Five senators are calling for an investigation into a system that gives surgeons a financial stake in the devices they use on their patients. The inquiry comes after a Wall Street Journal investigation of Dr. Vishal James Makker, a surgeon with a questionable track record for performing multiple spinal operations on his patients.
An analysis of Medicare data revealed that, among physicians who regularly performed these kinds of operations for Medicare patients, Makker had the highest rate of repeat surgeries in the nation -- nearly 10 times the national average. Makker operated on patients up to 7 times; many patients complained of additional health problems as a result of the extra surgeries. (These findings came from a Medicare claims database that is still not available to the public, though two senators are pushing to change that -- more on that here).
Makker told The Journal that he never convinces patients to have surgery, and that all the procedures he performed were medically necessary. He said that he has a high rate of repeat surgeries because people with particularly difficult cases are often referred to him. We reached out to Makker for comment through his office yesterday, and haven't heard back.
An unnamed source told the Journal that Makker told colleagues he was a partner in a physician-owned distributorship, or POD, called Omega Solutions. Documents show Omega paid surgeons up to $500,000 a year to use its spinal implants. Though Makker and Omega both denied he was part of the POD, the Journal's coverage brought this kind of arrangement between physicians and medical device makers to national attention.
PODs are groups that give doctors a financial incentive to use certain medical devices. From the Journal:
Distributorships act as links between medical-device makers and hospitals: In exchange for marketing and stocking the devices, they get a cut of each sale. When surgeons own a distributorship, that commission goes into their pockets. Since surgeons often dictate to their hospitals which devices to buy, surgeons involved in PODs can effectively steer business to themselves.
The current inquiry focuses on whether PODs violate the law, in particular whether they may violate a federal anti-kickback statute. According to an earlier Journal article, the Office of Inspector General of the Department of Health and the Centers for Medicare and Medicaid Services had both previously flagged some PODs as potential violators of the anti-kickback statute and other laws.
The issue of conflicts of interest potentially affecting doctors' recommendations goes beyond PODs. Earlier this year, The Chicago Tribune reported on a surgeon who implanted devices in patients without telling them he had invented them himself, that he made a profit every time one was used, and that the devices hadn't yet received FDA approval. The Palm Beach Post found that a third of doctors who prescribe antipsychotic drugs to youths in Florida's juvenile jails have received payments from pharmaceutical companies.
And at ProPublica, we've been reporting extensively on the issue too.
Last month, we detailed a few high-profile cases shedding light on the overuse of stents, devices that are surgically implanted into the heart to keep arteries open.
Earlier this week we also reported on a body imaging company that uses pressure sales tactics to convince people to sign on for unnecessary heart scans, without mentioning the associated risks.
We also have our long-running series on Dollars for Docs detailing pharmaceutical companies payments to doctors.