The U.S. Department of Health and Human Services (HHS) is reopening the comment period for the proposed rule titled “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.” HHS released the proposed rule on June 17, 2015, and the original comment period ended August 17, 2015.
The 340B Drug Pricing Program requires drug manufacturers participating in Medicaid to have an agreement with HHS under which the manufacturer provides discounts on certain outpatient drugs purchased by safety-net providers. The proposed rule establishes civil monetary penalties for drug manufacturers that charge safety-net providers above a ceiling price established under the 340B Drug Pricing Program.
The notice announcing the reopening of the comment period was published in the April 19, 2016, issue of the Federal Register. The new comment period will end on May 19, 2016. Comments may be submitted via email, mail, or the Federal eRulemaking Portal. Commenters do not need to resubmit comments, as previously submitted comments are currently under review and will be considered prior to the finalization of the proposed rule.