The Department of Health and Human Services (HHS) published in the Federal Register today that they are reopening the comment period for the June 17, 2015, proposed rule on “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.” Comments will be accepted on ANY aspect of the proposed rule but HHS is asking for additional comments and input in three specific areas:
Methodology for estimating the ceiling price for new covered outpatient drugs and which quarter should a manufacturer credit a covered entity if there is an overcharge for a new covered outpatient drug.
Further defining the "knowing and intentional" standard for purposes of civil monetary penalties for manufacturers.
The comment period will be reopened for 30 days ending on May 19, 2016. The Federal Register version can be viewed HERE. We will keep you posted as to when the final rule becomes published.