SECURE 340B Act

This bill strengthens the 340B drug discount program by establishing clearer rules for patient eligibility, contract pharmacies, child sites, patient assistance, data reporting, program integrity, and anti-discrimination. It also creates a data clearinghouse, a user fee program for oversight, and requires studies on dispensing fees and discounts.

Sec. 2, Establishing a clear patient definition: Defines a patient as an individual who received an outpatient health care service from a prescribing provider at a covered entity within the past 24 months, where the service is reimbursable under Medicare, and the covered entity maintains auditable records showing a provider-to-patient relationship and clinical responsibility.

Sec. 3, Allowable use and robust oversight of contract pharmacies: Requires manufacturers to offer covered outpatient drugs at or below the ceiling price regardless of whether dispensed directly or via a contract pharmacy, and prohibits manufacturers from restricting distribution options, requiring claims data submission directly to them, or conditioning participation based on the covered entity's use of contract pharmacies.

Sec. 4, Eligibility for child sites: Requires covered entities that own child sites to maintain documentation and annually certify that each child site is wholly owned, clinically and financially integrated, and complies with Medicare provider-based rules or alternative requirements, including registering with the Secretary and applying the same financial assistance policy.

Sec. 5, Improving patient affordability and protections: Requires covered entities to maintain and extend their financial assistance policy to patients at child sites and contract pharmacies, with transparency and public reporting. The policy must cover patients up to at least 400% of the federal poverty level for certain entities and 200% for others, and include a sliding fee scale.

Sec. 6, Data reporting for transparency: Requires covered entities to report annually to the Secretary, as an addendum to the Medicare cost report or by direct report, information including the total number of patients dispensed 340B drugs, total prescriptions by insurance type, and charity care costs.

Sec. 7, Enhancing program integrity: Authorizes the Secretary to audit covered entities, contract pharmacies, child sites, and manufacturers for compliance with program requirements, including improper eligibility, drug diversion, duplicate discounts, and use of contract pharmacies. Audits must follow generally accepted standards, and covered entities must contract only with vendors agreeing to submit data for audits.

Sec. 8, Facilitating data exchange to improve program integrity: Establishes a 340B Drug Discount Program Data Clearinghouse for four years, requiring manufacturers to offer drugs at the ceiling price as a reduction in purchase price, not through retrospective rebates. The obligation ends if the Secretary does not certify that all claims are processed through the clearinghouse and other conditions are met.

Sec. 9, Prohibition on discriminatory practices and contracting: Prohibits group health plans, health insurance issuers, and pharmacy benefit managers from discriminating against covered entities or contract pharmacies by imposing different requirements, exclusions, or reimbursement terms based on their 340B status, including reimbursing less than for other similarly situated entities.

Sec. 10, Ensuring HRSA has adequate resources to oversee the program: Establishes a user fee program starting in fiscal year 2027, assessing fees from covered entities at 0.1% of the amount paid for 340B drugs in the previous year. Fees are used for administering the program, including developing a web-based system, maintaining the data clearinghouse, and conducting audits.

Sec. 11, Studies and reports: Requires the Secretary to conduct a study on dispensing fees and reimbursements paid to pharmacies by payer category and 340B status, repeated every 24 months, and report to Congress. Also requires the Comptroller General to study the 340B discount retained by contract pharmacies, health plans, pharmacy benefit managers, vendors, patients, and covered entities, and report to Congress.

Sec. 12, Meanings: Defines 'child site' as an outpatient department, clinic, or facility separately registered as an outpatient facility of a covered entity, not the principal operating location. Defines 'contract pharmacy' as a pharmacy that dispenses covered outpatient drugs to patients on behalf of a covered entity under a contract or arrangement.

Sec. 13, Requirements for nonhospital covered entities and subgrantees: Requires nonhospital covered entities to be nonprofit or public, eligible only for patients receiving services at registered sites within the scope of their federal grant, and to oversee subgrantees through enforceable written agreements, with direct liability for noncompliance.

Sec. 14, Effective date: The amendments take effect on the date of enactment, except as otherwise provided. The Secretary must issue final regulations within 180 days, with transition periods of at least 180 days for substantive new compliance obligations, unless otherwise specified.