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HHS Issues Final Regulation on Anti-Kickback Statute and Civil Monetary Penalty Rules

For CEOs, CFOs, chief legal counsel, government relations staff

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The U.S. Department of Health & Human Services’ Office of Inspector General (OIG) has issued a final rule revising safe harbors under the anti-kickback statute, as well as civil monetary penalty rules for beneficiary inducements. The regulations are effective Jan. 19, 2021. 

The final rule creates seven new safe harbors, modifies four existing safe harbors, and codifies one new exception under the beneficiary inducements civil monetary penalty. 

Specifically, the final rule creates three new safe harbors for remuneration exchanged between or among eligible participants in a value-based arrangement if it aids better coordinated and managed patient care. In addition, the OIG finalizes new safe harbors for patient engagement, payment provided in connection with certain models sponsored by the centers for Medicare & Medicaid Services and accountable care organization beneficiary incentive programs, and donations of cybersecurity technology and services. 

The OIG finalizes modifications to four existing safe harbors for electronic health records, outcomes-based payments and part-time arrangements, warranties, and local transportation. 

For the beneficiary inducement civil monetary penalty, the final rule codifies a new exception to the rules for telehealth technologies for in home-based dialysis treatment. 

fact sheet is available with more information.