Clinical Guidelines and Payer Policies on Fusion for the Treatment of Chronic Low Back Pain

Department of Neurological Surgery, Vanderbilt University Medical Center, Medical Center North, Nashville, TN 37232, USA.
Spine (Impact Factor: 2.3). 10/2011; 36(21 Suppl):S144-63. DOI: 10.1097/BRS.0b013e31822ef5b4
Source: PubMed


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.

7 Reads
  • Source
    • "According to a systematic review carried out by Hancock et al. [41], magnetic resonance imaging findings such as endplate changes and presence of disc degeneration were found to increase the possibility of a discogenic origin related to discography. In patients with underlying degenerative disc disease and in whom other pathologies are completely ruled out, spinal fusion especially with an intervertebral cage may be recommended, but the clinicians should remember that these patients are not very good surgical candidates, and therefore, a trial of aggressive nonoperative management for >12 months should be carried out preoperatively, and all secondary gain issues should be sufficiently resolved (Fig. 5) [42,43]. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Lumbar spinal stenosis (LSS) is mostly caused by osteoarthritis (spondylosis). Clinically, the symptoms of patients with LSS can be categorized into two groups; regional (low back pain, stiffness, and so on) or radicular (spinal stenosis mainly presenting as neurogenic claudication). Both of these symptoms usually improve with appropriate conservative treatment, but in refractory cases, surgical intervention is occasionally indicated. In the patients who primarily complain of radiculopathy with an underlying biomechanically stable spine, a decompression surgery alone using a less invasive technique may be sufficient. Preoperatively, with the presence of indicators such as failed back surgery syndrome (revision surgery), degenerative instability, considerable essential deformity, symptomatic spondylolysis, refractory degenerative disc disease, and adjacent segment disease, lumbar fusion is probably recommended. Intraoperatively, in cases with extensive decompression associated with a wide disc space or insufficient bone stock, fusion is preferred. Instrumentation improves the fusion rate, but it is not necessarily associated with improved recovery rate and better functional outcome.
    Asian spine journal 08/2014; 8(4):521-30. DOI:10.4184/asj.2014.8.4.521
  • [Show abstract] [Hide abstract]
    ABSTRACT: "Chronic" low back pain (LBP), defined as present for 3 or more months, has become a major socioeconomic problem insufficiently addressed by five major entities largely working in isolation from one another - procedural based specialties, strength based rehabilitation, cognitive behavioral therapy, pain management and manipulative care. As direct and indirect costs continue to rise, many authors have systematically evaluated the body of evidence in an effort to demonstrate the effectiveness (or lack thereof) for various diagnostic and therapeutic interventions. The objective of this Spine Focus issue is not to replicate previous work in this area. Rather, our expert panel has chosen a set of potentially controversial topics for more in-depth study and discussion. A recurring theme is that chronic LBP is a heterogeneous condition, and this affects the way it is diagnosed, classified, treated, and studied. The efficacy of some treatments may be appreciated only through a better understanding of heterogeneity of treatment effects (i.e., identification of clinically relevant subgroups with differing responses to the same treatment). Current clinical guidelines and payer policies for LBP are systematically compared for consistency and quality. Novel approaches for data gathering, such as national spine registries, may offer a preferable approach to gain meaningful data and direct us towards a "results-based medicine." This approach would require more high-quality studies, more consistent recording for various phenotypes and exploration of studies on genetic epidemiologic undertones to guide us in the emerging era of "results based medicine."
    Spine 10/2011; 36(21 Suppl):S1-9. DOI:10.1097/BRS.0b013e31822f0a0d · 2.30 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Systematic review of spine care pathways and case study of the Saskatchewan Spine Pathway (SSP). (1) What are the differences between clinical pathways and clinical guidelines? (2) Are there examples of clinical pathways in the management of lower back pain (LBP)? Is there evidence that they are successful? (3) What is the SSP, and what are its key features? Adherence to evidence-based guidelines for LBP produces superior outcomes and may improve efficiency by reducing unnecessary imaging, ineffective treatments, and inappropriate surgical referrals. A clinical pathway is an attempt to bridge the "translation gap" between guidelines and clinical practice. A qualitative review was performed for question 1. For question 2, a systematic review of the English language literature was performed for articles published through March 31, 2011. A case study is provided for question 3. (1) Evidence for clinical pathways is mainly derived from guidelines, but pathways are distinguished by several features including the coordination of multidisciplinary care, facilitation of communication among care providers, resources for ongoing quality improvements, and a central focus on the patient experience. (2) Five articles describing four clinical pathways met the a priori criteria, but none tested comparative effectiveness. (3) The SSP is unique in that it is (a) inclusive for all types of LBP, (b) based on a classification system, (c) patient-focused mostly at primary care rather than in specialized clinics, (d) implemented in the health care system of a geopolitically defined region, and (e) includes all of the defining features of modern care pathways. Several clinical pathways for LBP have been described, but effectiveness has not been tested. Clinical pathways for LBP need to be further developed and investigated as a means to facilitate guidelines-concordant practice and improve patient outcomes. Level of evidence: Insufficient. Recommendation: Weak.
    Spine 10/2011; 36(21 Suppl):S164-71. DOI:10.1097/BRS.0b013e31822ef58f · 2.30 Impact Factor
Show more