“A bill to ensure accessibility of drugs furnished through the drug discount program under section 340B of the Public Health Service Act.”
No CRS summary available for this bill.
This section states congressional findings on the 340B drug discount program (i.e., discounts on covered outpatient drugs provided by manufacturers to covered entities such as safety-net hospitals and clinics), including that the program stretches resources to serve more patients, permits covered entities to use contract pharmacies, prohibits manufacturers from imposing conditions on discounted purchases or dispensing locations, and has saved $7 billion in Medicare Part D spending from 2013 to 2017 through related price controls. The section declares that the Act's purposes are to clarify manufacturers' obligations to provide discounts under the program regardless of dispensing method or location, to prohibit manufacturers from restricting covered entities' use of contract pharmacies, and to affirm that such requirements apply to covered entities contracting with pharmacies.
This section amends manufacturer agreement requirements under the 340B drug discount program—under which participating drug manufacturers must provide covered outpatient drugs to eligible covered entities (e.g., federally qualified health centers) at or below a ceiling price equal to the average manufacturer price minus the Medicaid rebate percentage—(1) to prohibit manufacturers from imposing conditions on covered entities' purchases or use of such drugs at or below ceiling price if the conditions limit delivery or purchase mechanisms, require compliance assurances or claims data submission, deviate from customary business practices, discourage program participation or disproportionately affect covered entities, or lack prior Secretary approval; and (2) to extend such requirements and prohibitions to covered entities using contract pharmacies to dispense the drugs to their patients. This section further (1) authorizes civil monetary penalties of up to $2 million per day, assessed per Secretary standards established by regulation within 180 days of enactment, for each day of a manufacturer's intentional violation of these requirements (other than overcharges), considering factors such as violation nature, extent, and harm; and (2) directs the Secretary to promulgate regulations within 180 days permitting covered entities to assert claims of such violations through the existing administrative dispute process.