FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

HHS to Fine Drugmakers for Overcharging Under the 340B Discount Program

Jan. 10, 2017

HHS has finalized a rule threatening fines against drugmakers that knowingly overcharge hospitals and providers under the 340B drug discount program.

Issued by the Health Resources and Services Administration, the rule includes civil penalties of up to $5,000 for each time a 340B provider paid a manufacturer more than the established ceiling price for a single drug product, regardless of the number of units purchased. This includes any order placed directly with a manufacturer, or through a wholesaler, authorized distributor or agent.

The rule will be enforced by the HHS inspector general’s office, on a case-by-case basis, beginning April 1.

The 340B program enrolls safety-net medical providers and requires drugmakers to offer outpatient drugs at discounts of up to 50 percent. HRSA’s rule, proposed in 2015, details the methods for calculating the ceiling price on a quarterly basis, and sets a minimum price of $0.01.

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