Earlier this month, Indianapolis, Indiana-based Anthem Blue Cross Blue Shield (BCBS), an Elevance Health subsidiary, issued a position statement on surgical treatments for scoliosis.
Anthem Declares Vertebral Body Tethering ‘Medically Necessary’
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The position statement addressed the use of a minimally invasive deformity correction system, vertebral body tethering, and vertebral body stapling for scoliosis treatment. It did not address spinal fusion for scoliosis treatment.
According to the position statement: “Vertebral body tethering for the treatment of scoliosis is considered medically necessary for all of the following criteria:
- Curve progression following conservative management (for example, observation, exercise therapy, or bracing); and
- Cobb angle 40 to 60 degrees; and
- Curve flexibility greater than 30%; and
- Skeletal immaturity, defined as either:
- Risser grade 0 or 1; or
- Sanders Maturity Scale less than or equal to 4.”
At least one spine company has already celebrated the decision. Westminster, Colorado-based ZimVie Inc., a company focused on spine, dental, and bone healing solutions, issued a press release on the Anthem BCBS decision.
OTW spoke with ZimVie Spine SVP and President Rebecca Whitney about the Anthem BCBS decision. Whitney told OTW, “With expanded coverage, more than 30 million patients who are indicated for anterior vertebral body tethering (AVBT) are now potentially eligible for ZimVie’s motion-preserving pediatric scoliosis treatment, The Tether, which may allow them to return to school in two weeks and play sports in four.”
Whitney continued, “The Tether is the first and only FDA-approved, spinal-fusion-alternative device for AVBT and is backed by seven years of clinical data and real-world evidence.”
ZimVie’s The Tether device is a non-fusion scoliosis treatment. In 2019, it received a humanitarian device exemption (HDE) for use in scoliosis correction. Since the HDE approval, more than 1,200 children have received The Tether.
Jaren Riley, M.D. was, per his biography, the first surgeon in the Rocky Mountain Region to perform vertebral body tethering. He is a board-certified, fellowship-trained pediatric orthopedic surgeon. In the ZimVie press release, Dr. Riley commented, “This policy change is a victory for families with scoliosis who need surgery, have researched their options, and have chosen a surgery that has the potential to maintain motion and decrease future complications.”
Dr. Riley continued, “I am also grateful to Anthem BCBS for taking the time to meet with me personally and examine the promising data I presented.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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