“To ensure the 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 declares nine congressional findings affirming the purposes and operations of the 340B drug discount program (i.e., section 340B of the Public Health Service Act, under which drug manufacturers must provide covered outpatient drugs at discounted ceiling prices to covered entities such as safety-net hospitals and clinics), including that the program permits covered entities to use contract pharmacies for dispensing such drugs, prohibits manufacturers from imposing conditions on purchases or dispensing locations, and has generated savings including $7 billion in Medicare Part D spending from 2013 through 2017. It states that the purposes of the Act are to clarify that the 340B program requires manufacturers to offer discounts regardless of dispensing method or location, prohibits manufacturer restrictions on covered entity purchases or contract pharmacy use, and authorizes covered entities to contract with pharmacies to dispense 340B-purchased drugs.
This section amends the 340B drug discount program (i.e., requires pharmaceutical manufacturers participating in agreements with the Department of Health and Human Services to provide covered outpatient drugs to eligible covered entities—such as safety-net providers serving low-income and uninsured patients—at discounted ceiling prices) to (1) require manufacturers to offer such drugs at or below the ceiling price regardless of the manner or location in which the drug is dispensed and prohibit manufacturers from imposing specified conditions on covered entities' purchases and use of such drugs (e.g., limits on delivery or purchase mechanisms, requirements for compliance assurances or claims data, non-customary practices, conditions discouraging 340B purchases or undermining the program, or unapproved restrictions); and (2) apply these requirements and prohibitions to covered entities that contract with pharmacies for dispensing. (Thus, manufacturers may not restrict 340B discounts based on dispensing arrangements or impose barriers disproportionately affecting covered entities.) The section further (1) authorizes civil monetary penalties of up to $2 million per day (to be assessed per standards established by regulation within 180 days of enactment) for intentional violations other than overcharges; 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 resolution process.