CurrentCignaPolicy 0274

High-intensity focused ultrasound (HIFU) and MR-guided focused ultrasound (MRgFUS)

Covers clinical indications, medical necessity criteria, and coding context for HIFU and MR-guided focused ultrasound therapies (including prostate, bone palliation, fibroids, renal) for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyHigh-intensity focused ultrasound (HIFU) and MR-guided focused ultrasound (MRgFUS)

Policy CodePolicy 0274

Change TypeAnnual review

Effective DateSep 15, 2025

Next Review DateDec 15, 2025

Key ActionObtain prior authorization and document recent repeat TRUS biopsy and absence of distant metastases when requesting salvage HIFU for recurrent localized prostate cancer.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1HIFU salvage prostate indication

1MRgFUS bone pain indication

1Not medically necessary (initial prostate tx)

2FDA-cleared prostate devices referenced

small studiesEvidence size/type

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Coverage Criteria for HIFU and MRgFUS

Coverage determinations for focused ultrasound procedures

Covered or not covered determinations for focused ultrasound procedures (HIFU, MRgFUS, MR‑guided TULSA).

HIFU for recurrent localized prostate cancer after radiation — Covered when ALL criteria are met

Positive, recent (repeat) transrectal ultrasound guided (TRUS) biopsy completed due to suspicion of local recurrence of prostate cancer.
Candidate for local therapy alone as evidenced by the absence of distant metastases.

MRgFUS for pain palliation of metastatic bone cancer — Covered when ALL criteria are met

Patient is 18 years of age or older with bone pain due to metastatic disease.
Patient has failed standard radiation therapy, is not a candidate for radiation therapy, or has refused radiation therapy.
The bone tumor to be treated is visible on non-contrast MR and is accessible to the MRgFUS device.

FDA-indicated MRgFUS coverage criteria

Device and patient selection consistent with FDA labeling (e.g., ExAblate system indications for uterine fibroids: women who have completed childbearing, do not intend to become pregnant, uterine size <24 weeks).
See device-specific contraindications and MRI-related exclusions below.
For uterine fibroids, MRgFUS is contraindicated for MRI-related issues (metallic implants or sensitivity to MRI contrast agents), obstructions in the treatment beam path (scar, skin folds, bowel, pubic bone, IUD, surgical clips, hard implants), fibroids close to sensitive organs or outside the image area.

Not medically necessary / Not covered

HIFU, including MRgFUS, is not medically necessary for any indication other than the covered uses described above, including when used as an initial treatment for localized prostate cancer.
Use of CPT/HCPCS codes related to MRgFUS/TULSA for prostate cancer (see code table) is considered experimental/investigational or not medically necessary as specified.

Investigational / Not established indications

HIFU for benign prostatic hypertrophy (BPH) is investigational / not medically necessary.
HIFU for glaucoma is investigational / not medically necessary.
HIFU for liver cancer (primary or metastatic) is investigational / not medically necessary.
HIFU for renal cancer is investigational / not medically necessary.
HIFU for thyroid nodules is investigational / not medically necessary.
MR-guided transurethral ultrasound ablation (TULSA) for treatment of prostate cancer is considered experimental, investigational or unproven.

Coverage criteria explanatory note

HIFU/MRgFUS are covered only for the specific indications above; all other uses are considered not medically necessary or investigational as noted.

MRgFUS uterine fibroid contraindications and MRI-related exclusions

MR-related contraindications (e.g., incompatible metallic implants, sensitivity to MRI contrast) preclude MRgFUS.
Obstructions in the treatment beam path (abdominal scar, skin folds, bowel, pubic bone, IUD, surgical clips, hard implants) preclude safe treatment.
Fibroids close to sensitive organs (bowel, bladder) or outside the MR image area are not treatable with MRgFUS.

MR-guided transurethral ultrasound ablation (TULSA) — Experimental/Investigational

TULSA for prostate cancer is considered experimental, investigational or unproven and is not covered.
Use of CPT codes 51721, 55881, 55882 to report TULSA is considered experimental/investigational/not medically necessary.

Coding and Billing Guidance

Referenced FDA 510(k) device clearancesmixed

K172721	Focal One ® (EDAP Technomed) 510(k) identifier referenced
K153023	Ablatherm Integrated Imaging 510(k) identifier referenced
K172285	Ablatherm Fusion 510(k) identifier referenced
K160942	Sonablate device 510(k) identifier referenced

Considered Medically Necessary for specific prostate indicationsCPTCovered

55880

Ablation of malignant prostate tissue, transrectal, with high intensity-focused ultrasound (HIFU), including ultrasound guidance

Considered Medically Necessary for pain palliation in metastatic bone cancer (when criteria met)HCPCSCovered

C9734

Focused ultrasound ablation/therapeutic intervention, other than uterine leiomyomata, with magnetic resonance (MR) guidance

Considered Not Medically Necessary for initial treatment of localized prostate cancer (codes often reported for HIFU/MRgFUS)mixedNot Covered

76999	Unlisted ultrasound procedure (eg, diagnostic, interventional)
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

Experimental/Investigational/Unproven for TULSA in prostate cancerCPTExperimental

51721	Insertion of transurethral ablation transducers for delivery of thermal ultrasound for prostate tissue ablation, including suprapubic tube placement during the same session and placement of an endorectal cooling device, when performed
55881	Ablation of prostate tissue, transurethral, using thermal ultrasound, including magnetic resonance imaging guidance for, and monitoring of, tissue ablation
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 transducers for delivery of the thermal ultrasound, including suprapubic tube placement and placement of an endorectal cooling device, when performed

Experimental/Investigational CPT Codes for MR-guided transurethral ultrasound ablation (TULSA)CPTNot Covered

51721	Insertion of transurethral ablation transducers for delivery of thermal ultrasound for prostate tissue ablation, including suprapubic tube placement during the same session and placement of an endorectal cooling device, when performed.
55881	Ablation of prostate tissue, transurethral, using thermal ultrasound, including magnetic resonance imaging guidance for, and monitoring of, tissue ablation.
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 transducers for delivery of the thermal ultrasound, including suprapubic tube placement and placement of an endorectal cooling device, when performed.

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for MRgFUS when reimbursement depends on meeting coverage criteria (e.g., metastatic bone pain or FDA‑indicated uterine fibroid uses) and for HIFU when used as salvage therapy after radiation failure. Requests for MRgFUS for metastatic bone pain or for MRgFUS of uterine fibroids should include the clinical documentation described below. Note that MRgFUS/TULSA uses outside covered indications and TULSA reporting codes may be denied as experimental.

Prior authorization required for MRgFUS for metastatic bone pain and MRgFUS for FDA‑indicated uterine fibroids
Prior authorization required for HIFU salvage therapy (recurrent localized prostate cancer) after radiation failure

Prior Authorization

Prior Authorization — Indication‑Specific Requirements

For MRgFUS pain palliation of metastatic bone cancer, prior radiotherapy must have been attempted and failed OR the patient must be an established contraindication/ineligible for radiotherapy. For MRgFUS of uterine fibroids, prior authorization will be confirmed only for patients meeting the FDA‑approved indication (women who have completed childbearing and do not intend future pregnancy, uterine size <24 weeks) and without MRI or beam‑path contraindications.

Background and Scope

Background: High-intensity focused ultrasound (HIFU) is a minimally invasive thermal ablation technique that uses focused ultrasound to create a focal zone of coagulation necrosis while sparing surrounding tissue. HIFU has been proposed for a range of benign and malignant conditions (including prostate disease and palliation of bone metastases). In this policy, HIFU is covered only for specified indications (salvage prostate after radiation failure) and MRgFUS is covered for bone pain palliation when criteria are met; other proposed uses are considered investigational or not medically necessary.

Key Definitions

High-intensity focused ultrasound (HIFU) — definition

DefinitionHigh-intensity focused ultrasound (HIFU) is a minimally invasive thermal ablation technique that creates coagulation necrosis in a targeted focal zone while sparing surrounding tissue.

MechanismDelivers focused ultrasound energy to heat and thermally coagulate targeted tissue, producing focal zone necrosis with limited adjacent tissue damage.

Clinical use examplesProposed for treatment of malignant and benign tumors (prostate, breast, brain, renal) and for palliation of bone metastasis.

Delivery approach (prostate specific)Transrectal HIFU uses a probe to image the prostate and deliver timed bursts of heat; procedures are typically outpatient and performed under spinal or general anesthesia.

MR-guided focused ultrasound (MRgFUS) — definition

Definition

Revision History

2025-09-15Focused ReviewLatest

Focused review performed; no clinical policy statement changes noted.

2024-12-15Annual Review

Removed policy statement for MRgFUS unilateral thalamotomy for treatment of essential tremor.

2024-01-15Annual Review

Policy Summary

PayerCigna

PolicyHigh-intensity focused ultrasound (HIFU) and MR-guided focused ultrasound (MRgFUS)

Policy CodePolicy 0274

Change TypeAnnual review

Effective DateSep 15, 2025

Next Review DateDec 15, 2025

Key ActionObtain prior authorization and document recent repeat TRUS biopsy and absence of distant metastases when requesting salvage HIFU for recurrent localized prostate cancer.

SourceLink

On This Page

Bone pain indication: document failure of standard radiation therapy or documented ineligibility/refusal of radiotherapy
Uterine fibroid indication: patient has completed childbearing and does not intend future pregnancy; uterine gestational size <24 weeks
Uterine fibroid contraindications to document: MRI contraindications (metallic implants, contrast sensitivity), obstructions in beam path (scars, skin folds, bowel, pubic bone, IUD, surgical clips, hard implants), fibroids close to sensitive organs or outside image area

Documentation Required

Required Clinical Documentation

MRgFUS for pain palliation: include documentation that the bone lesion is visible on non‑contrast MR and device accessible. For FDA‑indicated uses generally, include documentation of prior radiotherapy failure or clear rationale for ineligibility. For salvage HIFU in recurrent prostate cancer, include a recent repeat TRUS‑guided biopsy confirming local recurrence and documentation that disease is organ‑confined (no distant metastases) and the patient is a candidate for local therapy alone.

For MRgFUS (bone pain): non‑contrast MRI showing target lesion and statement of device accessibility; evidence of prior radiotherapy failure or contraindication
For FDA‑indicated MRgFUS uterine fibroid requests: documentation that patient meets FDA age/childbearing and uterine size criteria and absence of contraindications
For salvage HIFU (recurrent prostate cancer): recent repeat TRUS‑guided biopsy positive for local recurrence; imaging/staging to exclude distant metastases; documentation patient is candidate for local therapy only

Denial Risk

Prior Authorization / Noncoverage for TULSA and Initial Prostate Cancer Treatment

Requests for focused ultrasound/TULSA for prostate cancer will be scrutinized. MRgFUS/HIFU as initial treatment for localized prostate cancer is considered not medically necessary. MR‑guided transurethral ultrasound ablation (TULSA) for prostate cancer is considered experimental/investigational — requests that rely on TULSA codes may be denied.

HIFU/MRgFUS as initial treatment for localized prostate cancer: Not medically necessary
TULSA (MR‑guided transurethral ultrasound ablation) for prostate cancer: Experimental/Investigational/Unproven — prior authorization will not render investigational services covered

Step Therapy

Step Therapy and Prior Treatments

When requesting services, include trials of standard therapies and documentation of prior treatments when applicable. For bone pain palliation, document prior supportive/pharmacologic measures and radiotherapy trial or clear ineligibility. For uterine fibroids, document prior conservative and surgical options considered or attempted when relevant to care planning.

Step therapy note: no additional formal step‑therapy beyond radiation failure is required for salvage HIFU, but documentation of standard therapy trials is expected for indicated uses
Document trials of standard medical, pharmacologic, or interventional therapies prior to MRgFUS when applicable (e.g., NSAIDs, hormonal therapy, UAE, myomectomy as clinically appropriate)

Note

Consideration of Alternative Definitive Therapies

Consider definitive alternative therapies before approving focused ultrasound when appropriate; evidence shows higher re‑intervention rates with MRgFUS/HIFU compared with surgery or uterine artery embolization for fibroids and potentially different oncologic outcomes for prostate interventions. Discuss alternatives and include rationale if focused ultrasound is being considered to avoid or delay more definitive therapy.

For uterine fibroids: discuss myomectomy, uterine artery embolization, hysterectomy as alternatives; note higher long‑term re‑intervention rates with MRgFUS
For prostate disease: document why alternative definitive therapies (surgery, repeat radiation when applicable) are not appropriate or are declined by the patient

Documentation Required

TULSA — Typical Diagnostic and Follow‑up Documentation (Research/Protocol Context)

For TULSA-related protocols and investigative salvage TULSA, include detailed pre‑treatment and follow‑up diagnostics when available: pelvic multiparametric MRI, PSMA PET‑CT (or equivalent), pre‑TULSA biopsy and cystoscopy when performed, and scheduled post‑treatment follow‑up with PSA, imaging, biopsies and functional assessments as applicable. Note that inclusion of such documentation does not imply coverage if the procedure is investigational.

Typical pre‑treatment diagnostics in TULSA studies: pelvic mpMRI and PSMA PET‑CT within 3 months, pre‑treatment prostate biopsy, cystoscopy when performed
Typical follow‑up in TULSA studies: scheduled visits at 1–2 weeks then every 3 months to 12 months with adverse event assessment, PSA, uroflowmetry, IPSS/IPSS‑QoL, IIEF, and disease control evaluation with mpMRI and PSMA PET‑CT and biopsies at ~12 months

Magnetic resonance-guided focused ultrasound (MRgFUS) is focused ultrasound therapy performed with MRI guidance for visualization and monitoring of tissue effects, used in this policy for bone pain palliation.

MechanismCombines a high-intensity focused ultrasound beam that thermally ablates targeted tissue with MRI to visualize anatomy and monitor treatment effects in real time.

Clinical application (policy-relevant)Considered medically necessary for pain palliation in metastatic bone cancer when radiotherapy has failed or the patient is not a candidate for radiotherapy.

MRgFUS — MRI imaging and thermometry

Core descriptionMRgFUS combines high-intensity focused ultrasound for thermal ablation with magnetic resonance imaging and MR thermometry to visualize anatomy and continuously monitor tissue effects during treatment.

Imaging roleMRI provides real-time visualization of target anatomy and thermometry to monitor temperature and tissue response during ablation.

Studied indicationsHas been studied for uterine fibroids, essential tremor, metastatic bone cancer, and other tumor types; uterine fibroid use is the most extensively studied application.

TULSA-PRO — system definition

Device/SystemTULSA-PRO System — an MRI-guided transurethral directional ultrasound device that combines real-time MR imaging and MR thermometry with transurethral directional ultrasound and closed-loop control software to deliver thermal ablation of physician-prescribed prostate tissue.

ComponentsSystem includes hardware and software components for in-bore MRI treatment planning, monitoring, visualization, and active temperature feedback control.

Regulatory noteFDA granted 510(k) marketing clearance for the TULSA-PRO System (K191200) and for a modified TULSA-PRO system (K202286) with updated software.

MRgFUS — alternate label and context

Alternate labelMRgFUS / MR-guided focused ultrasound — noninvasive thermal ablation guided by MRI, used for fibroid ablation and studied in randomized comparisons versus uterine artery embolization.

SynonymAlso referred to as MRI-guided focused ultrasound surgery (MRgFUS or focused ultrasound with MR guidance).

Clinical contextIn uterine fibroid studies (e.g., FIRSTT trial), MRgFUS using systems like ExAblate has been compared with uterine artery embolization for symptom control and reintervention rates.

Revised policy statement for high-intensity focused ultrasound (HIFU) and MR-guided focused ultrasound (MRgFUS) for other indications.