The Biden administration last Friday, as widely expected, proposed withdrawing or repealing a Trump administration final rule that will automatically extinguish all U.S. Health and Human Services (HHS) regulations if HHS does not renew each regulation within a certain timeframe.
The 340B program has just two regulations, and ex-HHS Secretary Alex Azar’s Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET) rule applies to both: the 2017 ceiling price and manufacturer civil monetary penalties final rule, and the 2020 administrative dispute resolution final rule.
The SUNSET rule was published on Jan. 19—one day before President Biden was inaugurated—and was scheduled to take effect on March 22, 2021. Several health and public interest groups sued in federal district court in San Jose, Calif., on March 9, 2021, to have the rule vacated and set aside. The Biden administration next delayed the rule’s effective date by one year.
Under the SUNSET rule, virtually all HHS regulations would expire at the end of (1) five calendar years after the year that the SUNSET final rule first becomes effective, (2) 10 calendar years after the year of the regulation’s promulgation, or (3) 10 calendar years after the last year in which HHS “assessed” and, if required, “reviewed” the regulation, whichever is latest.
Comments on the Biden administration’s proposal to withdraw or repeal Azar’s rule are due on Dec. 28.
