Excessive bail shall not be required, nor excessive fines imposed, nor cruel and unusual punishments inflicted.
– U.S. Constitution, 8th Amendment
In late December, the U.S. Circuit Court of Appeals for the Eleventh Circuit issued its decision in Yates v. Pinellas Hematology & Oncology, P.A.1 The appellate court affirmed the district court's imposition of damages and penalties where the jury found that the defendant had violated the False Claims Act on 214 occasions by submitting claims for reimbursement of laboratory tests without a proper Clinical Laboratory Improvements Amendments (CLIA) certificate. The CLIA requires that any facility conducting tests on materials derived from the human body must obtain CLIA certification through the Centers for Medicare and Medicaid Services (CMS), and a valid CLIA certificate is required for Medicare reimbursement of those tests.
The trial evidence showed that Pinellas was a hematological and oncological medical practice that included a clinical laboratory with the appropriate CLIA certification. In 2016, Pinellas purchased an oncology practice (Bayfront) that also had a CLIA certificate, but that certificate did not transfer upon the sale. Because each laboratory facility must have its own certification, Pinellas could not use either its own or Bayfront's pre-existing certificate for tests conducted at Bayfront. Initially, Pinellas submitted claims for reimbursement for tests at Bayfront without a valid CLIA certificate number,...
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