This bill would amend section 340B of the Public Health Service Act to make several things clear. Drug manufacturers must offer discounted prices (at or below the 340B ceiling price) for covered outpatient drugs no matter where or how the drugs are dispensed. Manufacturers could not place conditions that limit delivery methods, where drugs may be dispensed, how drugs are purchased, or require claims data or other information from covered entities, unless the Secretary approves such conditions. The bill explicitly says covered entities may use one or more contract pharmacies to dispense drugs purchased at 340B prices. It also adds civil monetary penalties for intentional violations (other than overcharging), including fines up to $2,000,000 per day, and requires the Secretary to issue regulations within 180 days to set standards and allow covered entities to bring claims under the agency process.
No publicly available information on estimated costs or savings from enacting this bill. The bill text does note that inflationary penalty provisions under 340B saved $7,000,000,000 in Medicare Part D spending between 2013 and 2017 (finding reported in the bill).
Sponsors say the bill clarifies existing 340B rules so covered entities can continue to stretch resources, reach more patients, and provide services. The bill says contract pharmacy arrangements help covered entities, especially to access specialty drugs that may only be available through mail-order or distant specialty pharmacies. Proponents describe the changes as protecting covered entities from manufacturer practices that would reduce access to discounted drugs.
No publicly available information on opponents' views in the provided text.