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HRSA Finalizes Rule on 340B Overcharges, Ceiling Prices

Drug manufacturers will be fined up to $5,000 per instance of overcharging hospitals and other health care providers for medication purchased through the 340B Drug Pricing Program, under a Jan. 4 final rule from the Health Resources and Services Administration (HRSA).

The rule also settles questions surrounding 340B drug ceiling prices. It makes final a proposed “penny pricing” policy, which sets a drug’s relevant unit price (a single pill or a bottle of pills, for example) at $0.01 when the program’s standard discount formula results in a price of less than a penny. Also, for new covered outpatient drugs, the rule establishes a ceiling price calculation using wholesale acquisition cost.

With respect to 340B drug overcharges, the rule states that Department of Health and Human Services (HHS) will defer to the HHS Office of Inspector General (OIG) to determine whether overcharges are “knowing and intentional.”

Contact Director of Policy Erin O’Malley at or 202.585.0127 with questions.


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