MRI-guided Laser Interstitial Thermal Therapy for Neurological Indications

Description of Procedure or Service

Magnetic resonance imaging (MRI)-guided laser ablation technology has been proposed as a minimally invasive means of treating medically refractive epilepsy, brain tumors that are difficult to access or as an alternative to open craniotomy, and radiation necrosis. The procedure involves stereotactic insertion of a fiberoptic laser probe into the target area followed by laser activation. As light is delivered through the laser applicator, temperatures in the target area begin to rise, destroying the intended targeted tissue. When performed under MRI monitoring, the heat generation can be contoured to minimize injury to the surrounding normal tissue. In neurological applications, laser interstitial thermal therapy (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. The goal of therapy is selective thermal injury through the maintenance of a sharp thermal border, as monitored via the parallel use of realtime magnetic resonance (MR) thermography and controlled with the use of actively cooled applicators.

Proposed advantages of MRI-guided laser ablation technology over craniotomy for resection include:

• Decreased morbidity with a minimally invasive procedure 
• Faster recovery time 
• Shorter hospital and intensive care stay 
• Ability to access lesions not amenable to surgery 
• An alternative to surgery in individuals with significant comorbidities 

As the use of LITT for neurological indications evolves, so do the optimal indications and patient selection criteria for use. Contraindications to MRI are also applicable to the administration of LITT. Impact of the technology on several key outcomes, including survival in the treatment of tumors, is unknown.

Regulatory Status

Visualase™ MRI-Guided Laser Ablation (Medtronic; formerly Biotex, Inc.) received 510K marketing clearance (K071328) from the FDA in 2007. 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 individuals with medical conditions or implanted medical devices contraindicated for MRI and for individuals 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.

***Note: This Medical Policy is complex and technical. For questions concerning the technical language and/or specific clinical indications for its use, please consult your physician.

Policy

BCBSNC will provide coverage for MRI-guided Laser Interstitial Thermal Therapy for Neurological Indications when it is determined the medical criteria and guidelines below are met.

Some individuals may be eligible for coverage under Clinical Trials. Refer to the policy on Clinical Trial Services.

Benefits Application

This medical policy relates only to the services or supplies described herein. Please refer to the Member's Benefit Booklet for availability of benefits. Member's benefits may vary according to benefit design; therefore member benefit language should be reviewed before applying the terms of this medical policy.

When MRI-guided Laser Interstitial Thermal Therapy for Neurological Indications is covered

Treatment of epilepsy using laser interstitial thermal therapy (LITT) may be considered medically necessary when the following criteria are met:

1. There is documentation of disabling seizures despite use of two or more antiepileptic drug regimens (i.e., medically-refractory epilepsy), AND 
2. There are well-defined epileptogenic foci accessible by LITT. 

Treatment of brain tumors or radiation necrosis of the brain using LITT may be considered medically necessary when the following criteria are met:

1. LITT is being used to treat: 
   1. recurrent or progressive malignant tumor (primary or metastatic), or 
   2. lesion(s) inaccessible to surgical resection, or 
   3. the individual is unable to tolerate surgical resection due to medical comorbidities, AND 
2. The treatment plan to use LITT has been agreed upon by a multidisciplinary team of physicians to include at least two specialists (eg neurosurgery, oncology) and, after considering all relevant possible treatment approaches, is determined to be the best treatment option, AND
3. The LITT is being performed by a neurosurgeon who has completed procedure-specific training in the use of an FDA-approved LITT ablation system and who has been granted hospital privileges to perform brain tumor surgery and LITT ablation procedures. 

When MRI-guided Laser Interstitial Thermal Therapy for Neurological Indications is not covered

MRI-guided laser interstitial thermal therapy (LITT) when the criteria above are not met is considered investigational. 

Policy Guidelines

This procedure is also referred to as laser-induced interstitial thermotherapy (LITT), laser-induced thermotherapy, interstitial laser therapy and stereotactic laser ablation.

The evidence for use of LITT for neurological indications consists mainly of retrospective case series with systematic reviews of these low-quality studies. Prospective studies do not include comparative evidence. Published studies include heterogeneous patient populations and outcomes reported, limiting conclusions that can be drawn about the effectiveness of LITT. For epilepsy, case series suggest that for patients with medically-refractory epilepsy and well-defined lesions, treatment with LITT may lead to freedom from seizures without the morbidity of temporal lobe resection. For use of LITT for brain tumors, questions remain as to the optimal patient population, tumor type and treatment setting (primary vs recurrent). Ongoing, prospective registry data is being collected to track long-term outcomes and complication rates.

Cost analyses support LITT as a cost-effective alternative relative to open surgery.

Billing/Coding/Physician Documentation Information

This policy may apply to the following codes. Inclusion of a code in this section does not guarantee that it will be reimbursed. For further information on reimbursement guidelines, please see Administrative Policies on the Blue Cross Blue Shield of North Carolina web site at www.bcbsnc.com. They are listed in the Category Search on the Medical Policy search page.

Applicable service codes: 61736, 61737

Scientific Background and Reference Sources

U.S. Food and Drug Administration (FDA). Visualase ® Thermal Therapy System (k071328). Biotex, Inc., Houston, Texas. Accessed January 31, 2017.

Carpentier A. et.al. Laser thermal therapy: realtime MRI-guided and computer-controlled procedures for metastatic brain tumors. Lasers Surg Med. December 2011; 43(10): 94350.

American College of Radiology/American Society of Neuroradiology. (2014). ACR/ASNR practice parameter for the performance of non-breast magnetic resonance imaging (MRI) guided procedures. Retrieved January 31, 2017

Lewis, E. C., Weil, A. G., Duchowny, M., Bhatia, S., Ragheb, J., & Miller, I. (2015). MR-guided laser interstitial thermal therapy for pediatric drug-resistant lesional epilepsy. Epilepsia, 56 (10), 1590-1598. Retrieved January 31, 2017 

Medvid, R., Ruiz, A., Komotar, R. J., Jagid, J. R., Ivan, M. E., Quencer, R. M., et al. (June 2015). Current applications of MRI-guided laser interstitial thermal therapy in the treatment of brain neoplasms and epilepsy: a radiologic and neurosurgical overview. American Journal of Neuroradiology. Retrieved January 31, 2017 

Mohammadi, A. M., Hawasli, A. H., Schroeder, J. L., Laxton, A. W., Elson, P., et al. (2014). The role of laser interstitial thermal therapy in enhancing progression-free survival of difficult-to access high-grade gliomas: a multicenter study. Cancer Medicine, 3 (4), 971-979. Retrieved January 31, 2017

Sloan, A. E., Ahluwalia, M. S., Valerio-Pascua, J., Manjila, S., Torchia, M. G., Jones, S. E., et al. (2013). Results of the NeuroBlate System first-in-humans Phase I clinical trial for recurrent glioblastoma: clinical article. Journal of Neurosurgery, 118 (6), 1202-1219. Retrieved January 31, 2017

Sun, X. R., Patel, N. V., & Danish, S. F. (2015). Tissue ablation dynamics during magnetic resonance-guided, laser-induced thermal therapy. Neurosurgery, 77 (1), 51-58. Retrieved January 31, 2017 

Voigt JD, Torchia M. Laser interstitial thermal therapy with and without MRI guidance for treatment of brain neoplasms – A systematic review of the literature. Photon Lasers Med. 2014;3(2):77-93.

Gomez FM, Patel PA, Stuart S, Roebuck DJ. Systematic review of ablation techniques for the treatment of malignant or aggressive benign lesions in children. Pediatr Radiol. 2014;44(10):1281-1289.

Karsy M, Guan J, Ducis K, Bollo RJ. Emerging surgical therapies in the treatment of pediatric epilepsy. Transl Pediatr. 2016;5(2):67-78. Retrieved February 1, 2017 

Willie JT, Laxpati N, Drane D, et al. Real-Time Magnetic Resonance-Guided Stereotactic Laser Amygdalohippocampotomy for Mesial Temporal Lobe Epilepsy. Neurosurgery. 2014 June; 74(6):569- 585. Retrieved February 1, 2017

Kang JY, Wu C, Tracy J, et al. Laser interstitial thermal therapy for medically intractable mesial temporal lobe epilepsy. Epilepsia. 2016;57(2):325-334. Retrieved February 1, 2017

Specialty Matched Consultant Advisory Panel 10/2017

Epilepsy Foundation of America. Information For Professionals. Diagnosis & Treatment. MagneticResonance-Guided Laser Interstitial Thermal Therapy (MR-g LITT). Accessed September 2018. 

U.S. Food and Drug Administration. Safety Alerts for Human Medical Products. Magnetic Resonanceguided Laser Interstitial Thermal Therapy (MRgLITT) Devices: Letter to Health Care Providers - Risk of Tissue Overheating Due to Inaccurate Magnetic Resonance Thermometry. Posted 4/25/18. Accessed September 2018

Specialty Matched Consultant Advisory Panel 10/2018

U.S. Food and Drug Administration. Medical Devices. Medical Device Safety. Letters to Healthcare Providers. Update Regarding Risk of Tissue Overheating Due to Inaccurate Magnetic Resonance Thermometry. Posted 11/8/18. Accessed September 2019

U.S. Food and Drug Administration (FDA). NeuroBlate® System (K162762).  Accessed September, 2019.

Specialty Matched Consultant Advisory Panel 10/2019

Williams D, Loshak H. Laser Interstitial Thermal Therapy for Epilepsy and/or Brain Tumours: A Review of Clinical Effectiveness and Cost-Effectiveness [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Jun 17.

Rennert RC, Khan U, Bartek J Jr, et al. Laser Ablation of Abnormal Neurological Tissue Using Robotic Neuroblate System (LAANTERN): Procedural Safety and Hospitalization. Neurosurgery. 2019 May 11.

Shimamoto S, Wu C, Sperling MR. Laser interstitial thermal therapy in drug-resistant epilepsy. Curr Opin Neurol. 2019 Apr;32(2):237-245.

Specialty Matched Consultant Advisory Panel 10/2020

Specialty Matched Consultant Advisory Panel 10/2021

Specialty Matched Consultant Advisory Panel 10/2022

Specialty Matched Consultant Advisory Panel 10/2023

Medical Director review 10/2023

Specialty Matched Consultant Advisory Panel 10/2024

Medical Director review 10/2024

Policy Implementation/Update Information

4/28/17 New policy developed. MRI-guided Laser-induced Thermotherapy for Neurological Indications is considered investigational. Policy noticed 4/28/2017 for effective date 6/30/2017. (sk)

11/10/17 Specialty Matched Consultant Advisory Panel review 10/25/2017. (sk)

11/9/18 References added. Specialty Matched Consultant Advisory Panel review 10/24/2018. (sk)

2/25/20 Policy titled changed from MRI-Guided Laser-induced Thermotherapy for Neurological Indications to MRI-Guided Laser Interstitial Thermal Therapy for Neurological Indications. Medically necessary criteria added for refractory epilepsy. References added. Specialty Matched Consultant Advisory Panel review 10/16/2019. (sk)

7/21/20 Medically necessary criteria added for brain tumors and radiation necrosis. (hb)

11/10/20 Specialty Matched Consultant Advisory Panel review 10/21/2020. (sk)

12/30/21 Specialty Matched Consultant Advisory Panel review 10/20/2021. Added codes 61736 and 61737 to Billing/Coding section. (sk)

5/2/23 Policy update. Specialty Matched Consultant Advisory Panel review 10/19/2022. (sk)

11/7/23 Updated Description, Regulatory Status and references. Removed CPT code 64999. Specialty Matched Consultant Advisory Panel review 10/2023. Medical Director review 10/2023. (ldh)

11/13/24 Updated Regulatory Status and References. Specialty Matched Consultant Advisory Panel review 10/2024. Medical Director review 10/2024. (ldh)