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The Impact of Comparative Effectiveness Research on Spine Care Device Companies

Recent trends in healthcare expenditures related to spine care show increasing costs and significant geographical variations in treatment patterns. This data, along with a lack of consistent success for spinal surgeries, has led to increased scrutiny of the spine care industry by payers. Expenditures associated with spine problems totaled $86 billion in 2005, an increase of 65% since 1997. What some consider “overtreatment” of chronic back pain has occurred through the use of imaging, opioid analgesics, spinal injections, and surgery. Some studies on complex procedures and devices have even found that lumbar fusion surgery for discogenic axial low back pain appears to offer only limited relative benefits over cognitive behavioral therapy and intensive rehabilitation, and that as few as 50% of fusion patients are likely to have high-quality outcomes.
To promote lower costs and better outcomes, the American Recovery and Reinvestment Act of 2009 (ARRA), allocated $1.1 billion to Comparative Effectiveness Research (CER). The Institute of Medicine (IOM) defines CER as a comparison of the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. Ideally, policymakers would like to reduce costs without impacting the quality (or the perceived quality) of healthcare, and comparative effectiveness research is seen as one way to get there, since CER takes both clinical effectiveness and cost into consideration. By replacing ineffective treatments and standards of clinical care with effective ones, or by replacing more expensive treatments and standards with equally effective, but less expensive ones, the cost of care can be brought down, in the words of the Congressional Budget Office (CBO) “without adverse health consequences.”
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