The Health Resources and Services Administration (“HRSA”) and the Department of Health and Human Services (“HHS”) issued a notice and reopening of comment period for their June 17, 2015 notice of proposed rulemaking, “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.” In light of comments received, HHS is reopening the comment period for 30 days to invite public comments on three areas of rulemaking: the ceiling price for a covered outpatient drug exception, new drug price estimation, and the definition of “knowing and intentional.”
Specifically, HHS is considering alternatives to its penny pricing proposal as a limited ceiling price. HHS is also seeking comments on the specific methodology for estimating new covered outpatient drug pricing and the application of manufacturer-supported refunds and credits. Lastly, HHS is seeking input on whether and how to further define the “knowing and intentional” standard for purposes of civil monetary penalties.
The notice was published in the Federal Register on April 19, 2016. A full-text copy of the notice is available here. Comments must be received by HHS on or before May 18, 2016. HHS believes that a 30-day period is a sufficient period to encourage additional public consideration and comment about its proposed rulemaking.