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March 14, 2022

The Application of the Anti-Kickback Statute to Digital Health Arrangements

This Briefing is brought to you by AHLA’s Fraud and Abuse Practice Group.
  • March 14, 2022
  • Roger A. Cohen , Goodwin
  • Taylor Lauren Frazier , Goodwin

Much of the authority concerning the application of the Anti-Kickback Statute (AKS) focuses on arrangements involving remuneration to health care providers or patients. However, the AKS sweeps more broadly, and, in a series of Advisory Opinions, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) has held that the AKS may be implicated by arrangements involving the payment of remuneration by a health care provider to a digital health company, including payments for digital marketing, advertising, and information exchange related to referrals. For example, HHS OIG stated in a number of Advisory Opinions that arrangements for the provision of marketing services under a management services agreement, lead generation services, websites offering coupons for health care items and services, and patient scheduling platforms implicate the AKS because these arrangements involve the payment of remuneration to a party that is arranging for the provision of or recommending health care items and services. These Advisory Opinions have important implications for both health care providers and digital health companies that provide services to health care providers as HHS OIG has opined that such arrangements, when not protected by an AKS safe harbor, may present high risk or low risk of federal health care program fraud and abuse depending on a number of factors. Below, we review the relevant Advisory Opinions and discuss their implications for digital health companies and parties doing business with digital health companies.

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