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Wednesday, May 6, 2026

The Impact of the Decision in U.S. v. Holland on the One Purpose Test - JD Supra

The Court’s decision in U.S. v. Holland highlights the apparent contradiction between the judicially created and often relied upon “one purpose test” involving criminal and civil enforcement actions under the Federal Anti-Kickback Statute by government and relators’ counsel and compliance with criteria under the “Safe Harbor” regulations for protection from violations of the statute. The “one purpose test” has created the basis for a violation of the Anti-Kickback Statute if any purpose of a payment for services induced or was in exchange for, patient referrals, even if legitimate services were rendered and/or the arrangement fit into a regulatory “Safe Harbor.”

The Court’s decision was made within the context of determining whether or not to admit unindicted co-conspirator statements into evidence, which necessitated deciding whether or not there was a conspiracy in the first place to violate the Anti-Kickback Statute. The Court’s discussion was extensive in analyzing the “one purpose test," (which the Court found was not settled law) and considered whether there was a knowing and willful violation of the Anti-Kickback Statute where the arrangement arguably met the Safe Harbor regulation for personnel and management services.The Court concluded that the mere existence of an arrangement for services where referrals and payments were involved did not establish knowing and willful conduct, which violated the Anti-Kickback Statute.

The Court’s discussion directly addressed,...



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