New Study Exposes Quality Gaps in Policies and Guidelines that Influence Patient Access for Chronic Low Back Pain Care

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Over 13 million people seek treatment for chronic low back pain each year in the United States and insurers increasingly deny surgical care, quoting guidelines and health care policies in their decision-making. In a recent study published in Spine (2011 Oct 1;36(21 Suppl):S144-63.) AOSNA researchers reported inconsistencies in the quality of policies and guidelines and the scientific evidence used to support them, potentially compromising access to beneficial care for thousands who suffer from chronic low back pain.

Increasingly insurers around the US use policies and guidelines to judge if certain commonly performed procedures are “medically necessary” and going to be covered. This has become a contentious and increasingly bitter argument in certain areas, such as fusion for chronic low back pain, where insurers increasingly deny surgical care, quoting guidelines and health care policies in their decision-making. In theory, policies and guidelines should be based on synthesis of the highest quality scientific evidence.

In a new study published in Spine (Clinical Guidelines and Payer Policies on Fusion for the Treatment of Chronic Low Back Pain) Cheng JS, Lee MJ, Massicotte E, Ashman B, Gruenberg M, Pilcher LE, Skelly AC. Spine (Phila Pa 1976). 2011 Oct 1;36(21 Suppl):S144-63.), AOSNA researchers’ formal appraisal and evaluation of five guidelines and four policies revealed inconsistencies in recommendations for the use of fusion in chronic low back pain and the selection of evidence used to support these recommendations.

Five of the nine health policies and guidelines for fusion were rated as poor or fair using an objective appraisal tool. This study is the first to use such a tool for evaluation of payer policies. Policies and guidelines were rated with respect to the quality and transparency of the development, appraisal of scientific evidence and its linkage to recommendations. The modification of the Appraisal of Guidelines Research & Evaluation (AGREE) instrument developed by Spectrum Research, Inc. for this paper incorporates the primary quality factors described in the recently available Institute of Medicine (IOM) standards for clinical guidelines and requirements for guideline inclusion in the National Guideline Clearinghouse (NGC). While these standards have been applied to evaluation and development of clinical guidelines, this study is the first to evaluate payer policies using objective criteria to examine gaps in the quality of payer policy development.

Although all reports contained subsets of the same, fairly well-known body of evidence, there were substantial discrepancies in the final recommendations. The highest rated reports were the most transparently developed and provided the strongest links between the evidence and the recommendations/decisions suggesting fusion as an option when intensive rehabilitation with cognitive behavioral therapy was not available and that spine fusion was superior to routine conservative care. On the other hand, a number of lower quality guidelines and policies recommended against the use of fusion. Primary deficiencies identified included 1) absence of a systematic process for identification of relevant research evidence, 2) lack of formal critical appraisal or quality rating for evidence, 3) failure to link evidence to recommendations 4) lack of description of how recommendations were formulated, 5) failure to disclose conflicts of interest. Lack of transparency for the development process was evident in three of the four payer policies examined and all three received a rating of poor.

The authors emphasized that, in an environment motivated by evidence-based medicine to both control costs and provide patients with effective treatment options, guideline developers and policy makers should adopt a collaborative working relationship with the surgeons and patients to arrive at consistent, transparent and evidence-based decisions. “A patient’s access to beneficial medical care is frequently dictated by coverage decisions of insurance policies. While policies are expected to promote access to beneficial high quality care, it appears that other factors, including financial, could be a playing a larger role,” lead author, Dr. Joseph Cheng from Vanderbilt University stated.

This landmark article is part of a special edition of the journal Spine that takes a novel approach to tackle difficult questions about the evaluation and treatment of Chronic Low Back Pain. Evidence on controversial topics such as which patients may benefit most from fusion, whether or not MRI and popular conservative treatments are supported and the role of medications is presented and consensus recommendations based on the evidence are made using a formal scientifically valid process.

This study points to a need for a new approach to enhance insurance coverage decision making. In evaluating the quality gaps and calling for a new directions decision making, surgeon members of AOSpine North America (AOSNA) have taken the first bold steps and a leadership role in this new approach. This is evident in the group’s consensus recommendation from this paper: “Payer policies and treatment guidelines need to be transparently developed and based on the highest quality evidence available. Clinicians, guideline developers and policy makers should collaborate on their development. This process would also benefit from public and patient input.”


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Chi Lam
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