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January 14, 2022

FCA “Materiality” Claim against Doctor for Ordering Unnecessary Genetic Testing Allowed to Proceed

On January 7, the U.S. District Court for the Western District of Kentucky ruled that the government adequately alleged its False Claims Act case against a Kentucky doctor. The United States alleged that between May 2012 and March 2013, the physician ordered unnecessary pharmacogenomics tests, including more than one thousand tests reimbursed by Medicare, in return for alleged kickbacks received from a laboratory.  The allegations further state that the physician used pre-signed forms and directed staff to test all patients who met certain conditions rather than ordering each test based on patient medical necessity. The District Court ruled that the government adequately pleaded materiality in alleging that the physician made express—but allegedly false—certifications that the tests were medically necessary and can proceed with the express certification claim. However, the court noted, whether the government can prove that the physician did not in fact believe the tests to be medically necessary is a separate issue for summary judgment or trial.