Response to Comments: Repetitive Transcranial Magnetic Stimulation (rTMS) in Adults

Thank you for publishing the proposed LCD DL34869. We have reviewed the policy and provided comment.

1. TMS systems

The current LCD draft of the TMS coverage policy states that specifically the Brainsway Deep TMS system should be used to treat OCD. However, there is another system that also received FDA clearance, the MagVenture TMS Therapy system. Other manufactures in the future may also seek FDA clearance.

We suggest changing your policy to reflect that any TMS system that has received FDA clearance for OCD should be approved for Medicare patients.

2. Supervision

The current LCD draft of the TMS coverage policy states the following:

“The order for treatment (or retreatment) is written by a psychiatrist (MD or DO) who has examined the patient and reviewed the record. The physician will have experience in administering TMS therapy and will prescribe an evidence-based OCD TMS protocol. The treatment shall be given under direct supervision of this physician (physician) present in the area but does not necessarily personally provide the treatment).”

Per clinical standards from the Clinical TMS Society, the physical presence of a physician or licensed provider is not necessary as long as the technician or clinician who is physically present and directly administering the TMS treatment is adequately trained and otherwise competent to administer seizure first aid. It is the responsibility of prescribing physician to assure that the adequate personnel who are sufficiently trained and competent to execute a seizure plan are present whenever TMS is being administered under their prescription. TMS is a daily treatment, five days per week, for six consecutive weeks; many physicians, especially in rural areas, have multiple roles in different healthcare settings, splitting time between clinics and hospitals. If your policy requires the physical presence of a prescribing physician on site during TMS treatment, this will severely limit patient access to TMS, especially in rural areas, with no increase in patient safety to justify that limitation of access.

Furthermore, the CTMSS believes that rTMS is a non-surgical extended duration therapeutic service (NSEDTS). There is extremely low risk of complications after the assessment at the beginning of the service. We believe General Supervision is appropriate, meaning “that the procedure is furnished under the physician’s overall direction and control, but that the physician’s presence is not required during the performance of the procedure (CMS 42 CFR §410.32(b)(3)(i)).”

The CTMSS recommends the following statement be inserted into the coverage policy:

The order for treatment (or retreatment) is written by a psychiatrist (MD or DO) who has examined the patient and reviewed the record. The physician will have experience in administering TMS therapy and will prescribe an evidence-based OCD TMS protocol. The treatment shall be given under general supervision of this physician (physician) under the physician’s overall direction and control but does not necessarily personally provide the treatment or provide direct supervision.

3. OCD Coverage Algorithm

The current proposed LCD is difficult to follow. As it is currently drafted, OCD coverage is listed under criterion #4 for Major Depression. There should be a separate distinction for OCD. The current draft is uninterpretable, and we fear, given how closely and cautiously TMS providers follow Medicare coverage guidelines, this lack of interpretability will result in no one receiving OCD coverage.

Thank you for your comments.

1. The LCD language will be clarified to indicate that any TMS system which has received FDA clearance for treatment resistant OCD will be approved per the guidelines of the policy.
2. While the incidence of seizures is small, the risk of complications from those seizures is substantial. Palmetto GBA established a policy of Direct supervision based on SME input. The Contractor declines to change the language of the policy.
3. There were no specifics as to what was unclear to the commenter, nor specific suggestions as to clarification requested. Some language in the policy was clarified.

Please remove the restriction to Psychiatrist and allow TMS to be ordered by a Physician or Psychiatric Nurse Practitioner. 80% of patients with MDD and being treated with antidepressants are under the care of their PCP. It is estimated that 60% of the counties in the US DO NOT have a Psychiatrist, so in effect those Medicare beneficiaries are being denied access to care (simply because of their zip code). This is fundamentally unfair and unethical.

Please reduce the medication trials to match the FDA indication for TMS in MDD patients to 1 med failure. Novitas, Noridian and WPS have done this so, again it is unfair that those beneficiaries have better access to care.

Thank you for your comments. No peer reviewed published articles were submitted to support training adequacy of NPs to order or perform and supervise TMS. The Contractor declines to change the language of the policy.

Pharmacologic treatment is a proven therapy for MDD and many patients have good results on one drug after failing another drug. Evidence regarding repetitive transcranial magnetic stimulation, the appropriate length of its first course, the use of repetitive courses and its long-term durability is still under study. The Contractor would not drop a requirement for a proven known treatment in favor of one in which the evidence is still evolving. The policy will not be changed.

We thank Palmetto GBA for your efforts in drafting the proposed draft local coverage determination DL34869 and providing access to Deep TMS treatment for appropriate obsessive-compulsive disorder patients.

Provided below are our written comments to the draft LCD and support our presentation at the Palmetto open meeting on June 28, 2021.

1. MDD Indication

Indications for coverage

“TMS may be covered if prescribed and administered by a licensed physician who is knowledgeable in the use of rTMS. Outpatient rTMS may be indicated for patients with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) defined Major Depressive Disorder (MDD) who have failed to benefit from initial treatment of their depression.”

Comment: TMS is an extremely safe outpatient procedure and a technician without any medical background is trained in several hours to administer the therapy proficiently. The management of treatment resistant depression and OCD patients is complex and deserving of the highest trained clinicians available in the regions. If the state allows advance practice registered nurses to treat these patients independently, then they should be allowed to prescribe TMS as well. If not, then TMS prescriptions should only be ordered by psychiatrists. The administration of the treatment should be performed by any certified technician.

Recommendation: Recommend that nurse practitioner be added to the statement with a physician.

“TMS may be covered if prescribed and administered by a licensed physician or nurse practitioner who is knowledgeable in the use of rTMS. Outpatient rTMS may be indicated for patients with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) defined Major Depressive Disorder (MDD) who have failed to benefit from initial treatment of their depression.”

Initial treatment

1. "Has a confirmed diagnosis of severe MDD single or recurrent episode; and”

Comment: Deep TMS is indicated for patients with moderate-severe MDD. Studies were conducted in moderate-severe MDD patients who failed 1 or more medications in the current episode. Additionally, Transcranial Magnetic Stimulation (TMS) is effective in patients with major depressive disorder (MDD) with a range of depression symptom severity. This has been demonstrated in randomized controlled trials in which the patient groups had, on average, moderate depression. Further details and references are provided in the attached Clinical TMS Society Coverage Guidance for Transcranial Magnetic Stimulation (TMS) for Major Depressive Disorder (MDD).

Recommendation: add the words “moderate to”

“Has a confirmed diagnosis of moderate to severe 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 2 trials of psychopharmacologic agents in the current depressive episode from at least 2 different agent classes. At least 1 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 2 trials of psychopharmacologic agents from at least 2 different agent classes, with distinct side effects; or”

Comment: We appreciate Palmetto’s decision to reduce the number of medication trials from 4 to 2 by either a lack of a clinically significant response or intolerable to 2 psychopharmacologic agents. The literature including the Star*D study and recent update by Rush et al. (2016 and 2020) has demonstrated that patients with a major depressive episode who have failed to respond to their initial pharmacologic treatment show less and less response and remission with subsequent failed treatments. Rush stated that after in-efficacy with an initial failed SSRI trial, only 21% of patients achieved remission and 58% of patients achieve no meaningful benefit with a second step switch to another antidepressant. Over four levels of treatment, 1/3 of patients will not respond. In the pivotal trial of deep TMs, patients were shown to have a remission rate of 32.6% vs 14.6% sham and response rate of 38.4 % vs. 31.4% sham after the initial 4 weeks (20 sessions). Patients who failed 1 or 2 medications had a remission rate of 36.6% vs. 16.7% while patients who failed 3+ medications had a remission rate of 28.9% vs. 12.2% in the sham treatment. Additionally, approximately 64% of the acute phase (initial 20 sessions) non-responders, achieved remission during the continuation phase (24 sessions over 12 weeks).

Recommendation: Based upon clinical evidence supporting decreasing remission with subsequent failed antidepressant trials (Star*D trial, Rush et al.) we recommend that Palmetto lower the number of failed medication trials to 1 trial. This is consistent with policies published by Noridian, Novitas and WPS MACs.

“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 and 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 2 trials of psychopharmacologic agents from at least 2 different agent classes, with distinct side effects; or”

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.”

Comment: Transcranial magnetic stimulation (TMS) is a safe and effective treatment for patients with major depressive disorder. All United States Food and Drug Administration (FDA) cleared devices for this treatment have been cleared for use in patients who have failed to reach remission with one or more antidepressants. In three major pivotal trials for TMS, patients were not required to have failed multiple medication trials nor a trial of psychotherapy in the current episode of depression.

In 2007, 2010, and 2015 major pivotal trials were published using the Neuronetics and Brainsway TMS systems. The results of these studies showed the treatment to be effective in depressed patients with both a low and high degree of treatment resistance. These trials did not include burdensome restrictive requirements such as documentation of failed psychotherapy sessions.

While psychotherapy can be effective on its own for patients with mild-to-moderate depression, it is a safety concern when used alone to treat severe depression. In fact, American Psychiatric Association guidelines recommend psychiatric care for this population, whether it is in place of or in addition to psychotherapy.

Requiring psychotherapy and documentation of its progress prior to approving TMS treatment is restrictive, discriminatory, and inconsistent with policies for other treatments such as pharmacotherapy, Esketamine, and electroconvulsive therapy. These restrictions also are an increased risk to the patient. The burden of seeking psychotherapy during an episode of major depressive disorder can result in prolonged suffering.

Recommendation: We recommend that Palmetto delete this unnecessary requirement and hurdle for a psychotherapy trial which would delay and deny access to this safe, evidence based effective TMS treatment for patients with major depressive disorder.

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 physician will have experience in administering TMS therapy. The treatment shall be given under direct supervision of this physician (physician present in the area but does not necessarily personally provide the treatment).

Comment: (same comment as stated in MDD Indications for coverage)

Recommendation: Recommend that the treatment order and supervision of the TMS treatment also include psychiatric nurse practitioners.

“The order for treatment (or retreatment) is written by a psychiatrist (MD or DO) or nurse practitioner (NP) who has examined the patient and reviewed the record. The physician or NP will have experience in administering TMS therapy. The treatment shall be given under direct supervision of this physician or NP (present in the area but does not necessarily personally provide the treatment).”

2. OCD Indication

“TMS for Obsessive Compulsive Disorder (OCD) may be covered if prescribed and administered by a licensed physician who is knowledgeable in the use of rTMS. Outpatient rTMS may be indicated for patients with DSM-5 defined OCD who have failed to benefit from initial treatment of their OCD.”

Comment: (Same as previously stated)

Recommendation: Include NP in the statement to prescribe and administer rTMS:

“TMS for Obsessive Compulsive Disorder (OCD) may be covered if prescribed and administered by a licensed physician or nurse practitioner who is knowledgeable in the use of rTMS. Outpatient rTMS may be indicated for patients with DSM-5 defined OCD who have failed to benefit from initial treatment of their OCD.”

Initial Treatment

1. Diagnosis of OCD: OK
2. One or more of the following: ok. Lack of response to 2 distinct agents of 2 classes administered a minimum of 8 weeks or inability to tolerate agents from 2 classes. ok
3. Trial of psychotherapy: ok?
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 physician will have experience in administering TMS therapy and will prescribe an evidence-based OCD TMS protocol. The treatment shall be given under direct supervision of this physician (physician present in the area but does not necessarily personally provide the treatment).”

Comment: (same comment as stated in MDD Indications for coverage)

Recommendations: Include NPs in the statement to write the order for rTMS treatment.

“The order for treatment (or retreatment) is written by a psychiatrist (MD or DO) or nurse practitioner who has examined the patient and reviewed the record. The physician or nurse practitioner will have experience in administering TMS therapy and will prescribe an evidence-based OCD TMS protocol. The treatment shall be given under direct supervision of this physician or nurse practitioner (present in the area but does not necessarily personally provide the treatment).”

Retreatment: We agree with this for both MDD and OCD

Retreatment for MDD may be considered for patients who met the guidelines for initial treatment and subsequently developed relapse of depressive symptoms if the patient responded to prior treatments as evidenced by a greater than 50% improvement in standard rating scale measurements for depressive symptoms, (e.g., Geriatric Depression Scale (GDS), Patient Health Questionnaire Depression Scale (PHQ-9), Beck Depression Inventory (BDI), Hamilton Rating Scale for Depression (HAM-D), Montgomery-Asberg Depression Rating Scale (MADRS), Quick Inventory of Depressive Symptomatology (QIDS) or Inventory of Depressive Symptomatology-Systems Review (IDS-SR).

Retreatment for OCD may be considered for patients who met the guidelines for initial treatment and experienced at least a 30% reduction in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score, as long as the improvement persisted for at least 1 month after the prior treatments ended.

Utilization Guidelines

The treatment for OCD must be provided by a device cleared by the FDA for the purpose of TMS for OCD.

Comment: We agree.

“TMS is reasonable and necessary for OCD for a minimum of 29 visits over a 6-week period. Extensions in 2-to-4-week increments will be cleared based on clinical need with evidence of response from the first 29 sessions. If patients cannot come in 5 days a week, treatments may be administered 3 days a week over a longer period of time.

Retreatment for OCD may be considered for patients who met the guidelines for initial treatment and experienced at least a 30% reduction in the Y-BOCS score, as long as the improvement persisted for at least 1 month after the prior treatments ended. A repeat treatment program is allowed as above.”

Comment: We agree with the utilization guidelines as this is consistent with the Deep TMS pivotal trial protocol (Carmi et al. 2019) as well as the RWE study outcomes (by Roth et al. 2020) which demonstrated that patients achieved over a 30% improvement of response after 6 weeks of treatment and over 50% improvement of response over 8 weeks of treatment.

Thank you for the opportunity to comment on this draft policy.

References were provided for review.

Thank you for your comments.

1. Thank you for your comments. No peer reviewed published articles were submitted to support training adequacy of NPs to order or perform and supervise TMS. The Contractor declines to change the language of the policy.
2. Psychopharmacologic treatment is a proven therapy for MDD and OCD and many patients have good results on one drug after failing another drug. 21% remission rate is not an insignificant remission rate with a second drug. Evidence regarding repetitive transcranial magnetic stimulation, the appropriate length of its first course, the use of repetitive courses and its long-term durability is still under study. The Contractor would not drop a requirement for a proven known treatment in favor of one in which the evidence is still evolving. The policy will not be changed.
3. Psychotherapy is a proven therapy for MDD and OCD. Evidence regarding repetitive transcranial magnetic stimulation, the appropriate length of its first course, the use of repetitive courses and its long-term durability is still under study. The Contractor would not drop a requirement for a proven known treatment in favor of one in which the evidence is still evolving.
4. This reconsideration request was for inclusion of TMS for treatment for OCD. The language regarding the pharmacotherapy requirements for utilization of TMS for MDD was updated slightly (changing from previous 4 drug trials to 2 drug trials) to keep it consistent with the pharmacotherapy requirements for utilization of TMS for OCD. The expansion of coverage for TMS for moderate depression, rather than just for severe depression, can be evaluated through the LCD reconsideration process if a valid request is received.