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Physician Self-Referral Law (Stark), Anti-Kickback Statute, and Beneficiary Inducement CMPs – HHS Releases Final Rules

On November 20, 2020, the Department of Health & Human Services (HHS) released heavily anticipated final rules revising the regulatory exceptions to the Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statute (AKS) safe harbors, and the Beneficiary Inducements Civil Monetary Penalties (CMP) regulations.  The changes to the regulations go into effect on January 19, 2021 (except for one change to the Physician Self-Referral Law that becomes effective January 1, 2022). In a separate rule also released November 20th, HHS removed safe harbor protection for rebates involving prescription pharmaceuticals and created a new safe harbor for certain point-of-sale reductions in price on prescription pharmaceuticals and pharmacy benefit manager service fees.

The full text of each rule is available below.

The rules make a number of important changes to the regulations, and also provide new guidance on existing exceptions and safe harbors under those laws and regulations.

Revisions by CMS to the Physician Self-Referral Law regulations include, among others:

  • providing exceptions and integral definitions for value-based arrangements

  • a new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician

  • a new exception for donations of cybersecurity technology and related services

  • amending the existing exception for electronic health records (EHR) items

Revisions by the OIG to the Anti-Kickback Statute safe harbor regulations include, among others:

  • three safe harbors for value-based arrangements

  • safe harbor for certain patient engagement tools and supports in value-based arrangements

  • CMS-sponsored model arrangements safe harbor

  • cybersecurity technology and services safe harbor

  • electronic health records safe harbor

  • modifying the personal services and management contracts safe harbor

  • revising the warranty safe harbor

  • modifying the local transportation safe harbor including expanded mileage limits for rural areas and elimination of mileage limits to convey patients discharged from hospitals to their place of residence

  • codifying the statutory exception to “remuneration” relating to ACO Beneficiary Incentive Programs

Revisions by the OIG to the Beneficiary Inducements CMP regulations and related guidance include:

  • codifying the statutory exception for “telehealth technologies” furnished to certain in-home dialysis patients

  • clarifying that arrangements that fit into the new safe harbors for patient engagement and support, and local transportation, are protected under the Beneficiary Inducements CMP

Copyright © 2021 Robinson & Cole LLP. All rights reserved.National Law Review, Volume X, Number 326

About this Author

Melissa Lisa Thompson Healthcare Lawyer Robinson Cole Law Firm

Lisa Thompson advises companies, senior management, and their boards of directors, with a focus on the health care, life sciences and technology industries. She is a member of the firm’s Health Law Group and Data Privacy + Cybersecurity Team.  She is also an arbitrator on the Commercial panel and the Health Care panel of the American Arbitration Association.  

Health Care, Life Science and Technology Industries

Lisa represents domestic and international clients in the health care, life science and technology industries, including pharmaceutical companies,...

Conor Duffy Cybersecurity Attorney

Conor Duffy is a member of the firm's Health Law Group and its Data Privacy + Cybersecurity Team. He advises hospitals, physician groups, community providers, and other health care entities on general corporate matters and health law issues. He also counsels clients on what measures are needed to safeguard data and patient information.


Conor provides legal counsel to health care clients on various regulatory matters, such as Medicare and Medicaid program compliance, federal fraud and abuse laws, and the Emergency Medical Treatment & Labor Act...