Humana Commercial Clinical Policy

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


Effective Date

07/27/2023

Last Reviewed

NA

Original Document

  Reference



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.

Description

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.

Electrical Stimulators-Diaphragmatic/Phrenic, Functional and Neuromuscular

Effective Date: 07/27/2023
Revision Date: 07/27/2023
Review Date: 07/27/2023
Policy Number: HUM-0399-022

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

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. (Refer to Coverage Limitations section)

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. (Refer to Coverage Limitations section)

Diaphragmatic/Phrenic Nerve Stimulation

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.

Electrical Stimulators-Diaphragmatic/Phrenic, Functional and Neuromuscular

Effective Date: 07/27/2023
Revision Date: 07/27/2023
Review Date: 07/27/2023
Policy Number: HUM-0399-022

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

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.

For information regarding central sleep apnea and phrenic nerve stimulation, please refer to Obstructive Sleep Apnea and Other Sleep Related Breathing Disorders Surgical Treatments Medical Coverage Policy.

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. (Refer to Coverage Limitations section)

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 (Refer to Coverage Limitations section)
  • Empi Phoenix, Flex-MT Plus, Kneehab XP, NexWave and QB1 are combination NMES and transcutaneous electrical nerve stimulation (TENS) devices. (Refer to Coverage Limitations section)
  • 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. (Refer to Coverage Limitations section)
  • Guardian dysphagia therapy systems and VitalStim Therapy devices are proposed for muscle re-education by application of external stimulation for pharyngeal contraction. (Refer to Coverage Limitations section)
  • 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.

Electrical Stimulators-Diaphragmatic/Phrenic, Functional and Neuromuscular

Effective Date: 07/27/2023
Revision Date: 07/27/2023
Review Date: 07/27/2023
Policy Number: HUM-0399-022

Page: 4 of 19

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

(Refer to Coverage Limitations section)

  • 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. (Refer to Coverage Limitations section)
  • RS-4m muscle stimulator

NMES differs from a TENS and interferential current stimulation (ICS), which are used for pain management therapy. For information regarding these devices, please refer to Electrical Stimulators for Pain and Nausea/Vomiting Medical Coverage Policy.

Coverage Determination|Functional Electrical Stimulators

Humana members may be eligible under the Plan for FES, limited to individuals with SCI for ambulation (walking) (eg, Parastep I System) when the following criteria are met:

Electrical Stimulators-Diaphragmatic/Phrenic, Functional and Neuromuscular

Effective Date: 07/27/2023
Revision Date: 07/27/2023
Review Date: 07/27/2023
Policy Number: HUM-0399-022
Page: 5 of 19

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  • Absence of contraindications; AND
  • Ability to demonstrate brisk muscle contraction to FES and have sensory perception of electrical stimulation sufficient for muscle contraction; AND
  • Ability to demonstrate hand and finger function to manipulate controls; AND
  • Ability to transfer independently and demonstrate independent standing tolerance for at least 3 minutes; AND
  • Intact spinal nerve roots (L1 level and below, inclusive), and intact lower limb muscles and peripheral nerves; AND
  • Minimum of 6 months status post date of spinal cord injury and/or restorative spinal, pelvic, or lower limb surgery; AND
  • Muscle strength and joint stability adequate for weight bearing within the upper and lower extremities with demonstrated balance and control sufficient to independently maintain an upright supported posture; AND
  • No symptomatic or radiographically advanced (Kellgren-Lawrence grade 3 or 4)7 hip and/or knee degenerative disease, and no history of long bone fracture secondary to osteoporosis; AND
  • Possess high motivation, commitment and cognitive ability to use such device for walking and demonstrate willingness to use the device long-term; AND
  • Successful completion of a training program, consisting of at least 32 physical therapy (PT) sessions with the device over a 3 consecutive month period (for information regarding coverage determination/limitations, please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy)

Note: The criteria for FES are consistent with the FES portion of the Medicare National Coverage Policy for Neuromuscular Electrical Stimulation, and therefore apply to Medicare members.

Electrical Stimulators-Diaphragmatic/Phrenic, Functional and Neuromuscular

Effective Date: 07/27/2023
Revision Date: 07/27/2023
Review Date: 07/27/2023
Policy Number: HUM-0399-022
Page: 6 of 19

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Replacement

Humana members may be eligible under the Plan for the replacement of an FES when the following criteria are met:

  • Replacement is required due to a change in an individual’s condition that makes the current device/equipment non-functional; OR
  • Manufacturer’s warranty has expired; AND
  • Replacement cost is less than the repair cost; AND
  • Replacement is required due to current device/equipment being nonfunctional (malfunctioning and cannot be repaired); AND
  • Requested device/equipment is being prescribed according to its US Food & Drug Administration (FDA) approved indications

Coverage Functional Electrical Stimulators

Coverage Limitations

Functional Electrical Stimulators Humana members may NOT be eligible under the Plan for FES for any indications other than those listed above. This is considered experimental/investigational as it is not identified as widely used and generally accepted for any other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

FES are specifically contraindicated for the following indications:

  • Autonomic dysreflexia; OR
  • Individual with cardiac pacemaker; OR
  • Presence of irreversible contracture; OR
  • Presence of skin disease or cancer at area of stimulation; OR
  • Severe osteoporosis; OR
  • Severe scoliosis
Electrical Stimulators-Diaphragmatic/Phrenic, Functional and Neuromuscular

Effective Date: 07/27/2023
Revision Date: 07/27/2023
Review Date: 07/27/2023
Policy Number: HUM-0399-022
Page: 7 of 19

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

This is considered experimental/investigational as it is not identified as widely used and generally accepted for any other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for other FES devices for any indication including, but not limited to, the following:

  • Cionic Neural Sleeve NS-100 used for foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury; OR
  • ERGYS systems, MyoCycle, RT300 products or the RT600 Step and Stand Rehabilitation Therapy System for stationary exercise to prevent or reduce muscle atrophy in upper and lower extremities in individuals with hemiplegia or quadriplegia; OR
  • MyndMove systems, NESS H200 Hand Rehabilitation System and RT300 systems used for upper limb paralysis or hemiplegia; OR
  • NESS L300 systems used for foot drop, in children and adults, as a result of cerebral palsy, multiple sclerosis, traumatic brain injury, stroke or an incomplete spinal cord injury; OR
  • WalkAide or ODFS Dropped Foot Stimulator used for foot drop as a result of cerebral palsy, multiple sclerosis, traumatic brain injury, stroke or an incomplete spinal cord injury

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Coverage Diaphragmatic/Phrenic Nerve Stimulation

Diaphragmatic/Phrenic Nerve Stimulation Humana members may be eligible under the Plan for D/P nerve stimulation with a NeuRx DPS Diaphragm Pacing System when the following criteria are met:

Coverage Determination
Electrical Stimulators-Diaphragmatic/Phrenic, Functional and Neuromuscular

Effective Date: 07/27/2023
Revision Date: 07/27/2023
Review Date: 07/27/2023
Policy Number: HUM-0399-022
Page: 8 of 19

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  • 21 years of age or older; AND
  • ALS; AND
  • Chronic hypoventilation; AND
  • Intact phrenic nerve function; AND
  • Used as an alternative to mechanical ventilation

Humana members may be eligible under the Plan for D/P nerve stimulation with a NeuRx DPS RA/4 Respiratory Stimulation System when the following criteria are met:

  • 18 years of age or older; AND
  • Intact phrenic nerve function; AND
  • Quadriplegia at or above C3; AND
  • Will allow the individual to breathe without the assistance of a mechanicalventilator for at least 4 continuous hours a day

Humana members may be eligible under the Plan for D/P nerve stimulation with the Avery Diaphragm Pacing System/Mark IV when the following criteria are met:

  • Intact phrenic nerve function

AND one of the following:

  • Chronic alveolar hypoventilation; OR
  • Quadriplegia at or above C3;

Note: The criteria for diaphragmatic/phrenic stimulation are not consistent with the Medicare National Coverage Policy, and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Replacement

Humana members may be eligible under the Plan for the replacement of a diaphragmatic/phrenic stimulation system when the following criteria are met:

Electrical Stimulators-Diaphragmatic/Phrenic, Functional and Neuromuscular

Effective Date: 07/27/2023
Revision Date: 07/27/2023
Review Date: 07/27/2023
Policy Number: HUM-0399-022
Page: 9 of 19

Humana's documents are updated regularly online.

When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  • Replacement is required due to a change in an individual’s condition that makes the current device/equipment non-functional; OR
  • Manufacturer’s warranty has expired; AND
  • Replacement cost is less than the repair cost; AND
  • Replacement is required due to current device/equipment being nonfunctional (malfunctioning and cannot be repaired); AND
  • Requested device/equipment is being prescribed according to its US Food & Drug Administration (FDA) approved indications

Coverage Diaphragmatic/Phrenic Nerve Stimulation

Coverage Limitations

Diaphragmatic/Phrenic Nerve Stimulation Humana members may NOT be eligible under the Plan for D/P nerve stimulation for any indications other than those listed above, including for use in individuals whose phrenic nerve, lung or diaphragm function are not sufficient to achieve adequate diaphragm movement from the electrical stimulation. This is considered experimental/ investigational as it is not identified as widely used and generally accepted for any other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Coverage Neuromuscular Electrical Stimulators

Neuromuscular Electrical Stimulators

Humana members may be eligible under the Plan for a NMES when the following criteria are met:

Coverage Determination|
  • Contractures due to burn scarring; OR
  • Major knee surgery (eg, total knee replacement) with failure to respond to at least 3 consecutive months of physical therapy; OR
  • Previous immobilization of a joint or limb (arm or leg) by casting or splinting after a surgical intervention with failure to respond to at least 3 consecutive months of physical therapy; OR
Electrical Stimulators-Diaphragmatic/Phrenic, Functional and Neuromuscular

Effective Date: 07/27/2023
Revision Date: 07/27/2023
Review Date: 07/27/2023
Policy Number: HUM-0399-022
Page: 10 of 19

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  • Recent hip replacement surgery before physical therapy begins; AND all of the following:
  • Absence of contraindications; AND
  • Intact nerve supply to the muscle; AND
  • Muscle disuse atrophy due to an immobilized extremity

It is the Plan’s option to determine if the Durable Medical Equipment (DME) item shall be rented or purchased. If the cost of renting the item is more than the cost to buy it, only the cost of the purchase is considered to be a covered expense. In either case (rent or purchase), total covered expenses shall not exceed the purchase price. In the event the Plan determines to purchase the DME, any amount paid as rent for such equipment will be credited toward the purchase price.

Humana members may be eligible under the Plan for a form-fitting conductive garment for use in delivering NMES, when prescribed by a healthcare provider and the above criteria are met, for any of the following indications:

  • A skin problem or other medical condition that prevents the application or use of conventional electrodes, adhesive tape, etc.
  • Due to the number or frequency of treatments, it is not feasible to use conventional electrodes, adhesive tapes and lead wires; OR
  • Requires electrical stimulation beneath a cast to treat disuse atrophy and nerve supply to the muscle is intact; OR
  • Traditional electrodes cannot be used due to the large area or large number of sites that need to be stimulated

Note: The criteria for NMES are not consistent with the NMES portion of the Medicare National Coverage Policy for NMES and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Electrical Stimulators-Diaphragmatic/Phrenic, Functional and Neuromuscular

Effective Date: 07/27/2023
Revision Date: 07/27/2023
Review Date: 07/27/2023
Policy Number: HUM-0399-022
Page: 11 of 19

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Coverage Neuromuscular Electrical Stimulators

Coverage Limitations

Neuromuscular Electrical Stimulators Humana members may NOT be eligible under the Plan for NMES for any indications other than those listed above including, but not limited to, the following:

  • Cerebral palsy; OR
  • Congestive heart failure; OR
  • Dysphagia; OR
  • Multiple sclerosis; OR
  • Treatment of pain for various musculoskeletal conditions including but not limited to, lumbago (back pain), muscle strains/sprains, patellofemoral syndrome, scoliosis, spinal stenosis; OR
  • Upper extremity hemiplegia

This is considered experimental/investigational as it is not identified as widely used and generally accepted for any other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

NMES is specifically contraindicated for individuals with cardiac pacemakers. This is considered experimental/investigational as it is not identified as widely used and generally accepted for any other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for any of the following NMES devices:

  • Combination and sequential units including, but may not limited to, Empi Phoenix, Flex-MT Plus, Kneehab XP, NexWave, QB1 and RS-4i Plus devices; OR
  • EMG-triggered NMES including, but may not limited to, Biomove devices; OR
Electrical Stimulators-Diaphragmatic/Phrenic, Functional and Neuromuscular

Effective Date: 07/27/2023
Revision Date: 07/27/2023
Review Date: 07/27/2023
Policy Number: HUM-0399-022
Page: 12 of 19

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  • geko W-2 device; OR
  • Guardian dysphagia therapy systems and VitalStim Therapy devices; OR
  • Portable Neuromodulation Stimulator (PoNS) device

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Background

Additional information about dysphagia, muscular/disuse atrophy, spinal cord injuries, paralysis and other neurological conditions such as ALS, cerebral palsy or multiple sclerosis may be found from the following websites:

  • American College of Gastroenterology
  • National Institute of Neurological Disorders and Stroke
  • National Library of Medicine

Medical Alternatives

Alternatives to FES include, but may not be limited to, the following:

  • Occupational therapy (please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy)
  • Physical therapy (please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy)

Alternatives to diaphragmatic/phrenic nerve stimulation include, but may not be limited to, the following:

  • Invasive (mechanical) ventilation (please refer to Durable Medical Equipment Medical Coverage Policy)
  • Noninvasive ventilation (please refer to Noninvasive Home Ventilators Medical Coverage Policy)
Electrical Stimulators-Diaphragmatic/Phrenic, Functional and Neuromuscular

Effective Date: 07/27/2023
Revision Date: 07/27/2023
Review Date: 07/27/2023
Policy Number: HUM-0399-022
Page: 13 of 19

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Alternatives to NMES include, but may not be limited to, the following:

  • Occupational therapy (please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy)
  • Physical therapy (please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy)
  • Speech therapy for dysphagia (please refer to Speech Therapy Medical Coverage Policy)

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Humana may offer a disease management program for this condition. The member may call the number on his/her identification card to ask about our programs to help manage his/her care.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.

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