HHS Finalizes Highly Anticipated Final Rules Amending Anti-Kickback Statute and Stark Law Regulations

The National Law Review

Karen S. Lovitch, Rachel E. Yount

On November 20, 2020, the Department of Health & Human Services (HHS) finalized significant changes to the regulations implementing the Anti-Kickback Statute (AKS), the Physician Self-Referral Law (commonly known as the Stark Law), and the civil monetary penalty rules regarding beneficiary inducements (Beneficiary Inducements CMP). The sweeping changes come through corresponding final rules – one issued by the Office of Inspector General (OIG) addressing changes to the AKS and the Beneficiary Inducements CMP, and one issued by the Centers for Medicare & Medicaid Services (CMS) addressing changes to the Stark Law.

The agencies originally planned to finalize the rules earlier this year, but CMS announced that it was extending its deadline until August 2021, which led to speculation that the OIG’s final rule would be similarly delayed. Nevertheless, industry stakeholders urged HHS to issue the long-awaited final rules, particularly in light of speculation that a Biden administration might be less likely to finalize the rules.

The final rules are...

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