Description of Procedure or Service

Magnetic resonance imaging (MRI)-guided laser ablation technology has been proposed as a means of treating high-grade glioblastomas, medically refractive epilepsy, and brain tumors that are difficult to access. Laser energy is delivered to the target area using a laser applicator. As light is delivered through the laser applicator, temperatures in the target area begin to rise, destroying the unwanted tissue.

Proposed advantages of MRI-guided laser ablation technology include:

• Most procedures are completed in less time when compared to open procedures
• Most patients have little or no hair removed • Minimal sutures required
• Shorter stay when compared to open procedures
• Reduced scarring compared to open procedures

Regulatory Status

Visualase ^® Thermal Therapy System received 510K marketing clearance (K071328) from the FDA in 2007 and is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery, in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800nm through 1064nm. When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the Visualase system can process images to determine relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time. When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of Visualase analysis.

***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

MRI-guided Laser-induced Thermotherapy for Neurological Indications is considered investigational for all applications. BCBSNC does not provide coverage for investigational services or procedures. Some patients 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-induced Thermotherapy for Neurological Indications is covered

Not applicable.

When MRI-guided Laser-induced Thermotherapy for Neurological Indications is not covered

MRI-guided Laser-induced Thermotherapy for Neurological Indications is considered investigational for all applications.

Policy Guidelines

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

There has been interest in the use of minimally invasive surgery such as magnetic resonance-guided laser induced thermal therapy (MRgLITT) in the surgical management of a number of clinical conditions, including intra-cranial tumors and epilepsy. Surgical debulking, by both operational resection and by LITT, does not yet provide a significant solution to mortality in gliobastoma multiforme. Systematic evidence reviews of LITT for the treatment of intracranial neoplasms from 2014 concluded that large multi-center prospective trials are needed to establish its effectiveness. Preliminary findings suggest that MRgLITT has the potential to improve the effectiveness and reduce the morbidity associated with the surgical management of lesional, drug-resistant epilepsy in certain patients (depending on type of epilepsy, kind of lesion that is the source of the epilepsy, and other factors related to the particular laser treatment used). However, multi-center, prospective studies are needed to delineate optimal candidates for MRgLITT, and larger cohorts are needed to define outcome and complication rates. Long-term outcomes from laser ablation therapy are not known, and further studies are ongoing to track long-term outcomes.

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: 64999

BCBSNC may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Scientific Background and Reference Sources

U.S. Food and Drug Administration (FDA). Visualase ^® Thermal Therapy System (k071328). Biotex, Inc., Houston, Texas. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf7/k071328.pdf.
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 from www.acr.org.

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 from http://onlinelibrary.wiley.com/doi/10.1111/epi.13106/abstract

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 from http://www.ajnr.org/content/36/11/1998.full.pdf+html

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 from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4303165/pdf/cam40003-0971.pdf

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 from http://thejns.org/doi/pdf/10.3171/2013.1.JNS1291

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 from https://www.researchgate.net/profile/Xiaonan_Sun/publication/276439554_Tissue_Ablation_Dynamics_During_Magnetic_Resonance-Guided_Laser-Induced_Thermal_Therapy/links/55f3436008ae6a34f6605d15.pdf

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 from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4855197/pdf/tp-05-02-067.pdf

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 from http://neurosurgery.washington.edu/attachments/Willie_NSG_2014.pdf .

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 from file:///C:/Users/u748997/Downloads/Kang_et_al-2016-Epilepsia.pdf .

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)