Appeal type: DME/ Orthotics
Decision: Unfavorable

We decided that the Plan does not have to pre-approve implantable neurostimulator electrode and implanted electrical stimulator for spinal cord.
You asked the Plan to pre-approve implantable neurostimulator electrode (L8680) and implanted electrical stimulator for spinal cord (63650). You say that a spinal cord stimulator is medically necessary. The Plan denied your request. The Plan says the enrollee did not demonstrate pain relief with a temporary spinal cord stimulator implantation
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 implantable neurostimulator electrode (L8680) and implanted electrical stimulator for spinal cord (63650). Our reviewer says that the requested items/services are not considered medically reasonable and necessary in this case. Our physician reviewer found in this case request has been made for (permanent) implantation of a new spinal cord stimulator (SCS) for this enrollee with a history of chronic pain. According to the applicable NCD, this service is covered when all of the following requirements for coverage are met: a) The implantation of the stimulator is used only as a late resort (if not a last resort) for patients with chronic intractable pain; b) With respect to item a, other treatment modalities (pharmacological, surgical, physical, or psychological therapies) have been tried and did not prove satisfactory, or are judged to be unsuitable or contraindicated for the given patient; c) Patients have undergone careful screening, evaluation and diagnosis by a multidisciplinary team prior to implantation. (Such screening must include psychological, as well as physical evaluation); d) All the facilities, equipment, and professional and support personnel required for the proper diagnosis, treatment training, and follow up of the patient (including that required to satisfy item c) must be available; and e) Demonstration of pain relief with a temporarily implanted electrode precedes permanent implantation. In this case the records provided for review demonstrated that requirements A-D were all satisfied. However, there was no documentation provided that the enrollee has had a trial with a SCS (at the new level which it would be placed) to demonstrate that the proposed placement will result in pain relief. While the enrollee is noted to have a SCS in place currently it is said to not be adequately addressing pain needs and therefore a new temporary trial would be warranted. In as much the requirements for permanent implantation have not been met at this time and the service would not meet the definition of medical necessity. We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that Medicare rules for coverage of implantable neurostimulator electrode (L8680) and implanted electrical stimulator for spinal cord (63650) have not been met. Therefore, we decided that the Plan does not have to pre-approve implantable neurostimulator electrode and implanted electrical stimulator for spinal cord.