CMS is extending its national non-coverage policy for Johnson & Johnson/DePuy's Charité artificial lumbar disc to Synthes' ProDisc and all future products in that category for Medicare patients over age 60.

For disabled patients under age 60 who qualify for Medicare, coverage of artificial lumbar discs continues to be at the discretion of local carriers, the agency announced Aug. 14 in a final national ¹ coverage decision.

CMS says that the FDA-cleared trials of artificial lumbar discs completed so far have excluded patients over age 60.

The decision also cites the 2006 conclusion of the Medicare Coverage Advisory Committee that the evidence supporting lumbar discs for patients over 65 is insufficient. The committee also advised CMS that there is little evidence to support spinal fusion for the elderly population. Spinal fusion is the control therapy in artificial disc trials.

The agency also cites a 2005 Blue Cross Blue Shield Technology Evaluation Center assessment that concluded that available evidence does not support treating degenerative disc disease with an artificial disc. A June 2007 update to that assessment argues spinal fusion is not the best control therapy for the artificial disc trials.

Artificial lumbar disc replacement is an alternative to spinal fusion surgery approved to treat lower back pain caused by degenerative disc disease when other treatment methods have failed.

CMS established non-coverage for the 60-year-old-plus population for Charité in May 2006 in response to a physician skeptical of the procedure (² Also see "CMS Charité Policy Leaves Coverage Option Open For Under-60 Crowd" - Medtech Insight, 22 May, 2006., p. 3).

After FDA approved ProDisc late in 2006, CMS opened a new coverage analysis covering both the approved devices and any future lumbar discs.

Medtronic is awaiting PMA approval for its Maverick lumbar disc, and Stryker ( Flexicore ), Biomet ( CL-Disc ) and Axiomed ( Freedom ) are also developing replacement lumbar discs.

Lumbar disc replacement is primarily intended for relatively young patients, but manufacturers and orthopedic surgeons suspect that CMS' non-coverage decision for Medicare patients may predispose private payers to deny coverage of the procedure for younger patients as well.

"The sad impact is by having the ... non-coverage decision, what they do is they give license to the insurance carriers - the commercial carriers - to deny this to the less-than-60 covered lives," Richard Guyer, professor of orthopedics at the University of Texas Southwestern Medical School and president of the North American Spine Society told "The Gray Sheet" (³ Also see "CMS Extends Non-Coverage Policy To All Artificial Lumbar Discs" - Medtech Insight, 4 June, 2007., p. 5).

John Peloza, director of the Center for Spine Care in Dallas and an investigator of Medtronic's Maverick lumbar disc trials, believes the CMS policy will compel patients to leave the United States to get this procedure.

The new coverage policy does not impact cervical artificial discs, which recently entered the U.S. market. The first to market was Medtronic's Prestige disc, which FDA approved July 16. The following day, an FDA advisory panel recommended that FDA approve Medtronic's Bryan cervical disc despite outstanding questions about its long-term durability (⁴ Also see "FDA Panel Favors Medtronic’s Bryan Cervical Disc Despite Durability Question" - Medtech Insight, 23 July, 2007., p. 3).

NuVasive ( Cerpass ), Stryker ( CerviCore ), LDR Spine ( Mobi-C ) and Synthes ( ProDisc-C ) are also approaching this market.

David Blaszczak, a health policy analyst with the Stanford Group financial services company, says cervical artificial disc makers should avoid the mistake, made with the lumbar discs, of moving too quickly to earn a national Medicare policy.

"If CMS decides to open up a national coverage decision for cervical artificial discs, I think that would be a negative for all companies involved," he said. "If CMS felt like the product was reasonable and necessary for the Medicare population, I think they would leave it up to the local carriers and they wouldn't get involved unless they felt that the product was not reasonable and necessary for at least part of the Medicare population."

- Ingrid Mezo (i.mezo@elsevier.com)

CMS Denies Artificial Lumbar Disc Coverage For Patients Aged 60 And Over

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