Download Transcranial Magnetic Stimulation

TRANSCRANIAL MAGNETIC
STIMULATION
HS-067
Easy Choice Health Plan, Inc.
Harmony Health Plan of Illinois, Inc.
Missouri Care, Inc.
‘Ohana Health Plan, a plan offered by
WellCare Health Insurance of Arizona, Inc.
WellCare Health Insurance of Illinois, Inc.
WellCare Health Plans of New Jersey, Inc.
WellCare Health Insurance of Arizona, Inc.
WellCare of Florida, Inc.
WellCare of Connecticut, Inc.
WellCare of Georgia, Inc.
WellCare of Kentucky, Inc.
WellCare of Louisiana, Inc.
Transcranial Magnetic
Stimulation
WellCare of New York, Inc.
WellCare of South Carolina, Inc.
WellCare of Texas, Inc.
Policy Number: HS-067
Original Effective Date: 12/4/2008
WellCare Prescription Insurance, Inc.
Windsor Health Plan
Windsor Rx Medicare Prescription Drug Plan
Revised Date(s): 12/14/2009; 12/28/2010;
12/1/2011; 12/6/2012; 12/5/2013;
12/4/2014; 7/9/2015
APPLICATION STATEMENT
The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS)
National and Local Coverage Determinations and state-specific Medicaid mandates, if any.
Clinical Coverage Guideline
Original Effective Date: 12/4/2008 - Revised: 12/14/2009, 12/28/2010, 12/1/2011, 12/6/2012, 12/5/2013, 12/4/2014, 7/9/2015
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DISCLAIMER
The Clinical Coverage Guideline is intended to supplement certain standard WellCare benefit plans. The terms of a member’s particular Benefit Plan, Evidence of
Coverage, Certificate of Coverage, etc., may differ significantly from this Coverage Position. For example, a member’s benefit plan may contain specific exclusions
related to the topic addressed in this Clinical Coverage Guideline. When a conflict exists between the two documents, the Member’s Benefit Plan always supersedes
the information contained in the Clinical Coverage Guideline. Additionally, Clinical Coverage Guidelines relate exclusively to the administration of health benefit plans
and are NOT recommendations for treatment, nor should they be used as treatment guidelines. The application of the Clinical Coverage Guideline is subject to the
benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid
mandates, if any. Note: The lines of business (LOB) are subject to change without notice; consult www.wellcare.com/Providers/CCGs for list of current LOBs.
BACKGROUND
Transcranial magnetic stimulation (TMS) was first introduced in 1985 as a new method of noninvasive stimulation of
the brain. TMS is a non-invasive method of induction of a focal current in the brain and transient modulation of the
function of the targeted cerebral cortex. This procedure entails placement of an electromagnetic coil on the scalp;
high-intensity electrical current is rapidly turned on and off in the coil through the discharge of capacitors. Depending
on stimulation parameters (frequency, intensity, pulse duration, stimulation site), repetitive TMS (rTMS) to specific
cortical regions can either increase or decrease the excitability of the affected brain structures.
POSITION STATEMENT
Applicable To:
Medicaid
Medicare
Transcranial magnetic stimulation (TMS) is considered medically necessary in adults who have a confirmed
14,15,16
diagnosis of major depressive disorder (MDD), single or recurrent episode and meet the following criteria:

Resistance to treatment as evidenced by a lack of a clinically significant response to four (4) trials of
psychopharmacologic agents in the current depressive episode;
o Two different agent classes, at or above the minimum effective dose and duration and includes trials of
at least two (2) evidence-based augmentation therapies; or
OR

Inability to tolerate psychopharmacologic agents as evidenced by four (4) trials of psychopharmacologic
agents with distinct side effects; OR

History of response to TMS in a previous depressive episode; OR

History of response to electroconvulsive therapy (ECT) in a previous or current MDD episode, or inability to
tolerate ECT, and TMS is considered a less invasive treatment option.
In addition, ALL of the following must be met:

A trial of an evidence-based psychotherapy known to be effective in the treatment of MDD of an adequate
frequency and duration without significant improvement in depressive symptoms as documented by
standardized rating scales that reliably measure depressive symptoms; AND

The TMS treatment is delivered by a device that is FDA-approved or –cleared for the treatment of MDD in a
safe and effective manner. TMS treatment should generally follow the protocol and parameters specified in
the manufacturer’s user manual, with modifications only as supported by the published scientific evidence
base; AND

The order for treatment (or retreatment) is written by a physician (MD or DO) who has examined the patient
Clinical Coverage Guideline
Original Effective Date: 12/4/2008 - Revised: 12/14/2009, 12/28/2010, 12/1/2011, 12/6/2012, 12/5/2013, 12/4/2014, 7/9/2015
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and reviewed the record. The physician must have experience in administering TMS therapy and the
treatment must be given under direct supervision of this physician, i.e., he or she must be in the area and be
immediately available.
Left Prefrontal TMS
Left prefrontal TMS is considered reasonable and necessary for patients diagnosed with severe Major
Depression (single or recurrent episode) as defined by the Diagnostic and Statistical Manual of Mental Disorders
(DSM-IV), who also have at least one of the following:




Resistance to treatment with psychopharmacologic agents as evidenced by a lack of clinically significant
response to four trials of such agents, in the current depressive episode, from at least two different agent
classes. At least one of the treatment trials must have been administered at an adequate course of mono- or
poly–drug therapy; OR
Inability to tolerate psychopharmacologic agents as evidenced by trials of four such agents with distinct side
effects; OR
History of good response to TMS in a previous episode; OR
If patient is currently receiving electro-convulsive therapy, TMS may be considered reasonable and
necessary as a less invasive treatment option.
Exclusions and Coverage Limitations
19, 20
The benefits of TMS use must be carefully considered against the risk of potential side effects in patients with any of
the following:



Seizure disorder or any history of seizure (except those induced by ECT or isolated febrile seizures in
infancy without subsequent treatment or recurrence).
The presence of vagus nerve stimulator leads in the carotid sheath.
The presence of an implanted medical device located within 30 cm from the TMS magnetic coil, including
but not limited to pacemakers, implanted defibrillators, or vagus nerve stimulators.
TMS is considered not reasonable and necessary when used as a treatment modality for patients with any of the
following:






Presence of psychotic symptoms in 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;
Dementia or other degenerative neurologic conditions such as Parkinson’s Disease or Multiple Sclerosis.
Chronic or acute psychotic disorder such as Schizophrenia, Schizophreniform Disorder, or Schizoaffective
Disorder.
Active current substance use.
TMS should not be used in patients who have conductive, ferromagnetic or other magnetic-sensitive metals
implanted in their head which are non-removable and within 30cm of the TMS magnetic coil. Examples
include cochlear implants, implanted electrodes/stimulators, aneurysm clips or coil, stents, and bullet
fragments.
Maintenance therapy is not currently supported by evidence from clinical trials and therefore, is considered not
reasonable and necessary.
Note: Dental amalgam fillings are not affected by the magnetic field and are acceptable for use with TMS.
Clinical Coverage Guideline
Original Effective Date: 12/4/2008 - Revised: 12/14/2009, 12/28/2010, 12/1/2011, 12/6/2012, 12/5/2013, 12/4/2014, 7/9/2015
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CLINICAL EVIDENCE
A total of 23 studies involving 1774 patients met criteria for review. These studies evaluated a variety of TMS
approaches, including high-frequency (≥ 1 Hz) left-sided TMS (HFL-TMS), high-frequency rightsided TMS (HFRTMS), low-frequency (≤ 1 Hz) rightsided TMS (LFR-TMS), low-frequency left-sided TMS (LFLTMS), and bilateral
TMS involving LFR-TMS followed by HFL-TMS or HFL-TMS followed by LFR-TMS. Study populations consisted of
adult patients diagnosed with major depression, major depressive episode (MDE), or major depressive disorder
(MDD) based on criteria set forth in the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-IV) and/or the Structured Clinical Interview for the DSM-IV (SCID). Several studies included some patients
with bipolar depression (Klein et al., 1999;Fitzgerald et al., 2003; Rossini et al., 2005a; Fitzgerald et al., 2006;
McDonald et al., 2006; Eranti et al., 2007; Herwig et al., 2007; Mogg et al., 2008). Most studies specified that
patients had treatment-resistant depression (TRD), failed ≥ 1 trials of antidepressant medication, or had a prolonged
current MDE that suggested treatment resistance. However, one study excluded patients with TRD (Klein et al.,
1999) and two provided no data about treatment resistance or prolonged MDE (Fregni et al., 2004; Koerselman et
al., 2004). In a meta-analysis of 16 published clinical trials, a 2002 Cochrane Review concluded there was no strong
evidence of benefit from using TMS for the treatment of depression. A major conclusion of this report was the finding
that there was no difference between TMS and sham TMS based on patient results of the Beck Depression
Inventory (BDI, BDI II) or Hamilton Depression Rating Scale (HAM-D). In addition, this review found
electroconvulsive therapy (ECT) was more effective than TMS.
American Psychiatric Association. Based on the results of a multisite randomized sham-controlled clinical trial of
high-frequency TMS over the left dorsolateral prefrontal cortex, TMS was cleared by the FDA in 2008 for use in
individuals with major depressive disorder who have not had a satisfactory response to at least one antidepressant
trial in the current episode of illness. However, another large randomized sham-controlled trial of TMS added to
antidepressant pharmacotherapy showed no significant benefit of left dorsolateral prefrontal cortex TMS. In
comparisons of actual TMS versus sham TMS, most but not all recent meta-analyses have found relatively small to
moderate benefits of TMS in terms of clinical response. Although the primary studies used in these meta-analyses
are highly overlapping and the variability in TMS stimulus parameters and treatment paradigms complicates the
interpretation of research findings, these meta-analyses also support the use of high-frequency TMS over the left
dorsolateral prefrontal cortex. Lesser degrees of treatment resistance may be associated with a better acute
response to TMS. Across all studies, TMS was well tolerated and was associated with low rates of treatment
dropout. Transient scalp discomfort and headaches were the most commonly reported side effects. In clinical
practice, the need for daily TMS could produce logistical barriers for some patients.
The published literature regarding the use of transcranial magnetic stimulation (TMS), also known as repetitive
transcranial magnetic stimulation (rTMS), for the treatment of depression and other mood disorders is comprised of
small controlled trials of limited follow-up, consisting of differing patient populations and parameters. Additional
research is needed to determine the roles of various stimulation parameters of TMS for its optimal outcome as well
as its long-term effectiveness in the treatment of depression and other neuropsychiatric disorders. Given the paucity
of evidence supporting the safety and efficacy of transcranial magnetic stimulation this procedure is considered
experimental and investigational pending further data from properly controlled and populated trials.
Centers for Medicare and Medicaid Services. Janicak et al. (2010) studied 99 patients for 24 weeks who agreed to
participate and had met the criteria for at least partial response in either the randomized [O’Reardon et al. (2007)] or openlabel extension [Avery et al. (2008)] trials. Individual site investigators and their clinical and research staff were blinded to
the original patient assignment (active or sham rTMS). All patients underwent a three-week transition off rTMS while being
started on maintenance antidepressant therapy. Only dose adjustments of the antidepressant were allowed during the
study period without switching or augmentation of the drugs. Reintroduction of rTMS was allowed if the patient had a
Clinical Global Impressions Severity of Illness (CGI-S) score change of at least one point observed over two successive
weeks. The rTMS was discontinued when the CGI-S score returned to baseline.
There were 121/142 patients who completed the transition phase and thus eligible for the 24-week study. Ninety-nine
(81.8%) agreed to participate. Twenty-one (21.2%) had received a total of 12 weeks of active rTMS. Seventy of the 99
Clinical Coverage Guideline
Original Effective Date: 12/4/2008 - Revised: 12/14/2009, 12/28/2010, 12/1/2011, 12/6/2012, 12/5/2013, 12/4/2014, 7/9/2015
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(70.7%) completed the 24-week “durability” study. Approximately 75% maintained a full response and >50% maintained
remission using either the MADRS or HAMD24 scores. Thirty-eight (38.4%) had symptom worsening and received rTMS;
32 of these 38 (84.2%) responded. A second period of reintroduction occurred for 15 patients and five (5) had a third round
of rTMS. Twenty-one additional patients who had benefited from sham rTMS also entered the durability study and received
anti-depressants. Relapse occurred in three (16.0%). Eleven of the 21 (52.4%) had reintroduction of rTMS and 5/11
(45.5%) responded. The authors note the strength of this article is that it is the only prospective, follow-up study of rTMS
acute antidepressant effects with maintenance antidepressants. Limitations noted included the lack of a controlled
comparison. Since the two groups of patients were no longer fully randomized after entry into the long-term trial, the
authors noted that inferential statistical comparisons were not appropriate. In addition, the number of sham rTMS only
patients was small.
CODING
Covered CPT®* Codes [For dates of service on or after 10/01/2015]
90867
Therapeutic repetitive transcranial magnetic stimulation treatment planning, intial
90868
Therapeutic repetitive transcranial magnetic stimulation treatment, subsequent delivery and management
per session.
90869
Therapeutic repetitive transcranial magnetic stimulation treatment, subsequent motor threshold
re-determination with delivery and management
Non-Covered CPT Category III Codes
NOTE: Effective Jan 1, 2011 Category III Codes 0160T & 0161T have been deleted. To report, see 90867, 90869.
0310T Motor function mapping using non-invasive navigates transcranial magnetic stimulation (nTMS) for
Therapeutic treatment planning, upper and lower extremity
Covered ICD-9 Diagnosis Codes [For dates of service prior to 10/01/2015]
296.23
Major depressive disorder, single episode, severe, without mention of psychotic behavior
296.33
Major depressive disorder, recurrent episode, severe, without mention of psychotic behavior
Covered ICD-10 Diagnosis Codes [For dates of service prior to 10/01/2015]
F32.2
Major depressive disorder, single episode, without psychotic features
F33.3
Major depressive disorder, recurrent, without psychotic features
*Current Procedural Terminology (CPT®) ©2015 American Medical Association: Chicago, IL.
REFERENCES
1.
Eranti, S., Mogg, A., Pluck, G., & et al. (2007). A randomized, controlled trial with 6-month follow-up of repetitive transcranial magnetic
stimulation and electroconvulsive therapy for severe depression. American Journal of Psychiatry, 164(1), 73-81.
2. Fitzgerald, P.B., Benitez, J., de Castella, A., Daskalakis, Z.J., Brown, T.L., Kulkarni, J. (2006). A randomized, controlled trial of sequential
bilateral repetitive transcranial magnetic stimulation for treatment-resistant depression. American Journal of Psychiatry, 163(1), 88-94.
3. Fitzgerald, P.B., Brown, T.L., Marston, N.A., Daskalakis, Z.J., de Castella, A., & Kulkarni, J. (2003). Transcranial magnetic stimulation in the
treatment of depression: a double-blind, placebo-controlled trial. Archives of General Psychiatry, 60(10), 1002-1008.
4. Fregni, F., Santos, C.M., Myczkowski, M.L., & et al. (2004). Repetitive transcranial magnetic stimulation is as effective as fluoxetine in the
treatment of depression in patients with Parkinson's disease. Journal of Neurology, Neurosurgery, and Psychiatry, 75(8), 1171-1174.
5. Transcranial magnetic stimulation for major depression. Hayes Directory Web site. http://www.hayesinc.com. Published March 14, 2014
(updated March 18, 2015). Accessed June 9, 2015.
6. Herwig, U., Fallgatter, A.J., Höppner, J., & et al. (2007). Antidepressant effects of augmentative transcranial magnetic stimulation:
randomized multicenter trial. British Journal of Psychiatry, 191, 441-448.
7. Klein, E., Kreinin, I., Chistyakov, A., & et al. (1999). Therapeutic efficacy of right prefrontal slow repetitive transcranial magnetic stimulation in
major depression: a double-blind controlled study. Archives of General Psychiatry,56(4), 315-320.
8. Koerselman, F., Laman, D.M., van Duijn, H., van Duijn, M.A., & Willems, M.A. (2004). A 3-month, follow-up, randomized, placebo-controlled
study of repetitive transcranial magnetic stimulation in depression. Journal of Clinical Psychiatry, 65 (10), 1323-1328.
9. McDonald, W.M., Easley, K., Byrd, E.H., & et al. (2006). Combination rapid transcranial magnetic stimulation in treatment refractory
depression. Journal of Neuropsychiatric Disease and Treatment, 2(1), 85-94.
10. Mogg, A., Pluck, G., Eranti, S.V., & et al. (2008). A randomized controlled trial with 4-month follow-up of adjunctive repetitive transcranial
magnetic stimulation of the left prefrontal cortex for depression. Psychological Medicine, 38(3), 323-333.
11. Rossini, D., Lucca, A., Zanardi, R., Magri, L., & Smeraldi, E. (2005). Transcranial magnetic stimulation in treatment-resistant depressed
Clinical Coverage Guideline
Original Effective Date: 12/4/2008 - Revised: 12/14/2009, 12/28/2010, 12/1/2011, 12/6/2012, 12/5/2013, 12/4/2014, 7/9/2015
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patients: a double-blind, placebo-controlled trial. Psychiatry Research, 137(1-2), 1-10.
12. American Psychiatric Association. (2010). Practice guideline for the treatment of patients with major depressive disorder (3rd ed.). Retrieved
from http://www.psychiatryonline.com/pracGuide/pracGuideTopic_7.aspx
13. Kaiser Permanente Care Management Institute. (2006). Depression clinical practice guidelines (revised). Retrieved from
http://www.ngc.gov/content.aspx?id=9632
14. Local coverage determination: transcranial magnetic stimulation (L32038). Centers for Medicare and Medicaid Services Web site.
http://www.cms.hhs.gov/mcd/search.asp. Published 2014. Accessed June 9, 2015.
15. Local coverage determination: transcranial magnetic stimulation (L32220). Centers for Medicare and Medicaid Services Web site.
http://www.cms.hhs.gov/mcd/search.asp. Published 2014. Accessed June 9, 2015.
16. Local coverage determination: transcranial magnetic stimulation (L33676). Centers for Medicare and Medicaid Services Web site.
http://www.cms.hhs.gov/mcd/search.asp. Published 2014. Accessed June 9, 2015.
17. Local coverage determination: transcranial magnetic stimulation (L32055). Centers for Medicare and Medicaid Services Web site.
http://www.cms.hhs.gov/mcd/search.asp. Published 2014. Accessed June 9, 2015.
18. Local coverage determination: transcranial magnetic stimulation (L33495). Centers for Medicare and Medicaid Services Web site.
http://www.cms.hhs.gov/mcd/search.asp. Published 2014. Accessed June 9, 2015.
19. Local coverage determination: transcranial magnetic stimulation (L32055). Centers for Medicare and Medicaid Services Web site.
http://www.cms.hhs.gov/mcd/search.asp. Published 2014. Accessed June 9, 2015.
20. Local coverage determination: transcranial magnetic stimulation (L33660). Centers for Medicare and Medicaid Services Web site.
http://www.cms.hhs.gov/mcd/search.asp. Published 2014. Accessed June 9, 2015.
MEDICAL POLICY COMMITTEE HISTORY AND REVISIONS
Date
Action
7/9/2015
12/4/2014, 12/5/2013, 12/6/2012
12/1/2011



Approved by MPC. Updated coding sections to allow for CPT 90867, 90868, 90869 eff. 10/1/2015.
Approved by MPC. No changes.
Approved by MPC. Reformatted references; added 10 new. Added APA 2010 update; includes TMS cleared
by FDA in 2008 for use in those with major depressive disorder. No code changes. New template approved by
MPC.
Clinical Coverage Guideline
Original Effective Date: 12/4/2008 - Revised: 12/14/2009, 12/28/2010, 12/1/2011, 12/6/2012, 12/5/2013, 12/4/2014, 7/9/2015
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