Foot Drop denials in California external review

What the reviewers wrote

Where the denial was overturned

A 49-year-old male has requested coverage for a functional electrical stimulator (Bioness L300 neuromuscular electrical stimulation system) for treatment of his foot drop, secondary to multiple sclerosis. Findings: Two physician reviewers found that the patient has multiple sclerosis (MS). He has had difficulty with tingling, weakness, and gait. Foot drop has been observed. He has used an ankle foot orthosis (AFO), trekking poles, and a walker in the past. As a result of gait impairment, he has fallen, and sustained traumatic subdural hematomas requiring neurosurgical drainage. He has had treatment with Ampyra, Provigil, Keppra, and Neurontin. The provider notes show that the patient has had a trial with the Bioness L-300 neuromuscular electrical stimulator (NES), and his gait was reportedly much more stable than without it.

Nature of Statutory Criteria/Case Summary: An enrollee has requested the Bioness L300 foot drop system electrical stimulation (FES) device for treatment of the enrollee’s foot drop secondary to multiple sclerosis (MS). Findings: Two physician reviewers found that evidence based research and medical literature support the use of FES in this patient’s case. This patient has had MS, with residual spasticity and foot drop. The patient’s foot drop continues to impair gait, with frequent falls despite use of an ankle foot orthosis (AFO). The medical literature shows that foot drop gait is known to be inefficient, with increased fatigue and slowed walking speed.

Where the denial was upheld

A 26-year-old male enrollee has requested a NESS L300 Neuroprosthesis for the lower extremity and a NESS H200 Neuroprosthesis for the upper extremity for treatment of his spastic hemiplegia. Findings: Two physician reviewers found that overall, the clinical data from the scientific peer-reviewed literature is insufficient to establish the safety and efficacy of functional electrical stimulation devices for foot drop, including foot drop due to spastic hemiplegia. More significant research of a disinterested nature is needed to further evaluate the device manufacturer’s claims regarding these types of devices. Clinical trial of the device is currently ongoing to determine the effectiveness of the NESS L300 in improving gait parameters, function, and quality of life among stroke subjects with drop foot.

Nature of Statutory Criteria/Case Summary: An enrollee has requested the Bioness L-300 Foot Drop System for treatment of his medical condition. Findings: The physician reviewer found that the Bioness L-300 Foot Drop System is not medically necessary for treatment of the patient’s medical condition. According to the documentation submitted for review, the patient has not had a lengthy trial of a well fitted ankle-foot orthosis (AFO), custom made if necessary to improve compliance and comfort. An AFO is the first-line treatment for his condition and he has not exhausted the possibility of benefit from this type of device. In addition, researchers assessed the effects of a neuroprosthesis (NESS L300) designed to ameliorate foot drop on gait symmetry and rhythmicity during walking.

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 foot drop, then check the rights and deadlines that apply to your plan.