Federal regulators on Friday announced that Medicare planned to deny coverage of artificial disks implanted in the lower spines of beneficiaries older than age 60, the New York Times reports. Artificial disks "were seen as a potential alternative" for up to a quarter of the 220,000 spinal fusion surgeries performed annually, according to the Times. The preliminary decision is expected to become final in August and extends to the Pro Disc-L, manufactured by Synthes, a national coverage ban imposed last year on the Charité lumbar disk, manufactured by Johnson & Johnson. Medicare also is likely to deny coverage for Medtronic's Maverick lumbar disk when it reaches the market.

The coverage ban applies only to beneficiaries older than age 60. Younger disabled beneficiaries will continue to receive coverage for the disks on a case by case basis. CMS said that because clinical trials of the devices did not include people older than age 60, Medicare could not determine whether the devices were a reasonable or necessary therapy for older beneficiaries.

In addition, Medicare officials said comparisons between the disks and spinal fusion procedures are not conclusive because there is no evidence that fusion is a better therapy than rest and exercise alone. The agency also determined that studies have not proven claims that the disks preserve more freedom of motion in the spine than fusion (Feder, New York Times, 5/26).

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