There has been a fourfold rise in spine fusion treatments over the last 20 years. The higher expenditures have spurred an increase in clinical guidelines and payer policies to determine appropriate treatments and payments.
But are the clinical guidelines consistent with each other? Are payer policies developed by consultants like Milliman operating under the same rigorous transparent and consistent research requirements used to develop clinical guidelines? Are biased payer policies superseding physician determination?
A recent study published in Spine (SPINE Volume 36, Number 21S, pp S144–S163) sought to answer these questions.
Comparing Quality of Evidence
Joseph S. Cheng, M.D, MS, and his colleagues (Michael J. Lee, Eric Massicotte, Bryan Ashman, Marcelo Gruenberg, all M.D.s, and Leslie E. Pilcher, MPH, BA, and Andrea C. Skelly, Ph.D., MPH), sought to compare the quality and evidence base of fusion guidelines and select payer policies in a study called: “Clinical Guidelines and Payer Policies on Fusion for the Treatment of Chronic Low Back Pain.”
They began with the premise that the need for surgery based on literature is beginning to supersede physician determination. Since guidelines and policies have impact on the definition of “medical necessity, ” they decided to test the quality of those policies and guidelines.
“Payer policies define medical necessity and should be held to the same standards for transparency and development as guidelines, “ wrote the authors.
The study’s authors looked at PubMed, the National Guidelines Clearinghouse and the International Network of Agencies for Health Technology Assessment. They also searched Google for payer policies. They used an Appraisal of Guidelines Research and Evaluation instrument to provide a method for evaluating the quality of development of the evidence base.
The authors found that the general guidelines published through January 2011 were consistent with diagnosis, but inconsistent about treatment recommendations.
Study Conclusions
“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.” [Emphasis added.]
Or put another way, while the guidelines emanating from the surgeon societies are consistent in terms of diagnosing spinal disorders, they are inconsistent with regards to its treatment. Therefore the payers develop inconsistent payment policies and are able to pick and choose the guidelines that are in their best financial interest.
“This has led to the development of payer policies to temper the rise in health care utilization that appear to conflict with local standard of care and clinical guidelines. Physicians who specialize in spinal care have found themselves challenged to provide their patient with what they believe to be the most appropriate and beneficial care in an increasingly difficult financial environment with decisions increasingly influenced by the conflicting interests of doctors, hospitals, and insurers. Such conflicts have raised questions on what constitutes the standard of care for a patient, and what defines the best available evidence to support it.” [Emphasis added.]
Physician Response
David Polly, M.D. and head of spine services at the University of Minnesota told OTW that insurers/payers need to be as transparent as they are asking the surgeons to be about guideline development and treatment recommendations. “There is a presumed bias that payers will deny coverage in the absence of overwhelming data to demonstrate efficacy—a perpetually moving target. In order to preserve their own reputation they [insurers] may need to be even more forthcoming and err on the side of coverage rather than non-coverage since they are innately conflicted towards non-coverage, ” said Polly.
“Also at some point it should become a customer’s right to know how and what their coverage decision process is. Otherwise the presumption is that they are all like the Grisham novel/movie ‘Rainmaker’.”
Societies Respond
Gunnar Andersson and Chris BonoSpeaking on behalf of the North American Spine Society (NASS), Chris Bono, M.D., told us that the study highlights how guidelines are being used inconsistently. He said,
It points out that society data guidelines are not making it into payer guidelines. So payers are picking and choosing and are somewhat biased.
Gunnar Andersson, M.D., chair of the ISASS (The International Society for the Advancement of Spine Surgery) Public Policy Committee said the study “raises concerns and also illustrates the lack of rigor and transparency in creating guidelines and performing health technology assessments.”
He noted the study’s finding of inconsistencies in treatment recommendations between guidelines created, for example, by the American Pain Society and the Neurosurgical Societies and varying conclusions drawn by studies reporting outcomes following fusion surgery for degenerative conditions
“Most published reviews focus on the systematic review of primarily randomized controlled trials (RCTs). While these studies represent the highest level of evidence available, RCTs are not always feasible or practical to address surgical treatments. In addition, published studies are not reflective of more current fusion surgical techniques, ” added Andersson.
Andersson said the remaining body of literature provides value to the evidence-based medicine discussion and is often discounted during the guideline development process.
Payer Policy Discrepancies/Lack of Transparency
A more serious concern, said Andersson, arose when reviewing medical payer policies, “which revealed a high level of heterogeneity not only in recommendations, but also in the development process. Discrepancies were found in the evidence used for policy development and there was a general lack of transparency. Some payer policies are based on guidelines that are not publicly available for review.”
While agreeing that there is always room for greater efficiencies, Andersson said,
Spine fusion surgeries are increasingly being based on non-transparent assessments provided by consulting firms based on accounting principles, without input from the physician community or the totality of the evidence-based literature.
Payer Variations
For real world examples we went to Jeff Zigler, J.D., a reimbursement expert at MCRA (Musculoskeletal Clinical Regulatory Advisers. LLC). Zigler has noted variations (read: inconsistencies) in the standard of review for different therapies, by at least one national health plan: United Healthcare (UHC).
He said this wasn’t just an issue with fusion and cited the case of UHC’s policy of non-coverage for lumbar artificial disc replacement. “Such a policy of non-coverage seems unfair, in light of the robust randomized, controlled clinical trials supporting PMA [pre-market approval] approval of the Charité as early as 2004 and consistent data with published outcomes representing Levels I and II Evidence to support UHC’s coverage, ” said Zigler.
Continued Zigler,
UHC’s policy on artificial disc replacement, which states in the relevant part, ‘Lumbar artificial total disc replacement is unproven for the treatment of single or multiple level degenerative disc disease in skeletally mature patients, ’ is based upon an inconsistent standard of review internal to the payer.
In another example, Zigler said UHC coverage decisions for drug-eluting cardiac stents (DES) and bariatric surgery reveals inconsistencies regarding life-saving and life-enhancing therapy assessments.
“Despite demonstrating statistical significance in many objective categories of efficacy, sufficient to meet non-inferiority endpoints, UHC generally covers the use of DES, but specifically will not cover artificial disc replacement. Moreover, the medical community’s misgivings about late stent thrombosis in DES patients continue to prompt further investigation, and question the long-term durability of DES—yet UHC covers DES in the interim, while those studies are conducted. This UHC ‘interim coverage’ policy for novel, efficacious technology undergoing additional review and investigation has not been extended to disc.”
Lessons From Bariatrics
Zigler says that UHC also seems to be remiss in seriously considering its option of covering cases performed at qualifying Artificial Disc Centers of Excellence, as in the case of bariatric facilities performing Lap-Band. “Perhaps NASS, ISASS, AANS [American Association of Neurological Surgeons] and CNS [Congress of Neurological Surgeons] should take a page out of the playbook that professional bariatric societies used to secure limited Lap-Band coverage (American Society for Bariatric Surgery; Society of Gastrointestinal Endoscopic Surgeons).”
“This might at least secure coverage for qualifying centers, and would have the ancillary benefit of tracking patient outcomes from around the country. Even if a Center-of-Excellence model is impracticable, payers like UHC could still allow coverage while the evidence for artificial disc replacement develops, which has clearly been afforded to other technologies like DES.”
An Imperative for Physician Role
The authors of the study warn that transparency and complete disclosure of potential bias is required for credibility and compliance with any recommendations. “A patient, physician, hospital, or payer must have complete confidence in the recommendations generated by any authoritative organization with respect to determining what is considered appropriate and beneficial medical care.”
Unfortunately, say the authors, at this time, there seems to be a void and they feel that there is a pressing need for this in the era of health care reform and value-based medicine. “Otherwise, the care of our patients may be dictated more by economics and politics, than by what may be best to help our patients and ensure access to beneficial medical care. The authors of this article believe that as physicians it is imperative that we play a pivotal role in this.”
