  • Dr. Ge Bai, PhD, Professor of Health, Policy, and Management, Johns Hopkins Bloomberg School of Public Health – Testimony
  • William Hild, Executive Director, Consumers’ Research – Testimony

  • Dr. Christopher Whaley, PhD, Associate Director, The Center of Advancing Health Policy through Research, Brown University – Testimony

  • Dr. Stanley Goldfarb, Chairman of the Board, Do No Harm – Testimony

  • Dr. Jill R. Horwitz, Trobman Family Innovation Professor, Northwestern University Pritzker School of Law and Professor of Emergency Medicine, Northwestern Feinberg School of Medicine – Testimony

MEMBER DISCUSSION

Rural Hospital Viability

Rep. Gregory Murphy (R-NC-03) raised concerns about how rural hospitals can continue to survive in today’s strained health care environment. Dr. Whaley argued that strengthening competition and markets is essential to protecting rural hospitals, while Dr. Horwitz emphasized that without nonprofit hospitals, many rural communities would lose access to hospital services altogether. Members repeatedly acknowledged that rural hospitals face unique challenges, including shrinking patient populations, limited provider networks, and dependence on Medicaid and Medicare, which leave them financially vulnerable.

Medicaid Expansion and Savings

Rep. Terri Sewell (D-AL-07) asked how Medicaid expansion has affected the provision of community benefits, noting that expansion has enabled hospitals to treat more low-income individuals. Rep. Judy Chu (D-CA-28) built on this by asking how potential cuts to Medicaid would affect nonprofit hospitals, given their reliance on Medicaid reimbursements. Dr. Horwitz warned that cuts under the reconciliation bill would reduce hospitals’ ability to provide uncompensated care and limit their capacity to respond to community needs.

Rep. Suzan DelBene (D-WA-01) pressed witnesses on what Congress could do to help hospitals at a time when health care feels “under attack.” Dr. Horwitz responded that clearer IRS guidance could help nonprofit hospitals remain compliant with their obligations while ensuring they continue to serve vulnerable patients.

Affordable Care Act Premium Tax Credits (APTCs)

Rep. Thomas Suozzi (D-NY-03) highlighted that APTCs are set to expire at the end of December, warning that without congressional action, insurance rates could rise dramatically. He stressed that there is bipartisan recognition of the need to extend the credits. Mr. Hild agreed, emphasizing that affordability is the key concern for families, while Dr. Goldfarb echoed the affordability issue though acknowledged limited expertise in this area. Dr. Bai opposed extension, contending that subsidies do not address underlying problems and that insurance does not equate to true coverage. Dr. Whaley and Dr. Horwitz countered that rising hospital costs are fueling premium increases and warned that without extending APTCs, more Americans would lose coverage as insurance prices continue to climb.

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