The Office of Inspector General (“OIG”) for the Department of Health and Human Services recently issued an Advisory Opinion that provides insight into how the agency evaluates arrangements that deal with the integration of technology, medicine, and patient monitoring under the federal Anti-Kickback Statute (“AKS”). In Advisory Opinion No. 19-02, OIG evaluated whether a pharmaceutical manufacturer could temporarily loan a limited-functionality smartphone to financially needy patients enrolled in federal health care programs. OIG concluded that the proposed arrangement could violate federal health care fraud laws but OIG would not impose civil monetary penalties or administrative sanctions in light of the purpose of the arrangement and certain safeguards in place. This Advisory Opinion related to the promotion of remote patient monitoring and is useful to telehealth providers and other pharmaceutical manufacturers to evaluate how OIG might analyze similar arrangements.
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