Humana Electrical Stimulators for Pain and Nausea/Vomiting Form

Description

Electrical stimulators or electrical stimulation include a wide array of devices and treatments that have been proposed as a noninvasive method to treat various pain conditions as well as for nausea and vomiting. Many times, when the term electrical stimulator is used, the treatment that comes to mind is transcutaneous electrical nerve stimulation (TENS); hence the terms are often used interchangeably even though it is incorrect.

Transcutaneous electrical nerve stimulation (TENS)

TENS is the most common form of electrical stimulation used for pain management therapy. TENS sends electrical impulses from a portable, battery powered pulse generator using skin electrodes placed over the affected tissue.

Electrical Stimulators for Pain and Nausea/Vomiting

Effective Date: 04/27/2023
Revision Date: 04/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0412-033
Page: 2 of 32

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.

A number of electrical stimulators (the majority are TENS units) are available for purchase over-the-counter (OTC) (off-the-shelf) without a physician prescription. Examples of these devices include, but may not be limited to, the ActiPatch, Aleve Direct Therapy TENS, Avazzia, Icy Hot Smart Relief TENS, Viverity Pain Relief Pad - Rechargeable TENS and WiTouch Pro Bluetooth Wireless TENS Device. (Refer to Coverage Limitations section)

The Quell device is another example of a TENS unit that is available OTC; it is also the first and only OTC electrical stimulator to receive US Food & Drug Administration (FDA) approval for use during sleep. This device consists of a band worn around the upper calf to theoretically provide systemic relief of chronic pain and is controlled by an individual’s smartphone or tablet. It has been granted an additional expanded indication for moderate to severe symptoms of chemotherapy- induced peripheral neuropathy that have persisted for at least 6 months following discontinuation of chemotherapy. (Refer to Coverage Limitations section)

Percutaneous electrical nerve stimulation (PENS) uses very fine, acupuncture-like needles inserted into the tissues surrounding the spine. Electrical current (the same type as used in TENS) is applied to the needles which then stimulate the peripheral nerves. This treatment is performed by a healthcare professional in the office setting and is not intended for home use.

Auricular electrostimulation (also referred to as auricular electroacupuncture or pulsed stimulation) is the application of electrical impulses/stimulation to acupuncture points on the ear. It is theorized that stimulation of the corresponding acupuncture points will relieve pain in various locations in the body. Examples of this type of device include, but may not be limited to, Neuro-Stim System (NSS) and P-Stim which are disposable, preprogrammed units worn behind the ear and connected to acupuncture needles. (Refer to Coverage Limitations section)

The Cefaly Supraorbital Transcutaneous Neurostimulator (Cefaly Enhanced, Cefaly Connected), classified as a transcutaneous electrical nerve stimulator, has FDA- approved indications which are limited to the prophylactic treatment of episodic migraine and treatment of acute episodic migraine headaches (during a migraine attack), both of which are for an individual 18 years of age or older. For information regarding the Cefaly device, please refer to Headache and Occipital Neuralgia Treatments Medical Coverage Policy.

Electrical Stimulators for Pain and Nausea/Vomiting

Effective Date: 04/27/2023
Revision Date: 04/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0412-033
Page: 3 of 32

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.

Combined therapy, which consists of high frequency electrical stimulation and peripheral nerve block (also referred to as combination electrochemical therapy, combination electrochemical treatment or CET), is purported to treat peripheral neuropathy by first injecting the peripheral nerve with a local anesthetic, followed by a high frequency electrical stimulation. (Refer to Coverage Limitations section)

Electroceutical therapy is a noninvasive device that uses a variety of electrical modalities as a proposed treatment for acute and chronic pain. The device is similar to TENS, except electroceutical treatments use higher electrical frequencies, altering the electric current to theoretically mimic the human bioelectric system. This therapy may also be referred to as bioelectric nerve block, noninvasive neuron blockade, electroceutical neuron blockade and bioelectric treatment system. An example of this is the Hako-Med Pro ElecDT 2000. (Refer to Coverage Limitations section)

H-Wave stimulation is a form of electrical stimulation that differs from other types in terms of its waveform. The H-wave produces low frequency muscle stimulation and high frequency pain control. H-wave stimulation has been purported for use in pain control for conditions such as complex regional pain syndrome (also known as reflex sympathetic dystrophy), muscle sprains, temporomandibular joint dysfunctions or treatment of diabetic neuropathy. (Refer to Coverage Limitations section)

High frequency impulse therapy (HFIT) purportedly mimics a frequency wave similar to that of implanted neuromodulation devices (ie, some spinal cord stimulators). The stimulation is delivered via electrodes, applied to the skin, which are directly attached to the stimulator (without the need for lead wires). An example of this device includes, but may not be limited to, the ENSO device. (Refer to Coverage Limitations section)

Interferential current stimulation (ICS) is similar to TENS, in that both therapies send electrical impulses from a portable, battery powered pulse generator to skin electrodes placed over the affected tissue. ICS differs from TENS, however, by allowing the electrical impulses to have a deeper penetration of the tissue. The neo-GEN Series system is a form of ICS; it uses an ultra-high frequency generator to produce pulsed electrical cell-signaling treatment (referred to as EcST). The neo-GEN Series system is not for home use. (Refer to Coverage Limitations section)

Microcurrent electrical nerve stimulation (MENS) devices are noninvasive and apply precise, tightly controlled electrical current to specific areas on the body that correspond with classical acupuncture points. MENS is also referred to as microelectrical therapy (MET) or microelectrical neurostimulation. Examples of this type of device include, but may not be limited to, Alpha-Stim M, Electro-Myopulse 75L, iRelieve Microcurrent Pain Relief System and Myopulse. The ClearUP Sinus Pain Relief device is FDA-approved for relief of sinus pain due to allergic rhinitis, the flu or the common cold. It is purported to accomplish this by stimulation of the trigeminal nerve branches. It is available over-the-counter without a prescription.

Electrical Stimulators for Pain and Nausea/Vomiting

Effective Date: 04/27/2023
Revision Date: 04/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0412-033
Page: 4 of 32

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)For information regarding Alpha-Stim for cranial electrical stimulation, please refer to Transcranial Magnetic Stimulation and Cranial Electrical Stimulation Medical Coverage Policy.

A variation of auricular electrostimulation is percutaneous electrical nerve field stimulation (PENFS), which has been proposed as a treatment for functional abdominal pain associated with irritable bowel syndrome (IBS) in children 11 - 18 years of age. An example of a PENFS device is the IB-Stim stimulator. This device is a single-use, disposable battery-powered stimulator which is placed behind the ear. Low frequency electric pulses are delivered via electrodes to nerve branches of cranial nerves V, VII, IX and X as well as the occipital nerves. (Refer to Coverage Limitations section)

Another proposed use for PENFS is the treatment of pain associated with opioid withdrawal. The Bridge medical device uses needle array electrodes rather than acupuncture needles that are placed on the ear/earlobe and connect to a pulse generator that has been attached behind the ear. As with the IB-Stim device, low frequency electric pulses are delivered via the electrodes to the nerve branches of cranial nerves V, VII, IX and X as well as the occipital nerves. The system, including the electrodes, is left in place for up to 5 days, at which time it is removed and discarded. Additional examples of similarly designed PENFS devices (for the treatment of pain associated with opioid withdrawal) include the Drug Relief V1 device and the Morph Device. (Refer to Coverage Limitations section)

Electrical Stimulators for Pain and Nausea/Vomiting
Effective Date: 04/27/2023
Revision Date: 04/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0412-033
Page: 5 of 32

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.

Other devices in this classification include the First Relief system and the Primary Relief system. Both use auricular stimulation points for location of the electrodes. The First Relief system has been FDA-approved for treatment up to 56 days for chronic intractable pain due to diabetic peripheral neuropathy. The Primary Relief system was initially FDA-approved for post-cesarean section pain; it has been granted an expanded approval for treatment of pain after cardiac surgery. It may be used for up to 3 days for either indication. (Refer to Coverage Limitations section)

The Sparrow Therapy System is a variation of the PENFS devices. Rather than percutaneous needle array electrodes to deliver the stimulation, it utilizes transcutaneous electrodes attached to an earpiece to stimulate those same cranial and/or occipital nerves for treatment of opioid withdrawal. It is referred to as transcutaneous auricular neurostimulation (tAN) or a transcutaneous nerve field stimulator. (Refer to Coverage Limitations section)

Percutaneous neuromodulation therapy (PNT) is a variation of PENS, but utilizes different electrical impulses than PENS. The electrical stimulation, which is an alternating low and high frequency current at varying pulse impulses, is delivered via needle-like electrodes which is purported to allow the stimulation to reach the deep tissue. An example of this type of device includes, but may not be limited to, the BioWavePRO Neuromodulation Pain Therapy System. This device is not for home use and requires administration by a healthcare provider, such as a physician or physical therapist, in a clinic or office setting. The BioWaveGo (a wearable version of PNT) and the BioWaveHome are available for home use and utilize the same type of electrical stimulation as the office version. (Refer to Coverage Limitations section)

Percutaneous implanted peripheral nerve stimulation is a further variation of PNT.

The electrodes are implanted via a percutaneous, minimally invasive approach; when a 60 day treatment is completed, they are removed. Its purported use is for an individual with chronic and acute pain, including postoperative and post-traumatic pain. An example of this device includes, but may not be limited to, the Sprint PNS system, which utilizes either the Sprint endura (single lead) or the Sprint extensa (dual lead). (Refer to Coverage Limitations section)

Electrical Stimulators for Pain and Nausea/Vomiting

Effective Date: 04/27/2023
Revision Date: 04/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0412-033
Page: 6 of 32

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.

Peripherally implanted nerve stimulation, also referred to as peripheral nerve stimulation (PNS), transmits an electrical current via an electrode that has been implanted adjacent or parallel to the selected peripheral nerve. This electrical current purportedly blocks or disrupts the normal transmission of pain signals. The electrodes are connected by a wire to the peripherally implanted neurostimulator (also known as an implantable subcutaneous target stimulator). An external generator (similar to a remote control device) controls the degree of stimulation the individual receives. Examples of peripherally implanted nerve stimulators include, but may not be limited to, the Nalu Neurostimulation system and StimQ system. A similar treatment is peripheral nerve field stimulation (PNFS), which may also be referred to as peripheral subcutaneous field stimulation (PSFS). In this particular treatment, the electrode leads are placed subcutaneously in the region of the pain; there they stimulate smaller peripheral nerves and nerve endings, theoretically allowing overlapping fields of multiple nerves to be stimulated. (Refer to Coverage Limitations section)

For information regarding peripherally implanted nerve stimulation for headaches, please refer to Headache and Occipital Neuralgia Treatments Medical Coverage Policy.

A permanent peripheral implantable neuromodulator differs from PSFS/PNFS in that it targets a specific nerve, and not a general area/nerve field distribution. This minimally invasive procedure is proposed as another treatment option for an individual with chronic pain of peripheral pain origin. An example of this device includes, but may not be limited to, the StimRouter system. The ReActiv8 implantable device is a variation of an implantable neurostimulator that has been proposed for treatment of low back pain. Rather than disrupting transmission of pain signals, it purports that by stimulating the nerves that innervate the weakened lumbar multifidus muscle, the muscle will be strengthened and the back pain will be decreased. Treatment with the ReActiv8 may also be referred to as restorative neurostimulation. (Refer to Coverage Limitations section)

Pulsed electrical stimulation (PES) (also referred to as electrical joint stimulation) is a noninvasive, low amplitude device designed to decrease pain and increase function in an individual with conditions such as, but may not be limited to, osteoarthritis (OA) of the knee, carpal tunnel syndrome, rheumatoid arthritis (RA) of the hand or diabetic complications such as foot ulcers or diabetic neuropathy.

Electrical Stimulators for Pain and Nausea/Vomiting

Effective Date: 04/27/2023
Revision Date: 04/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0412-033
Page: 7 of 32

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.

The device consists of a signal generator, signal applicator and contact elements encased in a soft wrap with a Velcro closure, which is wrapped around the affected body part. Examples of this type of device include, but may not be limited to, the BioniCare Hand System (for OA or RA of the hand), the BioniCare Knee System (which includes the OActive Knee Brace) used for OA of the knee (integrates both the pulsed joint stimulator with their specialized knee brace to theoretically provide both stimulation and support of the knee joint) and the J-Stim 1000 which is proposed for use in OA of the knee or for rheumatoid arthritis of the hand.

High-volt pulsed galvanic (HVPG or HGV) stimulation is another type of pulsed electrical stimulator that is similar to BioniCare, except HVPG is proposed for the treatment of carpel tunnel syndrome and/or complications from diabetes, such as foot ulcers or diabetic neuropathy. (Refer to Coverage Limitations section)

Scrambler therapy/Calmare pain therapy treatment (also known as transcutaneous electrical modulation pain reprocessing or TEMPR) is intended to interrupt transmission of pain signals by delivering electrical stimulation that is interpreted by the nervous system as no pain (the stimulation scrambles the pain signal). Cutaneous nerves are stimulated using 5 surface electrode pairs that are placed in the dermatomes above and below the pain area. Unlike conventional TENS, scrambler therapy is administered in the office setting under physician supervision. (Refer to Coverage Limitations section)

Sympathetic therapy is a type of noninvasive therapy suggested for the treatment of chronic pain that uses electrostimulation of the peripheral nerves designed to stimulate the sympathetic nervous system. Unlike TENS, sympathetic therapy does not treat local pain but is designed to induce a systemic effect via the sympathetic nervous system. (Refer to Coverage Limitations section)

Transcutaneous electrical acupoint stimulation, also known as acustimulation, has been proposed as a method of treating severe nausea and vomiting that does not respond to other conservative treatments. A watch-like device is placed on the wrist and provides very mild electrical impulses to stimulate the median nerve (which is an acupuncture point thought to be effective for the treatment of nausea and vomiting). An example of a device used for this treatment includes, but may not be limited to, the ReliefBand. (Refer to Coverage Limitations section)

Electrical Stimulators for Pain and Nausea/Vomiting

Effective Date: 04/27/2023
Revision Date: 04/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0412-033
Page: 8 of 32

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.

A variation of transcutaneous electrical acupoint stimulation is transdermal neuromodulation. It is proposed as treatment for chemotherapy-induced nausea and vomiting. It purportedly works by stimulating the median nerve on the underside of the wrist. (Refer to Coverage Limitations section)

Transcutaneous magnetic stimulation, also referred to as therapeutic magnetic resonance (TMR), is a type of stimulation that has been purported as treatment for chronic pain. TMR delivers a focused low-frequency pulsed electromagnetic energy via two surgical steel probes that are placed against the surface of the skin, without piercing it. This treatment must be performed by a healthcare professional in an office or clinic setting.

Axon Therapy is an FDA-approved noninvasive treatment for neuropathic pain that is similar to TMR; it delivers focused magnetic pulses via a figure-8-shaped coil placed on the area of the body with nerve damage.

This treatment must also be performed by a healthcare professional in an office or clinic setting. (Refer to Coverage Limitations section)A variation of TMR is pulsed electromagnetic field therapy (PEMF); unlike TMR, this may be used at home, and utilizes a wrap that contains the coils that provide the electromagnetic energy. An example of a device used for the delivery of PEMF is the OrthoCor Active System; there are two forms of this device – one is for use on the joints (ie, ankle, elbow, knee, shoulder and wrist) and the other for the back and neck. Targeted pulsed electromagnetic field therapy (tPEMF) is similar to PEMF, and has been proposed as a treatment option for postoperative pain and swelling. An example of this device includes, but may not be limited to, the SofPulse tPEMF device. As with the OrthoCor, it is a wearable device, and can be placed directly over bandages, casts or clothing. (Refer to Coverage Limitations section)Transcutaneous pulsed radiofrequency stimulation is another proposed treatment for chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical pain, post-traumatic acute pain, as well as an adjunct for pain control due to rehabilitation. This treatment must be performed by a healthcare professional in an office or clinic setting. An example of a device used in this treatment includes, but may not be limited to, the STIMPOD NMS460. A further variation of this technology is the Venus Freedom device, which delivers nonthermal radiofrequency energy combined with magnetic field pulse stimulation and massage; it is FDA-approved for treatment of minor muscle aches and pains, toElectrical Stimulators for Pain and Nausea/Vomiting Effective Date: 04/27/2023 Revision Date: 04/27/2023 Review Date: 04/27/2023 Policy Number: HUM-0412-033 Page: 9 of 32Humana'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.relieve muscle spasms and temporarily improve local blood circulation. (Refer to Coverage Limitations section)Another approach to electrical stimulation has been the development of devices that use a combination of different stimulation modalities, such as combining TENS with ICS, TENS with ICS and galvanic direct current continuous stimulation, TENS with low level laser therapy (LLLT), TENS with neuromuscular electrical stimulation (NMES) or TENS with ultrasound. Examples of combination devices include, but may not be limited to, the Empi Phoenix and QB1 System (combines TENS with NMES devices); Flex-MT Plus and Neufit Neubie (combines TENS with ICS and galvanic direct current); the Neurolumen device (combines TENS with LLLT and light-emitting diode [LED] therapy); and UltraTENS (combines TENS with ultrasound). The InTENSity Select Combo has 4 treatment modality options (TENS, interferential current, microcurrent and NMES). Additionally, combined ICS and muscle stimulation (NMES) utilize ICS for pain and muscle stimulation to treat underlying muscle conditions. An example of this type of device is the RS-4i Plus sequential stimulator. (Refer to Coverage Limitations section)

Coverage Determination

TENS Humana members may be eligible under the Plan for TENS when prescribed by a healthcare provider for the following indications:

• Acute postoperative or post-traumatic pain ONLY in the first 30 days after surgery or injury; OR
• Chronic pain of at least 3 months duration that is not responsive to other methods of pain management (eg, medications [nonsteroidal anti-inflammatory drugs (NSAIDs)] if medically appropriate and not contraindicated and physical therapy [PT])

A 2 month rental period is used to assess an individual’s suitability for ongoing treatment.

If use of the TENS unit significantly alleviates pain during this 2 month rental period, continued rental or purchase may be approved.

Electrical Stimulators for Pain and Nausea/Vomiting

Effective Date: 04/27/2023
Revision Date: 04/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0412-033
Page: 10 of 32

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.

Humana members may be eligible under the Plan for the following supplies for use in delivering TENS when prescribed by a healthcare provider AND the previous indications for those devices are met:

• Electrodes, batteries, conductive gel or paste, skin prep and adhesive tape, adhesive remover or solvent (depending on the type of electrodes being used) – once every 30 days
• Lead wires:
  • For 2 lead units, 1 set every 12 months
  • For 4 lead units, 2 sets every 12 months
• Form-fitting conductive garment for use in delivering TENS for any of the following criteria:
  • A skin problem or other medical condition that prevents the application or use of conventional electrodes, adhesive tape, etc.
  • Area to be stimulated is inaccessible with use of conventional electrodes, adhesive tape and lead wires
  • Due to the number or frequency of treatments it is not feasible to use conventional electrodes, adhesive tape and lead wires
  • Traditional electrodes cannot be used due to the large area or large number of sites that need to be stimulated

PENS Humana members may be eligible under the Plan for PENS for up to a 30 day period when the following criteria are met:

• Diagnosis of chronic low back pain secondary to degenerative disc disease; AND
• When used as part of a comprehensive rehabilitation program, which would include medications (eg, NSAIDs, if medically appropriate and not contraindicated) and PT

Commercial Plan members: requests for PENS beyond 30 days, or for retreatment at a later date, require review by a medical director.

Note: The criteria for electrical stimulators for pain 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.

Note: The criteria for supplies used in the delivery of TENS 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.

Coverage Limitations

Humana members may NOT be eligible under the Plan for the use of a TENS unit or PENS for any indications other than those listed above. All other indications are considered not medically necessary as defined in the member’s individual certificate.

Please refer to the member's individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for the use of any other type of electrical stimulators or stimulation therapy for the treatment of pain and associated conditions including, but not limited to, any of the following:

• Auricular electrostimulation (also referred to as auricular electroacupuncture or pulsed stimulation) for any indication, including the treatment of pain associated with opiate withdrawal including, but not limited to the following devices:
  • Neuro-Stim System (NSS); OR
  • P-Stim; OR
• Combination stimulation devices including, but not limited to:

Electrical Stimulators for Pain and Nausea/Vomiting
Effective Date: 04/27/2023
Revision Date: 04/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0412-033
Page: 12 of 32

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.

• ICS with muscle stimulators (NMES) including, but not limited to, the RS-4i Plus sequential stimulator; OR
• TENS with ICS; OR
• TENS with ICS and galvanic direct current continuous stimulation including, but not limited to, the Flex-MT Plus and Neufit Neubie; OR
• TENS with ICS, microcurrent and NMES including, but not limited to, the InTENSity Select Combo; OR
• TENS with LLLT including, but not limited to, the Neurolumen device; OR
• TENS with NMES including, but not limited to, the Empi Phoenix and QB1 System; OR
• TENS with ultrasound device including, but not limited to, the UltraTENS; OR
• Combined therapy high frequency electrical stimulation and peripheral nerve block (also referred to as combination electrochemical therapy, combination electrochemical treatment or CET); OR
• Electroceutical therapy (also known as bioelectric nerve block) including, but not limited to, the Hako-Med Pro ElecDT 2000; OR
• H-wave stimulation; OR
• High frequency impulse therapy (HFIT) including, but not limited to, the ENSO; OR
• High-volt galvanic stimulation (HVPG or HVG); OR
• Interferential current stimulation (ICS) including, but not limited to, the neo-GEN Series system; OR
• Microcurrent electrical nerve stimulation (MENS) including, but not limited to, Alpha-Stim M, Electro-Myopulse 75L, iRelieve or Myopulse; OR

Electrical Stimulators for Pain and Nausea/Vomiting
Effective Date: 04/27/2023
Revision Date: 04/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0412-033
Page: 13 of 32

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.

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• Percutaneous electrical nerve field stimulation (PENFS) of the cranial nerves (without implantation) including, but not limited to, the following devices:
  • Bridge device for any indication including, but not limited to, pain associated with opioid withdrawal; OR
  • Drug Relief V1 device for any indication including, but not limited to, pain associated with opioid withdrawal; OR
  • First Relief system for any indication including, but not limited to, diabetic peripheral neuropathy; OR
  • IB-Stim stimulator for any indication including, but not limited to, IBS; OR
  • Morph device for any indication including, but not limited to, pain associated with opioid withdrawal; OR
  • Primary Relief system for any indication including, but not limited to, post cesarean section pain or post cardiac surgery pain; OR
• Percutaneous implanted peripheral nerve stimulation including, but not limited to, the Sprint endura, Sprint extensa or Sprint PNS system; OR
• Percutaneous neuromodulation therapy including, but not limited to, the BioWaveGo, BioWaveHome or BioWavePRO; OR
• Peripheral nerve field stimulation (PNFS) or peripheral subcutaneous field stimulation (PSFS) for ANY indication, including, but not limited to, trigeminal neuralgia or facial pain; OR
• Peripherally implanted nerve stimulation including, but not limited to, the Nalu Neurostimulation system or StimQ PNS system for ANY indication including, but not limited to, trigeminal neuralgia or facial pain; OR
• Permanent peripheral implantable neuromodulator including, but may not be limited to, the ReActiv8 or StimRouter system; OR

Electrical Stimulators for Pain and Nausea/Vomiting
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Revision Date: 04/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0412-033
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• Pulsed electrical stimulator (PES) including, but not limited to, the BioniCare Hand System, BioniCare Knee System or J-Stim 1000; OR
• Pulsed electromagnetic field therapy (PEMF) including, but not limited to, the OrthoCor Active System; OR
• Scrambler therapy/Calmare pain therapy treatment (also known as transcutaneous electrical modulation pain reprocessing or TEMPR); OR
• Sympathetic therapy; OR
• Targeted pulsed electromagnetic therapy (tPEMF) including, but not limited to, the SofPulse tPEMF; OR
• Transcutaneous auricular neurostimulation (tAN) (also known as transcutaneous nerve field stimulation) including, but not limited to, the Sparrow Therapy System; OR
• Transcutaneous magnetic stimulation (also known as therapeutic magnetic resonance [TMR]) including, but not limited to, Axon Therapy; OR
• Transcutaneous pulsed radiofrequency stimulation including, but not limited to, the STIMPOD NMS460 and Venus Freedom

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.

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

• ActiPatch; OR
• Aleve Direct Therapy TENS; OR
• Avazzia; OR
• ClearUP Sinus Pain Relief; OR

Electrical Stimulators for Pain and Nausea/Vomiting
Effective Date: 04/27/2023
Revision Date: 04/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0412-033
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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.

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Icy Hot Smart Relief TENS; OR
• Quell (including Quell Fibromyalgia); OR
• Viverity Pain Relief Pad-Rechargeable TENS; OR
• WiTouch Pro Bluetooth Wireless TENS Device

Although they may be prescribed by a health care practitioner, these devices are also available without a prescription and may be obtained over-the-counter (OTC) and are therefore generally excluded in the certificate. In the absence of a certificate exclusion for OTC items, these devices are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member's individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for any type of electrical stimulators or stimulation therapy for the treatment of nausea and vomiting including, but may not be limited to:

• Transcutaneous electrical acupoint stimulation including, but may not be limited to, the ReliefBand; OR
• Transdermal neuromodulation

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 low back pain, osteoarthritis, pain management, IBS or nausea and vomiting may be found from the following websites:

• American Academy of Orthopaedic Surgeons
• American College of Gastroenterology
• American Society of Regional Anesthesia and Pain Medicine
• National Library of Medicine

Electrical Stimulators for Pain and Nausea/Vomiting

Effective Date: 04/27/2023
Revision Date: 04/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0412-033
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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.

Medical Alternatives

Alternatives to electrical stimulation for the treatment of pain conditions include, but may not be limited to, the following:

• Physical or occupational therapy (please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy)
• Prescription drug therapy

Alternatives to electrical stimulation for the treatment of IBS or nausea and vomiting include, but may not be limited to, the following:

• Prescription drug therapy

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

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.

Electrical Stimulators for Pain and Nausea/Vomiting

Effective Date: 04/27/2023
Revision Date: 04/27/2023
Review Date: 04/27/2023
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A4558 Electrodes (e.g., apnea monitor), per pair Lead wires (e.g., apnea monitor), per pair Conductive gel or paste, for use with electrical device (e.g., TENS, NMES), per oz

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Interferential current stimulator, 2 channel Interferential current stimulator, 4 channel Electrical stimulation of auricular acupuncture points; each 15 minutes of personal one-on-one contact with patient

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References

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• Agency for Healthcare Research and Quality (AHRQ). Comparative Effectiveness Review (ARCHIVED). Treatment of osteoarthritis of the knee: an update review. https://www.ahrq.gov.

• Agency for Healthcare Research and Quality (AHRQ). Comparative Effectiveness Review. Interventional treatments for acute and chronic pain: systematic review. https://www.ahrq.gov. Published September 2021. Accessed March 28, 2023.
• American Academy of Neurology (AAN). Assessment: efficacy of transcutaneous electric nerve stimulation in the treatment of pain in neurologic disorders (an evidence-based review). https://www.aan.com. Published January 12, 2010. Updated May 22, 2021. Accessed April 4, 2023.
• American Academy of Neurology (AAN). Evidence-based guideline: treatment of painful diabetic neuropathy (ARCHIVED). https://www.aan.com. Published April 11, 2011. Accessed April 4, 2023.
• American Academy of Orthopaedic Surgeons (AAOS). Evidence-Based Clinical Practice Guideline. Management of osteoarthritis of the knee (non-arthroplasty). 3rd edition. https://www.aaos.org. Published August 31, 2021. Accessed April 4, 2023.
• American College of Physicians (ACP). Noninvasive treatments for acute, subacute, and chronic low back pain: a clinical practice guideline from the American College of Physicians. https://www.acponline.org. Published April 4, 2017. Accessed April 4, 2023.
• American College of Physicians (ACP). Nonpharmacologic and pharmacologic management of acute pain from non-low back, musculoskeletal injuries in adults: a clinical guideline from the American College of Physicians and American Academy of Family Physicians. https://www.acponline.org. Published 2020. Accessed April 4, 2023.
• American Society of Pain and Neuroscience (ASPN). The American Society of Pain and Neuroscience (ASPN) evidence-based clinical guideline of interventional treatments for low back pain. https://www.aspnpain.com. Published December 2022. Accessed February 8, 2023.
• Management of postoperative pain: a clinical practice guideline from the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council (ARCHIVED). https://www.asra.com. Published February 2016. Accessed March 30, 2022.
• Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). Assessing patient's suitability for electrical nerve stimulation (160.7.1). https://www.cms.gov. Published June 19, 2006. Accessed March 31, 2023.
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• Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). Supplies used in the delivery of transcutaneous electrical nerve stimulation (TENS) and neuromuscular electrical stimulation (NMES) (160.13). https://www.cms.gov. Published July 14, 1988. Accessed March 31, 2023.
• Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). Transcutaneous electrical nerve stimulation (TENS) for acute post-operative pain (10.2). https://www.cms.gov. Published June 8, 2012. Accessed March 31, 2023.

References

17. ECRI Institute. Clinical Evidence Assessment. IB-Stim (Innovative Health Solutions) for treating abdominal pain in patients with irritable bowel syndrome. https://www.ecri.org. Published February 10, 2021. Accessed March 22, 2023.
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19. ECRI Institute. Clinical Evidence Assessment. Nalu Neurostimulation System (Nalu Medical, Inc.) for treating chronic pain. https://www.ecri.org. Published November 1, 2020. Accessed March 22, 2023.
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22. ECRI Institute. Clinical Evidence Assessment. Sprint Peripheral Nerve Stimulation System (SPR Therapeutics, LLC) for treating peripheral nerve pain. https://www.ecri.org. Published May 18, 2018. Updated March 18, 2022. Accessed March 22, 2023.
23. ECRI Institute. Clinical Evidence Assessment. StimRouter Neuromodulation System (Bioness, Inc.) for treating peripheral nerve pain. https://www.ecri.org. Published April 24, 2018. Updated May 11, 2020. Accessed March 22, 2023.
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25. ECRI Institute. Evidence Report. H-wave device stimulation therapy for pain management. https://www.ecri.org. Published April 2, 2009. Accessed March 21, 2023.
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29. ECRI Institute. Hotline Response (ARCHIVED). Interferential current therapy for treating conditions other than low-back pain. https://www.ecri.org. Published August 9, 2007. Updated February 21, 2013. Accessed March 21, 2023.
30. ECRI Institute. Hotline Response (ARCHIVED). Pulsed electrical stimulation for knee osteoarthritis. https://www.ecri.org. Published May 19, 2011. Accessed July 2, 2013.
31. ECRI Institute. Hotline Response (ARCHIVED). Pulsed electromagnetic field therapy for musculoskeletal pain. https://www.ecri.org. Published July 8, 2015. Accessed March 21, 2023.
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Accessed March 22, 2023.

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33. Hayes, Inc. Emerging Technology Report. Quell wearable neurostimulation device for fibromyalgia. https://evidence.hayesinc.com. Published June 2, 2022. Accessed March 23, 2023.
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36. Hayes, Inc. Evidence Analysis Research Brief (ARCHIVED). IB-Stim (Innovative Health Solutions) for treatment of pain associated with irritable bowel syndrome. https://evidence.hayesinc.com. Published March 5, 2021. Accessed March 23, 2023.
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40. Hayes, Inc. Evidence Analysis Research Brief (ARCHIVED). SPRINT PNS System (SPR Therapeutics) for chronic pain. https://evidence.hayesinc.com. Published May 14, 2020. Accessed March 23, 2023.
41. Hayes, Inc. Evidence Analysis Research Brief (ARCHIVED). StimRouter Neuromodulation System (Bioness Inc.) for treatment of chronic pain.
    Electrical Stimulators for Pain and Nausea/Vomiting Effective Date: 04/27/2023
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48. Hayes, Inc. Health Technology Assessment. Percutaneous peripheral nerve stimulation for treatment of chronic pain. https://evidence.hayesinc.com. Published May 5, 2022. Accessed March 23, 2023.
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50. Hayes, Inc. Health Technology Assessment. Scrambler/Calmare Pain Therapy (Calmare Therapeutics Inc.) for the management of chronic pain related to cancer or cancer treatment. https://evidence.hayesinc.com. Published March 30, 2020. Updated March 18, 2022. Accessed March 23, 2023.
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52. Hayes, Inc. Health Technology Brief (ARCHIVED). BioniCare Knee System (VQ OrthoCare) for treatment of osteoarthritis of the knee. https://evidence.hayesinc.com. Published October 17, 2011. Updated October 18, 2013. Accessed March 23, 2023.
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61. Hayes, Inc. Medical Technology Directory (ARCHIVED). Motor cortex stimulation for neuropathic facial pain. https://evidence.hayesinc.com. Published November 9, 2012. Updated September 14, 2016. Accessed March 23, 2023.
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64. Hayes, Inc. Medical Technology Directory (ARCHIVED). Transcutaneous electrical nerve stimulation (TENS) for the treatment of nausea and vomiting. https://evidence.hayesinc.com. Published February 5, 2006. Updated March 17, 2010. Accessed March 23, 2023.
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66. Hayes, Inc. Search & Summary (ARCHIVED). Electrical stimulation for treatment of ankle synovitis/tenosynovitis in children. https://evidence.hayesinc.com. Published February 11, 2016. Accessed March 20, 2018.
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1. North American Spine Society (NASS). Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care. Diagnosis and treatment of cervical radiculopathy from degenerative disorders. https://www.spine.org. Published 2010. Accessed April 4, 2023.
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94. US Department of Veterans Affairs (VA). Clinical Practice Guideline. Diagnosis and treatment of low back pain. https://www.va.gov. Published February 2022. Accessed April 4, 2023.
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103. US Food & Drug Administration (FDA). 510(k) summary: STIMPOD NMS460 Nerve Stimulator. https://www.fda.gov. Published January 18, 2017. Accessed April 5, 2018.
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