On January 20, 2021, the Biden Administration issued a memorandum (the “Memo”) calling for a 60-day freeze on regulations that had not taken effect as of the date of the Memo, which included certain regulations related to employee benefits (see our prior blog post regarding the Memo here). The Memo also authorized additional postponement of such regulations following the 60-day period where deemed necessary for further review. Listed below are some of the previously discussed proposed and final regulations related to employee benefits that were impacted by the Memo and updates to their effective dates:

  • Independent Contractor Status Under the Fair Labor Standards Act. Final Rule.
    • Effective date is delayed until May 7, 2021. There is also a proposed withdrawal of this rule with comments due by April 12, 2021.
  • Medicare Program; Secure Electronic Prior Authorization for Medicare Part D. Final Rule.
    • Effective date was delayed until March 30, 2021.
  • Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”. Final Rule.
    • Effective date is delayed until May 15, 2021. An additional comment period is available with comments due by April 16, 2021.
  • Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees. Final Rule.
    • Effective date is delayed until January 1, 2023 pursuant to litigation challenging this final rule.
  • Proposed Modifications to the HIPAA Privacy Rule to Support, and Remove Barriers to, Coordinated Care and Individual Engagement. Proposed Rule.
    • Comment period has been extended to May 6, 2021.