On December 2, 2020, the Department of Health and Human Services (HHS), the Office of Inspector General (OIG) and the Center for Medicare and Medicaid Services (CMS) will jointly publish the final regulations first proposed on October 17, 2019:

1.     AKS Safe Harbors: https://public-inspection.federalregister.gov/2020-26072.pdf
2.     Stark Exceptions:  https://public-inspection.federalregister.gov/2020-26140.pdf

The regulations will become effective January 19, 2021.

The Federal Register publications occupy approximately 2,000 pages. MedLaw Blog will publish a series of posts. This post merely provides the source links and will list the AKS Safe Harbors and Stark Exceptions announced. Subsequent posts will deal with specific topics, i.e. Value Based Enterprises (VBEs), EHR and Cyber Security, Outcomes Based Payments, etc.

Anti-Kickback Safe Harbors:

HHS/OIG have published the following Safe Harbors, both new and amended:

A.     These new Safe Harbors for Value Based Enterprises

1.     Coordinated Care Arrangements without risk;
2.     VBEs with substantial downside risk; and
3.     VBEs with full financial risk.

B.     Outcomes Based Payments

C.     Patient Engagement and Support

D.     CMS Sponsored Models and Arrangements

E.     Cyber Security and EHR Technology and Services

Stark Exception:

The new Stark Exceptions also include compensation exceptions for “Value Based Arrangements” in the definitions of Financial Arrangements in 42 CFR Section 411.354(c)(4)(iii).