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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 say that repetitive transcranial magnetic stimulation (rTMS) is only considered medically necessary in adults who have a confirmed diagnosis of major depressive disorder (MDD), single or recurrent episode and meet the following criteria:
- Resistance to treatment as evidenced by a lack of a clinically significant response to four (4) trials of psychopharmacologic agents in the current depressive episode;
o Two different agent classes, at or above the minimum effective dose and duration and includes trials of at least two (2) evidence-based augmentation therapies; or
- Inability to tolerate psychopharmacologic agents as evidenced by four (4) trials of psychopharmacologic agents with distinct side effects; or
- History of response to rTMS in a previous depressive episode; or
- History of response to electroconvulsive therapy (ECT) in a previous or current MDD episode, or inability to tolerate ECT, and rTMS is considered a less invasive treatment option; and
- A trial of an evidence-based psychotherapy known to be effective in the treatment of MDD of an adequate frequency and duration without significant improvement in depressive symptoms as documented by standardized rating scales that reliably measure depressive symptoms; and
- The rTMS treatment is delivered by a device that is FDA-approved or -cleared for the treatment of MDD in a safe and effective manner. rTMS treatment should generally follow the protocol and parameters specified in the manufacturer's user manual, with modifications only as supported by the published scientific evidence base; and
- The order for treatment (or retreatment) is written by a physician (MD or DO) who has examined the patient and reviewed the record. The physician must have experience in administering rTMS therapy and the treatment must be given under direct supervision of this physician, i.e., he or she must be in the area and be immediately available.
Limitations:
The benefits of TMS use must be carefully considered against the risk of potential side effect in patients with any of the following:
- Seizure disorder or any history of seizure (except those induced by ECT or isolated febrile seizures in infancy or childhood without subsequent treatment or recurrence). Additional consideration should be
given for individuals on medications which may lower the seizure threshold or with conditions rendering the patient more prone to seizures, such as alcoholism;
- Presence of vagus nerve stimulators leads in the carotid sheath;
- Presence of an implanted medical device located <30 cm from the TMS magnetic coil, including but not limited to pacemakers, implanted defibrillators, or vagus nerve simulators.
TMS is not considered reasonable and necessary for any of the following:
- Presence of psychotic symptoms in the current depressive episode;
- Acute or chronic psychotic disorder such as schizophrenia, schizophreniform disorder, or schizoaffective disorder, or any other neuropsychiatric disorder;
- Neurologic conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the central nervous system;
- Persons with conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head which are non-removable and within 30 cm of the TMS magnetic coil. Examples include cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils stents, and bullet fragments. (Dental amalgam fillings are not affected by the magnetic field and are acceptable for use with TMS.)
- Maintenance therapy is not currently supported by evidence from clinical trials and therefore, is considered not reasonable and necessary.
- All other conditions not included in the above list of "Indications."
Deep TMS (d-TMS) is not considered reasonable and necessary for Obsessive Compulsive Disorder (OCD).
You can find this rule in the Centers for Medicare and Medicaid Services, Internet Only Manual, Local Coverage Determination (LCD): Transcranial Magnetic Stimulation (L33398). The rules say that medically necessary services are those that are reasonable and necessary for the diagnosis or treatment of an illness or injury. Medically necessary services include services to improve the functioning of a malformed body member. You can find this rule in the Social Security Act, Section 1862(a)(1)(A). The rules say that services that are not medically necessary are not covered. The rules also say that experimental and investigational devices are not covered. You can find this rule at 42 CFR Sections 411.15 and 411.15(o).
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.