Does the OIG issue opinions about the “Stark” law?
Opinions about the “Stark” law (section 1877 of the Act, also known as the “physician self-referral law”) come within the jurisdiction of the Centers for Medicare & Medicaid Services (“CMS”), which operates the Medicare and Medicaid programs. Information about the Stark advisory opinion process is available at 42 CFR ยงยง 411.370-.389 . The Stark law and the anti-kickback statute are separate statutes, and, depending on the facts, a particular arrangement might implicate one or both statutes. The Stark law applies in the case of direct and indirect financial relationships with referring physicians (as further described in that law). Although the OIG is not authorized to issue opinions about the Stark law, our regulations require that a party requesting an OIG advisory opinion notify us if the party will be separately requesting a Stark opinion from CMS about the same arrangement.