As noted in our recent alert (4.7.20), the Centers for Medicare & Medicaid Services (“CMS”) recently issued “blanket waivers” concerning several Stark Law requirements in response to the COVID-19 pandemic.  CMS enacted the Stark Law Blanket Waivers to ensure the availability of healthcare services for patients during the current public health emergency and to allow healthcare providers to receive payment for certain claims that, without a blanket waiver, would violate the Stark Law.

On April 3, 2020, the Office of Inspector General for Health & Human Services (“OIG”) issued a similar Policy Statement, also aimed at protecting patients and providing regulatory flexibility to allow healthcare providers to adequately respond to the COVID-19 pandemic. Pursuant to the Policy Statement, the OIG will “exercise its enforcement discretion not to impose administrative sanctions under the Federal anti-kickback statute for certain remuneration related to COVID-19 covered by the [Stark Law Blanket Waivers].”

Specifically, the OIG will not impose sanctions under the federal Anti-Kickback Statute with respect to conduct covered by Section II.B.(1)-(11) of the Stark Law Blanket Waivers, which relate to certain personal service arrangements, equipment and office space leases, medical staff incidental benefits, nonmonetary compensation and loan arrangements linked to “COVID-19 Purposes” (as defined in the Stark Law Blanket Waivers). The OIG’s Policy Statement applies to conduct occurring on or after April 3, 2020, and, like the Stark Law Blanket Waivers, will terminate upon the expiration or termination of the declared public health emergency.

Despite the enforcement relief granted under the Policy Statement, the OIG still advises that it will continue to investigate and prosecute fraudulent activities. Therefore, parties seeking to take advantage of the Stark Law Blanket Waivers and the OIG’s Policy Statement must be diligent in appropriately analyzing and documenting the arrangements to qualify for protection.