The Department of Health and Human Services (HHS) is seeking comments on an additional delay in the effective date of the January 5, 2017 Health Resources and Services Administration (HRSA) final rule addressing calculation of the ceiling price and application of civil monetary penalties under the 340B drug pricing program. Specifically, HHS proposes to push back the rule’s effective date from July 1, 2018 to July 1, 2019. HHS is proposing this action “to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking.” However, the agency only provided a 15-day comment period, through May 22, 2018.
In a related development, HHS has withdrawn from White House Office of Management and Budget consideration a proposed rule that would have amended certain provisions of the January 5, 2017 340B ceiling price regulations.