By: Alaina N. Crislip and Lindsay D. Petrosky
The Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) issued their long-awaited final rules on November 20, 2020. The final rules revise the Medicare Physician Self-Referral law (Stark law), the Federal Anti-kickback statute, and the Civil Monetary Penalties Rules.1 Each agency has issued a Fact Sheet highlighting the changes provided in the final rules, which are scheduled for publication on December 2, 2020. (CMS Fact Sheet) (OIG Fact Sheet)
The majority of the Stark law changes go into effect 60 days after publication. These changes are intended to provide health care providers with the ability to embrace value-based payment initiatives without fear of violating the law. Amongst other changes, the new modifications provide guidance for how to meet the “fair market value” requirement, which is an essential element of certain Stark law exceptions.
The OIG’s final rule implements seven new safe harbors, modifies four existing safe harbors, and codifies a new exception under the Beneficiary Inducements Civil Monetary Penalties. Three of the new safe harbors are for remuneration exchanged between or among parties in a value-based arrangement to foster coordinated and managed patient care.
Your Jackson Kelly Health Care Team will be providing further analysis of these rules over the coming weeks.
1 42 U.S.C. § 1395nn; 42 U.S.C. § 1320a-7b(b); and 42 U.S.C. § 1320a-7a(a)(5).