HHS OIG: Smartphone loaner to needy patients may not violate Anti-Kickback Statute

On Tuesday, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published Advisory Opinion No. 19-02, advising that OIG would not pursue enforcement under the Anti-Kickback Statute (AKS) or the beneficiary inducement provision of the Civil Monetary Penalties Law (beneficiary inducement CMP) regarding a pharmaceutical manufacturer's proposal to loan a limited-function smartphone to financially needy patients to facilitate collection of drug-adherence data.

Although OIG's guidance is limited to the narrow facts presented by this proposal, the advisory opinion shows the government engaging with new questions presented by the integration of technology and medicine, and by companies' increased involvement in patient management. Drug and device manufacturers and others considering how to incorporate technology into their products or how to engage more deeply with patients should take a careful look at this and future guidance from the government on the potential fraud and abuse implications of such initiatives.

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