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| Medical Policy: | Z-4-006 |
| Topic: | Transcranial Magnetic Stimulation (TMS) |
| Section: | Miscellaneous |
| Effective Date: | March 6, 2017 |
| Issue Date: | March 6, 2017 |
| Last Reviewed: | February 2017 |
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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 circumstances may warrant individual consideration, based on review of applicable medical records.
| Policy Position Coverage is subject to the specific terms of the member’s benefit plan. |
Repetitive transcranial magnetic stimulation (rTMS) of the brain may be considered medically necessary as a treatment of major depressive disorder when ALL of the following conditions have been met:
- Confirmed diagnosis of severe major depressive disorder (single or recurrent) documented by standardized rating scales that reliably measure depressive symptoms; and
- ANY ONE of the following:
- Failure of 4 trials of psychopharmacologic agents including 2 different agent classes and 2 augmentation trials; or
- Inability to tolerate a therapeutic dose of medications as evidenced by 4 trials of psychopharmacologic agents with distinct side effects; or
- History of response to rTMS in a previous depressive episode (at least 3 months since the prior episode); or
- 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);
AND
- Failure of 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; and
- None of the following conditions are present:
- Seizure disorder or any history of seizure with increased risk of future seizure; or
- Presence of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode; or
- 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); or
- 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.
rTMS should be performed using an FDA-cleared device in appropriately selected patients, by a physician who is adequately trained and experienced in the specific techniques used.
A treatment course should not exceed 5 days a week for 6 weeks (total of 30 sessions), followed by a 3-week taper of 3 TMS treatments in week 1, 2 TMS treatments the next week, and 1 TMS treatment in the last week.
All of the following must be present for the administration of rTMS and documented in the medical record and available upon request:
- An attendant trained in basic cardiac life support and the management of complications such as seizures, as well as the use of the equipment must be present at all times; and
- Adequate resuscitation equipment including, for example, suction and oxygen; and
- The facility must maintain awareness of response times of emergency services (either fire/ambulance or “code team”), which should be available within five minutes. These relationships are reviewed on at least a one 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, not covered. There is insufficient evidence in medical literature to support the effectiveness of this procedure.
Continued treatment with rTMS of the brain as maintenance therapy is considered experimental/investigational and therefore, not covered. There is insufficient evidence in medical literature to support the effectiveness of this procedure.
Transcranial magnetic stimulation of the brain is considered experimental/investigational and therefore not covered for any other indication. There is insufficient evidence in medical literature to support the effectiveness of this procedure.
| Place of Service: 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 |
| Denial Statements |
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This policy is intended to document those medical guidelines used by Highmark Blue Cross Blue Shield Delaware for the purpose of coverage and reimbursement determinations under Highmark Blue Cross Blue Shield Delaware health benefit plans. These guidelines are appropriate for the majority of individuals with a particular disease, illness, or condition; however, each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
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 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.
Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.
Medical policies are designed to supplement the terms of a member's contract. The member's contract defines the benefits available; therefore, medical policies should not be construed as overriding specific contract language. In the event of conflict, the contract shall govern.
Medical policies do not constitute medical advice, nor the practice of medicine. Application of a medical policy to determine coverage in an individual instance is not intended and shall not be construed to supercede the professional judgment of a treating provider. In all situations, the treating provider must use his/her professional judgment to provide care he/she believes to be in the best interest of the patient, and the provider and patient remain responsible for all treatment decisions.
Highmark Blue Cross Blue Shield Delaware retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark Blue Cross Blue Shield Delaware. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.
