Nearly impossible to eliminate the illegitimate practice. Kickbacks from the makers of hip implants and other joint replacements to orthopedic surgeons are so prevalent that it has become nearly impossible to eliminate the illegitimate practice, an assistant inspector general with the Health and Human Services Department told a Senate panel yesterday. Unfortunately, the practice of kickbacks is taking a toll on patients, who are often implanted with low quality devices because surgeons are influenced by such kickbacks.
Those allegations were part of testimony taken yesterday at a hearing of the Senate Special Committee on Aging. The hearing followed a probe of the orthopedic-device industry by U.S. prosecutors that resulted in a settlement for $311 million last September.
The government said the companies handed out excessive consulting agreements, lavish trips and other perks to reward surgeons who used their products. Among the companies involved in that settlement was Stryker Corp., which recalled some of its hip implant components earlier this month.
Stryker was also the recipient of two FDA warning letters in the past year, detailing contamination issues and other problems at its plants in New Jersey and Cork, Ireland.
Doctors paid more than $800 million by four makers of artificial hips and knees
Assistant inspector general Gregory Demske told lawmakers that four makers of artificial hips and knees paid doctors more than $800 million in royalties and fees in four years to influence their choice of implants.
While he did not identify these companies, Demske said that together they controlled three-quarters of the $9.4 billion worldwide market for hip implants and knee replacements. Demske and other witnesses told the panel such payments have enriched doctors and distorted the market by bolstering sales of lower-quality devices.
Demske said such payments are difficult to regulate, because it is hard for investigators to determine which are legitimate, and which are kickbacks.
Another witness, Charles Rosen, an Irvine, Calif., orthopedic surgeon, who started the Association for Ethics in Spine Surgery, said that so far, voluntary efforts to regulate payments to doctors have failed.
“I don’t believe the medical societies are capable of doing it, nor the industry,” he said. “It is so embedded now among most of the people running these societies, including the educational foundations, that I don’t think it’s possible to change that without something from the outside happening.”
Rosen told the panel that he has been vilified by leaders of his medical specialty, including medical journal editors, because of his opposition to company payments.
Require medical device makers with more than $100 million in annual revenue to disclose
Senator Herb Kohl (D-Wisc.), chairman of the panel, has proposed a so-called Sunshine Law that would require medical device makers with more than $100 million in annual revenue to disclose any money they give to doctors.
Several medical device makers, including Medtronic Inc., said they would support Kohl’s proposal if it covered every device maker rather than only those with more than $100 million in annual revenue.
Larger device makers worry that physician consultants may be tempted to shift their allegiance to competitors that fall below that revenue threshold in order to keep taking excessive fees, according to Senate committee staffers.