Repetitive Transcranial Magnetic Stimulation (rTMS) in Adults with Treatment Resistant Major Depressive Disorder

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Transcranial Magnetic Stimulation (TMS). Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for TMS and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:

IOM Citations:

• CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 60 Services and Supplies Furnished Incident To a Physician’s/NPP’s Professional Service.
• CMS IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 23, Section 10 Reporting ICD Diagnosis and Procedure Codes.
• CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD.

Social Security Act (Title XVIII) Standard References:

• Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.
• Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
• Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Notice: Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information
Transcranial Magnetic Stimulation (TMS) is a non-invasive treatment that uses pulsed magnetic fields to induce an electric current in a localized region of the cerebral cortex. An electromagnetic coil placed on the scalp induces focal current in the brain that temporarily modulates cerebral cortical function. Capacitor discharge provides electrical current in alternating on/off pulses. Stimulation parameters may be adjusted to alter the excitability of the targeted structures in specific cortical regions. Repetitive TMS (rTMS) has been investigated as treatment for pharmacoresistant depression.

TMS parameters include cranial location, stimulation frequency, duration, and intensity. TMS is delivered in outpatient settings without anesthesia or analgesia. Typically for the treatment of depression, the coil is located over the left prefrontal cortex. The rTMS is performed daily Monday through Friday (weekdays) for 30 treatments preferably over 6 weeks, but not to exceed 7 weeks duration. There is no need for anesthesia or analgesia and there are no restrictions about activities before or after treatment (e.g. driving, working, operating heavy machinery).

When used as an antidepressant therapy, TMS produces a clinical benefit without the systemic side effects attendant with standard oral medications. TMS does not have adverse effects on cognition. Unlike electroconvulsive therapy (ECT), rTMS does not induce amnesia or seizures.

Covered Indications

Initial Treatment
Left Prefrontal rTMS of the brain is considered medically necessary for use in an adult who meets all four of the following criteria:

1. Has a confirmed diagnosis of severe major depressive disorder (MDD) single or recurrent episode;
   
   AND
   
   
2. One or more of the following:
   
   • Resistance to treatment* with psychopharmacologic agents as evidenced by a lack of a clinically significant response to at least a single trial of psychopharmacologic agents in the current depressive episode; or
   • Inability to tolerate psychopharmacologic agents** as evidenced by two trials of psychopharmacologic agents from two different agent classes; or
   • History of response to rTMS in a previous depressive episode (see “Retreatment[s]” below for previous response criteria); or
   • A history of response to ECT in a previous or current episode or an inability to tolerate ECT, or is a candidate for, but has declined ECT and rTMS is considered a less invasive treatment option.
   
   *Resistance to treatment is defined by a failure to achieve a 50% reduction in depressive symptoms, in accordance with objective measures such as Geriatric Depression Scale (GDS), the Personal Health Questionnaire Depression Scale (PHQ-9), the Beck Depression Inventory (BDI), the Montgomery Asberg Depression Rating Scale (MADRS), the Quick Inventory of Depressive Symptomatology (QIDS), the Inventory for Depressive Symptomatology Systems Review (IDS-SR) or Hamilton Rating Scale for Depression (HAM-D), from a pharmacologic trial where the medication is administered at both an adequate dose and for an adequate period of time consistent with accepted standards of care. A dose will be considered adequate when the medication is administered consistent with the FDA label. Where starting dosage is lower than maximum recommended dosage, the dose of any medication will be considered adequate when an initial response failure is followed by titrating the dosage upwards towards the maximum recommended dosage. Where such titration does not occur, the record must document the rationale for the decision not to increase the dose. Duration of therapy will be considered adequate, when a particular medication is administered for a length of time consistent with expectations for expected response times for that medication or class of medications as defined in the medical literature supporting the efficacy of that medication or medication class and by the standard of care.
   
   **Psychopharmacologic agent side effects will be considered intolerable, when those side effects are of a nature where they are not expected to diminish or resolve with continued administration of the drug.
   
   AND
   
   
3. 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
   
   
4. The order for treatment (or retreatment) is written by a psychiatrist (MD or DO), who has examined the patient and reviewed the record. The treatment shall be given under direct supervision of a qualified physician* (physician present in the area and immediately available, but does not necessarily personally provide the treatment).
   
   *Note: Please refer to the “Provider Qualification” section for qualified physician and direct supervision requirements.

Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; subsequent motor threshold re-determination with delivery and management, is considered reasonable and necessary when there is a change in clinical status or medical regimen that is expected to alter cortical excitability. The medical record must clearly document the rationale for the performance of a motor threshold redetermination.

Retreatment(s)
Retreatment(s) may be considered medically reasonable and necessary for patients who meet all of the following criteria:

1. Patients must have met the guidelines for initial treatment and subsequently developed relapse of depressive symptoms as evidenced by a 50% worsening in the prior best response using the same rating scale (e.g., GDS, PHQ-9, BDI, HAM-D, MADRS, QIDS or IDS-SR scores).
2. Patients must have responded to prior treatments as evidenced by a greater than 50% improvement in standard rating scale measurements for depressive symptoms (e.g., GDS, PHQ-9, BDI, HAM-D, MADRS, QIDS or IDS-SR scores).

Limitations

1. The treatment must be provided by use of a device approved by the FDA for the purpose of supplying Transcranial Magnetic Stimulation.
2. TMS therapy not ordered by a psychiatrist and furnished under direct supervision of a qualified physician (MD or DO) will be considered not medically reasonable and necessary and not subject to coverage.
3. The benefits of TMS use must be carefully considered against the risk of potential side effects in patients. The use of TMS in patients with any of the following is considered not medically reasonable and necessary and therefore will be denied:
   
   • Seizure disorder or any history of seizures (except those induced by ECT or isolated febrile seizures in infancy without subsequent treatment or recurrence) or any condition or treatment that may lower the seizure threshold; or
   • Presence of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode; or
   • Neurological conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, history of repetitive or severe head trauma, or primary or secondary tumors in the central nervous system; or
   • Presence of an implanted magnetic-sensitive medical device located less than or equal to 30cm from the TMS magnetic coil or other implanted metal items including, but not limited to a cochlear implant, implanted cardiac defibrillator (ICD), pacemaker, Vagus nerve stimulator (VNS), or metal aneurysm clips or coils, staples or stents (Dental amalgam fillings are not affected by the magnetic field and are acceptable for use with TMS).
4. All other uses of TMS, including "maintenance therapy", “continuous therapy”, “rescue therapy”, and “extended active therapy” are considered investigational and experimental as they are not supported by controlled clinical trials and they are considered not reasonable and necessary. This non coverage is extended to any other terminology that may be given to a treatment episode that does not meet the defined requirements noted and defined as initial treatment or retreatment.
5. Retreatment(s) that occur in close temporal proximity to a previous episode of treatment may be considered maintenance therapy or continuous therapy and not reasonable and necessary. It is expected that the time between treatment episodes should allow for assessment, both clinically and by one or more standard rating scales, to clearly document that the patient responded and then relapsed. The number of retreatments is not limited at this time. However, frequent reporting of services may trigger focused medical reviews.
6. Routine performance of motor threshold re-determination during rTMS therapy will be considered not reasonable and necessary and may invite medical review.

Place of Service (POS)/Provider Qualifications
Medicare considers TMS therapy reasonable and necessary when it is furnished in accordance with the accepted standards of medical practice, when it is furnished in a setting appropriate to the patient’s medical needs and condition, when it meets but does not exceed the patient’s medical need and when it is ordered and furnished by qualified personnel.

It is expected that TMS therapy will be ordered by a psychiatrist and furnished under the direct supervision of a qualified physician (MD or DO) as follows: For additional information on the CMS requirements for direct physician supervision, please refer to CMS IOM Pub. 100-02, Chapter 15, Section 60 for services and supplies furnished incident to a physician’s professional service.

• Qualified Physicians (MD or DO) must possess evidence of knowledge, training, and expertise to perform TMS services.
  
  
• Qualified Physician and/or Prescribing Physician expectations are as follows:
• The attending physician who prescribes a treatment course of TMS (psychiatrist), which involves a medical device, is ultimately responsible for the overall daily management of the TMS treatment team. It is expected that the prescribing physician (psychiatrist) establish the anticipated clinical treatment plan based on assessment of the patient’s clinical history and review this treatment plan with the patient prior to beginning the course of treatment.
• It is expected that the prescribing physician or another physician in the practice should perform the initial motor threshold determination and identify the appropriate coil location for subsequent treatments. Subsequent motor threshold determinations may be delegated by the attending physician to another, appropriately qualified physician or member of the clinical staff. In this circumstance, the qualified physician must be available on-site.
• The qualified physician should review the clinical course of each daily treatment session to determine whether any modifications to the subsequent daily treatment should occur. It is expected that the qualified physician will provide appropriate documentation supporting the medical necessity of the services and that such documentation be made available upon request.
• Conduction and oversight of daily treatment sessions may be delegated by the attending physician to another qualified physician or member of the clinical staff, but must be furnished under direct physician supervision.
• TMS Training Requirements for Qualified Physicians and Personnel
• Peer-to-peer and graduate medical education have an important role in physician and staff training. In addition to industry sponsored training that is device specific, it is expected that TMS providers complete additional training either through a university affiliated or industry independent Continuous Medical Education (CME) program or through additional peer-to-peer direct supervision.
• Providers with a strong foundation in TMS through their training or extensive TMS experience may be exempt from the above expectation (i.e. Psychiatrist).
• It is also expected that the attending physician and all staff who are members of the TMS treatment team receive appropriate product training on the use of this technology. It is expected that at a minimum, the TMS team receive the detailed product training offered by the device manufacturer and maintain written documentation of training.
• Non-physician operators should also undergo manufacturers’ training prior to independently performing treatments. TMS is a medically complex treatment, and therefore emergency medical services must be accessible at all times. The operator should provide updates, progress notes or both every day that should be monitored by the prescribing physician. The use of repeated ratings with mood scales to document depression changes is expected.
• It is expected that all TMS clinical staff maintain appropriate training to support their role as first responders to potential medical emergencies.
• It is expected that a TMS clinic establish formal standard operating procedures (SOPs) related to training and ongoing criteria to maintain procedural skills for all staff who are involved in the delivery of TMS in the office setting. Documentation of implementation and adherence to these procedures must be included and made available upon request.

For frequency limitations please refer to the Utilization Guidelines section below.

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.

The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD.

Please refer to the “History/Background and/or General Information” section for background information on Transcranial magnetic stimulation (TMS).

Transcranial magnetic stimulation (TMS) is contained in several LCDs by various MACs but vary in several significant and not so significant areas. In addition, these policies are based on data that is at least 7 years old. There are several more recent studies that now clarify some of these variances. Guidelines are also now available on TMS from credible organizations.

Peer reviewed literature on TMS therapy was obtained by searching the publicly accessible literature database on PubMed and the ClinicalTrials.gov website. Several articles were reviewed with the studies so listed that were graded as meeting the acceptable strength of evidence with placing the greatest emphasis on evidence obtained from randomized controlled trials and prior systematic reviews. (Level 5, the lowest level, includes anecdotal evidence or non-human animal based evidence. Level 4 includes case series. Level 3 includes systematic reviews or controlled individual cases. Level 2 includes systematic reviews of controlled trials. Level 1, the highest level of evidence, includes large, prospective, randomized controlled trials).

A)  Systematic review of the evidence for (prefrontal, fast rTMS) TMS therapy:

Multi-site randomized controlled trials (RCT)

Three large, multisite, randomized sham-controlled trials included an aggregate sample of 703 adult patients with major depressive disorder (MDD) who had failed between 1 and 4 antidepressant trials.

Two of the studies were industry sponsored registration trials that led to FDA clearance for the NeuroStar TMS Therapy System (O’Reardon, et al. [2007]) and the Brainsway Deep TMS device in 2013 (Levkovitz, et al. [2015]). The third study was a National Institute of Mental Health (NIMH) - sponsored, multicenter study, which provided critical, industry-independent evidence of TMS effects on depression (George, et al. [2010]). This NIMH trial also used an active, sham-controlled condition and the primary outcome focused on the clinically important endpoint of remission. All three trials were consistent in their evidence, establishing a statistically significant and clinically relevant benefit with TMS therapy compared to the sham condition. Furthermore, the safety of Neuronetics TMS Therapy and Brainsway Deep TMS was affirmed in these three studies, consistent with the earlier scientific literature.

B)   Durability studies:

These include the results of studies Dunner, et al. (2014), O’Rearden, et al. (2007), and Janicak, et al. (2010). In Dunner, et al. (2014), patients placed back on antidepressant medications demonstrate high (i.e. 64–90%) durability for acute TMS benefits over a 3–12 month period, with a majority of patients who relapsed responding to additional TMS sessions.

C)  Continuation/maintenance studies:

Data is scant and only a small number of patients were included to support continuation/maintenance therapy.

The only published controlled trial to date of continuation TMS was performed in the Brainsway multicenter trial. MDD patients (N equal to 212) were randomized to sham or active TMS during the acute 4-week treatment phase followed by a continuation phase of 2 treatments a week for an additional 12 weeks (Levkovitz, et al. 2015). At the end of the continuation phase (week 16), the difference in response rates between Deep TMS (44.3%) and the sham group (25.6%) was significant (p less than 0.001) but the remission rates between TMS (31.8%) and sham (22.2%) were not significant (p equal to 0.15). The majority of patients who achieved remission after acute treatment (32.6% in the Deep TMS and 14.6% in the sham group) did not relapse (i.e. HAM-D 21 greater than 17) during the 12-week continuation phase.

Study was only conducted on 4 weeks of daily therapy and not 6 weeks which is usually prescribed (M-F).

D)   Defining level of resistance needed for initiation of treatment:

The study by Rush, et al. (2006) in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial describes the participants and compares the acute and longer-term treatment outcomes associated with each of four successive steps in the STAR*D trial in patient with MDD who received one to four successive acute treatment steps (3,671 patients for one to 123 patients for four). Accepted Depressive Scales were used to categorize remission and failures and relapse. Findings were that remission rates for each successive treatment steps were 36.8%, 30.6%, 13.7% and 13.0% for each of the four steps. The conclusion was that when more treatment steps are required, lower acute remission rates and higher relapse rates are to be expected. This was a meta-analysis of a series of randomized controlled treatment trials in a broadly representative group of outpatients with nonpsychotic major depressive disorder.

Society endorsements:

TMS for the treatment of depression has also received positive endorsements by specialty societies and technology assessment entities, including the American Psychiatric Association (Gelenberg. et al. [2010]), the World Federation of Societies for Biological Psychiatry, (George, et al. [2014]), the Canadian Network for Mood and Anxiety Disorders, the Royal Australia and New Zealand College of Psychiatrists (Position Statement #79, [Oct. 2013]), and the Agency for Healthcare Research and Quality (2012) (Gaynes, et al. [2011]). Thus, TMS is a recognized treatment in routine clinical practice for patients who have not benefited from treatment with antidepressant medications.

Overall conclusions based on summary of evidence:

The efficacy and safety of TMS using a specific, defined treatment protocol was confirmed in 3 trials as listed above and all three studies are consistent in their conclusion that support TMS as applied in routine clinical practice settings. There is reasonable data to support retreatment but not maintenance or continuation treatments at this time. Defining the number of treatment failures as one or two is consistent with longstanding evidence. Finally, several professional organizations have included TMS in their guidelines as recommended acute treatment for major depression.

Level of evidence*

A) Strong
B) Strong
C) Weak
D) Moderate

*Levels of Evidence framework published by the University of Oxford Centre for Evidence-Based Medicine.

Refer to the Local Coverage Article: Billing and Coding: Repetitive Transcranial Magnetic Stimulation (rTMS) in Adults with Treatment Resistant Major Depressive Disorder, A57072, for all coding information.

Documentation Requirements

1. All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
3. The medical record documentation must support the medical necessity of the services as stated in this policy.
4. The qualified physician must monitor and document the patient's clinical progress during treatment. The clinical record must document that the qualified physician met with the patient face-to-face for the initial assessment and subsequent delivery and management and when there has been a change in either the clinical or mental status of the patient. The qualified physician must use evidence-based validated depression monitoring scales such as the GDS, PHQ-9, BDI, HAM-D, MADRS, QIDS or IDS-SR to monitor treatment response and the achievement of remission of symptoms. The clinical record must reflect that the qualified physician provided direct supervision for these services.
   
   *Note: Please refer to the “Provider Qualification” section for additional information.

Utilization Guidelines
In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.

TMS is reasonable and necessary for up to 30 treatment sessions over a 6-7 week period followed by 6 treatment sessions for tapering over a 3 week period for those in remission. Further treatment of an episode of depression beyond this, for patients who have not achieved at least a 50% reduction in symptoms will be considered not medically reasonable and necessary and not subject to coverage. It is expected that TMS be reported only once per patient (for the initial planning).

Retreatment program(s) may be considered as outlined above for patients who meet the covered indication guidelines. The number of retreatments is not limited at this time. However, frequent reporting of services may trigger focused medical reviews.

It is expected that the services would be performed as indicated by current medical literature and standards of practice. Services performed in excess of established parameters may be subject to review for medical necessity.

Contractor is not responsible for the continued viability of websites listed.

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Pridmore S. Substitution of rapid transcranial magnetic stimulation treatments for electroconvulsive therapy treatments in a course of electroconvulsive therapy. Depress Anxiety. 2000; 12:118–123.

Rodriguez-Martin JL, Barbanoj JM, Schlaepfer TE, et al. Transcranial magnetic stimulation for treating depression. Cochrane Database of Systematic Reviews 2001, Issue 4. Art. No.: CD003493.

Rosa MA, Gattaz WF, Pascual-Leone A, et al. Comparison of repetitive transcranial magnetic stimulation and electroconvulsive therapy in unipolar non-psychotic refractory depression: a randomized, single-blind study. Int J Neuropsychopharmacol. 2006; 9:667–676.

Rosenberg O, Zangen A, Stryjer R, et al. Response to deep TMS in depressive patients with previous electroconvulsive treatment. Brain Stimulation 2010; 3:211-217.

Rossi S, Hallett M, Rossini PM, et al. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009; 120(12):2008-2039.

Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one of several treatment steps: a STAR*D report. Am J Psychiatry. 2006;163(11) 1905-1917.

Schulze-Rauschenbach SC, Harms U, Schlaepfer TE, et al. Distinctive neurocognitive effects of repetitive transcranial magnetic stimulation and electroconvulsive therapy in major depression. Br J Psychiatry. 2005; 186:410–416.

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.

Slotema CW, Blom JD, Hoek HW, et al. Should We Expand the Toolbox of Psychiatric Treatment Methods to Include Repetitive Transcranial Magnetic Stimulation (rTMS)? A Meta-analysis of the Efficacy of rTMS in Psychiatric Disorders. Journal of Clinical Psychiatry. 2010; 71(7):873-884.

The Regance Group. Medical Policy - Transcranial Magnetic Stimulation as a Treatment of Depression and Other Disorders. Policy No. 17. Updated 03/01/2011.

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.

Wellpoint Medical Policy BEH.00002. Transcranial Magnetic Stimulation for Depression and Other Neuropsychiatric Disorders. Last Review Date: 11/18/2010.

Westin GG, Bassi BD, Lisanby SH, et al. Determination of motor threshold using visual observation overestimates transcranial magnetic stimulation dosage: Safety implications. Clin Neurophysiol. 2014; 125(1):142-147.

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