The "340B ACCESS Act" proposes significant reforms to the 340B drug pricing program, aiming to strengthen its integrity, ensure patient access, and enhance transparency. It introduces a more stringent definition of an eligible "patient" for 340B discounts, requiring a direct link between the dispensed drug, a covered entity provider, and an ongoing patient relationship with auditable records. The bill also places new restrictions on telehealth prescriptions and defines "specified nonhospital covered entities" based on revenue or hospital affiliation, which may be subject to different rules.

The legislation establishes strict criteria for hospital off-campus outpatient facilities, known as "child sites," to qualify for 340B discounts. These sites must meet specific Medicare reporting, ownership, service provision, charity care, and Medicaid/CHIP revenue thresholds, with penalties for non-compliance and mandatory deregistration if requirements are not met. For contract pharmacies, the bill limits the number of agreements for certain hospital types and mandates that contract pharmacies operate within the covered entity's service area, with exceptions for mail-order pharmacies.

To prevent duplicate discounts and ensure program compliance, the bill requires the Secretary to issue regulations for identifying and billing 340B drugs, including for Medicaid managed care. It also mandates the use of 340B claims modifiers and requires covered entities to submit detailed, claim-level data to a newly established third-party claims clearinghouse. This clearinghouse will identify and resolve issues such as duplicate discounts, non-duplication with maximum fair price, and exclusion of 340B drugs from inflation rebate calculations, providing data access to manufacturers.

A key provision introduces patient affordability requirements, obligating hospital covered entities to implement sliding fee scales that cap out-of-pocket costs for eligible low-income and uninsured patients receiving 340B drugs. Nonhospital entities must also provide affordability assistance if required by their federal grants. Furthermore, the bill prohibits group health plans, health insurance issuers, and pharmacy benefit managers (PBMs) from discriminating against 340B entities or their patients through lower reimbursement, restrictive terms, or interference with patient choice, imposing civil monetary penalties for PBM violations.

The bill also revises hospital eligibility requirements, including specific criteria for private nonprofit hospitals with state or local government contracts, and introduces performance-based conditions for urban private nonprofit disproportionate share hospitals related to Medicaid/CHIP revenue and uncompensated care. It prohibits certain hospitals from engaging in extraordinary collection actions against vulnerable patients and requires DSH hospitals to demonstrate that their annual charity care costs meet or exceed their 340B margin, with penalties for non-compliance. Finally, the legislation clarifies that federal 340B provisions generally supersede differing state or local laws, except for state regulations on Medicaid duplicate discounts, and limits fees for third-party administrators and contract pharmacies to fair market value, flat-dollar amounts.