Appeal type: DME/ Orthotics
Decision: Unfavorable

We decided that the Plan does not have to pre-approve insertion of the interspinous Superion device.
You asked the Plan to pre-approve insertion of the interspinous Superion device. You say that the requested insertion of the interspinous Superion device is medically necessary. The Plan denied your request. The Plan says the requested insertion of the interspinous Superion device is not medically necessary.
The Plan must follow Medicare rules. Medicare rules say that items and services that are not medically necessary are not covered. We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to determine if the Plan was correct in denying the request to pre-approve insertion of the interspinous Superion device. Our reviewer says that the requested insertion of the interspinous Superion device is not medically necessary. Our physician reviewer found this enrollee presents with continued low back pain radiating into the left lower extremity to the left ankle with numbness and tingling. Signs/symptoms are consistent with neurogenic intermittent claudication. Clinical exam findings documented positive nerve tension sign and no focal neurologic deficits. Conservative treatment had included L4/5 and L5/S1 lumbar epidural steroid injection without relief, medications with insufficient relief, and aquatherapy with some improvement. There is imaging evidence of moderate L3/4 stenosis, mild L4/5 stenosis, and mild to moderate L5/S1 stenosis. There is grade 1 spondylolisthesis at L3/4 and L4/5 with no instability on flexion/extension films. Under consideration is a request for implantation of the Superion device at the L3/4 and L4/5 levels. Current evidence based medical guideline and peer reviewed literature do not fully support the spinal decompression device procedure over the 'gold standard' of lumbar laminectomy. There is a lack of large volume, long-term peer-reviewed outcome studies to support the safety and effectiveness of this device for this enrollee's medical condition as discussed above. FDA indications also have not been fully met at the requested levels. There is moderate stenosis documented at L3/4, but only mild stenosis is documented by the radiologist at L4/5. It is not clearly documented that the mild to moderate stenosis at the L5/S1 level with potential for nerve root impingement is not a pain generator. Additionally, the enrollee has not clearly been screened for FDA contraindications. There is no documentation of a DEXA bone scan with no evidence of osteoporosis given the enrollee's age and sex. There is also no documentation of the enrollee's current body mass index. Therefore, this insertion of the interspinous Superion device at the L3/4 and L4/5 levels is not reasonable and medically necessary for this enrollee's medical condition.
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that Medicare rules for coverage of insertion of the interspinous Superion device have not been met. Therefore, we decided that the Plan does not have to pre-approve insertion of the interspinous Superion device.