On Monday, April 18, the Health Resources and Services Administration (“HRSA”) published a Notice reopening comment on its June 17, 2015 Proposed Rule regarding 340B pricing and manufacturer civil monetary penalties.

Three specific areas are mentioned in the Notice – alternatives to penny pricing, the pricing of newly-launched covered drugs, and the definition of “knowing and intentional” for purposes of levying civil monetary penalties (“CMPs”) on manufacturers. Comments will be accepted, however, on any aspect of the Proposed Rule. From a manufacturer’s perspective, this re-opening of the Proposed Rule is a very welcome event, as it suggests that HRSA is contemplating changes to the 340B program that would make it more fair, easier to implement and more transparent.