MEDICARE COVERAGE SUMMARY: TRANSCRANIAL MAGNETIC STIMULATION

Transcription

1 OPTUM MEDICARE COVERAGE SUMMARY: TRANSCRANIAL MAGNETIC STIMULATION MEDICARE COVERAGE SUMMARY: TRANSCRANIAL MAGNETIC STIMULATION Guideline Number: Effective Date: April, 2018 INSTRUCTIONS FOR USE This guideline is used t make cverage determinatins as well as t infrm discussins abut evidence-based practices and discharge planning fr behaviral health benefit plans managed by Optum 1. When deciding cverage, the member s specific benefits must be referenced. All reviewers must first identify member eligibility, the member-specific benefit plan cverage, and any federal r state regulatry requirements that supersede the member s benefits prir t using this guideline. Other clinical criteria may apply. Optum reserves the right, in its sle discretin, t mdify its clinical criteria as necessary using the prcess described in Clinical Criteria. This guideline is prvided fr infrmatinal purpses. It des nt cnstitute medical advice. Optum may als use tls develped by third parties that are intended t be used in cnnectin with the independent prfessinal medical judgment f a qualified health care prvider and d nt cnstitute the practice f medicine r medical advice. Optum may develp clinical criteria r adpt externally-develped clinical criteria that supersede this guideline when required t d s by cntract r regulatin. TRANSCRANIAL MAGNETIC STIMULATION Transcranial magnetic stimulatin (TMS) is a nninvasive methd f brain stimulatin. The technique invlves placement f a small cil ver the scalp and passing a rapidly alternating current thrugh the cil wire which prduces a magnetic field that passes unimpeded thrugh the brain. Depending n stimulatin parameters (frequency, intensity, pulse duratin, stimulatin site), repetitive TMS (rtms) t specific crtical regins can either increase r decrease the excitability f the affected brain structures. The prcedure is usually carried ut in an utpatient setting and des nt require anesthesia r analgesia (CMS L33398, L34641, L34522, L34998, L36469, L34269). Optum is a brand used by United Behaviral Health and its affiliates. Transcranial Magnetic Stimulatin Prprietary Infrmatin f Optum. Cpyright 2018 Optum, Inc. Page 1 f 11

2 Transcranial magnetic stimulatin (TMS) is a nn-invasive treatment that uses pulsed magnetic fields t induce an electric current in a lcalized regin f the cerebral crtex. An electrmagnetic cil placed n the scalp induces fcal current in the brain that temprarily mdulates cerebral crtical functin. Capacitr discharge prvides electrical current in alternating n/ff pulses. Stimulatin parameters may be adjusted t alter the excitability f the targeted structures in specific crtical regins. Repetitive TMS (rtms) has been investigated as treatment fr pharmacresistant depressin (CMS L34869). When used as an antidepressant therapy, TMS prduces a clinical benefit withut the systemic side effects attendant with standard ral medicatins. TMS des nt have adverse effects n cgnitin. Unlike electrcnvulsive therapy (ECT), rtms des nt induce amnesia r seizures (CMS L33398, L34641, L34522, L34869, L34998, L36469, L34269). APPLICABLE STATES (CMS L33398) Cnnecticut Illinis Maine Massachusetts Minnesta New Hampshire New Yrk Rhde Island Vermnt Wiscnsin (CMS L34641) Alaska Alabama Arkansas Arizna Cnnecticut Flrida Gergia Iwa Idah Utah Virginia Virgin Islands Vermnt Washingtn Wiscnsin West Virginia Wyming (CMS L34869) Alabama Gergia Nrth Carlina Transcranial Magnetic Stimulatin Prprietary Infrmatin f Optum. Cpyright 2018 Optum, Inc. Page 2 f 11

3 Suth Carlina Tennessee Virginia West Virginia (CMS L34998) Arkansas Clrad Delaware District f Clumbia Luisiana Maryland Mississippi New Jersey New Mexic Oklahma Pennsylvania Texas (CMS L36469) Kentucky Ohi (CMS L34269) Alabama Gergia Tennessee (CMS L34522) Flrida Puert Ric Virgin Islands If services are delivered in anther state, please apply the Optum Transcranial Magnetic Stimulatin Behaviral Clinical Plicy. COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY Indicatins (CMS L33398, L34641, L34522, L34269, L34998, L36469) TMS may be cvered if prescribed and administered by a licensed physician wh is knwledgeable in the use f Transcranial Magnetic Stimulatin. TMS may be indicated fr patients with DSM defined Majr Depressive Disrder wh have failed t benefit frm initial treatment f their depressin. Initial treatment left Prefrntal TMS f the brain is cnsidered medically necessary fr use in an adult wh has a cnfirmed diagnsis f severe Majr Depressive Disrder (MDD) single r recurrent episde; and Resistance t treatment with psychpharmaclgic agents as evidenced by a lack f clinically significant respnse t fur trials f such agents, in the current depressive episde, frm at least tw different agent classes. At least ne f the treatment trials must have been administered at an adequate curse f mn- r ply drug therapy; r Inability t tlerate psychpharmaclgic agents as evidenced by trials f fur such agents, frm at least tw different agent classes, with distinct side effects; r Transcranial Magnetic Stimulatin Prprietary Infrmatin f Optum. Cpyright 2018 Optum, Inc. Page 3 f 11

4 Histry f gd respnse t TMS in a previus episde; r If patient is currently receiving electr-cnvulsive therapy, TMS may be cnsidered reasnable and necessary as a less invasive treatment ptin; and A trial f an evidence-based psychtherapy knwn t be effective in the treatment f MDD f an adequate frequency and duratin withut significant imprvement in depressive symptms as dcumented by standardized rating scales that reliably measure depressive symptms; and additinal LCD specific indicatins belw. The rder fr treatment (r retreatment) is written by a psychiatrist (MD r DO) wh has examined the patient, and reviewed the recrd. The physician will have experience in administering TMS therapy. The treatment shall be given under direct supervisin f this physician (physician present in the area, but des nt necessarily persnally prvide the treatment). Indicatins (CMS L33398) The TMS treatment is delivered by a device that is FDA-apprved r cleared fr the treatment f MDD in a safe and effective manner. TMS treatment shuld generally fllw the prtcl and parameters specified in the manufacturer s user manual, with mdificatins nly as supprted by the published scientific evidence base. Indicatins (CMS L34869) TMS may be cvered if prescribed and administered by a licensed physician wh is knwledgeable in the use f repetitive transcranial magnetic stimulatin. Outpatient rtms may be indicated fr patients with DSM-V defined Majr Depressive Disrder wh have failed t benefit frm initial treatment f their depressin. Treatment must be prvided by use f a device apprved by the FDA fr purpse f supplying Transcranial Magnetic Stimulatin. It is expected that the services wuld be perfrmed as indicated by current medical literature and standards f practice. Services perfrmed in excess f established parameters may be subject t review fr medical necessity. TMS is reasnable and necessary up t 20 visits ver a 4 week perid fllwed by five visits fr tapering fr thse in remissin; fr thse wh shw at least a 25% imprvement by means f the standard tests fr depressin, the therapy may be cntinued fr an additinal 2 weeks (an additinal 10 visits) with an additinal 6 visits fr tapering. Initial Treatment Left prefrntal rtms f the brain is cnsidered medically necessary fr use in an adult wh has a cnfirmed diagnsis f severed Majr Depressive Disrder (MDD) single r recurrent episde, and ne r mre f the fllwing are present: Resistance t treatment with psychpharmaclgical agents as evidenced by a lack f a clinically significant respnse t fur trials f psychpharmaclgic agents in the current depressive episde frm at least tw different agent classes. At least ne f the treatment trials must have been administered at an adequate curse f mn- r ply-drug therapy; r Inability t tlerate psychpharmaclgic agents as evidenced by fur trials f psychpharmaclgic agents frm at least tw different agent classes, with distinct side effects; r Histry f respnse t rtms in a previus depressive episde; r If patient is currently receiving electr-cnvulsive therapy, rtms may be cnsidered reasnable and necessary as a less invasive treatment ptins. A trial f an evidence-based psychtherapy knwn t be effective in the treatment f MDD f an adequate frequency and duratin withut significant imprvement in depressive symptms as dcumented by standardized rating scales that reliably measure depressive symptms. The rder fr treatment (r retreatment) is written by a psychiatrist (MD r DO) wh has examined the patient and reviewed the recrd. The physician will have experience in administering TMS therapy. The treatment shall be given under direct supervisin f this physician (physician present in the area, but des nt persnally prvide the treatment). Transcranial Magnetic Stimulatin Prprietary Infrmatin f Optum. Cpyright 2018 Optum, Inc. Page 4 f 11

5 Retreatment Indicatins (CMS L34998) Retreatment may be cnsidered fr patients wh met the guideline fr initial treatment and subsequently develped relapse f depressive symptms in the patient respnded t prir treatments as evidenced by a greater than 50% imprvement in standard rating scale measurements fr depressive symptms (e.g., Geriatric Depressin Scale (GDS), Patient Health Questinnaire Depressin Scale (PHQ-9), Beck Depressin Inventry (BDI), Hamiltn Rating Scale fr Depressin (HAM-D), Mntgmery-Asberg Depressin Rating Scale (MADRS), Quick Inventry f Depressive Symptmatlgy (QIDS), r Inventry f Depressive Symptmatlgy-Systems Review (IDS-SR). Retreatment(s) may be cnsidered medically reasnable and necessary fr patients wh meet all f the fllwing criteria: Patients must have met the guidelines fr initial treatment and subsequently develped relapse f depressive symptms as evidenced by a 50% wrsening in the prir best respnse using the same rating scale (e.g., GDS, PHQ-9, BDI, HAM-D, MADRS, QIDS r IDS-SR scres). Patients must have respnded t prir treatments as evidenced by a greater than 50% imprvement in standard rating scale measurements fr depressive symptms (e.g., GDS, PHQ-9, BDI, HAM-D, MADRS, QIDS r IDS-SR scres). *Resistance t treatment is defined by a failure t achieve a 50% reductin in depressive symptms, in accrdance with bjective measures such as Geriatric Depressin Scale (GDS), the Persnal Health Questinnaire Depressin Scale (PHQ-9), the Beck Depressin Inventry (BDI), the Mntgmery Asberg Depressin Rating Scale (MADRS), the Quick Inventry f Depressive Symptmatlgy (QIDS), the Inventry fr Depressive Symptmatlgy Systems Review (IDS-SR) r Hamiltn Rating Scale fr Depressin (HAM-D), frm a pharmaclgic trial where the medicatin is administered at bth an adequate dse and fr an adequate perid f time cnsistent with accepted standards f care. A dse will be cnsidered adequate when the medicatin is administered cnsistent with the FDA label. Where starting dsage is lwer than maximum recmmended dsage, the dse f any medicatin will be cnsidered adequate when an initial respnse failure is fllwed by titrating the dsage upwards twards the maximum recmmended dsage. Where such titratin des nt ccur, the recrd must dcument the ratinale fr the decisin nt t increase the dse. Duratin f therapy will be cnsidered adequate, when a particular medicatin is administered fr a length f time cnsistent with expectatins fr expected respnse times fr that medicatin r class f medicatins as defined in the medical literature supprting the efficacy f that medicatin r medicatin class and by the standard f care. **Psychpharmaclgic agent side effects will be cnsidered intlerable, when thse side effects are f a nature where they are nt expected t diminish r reslve with cntinued administratin f the drug. Indicatins (CMS L36469) Resistance t treatment is defined by a failure t achieve a 50% reductin in depressive symptms, in accrdance with bjective measures such as PHQ-9 and/r HAM-D, frm a pharmaclgic trial where the medicatin is administered at the recmmended adult dse, per the FDA label, fr a perid f nt less than 6 weeks. Psychpharmaclgic agent side effects will be cnsidered intlerable, when thse side effects are f a nature where they are nt expected t diminish r reslve with cntinued administratin f the drug. Limitatins (CMS L33398) The benefits f TMS use must be carefully cnsidered against the risk f ptential side effect in patients with any f the fllwing: Seizure disrder r any histry f seizure (except thse induced by ECT r islated febrile seizures in infancy r childhd withut subsequent treatment r recurrence). Additinal cnsideratin shuld be given fr individuals n medicatins which may lwer the seizure threshld r with cnditins rendering the patient mre prne t seizures, such as alchlism; Presence f vagus nerve stimulatrs leads in the cartid sheath; Presence f an implanted medical device lcated <30 cm frm the TMS magnetic cil, including but nt limited t pacemakers, implanted defibrillatrs, r vagus nerve simulatrs Transcranial Magnetic Stimulatin Prprietary Infrmatin f Optum. Cpyright 2018 Optum, Inc. Page 5 f 11

6 TMS is nt cnsidered reasnable and necessary fr any f the fllwing: Presence f psychtic symptms in the current depressive episde; Acute r chrnic psychtic disrder such as schizphrenia, schizphrenifrm disrder, r schizaffective disrder; Neurlgic cnditins that include epilepsy, cerebrvascular disease, dementia, increased intracranial pressure, having a histry f repetitive r severe head trauma, r with primary r secndary tumrs in the central nervus system; Persns with cnductive, ferrmagnetic r ther magnetic-sensitive metals implanted in their head which are nn-remvable and within 30 cm f the TMS magnetic cil. Examples include cchlear implants, implanted electrdes/stimulatrs, aneurysm clips r cils stents, and bullet fragments. (Dental amalgam fillings are nt affected by the magnetic field and are acceptable fr use with TMS.) Maintenance therapy is nt currently supprted by evidence frm clinical trials and therefre, is cnsidered nt reasnable and necessary. All ther cnditins nt included in the abve list f Indicatins. Limitatins (CMS L34641, L34869) The benefits f TMS use must be carefully cnsidered against the risk f ptential side effects in patients with any f the fllwing: Seizure disrder r any histry f seizures (except thse induced by ECT r islated febrile seizures in infancy withut subsequent treatment r recurrence); r Presence f acute r chrnic psychtic symptms r disrders (such as schizphrenia, schizphrenifrm r schizaffective disrder) in the current depressive episde; r Neurlgical cnditins that include epilepsy, cerebrvascular disease, dementia, increased intracranial pressure, histry f repetitive r severe head trauma, r primary r secndary tumrs in the central nervus system, r Presence f an implanted magnetic-sensitive medical device lcated less than r equal t 30 cm frm the TMS magnetic cil r ther implanted metal items including, but nt limited t a cchlear implant, implanted cardiac defibrillatr (ICD), pacemaker, Vagus nerve stimulatr (VNS), r metal aneurysm clips r cils, staples r stents. (Dental amalgam fillings are nt affected by the magnetic field and are acceptable fr use with TMS). All ther uses f Transcranial Magnetic are experimental and are nt cvered. Retreatment may be cnsidered fr patients wh met the guidelines fr initial treatment and subsequently develped relapse f depressive symptms if the patient respnded t prir treatments as evidenced by a greater than 50% imprvement in standard rating scale measurements fr depressive symptms. Limitatins (CMS L34522) The fllwing cautinary uses have nt been prven in clinical studies and n pst payment medical review f the recrds may be determined t be nt medically necessary and denied. Seizure disrder r any histry f seizure (except thse induced by ECT r islated febrile seizures in infancy withut subsequent treatment r recurrence); Presence f acute r chrnic psychtic symptms r disrders (such as schizphrenia, schizphrenifrm r schizaffective disrder) in the current depressive episde; Neurlgical cnditins that include epilepsy, cerebrvascular disease, dementia, increased intracranial pressure, having a histry f repetitive r severe head trauma, r with primary r secndary tumrs in the central nervus system (CNS); Presence f an implanted magnetic-sensitive medical device lcated less than r equal t 30 centimeters frm the TMS magnetic cil r ther implanted metal items, including but nt limited t a cchlear implant, implanted cardiverter defibrillatr (ICD), pacemaker, vagus nerve stimulatr (VNS), r metal aneurysm clips r cils, staples, r stents. (Nte: Dental amalgam fillings are nt affected by the magnetic field and are acceptable fr use with TMS). Transcranial Magnetic Stimulatin Prprietary Infrmatin f Optum. Cpyright 2018 Optum, Inc. Page 6 f 11

7 Limitatins (CMS L34998) 1. The treatment must be prvided by use f a device apprved by the FDA fr the purpse f supplying Transcranial Magnetic Stimulatin. 2. TMS therapy nt rdered by a psychiatrist and furnished under direct supervisin f a qualified physician (MD r DO) will be cnsidered nt medically reasnable and necessary and nt subject t cverage. 3. The benefits f TMS use must be carefully cnsidered against the risk f ptential side effects in patients. The use f TMS in patients with any f the fllwing is cnsidered nt medically reasnable and necessary and therefre will be denied: Seizure disrder r any histry f seizures (except thse induced by ECT r islated febrile seizures in infancy withut subsequent treatment r recurrence) r any cnditin r treatment that may lwer the seizure threshld; r Presence f acute r chrnic psychtic symptms r disrders (such as schizphrenia, schizphrenifrm r schizaffective disrder) in the current depressive episde; r Neurlgical cnditins that include epilepsy, cerebrvascular disease, dementia, increased intracranial pressure, histry f repetitive r severe head trauma, r primary r secndary tumrs in the central nervus system; r Presence f an implanted magnetic-sensitive medical device lcated less than r equal t 30 cm frm the TMS magnetic cil r ther implanted metal items including, but nt limited t a cchlear implant, implanted cardiac defibrillatr (ICD), pacemaker, Vagus nerve stimulatr (VNS), r metal aneurysm clips r cils, staples r stents (Dental amalgam fillings are nt affected by the magnetic field and are acceptable fr use with TMS). 4. All ther uses f TMS, including "maintenance therapy", cntinuus therapy, rescue therapy, and extended active therapy are cnsidered investigatinal and experimental as they are nt supprted by cntrlled clinical trials and they are cnsidered nt reasnable and necessary. This nn cverage is extended t any ther terminlgy that may be given t a treatment episde that des nt meet the defined requirements nted and defined as initial treatment r retreatment. 5. Retreatment(s) that ccur in clse tempral prximity t a previus episde f treatment may be cnsidered maintenance therapy r cntinuus therapy and nt reasnable and necessary. It is expected that the time between treatment episdes shuld allw fr assessment, bth clinically and by ne r mre standard rating scales, t clearly dcument that the patient respnded and then relapsed. The number f retreatments is nt limited at this time. Hwever, frequent reprting f services may trigger fcused medical reviews. 6. Rutine perfrmance f mtr threshld re-determinatin (CPT 90869) during rtms therapy will be cnsidered nt reasnable and necessary and may invite medical review. Limitatins (CMS L36469) The benefits f TMS use must be carefully cnsidered against the risk f ptential side effects in patients with any f the fllwing: Seizure disrder r any histry f seizures (except thse induced by ECT r islated febrile seizures in infancy withut subsequent treatment r recurrence); r Presence f acute r chrnic psychtic symptms r disrders (such as schizphrenia, schizphrenifrm r schizaffective disrder) in the current depressive episde; r Neurlgical cnditins that include epilepsy, cerebrvascular disease, dementia, increased intracranial pressure, histry f repetitive r severe head trauma, r primary r secndary tumrs in the central nervus system, r Presence f an implanted magnetic-sensitive medical device lcated less than r equal t 30 cm frm the TMS magnetic cil r ther implanted metal items including, but nt limited t a cchlear implant, implanted cardiac defibrillatr (ICD), pacemaker, Vagus nerve stimulatr (VNS), r metal aneurysm clips r cils, staples r stents. Dental amalgam fillings are nt affected by the magnetic field and are acceptable fr use with TMS. Transcranial Magnetic Stimulatin Prprietary Infrmatin f Optum. Cpyright 2018 Optum, Inc. Page 7 f 11

8 Retreatment Retreatment may be cnsidered fr patients wh met the guidelines fr initial treatment and subsequently develped relapse f depressive symptms if the patient respnded t prir treatments as evidenced by a greater than 50% imprvement in standard rating scale measurements fr depressive symptms. (e.g., GDS, PHQ-9, BDI, HAM-D, MADRS, QIDS r IDS-SR scres). All ther uses f Transcranial Magnetic Stimulatin, including "maintenance therapy" are experimental and are nt cvered. Limitatins (CMS L34269) 1. rtms is cnsidered nt reasnable and necessary when used as a treatment mdality fr patients with psychtic symptms. 2. Use f rtms is nt indicated in patients with: A. Seizure disrder, r B. A vagus nerve stimulatr, r C. An implanted medical device r metal in clse prximity t the brain. CLINICAL BEST PRACTICES (CMS L33398) In accrdance with CMS Ruling 95-1 (V), utilizatin f these services shuld be cnsistent with lcally acceptable standards f practice. It is expected that the services wuld be perfrmed as indicated by current medical literature and standards f practice. Services perfrmed in excess f established parameters may be subject t review fr medical necessity. Retreatment may be cnsidered fr patients wh met the guidelines fr initial treatment and subsequently develped relapse f depressive symptms if the patient respnded t prir treatments as evidenced by a greater than 50% imprvement in standard rating scale measurements fr depressive symptms r if there were a relapse after remissin [e.g., (GDS), PHQ-9, BDI, HAM-D, MADRS, QIDS r IDS-SR scre]. A repeat treatment prgram is allwed as abve. The TMS treatment planning service may be reprted nce per treatment episde. (CMS L34641) The treatment must be prvided by use f a device apprved by the FDA fr the purpse f supplying Transcranial Magnetic Stimulatin. It is expected that the services wuld be perfrmed as indicated by current medical literature and standards f practice. Services perfrmed in excess f established parameters may be subject t review fr medical necessity. TMS is reasnable and necessary fr up t 20 visits ver a 4 week perid fllwed by five visits fr tapering fr thse in remissin; fr thse wh shw at least a 25% imprvement by means f the standard tests fr depressin, the therapy may be cntinued fr an additinal 2 weeks (an additin 10 visits) with an additinal 6 visits fr tapering. Retreatment may be cnsidered fr patients wh met the guidelines fr initial treatment and subsequently develped relapse f depressive symptms if the patient respnded t prir treatments as evidenced by a greater than 50% imprvement in standard rating scale measurements fr depressive symptms r if there were a relapse after remissin (e.g., GDS, PHQ-9, BDI, HAM-D, MADRS, QIDS r IDS-SR scre.) A repeat treatment prgram is allwed as abve. (CMS L34522) It is expected that these services wuld be perfrmed as indicated by current medical literature and/r standards f practice. When services are perfrmed in excess f established parameters, they may be subject t review fr medical necessity. TMS is reasnable and necessary fr up t 30 visits ver a 7-week perid fllwed by 6 tapered treatments. Repeat acute treatment fr relapse f depressive symptms is cnsidered medically necessary if the patient respnded t prir treatments, specifically > 50% imprvement in a standard rating scale fr depressive symptms (e.g., (GDS), PHQ-9, BDI, HAM-D, MADRS, QIDS r IDS-SR scre). If patient meets the relapse criteria, up t 30 visits fr the acute phase treatment fllwed by an additinal 6 visits fr tapering is cnsidered reasnable and necessary. Transcranial Magnetic Stimulatin Prprietary Infrmatin f Optum. Cpyright 2018 Optum, Inc. Page 8 f 11

9 It is reasnable and necessary t reprt the treatment planning service nce per curse f treatment. (CMS L34998) In accrdance with CMS Ruling 95-1 (V), utilizatin f these services shuld be cnsistent with lcally acceptable standards f practice. TMS is reasnable and necessary fr up t 30 treatment sessins ver a 6-7 week perid fllwed by 6 treatment sessins fr tapering ver a 3 week perid fr thse in remissin. Further treatment f an episde f depressin beynd this, fr patients wh have nt achieved at least a 50% reductin in symptms will be cnsidered nt medically reasnable and necessary and nt subject t cverage. It is expected that CPT cde be reprted nly nce per patient (fr the initial planning). Retreatment prgram(s) may be cnsidered as utlined abve fr patients wh meet the cvered indicatin guidelines. The number f retreatments is nt limited at this time. Hwever, frequent reprting f services may trigger fcused medical reviews. It is expected that the services wuld be perfrmed as indicated by current medical literature and standards f practice. Services perfrmed in excess f established parameters may be subject t review fr medical necessity. Medicare cnsiders TMS therapy reasnable and necessary when it is furnished in accrdance with the accepted standards f medical practice, when it is furnished in a setting apprpriate t the patient s medical needs and cnditin, when it meets but des nt exceed the patient s medical need and when it is rdered and furnished by qualified persnnel. It is expected that TMS therapy will be rdered by a psychiatrist and furnished under the direct supervisin f a qualified physician (MD r DO) as fllws: Direct Supervisin T be cvered incident t the services f a physician, services and supplies must be furnished by the physician r by auxiliary persnnel under the physician s direct supervisin. In the ffice setting, this means the physician must be present in the ffice suite and immediately available t furnish assistance and directin thrughut the perfrmance f the prcedure. It des nt mean that the physician must be present in the rm when the prcedure is perfrmed. *Nte: Fr additinal infrmatin n the CMS requirements fr direct physician supervisin, please refer t CMS IOM Pub , Chapter 15, Sectin 60 fr services and supplies furnished incident t a physician s prfessinal service. Qualified Physicians (MD r DO) must pssess evidence f knwledge, training, and expertise t perfrm TMS services. Qualified Physician and/r Prescribing Physician expectatins are as fllws: The attending physician wh prescribes a treatment curse f TMS (psychiatrist), which invlves a medical device, is ultimately respnsible fr the verall daily management f the TMS treatment team. It is expected that the prescribing physician (psychiatrist) establish the anticipated clinical treatment plan based n assessment f the patient s clinical histry and review this treatment plan with the patient prir t beginning the curse f treatment. It is expected that the prescribing physician r anther physician in the practice shuld perfrm the initial mtr threshld determinatin and identify the apprpriate cil lcatin fr subsequent treatments. Subsequent mtr threshld determinatins may be delegated by the attending physician t anther, apprpriately qualified physician r member f the clinical staff. In this circumstance, the qualified physician must be available n-site. The qualified physician shuld review the clinical curse f each daily treatment sessin t determine whether any mdificatins t the subsequent daily treatment shuld ccur. It is expected that the qualified physician will prvide apprpriate dcumentatin supprting the medical necessity f the services and that such dcumentatin be made available upn request. Cnductin and versight f daily treatment sessins may be delegated by the attending physician t anther qualified physician r member f the clinical staff, but must be furnished under direct physician supervisin. TMS Training Requirements fr Qualified Physicians and Persnnel Peer-t-peer and graduate medical educatin have an imprtant rle in physician and staff training. In additin t industry spnsred training that is device specific, it is expected that TMS prviders cmplete additinal training either thrugh a university affiliated r industry independent Cntinuus Medical Educatin (CME) prgram r thrugh additinal peer-t-peer direct supervisin. Transcranial Magnetic Stimulatin Prprietary Infrmatin f Optum. Cpyright 2018 Optum, Inc. Page 9 f 11

10 Prviders with a strng fundatin in TMS thrugh their training r extensive TMS experience may be exempt frm the abve expectatin (i.e. Psychiatrist). It is als expected that the attending physician and all staff wh are members f the TMS treatment team receive apprpriate prduct training n the use f this technlgy. It is expected that at a minimum, the TMS team receive the detailed prduct training ffered by the device manufacturer and maintain written dcumentatin f training. Nn-physician peratrs shuld als underg manufacturers training prir t independently perfrming treatments. TMS is a medically cmplex treatment, and therefre emergency medical services must be accessible at all times. The peratr shuld prvide updates, prgress ntes r bth every day that shuld be mnitred by the prescribing physician. The use f repeated ratings with md scales t dcument depressin changes is expected. It is expected that all TMS clinical staff maintain apprpriate training t supprt their rle as first respnders t ptential medical emergencies. It is expected that a TMS clinic establish frmal standard perating prcedures (SOPs) related t training and nging criteria t maintain prcedural skills fr all staff wh are invlved in the delivery f TMS in the ffice setting. Dcumentatin f implementatin and adherence t these prcedures must be included and made available upn request. Ntice: This LCD impses frequency limitatins as well as diagnsis limitatins that supprt diagnsis t prcedure cde autmated denials. Hwever, services perfrmed fr any given diagnsis must meet all f the indicatins and limitatins stated in this plicy, the general requirements fr medical necessity as stated in CMS payment plicy manuals, any and all existing CMS natinal cverage determinatins, and all Medicare payment rules. As published in CMS IOM , Chapter 13, Sectin , in rder t be cvered under Medicare, a service shall be reasnable and necessary. When apprpriate, cntractrs shall describe the circumstances under which the prpsed LCD fr the service is cnsidered reasnable and necessary under Sectin 1862 (a)(1)(a). Cntractrs shall cnsider a service t be reasnable and necessary if the cntractr determines that the service is: Safe and effective. Nt experimental r investigatinal (exceptin: rutine csts f qualifying clinical trial services with dates f service n r after September 19, 2000, that meet the requirements f the Clinical Trials NCD are cnsidered reasnable and necessary). Apprpriate, including the duratin and frequency that is cnsidered apprpriate fr the service, in terms f whether it is: Furnished in accrdance with accepted standards f medical practice fr the diagnsis r treatment f the patient's cnditin r t imprve the functin f a malfrmed bdy member. Furnished in a setting apprpriate t the patient's medical needs and cnditin. Ordered and furnished by qualified persnnel. One that meets, but des nt exceed, the patient's medical needs. At least as beneficial as an existing and available medically apprpriate alternative. The redeterminatin prcess may be utilized fr cnsideratin f services perfrmed utside f the reasnable and necessary requirements in this LCD. (CMS L34269) rtms can be used up t 5 times per week ver a 6 week perid with a 2 week taper nly with imprvement in treatment respnse. Repeat acute treatment fr relapse f depressive symptms is cnsidered medically necessary if the patient respnded t prir treatments. Treatment planning with initial visit shuld be dne nly nce per curse f treatment. (CMS L36469) The treatment must be prvided by use f a device apprved by the FDA fr the purpse f supplying Transcranial Magnetic Stimulatin. It is expected that the services wuld be perfrmed as indicated by current medical literature and standards f practice. Services perfrmed in excess f established parameters may be subject t review fr medical necessity. Transcranial Magnetic Stimulatin Prprietary Infrmatin f Optum. Cpyright 2018 Optum, Inc. Page 10 f 11

11 TMS is reasnable and necessary fr up t 20 visits ver a 4 week perid fllwed by five visits fr tapering fr thse in remissin. Fr thse wh shw at least a 25% imprvement by means f the standard tests fr depressin, the therapy may be cntinued fr an additinal 2 weeks (an additinal 10 visits) with an additinal 6 visits fr tapering. Further treatment f an episde f depressin beynd this, fr patients wh have nt achieved at least a 50% reductin in symptms will be cnsidered nt medically reasnable and necessary and nt subject t cverage. Retreatment may be cnsidered fr patients wh met the guidelines fr initial treatment and subsequently develped relapse f depressive symptms if the patient respnded t prir treatments as evidenced by a greater than 50% imprvement in standard rating scale measurements fr depressive symptms r if there were a relapse after remissin (e.g., (GDS), PHQ-9, BDI, HAM-D, MADRS, QIDS r IDS-SR scre. A repeat treatment prgram is allwed as abve. REFERENCES 1. Centers fr Medicare and Medicaid, Lcal Cverage Determinatin. Medicine: Repetitive Transcranial Magnetic Stimulatin (rtms) fr Resistant Depressin (L34269). Cahaba Gvernment Benefits Administratrs, LLC. Alabama, Gergia and Tennessee. Octber 1, Retrieved frm 2. Centers fr Medicare and Medicaid, Lcal Cverage Determinatin. Transcranial Magnetic Stimulatin (L33398), Natinal Gvernment Services, Inc. Illinis, Minnesta, Wiscnsin, Cnnecticut, New Yrk, Maine, Massachusetts, New Hampshire, Rhde Island, Vermnt. Octber 1, Retrieved frm 3. Centers fr Medicare and Medicaid, Lcal Cverage Determinatin. Transcranial Magnetic Stimulatin (TMS) (L34641). Wiscnsin Physicians Service Insurance Crpratin. Alaska, Alabama, Arkansas, Arizna, Cnnecticut, Flrida, Gergia, Iwa, Idah, Illinis, Indiana, Kansas, Kentucky, Luisiana, Massachusetts, Maine, Michigan, Mississippi, Minnesta, Missuri, Mntana, Nrth Dakta, Nrth Carlina, Nebraska, New Hampshire, New Jersey, Ohi, Oregn, Rhde Island, Suth Carlina, Suth Dakta, Tennessee, Utah, Virginia, Virgin Islands, Vermnt, Washingtn, Wiscnsin, West Virginia, Wyming. December 1, Retrieved frm 4. Centers fr Medicare and Medicaid Services, Lcal Cverage Determinatin. Transcranial Magnetic Stimulatin (TMS) fr the Treatment f Depressin (L34998). Nvitas Slutins, Inc. Clrad, New Mexic, Oklahma, Texas, Arkansas, Luisiana, Mississippi, Delaware, District f Clumbia, Maryland, New Jersey, Pennsylvania. December 1, Retrieved frm 5. Centers fr Medicare and Medicaid Services, Lcal Cverage Determinatin. Transcranial Magnetic Stimulatin fr Majr Depressive Disrder (L34522). First Cast Service Optins, Inc. Flrida; Puert Ric; Virgin Islands. Octber 1, Retrieved frm 6. Centers fr Medicare and Medicaid, Lcal Cverage Determinatin. Repetitive Transcranial Magnetic Stimulatin (rtms) in Adults with Treatment Resistant Majr Depressive Disrder (L34869). Palmett. Alabama, Gergia, Nrth Carlina, Suth Carlina, Tennessee, Virginia, West Virginia. March 15, Retrieved frm 7. Centers fr Medicare and Medicaid, Lcal Cverage Determinatin. Repetitive Transcranial Magnetic Stimulatin (rtms) in Adults with Treatment Resistant Majr Depressive Disrder (L36469). CGS Administratrs. Kentucky and Ohi. February 1, Retrieved frm HISTORY/REVISION INFORMATION Date June, 2014 Versin 1 Octber, 2014 Versin 1-Revised March, 2015 Versin 2 August, 2015 Versin 2-Revised April, 2016 Versin 3 May, 2017 Versin 4 January, 2018 Versin 5 April, 2018 Versin 6 Actin/Descriptin Transcranial Magnetic Stimulatin Prprietary Infrmatin f Optum. Cpyright 2018 Optum, Inc. Page 11 f 11