HRSA issues final rule on 340B drug ceiling prices, manufacturer penalties

The Health Resources and Services Administration today released a final rule on drug ceiling prices and civil monetary penalties for manufacturers in the 340B Drug Pricing Program. Required by the Affordable Care Act, the rule amends Section 340B of the Public Health Service Act to impose monetary sanctions (not to exceed $5,000 per instance) on drug manufacturers who intentionally charge a 340B hospital or covered entity more than the ceiling price established under the procedures of the 340B program. The final rule codifies current policy on “penny pricing” for ceiling price calculations resulting in a zero value. It also establishes new drug pricing policy when sufficient information to establish a 340B ceiling price for a new drug is not yet available and would require manufactures to refund 340B covered entities within 120 days if the manufacturer determines an overcharge occurred. The final rule also requires greater transparency in calculating the 340B ceiling drug prices to ensure that drug manufacturers are not overcharging 340B covered entities. HRSA plans to begin enforcing the requirements of the final rule on April 1, and to issue further guidance on the 340B ceiling price reporting system and how 340B covered entities can access ceiling price information to establish instances of manufacturer overcharges.