Bill
HR 5256
The 340B ACCESS Act enhances drug pricing discounts for safety-net healthcare providers, ensuring patient affordability and compliance in underserved communities.
Bill Number: HR 5256
Title: 340B Affording Care for Communities and Ensuring a Strong Safety-net Act (340B ACCESS Act)
Status: Introduced in House
Introduced On: September 10, 2025
Primary Sponsor: Earl L. "Buddy" Carter
Cosponsor: Diana Harshbarger
The 340B ACCESS Act aims to enhance the 340B Drug Pricing Program, which allows certain healthcare providers, known as covered entities, to purchase outpatient drugs at discounted prices. The bill seeks to ensure that these discounts are effectively utilized to improve patient care and maintain the financial viability of safety-net providers, particularly in underserved communities.
The bill includes several significant provisions, organized as follows:
Definitions: Establishes clear definitions relevant to the 340B program.
Prevention of Duplicate Discounts: Implements measures to prevent Medicaid duplicate discounts and enhances oversight of covered entities.
Hospital Child Site Requirements: Sets specific requirements for hospital child sites to ensure compliance with 340B program standards.
Contract Pharmacies: Addresses the use of contract pharmacies by covered entities, ensuring they operate within the program's guidelines.
Patient Affordability: Mandates that covered entities ensure patient affordability for drugs purchased under the 340B program.
Non-Hospital Covered Entities: Outlines requirements for non-hospital covered entities and their subgrantees to maintain program integrity.
Claims Modifiers: Introduces claims modifiers and data submission requirements for covered entities.
Reporting Requirements: Establishes reporting obligations for covered entities regarding their grants, contracts, and projects.
Transparency: Enhances transparency requirements for covered entities to ensure accountability.
Hospital Eligibility Revisions: Revises existing eligibility requirements for hospitals participating in the 340B program.
Audits: Provides for audits of private nonhospital contracts with state and local governments to ensure compliance.
Service Fees Limitation: Imposes limitations on administrator service fees and contract pharmacy fees associated with the 340B program.
Equitable Treatment: Ensures equitable treatment of 340B covered entities and pharmacies participating in the program.
Effective Date: Specifies the effective date of the provisions outlined in the act.
The 340B ACCESS Act is expected to impact:
Covered Entities: Hospitals and other healthcare providers that qualify for the 340B program will need to comply with new requirements and reporting standards.
Patients: The act aims to improve drug affordability for patients receiving care from covered entities, particularly in low-income and underserved populations.
Pharmacies: Contract pharmacies will be subject to new regulations and oversight to ensure compliance with the 340B program.
This summary provides an overview of the 340B ACCESS Act, highlighting its purpose, key provisions, and potential impacts on healthcare providers and patients.
Compiled from official sources — confirm details with the bill’s official record.
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