Pending Policies - Surgery


Laser Induced Interstitial Tumor Therapy (LITT/ILT) and Laser Ablation of Tumors

Number:SUR701.031

Effective Date:11-01-2017

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Laser interstitial tumor therapy (LITT/ILT) and interstitial laser ablation (ILA) are considered experimental, investigational and/or unproven for any indication, including but not limited to:

  • Adrenal metastases;
  • Brain tumors;
  • Breast tumors (benign or malignant);
  • Liver metastases;
  • Pancreatic cancer;
  • Prostate cancer;
  • Radionecrosis;
  • Spinal metastasis; or
  • Thyroid nodules.

Description:

Laser induced interstitial thermal therapy (LITT/ILT) and laser ablation is a minimally invasive therapy for the treatment of solid tumors that utilizes image guided laser probes to heat and destroy the affected tissue. The absorption of light energy results in volumetric heating which ultimately leads to thermal destruction of the tumor. (1) The device is used to cut, destroy, or remove tissue by light energy emitted by carbon dioxide. It is also utilized as a dermatologic device intended to destroy or coagulate tissue by light energy emitted by argon. (2)

Regulatory Status

There are several devices that received U.S. Food and Drug Administration (FDA) approval under the 510K marketing clearance process, including but not limited to, the Kelsey Interstitial Laser Therapy System® (2), Novilase® (3) and Visualase® Thermal Therapy System (5).

Kelsey Interstitial Laser Therapy System® received FDA 510K marketing clearance (K070353) from the U.S. FDA in 2007 for the treatment of fibroadenomas of the breast, with tumor sizes up to 20 mm; and for general surgery procedures including incision, excision and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissue. (2)

Novilase® Laser Therapy System (K160392) received 510K marketing clearance from the FDA in 2007 for the treatment of breast fibroadenomas (benign tumors) of the breast that are 2 cm or less in diameter. It is also utilized for general surgery procedures (i.e. incision, excision and ablation of soft tissues, coagulative necrosis and interstitial laser coagulation of soft tissue). (3,4)

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. (5)

Rationale:

Adrenal

In 2007, Vogl and colleagues reviewed adrenal metastases: computerized tomography (CT) guided and magnetic resonance (MR) thermometry-controlled laser-induced interstitial thermotherapy. (6) The aim of the study was to evaluate the feasibility, safety and effectiveness of CT-guided and MR-thermometry-controlled laser-induced interstitial thermotherapy (LITT) in adrenal metastases. Nine patients (seven male, two female; average age 65.0 years; range 58.7-75.0 years) with nine unilateral adrenal metastases (mean diameter 4.3 cm) from primaries comprising colorectal carcinoma (n = 5), renal cell carcinoma (n = 1), esophageal carcinoma (n = 1), carcinoid (n = 1), and hepatocellular carcinoma (n = 1) underwent CT-guided, MR-thermometry-controlled LITT using a 0.5 T MR unit. LITT was performed with an internally irrigated power laser application system with an Nd:YAG laser. A thermosensitive, fast low-angle shot 2-dimensional sequence was used for real-time monitoring. Follow-up studies were performed at 24 h and 3 months and, thereafter, at 6-month intervals (median 14 months). All patients tolerated the procedure well under local anesthesia with no complications. Complete ablation was achieved in seven lesions, verified by MR imaging; progression was detected in two lesions in the follow up. The preliminary results suggest that CT-guided, MR-thermometry-controlled LITT is a safe, minimally invasive and promising procedure for treating adrenal metastases.

Brain Tumors

In 2006, Schwarzmaier et al. researched the survival after laser-induced interstitial thermotherapy in 16 patients suffering from recurrent glioblastoma multiforme. (7) The concept underlying the intervention is the cytoreduction of the tumor tissue by local thermocoagulation. All patients received standard chemotherapy (temozolomide). The median overall survival time after the first relapse was 9.4 months, corresponding to a median overall survival time after laser irradiation of 6.9 months. During the study, however, the median survival after laser coagulation increased to 11.2 months. This survival time is substantially longer than those reported for the natural history (<5 months) or after chemotherapy (temozolomide: 5.4-7.1 months). We conclude that cytoreduction by laser irradiation might be a promising option for patients suffering from recurrent glioblastoma multiforme. In addition, the data indicate the presence of a substantial learning curve. Future work should optimize the therapeutic regimen and evaluate this treatment approach in controlled clinical trials.

Carpentier et al. conducted a pilot clinical trial exploring the safety and feasibility of real-time magnetic resonance imaging (MRI) guided LITT for treatment of resistant focal metastatic intracranial tumors. (8) In 7 patients with chemotherapy, whole-brain radiation, and radiosurgery resistant metastatic intracranial tumors, minimally invasive stereotaxic placement of a saline-cooled interstitial fiber optic laser applicator under local anesthesia was followed by laser irradiation during continuous MRI scanning. A total of 15 metastatic tumors were treated in 7 patients. In all cases, the procedure was well tolerated, and patients were discharged home within 24 hours. Physical exam and imaging at up to 30 months showed an acute increase in apparent lesion volume followed by a gradual and steady decrease. No tumor recurrence within thermal ablation zones was noted. Kaplan-Meier analysis indicated that the median survival was 19.8 months. This small pilot study concluded that real-time MRI guidance of laser-induced thermal therapy (LITT) offers a high level of control. This tool therefore enables a minimally invasive option for destruction and treatment of resistant focal metastatic intracranial tumors. MR-guided LITT appears to provide a safe and potentially effective treatment for recurrent focal metastatic brain disease. A larger phase II and III series would be of interest to quantify potential median survival advantage.

In 2014, ECRI (9) reviewed literature related to the use of Visualase Thermal Therapy System for MRI-guided Laser Ablation for Neurologic Tumors. Evidence composed of 18 small case series (some of which may have reported on the same patients) suggests that the Visualase system can be used to ablate intracranial tumors and seizure foci with minimal complications. The evidence is insufficient to determine whether it works as well as or better than alternatives because no comparative studies are available. The treatment effect on patient survival and quality of life is unknown. Additional comparative studies are needed.

Clinical Guidelines And Position Statements

The NICE clinical guidelines for central nervous system cancers published in January 2016 does not identify LITT/ILT (interstitial laser thermotherapy) as a treatment modality. (10)

Breast Tumors

In 2008, Haraldsdóttir et al. studied ILT of the breast to evaluate if it could be utilized as radical treatment for breast cancer (11). Twenty-four patients, aged 39-84 (mean 61), with invasive breast cancer were treated with ILT. All underwent mammography, ultrasound and core biopsy before treatment. The tumor was an invasive ductal carcinoma in 15 patients, a lobular carcinoma in 8 Patients and a lobular-ductal cancer in one patient. Average tumor diameter was 14 mm on ultrasound. Patients were treated in the outpatient clinics under local anesthesia. Probes were placed under ultrasound guidance, in 19 patients, and ILT was performed with a diode laser at a steady-state temperature of 48 degrees C for 30 min using temperature feedback control. Standard surgical excision was performed 12 days after ILT and was preceded by Doppler ultrasound. Treatment-induced necrosis of invasive cancer was 33% (range 0-100) and was complete in three patients. At follow-up before surgery, the extent of laser damage could not be judged with ultrasound, although abolished tumor blood flow was demonstrated after treatment resulting in large necrosis. Efficacy of treatment varied negatively with tumor size. The inefficacy of ILT was mainly due to the underestimation of tumor size by mammography and ultrasound and the shortcomings of these methods to demonstrate tumor borders, tumor irregularity and carcinoma in situ (CIS). ILT was well tolerated. Five patients had breast tenderness, and three patients had pain, during the first day after treatment. Small skin necrosis was observed in two patients. The study concluded that small breast cancers can be treated radically with ILT. The method may become useful in the treatment of breast cancer but needs further refinement, even for small well-defined breast cancers, if it is going to be employed for radical treatment.

Clinical Guidelines And Position Statements

In June 2005, the National Institute for Health and Clinical Excellence (NICE) published guidelines related to interstitial laser therapy for fibroadenomas of the breast. (12) The experts expressed that because a sample of the lump is not removed during the laser treatment, it’s not possible to confirm that the lump is benign. During a standard operation, a biopsy can be performed and the tissue can be verified by the laboratory. Based on studies, adverse reactions may include burns at the needle insertion site, possible infection and risk for bleeding if the needle hits a blood vessel. It should be explained to the patient that a fibroadenoma of the breast is not breast cancer, and that one option is to take no further action except to keep an eye on the lump. There should be special arrangements in place so that the patient only consents to the procedure after this discussion has taken place. NICE concluded “there are still uncertainties over the safety of the procedure and how well it works. There should be special arrangements in place for patient consent after a discussion has taken place. Interstitial laser therapy for fibroadenoma of the breast should be carried out by doctors working within specialist breast services. Not all doctors do this procedure in the same way, and the differences in technique might make some more likely to be successful, than others.” NICE may evaluate the procedure again if more results from studies are published.

NICE clinical guidelines for advanced breast cancer published in January 2009 (13) and the National Comprehensive Cancer Network (NCCN) clinical guidelines for breast cancer published February 2016 does not identify LITT/ILT as a treatment modality. (14)

Liver Metastases

In 2004, Wietzke-Braun et al. studied LITT as a minimal invasive procedure for local tumor destruction within solid organs. (15) The aim of the study was to investigate quality of life and outcomes of ultrasound-guided LITT in patients with liver metastases of colorectal cancer. This was a prospective non-randomized study involving 45 patients with liver metastases from colorectal cancer and was palliatively treated by LITT. Patient survival was analyzed by the Kaplan-Meier method and the quality of life by questionnaire C30 of the European Organization for Research and Treatment of Cancer before, and 1 week, 1 month, and 6 months after initiation of LITT. Median survival after initiation of LITT was 8.5 +/- 0.7 months with a range of 1.5-18 months. Body weight was constant 1 month after LITT. In the multivariate analyses, quality-of-life symptoms and functioning scales did not deteriorate in patients alive at 6 months after initiation of LITT. Univariate analyses outlined a significant increase of the pain subscale before and at 1 week after LITT. The study determined potential benefits of LITT to include prolonged survival time by preserved quality of life. This first impression will need to be verified in a comparative study.

In 2011, the Swedish Council on Health Technology Assessment (SBU) evidence concluded, “Laser-induced thermotherapy is a non-surgical method for treating tumors in solid organs. The method is experimental and considered primarily in treating patients with liver metastases when surgery is not an option. It is uncertain whether or not laser-induced thermotherapy extends life in patients with liver metastases. Comparative studies are lacking. Studies published to date show that this treatment method can ablate metastases, and that risks associated with the procedure are minor. However, the beneficial effect of metastases ablation, in terms of symptoms and quality of life, has not been demonstrated in the literature. Use of this method should be limited to controlled trials. This implies that patients must be informed about the different treatment options and the scientific evidence available at the time.” (16)

In 2014, Eichler and colleagues (17) studied a small sample of MR-guided laser-induced thermotherapy (LITT) patients with liver metastases of uveal melanoma. LITT was performed in 18 patients with liver metastases (n = 44) from uveal malignant melanoma. All patients tolerated this intervention well. Survival rates were calculated with the Kaplan-Meier method. Indications for the procedure were defined for patients with no more than 5 metastases, none of which were larger than 5 cm in diameter. The indications for LITT treatment were recurrent liver metastases after partial liver resection (22%), locally non-resectable tumors (17%) or metastases in both liver lobes (61%). The mean survival rate for all treated patients was 3.6 years (95% CI: 2.19, 5.06). The median survival was 1.83 years; 1-year survival, 88%; 3-year survival 47%, 5-year survival 17%. After the first LITT treatment the median survival was 2.8 years (95% CI: 1.0, 5.0). Ten patients were treated by transarterial chemoembolization before LITT. The authors concluded MR-guided LITT treatment shows a high local tumour control and survival rates in patients with liver metastases of uveal malignant melanoma.

Pancreatic Cancer

In 2011, Saccomandi et al. researched LITT for pancreatic tumor ablation (18). This study aimed to develop and verify a theoretical model to reproduce the thermal response of pancreatic tissue that had undergone the LITT procedure. The model provides the evaluation of ablated volumes induced by thermal ablation, tissue response time to irradiation and heat extinction time. Theoretical volume values were compared with ex vivo healthy tissue and in vivo healthy and neoplastic tissue volume values. The theoretical model takes into account the differences between healthy and neoplastic tissue due to blood perfusion. Mathematical model shows that ablated volume of ex vivo healthy tissue is greater than in vivo one after the same treatment. Moreover, ablated neoplastic in vivo tissue volume is greater than healthy in vivo one, because of tumor angiogenesis. Ablated volume values were compared with experimental data obtained by laser treatment of 30 ex vivo porcine pancreases. Experimental ablated volume values show a good agreement with theoretical values, with an estimated increase of 61% when power increases from 3 W to 6 W, versus 46% of experimental data, and an estimated increase of 14% from 6 W to 10 W, versus 21% of experimental values. LITT could be an alternative or a neo-adjuvant treatment to surgical resection for pancreas cancer removal, and the proposed model could be the basis to supervising the evolution of ablated volumes during tumor treatment.

Clinical Guidelines And Position Statements

The NCCN clinical guideline for pancreatic adenocarcinoma published February 2016 does not identify LITT/ILT as a treatment modality. (19)

Prostate Cancer

In 2012 Nguyen et al. studied focal therapy in the management of localized prostate cancer in order to assess the rationale, efficacy, and morbidity of various methods of achieving focal prostatic ablation and to determine the current role of focal therapy in the management of localized prostate cancer. (20) A literature review was conducted with an emphasis on more established methods such as cryoablation and high-intensity focused ultrasound. It concluded that focal ablative methods allow targeted destruction of prostatic tissue while limiting the morbidity associated with whole-gland therapy. Local cancer control after focal therapy appears promising but does not approach that of established whole-gland therapies. Until we have the ability to identify patients reliably with truly focal disease and predict their natural history, focal therapy cannot be considered to be the definitive therapy for localized prostate cancer.

In 2012, Collin and colleagues (21) realized there were current challenges and innovations related to prostate cancer management that development of focal therapies that allow the treatment of only the cancer areas sparing the rest of the gland to minimize the potential morbidity. Focal laser ablation appears as a potential candidate to reach the goal of focusing energy delivery on the identified targets. The study reviewed current literature regarding this new therapeutic modality. Relevant literature was identified using MEDLINE database to include focal therapy, laser interstitial thermotherapy, prostate cancer, and focal laser ablation, Precision real-time monitoring, MRI compatibility, and low cost of integrated system are principal advantages of focal laser ablation. Feasibility and safety of this technique have been reported in phase I assay. Focal laser ablation might eventually prove to be a middle ground between active surveillance and radical treatment. In conclusion, Focal laser ablation may have found a role in the management of prostate cancer. However, further trials are required to demonstrate the oncologic effectiveness in the long term.

In 2012, Nomura et al. studied focal therapy in the management of prostate cancer. (22) Over the past decade, interest in focal therapy as a less morbid option for the treatment of localized low-risk prostate cancer has recently been renewed due to downward stage migration. Focal therapy stands midway between active surveillance and radical treatments, combining minimal morbidity with cancer control. Several techniques of focal therapy have potential for isolated ablation of a tumor focus with sparing of uninvolved surround tissue demonstrating excellent short-term cancer control and a favorable patient's quality of life. However, to date, tissue ablation has mostly used for near-whole prostate gland ablation without taking advantage of accompanying the technological capabilities. The available ablative technologies include cryotherapy, high-intensity focused ultrasound (HIFU), and vascular-targeted photodynamic therapy (VTP). Despite the interest in focal therapy, this technology has not yet been a well-established procedure nor provided sufficient data, because of the lack of randomized trial comparing the efficacy and morbidity of the standard treatment options.

In 2013, Bozzini et al. (23) noticed that focal therapy had emerged as an intermediate management technique between radical approaches (radical prostatectomy, external beam radiation, and brachytherapy) and to manage some early stage prostate cancers (CaP). The study was to review energy modalities and their indications. They focused on literature that concentrated on the practical aspects of focal therapy for CaP with the following key words: photodynamic therapy, high intensity focused ultrasound (HIFU), cryotherapy, focal laser ablation, electroporation, radio frequency, external beam radiation, organ-sparing approach, focal therapy, CaP, and then cross-referenced from previously identified studies. It was determined that prostatic tumor ablation can be achieved with different energies: freezing effect for cryotherapy, thermal effect using focalized ultrasound for HIFU, and using thermal effect of light for focal laser ablation (FLA) and activation of a photosensitizer by light for PDT, among others. Radio frequency and microwave therapy have been tested in this field and demonstrated their usefulness. Electroporation is currently being developed on preclinical models. External beam radiation with microboost on neoplastic foci is under evaluation. HIFU and cryotherapy require the use of sophisticated and expensive machines and, consequently, the procedure is expensive. Laser techniques seem to be less onerous, with the added advantage of size. Several energy modalities are being developed to achieve the trifecta of continence, potency, and oncologic efficiency. Those techniques come with low morbidity but clinical experience is limited regarding to oncologic outcome. Comparison of the different focal approaches is complex owing to important heterogeneity of the trials. In the future, it seems likely that each technique will have its own selective indications.

Clinical Guidelines And Position Statements

The NCCN clinical guideline for prostate cancer published January 2014 does not identify LITT/ILT as a treatment modality. (24)

Radionecrosis

Whole-brain radiotherapy and stereotactic radiosurgery (SRS) play a central role in the treatment of metastatic brain tumors. Radiation necrosis occurs in 5% of patients and can be very difficult to treat. The available treatment options for radiation necrosis include prolonged high-dose corticosteroids, hyperbaric oxygen, anticoagulation, bevacizumab, and surgical resection. In 2012, Rahmathulla et al. presented the first report and results using LITT for medically refractory radionecrosis. A 74-year-old diabetic patient who had a history of non-small cell lung cancer with brain metastases and subsequent treatment with SRS, presented with a focal lesion in the left centrum semiovale with progressively worsening edema. Image findings were consistent with radiation necrosis that was refractory despite prolonged, high-dose steroid therapy. The associated comorbidities obviated alternative interventions and the lesion was not in a location amenable to surgical resection. Laser thermal ablation was used to treat the biopsy-proven radionecrosis. The procedure was tolerated well and the patient was discharged 48 hours postoperatively. Imaging at 7-week follow-up showed near complete resolution of the edema and associated mass effect. Additionally, the patient was completely weaned off steroids. LITT may be an effective treatment modality for patients with medically refractory radiation necrosis with lesions not amenable to surgical decompression. (25)

Spinal Metastasis

A literature search failed to identify any randomized controlled trials of LITT for the treatment of spinal metastasis. One small study was identified as follows:

In 2015, Tatsui et al. (26) stated that high-grade malignant spinal cord compression is commonly managed with a combination of surgery aimed at removing the epidural tumor, followed by spinal stereotactic radiosurgery (SSRS) aimed at local tumor control. The researchers introduced the use of spinal LITT as an alternative to surgery prior to SSRS. Eleven (n=11) patients with a high degree of epidural malignant compression due to radioresistant tumors participated in the study. Visual analog scale (VAS) scores for pain and quality of life were obtained before and within 30 and 60 days after treatment. A laser probe was percutaneously placed in the epidural space. Real-time thermal MRI was used to monitor tissue damage in the region of interest. All patients received postoperative SSRS. The maximum thickness of the epidural tumor was measured, and the degree of epidural spinal cord compression (ESCC) was scored in pre- and postprocedure MRI. The mean VAS score for pain decreased from 6.18 in the preoperative period to 4.27 within 30 days and 2.8 within 60 days after the procedure. A similar VAS interrogating the percentage of quality of life demonstrated improvement from 60% preoperatively to 70% within both 30 and 60 days after treatment. Imaging follow-up 2 months after the procedure demonstrated a significant reduction in the mean thickness of the epidural tumor from 8.82 mm (95% CI 7.38-10.25) before treatment to 6.36 mm (95% CI 4.65-8.07) after spinal LITT and SSRS (p = 0.0001). The median preoperative ESCC Grade 2 was scored as 4, which was significantly higher than the score of 2 for Grade 1b (p = 0.04) on imaging follow-up 2 months after the procedure. The small study (n=11) concluded that spinal LITT provided local control with low morbidity and improvement in both pain and the quality of life of patients.

Currently, the evidence is insufficient to demonstrate that LITT improves health outcomes in patients with spinal metastasis. Additional well-conducted RCTs with sufficiently large sample sizes are needed to validate the safety and efficacy of LITT in patients with spinal metastasis and the impact to health outcomes.

Clinical Guidelines And Position Statements

The 2016 NCCN clinical guideline for the central nervous system does not identify LITT/ILT as a treatment modality for metastatic spine tumors. (10)

Thyroid

In 2011, Dossing et al. (27) researched the long-term outcome following interstitial laser photocoagulation (ILP) of benign cold thyroid nodules. A total of 78 euthyroid outpatients (45 participating in randomized trials) with a benign solitary solid and scintigraphically cold thyroid nodule causing local discomfort were assigned to ILP. ILP (using one laser fiber) was performed under continuous ultrasound (US) guidance and with an output power of 1.5-3.5?W. Thyroid nodule volume was assessed by US and thyroid function determined by routine assays, before and during follow-up. Pressure symptoms and cosmetic complaints were evaluated on a visual analogue scale (0-10?cm). Of the total patients, six had thyroid surgery 6 months after ILP and three were lost to follow-up. The median follow-up for the remaining 69 patients was 67 months (range 12-114). The overall median nodule volume decreased from 8.2?ml to 4.1?ml at the final evaluation, corresponding to a median reduction of 51%. This correlated with a significant decrease in pressure as well as cosmetic complaints. After 12--96 months of ILP, 21 patients (29%) had thyroid surgery because of an unsatisfactory result. All had benign histology. Thyroid function was unaltered throughout and side effects were restricted to mild local pain. This study concluded that US-guided ILP results in a satisfactory long-term clinical response in the majority of patients with a benign solitary solid cold thyroid nodule and additional large-scale studies should aim at optimizing selection criteria for ILP, preferably in randomized studies.

A search of peer reviewed literature through November 16, 2016 identified additional small clinical trial publications (n=14, n=15, n=22) related to the use of LITT/ILT on the thyroid. Additional well-conducted RCTs with sufficiently large sample sizes are needed to validate the safety and efficacy of LITT in these patients and the impact on health outcomes.

Clinical Guidelines And Position Statements

The 2016 NCCN clinical guideline for thyroid carcinoma does not identify LITT/ILT as a treatment modality for thyroid tumors. (28)

Summary

There is inadequate published peer reviewed literature to permit scientific conclusions regarding the safety and efficacy of laser interstitial tumor therapy (LITT/ILT) and interstitial laser ablation (ILA) and the impact to health outcomes therefore, laser interstitial tumor therapy (LITT/ILT) and interstitial laser ablation (ILA) is considered experimental, investigational and/or unproven.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

There is no specific code for LITT/IDL therefore this procedure typically is billed as an unlisted code.

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

19499, 47399, 48999, 53899, 55899, 60699, 64999

HCPCS Codes

N/A

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

  1. Visualase, Inc. Visualase laser technology glossary and FAQ. Available at <http://www.medtronic.com> (accessed November 11, 2016).
  2. U.S. Food and Drug Administration (FDA). Kelsey interstitial laser therapy system. 510(k) Summary (K070353). Kelsey, Inc. Chicago, IL. Rockville, MD. April 1, 2014. Available at <http://www.accessdatafda.gov> (accessed November 11, 2016).
  3. U.S. Food and Drug Administration (FDA). Novilase. (K160392) Novilian Health. Available at <http://www.accessdatafda.gov> (accessed November 14, 2016).
  4. Novian Health, Inc. Novilase ®. Chicago, IL. Available at <http://www.novianhealth.com> (accessed November 14, 2016).
  5. U.S. Food and Drug Administration (FDA). Visualase ® Thermal Therapy System (k071328). Biotex, Inc., Houston, Texas. Available at <http://www.fda.gov> (accessed November 14, 2016).
  6. Vogl T. J. et al. Adrenal metastases: CT-guided and MR-thermometry-controlled laser-induced interstitial thermotherapy. Eur Radiol. 2007; 17(8): 2020-2027. PMID 17180325.
  7. Schwarzmaier HJ et al. MR-guided laser-induced interstitial thermotherapy of recurrent glioblastoma multiforme: Preliminary results in 16 patients. Eur J Radiol. 2006; 59(2):208-215. PMID: 16854549.
  8. Carpentier A. et.al. Laser thermal therapy: real-time MRI-guided and computer-controlled procedures for metastatic brain tumors. Lasers Surg Med. December 2011; 43(10): 943-50. PMID 22109661.
  9. ECRI Institute. Visualase Thermal Therapy System (Visualase, Inc.) for MRI-guided Laser Ablation for Neurologic Tumors; 2014 August (Product Brief).
  10. National comprehensive cancer network (NCCN) clinical practice guidelines in oncology: Central nervous system cancer: V1.2016. Available at <http://www.nccn.org> (accessed November 15, 2016).
  11. Haraldsdóttir KH et al. Interstitial laser thermotherapy (ILT) of breast cancer. Eur J Surg Oncol. 2008; 34(7):739-745. PMID 18291614.
  12. Interstitial laser therapy for fibroadenomas of the breast, National institute for health and clinical excellence (NICE). June 2005. Available at < http://www.nice.org.uk> (accessed November 15, 2016).
  13. Advanced breast cancer: diagnosis and treatment guideline. National institute for health and clinical excellence (NICE). February 2009 (reaffirmed July 2014). Available at <http://www.nice.org.uk> (accessed November 15, 2016).
  14. National comprehensive cancer network (NCCN) clinical practice guidelines in oncology: Breast cancer: V2.2016. Available at <http://www.nccn.org> (accessed November 15,2016).
  15. Wietzke-Braun et al. Quality of life and outcome of ultrasound-guided laser interstitial thermo-therapy for non-resectable liver metastases of colorectal cancer. Eur J Gastroenterol Hepatol. 2004 April; 16(4):389-95. PMID 15028971
  16. Laser-induced interstitial thermal therapy for liver metastases. Swedish Council on Health Technology Assessment. Alert Report No. 2011-01. Stockholm, Sweden: SBU; March 2, 2011. Available at <http://www.sbu.se> (accessed November 16, 2016).
  17. Eichler K1, Zangos S, Gruber-Rouh T, et al. MR-guided laser-induced thermotherapy (LITT) in patients with liver metastases of uveal melanoma. J Eur Acad Dermatol Venereol. 2014 Dec;28(12):1756-60. Epub 2014 Mar 5. PMID 24593299.
  18. Saccomandi P, Schena E, Di Matteo FM, et al. Laser interstitial thermotherapy for pancreatic tumor ablation: Theoretical model and experimental validation. Conf Proc IEEE Eng Med Biol Soc. 2011; 5585-5588. PMID 22255605.
  19. National comprehensive cancer network (NCCN) clinical practice guidelines in oncology: Pancreatic adenocarcinoma. V2.2016. Available at <http://www.nccn.org> (accessed November 15, 2016).
  20. Nguyen CT, Jones JS. Focal therapy in the management of localized prostate cancer. BJU Int. 2011; 107(9):1362-1368. PMID 21223478.
  21. Colin P, Mordon S, Nevoux P, et al. Focal laser ablation of prostate cancer: Definition, needs, and future. Adv Urol. 2012. PMID 22666240.
  22. Nomura T, Mimata H. Focal therapy in the management of prostate cancer: An emerging approach for localized prostate cancer. Adv Urol. 2012; 391-437. PMID 22593764.
  23. Bozzini G, Colin P, Nevoux P, et al. Focal therapy of prostate cancer: Energies and procedures. Urol Oncol. 2012; July 11. PMID 22795500.
  24. National comprehensive cancer network (NCCN) clinical practice guidelines in oncology: Prostate cancer: V3.2016. Available at <http://www.nccn.org> (accessed November 15, 2016).
  25. Rahmathulla G, Recinos PF, Valerio JE, et al. Laser interstitial thermal therapy for focal cerebral radiation necrosis: A case report and literature review. Stereotact Funct Neurosurg. 2012; 90(3):192-200. PMID 22678505.
  26. Tatsui CE1, Stafford RJ2, Li J3 et al. Utilization of laser interstitial thermotherapy guided by real-time thermal MRI as an alternative to separation surgery in the management of spinal metastasis. J Neurosurg Spine. 2015 Oct; 23(4):400-11. PMID: 26140398.
  27. Dossing H, Bennedbæk FN, Hegedus L, et al. Long-term outcome following interstitial laser photocoagulation of benign cold thyroid nodules. Eur J Endocrinol. 2011; 165(1):123-128.
  28. National Comprehensive Cancer Network (NCCN) clinical practice guidelines in oncology: Thyroid carcinoma: V1.2016. Available at <http://www.nccn.org> (accessed November 16, 2016).

Policy History:

DateReason
11/1/2017 Reviewed. No changes.
1/1/2017 Document updated with literature review. Added spinal metastasis as an example under the experimental, investigational and/or unproven coverage statement.
7/15/2015 Reviewed. No changes.
7/1/2014 New Medical Document. Laser Interstitial Tumor Therapy (LITT/ILT) and Interstitial Laser Ablation (ILA) of Tumors are considered experimental, investigational and/or unproven: for any indication, including but not limited to: Adrenal metastases; brain tumors; breast tumors (benign or malignant); liver metastases; pancreatic cancer; prostate cancer; radionecrosis; thyroid nodules.

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