On December 23, 2016, the White House Office of Management and Budget (OMB) completed review of a final rule for penalties under the 340B Drug Pricing Program for drug manufacturers that intentionally charge a 340B covered entity a price above the required discounted amount. OMB’s review signals that the final rule should be issued soon.

The 340B Program allows covered entities like safety-net hospitals to receive discounted outpatient drugs from manufacturers participating in Medicaid.  The final rule from HHS “provides a critical enforcement mechanism” by imposing civil penalties “when drug manufacturers intentionally charge a covered entity a price above the ceiling price established under the procedures of the 340B Program,” according to OMB’s website.  In addition, the rule will define “the standards and methodology for the calculation of ceiling prices for purposes of the 340B Program.”

The Affordable Care Act requires the final rule, and HHS published a proposed rule in June 2015.  It includes monetary sanctions of up to $5,000 per instance for drug manufacturers that intentionally overcharge a covered entity.