Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Multiple Sclerosis
Treatment: E1399/RT 300 (functional electrical stimulation)
The insurer denied the E1399/RT 300 (functional electrical stimulation)
The denial is upheld

The patient is a female with history of Multiple sclerosis. She has significant reduction in volitional motor function of her lower extremities and loss of functional independence. She uses walker and bilateral AFOs (ankle foot orthoses).

The patient has gone through comprehensive home exercise program. The treating physician is requesting the FES (functional electrical stimulation) as medically necessary for her to maintain her physical condition and to minimize concomitant medical complications.

No, the requested health service is not medically necessary.
The RT300 FES (functional electrical stimulation) is not medically necessary, as it is not in accordance with generally accepted standards of medical practice, it is not clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient's illness, injury or disease, it cannot be established that it is not primarily for the convenience of the patient, Physician or other health care provider; and it cannot be established that it is not more intensive than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the patient's illness, injury or disease.

The health plan should not cover the RT300 FES (functional electrical stimulation). There is insufficient evidence in any peer-reviewed literature to establish the clinical efficacy and utility of the FES (functional electrical stimulation) long-term in a progressive chronic neurological condition.

Sivaramakrishnan, et al showed the TENS (transcutaneous electrical nerve stimulation) unit and FES (functional electrical stimulation) have equal efficacy for spasticity in Spinal Cord Injury patient as single session of electrical stimulation with FES (functional electrical stimulation). TENS (transcutaneous electrical nerve stimulation) is evidenced to have similar anti-spasticity effects that last for 4 hours. The findings of this preliminary study suggest that both TENS (transcutaneous electrical nerve stimulation) and FES (functional electrical stimulation) have the potential to be used as therapeutic adjuncts to relieve spasticity in the clinic.

De Freitas, et al stated that "there is some suggestion that NMES [neuromuscular electrical stimulation] increases voluntary strength in partially paralyzed muscle following SCI [spinal cord injury]. However, there is no strong evidence to affirm the superiority of NMES [neuromuscular electrical stimulation] over other treatment strategies used to gain strength in partially paralyzed muscles after SCI [spinal cord injury]. These findings need replicating in large high-quality randomized controlled trials."

Kapadia et al, also stated "Task-oriented training improves walking ability in individuals with incomplete SCI [spinal cord injury], even in the chronic stage. Further randomized controlled trials, involving a large number of participants are needed, to verify if FES [functional electrical stimulation]-assisted treadmill training is superior to aerobic and strength training."

Multiple Sclerosis with associated paraparesis is a type of spinal cord injury with associated motor and sensory loss.

The RT300 as a FES (functional electrical stimulation) is an exercise machine and therefore has not been proven to result in a better patient management or health outcomes than can be achieved with other modalities or exercise machine. Therefore, it is not medically necessary, as it is unproven.

In this instance, with the patient's history of Multiple Sclerosis with significant decrease in motor function sensory with loss of proprioception in both lower extremities, the effectiveness of any type of FES (functional electrical stimulation) in helping with muscle mass or ambulation is less likely. Also, the medical necessity stated by the treating physician is towards maintenance and exercise purposes, which could be provided by other means.

In this instance, the RT300 FES (functional electrical stimulation) is not a generally accepted standard for paraparesis due to Multiple Sclerosis with significant loss of volitional motor function. Therefore it is not clinically appropriate for the patient, it is evidenced to be mainly for the convenience of the patient as an exercise machine, and it is more intensive than a regular exercise program.

Yes, the health plan did act reasonably, with sound medical judgment, and in the best interest of the patient.
The FES (functional electrical stimulation) is an exercise machine ,and patient has other options to achieve this.