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Are You Paying for Defective Spinal Implants?

By Joe Paduda

Tuesday, October 26, 2010 | 0

By Joe Paduda

Are you paying for defective spinal implants?

The answer is probably YES.

When surgical implants are defective or implanted incorrectly, the patient has to go back in for more surgery. And the workers' comp insurer or health plan or self-insured employer or reinsurer has to pay. The only way to mitigate risk is to track the model and manufacturer for each implant yes, it's work, and yes, it's work worth doing internally or at the very least outsource it to a specialist firm.

How many dollars are we talking here?

Well, joint replacement devices are a $12 billion industry.

One survey reported that the total world market for spinal implant devices was $4.2 billion; note this study used 2006 data. Another  indicated the market was $5 billion in 2005, and predicted growth to $20 billion by 2015. Stryker, one of the major manufacturers, expects growth of 16% per year in the spinal implant market. Yet another report indicated the 2007 worldwide market was $7 billion, with the U.S. accounting for $5.4 billion of that total.

(I'm working on getting more current data and will include it in a follow up piece later this week)

The Oct. 13 edition of the Wall Street Journal reports on a new effort by the impant industry to set up a registry for joint replacements: "Manufacturers are backing the 'American Joint Replacement Registry' and have chipped in start-up funding."

By joining voluntarily and influencing development, manufacturers may dodge having to face mandated rules down the road. They'll gain product-durability insight that could help as new, higher-priced devices need to be justified by comparative-effectiveness testing... The nonprofit registry is incorporated in Illinois, which has strong data- protection laws...It also will produce detailed annual reports,"

Couple of notes.

First, this does NOT include spinal and other implants; it is limited to joint replacement implants.

Second, who gets access to the data, and how it is used, is still very much up in the air. Will insurers get to check on a member's/claimant's implant if the member requires additional treatment?

So, what to do?

Track those device serial numbers and manufacturers in a secure database. Follow the news to identify recalls and product liability issues and reference your database to identify possible matches.

It's not easy, and it isn't foolproof, but its likely to be very cost effective.

<i>Joe Paduda is a principal for Health Strategy Associates, an empoyer consulting frim in Connecticut, and co-owner of CompPharma, a consortium of pharmacy benefit managers. This column was reprinted with his permission from his blog, http://www.managedcarematters.com.</i>

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