Medicare Panel Seeks Further Study on Spinal Fusion

When the Centers for Medicare and Medicaid Services (CMS; Baltimore) announced a meeting to examine the clinical merits of spinal fusion, many industry analysts speculated that the agency was reconsidering its coverage of the surgical procedure. Their concern was piqued by the advance release of a technology assessment concluding that no clinical evidence exists to demonstrate short- or long-term benefits of lumbar spinal fusion when compared with nonsurgical treatment.

Given the stated mission of the Medicare Coverage Advisory Committee (MCAC)—which is to provide guidance and advice to CMS on specific clinical topics under review for Medicare coverage—premeeting concerns regarding continued funding of spinal fusion surgery persisted. Steve Phurrough, MD, director of the CMS coverage and analysis group emphasized that the purpose of the meeting was to review clinical evidence regarding the efficacy of the procedure—and not coverage. Yet, some analysts were not assuaged and alerted their clients that the outcome of the meeting could adversely affect the spine industry.

According to CMS, the degenerative changes that occur in the intervertebral disk in the spine are thought to be part of the normal process of aging and do not always lead to low back pain. However, up to 90% of the U.S. population will experience serious low back pain at some point in time. The agency believes that even when the pain is secondary to lumbar degenerative disk disease it can usually be successfully treated with nonoperative care, including drugs and physical therapy. However, when conservative treatment is not successful, surgical intervention becomes an option.

The MCAC meeting on spinal fusion included nine physician members—plus consumer and industry representatives and two guests. The panel reviewed a number of clinical studies and was asked to consider the efficacy of spinal fusion in relieving low back pain in patients with degenerative disk disease. Overall, while the panel concluded that the available research could not document the superiority of spinal fusion over more-conservative measures, panel members emphasized the inadequacy of the available clinical evidence for evaluating the results of the procedure.

John McCormick, managing director of HealthPoint Capital (New York City), a private equity firm focused on the orthopedics sector says “The real takeaway from the MCAC meeting would be that the current study designs are flawed. Back pain is an elusive phenomenon. While osteochondral defects of the hip or knee are fairly easy to pinpoint, pain generators in the back are extremely difficult to identify.”

McCormick describes the MCAC meeting as confused and inconclusive. “Panel participants generally agreed that fusion in the absolute sense is beneficial in terms of reducing pain and disability, but noted that the superiority of the procedure compared to nonoperative care cannot be demonstrated on the basis of current evidence,” he says. “MCAC is calling for better clinical studies—and asking how those studies can best be designed to provide the necessary data for a clear-cut, objective assessment of spinal fusion.”

More than 225,000 spinal fusion surgeries are performed each year in the United States, with 15% of the procedures covered by Medicare.

CMS' focus on spinal fusion comes at the same time the agency has said it will reconsider its coverage of artificial disks. Last February, citing a growing number of reported problems with the Charité artificial disk, the agency proposed a national noncoverage determination for the device. In response to pressure from medtech's spinal device sector, however, the decision was subsequently modified. In May, CMS issued a final coverage ruling that excluded reimbursement for patients age 60 and over, but permitted “local decisions” for others.

Charité is manufactured by DePuy Spine Inc., (Raynham, MA), a unit of DePuy Orthopaedics Inc., a Johnson & Johnson company. According to a CMS spokesperson, coverage of the Charité artificial disk will not be reconsidered at this time.

CMS' rethinking of coverage for artificial disks will initially focus on the ProDisc from Synthes Inc. (Solothurn, Switzerland). ProDisc received FDA approval during 2006 and has generally received positive reviews from spine surgeons and medtech analysts.

Other artificial disks currently undergoing clinical trials include the Maverick from Medtronic Inc. (Minneapolis), FlexiCore from Stryker Corp. (Kalamazoo, MI), and KineFlex from SpinalMotion Inc. (Mountain View, CA). While these devices will require FDA approval prior to any reimbursement consideration from CMS, medtech manufacturers increasingly focus their efforts on both processes simultaneously.

© 2006 Canon Communications LLC

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