Caris Life Sciences has agreed to pay $2,886,675 to settle claims of deliberately delaying genetic cancer screening tests to evade Medicare’s so-called 14-day rule.
Context: Lab tests are bundled into Medicare payment for hospital service and can’t be separately billed if a physician ordered the tests within 14 days of discharge from a hospital stay, whether in an inpatient or outpatient setting. However, the Medicare date of service (DOS) policy, commonly referred to as the 14-day rule, allows labs to directly bill for tests performed more than 14 days after discharge. The default date of service for a lab test is the date the specimen was collected.
The June 2 Caris settlement resolves claims that the Texas-based molecular testing firm carried out a “nationwide scheme” to delay testing of cancer patients so it could improperly bill Medicare for a pair of screening tests, the Caris Molecular Intelligence and the ADAPT Biotargeting System, for detecting genes within breast cancer tumors to predict the risk of cancer recurrence.
While not admitting any wrongdoing, Caris determined that discretion was the better part of valor and settled the claims, which began as a qui tam whistleblower lawsuit. The settlement only partially resolves the qui tam suit, which remains under seal [United States ex rel. Doe v. (UNDER SEAL) and United States ex rel. Caughron v. CDx Holdings, Inc. f/k/a Caris Life Science, Civil Action No. 18-CV-0352 (E.D.N.Y)].
Learn more in the upcoming July 2022 issue of National Lab Reporter.