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
This article is presented for informational purposes only
and is not intended to constitute legal advice.
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