Readers may remember that just one day before President Joe Biden was inaugurated as the 46th President of the United States, on January 19, 2021, a final rule issued by the Centers for Medicare and Medicaid Services (CMS) modernizing the physician self-referral law (the Stark Law) became effective.
Also effective on January 19, 2021, was a final rule issued by the United States Department of Health and Human Services Office of Inspector General (HHS OIG) that revised several safe harbors to the anti-kickback statute.
There was ambiguity and confusion around whether these two final rules were actually effective due to technical issues with publication dates. While HHS announced the rules in November and 61 days prior to the end of former President Donald Trump’s term and the start of President Biden’s term, the rules were not published in the Federal Register until December 2, 2020. Each of the final rules is considered a “major rule,” which generally requires a 60-day notice before regulations can become effective. The Government Accountability Office (GAO) determined that neither the Stark Law nor the Safe Harbor final rule met that 60-day notice requirement.
While this normally can be fixed, the inauguration of a new administration (of a different political party) happened amid this confusion. Further complicating the matter, on the same day that President Biden was inaugurated, his chief of staff issued a memo that asked government agencies to postpone any pending regulations and allow the new administration time to review pending rules.
The memo asked agencies to “consider postponing the rules’ effective dates for 60 days” for any rules that were published in the Federal Register but had not yet taken effect. Therefore, it was not clear if the CMS or the HHS OIG rules would be considered final, or if the new Administration would review them and potentially revoke or revise them.
However, based on a recent statement made by CMS, it seems that the agency has decided to not postpone the regulation, but instead move forward with it as finalized. The agency said, “The regulations finalized in CMS-1720-F (Medicare Program; Modernizing and Clarifying the Physician Self-Referral Regulations) are effective, except for the revisions to 42 CFR 411.352, which have the delayed effective date set forth in the final rule in order to give physician practices that qualify as ‘group practice’ time to comply with any changes that may affect their physician compensation models.”
What Does This Mean?
While HHS OIG has not come out and made a similar statement to the one made by CMS, CMS and HHS OIG have largely coordinated with one another on fraud and abuse and it is unlikely that one rule would stay while the other fell.
Additionally, neither President Biden’s nominee for HHS Secretary and or CMS Administrator have been confirmed by the United States Senate. It is possible once these appointments have been confirmed by the Senate, changes may be made to the Stark Law in the future. Those changes, of course, would have to go through notice-and-comment rulemaking, but it is still a possibility.