Magnetic resonance-guided focused ultrasound
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Defines medical necessity and investigational uses of MRgFUS for Capital BlueCross products, including indications for metastatic bone pain palliation and medication-refractory essential tremor, and exclusions for other uses.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-01: Medically necessary indications
Covered when ALL of the following are met for each indication:
Supported by an FDA approval (ExAblate) and a sham‑controlled randomized trial showing reductions in pain and opioid use; device/model compatibility (certain cradles) may be required for palliation treatment.
Supported by FDA approval of ExAblate Neuro and by RCTs and systematic reviews demonstrating decreased tremor severity and improved quality of life up to 2 years in trials.
inv-02: Investigational / Not covered
Not covered / investigational when ANY of the following apply:
Although FDA clearance exists for fibroid treatment, randomized trials are small or have limited follow-up and long-term data are lacking.
Insufficient evidence to determine health outcomes for these indications.
Evidence limited to a pilot RCT; insufficient to demonstrate improvement in net health outcome.
inv-03: Coverage stance by clinical indication
Coverage findings by indication based on the evidence summary
Includes 2 RCTs and observational studies; trials are small or have limited follow-up.
Supported by a sham‑controlled RCT showing pain reduction and reduced opioid use; adverse events generally transient.
Based on RCT(s), systematic reviews, and meta-analyses.
Based on a pilot RCT with positive tremor severity results but limited data.
This policy differentiates between medically necessary and investigational indications for magnetic resonance–guided focused ultrasound (MRgFUS). While MRgFUS is covered for palliation of pain from metastatic bone lesions in adults who have failed or are not candidates for radiotherapy and for medicine-refractory essential tremor, its use for uterine fibroids and for many other tumor sites is specifically identified as investigational in this policy segment. Examples of other tumor sites considered investigational include brain, prostate, breast, and desmoid tumors. The summary of evidence for uterine fibroids notes limited randomized data, short follow-up, and insufficient long-term outcomes (including effects on recurrence, fertility, and pregnancy), supporting the investigational designation for that indication.
Procedures billed with investigational procedure codes 0071T and 0072T are listed in this policy as investigational and are not covered.
Any indication for MRgFUS that is not explicitly listed as medically necessary in this policy is considered investigational / not supported by sufficient evidence for coverage. This includes uses for uterine fibroids and the range of other tumor indications for which the evidence is limited to small case series or short-term studies.
The evidence base for MRgFUS in uterine fibroids and numerous other tumor sites is limited. For uterine fibroids, available randomized trials are small or ongoing, with unclear clinical significance and a lack of long-term follow-up on recurrence and fertility outcomes; thus evidence is insufficient to determine net health benefit. For other tumor indications (eg, brain, prostate, breast, desmoid, nonspinal osteoid osteoma), the evidence consists mainly of small case series, and is likewise insufficient to establish medical necessity.
Covered Indications
inv-24: Palliation of pain from bone metastases
FDA approval (ExAblate) and randomized trial evidence support pain palliation; aim is to ablate periosteal nerves at the bone surface.
inv-25: Medication-refractory essential tremor
Supported by randomized trials and systematic reviews demonstrating decreased tremor severity and improved quality of life.
inv-26: Modality specification
Although FDA cleared for fibroids, the policy considers this indication investigational due to limited long‑term evidence.
Includes sham‑controlled RCT demonstrating pain and opioid use reduction.
Benefits noted up to 2 years; treatment effect may diminish over time.
Coding
| NRZ | FDA product code |
| POH | FDA product code |
| PLP | FDA product code |
| C79.51 | Secondary malignant neoplasm of bone |
| G25.0 | Essential tremor |
Provider Actions and Billing Notes
Prior Authorization Required
Prior authorization is required for MRgFUS procedures that meet medically necessary indications. Verify member benefit coverage and obtain any required prior authorization from Capital Bluecross before scheduling or performing MRgFUS.
Investigational Uses — Denial Risk
Procedures and uses outside the policy’s specified medically necessary indications are considered investigational and may be denied. Claims for investigational procedure codes will not be covered.
- Investigational procedure codes (not covered): 0071T, 0072T.
- MRgFUS considered investigational for indications such as uterine fibroids, treatment of other tumors (eg, brain, prostate, breast, desmoid), and medication-refractory tremor-dominant Parkinson disease unless otherwise noted as FDA-approved and specified in this policy.
Device and Model Documentation
Document device and model information in the medical record when submitting prior authorization requests and claims. Include the ExAblate system model when applicable to support medical necessity and coding.
- Record device details (e.g., ExAblate System Model 2000/2100/2100 VI, ExAblate Neuro, ExAblate Model 4000, Exablate Prostate) on the request/claim where relevant.
- Include FDA product codes (NRZ, POH, PLP) as appropriate in clinical documentation.
Benefit and Medical Necessity Verification
Final claim payment is subject to member eligibility, benefits, and a determination that the service was medically necessary and appropriate per the member’s benefit contract.
- Verify member eligibility and benefit limitations prior to treatment.
- Authorization or medical necessity determinations do not guarantee payment; claims are processed according to the member’s contract terms.
Prior Conservative/Standard Therapy Required
Prior conservative or standard therapies must have been tried and failed, or be contraindicated, for the covered indications before MRgFUS will be considered medically necessary.
- Metastatic bone pain: patients should have failed or be not candidates for external-beam radiotherapy and prior conservative measures (eg, analgesics, bisphosphonates, corticosteroids) where appropriate.
- Essential tremor: patients should be medicine-refractory (failed or intolerant to beta-blockers or anticonvulsant agents) before considering MRgFUS.
Background
Magnetic resonance–guided focused ultrasound (MRgFUS) is a noninvasive ablation technique that combines focused ultrasound energy with MRI guidance and online thermometric imaging to thermally ablate targeted tissue while aiming to spare surrounding structures. The technology has device-specific FDA clearances for certain indications, and MRI compatibility and device/cradle compatibility are considerations for treatment delivery.
Definitions
Contrast and Imaging Rules
Confirm MRI compatibility and thermometry capability for MRgFUS
MRI compatibility and online thermometric imaging are required during MRgFUS; ensure the ultrasound equipment used is designed to be compatible with the MRI magnet prior to scheduling and document compatibility.
- MRI provides online thermometric imaging (temperature mapping) during treatment
- Confirm the ultrasound equipment is compatible with the MR magnet and document this
Not Covered / Investigational Uses
MRgFUS is not covered for uterine fibroids and for the other tumor indications listed as investigational in this policy segment (eg, brain, prostate, breast, desmoid). In addition, procedures billed with investigational procedure codes 0071T and 0072T are explicitly listed as investigational and are not covered. Providers should verify member benefits and prior authorization requirements before proceeding, and recognize that services outside the specified medically necessary indications may be denied.
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