Humana Electrical Stimulators - Diaphragmatic/Phrenic Nerve, Functional and Neuromuscular - Medicare Advantage Form

Please refer to CMS website for the most current applicable CMS Online Manual System (IOMs)/National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/ Transmittals. Type Title ID Number Jurisdiction Medicare Administrative Applicable States/Territories Electrical Stimulators - Diaphragmatic/Phrenic Nerve, Functional and Neuromuscular Page: 2 of 6 Contractors (MACs) NCD Neuromuscular Electrical Stimulation (NMES) 160.12 NCD Phrenic Nerve Stimulator 160.19 NCD Supplies Used in the Delivery of Transcutaneous Electrical Nerve Stimulation (TENS) and Neuromuscular Electrical Stimulation (NMES) 160.13 Description Functional Electrical Stimulators A functional electrical stimulator (FES), a specialized type of neuromuscular stimulator, is designed to enhance the ability to stand and/or walk for individuals with a spinal cord injury (SCI) by emitting electrical impulses to stimulate paralyzed or weak muscles in a specific order. Functional electrical stimulation attempts to prevent or reverse muscle atrophy and bone demineralization by stimulating paralyzed lower limbs (legs) to perform stationary exercise or assist with standing and walking. Additionally, functional electrical stimulation has been investigated as a way to improve gait disorders of individuals with hemiplegia. An FES device may use surface electrodes or be an implanted system. Examples of FES devices to assist with ambulation in individuals with an SCI include, but may not be limited to, the Parastep I System. Currently, the Parastep I is the only device with US Food & Drug Administration (FDA) approval for restoring ambulation for individuals with an SCI. Examples of FES devices for the lower extremities include, but may not be limited to, Cionic Neural Sleeve NS-100, ERGYS systems, MyoCycle, NESS L300 systems, ODFS Dropped Foot Stimulator, RT300 systems, RT600 FES Step and Stand Rehabilitation Therapy system and the WalkAide stimulator. FES has also been proposed for individuals with upper extremity paralysis due to injury or disease of the central nervous system such as cervical spinal cord injuries or stroke. It is suggested as a treatment option for exercising the hand and/or conditioning selected muscles of the forearm and hand. Examples of FES devices for paralyzed upper extremities include, but may not be limited to, the MyndMove systems, NESS H200 Hand Rehabilitation System, and RT300 systems. Diaphragmatic/Phrenic Nerve Stimulation Electrical Stimulators - Diaphragmatic/Phrenic Nerve, Functional and Neuromuscular Page: 3 of 6 Diaphragmatic/phrenic (D/P) nerve stimulation (also referred to as diaphragmatic/ phrenic pacing) and diaphragm pacing may be an alternative to invasive, mechanical ventilation for individuals with a C3 level or above spinal cord injury or for some motor neuron diseases such as amyotrophic lateral sclerosis (ALS). This is most often accomplished by phrenic nerve pacing (electrodes are placed near the phrenic nerve), though direct pacing of the diaphragm muscle may be more helpful in some individuals (electrodes placed directly on or implanted into the diaphragm muscle). Phrenic nerve pacing devices consist of both internal (electrodes and a receiving unit) and external components (transmitting box connected to an antenna taped to the surface of the skin, just over the implanted receiving unit). For implanted diaphragm pacing devices, after motor point mapping of the diaphragm muscle has been done, electrodes are implanted into the identified motor points and connected to an external stimulator. Examples of these devices include, but may not be limited to, Avery Diaphragm Pacing System (also known as Breathing Pacemaker System), Mark IV Breathing Pacemaker System, NeuRx DPS Diaphragm Pacing System, and NeuRx DPS RA/4 Respiratory Stimulation System. Neuromuscular Electrical Stimulators Neuromuscular electrical stimulators (NMES) are small electronic devices that are affixed externally to the individual’s skin by way of electrodes to provide direct stimulation of affected muscles. NMES stimulates muscle to maintain its tone during temporary extremity immobilization. The goal of NMES for an immobilized extremity, following a documented injury or surgical intervention, is to control edema, increase local blood circulation, maintain muscle tone, or delay the development of disuse atrophy. NMES has also been proposed for other indications including treatment for muscle atrophy characteristic in conditions such as cerebral palsy, congestive heart failure and upper extremity hemiplegia (eg, stroke). NMES may also be used for neuromodulation of cranial nerves in conjunction with focused exercise therapy to improve neurological symptoms such as gait deficits with multiple sclerosis. Examples of a NMES include, but may not be limited to: • Biomove systems are devices where electromyography (EMG) is triggered by NMES. These devices are designed to detect any EMG signals (nerve impulses from the brain to the muscles) that are supposed to stimulate a muscle contraction but are too weak to do so. When the device detects these signals, it applies stimulation to the muscle and induces a contraction, to purportedly retrain the brain and muscle to properly coordinate contractions and movement. This device is also proposed for relaxation of muscle spasms and prevention or retardation of disuse atrophy • Empi Phoenix, Flex-MT Plus, Kneehab XP, NexWave and QB1 are combination NMES and transcutaneous electrical nerve stimulation (TENS) devices. • geko W-2 device delivers neuromuscular electro-stimulation via the common peroneal nerve to activate the calf and foot muscle pumps of the lower leg to increase blood circulation. • Guardian dysphagia therapy systems and VitalStim Therapy devices are proposed for muscle re- education by application of external stimulation for pharyngeal contraction. Electrical Stimulators - Diaphragmatic/Phrenic Nerve, Functional and Neuromuscular Page: 4 of 6 • Portable Neuromodulation Stimulator (PoNS) is a nonimplantable device, proposed for the use in individuals with multiple sclerosis, which delivers mild neuromuscular stimulation to the tongue stimulating the facial and trigeminal nerves sending impulses to the brain to purportedly provide treatment of short- term gait deficits. The device consists of a controller and mouthpiece that are connected to each other by a cable. • RS-2m muscle stimulator • RS-4i Plus sequential stimulator (also referred to as a combination unit) initially provides an interferential treatment followed by the muscle stimulation. • RS-4m muscle stimulator Coverage Determination Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare. Please refer to the above CMS guidance for Neuromuscular Electrical Stimulation (NMES) and Phrenic Nerve Stimulator In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria: Electrical Stimulators – Diaphragmatic/Phrenic Nerve, Functional and Neuromuscular The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy. Coverage Limitations US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage