NEJM Studies Continue to Haunt Vertebroplasty Companies

Article preview from In-Vivo- November 01, 2010

Now, vertebroplasty advocates look to be losing on a very significant front. A growing number of third-party payors - including at least one Medicare contractor - are reconsidering their coverage of procedures for vertebral compression fractures.

NEJM Studies Continue to Haunt Vertebroplasty Companies

Article preview from In-Vivo- November 01, 2010

Now, vertebroplasty advocates look to be losing on a very significant front. A growing number of third-party payors - including at least one Medicare contractor - are reconsidering their coverage of procedures for vertebral compression fractures.

For the past year, proponents of vertebral compression fracture procedures, particularly vertebroplasty (the injection of cement in a fractured vertebral body), have had to defend the efficacy of the procedure against the two critical clinical trials published last summer in The New England Journal of Medicine (NEJM) . Immediately after the studies were published, spinal specialists and companies worked to refute the conclusions that vertebroplasty isn't any more effective than a so-called sham procedure (although the sham label may be misapplied because the control patients in those trials did receive a spinal injection of pain killers). Defenders of vertebroplasty conceded the trial had a worthy design, but they felt the execution was poor given that many of the trial participants had injuries that were so old that they weren't likely to benefit from vertebroplasty. (See "Critical Vertebroplasty Studies Raise Questions," IN VIVO, September 2009 [2009800150].)

Now, vertebroplasty advocates look to be losing on a very significant front. A growing number of third-party payors – including at least one Medicare contractor – are reconsidering their coverage of vertebral compression procedures. At least three insurers have issued draft coverage policies that would end reimbursement for vertebroplasty procedures and, in some cases, kyphoplasty, an alternative procedure for vertebral compression fractures that uses a balloon to create space and restore the height of the injured vertebral body. The most notable is Noridian Administrative Services LLC, which manages Medicare payments for 11 western states.

Noridian first issued the draft of a local coverage decision (LCD) in May. Paul Orth, a director at Noridian, says the contractor doesn't expect to issue a final decision until the first quarter of 2011. Noridian could decide to pull coverage altogether, or it might adopt conditions under which it deems the procedures appropriate and worth covering, Orth says.

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