This bill aims to strengthen the 340B drug discount program by clarifying manufacturer obligations and ensuring drug accessibility for covered entities. It explicitly states that drug manufacturers must offer discounted prices on covered outpatient drugs to eligible entities, regardless of the method or location of dispensing. This includes situations where covered entities utilize contract pharmacies to distribute these vital medications to their patients, a long-standing practice intended to stretch scarce resources and support comprehensive patient care. A key provision of the bill prohibits drug manufacturers from imposing conditions that limit a covered entity's ability to purchase or use discounted drugs. Such prohibited conditions include those that restrict drug delivery, dictate dispensing mechanisms or locations, demand compliance assurances or data, or do not align with customary business practices. The legislation also disallows conditions that disproportionately affect covered entities or have not received prior approval from the Secretary. To ensure compliance, the bill introduces new civil monetary penalties for manufacturers who violate these clarified requirements, specifically regarding conditions on drug access or the use of contract pharmacies. These penalties can reach up to $2,000,000 per day for intentional violations, with the Secretary determining the amount based on the nature and extent of harm. Furthermore, it mandates that the Secretary establish regulations within 180 days to allow covered entities to formally assert claims of such violations.
This bill aims to strengthen the 340B drug discount program by clarifying manufacturer obligations and ensuring drug accessibility for covered entities. It explicitly states that drug manufacturers must offer discounted prices on covered outpatient drugs to eligible entities, regardless of the method or location of dispensing. This includes situations where covered entities utilize contract pharmacies to distribute these vital medications to their patients, a long-standing practice intended to stretch scarce resources and support comprehensive patient care. A key provision of the bill prohibits drug manufacturers from imposing conditions that limit a covered entity's ability to purchase or use discounted drugs. Such prohibited conditions include those that restrict drug delivery, dictate dispensing mechanisms or locations, demand compliance assurances or data, or do not align with customary business practices. The legislation also disallows conditions that disproportionately affect covered entities or have not received prior approval from the Secretary. To ensure compliance, the bill introduces new civil monetary penalties for manufacturers who violate these clarified requirements, specifically regarding conditions on drug access or the use of contract pharmacies. These penalties can reach up to $2,000,000 per day for intentional violations, with the Secretary determining the amount based on the nature and extent of harm. Furthermore, it mandates that the Secretary establish regulations within 180 days to allow covered entities to formally assert claims of such violations.