Spinal Fusion's Place in the Future: 9 Points on Fusion Efficacy and CoverageWritten by Laura Miller | March 08, 2011
The number of spinal fusions performed across the country has risen significantly over the past decade, which recently led some private payors to tighten guidelines associated with spinal fusion coverage. "If you look over the past 10 years, the growth in spinal fusions has been greater than the growth in decompressions," says Greg Przybylski, MD, director of neurosurgery at the New Jersey Neuroscience Institute at JKF Medical Center in Edison, N.J., and president of the North American Spine Society. "That doesn't tell us whether the change is appropriate or inappropriate, just that there's a change." Here, spine surgeons from around the country weigh in on nine points surrounding the controversy around spinal fusions.
1. Why the number of spinal fusions has increased. Many factors could contribute to why the number of spinal fusions performed in this country has significantly increased over the past decade. One possible reason is the number of patients who need the procedure and have access to healthcare coverage has changed rapidly as the baby boomers age. Additionally, technology developed over the past few years has enhanced the surgeon's ability to successfully perform spinal fusions, says Rick Delamarter, MD, director of Cedars-Sinai Spine Center at Cedars-Sinai Medical Center in Los Angeles. Minimally invasive surgeries allow patients to return home after one or two days — much quicker than they did in the past. However, these advances have come at a cost. "The technology explosion has greatly improved our ability to successfully fuse patients and for the patients to heal faster," says Dr. Delamarter. "But things are definitely more expensive with this new technology."
Another possibility, says William Abdu, MD, medical director of the spine center at Dartmouth-Hitchcock Medical Center in Lebanon, N.H., is that the indications for performing spinal fusions have changed. "Patients are getting fusions for reasons they didn't in the past," he says. "The technologies have improved in order to do fusions. The question is whether the indications are warranted. We don't know whether the indications we have now are right."
The indications for performing spinal fusions on patients with lower back pain and degenerative disorders are difficult to predict because even for studies that control for specifics of the patient, such as weight, gender or work status, the outcomes are different. This could mean some outcomes are partially dependent on the ability of the surgeon. "We don't know which rates are right because we don't know a lot of the data as to why the patients are fused," said Dr. Abdu. "We also don't know what the outcomes would have been if the patient continued with conservative treatment."
2. Spinal fusions for back pain patients. Most spine surgeons and industry experts agree that spinal fusions can be helpful for some patients — such as those with spondylolysis, complete fractures or tumors — but controversy surrounds performing fusions on patients with degenerative disc disease, disc herniations and low back pain. Beginning this year, Blue Cross Blue Shield of North Carolina announced it would no longer pre-approve coverage for spinal fusions on patients with DDD, and insurance companies in other states are following the Milliman Guidelines or stricter indications for spinal fusions. "There is no absolute guide when to do a fusion and when not to," says Ezriel Kornel, MD, a spine surgeon with the Brain & Spine Surgeons of New York. "For patients where the necessity for spinal fusions isn't immediately apparent, patients rely on the judgment of the clinician. What concerns me is that patients see surgeons who recommend surgery before they have been put through the rigorous non-surgical treatment."
Non-surgical treatment for back pain patients often includes physical therapy, treatments by chiropractors, epidural steroid injections and facet blocks. However, there is a big variation between physical therapists and chiropractors, which means patients may need to go through multiple modalities before obtaining surgical treatment. "If the patient has been through all the non-surgical solutions and the patient is still experiencing too much pain, surgery can be worthwhile," says Dr. Kornel.
Many orthopedic and spine societies are holding conferences, symposiums and educational seminars to educate surgeons on the appropriate indications for spinal fusions, says Dr. Delamarter. It's critical for the insurance companies to know the surgeons are choosing appropriate patients for spinal fusions because of the high costs associated with the procedure.
3. How to proceed when the insurance company denies fusion approval. If the surgeon has monitored the patient through non-surgical treatment and the surgeon and patient feel a spinal fusion is the best treatment option, surgeons can ask for pre-approval. In many states, if the insurance company denies approval, the surgeon can still advocate on behalf of the patient to perform the procedure. "The surgeon may need to undergo additional leg work in developing a response or having a verbal conversation with the insurer's medical director to explain the unique circumstances in the patient," says Dr. Przybylski. "Sometimes the conversation and written appeal are successful, sometimes they are not." If the request is still denied, the patient can appeal to the insurer for reconsideration of the treatment. Patients can also pursue insurance coverage from outside their primary company for the procedure.
4. The problem with insurance guidelines and indications. As insurance companies create coverage guidelines, many base their decisions on the most recent data available about a procedure. "Insurers look at scientific literature and have become much more stringent in the studies they value," says Dr. Przybylski. "They want to see prospective, randomized, double blind studies. There are very few of these for spine surgery and this somewhat limits our ability to prove to the insurer and demonstrate through literature that there is evidence to support a particular indication." A further problem occurs when several years down the line, the policies haven't changed as new technology and research emerges. "When I have seen problems with insurance companies, it's usually the indications that the companies have aren't up to date," says Dr. Abdu. Dr. Przybylski suggests re-evaluating guidelines at least every five years and updating them according to new data information.
When creating guidelines, insurance companies often aim to limit the number of patients who are able to receive spinal fusions, says Dr. Kornel, especially since the surgery isn't life-saving. However, for some patients, receiving the spinal fusion early can actually lower their cost of overall treatment. "When good amount of the facet is removed during surgery on patients with spinal stenosis, it doesn't make sense not to have the fusion," says Dr. Kornel. "The patient still has symptoms after surgery because he needed a foraminotomy. The surgeon has to do a second operation which could have been clearly predicted in the first place."
Many guidelines written by insurance companies or organizations are based on Class 1 studies, which are randomized, double-blind, prospective studies. However, the variation in each patient's case makes it very difficult to provide a clear-cut guideline. "Not everything is amenable to Class 1 evidence based data," says Dr. Kornel.
5. The importance of data collection. Several orthopedic and spine organizations are leading efforts to collect and catalogue data in registries on orthopedic and spine surgery outcomes, which can help foster further research and development of the best surgeries and indications. The adaptation of electronic medical records could also aid in the spine surgeon's quest to understand patient outcomes over time. "Without efforts to collect the data, we don't have the ability as spine surgeons to prove what we do really works," says Dr. Abdu. "If you use EMR, you can bridge the gap between patient outcomes and research because every data point becomes something you can analyze and research. Every spine surgeon thinks they are doing the right thing. But we can't all be doing something different and doing the right thing at the same time. Until we have the data gathered and analyzed, we can't go back and change practice or educate patients and providers about the outcomes and treatment options."
The push toward coverage for spinal procedures that have proven evidence of their efficacy has stimulated the spine surgeons and researchers to study indications where there isn't currently data, says Dr. Przybylski. "I think this should be a motivating time for spine surgeons to develop the evidence where it doesn't exist," he says. "There are indications where third party payors have demonstrated that they are willing to listen and look at new data and updated information and modify previous decisions they have made depending on what the data shows."
6. Discography use for finding the source of a patient's pain. One of the biggest contributors to the increase in spinal fusion procedures and subsequent bad outcomes in DDD or low back pain patients stems from the surgeon's inability to assess whether the pain is caused by degeneration. Many times, a surgeon decides on a diagnosis of DDD by eliminating other possible sources of the pain, which may not always be accurate or appropriate for the patient, says Dr. Przybylski. "As part of spine aging, discs degenerate and it becomes challenging to separate the normal aging affects of the spine from other things that could cause pain," he says. Discography is one of the tools the surgeon can use to assess whether a fusion would be appropriate for the patient, though these methods are not 100 percent accurate. Without the ability to completely understand where the pain is coming from, surgeons may decide upon an inaccurate diagnosis and inappropriate treatment.
7. What current spine studies are telling us. The Spine Patient Outcomes Research Trial paper recently published several studies examining spinal fusions for different types of patients. For patients with spondylolysis and degenerative conditions, the more complicated procedures, such as a bone graft with anterior and posterior fusion, produced the same outcomes as simpler fusions. "The people who conducted the research thought the patients would have increased pain if they didn't have an instrument fusion and the data didn't support that," says Dr. Abdu. "I think the primary problem isn't so much that we are doing these operations, but that we don't have the answers for the outcomes and alternative treatments."
A second key finding of the SPORT was that patients with lower back pain and leg pain who underwent surgery improved significantly more than patients who underwent non-operative treatment, according to an article published in Spine. Vertos II, published in The Lancet, found that vertebroplasty was an effective procedure for properly selected patients. On the other hand, a study published in the New England Journal of Medicine found that vertebroplasty was no better than a "sham" procedure. Spine surgeons and other healthcare professionals continue to engage in an ongoing debate about both vertebroplasty studies' designs and the appropriateness of the procedures.
8. Lowering the cost of spinal healthcare. Spine surgeons used to harvest cells from the patient's hip for fusions, but new technology allows surgeons to use synthetic biologics such as bone morphogenic protein products for the fusion. The new technology is expensive, and prices are higher for surgeons in the United States for several reasons, including litigation and distribution costs, says Dr. Delamarter. "You can get identical implants that are sold in foreign countries for half the price of what is paid in the United States," he says. "The industry in the United States has to get world equivalent pricing, which will help with this enormous expense of what is going on with this technology explosion."
For example, a single pedicle screw can cost around $1,000 and depending on the procedure, the surgeon might use six to ten screws. The BMP could cost anywhere from $5,000-10,000 per case. "The industry has high margins in all these implants and bone substitutes, and we just can't continue to afford these outrageous prices," says Dr. Delamarter. "The impetus for the companies to bring these prices back in line will be because the insurance companies won't want to pay exorbitant prices."
9. Patient education on spinal fusions. Any patient with internet access can search "spinal fusion" and find several articles in the consumer media about bad outcomes associated with spinal fusions. However, it's the surgeon's responsibility to discuss treatment options with the patient and if fusion is a recommendation, to explain why the patient's circumstances are different. Dr. Abdu takes a collaborative approach to the decision-making process by presenting patients with several different options and treatment guidelines from national organizations. "If I disagree with the guidelines, I explain that these are guidelines that have evidence supporting the indications and then I explain why I disagree with them," says Dr. Abdu. "The patient should understand why they have different risks or benefits than what the guidelines address."
For the best outcomes, spine surgeons also consider comorbidities and the patient's psychological state before performing the fusion. "There are always psychological factors to take into account before performing surgery," says Dr. Kornel. "If the patients are depressed or have extra stressors in their lives, I like to see them seek counseling before surgery."
Read other coverage on spinal fusions:
- Spinal Fusion Reimbursement: Q&A With NASS President Dr. Greg Przybylski
- ISASS President Dr. Thomas Errico: Spinal Fusion Coverage Update
- Spinal Fusions Face an Uncertain Future
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