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Wednesday, June 24, 2026

Diagnostics and Laboratory Services: Enforcement Trends and Practical Safeguards - ArentFox Schiff

Health care enforcement targeting diagnostic and laboratory services accelerated in 2025 and shows no signs of slowing down in 2026.

The US Department of Justice’s record-setting 2025 National Health Care Fraud Takedown, for example, reported that 49 defendants were charged in connection with the submission of over $1.1 billion in fraudulent claims linked to telemedicine and genetic testing alone.

The cases highlighted below — drawn from the past year’s enforcement actions against diagnostic testing companies and laboratories — offer a window into the trends shaping 2026 and practical steps to stay in compliance.

Continued Targeting of Illegal Remuneration

The federal Anti-Kickback Statute (AKS) prohibits offering, paying, soliciting, or receiving anything of value to induce or reward referrals for items or services covered by federal health care programs. AKS violations can also give rise to liability under the False Claims Act (FCA). In 2025, several diagnostic and testing companies faced enforcement actions for offering illegal kickbacks to providers in exchange for laboratory and testing referrals.

In December 2025, a Virginia clinical laboratory, NEXT Molecular Analytics (NEXT), agreed to pay at least $758,000 to resolve allegations that it knowingly paid kickbacks to induce laboratory referrals. As in the True Health matter, physician payments were disguised as consulting or medical director fees. NEXT also allegedly paid independent marketing contractors volume- and...



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