CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Magnetic Resonance Imaging–Guided Focused Ultrasound (MRgFUS) Coverage Policy

This policy governs coverage and medical necessity for MRgFUS procedures for Commercial products of Blue Cross & Blue Shield of Rhode Island, including uterine fibroids, palliation of metastatic bone pain, and treatment of medication-refractory essential tremor. It does not govern Medicare Advantage, for which CMS NCD/LCD criteria apply.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMagnetic Resonance Imaging–Guided Focused Ultrasound (MRgFUS) Coverage Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 11, 2021

Next Review DateN/A

Key ActionObtain prior authorization for MRgFUS (CPT 0398T) for Commercial members when medical criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA-approved indications described

3Medically necessary indications

1CPT codes listed

severalNot medically necessary / investigational

~30References cited

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

Commercial covered indications

Covered for Commercial products when medical criteria are met:

Commercial covered indications: Magnetic resonance-guided high-intensity ultrasound ablation (MRgFUS) may be considered medically necessary for pain palliation in adults with metastatic bone cancer who have failed or are not candidates for radiotherapy.

Supported by FDA approval and randomized trial evidence for palliation of metastatic bone pain.

Commercial covered indications: MRgFUS may be considered medically necessary for treatment of medication-refractory essential tremor when medical criteria are met (patients who have not responded to medication such as beta-blockers or anticonvulsants).

Supported by FDA approval of the ExAblate Neuro System and RCT/observational evidence showing sustained tremor reduction and improved quality of life up to 2 years.

Pain palliation for metastatic bone disease

Palliation of bone metastases: MRgFUS for palliation of pain associated with metastatic bone cancer in adults who have failed or are not candidates for radiotherapy is considered medically necessary.

FDA approval (October 2012) and sham-controlled RCT evidence support meaningful improvement in pain outcomes.

Medication-refractory essential tremor

Essential tremor: MRgFUS for treatment of medication-refractory essential tremor may be considered medically necessary when patients have not responded to medication (eg, beta-blockers or anticonvulsant drugs).

FDA approval of the ExAblate Neuro System (July 2016) and RCT/observational data demonstrate reductions in tremor severity and improved quality of life with effects maintained up to 2 years.

Not medically necessary / investigational

Not covered / considered not medically necessary for Commercial products:

Commercial not medically necessary indications: MRgFUS is considered not medically necessary for treatment of uterine fibroids; for treatment of other tumors (for example, brain cancer, prostate cancer, breast cancer, desmoid tumors, nonspinal osteoid osteoma); and for treatment of medication-refractory tremor-dominant Parkinson disease, except where other criteria in this policy specify coverage.

Policy lists these indications as not medically necessary or investigational due to insufficient evidence or lack of demonstrated net health benefit.

Magnetic resonance–guided high-intensity ultrasound ablation (MRgFUS) is considered not medically necessary in all situations that do not meet the specific medical criteria outlined in this policy for Commercial products. The policy lists MRgFUS as medically necessary only for pain palliation of metastatic bone lesions after failure of or when radiotherapy is not an option and for treatment of medication-refractory essential tremor; any use outside those specified indications is considered not medically necessary.

Examples of uses that are explicitly considered not medically necessary include, but are not limited to, treatment of uterine fibroids, treatment of other tumors (for example, brain, prostate, breast, desmoid), and treatment of medication-refractory tremor‑dominant Parkinson disease. Procedures performed for these indications are subject to denial as not medically necessary under this Commercial products policy.

Coding

Medically necessary CPT when criteria metCPTCovered

0398T

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

Uterine size gestational equivalence

Uterine gestational size thresholdUterine gestational size of fewer than 24 weeks

Patient pregnancy/childbearing statusIndicated for women who have completed childbearing

Regulatory approval date (uterine fibroids)FDA approval October 2004 for ExAblate System for uterine fibroids

Provider Actions & Billing

Prior Authorization

Prior Authorization and Benefit Verification

Prior Authorization Required. Providers must obtain prior authorization before performing magnetic resonance-guided high-intensity ultrasound (MRgHIFU) ablation for indications that may be covered under Commercial products. Use the payer's prior authorization web-based tool or provider call center to submit requests and confirm approval prior to scheduling.

Prior authorization recommended for Commercial products
Use web-based prior authorization tool or call provider call center to verify and obtain approval

Note

Verify Member Benefits and Eligibility

Verify member benefits and eligibility before rendering services. Coverage may vary by group or contract; refer to the member's Evidence of Coverage/Subscriber Agreement for applicable surgical services benefits. Confirmation of applicable benefits (including whether MRgHIFU is a covered benefit for the specific indication) is required to avoid claim denials.

Check Evidence of Coverage / Subscriber Agreement for the member
Confirm both eligibility and that the specific indication is a covered benefit prior to treatment

Prior Authorization

MRgFUS — prior authorization recommended for Commercial products

Prior authorization is recommended for MRgFUS procedures for Commercial products; participating providers should use the web-based tool referenced by the plan to request authorization.

MRgFUS prior authorization recommended for Commercial products.
Use the web-based prior authorization tool for participating providers.

Definitions

Magnetic Resonance–guided Focused Ultrasound

Definition (MRgFUS)Magnetic Resonance–guided Focused Ultrasound: noninvasive therapy combining focused ultrasound and MRI guidance to thermally ablate target tissue while sparing surrounding structures

MechanismUltrasound is focused to raise focal temperature sufficient to cause coagulation necrosis with MRI providing thermometric imaging for real-time monitoring

FDA-approved indications (device)ExAblate MRgFUS system approved for uterine fibroids and palliation of pain from metastatic bone lesions

FDA-approved device (InSightec) for uterine fibroids and bone metastasis; Neuro system for essential tremor

Device familyExAblate MRgFUS system (InSightec)

FDA-approved indicationsUterine fibroids (Premarket approval October 2004) and palliation of pain from bone metastases (Premarket approval October 2012)

Background

Magnetic resonance–guided focused ultrasound (MRgFUS) is a noninvasive therapy that combines focused ultrasound with magnetic resonance imaging to thermally ablate target tissues while visualizing surrounding anatomy. The policy frames MRgFUS as an evidence‑based option for pain palliation of metastatic bone cancer and for medication‑refractory essential tremor when the medical criteria are met, but notes that other clinical applications remain investigational or not medically necessary per this policy.

Not Covered / Investigational

MRgFUS for other tumor types is considered investigational or not medically necessary in this policy. Specifically, MRgFUS is not covered for treatment of brain, prostate, breast, desmoid tumors and similar neoplasms; these indications do not meet the medical necessity criteria laid out for Commercial products and therefore are excluded from coverage.