CurrentPremera BluecrossPolicy 7.01.109

Magnetic Resonance Imaging-Guided Focused Ultrasound (MRgFUS)

Defines medical necessity, investigational uses, coding, and clinical context for MR-guided high-intensity focused ultrasound procedures for Premera Blue Cross members and providers.

Policy Summary

PayerPremera Bluecross

PolicyMagnetic Resonance Imaging-Guided Focused Ultrasound (MRgFUS)

Policy CodePolicy 7.01.109

Change TypeNo material change

Effective DateOct 1, 2025

Next Review Date

Key ActionObtain prior authorization per payer processes for MRgFUS procedure codes listed in the coding section.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4FDA-approved indications listed

79%pooled response for bone metastases

18+age threshold (bone mets)

N=20; N=49RCT sizes (uterine fibroids)

2004–2021Key FDA approval years

Coverage Criteria and Determinations

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Medically necessary indications

Covered when ALL of the following apply for the specified indications:

Covered indications: MRgFUS may be considered medically necessary for: (1) palliation of pain in adults with bone metastases who have failed or are not candidates for radiotherapy; (2) treatment of medication-refractory essential tremor; and (3) other FDA-approved indications when supported by documentation and device labeling.age >= 18 for bone metastases

Bone metastases indication limited to adults; medication-refractory tremor requires prior medication trials (e.g., beta-blockers or anticonvulsants).

Investigational / Not medically necessary

Not covered / investigational when ANY of the following apply:

Investigational indications: MRgFUS is considered investigational for all other situations including but not limited to treatment of uterine fibroids, treatment of other tumors (e.g., breast, prostate, desmoid tumors, nonspinal osteoid osteoma, brain), and treatment of medication-refractory tremor-dominant Parkinson disease.

Uterine fibroids and many tumor indications have insufficient evidence to determine improvement in net health outcome.

Coverage by indication — coverage conclusions per indication

Coverage conclusions per indication based on available evidence:

Metastatic bone pain (palliation): Evidence is sufficient to determine a net health benefit for MRgFUS in adults with painful bone metastases who have failed or are not candidates for radiotherapy; supported by a phase III randomized trial and meta-analytic pooled response (~79%).age >= 18

Indication aligned with FDA PMA for palliation of painful bone metastases.

Essential tremor (medication-refractory): Evidence is sufficient to determine improvement in tremor severity and quality of life after unilateral MRgFUS thalamotomy for medication-refractory essential tremor; benefits may diminish over time but are supported by a sham-controlled RCT and meta-analyses.

FDA-approved for medication-refractory ET; NICE recommends use with governance/audit or research arrangements.

Tremor-dominant Parkinson disease (medication-refractory): Evidence is insufficient to determine net health outcome for MRgFUS in tremor-dominant Parkinson disease despite small RCTs and observational studies showing short-term tremor improvement.

Use of MR-guided high-intensity focused ultrasound (MRgFUS) for indications that are not specifically listed as medically necessary in this policy is excluded from coverage. Requests for MRgFUS for indications outside the specified covered indications (see investigational list) are considered investigational and may be denied.

Guidance from specialty organizations cautions against routine use of MRgFUS for brain metastases and other intracranial tumor indications. The Congress of Neurological Surgeons (2025) concluded there are insufficient qualifying data to create recommendations for interstitial modalities including MRgFUS and stated there is insufficient evidence to make recommendations regarding MRgFUS for parenchymal and leptomeningeal brain metastases; use outside of research settings is not supported by the guideline.

This medical policy is a coverage guidance document for Premera Blue Cross and does not apply to Medicare Advantage plans. Member benefit terms and coverage determination processes for Medicare Advantage are governed by the applicable Medicare Advantage contract and should be confirmed through the member benefit booklet or plan contact.

MRgFUS for uterine fibroids is considered investigational by this policy because the available randomized trials are small, short-term, or focused on feasibility, and meta-analyses and comparative data report higher reintervention rates with MRgFUS versus some surgical options. Given limited long-term data on durability, recurrence, and effects on fertility and pregnancy, evidence is insufficient to demonstrate an improvement in net health outcome.

Beyond uterine fibroids, many tumor indications (for example, breast tumors, prostate focal therapy, desmoid tumors, nonspinal osteoid osteoma, and certain brain tumor uses) lack sufficient comparative, long-term evidence to establish net health benefit. The policy therefore considers MRgFUS for these and other unspecified tumor indications to be investigational pending more robust clinical trial data.

Indication-Specific Coverage Rules

Modality-specific indications for MR-guided focused ultrasound — top-level node

Modality-specific indications for MR-guided focused ultrasound:

Modality-specific indications: MRgFUS is indicated for palliation of pain from bone metastases in adults after failed or contraindicated radiotherapy and for medication-refractory essential tremor; FDA has also approved uses for uterine fibroids and tremor-dominant Parkinson disease, though payer coverage distinguishes investigational uses.age >= 18 for bone metastases

Procedure is performed in an MRI suite with MR-compatible focused ultrasound transducer; device models and cradle types influence suitability for bone palliation.

Uterine fibroids — limited, patient-selection dependent use per ACR

ACR and trial evidence limit routine use; consider patient selection criteria:

Uterine fibroids (selection-dependent): Evidence is insufficient to determine net health benefit for MRgFUS for uterine fibroids overall; ACR Appropriateness Criteria indicates MRgFUS may be usually appropriate for selected reproductive-age patients desiring uterine preservation but is usually not appropriate for patients with adenomyosis or postmenopausal patients. Restrictions include limiting number of leiomyomas and total leiomyoma volume (e.g., ≤900 cm^3 per ACR guidance).

RCT data are small (e.g., N=20 feasibility trial; N=49 comparator trial) with limited long-term follow-up and higher reintervention rates in some analyses.

Palliative treatment of painful bone metastases after radiotherapy failure or ineligibility

Palliation considered when radiotherapy has failed or is not feasible:

Painful bone metastases (palliative): MRgFUS is considered medically necessary for palliation of painful bone metastases in adults who have failed or are not candidates for radiotherapy; supported by randomized controlled data and systematic reviews reporting substantial response rates (~79%).age >= 18

FDA PMA exists for this indication; most adverse events reported were transient and nonsevere in trials.

Medication-refractory essential tremor

Consider only for medication-refractory cases with documentation of prior trials:

Medication-refractory essential tremor (unilateral thalamotomy): Unilateral MRgFUS thalamotomy is considered medically necessary for medication-refractory essential tremor based on sham-controlled RCT and meta-analyses showing improvements in tremor severity and quality of life; benefits may diminish over time.

Documentation should show failure of or intolerance to appropriate medication trials (e.g., beta-blockers or anticonvulsants). NICE recommends use only with governance, consent, and audit or research arrangements.

Other indications referenced in citations (prostate, breast, osteoid osteoma, desmoid tumors, brain, etc.) — referenced but not necessarily covered

Additional indications are referenced in the evidence base but are generally considered investigational or lacking sufficient data for routine coverage:

Other referenced indications: Indications discussed in the literature include focal prostate cancer ablation, breast tumor ablation, osteoid osteoma (nonspinal), desmoid tumors, and investigational uses in brain tumors and blood–brain barrier disruption; these are generally considered investigational due to limited or early-phase evidence and lack of long-term comparative outcomes.

FDA approvals exist for some device-specific prostate and neuro indications, but payer assessments often still find insufficient evidence for routine coverage of many tumor sites outside defined indications.

Coverage by indication (duplicate mapping to ensure all indication-based conclusions are available here)

Coverage conclusions per indication based on available evidence:

Metastatic bone pain (palliation): Evidence sufficient to determine net health benefit for MRgFUS in adults with painful bone metastases who have failed or are not candidates for radiotherapy.age >= 18

Supported by phase III RCT and meta-analysis reporting ~79% response.

Essential tremor (medication-refractory): Evidence sufficient to determine improvement in tremor severity and quality of life after unilateral MRgFUS thalamotomy for medication-refractory essential tremor; benefits diminish over time.

Supported by sham-controlled RCT and meta-analyses.

Tremor-dominant Parkinson disease (medication-refractory): Evidence insufficient to determine net health outcome despite small RCT and observational studies showing short-term tremor improvement.

Improvements reported through 12 months (tremor) and 6 months (QOL) in systematic review.

Procedure, HCPCS/CPT, and Product Codes

Procedure and HCPCS/CPT Codes referencedmixed

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.
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 (code termed 12/31/24).
61715	Magnetic resonance image guided high intensity focused ultrasound (MRgFUS); stereotactic ablation of target; intracranial, including stereotactic navigation and frame placement; when performed (new code effective 01/01/25).
51721	Insertion of transurethral ablation transducer for delivery of thermal ultrasound for prostate tissue ablation, including suprapubic tube placement during the same session (01/01/25).
55881	Ablation of prostate tissue; transurethral; using thermal ultrasound; including magnetic resonance imaging guidance for, and monitoring of, tissue ablation. (new code effective 01/01/25).
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 (new code effective 01/01/25).
53899	Unlisted procedure; urinary system.
55899	Unlisted procedure; male genital system.
58999	Unlisted procedure; female genital system (nonobstetrical).

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FDA product codesmixed

NRZ	FDA product code referenced
POH	FDA product code referenced
PLP	FDA product code referenced

Coding history entries (added/removed codes)CPT

0398T	CPT code noted as termed/removed in later update
0071T	CPT code referenced as removed (history)
0072T	CPT code referenced as removed (history)
51721	CPT code added (history)
55881	CPT code added (history)
55882	CPT code added (history)
61715	CPT code added (history)
19499	CPT code removed previously (history)
53899	CPT code added (history)
55899	CPT unlisted/added/removed at various history points (history)

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Uterine fibroid volume thresholds (uterine leiomyomata coding limits)

Volume threshold (small fibroid burden)Total leiomyomata volume less than 200 cc

Volume threshold (larger fibroid burden)Total leiomyomata volume greater or equal to 200 cc

Associated CPT codes0071T = focused ultrasound ablation of uterine leiomyomata; 0072T = focused ultrasound ablation of uterine leiomyomata (volume-based distinction)

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for MRgFUS procedures. Providers must obtain prior authorization for the listed MRgFUS procedure codes before scheduling treatment.

Affected codes include CPT and HCPCS codes listed in the policy (e.g., 0071T, 0072T, 61715, 61715 (new codes effective 01/01/25), 76999, 51721, 55881, 55882, C9734, and relevant unlisted procedure codes).
Prior authorization should document the specific indication, prior treatments, and device-specific FDA approval status where applicable.

Prior Authorization

Prior Authorization Guidance

Prior authorization is recommended to ensure the indication aligns with FDA-cleared uses and the evidence requirements in this policy. Requests should include documentation of prior conservative therapies, treatment-refractory status where required (for example, medication-refractory essential tremor), and any device-specific approval or postapproval study requirements.

Document FDA-cleared indication (e.g., ExAblate approvals for uterine fibroids, metastatic bone pain, essential tremor, prostate ablation where applicable).
Include prior therapy details (e.g., failure of or ineligibility for radiotherapy for metastatic bone pain; failure of medications such as beta-blockers or anticonvulsants for essential tremor).

Denial Risk

Investigational / Not Medically Necessary Uses

Use of MRgFUS for indications without sufficient evidence or outside FDA-cleared indications may be denied. Investigational or unproven uses (such as many tumor types not specified in the FDA approvals, blood–brain barrier disruption for liquid biopsy, or other off‑label indications) are not supported by the evidence in this policy and may be declined.

Requests for procedures for indications not listed as medically necessary in this policy should include strong supportive clinical evidence; absent that, expect denial.
Examples of likely investigational denials: BBB disruption for liquid biopsy, treatment of tumors not covered by FDA approvals or sufficient clinical evidence.

Denial Risk

Benefit Limitations and Plan Coverage

Coverage is subject to member benefit plan limits and conditions. Benefit limitations, plan exclusions, or lack of coverage under a member’s specific contract may trigger denial even if the clinical criteria are met.

Always verify coverage and any plan-specific limitations in the member benefit booklet or by contacting member services prior to authorization or scheduling.
This policy does not apply to Medicare Advantage; check plan type and specific contract provisions.

Documentation Required

Procedure Setting and Coding Documentation

Document the procedure setting, equipment, and coding when submitting authorization and claims. MRgFUS is typically performed in an MRI suite with specialized equipment and often in an outpatient setting under conscious sedation; coding must match the procedure performed.

Include procedure setting (MRI suite), device used, and sedation/anesthesia level in documentation.
Use the specific CPT/HCPCS codes listed in the policy for authorization and billing; include unlisted procedure code descriptors when applicable and append supporting documentation for unlisted codes.

Prior Authorization

MRgFUS for Metastatic Bone Pain—Authorization Requirements

For metastatic bone pain, MRgFUS is considered medically necessary only after failure of, or when a patient is not a candidate for, radiotherapy. Authorization requests must document prior radiotherapy attempts or contraindications to radiotherapy.

Document attempts at radiotherapy, reason for radiotherapy ineligibility, or clinical circumstances preventing radiotherapy.
Include pain scores, functional impact, and previous palliative measures to support medical necessity.

Clinical and Technical Background

Magnetic resonance-guided high-intensity focused ultrasound (MRgFUS) is a noninvasive therapeutic modality that combines focused ultrasound energy with real-time magnetic resonance imaging guidance and thermometry. Focused ultrasound beams are targeted to a discrete tissue volume to induce localized thermal ablation while MRI provides anatomic targeting and temperature monitoring to help spare adjacent structures. The technique is typically performed in an MRI suite using an MR-compatible ultrasound transducer to ablate tissue without an open surgical approach.

Definition — MRgFUS (magnetic resonance-guided high-intensity focused ultrasound)

Concise definitionMagnetic resonance-guided high-intensity focused ultrasound (MRgFUS) is a noninvasive treatment that uses focused ultrasound beams guided and monitored by MRI to thermally ablate targeted tissue while sparing surrounding structures.

Key technologiesCombines focused ultrasound and magnetic resonance imaging (MRI) for targeting, thermometry, and real-time treatment monitoring.

Therapeutic effectUltrasound raises local tissue temperature causing coagulation necrosis at focal points, with MRI providing thermometric 'temperature maps' to confirm and adjust treatment.

Named MRgFUS devices with FDA premarket approvals (ExAblate systems)

ExAblate 2000 SystemFDA PMA (October 2004) for ablation of uterine fibroid tissue in pre- or perimenopausal women desiring uterine-sparing procedure.

ExAblate System Model 2000/2100/2100 VIFDA PMA (October 2012) for palliation of pain associated with metastatic bone cancer in adults who have failed or are not candidates for radiotherapy.

ExAblate Neuro / Model 4000 (Neuro)FDA PMA approvals: ExAblate Neuro (July 2016) for medication-refractory essential tremor; ExAblate Model 4000 (Dec 2018) for tremor-dominant Parkinson disease (medication-refractory tremor).

ExAblate Prostate SystemFDA PMA (November 2021) for prostate tissue ablation.

Policy Revision History

2012-04-25policy_update

Policy replaced and updated with literature review through December 2011; references added and reordered; no change to policy statements.

2013-04-08policy_update

Policy replaced and updated with literature review; policy changed to a single investigational statement with references updated.

2015-04-14policy_change

Annual review updated literature through January 2015 and added a statement that MRgFUS may be considered medically necessary for palliation in adult patients with metastatic bone cancer.

2018-10-01policy_update

Annual review (approved September 11, 2018) added policy statement that MRgFUS ablation may be considered medically necessary for medication-refractory essential tremor and added CPT codes 0398T, 53899, 55899, and 76999.

2020-06-10policy_administration

Policy reinstated after interim action to delete; reinstated effective June 10, 2020, and coding updates removed CPT codes 0071T and 0072T earlier that year.

2021-08-01coding_update

Coding update added CPT codes 0071T and 0072T (08/01/2021).

2023-10-01annual_review

Annual review (approved September 11, 2023) updated literature through 2023 and updated title wording and standardization; policy statements unchanged.

2024-10-01annual_review

Annual review (approved September 9, 2024) updated literature through May 15, 2024; policy statements unchanged.

2025-01-01coding_updateLatest

Coding update added new CPT codes 51721, 55881, 55882 and 61715 and removed termed CPT code 0398T.

OpenPayer

Magnetic Resonance Imaging-Guided Focused Ultrasound (MRgFUS)

Coverage Criteria and Determinations

Indication-Specific Coverage Rules

Procedure, HCPCS/CPT, and Product Codes

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization Requirements

Clinical and Technical Background

Not Covered / Investigational Uses

Policy Revision History