HHS’ Health Resources and Services Administration has finalized a rule that sets civil monetary penalties for drug manufactures that overcharge healthcare organizations that are part of the 340B Drug Pricing Program.
Here are four things to know about the final rule.
1. The final rule requires drug manufacturers to calculate the 340B ceiling price on a quarterly basis. The rule includes the methodology manufacturers must use when estimating the ceiling price for a newly covered outpatient drug.
2. Under the final rule, drug manufacturers that intentionally overcharge a covered hospital will face civil monetary penalties. HRSA can fine a manufacturer up to $5,000 for knowingly and intentionally overcharging a 340B hospital for drugs purchased through the program.
3. HRSA clarified that a drug manufacturer that overcharges a hospital for drugs purchased through the 340B program would not face penalties if the manufacturer made an “inadvertent, unintentional or unrecognized error in calculating the ceiling price.” A manufacturer would also be deemed not to have the requisite intent if it “acted on a reasonable interpretation of agency guidance,” or “has established alternative allocation procedures where there is an inadequate supply of product to meet market demand, as long as covered entities are able to purchase on the same terms as all other similarly situated non-340B covered entities.”
4. The final rule is effective March 6. Since the effective date falls in the middle of a quarter, HRSA said it plans to begin enforcing the requirements of the final rule at the start of the next quarter, which begins April 1.
HENRY KOTULA 