The "Strengthening the Exercise of Controls and Upgrading Requirements for Efficiency in 340B Act," or SECURE 340B Act, seeks to fortify the 340B drug discount program by introducing comprehensive reforms across various aspects of its operation. The bill focuses on improving program integrity, increasing transparency, and ensuring patient affordability and protections. A key provision establishes a clear patient definition , requiring an individual to have received an outpatient health care service from a prescribing provider at a covered entity within the preceding 24 months, with auditable records demonstrating an ongoing provider-to-patient relationship. It also outlines specific conditions for covered entities to provide 340B drugs to patients referred to outside providers, primarily for federally qualified health centers, critical access hospitals, and sole community hospitals, with strict documentation and audit requirements. For contract pharmacies , the bill mandates that manufacturers offer 340B drugs regardless of dispensing method and prohibits restrictive conditions on their use. Covered entities must register all contract pharmacy agreements with the Secretary, who will review them for compliance. New integrity measures include standard contract provisions, data submission requirements to a clearinghouse, and audits to prevent diversion and duplicate discounts. The legislation also clarifies eligibility for child sites of certain hospital types, requiring them to be wholly owned, clinically and financially integrated, and to apply the same financial assistance policies as the parent entity. A new "community need standard" is introduced, requiring child sites to be located in qualifying ZIP Code Tabulation Areas based on social vulnerability scores, or to meet a payor-mix exception for serving low-income or uninsured patients. To improve patient affordability and protections , covered entities must maintain and extend transparent financial assistance policies to patients at child sites and contract pharmacies, covering individuals up to at least 400% of the Federal poverty level for hospitals and 200% for other entities. The bill also prohibits certain medical debt collection practices for specific hospital types, such as selling patient debt or reporting adverse information to credit agencies, and limits interest charges on outstanding balances. Enhanced data reporting for transparency is mandated, requiring covered entities to annually report on program savings, patient demographics, charity care levels, and how 340B savings are utilized to benefit patients and communities. This information will be publicly available on the Department of Health and Human Services website, with aggregate and individual entity data. The bill significantly enhances program integrity through expanded audit authority for the Secretary, allowing audits of covered entities, contract pharmacies, child sites, and manufacturers for compliance issues like improper eligibility claims, diversion, and duplicate discounts. Covered entities will also be required to conduct biennial independent audits and implement corrective action plans, with new sanctions for non-compliance, including civil monetary penalties and potential disenrollment. A central feature is the establishment of a 340B drug discount program data clearinghouse to facilitate robust data exchange and prevent duplicate discounts and diversion. Manufacturers will initially offer 340B drugs at ceiling prices as a purchase price reduction for four years, contingent on the clearinghouse meeting performance benchmarks for claims submission, unique transaction identification, and adjudication timeliness. Covered entities must submit claims-level data to this clearinghouse, with penalties for non-compliance. The legislation includes a strong prohibition on discriminatory practices and contracting by group health plans, health insurance issuers, and pharmacy benefit managers against 340B covered entities or contract pharmacies. This includes preventing lower reimbursement rates, imposing different fees or network restrictions, interfering with patient choice, or requiring identification of 340B drugs outside the clearinghouse. It also prohibits these entities from demanding a share of 340B discounts from covered entities. Finally, the bill aims to ensure the Health Resources and Services Administration (HRSA) has adequate resources to oversee the program by implementing a user fee program for covered entities, with fees used to fund program administration, the data clearinghouse, and integrity activities. It also authorizes appropriations for audits and oversight and grants HRSA direct-hire authority for qualified personnel. The bill mandates various studies and reports by the Secretary and the Comptroller General on dispensing fees, discount retention, and hospital debt collection practices to further inform policy and program effectiveness.