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,”  we discussed the advanced publication of two significant final rules intended to “modernize” and “clarify” regulations regarding the Physician Self-Referral Law (“Stark Law Final Rule”) and the Anti-Kickback Statute (“AKS Final Rule”) – both formally published on December 2, 2020 by the Centers for Medicare and Medicaid Services (“CMS”) and the Department of Health and Human Services, Office of Inspector General (“OIG”), respectively.

Previously, Sheppard Mullin released its “Critical Analysis and Practical Implications of CMS’ Changes to the Stark Law’s Implementing Regulations” discussing the Stark Law Final Rule and the significant changes the Stark Law Final Rule made to the Stark Law exceptions and other provisions included in the Stark Law regulations at 42 C.F.R. 411.351 et seq.

As linked to this article, Sheppard Mullin presents its, “Analysis of OIG’s New and Revised Regulatory Safe Harbors to the Federal Health Care Program Anti-Kickback Statute and Beneficiary Inducement Prohibition” (the “AKS Analysis”).  The AKS Analysis includes a deep-dive into the AKS Final Rule including the addition of new AKS safe harbors for remuneration exchanged under various value-based arrangements, a new safe harbor applicable to financial arrangements designed to benefit program beneficiaries, and the revision of other AKS safe harbors to add compliance flexibility as deemed necessary to accommodate value-based arrangements.

Taken as a whole, the AKS Final Rule and the Stark Law Final Rule are further evidence that traditional Medicare and Medicaid fee-for-service reimbursement methodologies continue to be marginalized by payment systems designed to incentivize and reward patient care quality and efficiency.  As reimbursement methodologies change and the desire for greater innovation in the area of healthcare payment systems increases, CMS and the OIG are recognizing that the AKS and Stark Law regulations need to change too.

Sheppard Mullin will continue watching how the changes created by the AKS Final Rule and the Stark Law Final Rule are implemented by the new Biden Administration. Stay tuned!