OIG Issues Policy Statement Waiving Administrative Sanctions For Arrangements Covered By CMS’s Blanket Stark Waivers

Last week, we wrote about the blanket Stark Law waivers issued by the Center for Medicare and Medicaid Services (“CMS”) in relation to the COVID-19 crisis.

On April 3, 2020, the Department of Health and Human Services’ Office of Inspector General (“OIG”) released a policy statement stating that it will not impose administrative sanctions under its exclusion and civil monetary penalty (“CMP”) authorities related to violations of the federal Anti-Kickback Statute (“AKS”) with respect to the remuneration covered by CMS’ blanket waivers.  According to the OIG, by issuing the policy statement, the OIG “seeks to avoid the need for parties to undertake a separate legal review under the [AKS] for arrangements protected by the Blanket Waivers.” The OIG is careful to note, however, that the policy statement “has no bearing on arrangements that implicate the [AKS] that are not covered by the Blanket Waivers” and gives a specific example of an arrangement that would not be covered by the policy statement: “direct financial relationships between pharmaceutical or device manufacturers and physicians or between providers where there is no physician involved.”

Although the blanket Stark waivers are retroactive to March 1, 2020, the OIG’s Policy Statement applies only to conduct that occurs on or after April 3, 2020, and “[p]arties may not rely on the Policy Statement for conduct that occurs after the expiration of the Blanket Waivers and [the] Policy Statement,” which will coincidence with when the COVID-19 public health emergency declaration expires or is terminated.