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Meir Daller, a Fort Myers urologist, has agreed to pay $3.81 million to settle allegations he submitted claims to Medicare and Tricare for fluorescence in situ hybridization, or FISH, tests that weren't medically necessary, a violation of the False Claims Act, the Department of Justice announced.
FISH tests are performed on urine to detect genetic abnormalities associated with bladder cancer. They are not considered "reasonable or necessary" by Medicare unless it used to monitor for the recurrence of tumors in patients that have been previously diagnosed with bladder cancer, or when a urologist suspects a patient may have bladder cancer following a "full workup," the DOJ said.
Daller practiced urology at Gulfstream Urology, which was a division of nationwide cancer services provider 21st Century Oncology. Starting in 2009, Daller referred all FISH tests to a lab owned and operated by 21st Century. In that time, he ordered more than 13,000 FISH tests on his Medicare patients and was allegedly paid bonuses by 21st Century based in part on the number of FISH tests he referred, becoming the number one referring physician in the country related to FISH tests, the DOJ said.
The allegations brought against Daller were part of a whistleblower, or qui tam, lawsuit brought by a former medical assistant who worked for a physician at another division of 21st Century called Naples Urology. The whistleblower will receive $571,500 for their part in the case against Daller, which is in addition to $3.4 million for their role in cases and settlements against other 21st Century physicians.
As part of his settlement, Daller will complete a three-year Integrity Agreement with the Office of the Inspector General for Health and Human Services, which requires him to retain an independent review organization for the purpose of executing a claims review and electronic health records review to analyze any changes made to health records after their initial entry, according to Medicare and Medicaid requirements.
The United States' total recovery relating to the investigation of the use of FISH tests by doctors affiliated with 21st Century currently totals $24.9 million.