Magnetic Resonance-Guided Focused Ultrasound

POLICY NUMBER

A.7.01.109

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.

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.

TreatmentApproaches 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 treatments.

Metastatic Bone Disease

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

TreatmentExisting 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 related medical policy Radiofrequency Ablation of Miscellaneous Solid Tumors Excluding Liver Tumors ).

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.

TreatmentThe 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 (β-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 non-invasive treatment that combines two 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. 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 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 (i.e., 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 on-line 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 specially designed to be compatible with magnetic resonance magnets, and it is integrated into standard clinical MRI 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 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 the treatment of other tumors, including breast, prostate, brain, and desmoid tumors as well as nonspinal osteoid osteoma.

In October 2004, the ExAblate 2000 System (InSightec) was approved by the FDA through the premarket approval process 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 fewer than 24 weeks who have completed childbearing.

In October 2012, the ExAblate System, Model 2000/2100/2100 VI, was approved by the FDA through the premarket approval process for pain palliation in adults with metastatic bone cancer who have failed or are not candidates for radiotherapy. 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, the FDA approved the use of the ExAblate Neuro System for the treatment of essential tremors in patients who have not responded to medication (β-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.

In October 2023, Cordance Medical announced that the FDA granted a breakthrough device designation for its NeuroAccess device. MRgFUS for blood-brain barrier disruption (0947T) to facilitate liquid biopsy is not evaluated in this policy. Please refer to the Circulating Tumor DNA and Circulating Tumor Cells for Cancer Management (Liquid Biopsy) medical policy for more information on liquid biopsy.

POLICY

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–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 investigationalin all other situations including but not limited to:

• Treatment of uterine fibroids;

• Treatment of other tumors (e.g., brain cancer, prostate cancer, breast cancer, and desmoid);

• Treatment of medication-refractory tremor dominant Parkinson disease.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity. 

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

MRgFUS for blood-brain barrier disruption (0947T) to facilitate liquid biopsy is not evaluated in this policy. Please refer to the Circulating Tumor DNA and Circulating Tumor Cells for Cancer Management (Liquid Biopsy) medical policy for policy positions on liquid biopsy.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting. 

POLICY HISTORY

3/31/2005: Approved by Medical Policy Advisory Committee (MPAC).

6/6/2005: Code Reference section completed.

12/13/2006: Policy reviewed, ablation of tumors other than uterine fibroids as investigational added.

1/8/2009: Policy reviewed, no changes.

4/27/2010: Policy Title changed - "High-Intensity" and "Ablation of" were removed and "Focused (MRgFUS) for the Treatment" was added. Policy Description section was revised to add information about the ExAblate® 2000 system. Policy statement revise to add "palliative treatment of bone metastases" is considered investigational for treatment other than uterine fibroids.

04/20/2011: Policy description updated; policy statement unchanged. Added FEP verbiage to the Policy Exceptions section.

03/27/2012: Policy reviewed; no changes.

07/16/2013: Deleted "for the Treatment of Uterine Fibroids and Other Tumors" from the policy title. Policy description updated to reflect the scope of the policy. Policy statement re-written into one investigational statement; intent unchanged. Deleted outdated references from the Sources section.

03/17/2014: Policy reviewed; no changes.

03/17/2015: Policy title changed from "MRI-Guided High Focused Ultrasound (MRgFUS)" to "MRI-Guided Focused Ultrasound." Policy description updated to add information regarding treating pain associated with bone metastases. Added the following policy statement: Magnetic resonance imaging (MRI)–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. Revised investigational statement to state that MRI-guided high-intensity ultrasound ablation is considered investigational in all other situations. Removed "Pain palliation for patients with metastatic bone cancer;" from investigational criteria. Policy guidelines updated to add medically necessary and investigational definitions. Code Reference section updated to change "Investigational Codes" to "Covered Codes" and add ICD-9 diagnosis codes 170.0-170.8 and 198.5.

08/31/2015: Medical policy revised to add ICD-10 codes.

04/01/2016: Policy title, policy description, and policy statements updated to change "Magnetic Resonance Imaging-Guided Focused Ultrasound" to "Magnetic Resonance-Guided Focused Ultrasound."

05/31/2016: Policy number A.7.01.109 added.

08/07/2017: Policy description updated. Policy statement updated to include treatment of desmoid tumors as investigational.

11/01/2018: Policy description updated regarding essential tremors and devices. Added policy statement that magnetic resonance-guided high-intensity ultrasound ablation may be considered medically necessary for the treatment of medicine-refractory essential tremors. Added CPT code 0398T and ICD-10 diagnosis code G25.0.

08/14/2019: Policy reviewed; no changes.

08/18/2020: Policy reviewed; no changes.

04/14/2022: Policy description updated regarding tremor-dominant Parkinson disease and devices. Added "Treatment of medication-refractory tremor dominant Parkinson disease" as investigational. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

08/10/2022: Policy description updated regarding uterine fibroids. Policy statements unchanged.

08/09/2023: Policy description updated regarding the Exablate Prostate System. Policy statements unchanged.

08/12/2024: Policy reviewed; no changes.

12/18/2024: Code Reference section updated to add new CPT code 61715 effective 01/01/2025.

09/11/2025: Policy description updated regarding devices. Policy statements unchanged. Policy Guidelines updated regarding magnetic resonance–guided focused ultrasound for blood-brain barrier disruption.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.109

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.