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Magnetic Resonance Guided Focused Ultrasound (MRgFUS)

Policy Number: MP-178

Latest Review Date: July 2024

Category: Surgery                                                                 

POLICY:

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 may be considered medically necessary for pain palliation in adults with metastatic bone cancer who have failed or are not candidates for radiotherapy.

Magnetic resonance imaging (MRI)-guided high-intensity ultrasound ablation is considered investigational for all other situations, including but not limited to:

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

Transurethral Ultrasound Ablation of the Prostate (TULSA) is considered investigational. This includes, but is not limited to, its use in the following situations:

  • Treatment of prostate cancer.
  • Treatment of benign prostatic hypertrophy (BPH).

*For coverage information regarding radiofrequency ablation of bone tumors, refer to medical policy #119- Radiofrequency Ablation of Solid Tumors Excluding Liver Tumors.

*For coverage information regarding cryosurgical ablation of bone tumors, refer to medical policy #429- Cryosurgical Ablation of Miscellaneous Solid Tumors other than Liver, Prostate, or Dermatologic Tumors.

*For coverage information regarding focal treatments of the prostate, refer to medical policy 596- Focal Treatments for Prostate Cancer.

DESCRIPTION OF PROCEDURE OR SERVICE:

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

Uterine Fibroids

Uterine fibroids are one 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. Symptoms of uterine fibroids include menorrhagia, pelvic pressure, or pain.

Treatment

Several approaches currently available to treat symptomatic uterine fibroids include: hysterectomy, abdominal myomectomy, laparoscopic and hysteroscopic myomectomy, hormone therapy, uterine artery embolization, and watchful waiting. Hysterectomy and various myomectomy procedures are considered the criterion standard treatment.

Metastatic Bone Disease

Metastatic bone disease is one of the most common causes of cancer pain.

Treatment

Existing treatments include conservative measures (e.g., massage, exercise) and pharmacologic agents (e.g., analgesics, bisphosphonates, corticosteroids). For patients who do not respond to these treatments, the standard care is to use external-beam radiotherapy. However, a substantial proportion of patients have residual pain after radiotherapy.

Essential Tremors

Essential tremor (ET) is the most common movement disorder, with an estimated prevalence of 5% worldwide. ET most often affects the hands and arms, may affect head and voice, and rarely includes the face, legs, and trunk. ET 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.

Magnetic Resonance-Guided Focused Ultrasound

MRgFUS is a noninvasive treatment that combines two technologies, focused ultrasound and MRI. The ultrasound beam penetrates through the soft tissues and, using MRI for guidance and monitoring, the beam can be focused on targeted sites. The ultrasound causes a local increase in temperature in the target tissue, resulting in coagulation necrosis while sparing the surrounding normal structures. The ultrasound waves from each sonication are focused at a focal point which has a maximum focal volume of 20 nm in diameter and 15 nm in height/length. This causes a rapid rise in temperature (i.e., to approximately 65°C to 85°C), which is sufficient to achieve tissue ablation at the focal point. In addition to providing guidance, the associated MRI can provide on-line thermometric imaging that provides a temperature “map” that can further 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) have approved the ExAblate® MRgFUS system for two indications: treatment of uterine fibroids and for palliation of pain associated with tumors metastatic to bone. The ultrasound equipment is specially designed to be compatible with MR magnets and is integrated into standard clinical MRI units. It includes a patient table, which includes a cradle housing the focused ultrasound transducer in a water or light oil bath. Some models of the device 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 treatment of other tumors, including breast, prostate, and brain tumors.

KEY POINTS:

The most recent literature search was performed through May 15, 2024.

Summary of Evidence

For individuals who have uterine fibroids who receive magnetic resonance-guided focused ultrasound (MRgFUS), the evidence includes 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 posttreatment, 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 (UAE) group, as measured by time to return to work and time to normal activities. Long-term follow-up results reported that there was 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 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 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 goroup 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.The 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.

For individuals with medication-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. Another 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 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 evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American College of Radiology

In 2018, The American College of Radiology published appropriateness Criteria for the radiological management of uterine leiomyomas (fibroids). The clinical guidance states that "MR[magnetic resonance]-guided high-intensity focused US [ultrasound] (MRgFUS) is another uterine-sparing option to treat focal leiomyomas. It is noninvasive, though each treatment may take several hours to complete. Its use currently is restricted to patients with fewer than six leiomyomas or leiomyoma volume < 900 cm3," and "although a reasonable alternative for patients unable or unwilling to tolerate sedation or anesthesia, long-term data and viability results are still lacking."

These appropriateness criteria were most recently updated in 2023, with evidence summaries provided for each reviewed clinical scenario. Table 1 summarizes the appropriateness category for specific populations with uterine fibroids.

Table 1. ACR Appropriateness Criteria: Management of Uterine Fibroids

Clinical situation

MRgFUS Appropriateness Category

Reproductive age patient with uterine fibroids, symptomatic with heavy uterine bleeding or bulk symptoms (eg, pressure, pain, fullness, bladder, or bowel symptoms), and a desire to preserve fertility. Initial therapy.

Usually appropriate

Reproductive age patient with uterine fibroids, symptomatic with heavy uterine bleeding or bulk symptoms (eg, pressure, pain, fullness, bowel, or bladder symptoms), and no desire for future fertility. Initial therapy.

Usually appropriate

Reproductive age patient with uterine fibroids and concurrent adenomyosis, symptomatic with heavy uterine bleeding or bulk symptoms (eg, pressure, pain, fullness, bladder, or bowel symptoms), and no desire for future fertility. Initial therapy.

Usually not appropriate

Reproductive age patient with pedunculated submucosal uterine fibroids, symptomatic with heavy uterine bleeding. Initial therapy.

May be appropriate

Postmenopausal patient with uterine fibroids, symptomatic with heavy uterine bleeding or bulk symptoms (eg, pressure, pain, fullness, bladder, or bowel symptoms). Negative endometrial biopsy. Next step.

Usually not appropriate

Reproductive age patient with uterine fibroids desiring pregnancy and experiencing reproductive dysfunction. Initial therapy.

May be appropriate

ACR: American College of Radiology; MRgFUS: magnetic resonance-guided focused ultrasound.
Usually appropriate: the imaging procedure or treatment is indicated in the specified clinical scenarios at a favorable risk-benefit ratio for patients; May be appropriate: The imaging procedure or treatment may be indicated in the specified clinical scenarios as an alternative to imaging procedures or treatments with a more favorable risk-benefit ratio, or the risk-benefit ratio for patients is equivocal;
Usually not appropriate: The imaging procedure or treatment is unlikely to be indicated in the specified clinical scenarios, or the risk-benefit ratio for patients is likely to be unfavorable.

American Society for Radiation Oncology

In 2017, The American Society for Radiation Oncology (ASTRO) published guidelines on palliative radiotherapy for bone metastases, which stated that external-beam radiotherapy continues to be the primary therapy for treating painful uncomplicated bone metastases. The guidelines did not mention magnetic resonance-guided focused ultrasound. If patients experience persistent or recurrent pain more than 1 month after initial treatment, the guidelines recommended retreatment with external-beam radiotherapy. As for advanced radiotherapy such as stereotactic body radiotherapy for retreatment of recurrent pain in spine bone lesions, these “may be feasible, effective, and safe, but the panel recommends that this approach should be limited to clinical trial participation or on a registry given limited data supporting routine use.”

In 2022, the American Urological Association (AUA)/ ASTRO published guidance on the management of clinically localized prostate cancer. The guidelines states that "there is a lack of data to date to support the use of whole gland or focal ablation for the treatment of clinically localized prostate cancer".

National Comprehensive Cancer Network

Guidelines from the National Comprehensive Cancer Network (NCCN) on bone cancer (v.2.2024), breast cancer (2.2024), brain cancer (v.1.2023), do not mention magnetic resonance-guided ultrasound as a treatment option. The NCCN guideline for prostate cancer (v 3.2024) states that "Cryotherapy or other local therapies are not recommended as routine primary therapy for localized prostate cancer due to lack of long-term data comparing these treatments to radiation. At this time, the panel recommends only cryosurgery and high-intensity focused ultrasound (HIFU; category 2B) as local therapy options for RT [radiotherapy] recurrence in the absence of metastatic disease".

National Institute for Health and Care Excellence

Guidance from NICE (2018) on unilateral magnetic resonance-guided ultrasound for treatment-resistant essential tremor states "the evidence on the safety of unilateral MRI [magnetic resonance imaging]-guided focused ultrasound thalamotomy for treatment-resistant essential tremor raises no major safety concerns. However, current evidence on its efficacy is limited in quantity. Therefore, this procedure should not be used unless there are special arrangements for clinical governance, consent, and audit or research."

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Fibroids, ultrasound ablation, MRI-guidance, ultrasound ablation of uterine fibroids, ExAblate 2000, high intensity ultrasound ablation; uterine, leiomyoma; uterine; high intensity ultrasound ablation (HIFU), ExAblate, ultrasound ablation of breast tumors, ultrasound ablation of brain tumors, ultrasound ablation of prostate cancer, ultrasound ablation of bone metastasis, trans rectal high intensity focused ultrasound for prostate cancer, Ablatherm, Sonablate 500; MRgFUS, essential tremors, TULSA, TULSA-PRO, Transurethral Ultrasound Ablation of the Prostate

APPROVED BY GOVERNING BODIES:

In October 2004, the U.S. Food and Drug Administration (FDA) approved via the premarket application (PMA) process, the ExAblate 2000 System (Insightec, Inc., Haifa, Israel) for “ablation of uterine fibroid tissue in pre- or perimenopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure.” Treatment is indicated for women with a uterine gestational size of less than 24 weeks who have completed childbearing.

In October 2012, the FDA approved the ExAblate System, Model 2000/2100/2100 VI via the PMA process. The intended use of the device is for pain palliation in adult patients with metastatic bone cancer who failed or are not candidates for radiation therapy. The device was evaluated through an expedited review process. The FDA required a post-approval study with 70 patients to evaluate the effectiveness of the system under actual clinical conditions.

In July 2016, FDA approved the use of the ExAblate Neuro System for the treatment of essential tremors in patients who have not responded to medication (beta-blockers or anticonvulsant drugs) through the premarket approval process. In December 2018, the FDA approved the use of the ExAblate Model 4000 (Neuro) for the treatment of tremor-dominant PD with medication-refractory tremor through the premarket approval process.

In November 2021, the FDA approved the use of the Exablate Prostate System for prostate tissue ablation through the premarket approval process.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply.  Refer to member’s benefit plan. 

CURRENT CODING: 

CPT codes:

0071T

Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total leiomyomata volume of 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

20999

Unlisted procedure, musculoskeletal system, general
51721 Insertion of transurethral ablation transducer for delivery of thermal ultrasound for prostate tissue ablation, including suprapubic tube placement during the same session and placement of an endorectal cooling device, when performed (Effective 1/1/2025)
55881 Ablation of prostate tissue, transurethral, using thermal ultrasound, including magnetic resonance imaging guidance for, and monitoring of, tissue ablation; (Effective 1/1/2025)
55882 Ablation of prostate tissue, transurethral, using thermal ultrasound, including magnetic resonance imaging guidance for, and monitoring of, tissue ablation; with insertion of transurethral ultrasound transducer for delivery of thermal ultrasound, including suprapubic tube placement and placement of an endorectal cooling device, when performed (Effective 1/1/2025)
61715 Magnetic resonance image guided high intensity focused ultrasound (MRgFUS), stereotactic ablation of target, intracranial, including stereotactic navigation and frame placement, when performed (Effective 1/1/2025)

 

PREVIOUS CODING:

CPT codes:

0398T

Magnetic resonance image guided high intensity focused ultrasound (MRgFUS), stereotactic ablation lesion, intracranial for movement disorder including stereotactic navigation and frame placement when performed (Deleted 12/31/2024)

 

There is no specific code for MRgFUS in reference to bone cancer.  This code may come in on unlisted code 20999 along with the appropriate radiology guidance code.

These CPT codes should not be used in conjunction with 51702 (insertion of temporary indwelling bladder catheter, simple) or 77022 (magnetic resonance imaging guidance for, and monitoring of, visceral tissue ablation).  Prior to the introduction of the above codes, the procedure may have been coded for using several codes describing the individual components of the procedure. CPT codes 0071T-0072T describe the comprehensive service.

REFERENCES:

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POLICY HISTORY:

Medical Policy Group, June 2004 (3)

Medical Policy Administration Committee, July 2004

Available for comment September 7-October 21, 2004

Medical Policy Group, June 2005 (2)

Medical Policy Group, June 2006 (1)

Medical Policy Group, August 2006 (2)

Medical Policy Administration Committee, August 2006

Available for comment August 30-October 13, 2006

Medical Policy Group, August 2007 (1)

Medical Policy Group, October 2007 (3)

Medical Policy Group, May 2009 (1)

MPRM Update, February 2010

Medical Policy Group, February 2010 (2)

Medical Policy Administration Committee, February 2010

Available for comment February 23-April 8, 2010

Medical Policy Group, March 2011; Reference added to Policy section

Medical Policy Administration Committee, Marcy 2011

Available for comment April 4 – May 18, 2011

Medical Policy Group March 2012 (2): 2012 Update: Key Points & References

Medical Policy Panel February 2013

Medical Policy Group, May 2013 (4): Update to Title (removed for the treatment of Uterine Fibroids and Other Tumors), Description, changed Policy verbiage, Key Points, Approved governing bodies and references.

Medical Policy Administration Committee May 2013

Available for comment May 22 through July 5, 2013

Medical Policy Panel, February 2014

Medical Policy Group, February 2014 (1): Update to Key Points and References; no change to policy statement

Medical Policy Panel, February 2015

Medical Policy Group, February 2015 (4): Updates to Key Points, Coding, and References.  No change to policy statement.

Medical Policy Group (4): Added statement under policy section to refer to MP# 596 for Focal Treatments for Prostate Cancer.

Medical Policy Group, November 2015: 2016 Annual Coding Update.  Added CPT code 0398T to current coding.

Medical Policy Panel, February 2016

Medical Policy Group, February 2016 (4): Updates to Description, Key Points, and References. No change to policy statement. Title change to take out “Imaging”.

Medical Policy Panel, July 2017

Medical Policy Group, July 2017 (4): Updates to Description, Key Points, Coding and References. Removed CPT code 0398T from Current Coding. Code was added in error.

Medical Policy Panel, July 2018

Medical Policy Group, August 2018 (4): Updates to Description, Policy, Key Points, Key Words, Coding, and References.  Added 0398T to Current Coding for essential tremors.  Added Key Word essential tremors.  Updated policy section to include coverage for medicine refractory essential tremors. Available for comment August 18 through October 1, 2018

Medical Policy Panel, July 2019

Medical Policy Group, July 2019 (4): Updates to Key Points and Policy statements.  Added coverage for patients with metastatic bone cancer in those who have failed or are not candidates for radiotherapy.

Medical Policy Administrative Committee: August 2020

Available for Comment: July 27, 2020 through September 10, 2020.

Medical Policy Group, November 2020 (5): Updated Key Words, and Policy Statement to include: Transurethral Ultrasound Ablation of the Prostate (TULSA) is considered investigational. This includes, but is not limited to its use in the following situations: Treatment of prostate cancer and Treatment of benign prostatic hypertrophy (BPH). Available for Comment: November 18, 2020 through January 02, 2021.

Medical Policy Panel, July 2021

Medical Policy Group, July 2021 (5): Updates to Description, Key Points, Approved by Governing Bodies, Practice Guidelines and Position Statements, and References. Current Coding section updated to remove CPT code 55880. Policy statement updated to remove “not medically necessary,” no change to policy intent. Policy Statement updated to include treatment of medication-refractory tremor dominant Parkinson disease as investigational. Available for comment: July 15, 2021 through August 29, 2021.

Medical Policy Panel, July 2022

Medical Policy Group, July 2022 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Panel, July 2023

Medical Policy Group, July 2023 (11): Updates to Key Points, Benefit Application and References. No change to Policy Statement.

Medical Policy Panel, July 2024

Medical Policy Group, July 2024 (11): Updates to Key Points, and References. No change to Policy Statement.

Medical Policy Group, November 2024 (11): 1/1/2025 Coding update. Added 51721, 55881, 55882, 61715 to Current Coding Section. Created Previous Coding Section to include 0398T. Removed policy statements effective for dates of service prior to July 15, 2021. No change to policy intent. 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.