HR 5256119th CongressIn Committee

340B ACCESS Act

Introduced: Sep 10, 2025

Healthcare

Standard Summary

Comprehensive overview in 1-2 paragraphs

The 340B ACCESS Act (340B Affording Care for Communities and Ensuring a Strong Safety-net Act) would overhaul the 340B drug pricing program under the Public Health Service Act. Its overall aim is to tighten oversight, increase transparency, and broaden accountability for who can participate in the program, how discounts are used, and how 340B drugs are dispensed. It would create stricter eligibility rules for nonhospital entities, add new requirements for hospital “child sites” (off-campus facilities), expand the use and supervision of contract pharmacies, and strengthen protections against Medicaid duplicate discounts. The bill also establishes new reporting, auditing, and data-tracking mechanisms and imposes penalties for noncompliance. Several provisions would take effect 120 days after enactment, with implementing guidance issued beforehand.

Key Points

1Strengthened definitions and eligibility rules for patients and entities
2- Expands the definition of who is a “patient” linked to the 340B price, including on-site and certain off-site facilities and specific provider-patient relationships.
3- Creates a new category of “specified nonhospital covered entities” based on large revenue thresholds or hospital affiliation, potentially limiting or reshaping which nonhospital providers can participate in 340B.
4Prevention of Medicaid duplicate discounts and new oversight
5- Requires new regulations within one year describing how states and covered entities identify and bill drugs purchased under 340B to avoid duplicate discounts (relevant to Medicaid and Medicaid managed care).
6- Adds provisions for auditing a covered entity’s records to determine how the margin on 340B drugs is used and to ensure compliance with related rules.
7- Imposes record retention and civil monetary penalties for certain violations, with penalties tied to inflation.
8Hospital child site requirements
9- Off-campus outpatient facilities (child sites) can participate in 340B only if they meet a detailed set of criteria, including:
10- Being listed on a Medicare cost report or certifiable as having reimbursable outpatient services.
11- Being wholly owned by the covered entity and meeting Medicare provider-based standards.
12- Providing more than just dispensing/administering drugs, having charity care policies, serving areas with health care shortages, and meeting specific revenue and charity care metrics.
13- If a facility fails to meet these requirements, it must be deregistered from 340B, with ongoing reporting obligations and potential penalties.
14- Covered entities must self-disclose noncompliant purchases and undergo Secretary-supervised audits; failure to comply can trigger monetary penalties.
15Contract pharmacies and drug distribution
16- Allows covered entities to contract with pharmacies to dispense 340B drugs, with manufacturers shipping 340B drugs to these contract pharmacies.
17- Reaffirms that manufacturers generally are not obligated to provide discounts for drugs shipped to locations not registered as a 340B address.
18- Adds governance around contract pharmacies to ensure proper use of 340B discounts and prevent improper transfers.
19Patient affordability, transparency, and program integrity
20- Introduces a 340B data clearinghouse and expands reporting and data submission requirements by covered entities.
21- Requires increased transparency about program participation, including public reporting of facilities meeting child-site criteria and other compliance indicators.
22- Sets up auditing and claims-modifier procedures to ensure accurate pricing and prevent improper use of discounts.
23Effective date and implementation
24- The act would become effective 120 days after enactment.
25- Secretary would issue program instructions at least 60 days before the effective date to guide registration/deregistration of off-campus facilities and to enforce the new standards.

Impact Areas

Primary affected groups/areas- 340B-covered entities, especially hospitals and large nonhospital entities that might be reclassified as “specified nonhospital covered entities.”- Contract pharmacies that dispense 340B drugs on behalf of covered entities.- Drug manufacturers selling 340B products to covered entities and contract pharmacies.- State Medicaid programs and Medicaid managed care plans (due to new rules on duplicate discounts and rebates).Secondary affected groups/areas- Patients who use 340B-discounted drugs, particularly those at safety-net and rural facilities (as child-site criteria emphasize serving underserved areas and providing more than drug dispensing).Additional impacts- Expanded compliance burden: more extensive reporting, audits, and data submission could require substantial administrative resources for covered entities.- Increased program integrity and potential price/discount realignments as entities adjust to new eligibility rules, child-site standards, and penalties.- Possible consolidation effects if some nonhospital providers become ineligible as “specified nonhospital covered entities.”Sponsor is listed as unknown in the provided text.The bill lays out a comprehensive set of changes to eligibility, oversight, and transparency, with a strong emphasis on preventing fraud, waste, and abuse, ensuring patient access, and bringing more elements of the 340B program into formal regulatory oversight and public reporting.

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