Nine spine medical societies sent a stirring and compelling response to Blue Cross/Blue Shield of North Carolina last week as a call to rationality after that insurer issued a proposed, restrictive lumbar fusion reimbursement policy.
The nine societies: AANS/CNS, AAOS, CNS, ISASS, NASS, POANA, SRS and the North Carolina Neurological Society, told the insurer in a December 15 letter, that while they understood and would help Blue Cross/Blue Shield achieve its goal of properly paying (i.e., not over paying) for spine surgeries, they also had serious “concerns” regarding criteria and guidelines for which [the insurer] would provide coverage for lumbar spinal fusion.
Joseph Cheng, M.D., and Chris Bono, M.D.
“We understand the concern regarding the over utilization of lumbar fusions in the hands of certain practitioners, which becomes the impetus for such policy revisions, ” stated the letter drafted by Joseph Cheng, M.D., and Chris Bono, M.D.
Getting the Definition of “Necessary Care” Right
At the heart of the engagement between the societies and the insurer lies the question of what constitutes “Necessary Care” and therefore reimbursable treatment protocols. The societies played to their collective strengths by focusing on patient outcomes and the science of treating severe back pain in order to help Blue Cross/Blue Shield arrive at a definition of “Necessary Care”. Simply put, the societies argued well that the best reimbursement policy is one that aligns with the presenting spinal disorders. All the disorders. Including degenerative disc disease (DDD).
The timing of appropriate surgery should be determined by “clinical criteria and not surrogate measures, ” stated the letter.
The Voices of the Practitioner in the Field
In the society’s response, one can find traces of the voices from Dr. Paul Slosar’s email stream, or what NASS Exec Eric Muehlbauer calls, “The Field.”
The energy and level of discussion by the surgeons over the Internet surely fueled the intensity and speed of the joint response by the nine societies.
The nine-society letter called for respecting the “informed” treatment decisions made by patients. This echoed calls from practitioners in the field for insurers to incorporate patient outcome data from peer review studies, registries and to also use surgeon performance data in their coverage decisions. In addition, the letter called for defining “Impairment” as a quality of life issue.
Repeatedly, the society’s letter put sound medical judgment and evidence at the forefront of the discussion. This naturally led to the authors mentioning comparative effectiveness data when citing evidence that surgery is superior to conservative care in the right cases. Finally, the societies tackled the issue of mandates and asked that mandates be excluded from Blue Cross / Blue Shield’s policy if it would supplant sound medical judgment and evidence.
Degenerative Disc Disease and Pain
A central issue that triggered the explosion of surgeon concern was the insurer’s proposal to deny reimbursement in those cases where DDD was the sole diagnostic reason to perform lumbar spine fusion.
In addressing this point, the societies’ letter began by acknowledging that DDD is a broad term that encompasses problems for “which no reasonable spine surgeon would recommend a fusion (e.g., multilevel degeneration with nonspecific, nonlocalized back pain) as well as those for which many reasonable spinal surgeons would recommend fusion in specific circumstances (i.e., localized back pain, unresponsive to exhaustive nonoperative care, that is reasonably correlated to a single, highly degenerated motion segment).”
BUT,
Severe intractable symptoms can be reasonably attributed to the specific motion segment in question by history, physical examination, and sometimes provocative discography. In such a scenario, it would be reasonable to consider a lumbar fusion for so-called degenerative disc disease.
Below are the specific recommendations offered by the societies and, both according to the letter and data from PearlDiver Technologies, Inc., it appears likely that such adjustments to the North Carolina proposed policy would affect a limited number of patients.
Matt Menze, Senior Analyst at PearlDiver, completed a basic query of the PearlDiver database looking at private pay insured patients in the state of North Carolina. Menze found that from 2007-2009; there were 938 patients who underwent inpatient lumbar spine fusion in the state. Of those, 383, or 40.8% were diagnosed with spondylolisthesis.
The Societies’ DDD Recommendations
Here are the highlights of the societies’ recommendations.
Criteria for lumbar fusion in patient with low back pain and DDD
Recognizing the controversy surrounding indications for fusion for DDD, the societies offered the following criteria for lumbar fusion in a patient with low back pain and degenerative disc disease
- single or two level disc degeneration
- inflammatory endplate changes (i.e., Modic changes)
- moderate to severe disc space collapse
- absence of significant psychological distress or psychological comorbidities (e.g., depression, somatization disorder)
- absence of litigation or compensation issues
- failure to respond to at least one year of nonoperative care that includes physical and cognitive therapy
In one section, replace DDD with the term “disc herniations”
According to the letter, the term DDD is too broad and encompasses many different pathologies.
Expand coverage to spinal infections
The societies agreed with the insurer on coverage for “spinal repair surgery for dislocation, abscess or tumor”, but requested expansion of the coverage of fusion for not only “abscess, ” but also for other spinal infections.
“Spinal discitis and osteomyelitis often require debridement and can be a cause of lumbar spine instability with potential for involvement of the cauda equina, nerve roots, and lumbosacral plexus. Discitis, especially in patients who are immunocompromised, may require operative debridement, even when aspinal abscess is not present.”
Add iatrogenic instability (facet) to coverage
“Removal of a substantial portion of the facet joints in order to afford adequate decompression can create incompetence of the vertebral motion segment. In such situations, fusion is appropriately performed in order to avoid postoperative instability.”
Add radiculopathy as a progressive symptom as an indication for fusion
“Patients with spinal stenosis can have profound and progressive neurologic deficits that may only present with a radicular distribution (e.g., foot drop), ”
Don’t mandate three-month conservative therapy for adult degenerative scoliosis patients
Delay of compression for scoliosis patients may cause permanent impairment and treatment should be patient specific.
The definition of “impairment” in these patients will be crucial:
The letter asked, “Is limitation in daily activities or reduction in ambulatory tolerance adequate to merit operative intervention? In this subset of patients, we emphasize as clinicians that surgery is a quality of life decision, with choice of surgery made after conservative therapies have been exhausted and when the degree of functional impairment is significant enough to merit operative therapies.”
Add Type 1 (dysplastic) spondylosthesis to coverage
The societies agreed that patients with isthmic spondylolisthesis who are unresponsive to conservative nonsurgical care are candidates for lumbar spinal fusion.
However the societies wanted the insurer to clarify that the policy denoting type II spondylolisthesis would be referring to the Wiltse et al. classification system, which describes this type as isthmic in nature, and not the Meyerding classification, which defines a grade II slip as that which is 25% to 50% slipped.
“The best available randomized control trial of comparative effectiveness between spinal fusion and nonoperative conservative care in this patient population has demonstrated superior results with surgery, ” said the letter.
Exclude mandate for documentation of gross radiographic “progression”
“Documentation requires years in many, if not most, patients and may not always be available. Many asymptomatic patients do not have spinal x-rays, and many individuals with acute onset of symptoms will not have x-rays obtained until they fail conservative management with their primary care physician.”
Remove criteria “at least six months after previous disk surgery” for disc herniations patients
Recurrent disc herniations may occur within that time frame after a discectomy. For instance, an early recurrence may occur at one to two months from index surgery. The letter said that in the current Blue Cross/Blue Shield proposed policy, such a patient would have to undergo six months of non-operative treatment before a revision discectomy and fusion could be approved.
The societies recommended that the number of herniation recurrences be part of appropriateness criteria and to delete the requirement which proposes that a patient must be ‘unresponsive’ to at least three months of conservative nonsurgical care before further interventional treatment.
Review With Medical Director
Finally, the societies suggested that they participate in a review of spine treatment coverage with the insurer’s medical director in those cases where the patient’s conditions are less well defined or where proposed treatment is more controversial. To that end, the societies asked that the insurer’s policy include a statement which accommodates coverage consideration outside of clearer clinical applications of fusion with a case-by-case review.
The “Societies”
Not only have the policy changes proposed by BlueCross/Blue Shield been controversial with physicians, but so also has the question of who speaks for the surgeons and spine care providers. The speed and unanimity of the response to the insurer shows a strong level of cooperation and agreement particularly regarding the definition of “Necessary Care.”
The next event in this story is how Blue Cross/Blue Shield responds to this united and cogent letter. North Carolina is but 1/50th of the country and undoubtedly other insurers are watching closely as they also consider changing their own policies regarding lumbar fusion.
The following presidents of their organizations signed the letter:
James T. Rutka, M.D., PhD, American Association of Neurological Surgeons
John J. Callaghan, M.D., American Association of Orthopaedic Surgeons
Christopher C. Getch, M.D., Congress of Neurological Surgeons
Ziya L. Gokaslan, M.D., Chairman AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves
Thomas J. Errico, M.D., International Society for the Advancement of Spine Surgery
Gregory J. Przybylski, M.D., North American Spine Society
John A. Wilson, M.D., North Carolina Neurological Society
James W. Roach, M.D., Pediatric Orthopaedic Association of North America
Lawrence G. Lenke, M.D., Scoliosis Research Society
To read the Society letter to Don Bradley, M.D., Senior Vice President, Healthcare & Chief Medical Officer for Blue Cross and Blue Shield of North Carolina, please click here.
