OIG Issues Blanket Waivers of Anti-Kickback Statute to Address COVID-19 Pandemic

On April 3, 2020, the Office of Inspector General (“OIG”) announced it will exercise its enforcement discretion to not impose administrative sanctions under the federal Anti-Kickback Statute (“AKS”) with respect to remuneration that is covered in most—but not all—of the blanket waivers for the Stark Law that the Centers for Medicare and Medicaid Services (“CMS”) published on March 30, 2020.

OIG’s statement applies to the first 11 waivers issued by CMS. These waivers cover situations including remuneration to or from physicians that is above or below fair market value, remuneration to a physician in the form of medical staff incidental benefits that exceeds the limits set in applicable Stark Law exceptions, and rental charges by a physician to an entity above or below fair market value. OIG stated that all conditions and definitions that apply to the Stark Law blanket waivers would need to be satisfied for a provider to receive this enforcement discretion. The conditions include: (i) the providers are acting in good faith to provide care in response to the COVID-19 pandemic, (ii) the government does not determine that the financial relationship creates fraud and abuse concerns, and (iii) providers seeking protection under this policy statement maintain sufficient documentation.

Notably, the AKS blanket waivers apply to conduct occurring on or after April 3, 2020. By contrast, the Stark Law blanket waivers applied retroactively effective March 1, 2020. Thus, there will be about 30 days in which an arrangement could be legal under Stark but violate the AKS. The AKS blanket waivers will terminate on the same date as the Stark blanket waivers terminate—which will stay effective during the COVID-19 public health emergency.

Unlike the Stark Law, which is a strict liability law that does not require a person or entity to intend to violate the law, AKS is an intent-based statute. While it seems clear that OIG will apply its enforcement discretion and be lenient toward relationships designed to support the COVID-19 public health emergency, there should be no assumption that the OIG will extend the same or any leniency to conduct that outright intends to induce referrals. Hence, despite the current circumstances, the most prudent course of action is compliance with AKS absent exigent circumstances.

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