After multiple implementation delays, the Health Resources and Services Administration (HRSA) now seeks to move up the effective date of its January 5, 2017 rule on 340B drug pricing program ceiling price calculation and civil monetary penalties (CMPs). By way of background, HRSA most recently delayed implementation of the 2017 rule because the Trump Administration was "developing new comprehensive policies to address the rising costs of prescription drugs." However, in a proposed rule scheduled to be published on November 2, 2018, HRSA states that it has "determined that the finalization of the 340B ceiling price and civil monetary penalty rule will not interfere with the Department's development of these comprehensive policies." Thus HRSA now proposes to "cease any further delay" and change the effective date from July 1, 2019, to January 1, 2019.
HRSA is providing a comment period of only 21 days, which HRSA deems "sufficient to provide affected parties the opportunity to provide their views as this rule is uncomplicated and simply proposes to change an effective date," and because "affected parties have had multiple opportunities to provide comments on the appropriate effective date of the January 5, 2017 final [rule]." Note that the extended implementation delay has also been the subject of a lawsuit by hospital associations and other stakeholders.
This article is presented for informational purposes only and is not intended to constitute legal advice.