BUSINESS NEWS
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.
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, 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 with 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."
