The Department of Health and Human Services (HHS) Sept 28 released a rule that further delays the implementation date for the calculation of the 340B ceiling price and application of civil monetary penalties (CMPs) that will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Drug Pricing Program. The policy changes have been delayed numerous times. The policies are now scheduled to begin on July 1, 2018.
CMS notes the delay will provide affected parties sufficient time to make needed changes to facilitate compliance and allow additional time for the department to consider alternatives for future rulemaking.
On Jan. 4, 2017, HHS released the final rule that outlined the requirements for calculation of ceiling prices and CMPs. That rule finalized the:
- requirement that a manufacturer calculate the 340B ceiling price on a quarterly basis;
- new “penny pricing” policy for certain drugs that requires manufacturers to charge $0.01 per unit measure for a drug whose calculated ceiling price is less than $0.01;
- new methodology manufacturers must use when estimating the ceiling price for a covered outpatient drug; and
- explanation of how a CMP would be imposed on a manufacturer that knowingly and intentionally overcharges a covered entity.