Bone Growth Stimulator denials in California external review

What the reviewers wrote

Where the denial was overturned

Physician 1: The patient is a 64-year-old woman who sustained a clavicle fracture in May 2004. At the time the patient was evaluated by an orthopedist union was not yet established and osteopenia was noted. A bone growth stimulator was recommended. The Health Plan indicates a bone growth stimulator is considered investigational for treatment of patients such as this patient. Bone growth stimulators are of proven efficacy and have been used with great success over the past twenty years. As the patient’s provider indicates, the only other treatment option for this patient who was at eight weeks from date of injury with no obvious callus formation or union, would have been surgery, plating and bone grafting of the fracture. Use of a bone growth stimulator was medically appropriate and necessary to attempt union of the patient’s fracture.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary:A patient has requested authorization and coverage for a bone growth stimulator. Bone growth stimulation is indicated in patients at high risk for nonunion or impaired fusion, particularly following revision spinal surgery. In this case, the patient underwent reoperation with removal of prior cervical implants, which is associated with disruption of endplates and increased risk of impaired healing. Revision procedures and prior surgical interventions place the patient at elevated risk for nonunion. Given the potential for significant complications if fusion is not achieved, adjunctive therapy to promote bone healing is appropriate.

Where the denial was upheld

Physician 1: The patient is a 41-year-old female who underwent a cervical discectomy and fusion at C5-6 and C6-7. Her physician has recommended she receive a Spinal Logic bone growth stimulator post-operatively. The Health Plan has denied this request indicating the efficacy of the requested equipment has not been established.Bone growth stimulators are of proven efficacy as is demonstrated by the studies provided. They have been used for nearly two decades to increase bone growth for fractures and other orthopedic ailments. Numerous studies, including those that have been provided, have shown increased bone growth with the use of bone growth stimulators. There is sufficient data demonstrating that use of the requested equipment is likely to result in a superior outcome to standard treatments.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for a bone growth stimulator. The records provided for review document that this patient has sustained an injury to her left fifth toe. X-rays demonstrated fracture through the conjoint phalanx of the fifth toe without significant displacement. Physical examination revealed no appreciable swelling around the forefoot or fifth toe. The patient’s provider has recommended a bone growth stimulator. Electrical stimulation has been used as an adjunct for treatment of nonunion in an effort to achieve bony healing of surgical fusions. There is paucity of peer-reviewed medical literature to support the routine use of a bone growth stimulator in the setting of toe fracture with delayed union. Typically, a fracture is considered to have gone on to nonunion six months following injury.

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 Bone Growth Stimulator, then check the rights and deadlines that apply to your plan.