HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
Z-7-054
Topic:
Electrical Nerve Stimulation
Section:
Miscellaneous
Effective Date:
October 1, 2023
Issued Date:
October 1, 2023
Last Revision Date:
September 2023
Annual Review:
July 2022
 
 

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

Policy Position

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 30 days from the day of surgery; or
  • For chronic pain, an individual is unresponsive to at least three (3) months of conservative therapy (i.e., 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 (i.e., physical therapy). For example, a demonstration of a reduction in pain that is clinically significant as defined by accepted documented outcome measures (i.e., pain scale); and
    • The trial period is monitored and documented by a licensed professional that is qualified to provide treatment (i.e., 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. 

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 device, four (4)  electrodes per month; or
  • For four (4) lead device, 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.

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 (i.e., the Remede System) and central sleep related hypoventilation/hypoxemic syndromes.
     
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.

64575

64580

64585

64590

64595

95970

95971

L8678

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

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 (aged four (4) years and older) with partial onset seizures who have not undergone a bilateral or left cervical vagotomy.

 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.

Vagus (vagal) nerve stimulation not meeting the criteria as indicated in this policy is considered not medically necessary.

61885

61886

64553

64568

64569

64570

95970

95976

95977

E1399

L8678

L8679

L8680

L8681

L8682

L8683

L8685

L8686

L8687

L8688

L8689

L8695

 

 

 

 

 

 




Non-Implantable Vagus Nerve Stimulator

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 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 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 (i.e., gammaCore) may be considered medically necessary for the preventive treatment of migraine headache or for the acute treatment of pain associated with migraine headache under ALL of the following circumstances:

  • The individual is aged between twelve 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. 

K1020

 

 

 

 

 

 




Percutaneous Nerve Field Stimulator

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.

64999

 

 

 

 

 

 




Percutaneous Neuromodulation Therapy

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.

64999

 

 

 

 

 

 




Percutaneous or Open Implantation of Neuromuscular Neurostimulator

The percutaneous or open (via incision) implantation of neuromuscular neurostimulator electrodes for chronic pain relief 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. 

64580

 

 

 

 

 

 




Occipital Nerve Stimulation (ONS)

ONS 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.

61885

61886

64553

64568

64569

64570

64999

L8678

L8680

L8681

L8682

L8683

L8685

L8686

L8687

L8688

L8689

 

 

 

 




Remote Electrical Neuromodulation 

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.

E1399

 

 

 

 

 

 




Percutaneous Electrical Nerve Field Stimulator

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.

64999

E1399

0720T

 

 

 

 




External Trigeminal Nerve Stimulation System

An external trigeminal nerve stimulation (eTNS) system 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.

K1016

K1017

 

 

 

 

 




External Upper Limb Tremor Stimulator

An external upper limb tremor stimulator 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.

K1018

K1019

 

 

 

 

 




Transcutaneous Electrical Modulation Pain Reprocessing Therapy

Transcutaneous electrical modulation pain reprocessing therapy (TEMPR) (i.e., scrambler 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.

0278T

 

 

 

 

 

 




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

A4630

 

 

 

 

 

 



C1767

C1778

C1816

C1820

C1822

C1823

C1826

C1883

C1897

 

 

 

 

 




Related Policies

Refer to Medical Policy S-131, Sacral Nerve Neuromodulation/Stimulation, for additional information.

Refer to Medical Policy S-155, Gastric Electrical Stimulation, Gastric Pacing, for additional information.  

Refer to Medical Policy Y-16, Chronic Wound Management, for additional information.

Refer to Medical Policy E-40, Functional Neuromuscular Electrical Stimulation (NMES), for additional information.

Refer to Medical Policy Z-8, Diagnosis and Treatment of Obstructive Sleep Apnea for Adults, for additional information.

Refer to Medical Policy Z-100, Deep Brain Stimulation, for additional information.

Refer to Medical Policy S-51, Responsive Neurostimulation for the Treatment of Refractory Partial Epilepsy, for additional information.

Refer to Medical Policy V-23, Temporomandibular Joint (TMJ) Dysfunction, for additional information.

Refer to Medical Policy Z-64, Diagnosis and Treatment of Obstructive Sleep Apnea in Pediatric Individuals, for additional information.


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

G40.C01

G40.C09

G40.C11

G40.C19

Z45.42

 

 

 

 

 

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 (0424T, 0425T, 0426T, 0427T, 0428T, 0429T, 0430T, 0431T, 0432T, 0433T, 0434T, 0435T, and 0436T)

 

G47.31

G47.34

G47.35

G47.36

G47.37

 

 



Place of Service: Inpatient/Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Electrical Nerve Stimulation is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business



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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.





Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.