SUSTAIN 340B Act

The SUSTAIN 340B Act aims to strengthen the 340B drug discount program by introducing comprehensive reforms focused on transparency, accountability, and integrity. It seeks to ensure that the program effectively supports safety net providers in expanding patient access to healthcare services by stretching scarce federal resources. The bill establishes new regulations for contract pharmacies , requiring covered entities to register and annually recertify all contract arrangements. It mandates written agreements with standard provisions, including data sharing for duplicate discount prevention and annual independent audits. Manufacturers are explicitly required to offer 340B pricing regardless of dispensing method and are prohibited from placing restrictive conditions on drug purchases. A revised patient definition is introduced, requiring individuals to have received an outpatient health service from the covered entity within the past two years and to have an auditable medical record. Exceptions are made for discharge prescriptions and certain referred patients, with specific requirements for documenting these referrals. The bill also outlines conditions for when a covered entity can provide drugs to patients referred to non-340B providers, including volume limits and reporting. For child sites , the bill sets stringent eligibility criteria, requiring them to be wholly-owned, clinically, and financially integrated with the parent covered entity. These sites must meet specific operational, financial, and clinical integration standards, or be deemed provider-based by CMS. Newly acquired or constructed child sites face eligibility delays, with limited hardship exemptions. Enhanced transparency measures require covered entities to annually report detailed information, including the number of patients served, prescription volume by insurance type, charity care costs, and how 340B savings are utilized. This information, along with contract pharmacy details, will be publicly available on the HHS website. The bill also significantly enhances program integrity through expanded audit authority for the Secretary and manufacturers, with new sanctions for non-compliance, including potential ineligibility and civil monetary penalties. To prevent duplicate discounts , the bill establishes a 340B Drug Discount Program Data Clearinghouse, contracting with an independent third-party entity. This clearinghouse will collect claims-level data from states and covered entities to identify and prevent duplicate discounts, with strict restrictions on how manufacturers and PBMs can use this data. Covered entities are required to facilitate data transmission and repay identified duplicate discounts. The legislation also addresses equitable treatment , prohibiting group health plans, health insurance issuers, and PBMs from discriminating against 340B entities or pharmacies through differing reimbursement terms, fees, or network participation requirements. It also creates a user fee program , starting in fiscal year 2031, to be paid by covered entities to fund program administration, oversight, and the data clearinghouse. Finally, the bill mandates various studies and reports by the GAO and HHS on debt collection practices, dispensing fees, and program interactions, while authorizing additional appropriations for increased oversight and enforcement activities.