On January 7, 2022, a district court in the Western District of Kentucky dismissed DOJ’s implied false certification theory relating to allegedly medically unnecessary genetic tests, holding that the prosecutors failed to adequately plead materiality. In so holding, the court set forth a novel test for materiality that forecloses the government’s ability to argue that certain regulations are per se material based on the government’s characterization of them as conditions of payment. Instead, plaintiffs must still plead “specific facts regarding the effect of a violation of that regulation” to survive dismissal.
Federal prosecutors alleged that the defendant violated the FCA by submitting claims for genetic tests while not in compliance with three particular regulations. The first required that physicians “use the results [of a test] in the management of the beneficiary’s specific medical problem.” The second imposed special requirements for the ordering of warfarin-responsiveness tests. And the third stated that “[t]ests not ordered by the physician who is treating the beneficiary are not reasonable and necessary,” and thus are ineligible for reimbursement because they fail to satisfy Medicare’s statutory criteria for reimbursement. The prosecutors asserted that these regulations—in particular the last, compliance with which they claimed is self-designated as necessary for payment—were material to the government’s decision to pay.
However, the court found these allegations...
By JAMELLE BOUIE Donald Trump knew as well as anyone that he had lost the 2020 presidential election fair and square. He knew there was no conspiracy to commit voter fraud — no mysterious mail bal...