The final rule imposes 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. HRSA plans to begin enforcing the rule on April 1.
The American Hospital Association (AHA) says the 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.
It also requires greater transparency in calculating ceiling prices to ensure drug manufacturers are not overcharging 340B-covered entities.