21st Century Oncology: The FISH Tests Behind the Physician Bonuses

In the 21st Century Oncology FISH testing settlement, the company agreed to pay $19.75 million to resolve allegations that it billed Medicare and TRICARE for unnecessary urine tests and encouraged the orders through physician bonuses. A former medical assistant brought the case, alleging that original negative urine results contradicted the electronic records used to justify further testing. Her account began with what the urine test showed before the chart told a different story.

The Justice Department announced the company settlement on December 18, 2015. It described 21st Century Oncology as a nationwide cancer-care provider headquartered in Fort Myers, Florida, and alleged that four of its urologists in the Fort Myers area ordered unnecessary FISH tests. The alleged laboratory referral bonuses connected those clinical decisions to the company’s own laboratory and back to the ordering physicians’ pay.

What Was the FISH Testing Allegation?

The government alleged that 21st Century Oncology submitted claims for FISH tests that patients did not need. FISH, short for fluorescence in situ hybridization, tests urine for genetic abnormalities associated with bladder cancer. The patient’s history and the reason for ordering that test were central to the government’s account.

In its announcement of the physician’s separate settlement, the Justice Department described Medicare coverage for monitoring tumor recurrence in a patient previously diagnosed with bladder cancer, or investigating suspected bladder cancer after a full urologic workup of a patient with hematuria, meaning blood in the urine. The whistleblower alleged that the urologist changed negative results to show blood and also ordered FISH tests without the full workup needed to support them.

How the Physician Bonus Connected the Order to the Laboratory

The company allegedly encouraged unnecessary FISH testing with bonuses based partly on the number of tests physicians referred to its laboratory. That arrangement gave the ordering decision a financial consequence for both the laboratory receiving the work and the physician sending it. The complaint alleged that the company billed government health care programs for the tests and their interpretation, using its own laboratory equipment.

The whistleblower’s complaint went further, alleging that the company held competitions and paid a bonus to the physician in a practice who ordered the most FISH tests during a particular period. It alleged that orders from physician assistants and nurse practitioners working under a physician counted toward that physician’s total. We see the absurdity in that alleged contest: the winning number was how many tests a physician ordered. The patient’s need for the test was the very thing the lawsuit disputed.

The Robert Wood Johnson Foundation’s 2008 research synthesis, Physician Self-Referral and Physician-Owned Specialty Facilities, describes two conflicts created by a physician’s financial relationship with a facility: an incentive to recommend additional services, including unnecessary ones, and an incentive to send patients to that facility. The FISH allegations join those decisions in a particularly concrete way. The government said the bonus depended partly on both the number of tests and their referral to the company laboratory.

The Original Urine Record and the Electronic Chart

The complaint alleged that the urologist changed a patient’s electronic record after a urine test came back negative for blood, entered a trace of blood instead, and claimed a diagnosis of hematuria. It further alleged that he ordered the original results shredded after creating the replacement account. The medical assistant’s allegation was specific about the documents she could compare:

That comparison gives the medical necessity allegation its force. The complaint described an original result that undermined the reason recorded for the next test, with government programs billed for that testing. For someone who handled the urine results, the revealing evidence was the difference between the original and the chart.

The complaint also alleged that the urologist sometimes checked hematuria on the chart and ordered FISH testing without another examination or less expensive testing. In other instances, it alleged that the chart contained no diagnosis supporting the order at all. Those allegations reach both the truth of the recorded result and the clinical work behind the decision to send another test to the laboratory.

The Separate Physician Settlement in the FISH-Testing Case

The company settlement resolved the allegations against the company, while the urologist later reached his own agreement. On January 29, 2016, the Justice Department announced that the physician had agreed to pay $1,050,000 to resolve allegations that he caused claims for unnecessary laboratory tests to be submitted to federal health care programs. He practiced at Naples Urology Associates, a division of 21st Century Oncology.

According to that announcement, he became a company employee in January 2010 and began sending all the FISH testing he ordered to a laboratory the company owned and operated. The government described bonuses based partly on the number of FISH tests he referred there. His separate settlement concerned the ordering physician’s conduct within the same testing arrangement.

The whistleblower worked directly for that physician. The government announced a $3.2 million whistleblower reward from the corporate resolution and a separate share from the physician’s recovery. Her position beside the ordering doctor gave her a view of the original results and the entries that followed them.

What Evidence Does a Whistleblower Need?

For a case about unnecessary testing and referral bonuses, the evidence connects the clinical reason for the order to the laboratory claim and the compensation it generated. We examine the original result, what the chart said, who ordered the test, where it went, and what the bonus calculation counted. The complaint’s alleged competitions make the attribution of orders especially revealing: whose testing was credited to which physician?

The Medicare Claims Processing Manual’s laboratory chapter connects diagnostic testing to the patient’s illness, injury, symptom or complaint and the physician’s order. In this case, the alleged alteration occurred in the clinical record that was supposed to explain why the test was needed.

The compensation records answer a different question: what earned the physician money? Clinical laboratory services fall within the physician self-referral rules, and the financial relationship can be compensation as well as ownership. We put the actual bonus calculation beside the orders and government claims, so a compensation label does not obscure what the payment rewarded.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers. If you know why the recorded result changed or how a laboratory referral affected pay, we can work through the connection between those decisions with you.

The Other Oncology Settlements Concerned Different Conduct

The company’s March 2016 Gamma-function settlement concerned a radiation procedure used to measure the dose exiting a patient after treatment. The government alleged improper billing when the procedure served no medically appropriate purpose, including when staff lacked training to interpret the results or technical failures produced no result. The December 2017 settlement addressed the company’s disclosure of false statements about electronic health record software use and separate allegations of improper physician compensation. The FISH case centered on urine testing, the clinical justification for those orders and bonuses for sending them to the company laboratory.

You Know What the Test Record Said

If you saw urine results changed, tests ordered to meet a target, or bonuses calculated from laboratory referrals, talk with our whistleblower experts about what you saw. We build your case around the clinical and financial decisions you understand, bring in healthcare fraud whistleblower lawyers who know laboratory testing and physician compensation, and stand with you through the case.