The U.S. Supreme Court recently denied two certiorari petitions relating to the willfulness standard of the federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b (AKS), an issue with profound implications for health care companies and providers defending against AKS allegations.
On October 7, 2024, the Supreme Court denied the petition for certiorari in U.S. ex rel. Hart v. McKesson Corporation, and on October 15, 2024, denied the cert petition in Sayeed v. Stop Illinois Health Care Fraud, LLC.[1]
“Knowingly and Willfully”
The AKS prohibits persons from, among other things, “knowingly and willfully” soliciting or receiving “any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind—
A. in return for referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a federal health care program, or
B. in return for purchasing, leasing, ordering, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program[.]”
Recent Updates
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- The Structural Pressures Behind Senior Living and Long-Term Care Distress
- CMS Proposed Rule to Implement Section 6224 of the Consolidated Appropriations Act
- FDA Finalizes Key Parts of Its NDIN Guidance Related to Identity and Safety Information: What Dietary Supplement Companies Should Know
- The Whistleblower Windfall? DOJ Announces Another Incentive Program for Reporting Fraud