Clinical Guidelines and Payer Policies on Fusion for the Treatment of Chronic Low Back Pain
Systematic review. The purpose of this review is to provide a critical appraisal of general and fusion-specific clinical practice guidelines on the treatment of chronic nonradicular low back pain and compare the quality and evidence base of fusion guidelines and select payer policies. SUMMARY OF BACKGROUND DATA.: The treatment of lumbar spondylosis associated with low back pain with lumbar arthrodesis, or fusion, has risen fourfold in the past two decades. Given the significant associated health care costs, there is an increase in clinical guidelines and payer policies influencing patient treatment options. Assessment of the medical necessity of a treatment, such as lumbar fusions, based on medical literature will frequently supersede the determination of the physician in the care of their patient. Concerns regarding the effectiveness and costs of the surgical treatment of spinal disorders presenting with low back pain has placed enormous scrutiny on the value of surgical treatments to our patients. As both clinical guidelines and payer policies have a major impact on the perceived effectiveness, or medical necessity, of lumbar fusions for the treatment of chronic nonradicular low back pain, a review of this topic was undertaken. An electronic literature search of PubMed, the National Guideline Clearinghouse and the International Network of Agencies for Health Technology Assessment was performed to identify clinical practice guidelines on assessment and treatment of chronic nonradicular low back pain, including those on use of lumbar fusion, as well as relevant technology assessments. A Google search for publicly available private and public payer policies related to fusion was also performed. A hand search was used to identify specific studies cited for support of the recommendations made. A modified Appraisal of Guidelines Research and Evaluation instrument was used to provide a standardized assessment method for evaluating the quality of development of the evidence base and recommendations in guidelines and selected health policies. This was combined with appraisal of the evidence base supporting the recommendations. Three systematic reviews of general guidelines from a PubMed search yielding 94 citations were included. A convenience sample of five guidelines with recommendations on fusion was taken from 182 citations identified by the National Guideline Clearinghouse and the International Network of Agencies for Health Technology Assessment searches. Two guidelines were developed by US professional societies, (neurosurgery and pain management), and three were European-based guidelines (Belgium, United Kingdom, and the European Cooperation in Science and Technology). The general guidelines were consistent with their recommendations for diagnosis, but inconsistent regarding recommendations for treatment. All guidelines and payer policies with recommendations on fusion included some set of the primary randomized controlled trials comparing fusion to other treatment options with the exception of one policy. However, no clear pattern with regard to the quality of development was identified based on the modified Appraisal of Guidelines Research and Evaluation tool. There were differences in specialty society recommendations. Three systematic reviews of evidence-based guidelines that provide general guidance for the assessment and treatment of chronic low back pain described consistent recommendations and guidance for the evaluation of chronic low back pain but inconsistent recommendations and guidance for treatment. Five evidence-based guidelines with recommendations on the use of fusion for the treatment of chronic low back pain were evaluated. There is some consistency across guidelines and policies that are government sponsored with regard to development process and critical evaluation of index studies as well as overall recommendations. There were differences in specialty society recommendations. There is heterogeneity in the medical payer policies reviewed possibly due to variations in the literature cited and transparency of the development process. A description of how recommendations are formulated and disclosure of any potential bias in policy development is important. Three-medical payer policies reviewed are of poor quality with one rated as good with respect to their development based on the modified Appraisal of Guidelines Research and Evaluation tool. Medical payer policies influence patient care by defining medical necessity for approving treatments, and should be held to the same standards for transparency and development as guidelines. The spine care community needs to develop (or update) high-quality treatment guidelines. The process should be transparent, methodologically rigorous, and consistent with the Appraisal of Guidelines Research and Evaluation and Institute of Medicine recommendations. This effort should be collaborative across specialty/society groups and would benefit from patient and public input. Payer policies and treatment guidelines need to be transparent and based on the highest quality evidence available. Clinicians from specialty/society groups, guideline developers and policy makers should collaborate on their development. This process would also benefit from public and patient input.