In a Policy Statement released on April 3, 2020, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) announced that it will exercise its enforcement discretion and not impose administrative sanctions under the federal Anti-Kickback Statute (AKS) for certain financial arrangements related to COVID-19 covered by the blanket waivers issued by the Secretary of HHS on March 30, 2020 (the Blanket Waivers). The Blanket Waivers apply to sanctions for potential violations of the federal Physician Self-Referral Law (also known as the Stark Law) with respect to specific “COVID-19 Purposes,” which Husch Blackwell summarized in a recent blog. The OIG’s Policy became effective upon release (while the Blanket Waivers are retroactively effective March 1, 2020), and will terminate upon termination of the Blanket Waivers, unless otherwise specified by the OIG.
Acknowledging that the AKS may be implicated in financial arrangements that implicate the Stark Law, the OIG provided that the Policy’s purpose is to ensure that healthcare providers have the regulatory flexibility necessary to effectively address COVID-19 concerns and alleviate the burden of seeking a separate AKS legal review for the financial arrangements covered by the Blanket Waivers.
While the OIG’s Policy is welcome news to healthcare providers, the Policy has its limits. The Policy does not extend protection to arrangements that implicate the AKS that are not otherwise protected by the Blanket Waivers. As a result, the OIG emphasized that the Policy does not protect direct financial arrangements, which potentially implicate the AKS, between pharmaceutical or device manufactures and physicians or between other providers where no physician is involved.
Moreover, the Policy only protects eleven of the eighteen Blanket Waivers (see section II.B.(1)-(11) of the Blanket Waivers). The seven remaining Blanket Waivers not covered by the Policy apply to arrangements involving referrals by physician-owned hospitals, home health agencies, and physician groups. Although some of these arrangements may implicate the AKS, structuring these arrangements in accordance with one of AKS safe harbors may be a feasible option. Arrangements that fit squarely within an AKS safe harbor are protected from AKS enforcement; however, failure to strictly adhered to a given safe harbor is not a per se violation of the AKS. Additionally, providers have the option to consult with the OIG regarding its enforcement of the AKS as it relates to one of these seven arrangements not protected by the Policy. The OIG encouraged providers to submit questions regarding its enforcement to OIGComplianceSuggestions@oig.hhs.gov, detailing the facts of the arrangement “to allow for an understanding of the key parties and terms of the arrangement at issue.”
Consistent with the guidance provided with respect to the Blanket Waivers, providers seeking to take advantage of the Policy to address COVID-19 concerns should use caution to ensure that (1) the remuneration and referrals resulting from the arrangement is solely related COVID-19 Purposes (specifically defined in the guidance to the Blanket Waivers); (2) the parties to the arrangement make records relating to the use of the Blanket Waiver and OIG’s Policy; and (3) in structuring the arrangements, the parties remain cognizant of the Stark Law exceptions and AKS safe harbor requirements and implement these additional protections where feasible to provide further support that the arrangement is absent of fraud or abuse.
