Commercial

Medical Policy

Title:

Magnetic Resonance Imaging (MRI)-Guided Focused Ultrasound Ablation

Policy #:

11.06.06g

Policy

MEDICALLY NECESSARY

Magnetic resonance imaging (MRI)‒guided focused ultrasound ablation may be considered medically necessary for pain palliation in adult individuals with metastatic bone cancer who failed or are not candidates for radiotherapy.

Magnetic resonance imaging (MRI)‒guided focused ultrasound ablation may be considered medically necessary for medicine-refractory essential tremors in adult individuals aged 22 years of age or older, when all of the following criteria are met:

Documented diagnosis of essential tremor was confirmed by a neurologist specializing in movement disorders
Score two or greater on the Clinical Rating Scale for Tremor
Substantial disability in the performance of at least two daily activities from the disability subsection of the Clinical Rating Scale for Tremor

EXPERIMENTAL/INVESTIGATIONAL

All other uses for MRI-guided focused ultrasound ablation are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature. This includes, but is not limited to, the following:

Treatment of uterine leiomyomata (fibroids)
Treatment of other tumors (e.g., breast cancer, brain cancer, desmoid tumors and prostate cancer)
Treatment of medication-refractory tremor dominant Parkinson disease

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, magnetic resonance imaging (MRI)‒guided focused ultrasound ablation is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as experimental/investigational are not eligible for coverage or reimbursement by the Company.

CLINICAL RATING SCALE FOR TREMOR

Fahn, Tolosa, and Marin* developed a rating scale used for quantifying rest, postural, and action/intention tremors. The scale evaluates voice tremor, handwriting/drawing, and other specific functional daily living tasks. The scale is measured for severity on a five-point assessment, with a maximum total score of 144. Higher scores indicate higher tremor severity.

The rating scale is divided into three parts (A, B, and C):

Part A (scores 1 to 9; maximum score of 80) quantifies the tremor at rest, with maintaining a posture, and with performing an action or intentional maneuvers, for nine parts of the body (e.g., limbs, tongue, head, and trunk). All body parts would not naturally present with tremor and as such, not all body parts would be measured in all situations.

Part B (scores 10 to 14; maximum score of 36) relates to action tremors of the upper extremities; five tasks are measured involving handwriting, drawing, and pouring. To assess handwriting, the dominant hand will write a standard sentence. Drawing is evaluated by having the individual perform the activity on the scale. Pouring is analyzed using specified water levels to measure the amount of spillage after pours between two cups.

Part C (scores 15 to 21; maximum score of 28) assesses functional disability. Tremor severity scores are evaluated for speaking, feeding, ability to bring liquids to the mouth, hygiene, dressing, and working. All scores except speaking are self-reported based on the definitions provided in the scale.

Refer to

https://www.researchgate.net/profile/Eduard_Tolosa/publication/307538277_Clinical_Rating_Scale_for_Tremor/links/5832e79508ae004f74c57ae1/Clinical-Rating-Scale-for-Tremor.pdf

for the direct link to the Clinical Rating Scale for Tremor to represent the medically necessary criteria in the policy.

*Fahn S, Tolosa E, Marin C. Clinical rating scale for tremor. In: Jankovik J, Tolosa E. Parkinson's Disease and Movement Disorders. Baltimore-Munich: Urban & Schwarzenberg;1988:225-34.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

In October 2004, the ExAblate® 2000 System (InSightec Inc., Haifa, Israel) received FDA approval through the premarket approval (PMA) process. This device is indicated for "ablation of uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine-sparing procedure. Patients must have a uterine size of less than 24 weeks and have completed child bearing."

In October 2012, the ExAblate® System, Model 2000/2100/2100 VI received FDA approval through the PMA process. This device is indicated for "pain palliation of metastatic bone cancer in patients 18 years of age or older who are suffering from bone pain due to metastatic disease and who are failures of standard radiation therapy, or not candidates for, or refused radiation therapy."

In July 2016, the ExAblate® Neuro System received FDA approval through the PMA process. The device is indicated for "essential tremors in patients who have not responded to medication (beta-blockers or anticonvulsant drugs)."

Description

MAGNETIC RESONANCE IMAGING (MRI)‒GUIDED FOCUSED ULTRASOUND (MRgFUS)

Magnetic resonance imaging (MRI)‒guided focused ultrasound (MRgFUS) is a noninvasive thermal ablation technique that combines high-intensity focused ultrasound (HIFU) with real time magnetic resonance imaging (MRI). Focused ultrasound penetrates through soft tissues and delivers acoustic energy to heat targeted lesions to ablative temperatures (i.e., to approximately 65°C‒85°C), which is sufficient to achieve tissue ablation at the focal point while minimizing damage to surrounding tissues. With the addition of MRI, providers are able to perform precise localized tumor tissue ablation with real-time thermal monitoring.

BONE METASTASES

Bone metastases, or metastatic bone disease, is a class of cancer metastases that results from primary tumor invasion to bone. Bone-originating primary tumors such as osteosarcoma, chondrosarcoma, and Ewing's sarcoma are rare. Unlike hematological malignancies that originate in the blood and form nonsolid tumors, bone metastases generally arise from epithelial tumors and form a solid mass inside the bone. Primary bone neoplasms account for ~0.2% of all cancer. In children, adolescents and young adults, osteosarcoma is the most common malignant (cancerous) bone tumor, however, it is still a rare disorder. This bone cancer affects approximately 400 children younger than age 20 every year in the United States.

Bone is the third most common location for metastasis, after the lung and liver. Bone metastases can develop in any bone; however, some cancers, particularly solid tumors (e.g., breast, prostate, lung, thyroid, and kidney cancers), are more likely to spread to the bone than others. Common sites of bone metastases are the spine, pelvis, ribs, skull, and proximal femur.

Bone metastases cause severe pain, characterized by a dull, constant ache with periodic spikes of incident pain. Between 50% and 70% of patients with bone metastases experience severe pain that can significantly interfere with daily functioning and quality of life.

Current treatments for pain from bone metastases include conservative measures (e.g., massage, exercise) and pharmacologic agents (e.g., analgesics, bisphosphonates, corticosteroids). Standard second-line treatment for patients who fail conservative measures and pharmacological agents is external beam radiation therapy (EBRT); however, treatment is only effective in 60% to 65% of patients, and there is additional concern regarding the radiation effects to healthy surrounding tissue.

For individuals with metastatic bone cancer who have failed or are not candidates for radiotherapy who receive MRgFUS, the evidence includes a sham-controlled randomized trial, a systematic review of RCTs and observational studies, and case series. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment-related morbidity. The RCTs found statistically significant improvements after MRgFUS in a composite outcome comprising a reduction in pain and morphine use, and in pain reduction as a stand-alone outcome. A substantial proportion of individuals in the treatment group experienced adverse events, but most events were transient and not severe. Pooled efficacy data from a systematic review reported a treatment response to MRgFUS of 79%. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

ESSENTIAL TREMOR

Essential tremor (ET) is the most prevalent movement disorder, with an estimated prevalence of 5% of the population. ET commonly affects the hands and arms, may affect head and voice, and rarely presents in the face, legs, and trunk. ET is heterogeneous among individuals, with variations in frequency, amplitude, causes of exacerbation, and association with other neurologic deficits.

ET may be idiopathic with no known etiology. For individuals with intermittent or persistent disability due to the tremor, medical management with pharmaceuticals is considered first-line therapy. In individuals who are found to be medicine refractory, surgery (e.g., deep-brain stimulation [DBS] or thalamotomy) may be offered; however, for individuals who are found to not be good surgical candidates and because high rates of adverse events have been reported in surgical procedures, MRgFUS could be a treatment.

For individuals with medicine-refractory essential tremors who receive MRgFUS, the evidence includes a technology assessment, meta-analyses, and a double-blind, sham-controlled randomized trial. Relevant outcomes include symptoms, functional outcomes, quality of life, and treatment-related morbidity. The assessment did not pool study results but concluded that, overall, MRgFUS decreased tremor severity and improved quality of life. One meta-analysis reported significant improvements in hand tremor scores from baseline up to 24 months posttreatment, with evidence of a diminishing treatment benefit over time. Another meta-analysis found similar improvements in tremor severity with MRgFUS to unilateral DBS, but improvements in both were inferior to bilateral DBS. The sham-controlled randomized trial found significant improvements in the treatment group in tremor severity, functional improvement, and quality of life after 3 months of follow-up. The improvements in hand tremor score, function, and quality of life were maintained at the 2-year follow-up. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

OTHER TUMORS (E.G., BREAST CANCER, BRAIN CANCER, DESMOID TUMORS, PROSTATE CANCER)

BRAIN CANCER

Only small case series have assessed the safety and/or efficacy of MRgFUS for treating tumors related to brain cancer.

BREAST CANCER

Only small case series have assessed the safety and/or efficacy of MRgFUS for treating tumors related to breast cancer. The most recent case series on the use of MRgFUS for breast cancer ablation was published by Merckel et al. (2016). Ten individuals with early-stage invasive breast cancer underwent MRgFUS prior to surgical resection. Ablation was confirmed histopathologically in six of these individuals. The investigators concluded that MRgFUS is safe and feasible. A noted limitation is the long procedure time (average, 145 minutes) due to waiting time after contrast injection and time to find a proper magnetic resonance navigator signal.

DESMOID TUMORS

Several case series have investigated the use of MRgFUS for desmoid tumors. Avedian et al. (2016) used MRgFUS to treat nine patients with desmoid tumors. Five individuals were available for follow-up for at least 12 months. Mean decrease in tumor size was 36% (95% CI, 7%‒66%). Bucknor et al. (2017) described the use of MRgFUS to treat three individuals with large aggressive desmoid tumors within the posterior thigh. Each individual received multiple MRgFUS treatments. In this case series, the use of MRgFUS for desmoid tumors required different treatment parameters than those used for fibroids or bone lesions, due to differences in vascularity of the target tissue and the need for effective skin protection when using MRgFUS on extremities. Ghanouni et al. (2017) used MRgFUS to treat 15 individuals with extra-abdominal desmoid tumors. Treatment times ranged from 0.8 to 8 hours. Results were presented on nine individuals (three were lost to follow-up before 6 months, three received additional treatments). Seven of nine individuals experienced durable clinical benefits, with a median reduction in tumor volume of 98%. Treatment-related adverse events included skin burns, nerve injury, and off-target heating.

PROSTATE CANCER

Evidence on the use of MRgFUS for the treatment of prostate cancer consists of a nonrandomized, uncontrolled phase II trial, which reported a 93% success rate at 5 months. Evidence on the use of MRgFUS for the treatment of nonspinal osteoid osteoma consists of several case series, including a propensity score-matched retrospective study that reported similar reductions in pain with radiofrequency ablation and MRgFUS.

Currently, evidence on the use of MRgFUS for the treatment of other tumors consists of small case series, which is insufficiently robust to draw conclusions about efficacy. RCTs comparing MRgFUS with other noninvasive procedures would be informative.

TREMOR-DOMINANT PARKINSON DISEASE

A double-blind, sham-controlled, pilot randomized trial by Bond et al. (2017) assessed the safety and efficacy of unilateral MRgFUS thalamotomy in individuals with tremor-dominant Parkinson disease. The primary efficacy outcome evaluated was the change from baseline (on-medication state) to 3 months after the procedure in the hand tremor subscore in the Clinical Rating Scale for Tremor. Trial characteristics and results are summarized in Tables 3 and 4. After unblinding at 3 months, six of the seven individuals who received sham procedures crossed over to undergo open-label treatment with MRgFUS. The most common thalamotomy-related adverse events reported for all 26 individuals treated were finger paresthesia (39%), ataxia (35%), and orofacial paresthesia (27%). Paresthesia and ataxia persisted to 1 year in 19% and 4% of patients, respectively. Eight severe adverse events were reported in four individuals, and three were thalamotomy-related (two individuals with persistent mild hemiparesis and one had an associated persistent mild ataxia). The sham-controlled randomized trial found significant improvements in the treatment group in tremor severity after 3 months of follow-up. Authors of the study noted that a larger study is needed to prove efficacy.

UTERINE LEIOMYOMATA (FIBROIDS)

Uterine leiomyomata, commonly known as fibroids or myomas, are the most common uterine neoplasm of the female genital tract. They are diagnosed in up to 25% of women and are a significant source of morbidity for reproductive-aged women.

Most fibroids are asymptomatic and require no treatment, but women with problematic fibroids often experience heavy menstrual bleeding, constant cramping, feelings of fullness in the lower abdomen, frequent urination, incontinence, pain during sexual intercourse, lower back pain, and infertility. The number and severity of symptoms is typically related to the size, location, and number of fibroids in the uterus. Until recently, hysterectomy (removal of the uterus) was considered the most effective method of treating symptomatic uterine fibroids.

Less-invasive alternatives to hysterectomy include myomectomy (laparoscopic, hysteroscopic, and vaginal), uterine artery embolization (UAE), laser myolysis, and hormonal therapy. However, they allow for the possibility of new leiomyomas to form. In addition, pre-existing leiomyomas that were previously too small to be detected, or were intentionally not removed may exhibit significant growth, which can lead to other problems.

For the treatment of uterine fibroids, there are two small RCTs: one with 49 women that compared MRgFUS with UAE and the other a feasibility trial assessing 20 women that had a sham control. Several nonrandomized studies have also compared MRgFUS with different treatments. The sham-controlled randomized trial concluded that a larger trial would be feasible. The trial reported significantly lower fibroid volumes in the active treatment group; however, there were no statistically significant differences in quality of life between the groups. The other RCT reported no significant differences in medication use or symptoms between the MRgFUS and UAE groups. Recovery was significantly faster in the MRgFUS group than in the UAE group. A 2014 systematic review, which identified only noncomparative studies, did not pool results due to heterogeneity in outcomes among the studies. Although reviewers concluded that MRgFUS may be a safe and effective minimally invasive option for the treatment of fibroids, they noted that RCTs comparing MRgFUS with other noninvasive procedures would be informative. In a 2013 comparative study, outcomes appeared to be better with UAE than with MRgFUS. There is insufficient evidence on the long-term treatment effects, recurrence rates, and impact on future fertility and pregnancy of this therapy.

References

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Blue Cross Blue Shield Association Technology Evaluation Center (TEC). Magnetic resonance-focused ultrasound therapy for symptomatic uterine fibroids. TEC Assessments. 2005;Volume 20, Tab 10.

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Elias WJ, Lipsman N, Ondo WG, et al. A randomized trial of focused ultrasound thalamotomy for essential tremor. N Engl J Med. 2016;375(8):730-9.

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Fahn S, Tolosa E, Marin C. Clinical rating scale for tremor. In: Jankovik J, Tolosa E. Parkinson's Disease and Movement Disorders. Baltimore-Munich: Urban & Schwarzenberg; 1988:225-34.

Fennessy FM, Tempany CM, McDannold NJ, et al. Uterine leiomyomas: MR imaging-guided focused ultrasound surgery: results of different treatment protocols. Radiology. 2007;243(3):885-93.

Froeling V, Meckelburg K, Schreiter NF, et al. Outcome of uterine artery embolization versus MR-guided high-intensity focused ultrasound treatment for uterine fibroids: long-term results. Eur J Radiol. 2013;82(12):2265-9.

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Gelet A, Chapelon JY, Bouvier R, et al. Local control of prostate cancer by transrectal high intensity focused ultrasound therapy: preliminary results. J Urol. 1999;161(1):156-62.

Ghai S, Finelli A, Corr K, et al. MRI-guided focused ultrasound ablation for localized intermediate-risk prostate cancer: early results of a phase II trial. Radiology. 2021;298(3):695-703.

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Gianfelice D, Khiat A, Amara M, et al. MR imaging-guided focused ultrasound surgery of breast cancer: correlation of dynamic contrast-enhanced MRI with histopathologic findings. Breast Cancer Res Treat. 2003;82(2):93-101.

Gianfelice D, Khiat A, Amara M, et al. MR imaging-guided focused US ablation of breast cancer: histopathologic assessment of effectiveness: initial experience. Radiology. 2003;227(3):849-55.

Gianfelice D, Khiat A, Boulanger Y, et al. Feasibility of magnetic resonance imaging-guided focused ultrasound surgery as an adjunct to tamoxifen therapy in high-risk surgical patients with breast carcinoma. J Vasc Interv Radiol. 2003;14(10):1275-82.

Giordano M, Caccavella VM, Zaed I, et al. Comparison between deep brain stimulation and magnetic resonance-guided focused ultrasound in the treatment of essential tremor: a systematic review and pooled analysis of functional outcomes. J Neurol Neurosurg Psychiatry. 2020; 91(12):1270-8.

Gizzo S, Saccardi C, Patrelli TS, et al. Magnetic resonance-guided focused ultrasound myomectomy: safety, efficacy, subsequent fertility and quality-of-life improvements: a systematic review. Reprod Sci. 2014;21(4):465-76.

Gorny KR, Woodrum DA, Brown DL, et al. Magnetic resonance-guided focused ultrasound of uterine leiomyomas: review of a 12-month outcome of 130 clinical patients. J Vasc Interv Radiol. 2011;22(6):857-64.

Hindley J, Gedroyc WM, Regan L, et al. MRI guidance of focused ultrasound therapy of uterine fibroids: early results. AJR Am J Roentgenol. 2004;183(6):1713-19.

Huber PE, Jenne JW, Rastert R, et al. A new noninvasive approach in breast cancer therapy using magnetic resonance imaging-guided focused ultrasound surgery. Cancer Res. 2001;61(23):8441-7.

Hurwitz MD, Ghanouni P, Kanaev SV, et al. Magnetic resonance-guided focused ultrasound for patients with painful bone metastases: phase III trial results. J Natl Cancer Inst. 2014;106(5).

Hynynen K, Pomeroy O, Smith DN, et al. MR imaging-guided focused ultrasound surgery of fibroadenomas in the breast: a feasibility study. Radiology. 2001;219(1):176-85.

Jaaskelainen J. Non-invasive transcranial high intensity focused ultrasound (HIFUS) under MRI thermometry and guidance in the treatment of brain lesions. Acta Neurochir Suppl. 2003;88:57-60.

Jacoby VL, Kohi MP, Poder L, et al. PROMISe trial: a pilot, randomized, placebo-controlled trial of magnetic resonance guided focused ultrasound for uterine fibroids. Fertil Steril. 2016;105(3):773-80.

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Coding

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

0398T

THE FOLLOWING CODE CAN BE USED TO REPRESENT MRI GUIDED FOCUSED ULTRASOUND ABLATION FOR THE PALLIATION OF METASTATIC BONE CANCER:

76498

EXPERIMENTAL/INVESTIGATIONAL

0071T, 0072T

THE FOLLOWING CODE IS USED TO REPRESENT ABLATION OF PROSTATE, TRANSRECTAL, HIGH INTENSITY FOCUSED ULTRASOUND (HIFU), INCLUDING IMAGING GUIDANCE PROCEDURE:

55899

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

C79.51 Secondary malignant neoplasm of bone

C79.52 Secondary malignant neoplasm of bone marrow

G25.0 Essential tremor

HCPCS Level II Code Number(s)

MEDICALLY NECESSARY

C9734 Focused ultrasound ablation/therapeutic intervention, other than uterine leiomyomata, with magnetic resonance (MR) guidance

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From 11.06.06g:

08/09/2023	This policy has been reissued in accordance with the Company's annual review process.
08/29/2022	This version of the policy will become effective on 08/29/2022. This policy was updated to communicate the Company position for Magnetic resonance imaging (MRI)‒guided focused ultrasound ablation for the treatment of medication-refractory tremor dominant Parkinson disease and desmoid tumors as Experimental/Investigational.

Revisions From 11.06.06f:

06/02/2021

This policy has been reissued in accordance with the Company's annual review process.

01/01/2021

This policy has been identified for the HCPCS code update, effective 01/01/2021.

Inclusion of a policy in a Code Update memo does not imply that a full review of
the policy was completed at this time.

The following HCPCS code has been termed and removed from this policy:

C9747 Ablation of prostate, transrectal, high intensity focused ultrasound (hifu), including imaging guidance

The following not otherwise classifed code has been added to this policy to represent ablation of prostate, transrectal, high intensity focused ultrasound (HIFU), including imaging guidance procedure:

55899

Revisions From 11.06.06e:

02/26/2020	This policy has been reissued in accordance with the Company's annual review process.
10/29/2018	This version of the policy will become effective on 10/22/2018. This policy was updated to communicate Company position for essential tremors. Essential Tremor was added as a Medically Necessary indication. The following diagnosis code were added to the policy: G25.0.

Revisions From 11.06.06d:

11/22/2017

This policy has undergone a routine review, and no revisions have been made.

Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date:

8/29/2022

Version Issued Date: