Rural 340B Access Act of 2025

Bill Number

H.R. 44

Origin Chamber

House

Congress

119th Congress, Session 1

Policy Area

Health

Status

Introduced

Latest Action

2025-01-03: Referred to the House Committee on Energy and Commerce.

Last Updated

2026-04-14T08:05:40Z

AI-Generated Summary

Purpose

The Rural 340B Access Act of 2025 aims to expand access to discounted prescription drugs for certain rural emergency hospitals by including them as eligible entities under the 340B drug discount program. This program, established under the Public Health Service Act, requires drug manufacturers to provide outpatient drugs at reduced prices to qualifying health care organizations serving vulnerable populations, such as low-income or uninsured individuals.

Key Provisions

• Amendment to the Public Health Service Act: The bill amends Section 340B(a)(4) (42 U.S.C. 256b(a)(4)) by adding a new subparagraph (P).
• Definition of Eligible Rural Emergency Hospitals: These hospitals, as defined in Section 1861(kkk)(2) of the Social Security Act (a type of facility focused on emergency and outpatient care in rural areas), qualify if they meet one of the following criteria:
• Owned or operated by a unit of state or local government.
• A public or private non-profit corporation formally granted governmental powers by a state or local government.
• A private non-profit hospital with a contract with a state or local government to provide health care services to low-income individuals who are not eligible for Medicare (title XVIII of the Social Security Act) or Medicaid (under the state plan).
• Short Title: The legislation is titled the "Rural 340B Access Act of 2025."

Significant Changes to Existing Law

• Expansion of Covered Entities: Prior to this amendment, rural emergency hospitals were not explicitly listed as "covered entities" under the 340B program. This bill adds them to the existing list (which includes entities like federally qualified health centers, critical access hospitals, and certain public hospitals), broadening eligibility without altering the program's core discount requirements or mechanisms.
• No changes are made to the discount rates, compliance rules, or manufacturer obligations under 340B; the focus is solely on adding this new category of providers.

Potential Impacts

• On Government Agencies: The Department of Health and Human Services (HHS), which administers the 340B program, would need to update eligibility determinations and oversight to include these hospitals, potentially increasing administrative workload but also extending program reach to rural areas.
• On Citizens: Low-income and uninsured patients in rural communities could gain better access to affordable medications through these hospitals, improving health outcomes in underserved areas where emergency care options are limited.
• On International Relations: Minimal direct impact, as the bill focuses on domestic health policy; however, it indirectly affects U.S. drug manufacturers with global operations by expanding the scope of mandatory discounts.
• Broader Effects: Rural hospitals may reduce costs for essential drugs, helping sustain operations in financially strained areas, though it could increase overall program spending without specified funding offsets.

Main Stakeholders Affected

• Rural Emergency Hospitals: Primary beneficiaries, gaining eligibility for drug discounts to support emergency and outpatient services.
• Low-Income and Rural Patients: Improved access to discounted medications, particularly those not covered by Medicare or Medicaid.
• State and Local Governments: Involved through ownership, contracts, or grants of authority to qualifying hospitals, potentially enhancing public health services.
• Drug Manufacturers: Required to provide discounts to a larger pool of entities, which may raise compliance costs and spark debates over program expansion.
• HHS and Health Resources and Services Administration (HRSA): Responsible for program implementation, auditing, and dispute resolution.

Notable Legal, Constitutional, or Political Implications

• Legal Implications: The amendment aligns with the 340B program's intent to support safety-net providers but could invite challenges from drug manufacturers, who have previously litigated over program scope (e.g., contract pharmacy arrangements). It relies on existing definitions from the Social Security Act, reducing ambiguity.
• Constitutional Implications: None significant; the bill operates within Congress's authority under the Commerce Clause to regulate health care and interstate commerce in pharmaceuticals.
• Political Implications: Introduced on a bipartisan basis (by Rep. Bergman and Rep. Dingell) and referred to the House Committee on Energy and Commerce, it reflects efforts to address rural health disparities amid ongoing debates over 340B's growth and manufacturer participation. Passage could set a precedent for further expansions to other provider types.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Bergman, Jack [R-MI-1]

Cosponsors (6)

Rep. Dingell, Debbie [D-MI-6], Rep. Stansbury, Melanie A. [D-NM-1], Rep. Tokuda, Jill N. [D-HI-2], Rep. Vindman, Eugene Simon [D-VA-7], Rep. Thompson, Glenn [R-PA-15], Rep. Sewell, Terri A. [D-AL-7]

Recent Actions

• 2025-01-03: Referred to the House Committee on Energy and Commerce.
• 2025-01-03: Introduced in House
• 2025-01-03: Introduced in House

Bill Versions

• Rural 340B Access Act of 2025 — issued 2025-01-03 — PDF (2 pages)