Electrical Nerve Stimulation

Policy ID: Z-7-049

Section: Miscellaneous

Effective Date: July 01, 2018

Revised Date: October 18, 2021

Revision Effective Date: January 04, 2022

Last Reviewed: November 23, 2021

Applies To: Commercial and Medicaid Expansion

Description

Electrical nerve stimulation is the use of electric current produced by a device to stimulate the nerves for therapeutic purposes.

Criteria

Electrical nerve stimulation, (Transcutaneous electrical nerve stimulation (TENS) and Percutaneous electrical nerve stimulation) (PENS) may be considered medically necessary when used for the treatment of acute or chronic pain and as a means of assessing the need for continued treatment with an implanted electrical nerve stimulator.

Electrical nerve stimulation for pain control may be considered medically necessary when the following criteria have been met:

For acute pain including post-operative pain the first thirty (30) days from the day of surgery; or
For chronic pain, an individual is unresponsive to at least three (3) months of conservative therapy (e.g., non-steroidal anti-inflammatory medications, ice, rest and/or physical therapy); and
- The individual is responsive to a trial of electrical stimulation for chronic pain control for at least two (2) weeks performed under medical supervision (e.g., physical therapy). For example, a demonstration of a reduction in pain that is clinically significant as defined by accepted documented outcome measures (e.g., pain scale); and
- The trial period is monitored and documented by a licensed professional that is qualified to provide treatment (e.g., physical therapist).

The use of PENS and TENS not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer reviewed literature.

Procedure Codes

A4595

E0720

E0730

64555

64999

Supplies for electrical stimulation device may be considered medically necessary when annual documentation is noted in the individual's medical record.

Normal utilization with a covered electrical stimulation device is:

For two (2) lead devices, four (4) electrodes per month; or
For four (4) lead devices, eight (8) electrodes per month.

Procedure code A4595 is allowed 12 every one (1) floating month.

Quantity of supplies that exceed the frequency guidelines listed on this policy are considered not medically necessary.

Procedure Codes

A4595

E0720

E0730

Phrenic Nerve Stimulator

The implantation of a United States Food and Drug Administration (U.S. FDA) approved phrenic nerve stimulator may be considered medically necessary:

The phrenic nerve is viable and intact; and
Diaphragmatic function is sufficient to accommodate chronic stimulation; and
For treatment of chronic ventilator or respiratory insufficiency requiring mechanical ventilation due to ONE (1) of the following conditions:
- Lesions/injury of the spinal cord at or above the C-3 vertebral level; or
- Central alveolar hypoventilation, either primary or secondary to a brain stem disorder; or
- Central sleep apnea (e.g. the Remede System) and central sleep related hypoventilation/hypoxemic syndromes.

The use of phrenic nerve stimulation not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer reviewed literature.

Procedure Codes

64575

64580

64585

64590

64595

95970

95971

L8680

L8682

L8683

L8685

L8686

L8687

L8688

L8689

L8696

0424T

0425T

0426T

0427T

0428T

0429T

0430T

0431T

0432T

0433T

0434T

0435T

0436T

64999

Vagus Nerve Stimulator

The implantation of a vagus (vagal) nerve stimulator for seizure control may be considered medically necessary only when used as a last resort for individuals with epilepsy with partial onset seizures.

A U.S. FDA approved vagus nerve stimulator for the management of epilepsy with partial onset seizures may be considered medically necessary for individuals when seizures cannot be controlled by any other method, such as:

Drug-resistant epilepsy (“failure to control seizures with two (2) or more appropriately chosen drugs in adequate doses”); or
When surgery cannot be performed.

The use of vagus (vagal) nerve stimulation not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer reviewed literature.

Procedure Codes

61885

61886

64553

64568

64569

64570

95970

95976

E1399

L8680

L8681

L8682

L8683

L8685

L8686

L8687

L8688

L8689

U.S. FDA approved non-implantable vagus nerve stimulation devices (i.e. gammaCore) may be considered medically necessary for the abortive treatment of migraine or cluster headache under ALL of the following circumstances:

The individual is aged eighteen (18) years or older; and
The individual has a diagnosis of migraine or cluster headache; and
The individual has failed or has contraindication or has intolerance to at least two (2) medications from each of the following categories: NSAIDS, Triptans, and Ergotamines; and
The individual must be re-evaluated in 30 days. In order to obtain renewal of the device, there must be documentation of significant efficacy in the medical record.

In order to maintain coverage for gammaCore, the following efficacy must be documented:

Reduction of pain from moderate or severe to mild or pain free within 60 minutes, without the use of rescue medicine, for at least 50% of attacks.

U.S. FDA approved non-implantable vagus nerve stimulation devices (e.g., gammaCore) may be considered medically necessary for the preventive treatment of migraine headache or for the acute treatment of pain associated with migraine headaches under ALL of the following circumstances:

The individual is aged between 12 to 17 years of age; and
The individual has a diagnosis of migraine; and
The individual has failed or has contraindication or has intolerance to at least two (2) medications from each of the following categories: NSAIDS, Triptans, and Ergotamines; and
The individual must be re-evaluated in 30 days. In order to obtain renewal of the device, there must be documentation of significant efficacy in the medical record.

In order to maintain coverage for gammaCore, the following efficacy must be documented:

Reduction of pain from moderate or severe to mild or pain free within 60 minutes, without the use of rescue medicine, for at least 50% of attacks.

Non-implantable stimulation devices not meeting the criteria as indicated in this policy are considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer reviewed literature.

Procedure Code

K1020

E1399

The use of a Percutaneous nerve field stimulator in opioid withdrawal treatment is considered experimental/investigational and therefore non-covered, because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

The use of Percutaneous neuromodulation therapy is considered experimental/investigational and therefore non-covered, because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

64999

Implantable peripheral nerve stimulation to include temporary and permanent placement of neuromuscular neurostimulation electrodes, for the management of chronic pain is considered experimental/investigational; for ANY indications and therefore non-covered, because the safety and/or effectiveness of this service cannot be established by the available published peer reviewed literature.

Procedure Codes

64555

64580

64999

Occipital Nerve Stimulation (ONS)

ONS is considered experimental/investigational for ALL indications, and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

61885

61886

64553

64555

64568

64569

64570

64999

L8680

L8681

L8682

L8683

L8685

L8686

L8687

L8688

L8689

The use of a Remote Electrical Neuromodulation (REN) device (i.e.; Nerivio) is considered experimental/investigational and therefore non-covered, because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

E1399

The use of a Percutaneous Electrical Nerve Field Stimulator (PENFS) device is considered experimental/investigational and therefore non-covered, because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

64999

E1399

Replacement batteries are not eligible for payment and therefore non-covered.

Procedure Codes

A4630

Outpatient HCPCS (C Codes)

C1767

C1778

C1816

C1820

C1822

C1823

C1883

C1897

Diagnosis Codes

Covered Diagnosis Codes for Vagus Nerve Stimulation: 61885, 61886, 64553, 64568, 64569, and 64570

G40.001

G40.009

G40.011

G40.019

G40.101

G40.109

G40.111

G40.119

G40.201

G40.209

G40.211

G40.219

Covered Diagnosis Codes for Non-implantable Vagus Nerve Stimulation (K1020) for individuals aged 18 or older

G43.001

G43.009

G43.011

G43.019

G43.101

G43.109

G43.111

G43.119

G44.011

G44.019

G44.021

G44.029

G44.001

G44.009

Covered Diagnosis Codes for Non-implantable Vagus Nerve Stimulation (K1020) for Individuals aged twelve 12-17

G43.001

G43.009

G43.011

G43.019

G43.101

G43.109

G43.111

G43.119

Covered Diagnosis Codes for Phrenic Nerve Stimulation (64575, 64580, 64585, 64590, 64595, L8680, L8682, L8683, L8685, L8686, L8687, L8688, L8689, L8696, 0424T, 0425T, 0426T, 0427T, 0428T, 0429T, 0430T, 0431T, 0432T, 0433T, 0434T, 0435T, and 0436T)

G47.31

G47.34

G47.35

G47.36

G47.37

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-22-2020 Removed Deep Brain Stimulation and made it, it's own policy

Internal Medical Policy Committee 11-19-2020 Revision of policy

Expanding indications and expanding definitions of indications; expanded E/I statements
Removed Procedure Codes
Added Procedure Codes
Added Diagnosis codes: G47.31; G47.34; G47.35; G47.36; and G47.37for Phrenic Nerve Stimulation (64575, 64580, 64585, 64590,64595, L8680, L8682, L8683, L8685, L8686, L8687, L8688, L8689, L8696, 0424T, 0425T, 0426T, 0427T, 0428T, 0429T, 0430T, 0431T, 0432T, 0433T, 0434T, 0435T, 0436T)

Internal Medical Policy Committee 1-19-2021 Coding update:

Removed procedure codes 64561 and 64581;
Added procedure codes 64999

Internal Medical Policy Committee 3-17-2021 Coding update: Added K1020 Effective April 1, 2021

Internal Medical Policy Committee 9-21-2021 Coding update Effective October 01, 2021: Added Procedure codes: 64555; 64999; 95976; E1399 and Added Diagnosis codes: G43.001; G43.009; G43.011; G43.019; G43.101; G43.109; G43.111; G43.119; G44.021; G44.029; G44.001; and G44.009 and Revision of language for clarity

Internal Medical Policy Committee 11-23-2021 Added statement regarding PENFS device

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: Z-7-047

Section: Miscellaneous

Effective Date: July 01, 2018

Revised Date: March 15, 2021

Revision Effective Date: April 01, 2021

Last Reviewed: March 17, 2021

Archived Date:September 30, 2021

Applies To: Commercial Only

Description

Electrical nerve stimulation is the use of electric current produced by a device to stimulate the nerves for therapeutic purposes.

Criteria

Electrical nerve stimulation for pain control may be considered medically necessary when the following criteria have been met:

For acute pain including post-operative pain the first thirty (30) days from the day of surgery; or
For chronic pain, an individual is unresponsive to at least three (3) months of conservative therapy (e.g., non-steroidal anti-inflammatory medications, ice, rest and/or physical therapy); and
The individual is responsive to a trial of electrical stimulation for chronic pain control for at least two (2) weeks performed under medical supervision (e.g., physical therapy). For example, a demonstration of a reduction in pain that is clinically significant as defined by accepted documented outcome measures (e.g., pain scale); and
The trial period is monitored and documented by a licensed professional that is qualified to provide treatment (e.g., physical therapist).

The use of PENS and TENS for conditions not listed above is considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer reviewed literature.

Procedure Codes

64555

64999

A4595

E0720

E0730

Supplies for electrical stimulation device may be considered medically necessary when annual documentation is noted in the individual's medical record.

Normal utilization with a covered electrical stimulation device is:

For two (2) lead devices, four (4) electrodes per month; or
For four (4) lead devices, eight (8) electrodes per month.

Procedure Codes

A4595

E0720

E0730

Phrenic Nerve Stimulator

Phrenic nerve stimulator implantation may be considered medically necessary:

For treatment of chronic ventilator or respiratory insufficiency requiring mechanical ventilation due to:
- Lesions/injury of the spinal cord at or above the C-3 vertebral level; or
- Central alveolar hypoventilation, either primary or secondary to a brain stem disorder; or
- Central sleep apnea (e.g. the Remede System) and central sleep related hypoventilation/hypoxemic syndromes; and
The phrenic nerve is viable and intact; and
Diaphragmatic function is sufficient to accommodate chronic stimulation.

The use of phrenic nerve stimulation for ANY other indication is considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer reviewed literature.

Procedure Codes

64575

64580

64585

64590

64595

64999

L8680

L8682

L8683

L8685

L8686

L8687

L8688

L8689

L8696

0424T

0425T

0426T

0427T

0428T

0429T

0430T

0431T

0432T

0433T

0434T

0435T

0436T

Vagus Nerve Stimulator

Medical necessity is limited to those cases where the seizures cannot be controlled by any other method, such as:

drug-resistant epilepsy (“failure to control seizures with two (2) or more appropriately chosen drugs in adequate doses”); or
when surgery cannot be performed.

The use of vagus (vagal) nerve stimulation for ANY other indication is considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer reviewed literature.

Procedure Codes

61885

61886

64553

64568

64569

64570

95970

E1399

L8680

L8681

L8682

L8683

L8685

L8686

L8687

L8688

L8689

Non-implantable vagus nerve stimulation devices (e.g., gammaCore) may be considered medically necessary for the abortive treatment of episodic migraine or episodic cluster headache under ALL of the following circumstances:

The individual has a diagnosis of episodic migraine or episodic cluster headache; and
The individual has failed or has contraindication or has intolerance to at least two (2) medications from each of the following categories: NSAIDS, Triptans, and Ergotamines; and
The individual must be re-evaluated in 30 days. In order to obtain renewal of the device, there must be documentation of significant efficacy in the medical record.

In order to maintain coverage for gammaCore, the following efficacy must be documented:

Reduction of pain from moderate or severe to mild or pain free within 60 minutes, without the use of rescue medicine, for at least 50% of attacks.

Non-implantable stimulation devices are considered experimental/investigational for ANY other indications and circumstances except those outlined above and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer reviewed literature.

Procedure Code

E1399

K1020

Procedure Codes

64999

Implantable peripheral nerve stimulation to include temporary and permanent placement of neuromuscular neurostimulation electrodes, for the management of chronic pain is considered experimental / investigational; for ANY indications and therefore non-covered, because the safety and / or effectiveness of this service cannot be established by the available published peer reviewed literature.

Procedure Codes

64555

64580

64999

Occipital Nerve Stimulation (ONS)

Procedure Codes

61885

61886

64553

64555

64568

64569

64570

64999

L8680

L8681

L8682

L8683

L8685

L8686

L8687

L8688

L8689

Outpatient HCPCS (C Codes)

C1767

C1778

C1816

C1820

C1822

C1823

C1883

C1897

Diagnosis Codes

Covered Diagnosis Codes for Vagus Nerve Stimulation: 61885, 61886, 64553, 64568, 64569, 64570

G40.001

G40.009

G40.011

G40.019

G40.101

G40.109

G40.111

G40.119

G40.201

G40.209

G40.211

G40.219

Covered Diagnosis Codes for Non-implantable Vagus Nerve Stimulation: E1399, K1020

G43.001

G43.009

G43.011

G43.019

G43.101

G43.109

G43.111

G43.119

G44.011

G44.019

Covered Diagnosis Codes for Phrenic Nerve Stimulation: 64575, 64580, 64585, 64590, 64595, L8680, L8682, L8683, L8685, L8686, L8687, L8688, L8689, L8696, 0424T, 0425T, 0426T, 0427T, 0428T, 0429T, 0430T, 0431T, 0432T, 0433T, 0434T, 0435T, 0436T

G47.31

G47.34

G47.35

G47.36

G47.37

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-22-2020 Removed Deep Brain Stimulation and made it, it's own policy

Internal Medical Policy Committee 11-19-2020 Revision of policy

Expanding indications and expanding definitions of indications; expanded E/I statements
Removed Procedure Codes
Added Procedure Codes
Added Diagnosis codes: G47.31; G47.34; G47.35; G47.36; and G47.37for Phrenic Nerve Stimulation (64575, 64580, 64585, 64590,64595, L8680, L8682, L8683, L8685, L8686, L8687, L8688, L8689, L8696, 0424T, 0425T, 0426T, 0427T, 0428T, 0429T, 0430T, 0431T, 0432T, 0433T, 0434T, 0435T, 0436T)

Internal Medical Policy Committee 1-19-2021 Coding update:

Removed procedure codes 64561 and 64581;
Added procedure codes 64999

Internal Medical Policy Committee 3-17-2021 Coding update: Added K1020 Effective April 1, 2021

Links

References (PDF)

Disclaimer

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