243 Form

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Medical Policy Magnetic Resonance‒Guided Focused Ultrasound
Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 243

BCBSA Reference Number: 7.01.109 (For Plan internal use only) Related Policies
Radiofrequency Ablation of Miscellaneous Solid Tumors Excluding Liver Tumors #259 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity

Magnetic resonance guided high-intensity ultrasound ablation may be considered MEDICALLY NECESSARY for pain palliation in adult patients with metastatic bone cancer who failed or are not candidates for radiotherapy.

Magnetic resonance-guided high-intensity ultrasound ablation may be considered MEDICALLY NECESSARY for the treatment of medicine-refractory essential tremors.

Magnetic resonance-guided high-intensity ultrasound ablation is considered INVESTIGATIONAL in all other situations including but not limited to: • Treatment of uterine fibroids
• Treatment of other tumors (eg, brain cancer, prostate cancer, breast cancer, desmoid)
• Treatment of medication-refractory tremor dominant Parkinson disease.

Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) Prior authorization is not required. Commercial PPO and Indemnity Prior authorization is not required.

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CPT Codes / HCPCS Codes / ICD Codes Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The following codes are included below for informational purposes only; this is not an all-inclusive list.

The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity:

CPT Codes CPT codes:

Code Description 61715 Magnetic resonance image guided high intensity focused ultrasound (MRgFUS), stereotactic ablation of target, intracranial, including stereotactic navigation and frame placement, when performed

The following ICD Diagnosis Code is considered medically necessary when submitted with the CPT code above if medical necessity criteria are met:

ICD-10 diagnosis coding ICD-10 Diagnosis code Description G25.0 Essential tremor

The following CPT codes are considered investigational for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue:

CPT Codes CPT codes:

Code Description 0071T Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total leiomyomata volume less than 200 cc of tissue 0072T Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total leiomyomata volume greater or equal to 200 cc of tissue 0947T Magnetic resonance image guided low intensity focused ultrasound (MRgFUS), stereotactic blood-brain barrier disruption using microbubble resonators to increase the concentration of blood-based biomarkers of target, intracranial, including stereotactic navigation and frame placement, when performed

Description Uterine Fibroids Uterine fibroids are 1 of the most common conditions affecting women in the reproductive years. African American women have a greater lifetime incidence of uterine fibroids compared to other racial groups.1, Symptoms of uterine fibroids include menorrhagia, pelvic pressure, or pain.

Treatment Approaches currently available to treat symptomatic uterine fibroids include hysterectomy, abdominal myomectomy, laparoscopic and hysteroscopic myomectomy, hormone therapy, uterine artery embolization,

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and watchful waiting. Hysterectomy and various myomectomy procedures are considered the criterion standard treatments.

Metastatic Bone Disease Metastatic bone disease is 1 of the most common causes of cancer pain.

Treatment Existing treatments include conservative measures (eg, massage, exercise) and pharmacologic agents (eg, analgesics, bisphosphonates, corticosteroids). For patients who do not respond to these treatments, standard care is external-beam radiotherapy. However, a substantial proportion of patients have residual pain after radiotherapy, and there is a need for alternative treatments for these patients. (One option, radiofrequency ablation, is addressed in policy #259.

Essential Tremors Essential tremor (ET) is the most common movement disorder, with an estimated prevalence of 5% worldwide. Essential tremor most often affects the hands and arms, may affect head and voice, and rarely includes the face, legs, and trunk. Essential tremor is heterogeneous among patients, varying in frequency, amplitude, causes of exacerbation, and association with other neurologic deficits.

Treatment The neuropathology of ET is uncertain, with some evidence suggesting that ET is localized in the brainstem and cerebellum. If patients with ET experience intermittent or persistent disability due to the tremors, initial therapy is with drugs (beta-blockers or anticonvulsants). For medicine-refractory patients, surgery (deep brain stimulation or thalamotomy) may be offered, though high rates of adverse events have been observed.

Tremor-Dominant Parkinson Disease The 3 cardinal features of Parkinson disease (PD) are tremor, bradykinesia, and rigidity. The tremor in PD is a resting tremor that occurs when the body part is not engaged in purposeful activities. Major subtypes of PD include tremor-dominant, akinetic-rigid, and postural instability and gait difficulty. The progression of PD is highly variable and patients can change subtypes as the disease progresses.

Treatment Dopaminergic therapy (ie, levodopa or a dopamine agonist) is the first-line treatment for PD, which improves tremor. Amantadine and anticholinergics (eg, trihexyphenidyl) can also be considered as initial treatment for tremor-dominant PD or as add-on therapy in patients who have persistent tremor despite dopaminergic therapy. For medication-refractory patients, surgery (deep brain stimulation or lesioning procedures) may be offered. Lesioning procedures include conventional unilateral thalamotomy and focused ultrasound thalamotomy. Deep brain stimulation is the most frequently performed surgical procedure for the treatment of PD.

Magnetic Resonance-Guided Focused Ultrasound Magnetic resonance-guided focused ultrasound (MRgFUS) is a noninvasive treatment that combines 2 technologies: focused ultrasound and magnetic resonance imaging (MRI). The ultrasound beam penetrates through the soft tissues and, using MRI for guidance and monitoring, the beam can be focused on targeted sites. Ultrasound causes a local increase in temperature in the target tissue, resulting in coagulation necrosis while sparing the surrounding normal structures. Ultrasound waves from each sonication are directed at a focal point that has a maximum focal volume of 20 nm in diameter and 15 nm in height/length. This causes a rapid rise in temperature (ie, to 65°C to 85°C), which is sufficient to ablate tissue at the focal point. In addition to providing guidance, the associated MRI can provide online thermometric imaging, a temperature "map", to confirm the therapeutic effect of the ablation treatment and allow for real-time adjustment of the treatment parameters.

The U.S. Food and Drug Administration (FDA) approved the ExAblate® MRgFUS system (InSightec) for 4 indications: treatment of uterine fibroids (leiomyomata), palliation of pain associated with tumors metastatic to bone, medication refractory ET, and tremor-dominant PD. The ultrasound equipment is specifically designed to be compatible with magnetic resonance magnets, and it is integrated into standard clinical MRI

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units; it also includes a patient table, which has a cradle that houses the focused ultrasound transducer in water or a light oil bath. Some models have a detachable cradle; only certain cradle types can be used for palliation of pain associated with metastatic bone cancer. For treating pain associated with bone metastases, the aim of MRgFUS is to destroy nerves in the bone surface surrounding the tumor. MRgFUS is also being investigated for the treatment of other tumors, including breast, prostate, brain, and desmoid tumors as well as nonspinal osteoid osteoma.

Summary Description An integrated system providing magnetic resonance-guided focused ultrasound (MRgFUS) treatment is proposed as a noninvasive therapy for uterine fibroids and pain palliation of bone metastases. MRgFUS is also being investigated as a treatment of other benign and malignant tumors as well as essential tremors.

Summary of Evidence For individuals who have uterine fibroids who receive magnetic resonance-guided focused ultrasound (MRgFUS), the evidence includes systematic reviews, 2 randomized controlled trials (RCTs), nonrandomized comparative studies, and case series. Relevant outcomes are symptoms, quality of life, resource utilization, and treatment-related morbidity. One RCT (N=20) has reported some health outcomes but its primary purpose was to determine the feasibility of a larger trial. It did not find statistically significant differences in quality-of-life outcomes between active and sham treatment groups but it did find lower fibroid volumes after active treatment. This trial did not have an active comparator, the clinical significance of the primary outcome was unclear, and there were no follow-up data beyond 1 year. The second RCT (N=49) had preliminary results at 6 weeks post treatment, comparing MRgFUS with uterine artery embolization (UAE), and demonstrated that the 2 groups are comparable in medication use and symptom improvement following treatments. Patients in the MRgFUS group reported recovering significantly faster than patients in the uterine artery embolization group, as measured by time to return to work and time to normal activities. Long-term follow-up results reported a lower reintervention rate and greater improvement in symptoms after UAE compared to MRgFUS. A 2021 meta-analysis reported that, comparatively, myomectomy had the lowest re-intervention rate of the 3 regimens (myomectomy vs UAE vs MRgFUS) in all time points assessed, while the MRgFUS had the highest re-intervention rate. Long-term data on the treatment effects, recurrence rates, and impact on future fertility and pregnancy are lacking. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

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 RCT found statistically significant improvements after MRgFUS in a composite outcome comprised of a reduction in pain and morphine use, and in pain reduction as a stand-alone outcome. A substantial proportion of patients 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.

For individuals with other tumors (eg, breast cancer, brain cancer, prostate cancer, desmoid, nonspinal osteoid osteoma) who receive MRgFUS, the evidence includes nonrandomized, uncontrolled phase II trials and several case series. Relevant outcomes are symptoms, health status measures, and treatment-related morbidity. A nonrandomized, uncontrolled phase II trial evaluating MRgFUS for prostate cancer reported a 93% success rate at 5 months and an 86% success rate at 2 years. Another nonrandomized, phase II trial in patients with prostate cancer reported that at 24 months, 88% (78 out of 89) of patients had no evidence of grade group 2 or higher prostate cancer in the treated area. Use of MRgFUS for the treatment of nonspinal osteoid osteoma consists of several larger case series, including a propensity score-matched retrospective study that reported similar reductions in pain with radiofrequency ablation and MRgFUS. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

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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 post-treatment, with evidence of a diminishing treatment benefit over time. A second meta-analysis showed significant improvements in hand tremor scores and quality of life through 36 months post treatment. A third meta-analysis found similar improvements in tremor severity with MRgFUS to unilateral deep brain stimulation (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.

For individuals with medicine-refractory tremor-dominant Parkinson disease (PD) who receive MRgFUS, the evidence includes a systematic review and pilot RCT. Relevant outcomes include symptoms, functional outcomes, quality of life, and treatment-related morbidity. The double-blind,sham-controlled, pilot randomized trial (N=27) found significant improvements in the treatment group in tremor severity after 3 months of follow-up. The systematic review, which included the RCT plus additional small observational studies, found significant improvements in tremor severity through 12 months and quality of life through 6 months post procedure. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Policy History Date Action 9/2025 Annual policy review. Policy updated with literature review through May 19, 2025; references added. Policy statements unchanged. 1/2025 Clarified coding information. 9/2024 Annual policy review. Policy updated with literature review through May 15, 2024; references added. Policy statements unchanged. 9/2023 Annual policy review. References added. Policy statements unchanged. 9/2022 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 12/2021 Annual policy review. New investigational statement described for
treatment of medication-refractory tremor dominant Parkinson disease. Effective 12/1/2021. 1/2021 Medicare information removed. See MP #132 Medicare Advantage Management for local coverage determination and national coverage determination reference.
9/2020 Annual policy review. Description, summary and references updated. Policy statements unchanged. 9/2019 Annual policy review. Description, summary and references updated. Policy statements unchanged. 2/2019 Annual policy review. New medically necessary statement added for MRgFUS ablation for treatment of medicine-refractory essential tremors. Clarified coding information. Effective 2/1/2019. 4/2018 Local Coverage Determination (LCD): Magnetic Resonance Image Guided High Intensity Focused Ultrasound (MRgFUS) for Essential Tremor (L37421) added.
Effective 4/1/2018. 8/2017 New references added from Annual policy review. 4/2016 Annual policy review. Policy statements unchanged. Global change to policy to remove “imaging” (eg, title, policy statement) to standardize terminology to magnetic resonance‒guided focused ultrasound (MRgFUS). 1/2016 Clarified coding information. 7/2015 Annual policy review. New medically necessary indications described. Effective 7/1/2015.

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5/2014 New references from Annual policy review. 8/2013 Annual policy review. Policy changed to single investigational statement; no change to intent of policy. Policy title changed to MRI-Guided Focused Ultrasound (MRgFUS). Effective 8/1/2013. 11/2011-4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates. No changes to policy statements.
9/2011 Reviewed - Medical Policy Group - Obstetrics and Gynecology. No changes to policy statements.
10/2010 Reviewed - Medical Policy Group - Obstetrics and Gynecology. No changes to policy statements.
7/2010 New policy describing ongoing non-coverage. Effective 7/1/2010. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

References

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