Fluorescent In Situ Hybridization (“FISH”) Test Fraud

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In 2014, Medicare Part B paid $7.0 billion for 451 million lab tests provided to its beneficiaries. For the top 25 lab tests in 2014:

  • Medicare Part B payments totaled $4.2 billion;
  • Independent labs accounted for the majority of Medicare Part B payments;
  • A small portion of labs accounted for the majority of Medicare Part B payments;
  • A relatively new set of assays – entitled cytogenetics – accounts for a significant proportion of current lab testing.

Excessive fluorescence in situ hybridization (“FISH”) testing in the absence of unambiguous clinical value AND the associated payment of kickbacks by clinical laboratory providers to physicians involved in direct patient care established clear evidence of Medicare fraud.

In December 2015 the Department of Justice announced a nearly $20 million recovery against a Florida provider group specializing in cancer diagnoses and treatment. The government’s allegations stated that 21st Century Oncology LLC submitted claims to Medicare and Tricare for FISH tests that were not medically necessary and, furthermore, that kickbacks (bonuses) were offered to referring urologists for inducing referrals and for the testing of patients. To the extent that the two conditions above accompanied the test ordering, the government alleged the testing violated the federal Anti-Kickback Statute.