Stark Waivers Might Clash with Anti-Kickback Statute

April 17, 2020

On March 30, 2020, HHS issued blanket waivers to permit eighteen types of financial relationships that would otherwise violate the Physician Self-Referral (“Stark”) Law when those financial relationships relate to a defined “COVID-19 Purpose.” However, in this April 3, 2020 statement, the HHS Office of Inspector General (OIG) said that seven of the permitted financial relationships under the Stark waivers may still potentially violate the Anti-Kickback Statute (AKS) and expose providers to sanctions under the AKS. The OIG is inviting providers who have questions about possible conflicts between the Stark law waivers and the Anti-Kickback statutes to submit such questions by email to OIGComplianceSuggestions@oig.hhs.gov with a sufficient description to allow for an understanding of the key parties and terms of the arrangement at issue. This invitation to consult with the OIG, on what appears to be an informal basis, is highly unusual for the OIG, and warrants consultation with counsel before doing so. Providers should also be careful to maintain contemporaneous documentation of the rationale and circumstances surrounding the use of the Stark waivers.