As mentioned in our November 25, 2000 Healthcare Law Blog article, “Big Changes for Health Care Fraud and Abuse: HHS Gifts Providers Updates to the Stark Law and the AKS, Just in Time for the Holidays,” the Centers for Medicare & Medicaid Services (CMS) published a final rule (“Final Rule”) on December 2, 2020 making significant changes to the regulatory framework implementing the federal physician self-referral prohibition (the “Stark Law”), 42 C.F.R. 411.351 et seq.

Sheppard Mullin is pleased to now present “Critical Analysis and Practical Implications of CMS’ Changes to the Stark Law’s Implementing Regulations” (“Critical Analysis”), a comprehensive analysis of the Final Rule.  This Critical Analysis is designed not as an alert or summary of the Final Rule, but rather as a comprehensive examination of the Final Rule and the changes made to the Stark Law regulations through the Final Rule.  In addition, the Critical Analysis compares the regulatory changes as originally proposed by CMS in its October 17, 2019 proposed rule to those changes that were finalized in the Final Rule.  Finally, the Critical Analysis includes a thorough analysis of each regulatory change made to the Stark Law regulations by the Final Rule, a discussion of each changes’ practical implications for physicians and entities, and a review of remaining open questions.  In short, we hope the Critical Analysis will serve as resource for you now and into the future.

Sheppard Mullin’s critical analysis of the Office of Inspector General’s contemporaneously published final rule implementing the federal health care program Anti-Kickback Statute is forthcoming.