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. Even without an adjudicated finding of liability, the size of the recovery is notable. It reflects the government’s continued willingness to pursue laboratories, executives, and outside business actors together when it believes marketing, compensation, and billing practices are intertwined.

For legal professionals, the significance goes beyond the dollar figure. This matter highlights the familiar but still evolving intersection of the Anti-Kickback Statute and the False Claims Act: once remuneration is alleged to have tainted referrals, the downstream reimbursement claims can become the basis for substantial FCA exposure. In the genetic-testing space in particular, DOJ has repeatedly scrutinized lead-generation models, telemarketing-style outreach, physician-order practices, and compensation structures that can blur the line between legitimate business development and unlawful inducement.

For litigators, the settlement is a reminder that DOJ continues to build healthcare cases around patterns of referrals, internal communications, and medical-necessity evidence, while also targeting individuals. For in-house counsel and compliance teams, it underscores the need to stress-test relationships with marketers, consultants, and other third parties; confirm that physician orders and supporting documentation are robust; and ensure billing controls can withstand retrospective government review.

The inclusion of a former CEO and an outside businessman is especially important. Enforcement agencies have made clear that corporate form will not necessarily shield decisionmakers or referral sources from direct scrutiny. Companies operating in diagnostics, laboratory services, and adjacent healthcare sectors should read this settlement as a warning that compensation arrangements that appear commercially efficient can still create significant FCA and kickback risk if they influence ordering behavior or support claims lacking medical necessity.

More broadly, the matter fits squarely within DOJ’s ongoing strategy of using large civil recoveries to police federal healthcare-program integrity. For companies reimbursed by Medicare or Medicaid, the message is straightforward: referral economics, documentation practices, and necessity review remain core enforcement priorities—and they remain fertile ground for whistleblower suits and government intervention.