The Health Resources and Services Administration (HRSA) is delaying the effective date of its January 5, 2017 final rule on the calculation of the ceiling price and application of civil monetary penalties (CMPs) under the 340B drug pricing program until May 22, 2017 – with a longer delay being contemplated. The January 5, 2017 final rule was scheduled to be effective March 21, 2017 and enforced beginning April 1, 2017, pursuant to a March 6, 2017 notice conforming to the Trump Administration’s regulatory review policy. However, a rule to be published March 20, 2017 further delays the effective date to May 22, 2017 – “at the earliest.” Given that the agency previously expressed a preference for enforcing the new requirements at the start of a quarter, the latest change to the effective date is likely to push the actual enforcement date to at least July 1, 2017.
Furthermore, HRSA is soliciting comments for 30 days on whether a longer delay of the effective date — until October 1, 2017 — would be more appropriate. The March 20 rule states that “after further consideration and to provide affected parties sufficient time to make needed changes to facilitate compliance, and because there are substantive questions raised, we intend to engage in longer rulemaking.” HHS wants to ensure that the rulemaking “is coordinated with and takes into consideration overall 340B Program implementation.” Furthermore, HHS will “consider questions of fact, law, and policy raised in the rule, consistent with the “Regulatory Freeze Pending Review” memorandum.”