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Device-maker kickbacks: Ending the cycle?

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In this newsletter, you'll see a story every week or two about some medical device manufacturer who's caught providing kickbacks or bribes for doctors who use its product. When they're caught, the device maker makes its mea culpas, pay its fines and goes right back to business--where, if history is any indication, they go right back to finding new ways to buy business.

The question is, what can regulators do to take the potential for corruption out of this system?  Obviously, device and drug-makers are always going to have close relationships with physicians, so the incentive is always there, but perhaps it's possible to raise the risk or lower the reward.

Maybe it's time to try one or more of the following:

  • Dramatically raise the penalties for manufacturers trying this kind of hanky-panky, up to and including a halt on sales of the affected product for 12 months or more.
  • In egregious cases, ban the device manufacturer from doing any form of business in the U.S. for a short stretch.
  • Kick up fines to the point where it really, truly hurts. Yes, I know some kickback settlements are in the multiple hundreds of millions, and that ought to be a scary number. Still, device maker behavior suggests that this just isn't quite scary enough. So turn the pain meter up even higher.
  • Expand whistle-blower programs and raise awareness. Maybe regulators can do more to make themselves accessible to not only device-maker employees, but also doctors who feel pressured to make these deals or lose, say, favorable terms on equipment.

I'm not a device manufacturing business expert, nor am I an attorney, so I may be way off base here. What do you think regulators, professional associations or other stakeholders can take to lower the corruption level in medical device marketing?  I'd love to hear your ideas. -Anne

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It is unfortunate that this continues to happen and regulation becomes a stronger option the more it happens, but it is a two way street. Someone must be accepting as well as giving. It shouldn't be directed at only the manufactuers, but those associations and affiliations of the receivers need to take responsibility to communicate, educate and take action against both sides. Also - action is sometimes taken 1-3 years after the offense and the world has already put into place restraints - so it is always important to look at the timeing of what is being reported.

Fine the doctors who take the bribes.

You have only hit the top of the iceberg. The unhealthy relationship goes both ways. Some prominent physicians use their position to demand up to six digits in grants, inflated proctor fees and other forms of remuneration to write favorable papers on equipment. They often change positions based upon the “highest bidder”. Also, equipment manufactures set up LLC for Physicians, donating their equipment provided they force the hospital to use only that brand equipment with their LLC and purchase the manufactures disposable product at an inflated price! I only hope that Stark III, if passed, implemented and enforced, will slow some of the corruption! It is of little value to put laws on the books if they are not enforced! Stiffer fines on both parties need to be implemented!

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