Transcranial Magnetic Stimulation (TMS) (DL32220)
Contractor Information
|
Contractor Name Wisconsin Physicians Service Insurance Corporation |
Contractor Number 00951, 00952, 00953, 00954, 52280, 05101, 05201, 05301, 05401, 05102, 05202, 05302, 05402 |
Contractor Type Carrier - FI - MAC |
LCD Information
Document Information
DL32220 LCD Title Transcranial Magnetic Stimulation (TMS) Contractor's Determination Number NEURO-010 AMA CPT/ADA CDT Copyright Statement CPT codes, descriptions and other data only are copyright 2010 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply. |
Primary Geographic Jurisdiction
Oversight Region Original Determination Effective Date Original Determination Ending Date Revision Effective Date Revision Ending Date |
CMS National Coverage Policy
CMS IOM Publication 100-1
SSA §1816 & 1842 Contractor responsibility for determination of medically reasonable and necessary services, items
1862 (a)(1)(A) Medically Reasonable & Necessary.
1862 (a)(1)(D)&(E) Investigational or Experimental.
SSA §1816 & 1842 Contractor responsibility for determination of medically reasonable and necessary services, items
1862 (a)(1)(A) Medically Reasonable & Necessary.
1862 (a)(1)(D)&(E) Investigational or Experimental.
Indications and Limitations of Coverage and/or Medical Necessity
Transcranial
magnetic stimulation (TMS) is a noninvasive method of brain
stimulation. The technique involves placement of a small coil over the
scalp and passing a rapidly alternating current through the coil wire
which produces a magnetic field that passes unimpeded through the brain.
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. The procedure is usually carried out in an outpatient
setting and does not require anesthesia or analgesia.
Transcranial magnetic stimulation has been investigated in the treatment of various disorders, primarily depression. In 2008 the U.S. Food and Drug Administration (FDA) granted 510(k) marketing clearance as a de novo device (assessed as low risk, no predicate device) for NeuroStar® TMS to be utilized as a Class II rTMS device for the treatment of major depressive disorder in patients who had not responded to one adequate trial of antidepressant medication. A 510(k) designation means a device is the equivalent to something already on the market that was "grandfathered in" by the Federal Drug Administration (FDA). This is not the same as FDA approval. Under section 510(k), a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective: that it is, substantially equivalent, to a legally marketed device (that is not subject to PMA). Such a reference device is a legally marketed device that was legally marketed prior to May 28, 1976 (preamendments device), for which a PMA is not required, or a device which has been reclassified from Class III to Class II or I, or a device which has been found SE through the 510(k) process. The term "preamendments device" refers to devices legally marketed in the U.S. by a firm before May 28, 1976 which are exempted (with some conditions) form marketing clearance. Thus, 510(k) clearance does not mean that a device works: it means that it is just as good (or as bad) as a device that came on to the market before the FDA changed its standards. 510(k) clearance does NOT mean the device is safe, effective, or covered by Medicare.
This is a non-coverage policy for the FDA-approved indication of repetitive transcranial magnetic stimulation for the treatment of major depression and any off-label uses.
Rationale/Review of Literature
Blue Cross Blue Shield TEC Assessments. Transcranial Magnetic Stimulation for Depression (October 2009, In Press, April 2011): The Blue Cross and Blue Shield Association performed an extensive literature review to evaluate the efficacy of transcranial magnetic stimulation for depression and published its findings as a TEC Assessment in 2009. The Blue Cross and Blue Shield Association Medical Advisory Panel concluded that "transcranial magnetic stimulation for the treatment of depression does not meet the TEC criteria." In 2011 an updated report was issued. Literature was reviewed through January 2011 and meta-analyses of sham-controlled studies of TMS were selected for review to determine whether TMS therapy was effective for the treatment of depression.
The authors concluded:
Although the meta-analyses and recent clinical trials of TMS generally show statistically significant effects on depression outcomes at the end of the TMS treatment period (1-4 weeks), there is a lack of rigorous evaluation beyond the period of treatment. Therefore, the Advisory Panel concluded that "the available evidence does not permit conclusions regarding the effect of TMS on health outcomes or compared with alternatives." (Blue Cross BlueShield TEC Assessment, Transcranial Magnetic Stimulation for Depression. In Press, April 2011)
O'Reardon (2007) conducted a study under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to determine whether repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) was effective and safe.
Three hundred and one (301) patients with major depressive disorder (MDD) were enrolled at 23 study sites and randomized to either active or sham rTMS. Treatment and rating personnel were blinded to patient assignments. Eligible patients were antidepressant medication-free, aged 18-70, with a single or recurrent MDD episode and a current MDD episode duration of three (3) years or less. Treatments occurred daily five days a week for six (6) weeks followed by a tapering period of three additional weeks during which time patients were begun on an antidepressant. Subjects achieving less than a 25% reduction on the Hamilton Depression Rating Scale-17 (HAMD-17) at four weeks could crossover to an open-label, acute treatment extension study. The primary outcome was the difference between active and sham TMS using the last visit Montgomery-Asberg Depression Rating Scale (MADRS). Secondary outcomes included changes on the 17- and 24-item Hamilton Depression Rating Scale and response and remission rates using the MADRS and HAMD.
At the primary efficacy point of four weeks, the baseline to endpoint change on both the HAMD-17 and the HAMD-24 but not the MADRS showed a significant improvement for the active rTMS group. The result was sustained at six weeks. Significant response rates (> 50% improvement from baseline) were present at four and six weeks for the active treatment group using each of the three scales (HAMD-17, HAMD-24, and MARDS). A significant difference in remission rates did not occur at four weeks but was higher for the active group at six weeks for the MARDS and HAMD-24.
Limitations of the study included the period of randomization lasting only through the first four weeks of the study with 74 (47.7%) in the active group and 92 (63.0%) in the sham group electing to enter the open-label extension study; no follow-up after the study; and the study was supported by the manufacturer.
Avery (2008) reported on the results of the open-label study summarized immediately above [O'Reardon (2007)]. Non-responders at four weeks could enroll in a second six-week extension trial of open-label rTMS at each of the 23 treatment sites. The first six-week phase of the study was anti-depressant free followed by a three-week rTMS taper phase with initiation of one of 15 different antidepressants. During the taper phase rTMS was delivered three, two and one time in the first, second and third weeks, respectively. As noted above, 166 patients entered the study but only 158 were present for at least one post-baseline observation, 73 of whom had been in the active arm and 85 in the sham. The primary efficacy outcome was the change in total score on the MADRS from the start of the open-label phase to six weeks or study endpoint. Secondary outcome measures included the HAMD-17 and HAMD-24. Remission was defined as a score <10 on the MARDS, <8 on the HAMD-17, or <11 on the HAMD-24. Improvement was noted in both groups over the six-week active and the three-week taper periods. Response was defined as > 50% reduction from baseline. Remission at the end of the taper phase was achieved by 30.6% using MARDS and 36.7% using the HADM-24. Study limitations included its open-label design and a probabilistic surface anatomy approach for magnet positioning.
George et al (2010) conducted a National Institutes of Health-sponsored, industry-independent sham controlled randomized trial to test whether daily left prefrontal rTMS safely and effectively treats major depressive disorder. This was a prospective, multisite, randomized, active sham-controlled (1:1 randomization), duration-adaptive design with 3 weeks of daily weekday treatments (fixed-dose phase) followed by continued blinded treatment for up to 3 weeks for improvers. Study participants were all antidepressant drug-free with unipolar nonpsychotic major depressive disorder. One hundred ninety patients entered the intention-to-treat group from approximately 860 screened patients. The group had an average of 1.5 failed research-quality adequate treatment trials and study participants were considered to be moderately treatment resistant. The major goal of this study was to assess whether active, compared with sham rTMS increased the remission rate during phase 1 of the rTSM.
The authors concluded:
Daily left prefrontal rTMS as monotherapy produced statistically significant and clinically meaningful antidepressant therapeutic effects greater than sham. The odds of attaining remission were 4.2 times greater with active rTMS than with sham (95% confidence interval, 1.21-13.24). The number needed to treat was 12. Study strengths included the successful blinding of patients, those providing the treatment and clinical raters to the randomization status of the study participants; the rigorous rater certification process; and methodological improvements over previous studies including MRI adjustment for coil placement in approximately one-third of patients. Study limitations noted included failure to enroll the projected 240 individuals suggested by the original power analysis; a patient population that was antidepressant medication free (not using rTMS in conjunction with pharmacotherapy which may have increased the positive response rate); and a treatment protocol which assessed patients after 3 weeks to determine whether there was substantial improvement. No one received treatment for a full six weeks which was the point at which O'Reardon et al (2007) found a significant difference in remission rates.
Martin et al (2003) published a systematic review and meta-analysis of data from 14 randomized controlled trials with similar rTMS delivery that compared rTMS with sham in patients with depression. The goal of the study was to assess the efficacy of rTMS in treating depression.
The authors concluded:
Current trials are of low quality and provide insufficient evidence to support the use of rTMS in the treatment of depression. Systematic and large-scale studies will be needed to identify patient populations most likely to benefit from its use and treatment parameters most likely to establish sustained response.
Schutter (2007) conducted this meta-analysis to provide an update on the clinical efficacy of fast-frequency rTMS applied to the left dorsolateral prefrontal cortex (DLPFC) for the treatment of depression. The meta-analysis included all available published clinical trials that have studied the antidepressant effects of rTMS; applied at least five treatment sessions of high-frequency rTMS over the left DLPFC; and were double-blind sham-controlled designs. Thirty double-blind sham-controlled parallel studies with 1164 patients comparing the percentage change in depression scores from baseline to endpoint of active versus sham treatment were included. Study participants' treatment must have been completed within 6 weeks after the first session. The goal of this study was to determine whether DLPFC can be considered an effective treatment method for depression.
The author concluded:
High frequency rTMS over the left DLPFC is superior to sham in the treatment of depression and the effect is comparable to at least a subset of commercially available antidepressant drug agents.
The author noted that the integrity of blinding and lack of a proper control condition, age bias, medication, suboptimal stimulation parameters, and lack of biological information and follow up assessment are study limitations which warrant caution and need to be addressed in future studies.
Lam (2008) performed a systematic review and meta-analysis of randomized controlled trials of active versus sham rTMS for patients with treatment-resistant depression (TRD). A total of 24 studies with 1092 patients were reviewed. The primary outcome was clinical response defined as either a percentage improvement on a continuous score from a depression rating scale, or by a global rating scale. Secondary outcomes included clinical remission, defined as either a score within the normal range of a depression rating scale or a global rating of not depressed or an equivalent. The definitions of TRD were not uniform. Treatment duration varied. Most studies used one to two weeks of rTMS, three used three weeks and two used four weeks. Anti-depressant medication was used in all but four studies. Follow-up was described in only eight studies.
The author concluded:
For patients with TRD, rTMS appears to provide significant benefits in short-term treatment studies. However, the relatively low response and remission rates, the short durations of treatment, and the relative lack of systematic follow-up studies suggest that further studies are needed before rTMS can be considered as a first-line monotherapy treatment for TRD.
Daskalakis et al (2008) reviewed existing literature evaluating the efficacy of rTMS for MDD and neurophysiological literature describing mechanisms through which rTMS may exert its therapeutic effect. They summarized the most important studies in 5 broad categories: first-generation studies that have evaluated the efficacy of 10 rTMS sessions (that is, 2 weeks) for TRD; second-generation studies that have evaluated the efficacy of rTMS for more than 10 rTMS sessions; third-generation studies that evaluate the efficacy of rTMS using several novel treatment approaches (for example, bilateral rTMS): meta-analytic studies of rTMS for TRD; and future studies proposing novel methods to optimize the efficacy of treatment resistant depression (TRD). Efficacy studies evaluating HFL-rTMS to date suggest that rTMS is therapeutically effective, but the magnitude of this clinical effect remains in question. All meta-analyses reviewed by the authors included treatment studies with several limitations including an inconsistent means of defining and quantifying treatment resistance; inconsistency regarding the maintenance, and diagnostic heterogeneity. Additional factors limiting current rTMS trials in MDD to date were that most of the studies involved left-sided treatment alone with the DLPFC; suboptimal methods used to target the DLPFC; treatment durations that were typically short (2-4weeks); and stimulation intensity might have been insufficient by not taking into consideration coil-to-cortex distance which is of particular importance when considering that this parameter may contribute significantly to the rTMS-induced antidepressant response. Another concern was the link between the severity of the MDD symptoms and placebo response. There is evidence to suggest that when subjects with more severe depressive symptoms have lower placebo response rates. In studies that include subjects experiencing mild-to-moderate depressive symptoms, placebo response rates are anticipated to be as high as 50%, potentially undermining the benefits of rTMS.
The authors concluded:
Although rTMS was demonstrated in several studies and meta-analyses to be a promising and effective treatment tool for resistant depression, the clinical efficacy is often modest and varies widely between treatment studies. Future studies designed to directly target brain regions associated with depression, to further evaluate bilateral stimulation and to optimize treatment duration intensity are necessary to optimize the efficacy of this treatment for resistant depression.
Summary
A number of studies have shown a short-term treatment benefit for patients with a major depressive disorder receiving active versus sham rTMS. "Treatment benefit" has been defined by response or remission rates using depression rating scales. The literature has the following limitations:
Therefore, the evidence is insufficient to determine rTMS improves health outcomes in the Medicare or general population.
Other Comments:
Bill type codes only apply to providers who bill these services to the fiscal intermediary or Part A MAC. Bill type codes do not apply to physicians, other professionals and suppliers who bill these services to the carrier or Part B MAC.
Limitation of liability and refund requirements apply when denials are likely, whether based on medical necessity or other coverage reasons. The provider/supplier must notify the beneficiary in writing, prior to rendering the service, if the provider/supplier is aware that the test, item or procedure may not be covered by Medicare. The limitation of liability and refund requirements do not apply when the test, item or procedure is statutorily excluded, has no Medicare benefit category or is rendered for screening purposes.
Transcranial magnetic stimulation has been investigated in the treatment of various disorders, primarily depression. In 2008 the U.S. Food and Drug Administration (FDA) granted 510(k) marketing clearance as a de novo device (assessed as low risk, no predicate device) for NeuroStar® TMS to be utilized as a Class II rTMS device for the treatment of major depressive disorder in patients who had not responded to one adequate trial of antidepressant medication. A 510(k) designation means a device is the equivalent to something already on the market that was "grandfathered in" by the Federal Drug Administration (FDA). This is not the same as FDA approval. Under section 510(k), a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective: that it is, substantially equivalent, to a legally marketed device (that is not subject to PMA). Such a reference device is a legally marketed device that was legally marketed prior to May 28, 1976 (preamendments device), for which a PMA is not required, or a device which has been reclassified from Class III to Class II or I, or a device which has been found SE through the 510(k) process. The term "preamendments device" refers to devices legally marketed in the U.S. by a firm before May 28, 1976 which are exempted (with some conditions) form marketing clearance. Thus, 510(k) clearance does not mean that a device works: it means that it is just as good (or as bad) as a device that came on to the market before the FDA changed its standards. 510(k) clearance does NOT mean the device is safe, effective, or covered by Medicare.
This is a non-coverage policy for the FDA-approved indication of repetitive transcranial magnetic stimulation for the treatment of major depression and any off-label uses.
Rationale/Review of Literature
Blue Cross Blue Shield TEC Assessments. Transcranial Magnetic Stimulation for Depression (October 2009, In Press, April 2011): The Blue Cross and Blue Shield Association performed an extensive literature review to evaluate the efficacy of transcranial magnetic stimulation for depression and published its findings as a TEC Assessment in 2009. The Blue Cross and Blue Shield Association Medical Advisory Panel concluded that "transcranial magnetic stimulation for the treatment of depression does not meet the TEC criteria." In 2011 an updated report was issued. Literature was reviewed through January 2011 and meta-analyses of sham-controlled studies of TMS were selected for review to determine whether TMS therapy was effective for the treatment of depression.
The authors concluded:
Although the meta-analyses and recent clinical trials of TMS generally show statistically significant effects on depression outcomes at the end of the TMS treatment period (1-4 weeks), there is a lack of rigorous evaluation beyond the period of treatment. Therefore, the Advisory Panel concluded that "the available evidence does not permit conclusions regarding the effect of TMS on health outcomes or compared with alternatives." (Blue Cross BlueShield TEC Assessment, Transcranial Magnetic Stimulation for Depression. In Press, April 2011)
O'Reardon (2007) conducted a study under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to determine whether repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) was effective and safe.
Three hundred and one (301) patients with major depressive disorder (MDD) were enrolled at 23 study sites and randomized to either active or sham rTMS. Treatment and rating personnel were blinded to patient assignments. Eligible patients were antidepressant medication-free, aged 18-70, with a single or recurrent MDD episode and a current MDD episode duration of three (3) years or less. Treatments occurred daily five days a week for six (6) weeks followed by a tapering period of three additional weeks during which time patients were begun on an antidepressant. Subjects achieving less than a 25% reduction on the Hamilton Depression Rating Scale-17 (HAMD-17) at four weeks could crossover to an open-label, acute treatment extension study. The primary outcome was the difference between active and sham TMS using the last visit Montgomery-Asberg Depression Rating Scale (MADRS). Secondary outcomes included changes on the 17- and 24-item Hamilton Depression Rating Scale and response and remission rates using the MADRS and HAMD.
At the primary efficacy point of four weeks, the baseline to endpoint change on both the HAMD-17 and the HAMD-24 but not the MADRS showed a significant improvement for the active rTMS group. The result was sustained at six weeks. Significant response rates (> 50% improvement from baseline) were present at four and six weeks for the active treatment group using each of the three scales (HAMD-17, HAMD-24, and MARDS). A significant difference in remission rates did not occur at four weeks but was higher for the active group at six weeks for the MARDS and HAMD-24.
Limitations of the study included the period of randomization lasting only through the first four weeks of the study with 74 (47.7%) in the active group and 92 (63.0%) in the sham group electing to enter the open-label extension study; no follow-up after the study; and the study was supported by the manufacturer.
Avery (2008) reported on the results of the open-label study summarized immediately above [O'Reardon (2007)]. Non-responders at four weeks could enroll in a second six-week extension trial of open-label rTMS at each of the 23 treatment sites. The first six-week phase of the study was anti-depressant free followed by a three-week rTMS taper phase with initiation of one of 15 different antidepressants. During the taper phase rTMS was delivered three, two and one time in the first, second and third weeks, respectively. As noted above, 166 patients entered the study but only 158 were present for at least one post-baseline observation, 73 of whom had been in the active arm and 85 in the sham. The primary efficacy outcome was the change in total score on the MADRS from the start of the open-label phase to six weeks or study endpoint. Secondary outcome measures included the HAMD-17 and HAMD-24. Remission was defined as a score <10 on the MARDS, <8 on the HAMD-17, or <11 on the HAMD-24. Improvement was noted in both groups over the six-week active and the three-week taper periods. Response was defined as > 50% reduction from baseline. Remission at the end of the taper phase was achieved by 30.6% using MARDS and 36.7% using the HADM-24. Study limitations included its open-label design and a probabilistic surface anatomy approach for magnet positioning.
George et al (2010) conducted a National Institutes of Health-sponsored, industry-independent sham controlled randomized trial to test whether daily left prefrontal rTMS safely and effectively treats major depressive disorder. This was a prospective, multisite, randomized, active sham-controlled (1:1 randomization), duration-adaptive design with 3 weeks of daily weekday treatments (fixed-dose phase) followed by continued blinded treatment for up to 3 weeks for improvers. Study participants were all antidepressant drug-free with unipolar nonpsychotic major depressive disorder. One hundred ninety patients entered the intention-to-treat group from approximately 860 screened patients. The group had an average of 1.5 failed research-quality adequate treatment trials and study participants were considered to be moderately treatment resistant. The major goal of this study was to assess whether active, compared with sham rTMS increased the remission rate during phase 1 of the rTSM.
The authors concluded:
Daily left prefrontal rTMS as monotherapy produced statistically significant and clinically meaningful antidepressant therapeutic effects greater than sham. The odds of attaining remission were 4.2 times greater with active rTMS than with sham (95% confidence interval, 1.21-13.24). The number needed to treat was 12. Study strengths included the successful blinding of patients, those providing the treatment and clinical raters to the randomization status of the study participants; the rigorous rater certification process; and methodological improvements over previous studies including MRI adjustment for coil placement in approximately one-third of patients. Study limitations noted included failure to enroll the projected 240 individuals suggested by the original power analysis; a patient population that was antidepressant medication free (not using rTMS in conjunction with pharmacotherapy which may have increased the positive response rate); and a treatment protocol which assessed patients after 3 weeks to determine whether there was substantial improvement. No one received treatment for a full six weeks which was the point at which O'Reardon et al (2007) found a significant difference in remission rates.
Martin et al (2003) published a systematic review and meta-analysis of data from 14 randomized controlled trials with similar rTMS delivery that compared rTMS with sham in patients with depression. The goal of the study was to assess the efficacy of rTMS in treating depression.
The authors concluded:
Current trials are of low quality and provide insufficient evidence to support the use of rTMS in the treatment of depression. Systematic and large-scale studies will be needed to identify patient populations most likely to benefit from its use and treatment parameters most likely to establish sustained response.
Schutter (2007) conducted this meta-analysis to provide an update on the clinical efficacy of fast-frequency rTMS applied to the left dorsolateral prefrontal cortex (DLPFC) for the treatment of depression. The meta-analysis included all available published clinical trials that have studied the antidepressant effects of rTMS; applied at least five treatment sessions of high-frequency rTMS over the left DLPFC; and were double-blind sham-controlled designs. Thirty double-blind sham-controlled parallel studies with 1164 patients comparing the percentage change in depression scores from baseline to endpoint of active versus sham treatment were included. Study participants' treatment must have been completed within 6 weeks after the first session. The goal of this study was to determine whether DLPFC can be considered an effective treatment method for depression.
The author concluded:
High frequency rTMS over the left DLPFC is superior to sham in the treatment of depression and the effect is comparable to at least a subset of commercially available antidepressant drug agents.
The author noted that the integrity of blinding and lack of a proper control condition, age bias, medication, suboptimal stimulation parameters, and lack of biological information and follow up assessment are study limitations which warrant caution and need to be addressed in future studies.
Lam (2008) performed a systematic review and meta-analysis of randomized controlled trials of active versus sham rTMS for patients with treatment-resistant depression (TRD). A total of 24 studies with 1092 patients were reviewed. The primary outcome was clinical response defined as either a percentage improvement on a continuous score from a depression rating scale, or by a global rating scale. Secondary outcomes included clinical remission, defined as either a score within the normal range of a depression rating scale or a global rating of not depressed or an equivalent. The definitions of TRD were not uniform. Treatment duration varied. Most studies used one to two weeks of rTMS, three used three weeks and two used four weeks. Anti-depressant medication was used in all but four studies. Follow-up was described in only eight studies.
The author concluded:
For patients with TRD, rTMS appears to provide significant benefits in short-term treatment studies. However, the relatively low response and remission rates, the short durations of treatment, and the relative lack of systematic follow-up studies suggest that further studies are needed before rTMS can be considered as a first-line monotherapy treatment for TRD.
Daskalakis et al (2008) reviewed existing literature evaluating the efficacy of rTMS for MDD and neurophysiological literature describing mechanisms through which rTMS may exert its therapeutic effect. They summarized the most important studies in 5 broad categories: first-generation studies that have evaluated the efficacy of 10 rTMS sessions (that is, 2 weeks) for TRD; second-generation studies that have evaluated the efficacy of rTMS for more than 10 rTMS sessions; third-generation studies that evaluate the efficacy of rTMS using several novel treatment approaches (for example, bilateral rTMS): meta-analytic studies of rTMS for TRD; and future studies proposing novel methods to optimize the efficacy of treatment resistant depression (TRD). Efficacy studies evaluating HFL-rTMS to date suggest that rTMS is therapeutically effective, but the magnitude of this clinical effect remains in question. All meta-analyses reviewed by the authors included treatment studies with several limitations including an inconsistent means of defining and quantifying treatment resistance; inconsistency regarding the maintenance, and diagnostic heterogeneity. Additional factors limiting current rTMS trials in MDD to date were that most of the studies involved left-sided treatment alone with the DLPFC; suboptimal methods used to target the DLPFC; treatment durations that were typically short (2-4weeks); and stimulation intensity might have been insufficient by not taking into consideration coil-to-cortex distance which is of particular importance when considering that this parameter may contribute significantly to the rTMS-induced antidepressant response. Another concern was the link between the severity of the MDD symptoms and placebo response. There is evidence to suggest that when subjects with more severe depressive symptoms have lower placebo response rates. In studies that include subjects experiencing mild-to-moderate depressive symptoms, placebo response rates are anticipated to be as high as 50%, potentially undermining the benefits of rTMS.
The authors concluded:
Although rTMS was demonstrated in several studies and meta-analyses to be a promising and effective treatment tool for resistant depression, the clinical efficacy is often modest and varies widely between treatment studies. Future studies designed to directly target brain regions associated with depression, to further evaluate bilateral stimulation and to optimize treatment duration intensity are necessary to optimize the efficacy of this treatment for resistant depression.
Summary
A number of studies have shown a short-term treatment benefit for patients with a major depressive disorder receiving active versus sham rTMS. "Treatment benefit" has been defined by response or remission rates using depression rating scales. The literature has the following limitations:
- The dorsal lateral prefrontal cortex (DLPFC) is presumed to be the treatment target area of the brain. There is some question whether the "standard procedure" used for coil placement is sufficiently precise (Herwig, 2001). Recent work is exploring methods to address coil placement (Fitzgerald, (2009; Herbsman, 2009).
- Stimulation parameters vary and the optimal treatment has not been determined. High-frequency left-sided TMS (HFL-TMS), high-frequency right-sided TMS (HFR-TMS), low-frequency right-sided TMS (LFR-TMS), low-frequency left-sided TMS (LFL-TMS) and bilateral TMS involving LFR-TMS and HFL-TMS have been used.
- Definitive patient selection criteria have not been determined. Non-response to one or more six-week trials of antidepressant therapy as well as duration of major depressive episode has varied among study participants.
- Study populations have usually been small, < 100 patients.
- Studies vary in the concomitant use of anti-depressants.
- The optimal treatment duration is not known. Most studies have short treatment periods, varying from one to four weeks. More recently there have been studies of six weeks or longer.
- Few studies have included patient follow-up and when performed, is short.
Therefore, the evidence is insufficient to determine rTMS improves health outcomes in the Medicare or general population.
Other Comments:
Bill type codes only apply to providers who bill these services to the fiscal intermediary or Part A MAC. Bill type codes do not apply to physicians, other professionals and suppliers who bill these services to the carrier or Part B MAC.
Limitation of liability and refund requirements apply when denials are likely, whether based on medical necessity or other coverage reasons. The provider/supplier must notify the beneficiary in writing, prior to rendering the service, if the provider/supplier is aware that the test, item or procedure may not be covered by Medicare. The limitation of liability and refund requirements do not apply when the test, item or procedure is statutorily excluded, has no Medicare benefit category or is rendered for screening purposes.
Coding Information
Bill Type Codes:
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
| 013x | Hospital Outpatient |
| 023x | Skilled Nursing - Outpatient |
| 071x | Clinic - Rural Health |
| 073x | Clinic - Freestanding |
| 077x | Clinic - Federally Qualified Health Center (FQHC) |
| 085x | Critical Access Hospital |
Revenue Codes:
CPT/HCPCS Codes
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
| 0900 | Behavioral Health Treatment/Services - General Classification |
| 90867 | THERAPEUTIC REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION TREATMENT; PLANNING |
| 90868 | THERAPEUTIC REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION TREATMENT; DELIVERY AND MANAGEMENT, PER SESSION |
ICD-9 Codes that Support Medical Necessity
| XX000 | Not Applicable |
Diagnoses that Support Medical Necessity
ICD-9 Codes that DO NOT Support Medical Necessity
ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation
Diagnoses that DO NOT Support Medical Necessity
General Information
Avery DH, Isenberg
KE, Sampson SM, et al. Transcranial magnetic stimulation in the acute
treatment of major depression: clinical response in an open-label
extension trial. J Clin Psychiatry. 2008;6(3):441-451
Blue Cross Blue Shield Association (BCBSA). Technology Evaluation Center (TEC). Transcranial magnetic stimulation for depression. TEC Assessment Program. Chicago, IL:BCBSA. 2009:24(5). http://www.bcbs.com/blueresources/TEC/press/transcranial-magnetic.html. Accessed 04/28/2011.
Blue Cross Blue Shield Association (BCBSA). Technology Evaluation Center (TEC). Transcranial magnetic stimulation for depression. TEC Assessments in Press. April 2011. http://www.bcbs.com/blueresources/TEC/press/transcranial-magnetic.html. Accessed 04/28/2011.
CIGNA Medical Policy Transcranial Magnetic Stimulation updated 01/15/2011.
Clinical Trials Search of Transcranial Magnetic Stimulation/Depression found 9 new studies with 8 recruiting patients and 1 study not yet recruiting. http://www.clinicaltrias.gov/ct2/results?term=Transcranial+Magnetic+Stimulation&recr=&rslt.
Accessed 04/26/2011.
Couturier JL. Efficacy of rapid-rate repetitive transcranial magnetic stimulation in the treatment of depression: a systematic review and meta-analysis. J Psychiatry Neurosci. 2005;30(2):83-90.
Daskalakis ZJ, Levinson AJ, Fitzgerald PB. Repetitive transcranial magnetic stimulation for major depressive disorder. A review. Can J Psychiatry. 2008;53(9):555-566.
Fitzgerald PB, Hoy K, McQueen S, et al. A randomized trial of rTMS targeted with MRI based neuro-navigation in treatment-resistant depression. Neuropsycholpharmacology. 2009;34(5):1255-1262.
George MS, Lisanby SH, Avery D, et al. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder. A sham-controlled randomized trial. Arch Gen Psychiatry. 2010;60(5)5007-516.
Gross M, Nakamura L, Pascual-Leone A, Fregni F. Has repetitive transcranial magnetic stimulation (rTMS) treatment for depression improved? A systematic review and meta-analysis comparing the recent vs. the earlier rTMS studies. Acta Psychiatr Scand. 2007;116:165-73.
Hayes Inc. Evaluating the efficacy of transcranial magnetic stimulation to treat major depression. Hayes Overview. Lansdale, PA; Hayes, May 25, 2010.
Herbsman T, Avery D. Ramsey D, et al. More lateral and anterior prefrontal coil location is associated with better repetitive transcranial magnetic stimulation antidepressant response. Biol Psychiatry. 2009;66(5):509-515.
Lam RW, Chan P, Wilkins-Ho M, Yatham LN. Repetitive transcranial magnetic stimulation for treatment-resistant depression: a systematic review and metaanalysis. Can J Psychiatry. 2008;53:621-631.
Lisanby SH, Husain MM, Rosenquist PB, et al. Daily left prefrontal repetitive transcranial magnetic stimulation in the acute treatment of major depression: clinical predictors of outcome in a multisite, randomized controlled clinical trial. Neuropsychopharmacology. 2009;34:522-534.
Loo CK, McFarquhar TF, Mitchell PB. A review of the safety of repetitive transcranial magnetic stimulation as a clinical treatment for depression. Int J Neuropsychopharmacol. 2008;11(1):131-147.
Martin JL, Barbanoj MJ, Schlaepfer TE, et al. Repetitive transcranial magnetic stimulation for the treatment of depression. Systematic review and meta-analysis. Br J Psychiatry. 2003;182:480-491.
O'Reardon JP, Solvason HB, Janicak PG et al. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007;62:1208-1216.
Other Medicare contractors' Non-Covered Services LCDs - First Coast Service Options (L29023); Noridian Administrative Services, LLC (L24471); Trailblazer Health Enterprises, LLC (L26811).
Rodriguez-Martin JL, Barbanoj JM, Schlaepfer TE, Clos SSC, Pérez V, Kulisevsky J, Gironelli A. Transcranial magnetic stimulation for treating depression. Cochrane Database of Systematic Reviews 2001, Issue 4. Art. No.: CD003493. DOI:10.1002/14651858.CD003493. Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. http://www.thecochranelibrary.com. Accessed 04/28/2011.
Rush AJ, Trivedi MY, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006;163:1905-1917.
Schutter DJ. Antidepressant efficacy of high frequency transcranial magnetic stimulation over the left dorsolateral prefrontal cortex in double-blind sham controlled designs: a meta-analysis. Psychol Med. 2009;39:65-75.
The Regance Group. Medical Policy -Transcranial Magnetic Stimulation as a Treatment of Depression and Other Disorders. Policy No. 17. Updated 03/01/2011.
Uwe H, Padberg F, Unger J, Spitzer M, and Schonfeldt-Lecuona S. Transcranial magnetic stimulation in therapy studies: examination of the reliability of "standard" coil positioning by neuronavigation. Biol Psychiatry. 20001;50:58-61.
UnitedHealthCare Medical Policy 2011T0536B effective January 1, 2011. Transcranial Magnetic Stimulation. https://www.unitedhealthcareonline.com. Accessed 04/28/2011.
U.S. Food and Drug Administration (2007) Neurological Devices Panel of the Medical Devices Advisory Committee. January 26, 2007. FDA Executive Summary. http://www.fda.gov/AdvisoryCommittees/CommitteesMetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommitteee/NeurologicalDevices Panel/ucm124779.htm.
Accessed 04/28/2011.
Wellpoint Medical Policy BEH.00002 (2010, November 18) Transcranial magnetic stimulation for depression and other neuropsychiatric disorders. Retrieved from the internet 07/22/2011
Advisory Committee Meeting Notes
Blue Cross Blue Shield Association (BCBSA). Technology Evaluation Center (TEC). Transcranial magnetic stimulation for depression. TEC Assessment Program. Chicago, IL:BCBSA. 2009:24(5). http://www.bcbs.com/blueresources/TEC/press/transcranial-magnetic.html. Accessed 04/28/2011.
Blue Cross Blue Shield Association (BCBSA). Technology Evaluation Center (TEC). Transcranial magnetic stimulation for depression. TEC Assessments in Press. April 2011. http://www.bcbs.com/blueresources/TEC/press/transcranial-magnetic.html. Accessed 04/28/2011.
CIGNA Medical Policy Transcranial Magnetic Stimulation updated 01/15/2011.
Clinical Trials Search of Transcranial Magnetic Stimulation/Depression found 9 new studies with 8 recruiting patients and 1 study not yet recruiting. http://www.clinicaltrias.gov/ct2/results?term=Transcranial+Magnetic+Stimulation&recr=&rslt.
Accessed 04/26/2011.
Couturier JL. Efficacy of rapid-rate repetitive transcranial magnetic stimulation in the treatment of depression: a systematic review and meta-analysis. J Psychiatry Neurosci. 2005;30(2):83-90.
Daskalakis ZJ, Levinson AJ, Fitzgerald PB. Repetitive transcranial magnetic stimulation for major depressive disorder. A review. Can J Psychiatry. 2008;53(9):555-566.
Fitzgerald PB, Hoy K, McQueen S, et al. A randomized trial of rTMS targeted with MRI based neuro-navigation in treatment-resistant depression. Neuropsycholpharmacology. 2009;34(5):1255-1262.
George MS, Lisanby SH, Avery D, et al. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder. A sham-controlled randomized trial. Arch Gen Psychiatry. 2010;60(5)5007-516.
Gross M, Nakamura L, Pascual-Leone A, Fregni F. Has repetitive transcranial magnetic stimulation (rTMS) treatment for depression improved? A systematic review and meta-analysis comparing the recent vs. the earlier rTMS studies. Acta Psychiatr Scand. 2007;116:165-73.
Hayes Inc. Evaluating the efficacy of transcranial magnetic stimulation to treat major depression. Hayes Overview. Lansdale, PA; Hayes, May 25, 2010.
Herbsman T, Avery D. Ramsey D, et al. More lateral and anterior prefrontal coil location is associated with better repetitive transcranial magnetic stimulation antidepressant response. Biol Psychiatry. 2009;66(5):509-515.
Lam RW, Chan P, Wilkins-Ho M, Yatham LN. Repetitive transcranial magnetic stimulation for treatment-resistant depression: a systematic review and metaanalysis. Can J Psychiatry. 2008;53:621-631.
Lisanby SH, Husain MM, Rosenquist PB, et al. Daily left prefrontal repetitive transcranial magnetic stimulation in the acute treatment of major depression: clinical predictors of outcome in a multisite, randomized controlled clinical trial. Neuropsychopharmacology. 2009;34:522-534.
Loo CK, McFarquhar TF, Mitchell PB. A review of the safety of repetitive transcranial magnetic stimulation as a clinical treatment for depression. Int J Neuropsychopharmacol. 2008;11(1):131-147.
Martin JL, Barbanoj MJ, Schlaepfer TE, et al. Repetitive transcranial magnetic stimulation for the treatment of depression. Systematic review and meta-analysis. Br J Psychiatry. 2003;182:480-491.
O'Reardon JP, Solvason HB, Janicak PG et al. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007;62:1208-1216.
Other Medicare contractors' Non-Covered Services LCDs - First Coast Service Options (L29023); Noridian Administrative Services, LLC (L24471); Trailblazer Health Enterprises, LLC (L26811).
Rodriguez-Martin JL, Barbanoj JM, Schlaepfer TE, Clos SSC, Pérez V, Kulisevsky J, Gironelli A. Transcranial magnetic stimulation for treating depression. Cochrane Database of Systematic Reviews 2001, Issue 4. Art. No.: CD003493. DOI:10.1002/14651858.CD003493. Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. http://www.thecochranelibrary.com. Accessed 04/28/2011.
Rush AJ, Trivedi MY, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006;163:1905-1917.
Schutter DJ. Antidepressant efficacy of high frequency transcranial magnetic stimulation over the left dorsolateral prefrontal cortex in double-blind sham controlled designs: a meta-analysis. Psychol Med. 2009;39:65-75.
The Regance Group. Medical Policy -Transcranial Magnetic Stimulation as a Treatment of Depression and Other Disorders. Policy No. 17. Updated 03/01/2011.
Uwe H, Padberg F, Unger J, Spitzer M, and Schonfeldt-Lecuona S. Transcranial magnetic stimulation in therapy studies: examination of the reliability of "standard" coil positioning by neuronavigation. Biol Psychiatry. 20001;50:58-61.
UnitedHealthCare Medical Policy 2011T0536B effective January 1, 2011. Transcranial Magnetic Stimulation. https://www.unitedhealthcareonline.com. Accessed 04/28/2011.
U.S. Food and Drug Administration (2007) Neurological Devices Panel of the Medical Devices Advisory Committee. January 26, 2007. FDA Executive Summary. http://www.fda.gov/AdvisoryCommittees/CommitteesMetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommitteee/NeurologicalDevices Panel/ucm124779.htm.
Accessed 04/28/2011.
Wellpoint Medical Policy BEH.00002 (2010, November 18) Transcranial magnetic stimulation for depression and other neuropsychiatric disorders. Retrieved from the internet 07/22/2011
Meeting Date:
Wisconsin 09/23/2011
Illinois 09/21/2011
Michigan 09/14/2011
Minnesota 09/14/2011
J5 10/06/2011
Open Meeting Date:
09/01/2011
This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the MAC contractor this policy was developed in cooperation with advisory groups which include representatives from various specialties, and adapted for the purpose of converting to MAC jurisdiction.
Start Date of Comment Period
Wisconsin 09/23/2011
Illinois 09/21/2011
Michigan 09/14/2011
Minnesota 09/14/2011
J5 10/06/2011
Open Meeting Date:
09/01/2011
This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the MAC contractor this policy was developed in cooperation with advisory groups which include representatives from various specialties, and adapted for the purpose of converting to MAC jurisdiction.
10/06/2011
End Date of Comment Period
11/20/2011
Start Date of Notice Period
07/28/2011
Related Documents
This LCD has no Related Documents.
LCD Attachments
Draft CBG DL32220 NEURO-010 (PDF - 18 KB)
NOTE: Should you have landed here as a result of a search engine (or other) link, be advised that these files contain material that is copyrighted by the American Medical Association. You are forbidden to download the files unless you read, agree to, and abide by the provisions of the copyright statement. Read the copyright statement now and you will be linked back to here.
Page Last Updated: Thursday, 18-Aug-2011 12:15:51 CDT
Home |
Web Help |
Feedback |
About WPS
© Wisconsin Physicians Service Insurance Corporation | All Rights Reserved
Privacy Statement | Legal Disclaimer
