March 2021 rule delays

 In addition to MCIT rule delay...

HHS Continues Rule Effective Date Delays

Ongoing litigation, COVID-19, and a January executive order continue to impact agency actions regarding several major regulations finalized in the last several months of the Trump administration. This week saw the delay of effective dates for three major HHS rules which are under legal challenges. First, pursuant to a March 15 court order, HHS-Office of Inspector General delayed the effective date of all amendments to the anti-kickback statute rebate safe harbor rule until January 1, 2023. Second, HHS issued an administrative delay of the so-called “SUNSET” rule which generally requires thousands of Department regulations to be reviewed within five years or else expire if the regulation has not been reviewed in the last 10 years. The effective date for the SUNSET rule is now delayed for one year, to March 22, 2022. HHS explains that the delay will allow them to review the rule in light of a lawsuit filed March 9 by a diverse set of stakeholders alleging the rule is contrary to law, arbitrary and capricious, and in violation of the APA’s notice-and-comment requirements. Lastly, on Friday, HHS’ Health Resources and Services Administration (HRSA) delayed until July 20 a final rule requiring HRSA-funded community health centers to pass through rebates for insulin and epinephrine to patients. HRSA explained the delay would allow the agency to assess whether enforcing the rule is appropriate given the focus on the pandemic.

 

More broadly, as the 60-day effective dates for so-called “midnight” regulations by the Trump administration arrive this week and next week, HHS may delay the effective dates to allow the agency more time to review the rule in light of the administration’s priorities. A January executive order called for review of any published final rule whose effective dates had not passed by President Biden’s inauguration to allow the new administration’s appointed officials (or designees) to review the rule and consider the merits of moving forward with the rule or delay the effective date and solicit comment on areas where the administration is considering changes.

Articles & Resources

Link to SUNSET rule delay

 

Link to HHS-OIG rebate rule delay

 

Link to HRSA drug discount rule delay