OIG Issues Special Fraud Alert Regarding Laboratory Relationships with Physicians

On June 25, 2014, the U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) released a Special Fraud Alert addressing two increasingly common relationships between clinical laboratories and physicians that may raise fraud and abuse concerns—payments to referring physicians for (i) specimen collection and (ii) data submission/review for laboratory registries. This Special Fraud Alert is likely a response to the increasingly competitive nature of the clinical laboratory industry as a result of downward pressure on reimbursement, new health reform delivery structures and the influx of small esoteric laboratories offering limited, specialized test menus. In this environment the OIG is concerned that some laboratories may be taking steps to win business from referring physicians in potential violation of the Federal Anti-Kickback Statute. Arrangements that are the focus of Special Fraud Alerts are common targets for FCA claims.