Laser Interstitial Thermal Therapy for Neurological Conditions Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM

EFFECTIVE DATE: 11|01|2024 POLICY LAST REVIEWED: 01|22|2025

OVERVIEW Laser interstitial thermal therapy (LITT) involves the introduction of a laser fiber probe to deliver thermal energy for the targeted ablation of diseased tissue. The goal of therapy is selective thermal injury through the maintenance of a sharp thermal border, as monitored via the parallel use of real-time magnetic resonance (MR) thermography and controlled with the use of actively cooled applicators. In neurological applications, LITT involves the creation of a transcranial burr hole for the placement of the laser probe at the target brain tissue. Probe position, ablation time, and intensity are controlled under MRI guidance. LITT has been proposed as a less invasive treatment option for patients with neurological conditions compared to surgery. Two LITT systems, Visualase and NeuroBlate, have received marketing clearance from the FDA.

MEDICAL CRITERIA Not applicable

PRIOR AUTHORIZATION
Not applicable

POLICY STATEMENT Medicare Advantage Plans and Commercial Products Laser interstitial thermal therapy (LITT) is considered medically necessary in the treatment of the following conditions:
• refractory epilepsy
• symptomatic, recurrent, primary, or metastatic malignant brain neoplasms
• symptomatic radiation necrosis in the brain

Medicare Advantage Plans Laser interstitial thermal therapy (LITT) is not covered for all other indications as the evidence is insufficient to determine the effects of the technology on health outcomes.

Commercial Products Laser interstitial thermal therapy (LITT) is not medically necessary for all other indications as the evidence is insufficient to determine the effects of the technology on health outcomes.

COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for applicable not medically necessary/not covered benefits/coverage.

BACKGROUND Laser Interstitial Thermal Therapy Laser interstitial thermal therapy (LITT) involves the introduction of a laser fiber probe to deliver thermal energy for the targeted ablation of diseased tissue. Thermal destruction of tissue is mediated via DNA damage, necrosis, protein denaturation, membrane dissolution, vessel sclerosis, and coagulative necrosis. The goal of therapy is selective thermal injury through the maintenance of a sharp thermal border, as monitored via the parallel use of real-time magnetic resonance (MR) thermography and controlled with the use of actively cooled applicators. In neurological applications, LITT involves the creation of a transcranial burr hole for the placement of the laser probe at the target brain tissue. Probe position, ablation time, and intensity are controlled under magnetic resonance imaging (MRI) guidance. Medical Coverage Policy | Laser Interstitial Thermal Therapy for Neurological Conditions

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

The majority of neurological LITT indications described in the literature involve the ablation of primary and metastatic brain tumors, epileptogenic foci, and radiation necrosis in surgically inaccessible or eloquent brain areas. LITT may offer a minimally invasive treatment option for patients with a high risk of morbidity with traditional surgical approaches. The most common complications following LITT are transient and permanent weakness, cerebral edema, hemorrhage, seizures, and hyponatremia. Delayed neurological deficits due to brain edema are temporary and typically resolve after corticosteroid therapy. Contraindications to MRI are also applicable to the administration of LITT.

Regulatory Status In August 2007, the Visualase™ MRI-Guided Laser Ablation System (Medtronic; formerly Biotex, Inc.) received initial marketing clearance by the FDA through the 510(k) pathway (K071328). In January 2022 (K211269), the system (software version 3.4) was classified as a neurosurgical tool with narrowed indications for use, including "to ablate, necrotize or coagulate intracranial soft tissue including brain structures (for example, brain tumor, radiation necrosis and epileptic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 800 nm through 1064 nm lasers." The device is contraindicated for patients with medical conditions or implanted medical devices contraindicated for MRI and for patients whose physician determines that LITT or invasive surgical procedures in the brain are not acceptable. Data from compatible MRI sequences can be processed to relate imaging changes to relative changes in tissue temperature during therapy. The Visualase™ cooling applicator utilizes saline.

In April 2013, the NeuroBlate® System (Monteris Medical) received initial clearance for marketing by the FDA through the 510(k) pathway (K120561). As of August 2020, the system is indicated for use “to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures (eg, brain tumor and epileptic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging), through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers” (K201056). The device is intended for planning and monitoring of thermal therapy under MRI guidance, providing real-time thermographic analysis of selected MRI images. The NeuroBlate® system utilizes a laser probe with a sapphire capsule to promote prolonged, pulsed laser firing and a controlled cooling applicator employing pressurized CO2.

CODING Medicare Advantage Plans and Commercial Products The following CPT code(s) are considered medically necessary when filed with the ICD-10 Diagnosis Codes* listed below: 61736 Laser interstitial thermal therapy (LITT) of lesion, intracranial, including burr hole(s), with magnetic
resonance imaging guidance, when performed; single trajectory for 1 simple lesion
61737 Laser interstitial thermal therapy (LITT) of lesion, intracranial, including burr hole(s), with magnetic
resonance imaging guidance, when performed; multiple trajectories for multiple or complex lesion(s)

*ICD-10 Diagnosis Code(s) C71.0
C71.1
C71.2
C71.3 - C71.9
C79.31
G40.011 -G40.019 G40.111 -G40.119 G40.211 - G40.219 G40.311 - G40.319
G40.A11 - G40.A19
G40.B11 - G40.B19
G40.411 - G40.419
G40.803 - G40.804

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM G40.813 - G40.814 G40.823 - G40.824 G40.911 - G40.919 T66.XXX+
RELATED POLICIES None PUBLISHED Provider Update, March 2025 Provider Update, March/September 2024 Provider Update, March 2023 Provider Update, March 2022 REFERENCES 1. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination: Laser Procedures (140.5). 1997; https://www.cms.gov/medicare-coverage- database/view/ncd.aspx?NCDId=69&ncdver=1&DocID=140.5. Accessed October 11, 2024. 2. Lagman C, Chung LK, Pelargos PE, et al. Laser neurosurgery: A systematic analysis of magnetic resonance-guided laser interstitial thermal therapies. J Clin Neurosci. Feb 2017; 36: 20-26. PMID 27838155 3. Medvid R, Ruiz A, Komotar RJ, et al. Current Applications of MRI-Guided Laser Interstitial Thermal Therapy in the Treatment of Brain Neoplasms and Epilepsy: A Radiologic and Neurosurgical Overview. AJNR Am J Neuroradiol. Nov 2015; 36(11): 1998-2006. PMID 26113069 4. Holste KG, Orringer DA. Laser interstitial thermal therapy. Neurooncol Adv. 2020; 2(1): vdz035. PMID 32793888 5. Pandey A, Chandla A, Mekonnen M, et al. Safety and Efficacy of Laser Interstitial Thermal Therapy as Upfront Therapy in Primary Glioblastoma and IDH-Mutant Astrocytoma: A Meta-Analysis. Cancers (Basel). Jun 03 2024; 16(11). PMID 38893250 6. Zhao X, Li R, Guo Y, et al. Laser interstitial thermal therapy for recurrent glioblastomas: a systematic review and meta-analysis. Neurosurg Rev. Apr 16 2024; 47(1): 159. PMID 38625588 7. Alkazemi M, Lo YT, Hussein H, et al. Laser Interstitial Thermal Therapy for the Treatment of Primary and Metastatic Brain Tumors: A Systematic Review and Meta-Analysis. World Neurosurg. Mar 2023; 171: e654-e671. PMID 36549438 8. Chen C, Guo Y, Chen Y, et al. The efficacy of laser interstitial thermal therapy for brain metastases with in-field recurrence following SRS: systemic review and meta-analysis. Int J Hyperthermia. 2021; 38(1): 273-281. PMID 33612043 9. de Franca SA, Tavares WM, Salinet ASM, et al. Laser interstitial thermal therapy as an adjunct therapy in brain tumors: A meta-analysis and comparison with stereotactic radiotherapy. Surg Neurol Int. 2020; 11:

360. PMID 33194293
361. Barnett GH, Voigt JD, Alhuwalia MS. A Systematic Review and Meta-Analysis of Studies Examining the Use of Brain Laser Interstitial Thermal Therapy versus Craniotomy for the Treatment of High-Grade Tumors in or near Areas of Eloquence: An Examination of the Extent of Resection and Major Complication Rates Associated with Each Type of Surgery. Stereotact Funct Neurosurg. 2016; 94(3): 164-73. PMID 27322392
362. Grabowski MM, Srinivasan ES, Vaios EJ, et al. Combination laser interstitial thermal therapy plus stereotactic radiotherapy increases time to progression for biopsy-proven recurrent brain metastases. Neurooncol Adv. 2022; 4(1): vdac086. PMID 35795470
363. Fadel HA, Haider S, Pawloski JA, et al. Laser Interstitial Thermal Therapy for First-Line Treatment of Surgically Accessible Recurrent Glioblastoma: Outcomes Compared With a Surgical Cohort. Neurosurgery. Nov 01 2022; 91(5): 701-709. PMID 35986677
364. Mohammadi AM, Sharma M, Beaumont TL, et al. Upfront Magnetic Resonance Imaging-Guided Stereotactic Laser-Ablation in Newly Diagnosed Glioblastoma: A Multicenter Review of Survival

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 (401) 274-4848 WWW.BCBSRI.COM

Outcomes Compared to a Matched Cohort of Biopsy-Only Patients. Neurosurgery. Dec 01 2019; 85(6): 762-772. PMID 30476325

14. Rennert RC, Khan U, Bartek J, et al. Laser Ablation of Abnormal Neurological Tissue Using Robotic Neuroblate System (LAANTERN): Procedural Safety and Hospitalization. Neurosurgery. Apr 01 2020; 86(4): 538-547. PMID 31076762
15. Kim AH, Tatter S, Rao G, et al. Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN): 12-Month Outcomes and Quality of Life After Brain Tumor Ablation. Neurosurgery. Sep 01 2020; 87(3): E338-E346. PMID 32315434
16. de Groot JF, Kim AH, Prabhu S, et al. Efficacy of laser interstitial thermal therapy (LITT) for newly diagnosed and recurrent IDH wild-type glioblastoma. Neurooncol Adv. 2022; 4(1): vdac040. PMID 35611270
17. Gecici NN, Gurses ME, Kaye B, et al. Comparative analysis of bevacizumab and LITT for treating radiation necrosis in previously radiated CNS neoplasms: a systematic review and meta-analysis. J Neurooncol. May 2024; 168(1): 1-11. PMID 38619777
18. Vellayappan B, Lim-Fat MJ, Kotecha R, et al. A Systematic Review Informing the Management of Symptomatic Brain Radiation Necrosis After Stereotactic Radiosurgery and International Stereotactic Radiosurgery Society Recommendations. Int J Radiat Oncol Biol Phys. Jan 01 2024; 118(1): 14-28. PMID 37482137
19. Palmisciano P, Haider AS, Nwagwu CD, et al. Bevacizumab vs laser interstitial thermal therapy in cerebral radiation necrosis from brain metastases: a systematic review and meta-analysis. J Neurooncol. Aug 2021; 154(1): 13-23. PMID 34218396
20. Sankey EW, Grabowski MM, Srinivasan ES, et al. Time to Steroid Independence After Laser Interstitial Thermal Therapy vs Medical Management for Treatment of Biopsy-Proven Radiation Necrosis Secondary to Stereotactic Radiosurgery for Brain Metastasis. Neurosurgery. Jun 01 2022; 90(6): 684-690. PMID 35311745
21. Sujijantarat N, Hong CS, Owusu KA, et al. Laser interstitial thermal therapy (LITT) vs. bevacizumab for radiation necrosis in previously irradiated brain metastases. J Neurooncol. Jul 2020; 148(3): 641-649. PMID 32602021
22. Hong CS, Deng D, Vera A, et al. Laser-interstitial thermal therapy compared to craniotomy for treatment of radiation necrosis or recurrent tumor in brain metastases failing radiosurgery. J Neurooncol. Apr 2019; 142(2): 309-317. PMID 30656529
23. Ahluwalia M, Barnett GH, Deng D, et al. Laser ablation after stereotactic radiosurgery: a multicenter prospective study in patients with metastatic brain tumors and radiation necrosis. J Neurosurg. May 04 2018; 130(3): 804-811. PMID 29726782
24. Kwan P, Arzimanoglou A, Berg AT, et al. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia. Jun 2010; 51(6): 1069-77. PMID 19889013
25. Wieser HG, Blume WT, Fish D, et al. ILAE Commission Report. Proposal for a new classification of outcome with respect to epileptic seizures following epilepsy surgery. Epilepsia. Feb 2001; 42(2): 282-6. PMID 11240604
26. Ekman F, Bjellvi J, Ljunggren S, et al. Laser interstitial thermal therapy versus open surgery for mesial temporal lobe epilepsy: A systematic review and meta-analysis. World Neurosurg. Sep 25 2024. PMID 39332763
27. Hect JL, Harford E, Maroufi SF, et al. Clinical outcomes of MR-guided laser interstitial thermal therapy corpus callosum ablation in drug-resistant epilepsy: a systematic review and meta-analysis. J Neurosurg Pediatr. Jan 01 2024; 33(1): 12-21. PMID 37856385
28. Barot N, Batra K, Zhang J, et al. Surgical outcomes between temporal, extratemporal epilepsies and hypothalamic hamartoma: systematic review and meta-analysis of MRI-guided laser interstitial thermal therapy for drug-resistant epilepsy. J Neurol Neurosurg Psychiatry. Feb 2022; 93(2): 133-143. PMID 34321344
29. Marathe K, Alim-Marvasti A, Dahele K, et al. Resective, Ablative and Radiosurgical Interventions for Drug Resistant Mesial Temporal Lobe Epilepsy: A Systematic Review and Meta-Analysis of Outcomes. Front Neurol. 2021; 12: 777845. PMID 34956057

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 5 (401) 274-4848 WWW.BCBSRI.COM

30. Kohlhase K, Zöllner JP, Tandon N, et al. Comparison of minimally invasive and traditional surgical approaches for refractory mesial temporal lobe epilepsy: A systematic review and meta-analysis of outcomes. Epilepsia. Apr 2021; 62(4): 831-845. PMID 33656182
31. Brotis AG, Giannis T, Paschalis T, et al. A meta-analysis on potential modifiers of LITT efficacy for mesial temporal lobe epilepsy: Seizure-freedom seems to fade with time. Clin Neurol Neurosurg. Apr 20 2021; 205: 106644. PMID 33962146
32. Grewal SS, Alvi MA, Lu VM, et al. Magnetic Resonance-Guided Laser Interstitial Thermal Therapy Versus Stereotactic Radiosurgery for Medically Intractable Temporal Lobe Epilepsy: A Systematic Review and Meta-Analysis of Seizure Outcomes and Complications. World Neurosurg. Feb 2019; 122: e32-e47. PMID 30244184
33. Xue F, Chen T, Sun H. Postoperative Outcomes of Magnetic Resonance Imaging (MRI)-Guided Laser Interstitial Thermal Therapy (LITT) in the Treatment of Drug-Resistant Epilepsy: A Meta-Analysis. Med Sci Monit. Dec 21 2018; 24: 9292-9299. PMID 30573725
34. Hoppe C, Helmstaedter C. Laser interstitial thermotherapy (LiTT) in pediatric epilepsy surgery. Seizure. Apr 2020; 77: 69-75. PMID 30591281
35. Hale AT, Sen S, Haider AS, et al. Open Resection versus Laser Interstitial Thermal Therapy for the Treatment of Pediatric Insular Epilepsy. Neurosurgery. Oct 01 2019; 85(4): E730-E736. PMID 30888028
36. Petito GT, Wharen RE, Feyissa AM, et al. The impact of stereotactic laser ablation at a typical epilepsy center. Epilepsy Behav. Jan 2018; 78: 37-44. PMID 29172137
37. Esmaeili B, Hakimian S, Ko AL, et al. Epilepsy-Related Mortality After Laser Interstitial Thermal Therapy in Patients With Drug-Resistant Epilepsy. Neurology. Sep 26 2023; 101(13): e1359-e1363. PMID 37202163
38. Kanner AM, Irving LT, Cajigas I, et al. Long-term seizure and psychiatric outcomes following laser ablation of mesial temporal structures. Epilepsia. Apr 2022; 63(4): 812-823. PMID 35137956
39. Landazuri P, Shih J, Leuthardt E, et al. A prospective multicenter study of laser ablation for drug resistant epilepsy - One year outcomes. Epilepsy Res. Nov 2020; 167: 106473. PMID 33045664
40. Wu C, Jermakowicz WJ, Chakravorti S, et al. Effects of surgical targeting in laser interstitial thermal therapy for mesial temporal lobe epilepsy: A multicenter study of 234 patients. Epilepsia. Jun 2019; 60(6): 1171-1183. PMID 31112302
41. Barnett G, Leuthardt E, Rao G, et al. American Association of Neurological Surgeons and Congress of Neurological Surgeons (AANS-CNS) Position Statement on MR-guided Laser Interstitial Thermal Therapy (LITT) for Brain Tumors and Radiation Necrosis. September 2021; https://www.aans.org/- /media/Files/AANS/Advocacy/PDFS/AANS-CNSPositionStatementPaperLITTTumor- Oncology090721.ashx. Accessed October 23, 2023.
42. Vogelbaum MA, Brown PD, Messersmith H, et al. Treatment for Brain Metastases: ASCO-SNO-ASTRO Guideline. J Clin Oncol. Feb 10 2022; 40(5): 492-516. PMID 34932393
43. Wu C, Schwalb JM, Rosenow J, et al. American Society for Stereotactic and Functional Neurosurgery Position Statement on Laser Interstitial Thermal Therapy for the Treatment of Drug-Resistant Epilepsy. September 2021; https://www.aans.org/- /media/Files/AANS/Advocacy/PDFS/ASSFNPositionStatementonLITTfortheTreatmentof DrugResistantEpilepsy091321.ashx. Accessed October 23, 2023.
44. Elder JB, Nahed BV, Linskey ME, et al. Congress of Neurological Surgeons Systematic Review and Evidence-Based Guidelines on the Role of Emerging and Investigational Therapties for the Treatment of Adults With Metastatic Brain Tumors. Neurosurgery. Mar 01 2019; 84(3): E201-E203. PMID 30629215
45. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Central Nervous System Cancers. Version 3.2024; https://www.nccn.org/professionals/physician_gls/pdf/cns.pdf. Accessed October 11, 2024.
46. National Institute for Health and Care Excellence (NICE). Interventional procedures guidance: MRI- guided laser interstitial thermal therapy for drug-resistant epilepsy [IPG671]. March 4, 2020; https://www.nice.org.uk/guidance/ipg671. Accessed October 11, 2024.

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 6 (401) 274-4848 WWW.BCBSRI.COM

i

This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS