Artificial Disc Replacement denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for cervical spine surgery (artificial disc replacement at C4-5 and C5-6 and foraminotomy with anterior cervical discectomy and fusion (ACDF) at C7-T1). Findings: The physician reviewer found that Boddapati and colleagues have noted that many patients with multilevel disease are not good candidates for cervical disc arthroplasty (CDA) at all levels. For such patients, hybrid surgery, a combination of adjacent anterior cervical discectomy and fusion (ACDF) and CDA, may be more appropriate. They concluded that patients undergoing hybrid surgery are not at increased risk of perioperative complications relative to a 2-level ACDF and may benefit from shorter length of stay.

Nature of Statutory Criteria/Case Summary: An enrollee has requested coverage for L4-5 artificial disc replacement. Findings: The physician reviewer found that there is sufficient support for the requested services in this patient’s case. The U.S. Food and Drug Administration (FDA) approval for the ProDisc-L total disc replacement states that this device is indicated for spinal arthroplasty in patients who are skeletally mature, have degenerative disc disease at one level in the lumbar spine from L3 to S1, have no more than grade 1 spondylolisthesis at the involved level, and have had no pain relief after at least six months of non-surgical treatment. FDA exclusions include bony lumbar spinal stenosis and isolated radicular compression syndromes, especially due to disc herniation.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for (1) four cervical levels (two levels approved by plan and two levels denied by plan) of artificial disc replacement (ADR) (CPT 22856) and (2) four lumbar levels (one level approved by plan, and three levels denied by plan) of ADR (CPT 0163T). In this clinical setting, four cervical levels of ADR are not likely to be more beneficial than any available standard treatment for this patient’s medical condition. In a prospective, randomized, controlled multicenter clinical trial on two-level symptomatic degenerative disc disease, Davis and colleagues noted findings supporting the use of cervical arthroplasty at two contiguous levels and demonstrated advantages over two-level anterior cervical discectomy and fusion.

Physician 1: The patient is a 43-year-old female with low back and bilateral leg pain. She has had back pain for a number of years with leg pain beginning in 2005. She has been treated with medication, therapy injections and rhizotomy.X-rays performed in January 2006 showed moderate L4-5 disc space narrowing and modest L5-S1 narrowing. There was L4-5 spur formation with no spondylosis. In February 2006 the patient was evaluated for low back and left leg pain to the foot. On examination sensation was grossly intact. Reflexes were symmetrical and active. The patient had a normal gait, more pain with extension and positive left straight leg raise. Strength was 5/5. The provider reported that an MRI showed degenerative disc disease and bulging at L3-4, L4-5 and L5-S1. A discogram in April 2006 revealed L2-3 was not painful. At L3-4 there was concordant pain of 8/10.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Artificial Disc Replacement, then check the rights and deadlines that apply to your plan.