UCI Admits Improper Charges in Cancer Cases
UC Irvine improperly charged dying cancer patients and Medicare more than $55,000 for experimental drug treatments in 1995 and 1996, payments tied to a problem-plagued research project that was later shut down, university officials acknowledged Friday.
The billing problems were uncovered in a UCI audit launched shortly after federal health officials began investigating reports of unauthorized research by the cancer laboratory’s doctors.
Of the 30 patients in the UCI clinical trial, 18 were billed for experimental medication in violation of federal law. The university has refunded $24,700 to nine patients or their families, and returned $8,913 to Medicare. UCI could not locate the remaining patients or their relatives, who are owed a total of $21,709.
“We’ve taken great steps to make sure this does not happen again,” said Mark Laret, executive director of UCI Medical Center. “We intend to do everything we can to operate with the greatest level of integrity, and to follow federal regulations to the letter.”
The lab itself--at the Chao Family Comprehensive Cancer Center--was padlocked in December 1996 after UCI found its researchers engaged in unauthorized experiments and sloppy protocol, including the use of an unapproved drug on a Florida girl stricken with a brain tumor.
A UCI internal inquiry also found that the researchers solicited $19,900 in donations from patients trying get into clinical trials, a practice that the university investigators called inappropriate and ethically suspect.
The donations and improper drug billings were collected from cancer patients enrolled in UCI-sponsored clinical trials at Good Samaritan Hospital in Los Angeles. The money was used to fund research at the UCI cancer lab and was collected by staff members at the medical center, at the direction of the cancer researchers.
UCI biochemist Gale Granger, head of the research team, told a top UCI administrator in a 1997 letter that the cancer lab had some organizational difficulties, but said they had been corrected. Granger could not be reached Friday for comment.
Under federal law, researchers must have approval from the Food and Drug Administration to charge patients for the cost of experimental drugs. UCI never received nor applied for FDA approval in this case.
UCI was forced to refund Medicare because the federal heath-care program does not pay for treatment that is exclusively experimental. Medicare was billed $8,913 for four Medicare recipients in the clinical trial.
“If they identified they charged Medicare inappropriately, they have an obligation to repay that money,” said Alwyn Cassil, spokeswoman for the inspector general’s office of the U.S. Department of Health and Human Services.
Cassil declined to comment on the UCI case but said most cases involving overbilling are reviewed to determine if further investigation is warranted.
The university discovered the billing problems three years ago but never thoroughly reviewed patient records so that the money could be refunded. In December, UCI Chancellor Ralph Cicerone said the university’s inaction was inexcusable, and the audit of the patient’s billing records soon followed.
The UCI Medical Center is switching to a centralized billing system to improve the university’s ability to monitor billing compliance by researchers, Laret said. All charges involving patients in clinical trials will require advance approval.
In the past, individual UCI departments often maintained separate billing systems, making it difficult to determine what care individual patients were billed for, Laret said.
UCI also is conducting spot-check audits on current research projects to make sure that they do not violate university and federal guidelines and that patients are treated and billed properly.
“In retrospect, a big part of the problem was the autonomous way the labs operated,” Laret said. “What we have done is to put systems in place to keep occurrences like this from happening.”
The FDA and National Institutes of Health launched investigations last summer after a UCI inquiry found that one of the cancer project’s researchers, Dr. John Hiserodt, violated federal and university rules when he shipped an unauthorized cancer vaccine to Florida for use on a terminally ill 8-year-old girl. Hiserodt left the university in 1997. “It’s an ongoing investigation, that’s about all I can say at this point,” said Dwight Rawls, senior special agent at the FDA Office of Criminal Investigation.
In December, Cicerone acknowledged that the university failed to act on extensive evidence of wrongdoing at the cancer center laboratory and that it repeatedly disregarded those findings and allowed scientists involved in the unauthorized research to go unpunished.
