Appeal type: unknown
Decision: unknown

 
The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules state that the following is considered an ABSOLUTE CONTRAINDICATION: 
The presence of a medically implanted magnetic-sensitive device or other implanted metal items including, but 
not limited to, a cochlear implant, implanted cardiac defibrillator (ICD), pacemaker, vagus nerve stimulator 
(VNS), metal aneurysm clips/coils, staples, or stents, that are located less than or equal to 30 cm from the TMS 
magnetic coil.
1,6,15
 
The following are considered RELATIVE CONTRAINDICATIONS: 
1. The presence of a seizure disorder or any history of seizures (except those induced by Electroconvulsive 
therapy [ECT] or isolated febrile seizures in infancy without subsequent treatment or recurrence). 
2. The presence of acute or chronic psychotic symptoms or disorders in the current depressive episode. 
3. The presence of any neurological conditions including epilepsy, cerebrovascular disease, dementia, 
increased intracranial pressure, history of repetitive or severe head trauma, or primary or secondary 
tumors in the central nervous system. 

The following is considered not medically reasonable and necessary: 
All other uses of TMS, including the use of TMS for OCD. 
Coverage of items and services in the Medicare program is provided based on what is reasonable and necessary 
for the Medicare population. This concept is operationalized by the application of evidentiary standards, 
clinical validity, and clinical utility. Through the process of review and reconsideration the focus remains on 
patient outcomes that demonstrate reduced mortality and morbidity, and that will improve patient quality of life 
and function. The evidence thresholds for coverage are a careful balance of benefits and harms in the 
consideration of net health outcomes. 

The level of treatment resistance related to the failure of medication trials and intolerance to 
psychopharmacologic medications shows direct correlation with the level of treatment resistance and aids in the success of TMS treatment, for patients with MDD. The clear and reported treatment success was identified 
in studies related to the failure of at least one pharmacological trial and/or an intolerance of a 
psychopharmacologic medication. Two consensuses' statements from the neurological societies indicate an 
improved status and follow up for the patients that received TMS treatment with only having failed one or 
more trials. 

The FDA provided special controls and guidance in 2008 for the use of TMS in MDD. Within the clinical 
manifestations of MDD there are varying degrees of depression (mild, moderate, and severe). There are various 
clinical evaluation and rating tools such as Quick Inventory of Depressive Symptomatology - Self Rating 
(QIDS-SR)16, Inventory of Depressive Symptomatology - Self Rating (IDS-SR30), HAMD17, HAMD21 and 
HAMD24, available to assist the provider in diagnosing major depressive disorders per the DSM. 

The evaluations and rating tools can provide guidance to severity, but there is no defined standard of 
measurement or classification to determine mild, moderate, or severe. This hinders any standardized treatment 
protocols, expected outcomes or benefits to the patient but aids the healthcare professional in diagnosing MDD. 
The clinical trials, RCTs, Meta-analyses, societal recommendations, and literature provided in this LCD 
demonstrated different standards for entry into the studies, different rating/evaluation tools, different outcome 
standards and differences in post treatment follow up. With the varied protocol standards, clinical validity, and 
clinical utility there is no existing evidence that meets the requirement of reasonable and necessary to expand 
the criteria of MDD to other than 'severe' as defined by the most current DSM criteria when diagnosed by the 
psychiatrist that examined the patient face to face. 

In 2018, the FDA expanded the use of TMS in OCD based on a RCT multi-center study with 100 patients and 
reviewed the 'Brainsway' device through the de nova premarket pathway. Even though TMS was determined 
to be safe in the treatment of OCD, the current evidence has not been standardized or replicated to the standard 
and quality needed in providing a balance of benefits and harm when considering net health outcomes for the 
beneficiary. 

Within the literature available, limitations include a lack of standardized protocol and a lack of high-quality 
studies. Current studies have small sample sizes, bias, poor design, limited follow-up, and inconsistent results. 
The authors agree there is a low risk associated with treatment, but the literature suggests safety and long-term 
data has not been obtained. There is a trend towards a benefit, as noted in the meta-analysis and randomized 
control trials, that suggest there may be a role in refractory OCD. However, many questions remain in terms of 
the efficacy, location of the device application, and the frequency/duration of the treatment. Several systematic 
reviews/meta-analyses conclude that TMS demonstrated a range from no-response to modest effect on the 
reduction of OCD symptoms. Further research is required to determine optimal frequency, total pulses per 
session, and duration of treatment. This will be closely monitored for any future research. At this time, TMS 
treatment for OCD has been determined to be not medically reasonable and necessary. 

Following extensive literature review, discussions with CAC members, and SMEs it has been determined that 
TMS treatment will be considered medically reasonable and necessary for patients with a confirmed diagnosis 
of severe major depressive disorder and that have demonstrated a failure of one or more pharmacological 
medications and/or intolerance to psychopharmacologic medications. At this time TMS treatment for OCD has 
been determined to be not medically reasonable and necessary. 
You can find this rule at the Medicare Local Coverage Determination (LCD) L34522: Transcranial Magnetic 
Stimulation (TMS) in the Treatment of Adults with Major Depressive Disorder. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.