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Final Rules Issued Under Stark Law and Anti-Kickback Statute Final Rules Issued Under Stark Law and Anti-Kickback Statute

Final Rules Issued Under Stark Law and Anti-Kickback Statute

On November 20, 2020, the Centers for Medicare and Medicaid Services  (“CMS”) published a final rule “to modernize and clarify” the Stark Law regulations, and the Office of Inspector General (“OIG”) of the Department of Health and Human Services published a final rule revising the safe harbors to the Anti-Kickback Statute and the civil monetary penalty rules regarding beneficiary inducements. The final Stark rule creates new exceptions for value-based arrangements, provides guidance on how to determine if compensation meets the fair market value requirement, provides clarity on a wide range of “technical compliance requirements,” and creates new exceptions, such as for the donation of cybersecurity technology. The OIG’s final rule implements seven new safe harbors (including for value-based arrangements and donations of cybersecurity technology and services), modifies four existing safe harbors, and codifies a new exception under the beneficiary inducements CMP (related to telehealth for in-home dialysis). Most of the final rules will be effective 60 days from publication in the Federal Register.

Ice Miller’s Health Group is currently reviewing the final rules. We will provide some initial guidance on the final rules during our Health Law webinar scheduled from noon to 1:30 p.m. EST on December 17, 2020. You can register for the webinar here.

This publication is intended for general information purposes only and does not and is not intended to constitute legal advice. The reader should consult with legal counsel to determine how laws or decisions discussed herein apply to the reader's specific circumstances.
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