340B ACCESS Act

The 340B ACCESS Act amends the Public Health Service Act to reform the 340B drug pricing program, which provides discounts on outpatient drugs to certain healthcare entities serving low-income and vulnerable populations. The bill establishes new definitions, requirements, and oversight mechanisms for covered entities, contract pharmacies, and drug manufacturers.

Sec. 2, Definitions: Defines a 'patient' as an individual who receives a covered outpatient drug from a covered entity provider, dispensed on-site at a covered entity location, child site, entity pharmacy, or contract pharmacy, with the drug directly related to the health care service provided.

Sec. 3, Prevention of Medicaid duplicate discounts: Requires the Secretary to issue regulations within one year for State Medicaid programs and covered entities to identify and bill 340B drugs to prevent duplicate discounts or rebates, including for Medicaid managed care enrollees.

Sec. 4, Hospital child site requirements: Allows certain hospitals to register off-campus outpatient facilities as 'child sites' for 340B participation if they meet requirements, such as being listed on the hospital's Medicare cost report.

Sec. 5, Contract pharmacies: Permits covered entities to use contract pharmacies to dispense 340B drugs under written agreements, with conditions including that manufacturers ship drugs to contract pharmacies only at the entity's request and have no obligation to discount drugs delivered elsewhere.

Sec. 6, Patient affordability: Requires hospital covered entities to establish a sliding fee scale ensuring eligible patients pay no more than a maximum out-of-pocket obligation for 340B drugs, with the scale posted prominently and included in billing communications.

Sec. 7, Nonhospital covered entities: Requires nonhospital covered entities to be nonprofit or public, purchase drugs only for patients within the scope of their federal grant, oversee subgrantees, and have enforceable written agreements with subgrantees.

Sec. 8, Claims modifiers: Mandates that claims for 340B drugs include a specific modifier (e.g., 'JG' or 'TB') and that claims for non-340B drugs include a non-340B modifier, with covered entities submitting data to the Secretary.

Sec. 9, Reporting on scope: Requires nonhospital covered entities to annually submit information to the Secretary describing the scope of their federal grant or project, including agreements with subgrantees, accessible to manufacturers upon request.

Sec. 10, Transparency: Requires certain covered entities to annually report to the Secretary the total number of patients dispensed 340B drugs, broken down by categories, and the percentage of patients receiving such drugs.

Sec. 11, Hospital eligibility revisions: Revises eligibility for hospitals, including requiring that hospitals registered as 340B entities by December 1, 2023, meet specific criteria, and updates definitions for critical access and rural emergency hospitals.

Sec. 12, Additional hospital requirements: Clarifies that private nonprofit hospitals must have a contract with a state or local government to provide care to low-income uninsured individuals, with the contract representing at least 10% of the hospital's total costs of care.

Sec. 13, 340B program intent: States that the program's intent is to provide manufacturer price reductions to enable covered entities serving underserved communities to increase access to affordable drugs and health services.

Sec. 14, Audits of contracts: Requires the Secretary to conduct annual audits of at least 10% of private nonprofit hospitals' contracts with state or local governments, with public disclosure of standards and findings, and removal of non-compliant entities.

Sec. 15, Compliance with transparency: Authorizes the Secretary to impose civil monetary penalties on covered entities not in compliance with transparency reporting requirements.

Sec. 16, Claims data clearinghouse: Requires the Secretary to contract with a third-party entity to establish a clearinghouse within one year to identify 340B drug claims and ensure they are not included in State rebate requests, preventing duplicate discounts.

Sec. 17, Fee limitations: Limits third-party administrator fees to flat dollar amounts based on fair market value, not tied to drug prices, and requires contract pharmacy fees to be consistent with fair market value for actual services.

Sec. 18, Clarification: States that the 340B program provisions supersede any conflicting state or local laws, except for state regulations issued to carry out duplicate discount prevention.

Sec. 19, Equitable treatment: Prohibits group health plans, health insurance issuers, and pharmacy benefit managers from discriminating against 340B covered entities or contract pharmacies by imposing different requirements or reimbursement terms.

Sec. 20, Effective date: The provisions of the Act become effective one year after enactment, except as otherwise specified.