OIG and CMS Issue Long-Awaited Value-Based Safe Harbors and Exceptions; Now What?

Compliance Today Magazine April 2021

Jason E. Christ, Anjali N.C. Downs, and Victoria Vaskov Sheridan, Members of the Firm in the Health Care & Life Sciences practice, co-authored an article in Compliance Today, titled “OIG and CMS Issue Long-Awaited Value-Based Safe Harbors and Exceptions; Now What?” This article was authored in significant collaboration with Arthur Fried, Member of the Firm in the Health Care & Life Sciences practice.

Following is an excerpt:

On December 2, 2020, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) of the Department of Health & Human Services published long-awaited companion final rules modifying and updating the federal Physician Self-Referral Law (commonly referred to as the Stark Law), the federal healthcare program’s Anti-Kickback Statute (AKS), and the federal Civil Monetary Penalties Law. These companion final rules comprise more than 400 pages of discussion and regulation and bring to a close Department of Health & Human Services’ Regulatory Sprint to Coordinated Care, an initiative ostensibly designed to remove regulatory barriers to coordinated and value-based care, and follow the proposed rules that were issued by both CMS and OIG in 2019. The final rules make changes to the existing regulatory framework, including through the modification and clarification of existing AKS safe harbors and Stark Law exceptions as well as the promulgation of new safe harbors and exceptions. These changes became effective January 19, 2021 (with one exception related to certain modifications of the Stark Law’s “group practice” rules, which become effective January 1, 2022).

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