Letter from NC Dept of Insurance

The following is a letter from the North Carolina Department of Insurance which resulted in the reimbursement payment by Blue Cross Blue to a patient of Prof. Dr. Bertagnoli. The patient's name and details are omitted.

Question to be Answered:

Was artificial disc replacement surgery medicaily necessary for the treatment of this member's condition? Is the requested procedure experimental/investigational for the treatment of this member's condition?

Reviewer's Decision and Principal Reasons for Decision:

The decisiqn of the carrier to deny coverage of the artificial disc placement surgery is incorrect and should be overtrned. Artificial disc replacement surgery is not experimental/investigational and was medically necessary for the treatment of this member's condition.

The member is a __-year-old right-handed woman with a longstanding history of chronic back pain that had been treated conservatively with physical therapy, as well as pain management for greater than two years.

She had been under the care of Dr.____ an orthopedic surgeon at ________ University Medical School, who felt that the member was a candidate for either a lumbar disc arthroplasty/replacement or a lumbar fusion atL4-5 due to the degenerative disc disease that was present on imaging studies, such as MRI and x-rays. She did not have any noted spondylosis, foraminal or central stenosis and no radiculopathy as opposed to the chronic back pain that was beginning to become permanent in nature, preventing her from enjoying activities of daily living, as well as other activities.

On she elected to undergo a lumbar disc replacement via an anterior approach by Dr. Bertagnloi, a world-renowned spinal surgeon at the Prospine Clinic in Germany. This physician is a professor of spinal surgery in the European community and is quite experienced in the evaluation and treatment of patients with back pain, as well as the application of lumbar disc replacement as a treatment for chronic/debilitating back pain as opposed to lumbar fusion.

The member underwent the procedure without any difficulty after being determined to be a suitable candidate. She experienced no complications from her hospitalization that lasted four days and has returned at this point to a normal lifestyle. She has had near complete resolution of all of her back symptoms without any restrictions in range of motion.

The Prodisc-L was approved by the FDA in 2006 as an alternative treatment for patients with chlonic/debilitating discogenic, single level back pain who did not have any evidence of central or foraminal stenosis or significant joint disease contributing to the back pain. The traditional treatments for this would have been lumbar fusion, either through an anterior or posterior approach with the employment of segmental instrumentation. The device itself has been available in Europe over 7 years prior to its employment in the United States. The success rate of the devices over lumbar fusion is equivocal; however, the improvement in range of motion over lumbar fusion far exceeds the expectation rate of lumbar fusion (reference 1).

An article regarding lumbar disc replacement clearly indicates that the need for lumbar fusion outweighs disc replacement in those cases where there is multiple level disc degeneration and spondylotic changes leading to multiple causes for back pain. It has been the standard of care for those patients up until recently when it was felt that a singie level disc replacement could be employed in those patients with chronic, debilitating back pain with a single level degenerative disc focus who have undergone full conservative therapy to include physiotherapy, medications, and injections. Additionally, it was felt that disc replacement in the early phases after the failure of conservative therapy had a higher success rate than those patients with greater than a two-year history of consistent/persistent back pain (reference 2).

The member had approximately a two-year history of chronic, intermittent back pain with the iatter part of 2010 into early 2011 developing more persistent back pain to the point that activities of daily living u'ere curtailed. In this particular case the member satisfied the medical necessity of the device.

An article in the European Spine Journal (reference 3) stipulated that the indications for placement of the device had to be strictly foiiowed and that the complication/failure rate of the devices versus lumbar fusion were comparable and that the revision rate was similar, noting that a re-exploration from the anterior spine was just as complicated for both procedures.

To consider this procedure experimental is incorrect and inappropriate, as the exposure and discectomy are not to be considered anything other than the standard of care in the neurosurgical community.

Artificial disc replacement surgery ra'as medically necessary for the treatment of this member's condition.

Bibliography of References:

1. Prodisc-L Total Disc Replacement. Approved on: August 14,2006. Available at:
http:l/www.fda.gov/cdrhJmda/docs/p050010.htm1. Accessed on: July 28,2007
2. Cluett J. New Treatment for low back pain. Lumbar Disc Replacement. About.com Guide updated 02/26/07.
3. Van den Erenbeemt KD, Ostelo RW, et al. Total disc replacement surgery for
symptomatic degenerative lumbar disc disease: a systematic review of the literature. Eur Spine -/. August 19.2010; 19(8)1262-1280.

Reviewer's Professional Oualifications:

A physician, Board Certified in Neurologicai Surgery by the American Board of Neurological
Surgery, conducted the review. This physician is licensed to practice medicine in the state of
North Carolina.