The Department of Health and Human Services (HHS) has once again delayed the 340B final rule which would penalize pharmaceutical manufacturers that knowingly overcharge hospitals beyond the ceiling price for drugs purchased through the program. HHS has now decided to delay the final rule until July 2018. Filed on August 17, 2017, HHS states that the delay has been proposed in order to allow more time to consider alternative and supplemental comments about the rule.
The final rule would allow HHS to issue fines of up to $5,000 to pharmaceutical manufacturers that overcharge hospitals for medications under the 340B program. The rule also included methodology for drug companies to follow when estimating the ceiling cost of a new covered outpatient drug.
The pushback of the implementation of the 340B final rule can have an impact on covered entities, as the government continues to be limited in the actions that it can take against pharmaceutical manufacturers that overcharge and fail to provide covered entities discounts on eligible 340B drugs. Frier Levitt encourages covered entities to exercise their option of commenting on the proposed rule and can also help covered entities craft comments for submission to HHS.
If you are a covered entity and would like additional information, contact Frier Levitt today.