HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
Z-4-017
Topic:
Transcranial Magnetic Stimulation
Section:
Miscellaneous
Effective Date:
October 28, 2024
Issued Date:
October 28, 2024
Last Revision Date:
September 2024
Annual Review:
September 2024
 
 

Transcranial magnetic stimulation (TMS) is a method of noninvasive stimulation of the brain through a small coil placed over the scalp to produce a magnetic field that will stimulate the cortex of the brain. TMS is used in the treatment of major depressive disorders and obsessive-compulsive disorders (OCD) that are resistant to treatment.

Policy Position

Repetitive transcranial magnetic stimulation (rTMS) of the brain using an FDA-cleared device may be considered medically necessary as a treatment of major depressive disorder when ALL of the following conditions have been met:

  • The individual is age 15 or older
  • The individual has a confirmed diagnosis of severe major depressive disorder (single or recurrent) documented by standardized rating scales that reliably measure depressive symptoms, such as Hamilton depression scale
  • Treatment is indicated by ONE or more of the following
    • The individual has tried and had an inadequate response to two (2) antidepressant agents from two (2) different antidepressant classes (i.e., selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, bupropion, or mirtazapine) and ALL of the following are met
      • The trial length was at least 6 weeks at generally accepted doses or sufficient duration as determined by the treating physician at the generally accepted doses
      • The individual was at least 80% adherent to the agent during the trial
    • The individual is unable to tolerate a therapeutic dose of medications as evidenced by two (2) trials of psychopharmacologic agents with distinct side effects
    • The individual has a history of positive response to rTMS, as documented by standardized rating scales that reliably measure depressive symptoms, in a previous depressive episode (at least three (3) months since the prior episode)
    • The individual is a candidate for electroconvulsive therapy (ECT) and ECT would not be clinically superior to rTMS (e.g., in cases with psychosis, acute suicidal risk, catatonia or life-threatening inanition rTMS should NOT be utilized)
  • The individual has failed a trial of a psychotherapy known to be effective in the treatment of major depressive disorder of an adequate frequency and duration, without significant improvement in depressive symptoms, as documented by standardized rating scales that reliably measure depressive symptoms
  • The individual has NONE of the following conditions
    • Seizure disorder or any history of seizure with increased risk of future seizure
    • Presence of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode
    • Neurologic conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the central nervous system (CNS)
    • Presence of an implanted magnetic-sensitive medical device located 30 centimeters or less from the TMS magnetic coil or other implanted metal items, including but not limited to a cochlear implant, implanted cardioverter defibrillator (ICD), pacemaker, vagus nerve stimulator, or metal aneurysm clips or coils, staples, or stents.
  • Prescribed treatment does not exceed five (5) days a week for six (6) weeks (total of 30 sessions), followed by a three (3)-week taper of three (3) TMS treatments in week one (1), two (2) TMS treatments the next week, and one (1) TMS treatment in the last week

NOTE: A facility providing TMS is required to have ALL of the following

  • A physician who is adequately trained and experienced in the specific techniques used
  • An attendant trained in basic cardiac life support and the management of complications such as seizures, as well as the use of the equipment who is present at all times
  • Adequate resuscitation equipment including suction and oxygen
  • Awareness of response times of emergency services (either fire/ambulance or “code team”), which should be available within five (5) minutes. These relationships are reviewed on at least a one (1) year basis and include mock drills.

rTMS for major depressive disorder that does not meet the criteria 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.

Continued treatment with rTMS of the brain as maintenance 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.

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Repetitive transcranial magnetic stimulation (rTMS) of the brain using an FDA-cleared device may be considered medically necessary as a treatment of obsessive-compulsive disorder when ALL of the following conditions have been met

  • The individual is age 18 or older
  • The individual has a confirmed diagnosis of obsessive-compulsive disorder (OCD) documented by standardized rating scales that reliably measure symptoms such as Yale-Brown Obsessive-Compulsive Scale (YBOCS)
  • Treatment is indicated by ONE or more of the following
    • The individual is resistant to treatment as evidenced by persistent OCD symptoms after two (2) indicated therapies (two (2) medications or one (1) medication plus psychotherapy) were tried each for a minimum of eight (8) weeks (cognitive behavior therapy (CBT) psychotherapy, while a valuable treatment option, is not required as a pre-requisite to TMS OCD treatment)
    • The individual is unable to tolerate psychopharmacologic agents as evidenced by trials with two (2) psychopharmacologic agents with distinct side effects
    • The individual has a history of positive response to rTMS for OCD (as documented by standardized rating scales that reliably measure symptoms of OCD), and at least three (3) months have elapsed since the prior treatment
    • The individual is currently receiving antipsychotics, opioids, benzodiazepines, glutamatergic agents or other agents which could be considered investigational or relatively risky treatments, and TMS may be considered medically necessary and a safer alternative than additional treatment trials.
  • The individual has NONE of the following conditions
    • Seizure disorder or any history of seizure with increased risk of future seizure
    • Presence of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current OCD episode
    • Neurologic conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the central nervous system (CNS)
    • Presence of an implanted magnetic-sensitive medical device located 30 centimeters or less from the TMS magnetic coil or other implanted metal items, including but not limited to a cochlear implant, implanted cardioverter defibrillator (ICD), pacemaker, vagus nerve stimulator, or metal aneurysm clips or coils, staples, or stents. 
  • Prescribed treatment does not exceed 29 visits over a six (6) week period

NOTE: A facility providing TMS is required to have ALL of the following

  • A physician who is adequately trained and experienced in the specific techniques used
  • An attendant trained in basic cardiac life support and the management of complications such as seizures, as well as the use of the equipment who is present at all times
  • Adequate resuscitation equipment including suction and oxygen
  • Awareness of response times of emergency services (either fire/ambulance or “code team”), which should be available within five (5) minutes. These relationships are reviewed on at least a one (1) year basis and include mock drills.

rTMS for obsessive-compulsive disorder that does not meet the criteria 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.

Retreatment may be considered for patients who met the guidelines for initial treatment and experienced at least a 30% reduction in the YBOCS score, as long as the improvement persisted for at least one month after the prior treatments ended.

Retreatment with rTMS for OCD 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.

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TMS of the brain is considered experimental/investigational and therefore non-covered for any other indication, including, but not limited to Alzheimer’s disease because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

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Professional Statements and Societal Positions Guidelines

Clinical TMS Society, Inc. 2021

Unlike major depressive disorder (MDD), which tends to be an episodic illness, OCD is a chronic lifelong disorder that typically begins in adolescence. It is the fourth most common mental illness and can cause significant distress and disability. Patients exhibit obsessions, compulsions and avoidance symptoms, which are correlated to abnormal activity in the cortico-striato-thalamic-cortical circuit.4 Severe refractory cases are referred for neurosurgery (lesional or with an implanted brain stimulator).There is now a non-invasive approach using TMS to target the abnormal circuitry of OCD. In this approach, a coil is placed over the anterior cingulate cortex, which is 4 cm anterior to the foot motor cortex and beneath the dorsomedial prefrontal cortex. TMS for OCD is performed 5 days per week for 6 weeks for a total of 29 sessions. Prior to each treatment, patients undergo individually tailored provocations to activate the abnormal OCD circuitry (for instance, asking a person with germ-related obsessions and compulsions to touch the floor and then not use hand sanitizer). There is no need for anesthesia or analgesia and there are no activity restrictions before or after treatment (e.g., driving, working, operating heavy machinery). Other non-invasive treatments for OCD include cognitive behavioral therapy (CBT) and pharmacotherapy. CBT specific to OCD is known as exposure and response prevention (ERP), utilizing a trained cognitive behavioral therapist to guide the treatment. Pharmacotherapy options include serotonin reuptake inhibitors (SRIs), such as fluoxetine, paroxetine, sertraline and fluvoxamine, and the predominantly serotonergic tricyclic antidepressant clomipramine


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Place of Service: Inpatient/Outpatient

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

Transcranial Magnetic 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.