Elizabethtown cancer clinic pays $3.7 million to resolve claims it diluted drugs, prolonged chemotherapy to make more money

Elizabethtown Hematology Oncology PLC and its owners has paid $3,739,325 to settle claims "that they submitted false claims for payment to the Medicare, Medicaid and the military's medical provider for extending the duration of chemotherapy infusion treatment to patients and inappropriately billing office visits for infusion therapy," Andrew Wolfson reports for The Courier-Journal.

"To subject cancer patients to unnecessary treatments that are physically draining and emotionally stressful is utterly unconscionable," said Patrick McFarland, inspector general of the U.S. Office of Personnel Management.

The settlement agreement not only explains that the clinic's owners, Dr. Rafiz Ur Rahman and Dr. Yusuf K. Deshmukh, extended the time period of chemotherapy and infusion treatments for patients just to make more money but also says the clinic wrongly billed for office evaluations of patients getting chemotherapy, Wolfson writes.

"Manipulating treatment protocols and lengthening infusion times to increase reimbursement reflect an extraordinary lack or regard for patient welfare and the integrity of our health care system," David Hale, U.S. attorney for the western half of Kentucky, said in a news release.

In 2011, Dr. Ijaz Mahmood of Elizabethtown filed a lawsuit against the clinic, saying it created written protocols designed to prolong chemotherapy infusion times "by a factor of three or more beyond what is generally recognized." Mahmood said Deshmukh and Rahman provided patients with the correct dose of chemotherapy but administered it over a longer period of time by diluting it. They could make more money that way because Medicaid and Medicare pay partially based on how long a procedure takes.

Aside from the $3.7 million payment, the inspector general of the U.S. Department of Health and Human Services will monitor the clinic for three years. The clinic will still be allowed to bill federal medical programs, Wolfson writes. The government could still potentially prosecute the doctors. (Read more)

People with a genetic risk of obesity should avoid saturated fat, national study of 2,800 people suggests

A new study shows that avoiding saturated fat may be advantageous for those whose genetic makeup predisposes them to obesity. Researchers from the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University used 63 gene variants associated with obesity to determine a genetic risk score for obesity for more than 2,800 white, American adults participating in two studies about heart disease prevention.

"People with a higher genetic risk score, who also consumed more of their calories as saturated fat, were more likely to have a higher body mass index, the ratio of body weight to height," Newswise reports.

"We already know there are certain genes that interact with dietary fat and affect BMI," said senior author Jose M. Ordovas, Ph.D., director of the Nutrition and Genomics Laboratory at the USDA center and a professor at the Friedman School of Nutrition Science and Policy at Tufts. We "saw that while total fat intake was related to higher BMI, people who were genetically predisposed to obesity and ate the most saturated fat had the highest BMIs."

The study is published in the Journal of the Academy of Nutrition and Dietetics. The findings also take into consideration factors like age, sex and physical activity levels. Ordovas and the other researchers believe that those who have genetic makeups predisposing them to obesity might be more easily affected by saturated fat, which is often found in fatty cuts of meats, butter, cheese and other high-fat dairy products.

Ordovas said that although they cannot yet explain with confidence the "role of saturated fat intake in obesity . . . Some clinical models suggest that saturated fat might interfere with activity in the part of the brain that lets us know we're full, in addition to a few studies in people that suggest a diet high in saturated fat interferes with satiety." Ordovas also said that if additional research could explain the connection between obesity-related genes and saturated fat, people would have even more convincing reasons to eat less saturated fat. (Read more)

Kentucky gets $1.75 million in national settlement with big drug maker; marketing and promotional practices reined in

Kentucky will receive approximately $1.75 million from a $105 million national settlement with GlaxoSmithKline to resolve allegations that the pharmaceutical manufacturer unlawfully promoted its asthma drug, Advair, and its antidepressant drugs, Paxil and Wellbutrin, according to a press release from Attorney General Jack Conway's office.

The complaint and consent judgment alleges that GSK violated state consumer-protection laws by misrepresenting the uses and qualities of these drugs. Conway said in the release that this settlement will change the way pharmaceutical sales teams are motivated and paid.

The consent judgement requires GSK to reform its marketing and promotional practices, stating the company shall not: make any false, misleading or deceptive claim about its products; make claims not approved by the U.S. Food and Drug Administration; present information or conclusions from inadequate clinical studies; provide samples to health care professionals if they know it is being prescribed for non-approved use; or provide information describing any off-label use of a GSK product, unless consistent with applicable Food and Drug Administration regulations.

They must also continue a program through March 2019 that decreases financial incentives for sales representatives who use deceptive marketing practices, says the release.  In addition, scientifically trained personnel will be responsible for providing unbiased and non-promotional information to health care providers.

Kentucky joined 43 other states and the District of Columbia in reaching the national settlement with GSK.