Introduction
The SpineCor Dynamic Scoliosis Brace was designed at the Research Centre at St. Justine’s Children’s hopital in Montreal Canada over 20 years ago by a team of 165 that included doctors, therapists, researcher, orthotists and engineers who were lead by two prominenent orthopedic spine surgeons. Because of it’s birth place, SpineCor is one of the most researched scoliosis braces in the world, yet despite 20 years of research showing it’s efficacysome in the medical and insurance industry have wrongly implied that SpineCor is some how experimental.
SpineCor Cited By Aenta as “Experimental of Investigational”
A few of our patients have brought to our attention that a major insurance carrier Aetna has denied reimbursement for the SpineCor brace. They based their denial on their opinion that the SpineCor scoliosis brace is “experimental or investigational”.
How could Aetna make such a statement about a scoliosis therapy that has a 20 year track record of successfully treating scoliosis? Let’s examine their flawed rational.
Aetna’s Clinical Policy Bulletin – Idiopathic Scoliosis
Aetna has a Clinical Policy Bulletin that they use to determine if a treatment is medically necessary and reimbursable. They state that they reach their conclusions based upon a review of currently available clinical information:
- Clinical outcome studies in the peer-reviewed published medical literature
- Regulatory status of the technology
- Evidence-based guidelines of public health and health research agencies
- Evidence-based guidelines and positions of leading national health professional organizations
- Views of physicians practicing in relevant clinical areas
- and other relevant factors
Aetna’s position is far from the truth and its guidelines should be modified to include reimbursement for this research tested and proven effective type of dynamic scoliosis brace.
Aetna’s Position Statement As A Rational for Denial of SpineCor
1. There is a lack of scientific evidence in the peer-reviewed published medical literature to support the effectiveness of the SpineCor Scoliosis System in treating idiopathic scoliosis
2. insufficient data on its long-term effectiveness and a lack of studies directly comparing the dynamic corrective brace with rigid bracing systems.
Let’s examine the accuracy of these statements in closer detail.
Position Statement Used For Denial Vs. Scoliosis Research Rebuttal
Position Statement 1. Lack of Clinical Outcome Studies in Peer Reviews Published Medical Journals
1. Aetna’s Position on SpineCor being “Experimental and Investigational” because of a lack of scientific evidence in the peer-reviewed published medical literature to support the effectiveness of the SpineCor Scoliosis System in treating idiopathic scoliosis.
Rebuttal:
The SpineCor brace is far from investigational and has been examined extensively in the peer review literature. The SpineCor brace was created in the early 1990’s by two Orthopedic Surgeons, Dr. Christine Collaird and Dr. Charles Rivard, both very prominent in the world of scoliosis treatment. Prior to their creation of the brace it had undergone extensive clinical testing before it became FDA Approved in the early 1990’s.
While it is true that SpineCor’s “Corrective Movement Approach” to scoliosis treatment is a departure from traditional hard braces that immobilize the spine (which Aetna will pay for despite their lack of research results) the SpineCor brace has been extensively researched and found to be a valid scoliosis treatment tool. (See List of Studies at the bottom)
A study that Aetna references in support of their position is a Prospective Observational Study done by Dr. Christine Collaird in 2007. The definition of a Prospective Observational Study is a clinical research study in which people who presently have a certain condition or receive a particular treatment are followed over time and compared with another group of people who are not affected by the condition. In this study of a sample of 170 scoliosis patients were followed for 2 years after their stopping the SpineCor treatment and it was found that nearly 60% of the patients had a successful treatment for halting or reversing the progression at 2 years.
It is interesting to note that the study they cite as their rational for excluding reimbursement for the SpineCor brace supports it’s effectiveness, rather than ineffectiveness. The treatment was found to be successful in nearly 60% of the cases in the study and the conclusions by the authors were that the Spinecor brace was an effective treatment for scoliosis.
- Another study done more recently at the Italian Scientific Spine Institute in Milan Italy in 2009 researcher actually changed their treatment protocols in favor of the SpineCor dynamic scoliosis over static bracing. In the study titled “Effectiveness of Comprehensice Conservative Treatment for Adolescent Idiopathic Scoliosis (bracing and exercises)” which was based on the SOSORT Management Criteria: Results According to SRS Criteria for Bracing Studies” by scoliosis researchers was the 2009 SOSORT Award Winner for scoliosis research.
This study showed the a combination of bracing and exercise was found to be the most effective way to conservatively treat scoliosis and that when patients complied with the program the success rate was very high. An important point to note was that during the course of the study the researchers changed their treatment protocols to include the SpineCor dynamic brace in favor of static bracing, presumably because of the superior effectiveness of the SpineCor brace in the clinical setting. (See Study Results)
2. Another study showing validity of the SpineCor brace for treating Idiopathic Scoliosis are as follows (See Pdf Article below for Full Details): Survival analysis of a group of 365 idiopathic scoliosis patients treated with the Dynamic SpineCor Brace Published in: Résonnances Européennes du Rachis, Août 2006, Volume 14, No 43, 1782-1786
The conclusion of this study showed that the results of stabilization or correction of the scoliosis for the SpineCor brace remained high for patients followed for up to 5 years post studies. In fact, of those scoliosis patients using the SpineCor brace that were followed for the full 5 years, 96.2% of them showed continued stabilization or correction of their scoliosis curvatures.
Aetna’s Position Statement:
Position Statement 2. Aetna’s position statement on SpineCor being Experimental or Investigational because that there is “insufficient data on its long-term effectiveness and a lack of studies directly comparing the dynamic corrective brace with rigid bracing systems.”.
Scoliosis Research Rebuttal:
The above study also showed a comparison of the Rate of Success for different types of scoliosis braces. It compared the dynamic SpineCor brace as compared to the rigid Boston Brace, Charleston and TLSO Braces and found that the SpineCor brace had the highest Rates of Success of any of the braces tested.
This and other studies that compare the rates of success for the SpineCor brace show similar results. It is clear that the dynamic SpineCor scoliosis brace is far from experimental or investigational as it has a much greater rate of success than the static braces, like the Boston brace.
Based on Aetna’s own written guidelines the Spine Cor brace should not be considered either experimental nor investigational. Aetna’s own Clinical Coverage Criteria and Clinical Policy Development are listed each of these charts. (See Charts below) The red check marks indicate each of these criteria that are met by the SpineCor Dynamic Corrective brace. As you can see, the SpineCor brace should not be considered “experimental and investigational” based on Aetna’s own guidelines.
Conclusion:
Based on the overwhelming scoliosis research support for the efficacy of the SpineCor brace in evidence based research literature and endorsement by authoritative clinical research societies on scoliosis, Aetna’s position not to reimburse for the SpineCor brace is found to be arbitrary, discriminatory and without just cause. We are requesting that Aetna’s Medical Policy and Operations Department review and overturn of their Clinical Policy Guidelines regarding the treatment of Ideopathic Scoliosis with the SpineCor dynamic scoliosis brace.
SpineCor Scoliosis Research Rebuttal Studies Reference Article Pdf’s
Survival analysis of a group of 365 idiopathic scoliosis patients treated with the Dynamic SpineCor Brace Published in Résonnances Européennes du Rachis, Août 2006, Volume 14, No 43, 1782-1786 http://www.spinecorresearch.com/Survival-Analysis2.pdf
Effectiveness of Complete Conservative Treatment for Adolescent Idiopathic Scoliosis (bracing and exercises) was a retrospective scoliosis research study based on the Society of Scoliosis Orthopedic and Rehabilitation Treatment, (aka – SOSORT) managment criteria: results according to the SRS criteria for bracing studies – SOSORT Award Winner Authors of the study were Stephano Negrini, Salvatore Atanansio, Claudia Fusco and Fabio Zaina.
Effectiveness of the SpineCor Brace Based on the New Standardized Criteria Proposed by the Scoliosis Research Society for Adolescent Idiopathic Scoliosis Published in Pediatric Orthopedics. 2007 Jun;27(4)
Treatment of Early Adolescent Idiopathic Scoliosis Using the SpineCor System published in Study Health Technology Information in 2008. http://www.ncbi.nlm.nih.gov/pubmed/18401103?dopt=Abstract
Effectiveness of the SpineCor brace based on the new standardized criteria proposed by the scoliosis research society for adolescent idiopathic scoliosis Published in the Journal of Pediatric Orthopedics in June 2007 http://www.ncbi.nlm.nih.gov/pubmed/17513955?dopt=Abstract
SpineCor–a non-rigid brace for the treatment of idiopathic scoliosis: post-treatment results is a scoliosis research article Published in the European Spine Journal April 2003 http://www.ncbi.nlm.nih.gov/pubmed/12709852?dopt=Abstract