First Circuit Clarifies Application of Medicare’s “Reasonable and Necessary” Standard in FCA Cases Against Clinical Labs
Earlier this week, the First Circuit in OMNI Healthcare held that “in FCA cases alleging Medicare fraud based on laboratory testing, generally a laboratory can rely on a doctor’s order to show that the test is ‘reasonable and necessary’” under the Medicare statute. U.S. ex rel. OMNI Healthcare Inc. v. MD Spine Solutions LLC, No. 25-1110 (1st Cir. Dec. 1, 2025).
Data Analytics Firm Files Qui Tam Based on Billing Outliers
Earlier this month, a federal court unsealed a declined qui tam complaint filed by a data analytics firm based on identification of Medicare billing outliers. See United States ex rel. Lincoln Analytics, Inc. v. Global Integrated Medical Group, Inc., No. 2:22-cv-06501 (C.D. Cal.). Despite asserting a claim as an original source, the relator, Lincoln Analytics, Inc., appears to have assembled its allegations through its own analysis of Medicare data and a single interview. DOJ has increasingly been deploying data analytics to develop FCA cases and this unsealed complaint demonstrates that relators are also beginning to use data analytics in a similar manner.
