The Justice Department has announced a $36.4 million settlement with Access DX Laboratory, its former CEO Michael Stewart, and Florida businessman Harold Shatz to resolve allegations that the defendants participated in a kickback-driven scheme involving medically unnecessary genetic testing billed to Medicare and Medicaid. The case is the latest sign that federal healthcare-fraud enforcement remains sharply focused on laboratory testing arrangements, referral relationships, and claims tied to questionable medical necessity.

According to the government, the settlement resolves allegations under the False Claims Act arising from payments intended to generate referrals for expensive genetic tests, along with the submission of claims to federal healthcare programs for tests that were not medically necessary.

The U.S. Supreme Court declined to hear Eli Lilly’s constitutional challenge to the False Claims Act’s qui tam mechanism, preserving one of the government’s most potent civil fraud enforcement tools. The petition arose from litigation brought by whistleblower Ronald Streck, who accused Lilly of misconduct tied to Medicaid drug rebate reporting.

By denying review, the Court leaves in place lower-court rulings that allowed the case to proceed and, more broadly, avoids reopening a recurring defense-side attack on the False Claims Act’s structure.