The D.C. Court corrects itself on labs and medical necessity

In U.S. ex rel Groat v. Boston Heart Diagnostics Corp (D.D.C. Dec. 11, 2017)., the D.C. District Court granted a motion for reconsideration of its June 2017  decision which held that clinical laboratories were responsible for determining medical necessity. In the new Order, the Court relied on longstanding OIG guidance and clarified that a laboratory cannot and is not required to determine medical necessity, and is allowed to rely on an ordering physician's determination of medical necessity in its requests for government reimbursement.  

The Court further explained that although it previously overstated the obligation of a laboratory to make independent decisions regarding medical necessity, a duty still exist for laboratories to ensure that they do not submit claims for medically unnecessary tests.