CurrentPriority HealthPolicy N/A

High Intensity Focused Ultrasound (HIFU) / MRgFUS

Priority Health clinical policy on coverage and medical necessity criteria for high-intensity focused ultrasound (HIFU), including magnetic resonance-guided focused ultrasound (MRgFUS), across indications (neurologic and prostate), and which CPT/ICD-10 codes support coverage. Applies to Priority Health commercial, Medicare (when CMS criteria absent), and Medicaid products as described.

Policy Summary

PayerPriority Health

PolicyHigh Intensity Focused Ultrasound (HIFU) / MRgFUS

Policy CodePolicy N/A

Change TypeClinical criteria and regulatory guidance added

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionWhen prior authorization is required for MRgFUS/HIFU, submit documentation demonstrating medical necessity and ensure InterQual criteria are documented for MRgFUS neurologic indications.

SourceLink

POLICY UPDATE CHANGES

MRgFUS is medically necessary for medication-refractory essential tremor and medication-refractory, tremor-dominant Parkinson's disease when InterQual criteria are met.

New Government Regulations section listing applicable CMS NCDs or LCDs; jurisdictions without an applicable LCD will follow NGS criteria for MRgFUS.

New FDA/Regulatory section and Medical/Professional Society Guidelines section added to policy.

2neurologic indications listed as medically necessary when InterQual criteria met

1prostate indication allowed as secondary therapy per NCCN (salvage/recurrent after radiotherapy)

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.

Medically Necessary and Not Medically Necessary Indications

Medically Necessary (MRgFUS - Neurology)

Magnetic resonance-guided focused ultrasound (MRgFUS) is medically necessary when InterQual criteria are met for the following:

ANY of the following

Medication-refractory essential tremor>= 22 years
InterQual criteria must be met; FDA-labeled device indication requires patients aged >= 22 years for idiopathic essential tremor
Medication-refractory, tremor-dominant Parkinson's disease>= 30 years
InterQual criteria must be met; FDA-labeled device indication requires patients aged >= 30 years for tremor-dominant Parkinson's disease

Medically Necessary (HIFU - Prostate)

High-intensity focused ultrasound may be medically necessary for prostate cancer in specific contexts:

ALL of the following

HIFU as secondary local therapy for recurrent prostate cancer after definitive radiotherapy
Must be in the absence of metastatic disease and may be considered medically necessary according to NCCN guidelines

Experimental / Investigational / Not Medically Necessary

HIFU (including MRgFUS where not specified above) is considered experimental and investigational for the following indications due to insufficient evidence of long-term effectiveness:

ANY of the following

Atrial fibrillation
Benign prostatic hypertrophy
Central nervous system diseases/disorders (e.g., brain cancer and stroke)
Fractures
Liver metastasis from colon and stomach cancer

Relevant CPT/HCPCS and ICD-10 Codes

ICD-10 codes that support medical necessityICD-10Covered

C61	Malignant neoplasm of prostate
R97.21	Rising PSA following treatment for malignant neoplasm of prostate
Z92.3	Personal history of irradiation

Procedure codes that support medical necessityCPT|HCPCSCovered

55880	Ablation of malignant prostate tissue, transrectal, with high intensity-focused ultrasound (HIFU), including ultrasound guidance
61715	Magnetic resonance image guided high intensity focused ultrasound (MRgFUS), stereotactic ablation of target, intracranial, including stereotactic navigation and frame placement, when performed

Not covered / Not supported codesCPT|HCPCSNot Covered

0950T	Ablation of benign prostate tissue, transrectal, with high intensity-focused ultrasound (HIFU), including ultrasound guidance
27599	Unlisted procedure, femur or knee
47399	Unlisted procedure, liver
48999	Unlisted procedure, pancreas
50549	Unlisted laparoscopy procedure, renal
55899	Unlisted procedure, male genital system [when specified as destruction of prostate tissue by high intensity focused ultrasound]
58999	Unlisted procedure, female genital system (nonobstetrical)
60699	Unlisted procedure, endocrine system
64999	Unlisted procedure, nervous system
76999	Unlisted ultrasound procedure (eg, diagnostic, interventional) Explanatory notes must accompany claims billed with unlisted codes

Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior authorization may be required

Prior authorization may be required for MRgFUS/HIFU depending on product and provider contract; when required, submit documentation demonstrating medical necessity per Priority Health procedures.

55880
61715
Follow Priority Health Provider Manual for PA submission and required documentation

Documentation Required

Use InterQual criteria for MRgFUS neurologic indications

InterQual clinical criteria must be met and documented in the prior authorization request for MRgFUS to be considered medically necessary for medication-refractory essential tremor or tremor-dominant Parkinson's disease.

Affected CPT: 61715

Clinical and Regulatory Context

High-intensity focused ultrasound (HIFU) is a noninvasive thermal ablation technology that uses externally generated sonic waves focused to a single point to thermally destroy target tissue. HIFU is applied in oncology—most commonly as transrectal ablation of prostate tissue for either focal or whole-gland treatment and as salvage therapy after radiotherapy—and in functional neurosurgery using magnetic resonance guidance (MRgFUS) for intracranial targets. MRgFUS thalamotomy typically targets the ventral intermediate nucleus (VIM, ventralis intermedius) of the thalamus for tremor control and is planned, guided, and monitored with MRI and thermal mapping. (Sources: device/technology descriptions and clinical application summaries.)

The ExAblate Neuro (ExAblate Model 4000) system (Insightec) holds FDA premarket approval (PMA P150038 with subsequent supplements) for specified unilateral intracranial indications. The labeled indications include unilateral thalamotomy for idiopathic essential tremor with medication-refractory tremor (patients must be at least 22 years), unilateral thalamotomy for tremor-dominant Parkinson's disease with medication-refractory tremor (patients must be at least 30 years), and unilateral pallidotomy for advanced idiopathic Parkinson's disease with medication-refractory motor complications (also with an age threshold of ≥30 years).

Randomized and prospective trials and systematic reviews indicate that MRgFUS thalamotomy produces symptomatic improvement in medication-refractory essential tremor, with durable reductions in tremor scores and improvements in quality-of-life measures out to 12 months and in many series to 2 years; adverse effects can include gait disturbance and paresthesia, some of which persist in a minority of patients. Evidence for MRgFUS pallidotomy or thalamotomy in tremor-dominant Parkinson's disease is more limited but growing; systematic reviews and meta-analyses report improvement in motor scores and dyskinesia measures with an acceptable safety profile in selected patients.

For prostate cancer, HIFU can be used to ablate part or all of the gland and has been studied as focal/hemiablation and as a salvage option after radiotherapy. Guidelines (including NCCN) allow HIFU as a secondary local therapy for recurrent prostate cancer after definitive radiotherapy in the absence of metastatic disease. However, the role of HIFU as a primary, first-line definitive treatment for localized prostate cancer remains uncertain because long-term oncologic effectiveness compared with standard therapies (radical prostatectomy or radiation) has not been established.

Key Terms

Definitions

MRgFUSMagnetic resonance-guided focused ultrasound: a noninvasive transcranial focused ultrasound procedure guided and monitored by MRI thermal mapping, commonly used for thalamotomy (targets the ventral intermediate nucleus) for essential tremor and Parkinson's disease.

HIFUHigh-intensity focused ultrasound: externally generated sonic waves focused to thermally ablate target tissue; used transrectally for prostate ablation or transcranially for neurosurgical targets.

Age and Label Thresholds

Age Thresholds (ExAblate Neuro FDA labeling)

Age threshold - FDA label for ExAblate Neuro (ET)>= 22 years for idiopathic essential tremor

Age threshold - FDA label for ExAblate Neuro (PD/pallidotomy)>= 30 years for tremor-dominant Parkinson's disease and pallidotomy indications

Policy Updates

2025-06-01policy effectiveLatest

Policy effective date updated to June 1, 2025; includes addition that MRgFUS is medically necessary for medication‑refractory essential tremor and medication‑refractory, tremor‑dominant Parkinson’s disease when InterQual criteria are met.

2025-05review/update

Added a Government Regulations section specifying applicable CMS NCDs/LCDs and that jurisdictions without an applicable LCD will follow National Government Services (NGS) criteria for MRgFUS.

2023-07-27regulatory (PMA supplement)