CurrentAetnaPolicy 0766

High Intensity Focused Ultrasound

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Defines Aetna's coverage and investigational stance for high intensity focused ultrasound across indications, specifying medical necessity for radio-recurrent prostate cancer without metastasis and listing numerous indications considered experimental/investigational.

Policy Summary

PayerAetna

PolicyHigh Intensity Focused Ultrasound

Policy CodePolicy 0766

Change TypeNo material change

Effective DateOct 24, 2008

Last ReviewOct 11, 2023

Next Review DateAug 22, 2024

Key ActionObtain prior authorization when billing CPT code 55880 to confirm selection criteria for covered prostate HIFU.

SourceLink

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CurrentAetnaPolicy 0766

High Intensity Focused Ultrasound

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Policy Summary

PayerAetna

PolicyHigh Intensity Focused Ultrasound

Policy CodePolicy 0766

Change TypeNo material change

Effective DateOct 24, 2008

Last ReviewOct 11, 2023

Next Review DateAug 22, 2024

Key ActionObtain prior authorization when billing CPT code 55880 to confirm selection criteria for covered prostate HIFU.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1Medically necessary indications

44Experimental/Investigational listed

2CPT/HCPCS/ICD codes mentioned

C61Covered ICD-10 example

10/24/2008Policy effective (historical)

Coverage Criteria and Indications

Prostate cancer — focal HIFU candidate selection (per trials/guidance)

Covered when ALL of the following are met (per trials and guidance for focal/primary hemi-gland HIFU candidate selection):

ALL of the following

Diagnosis of clinically localized prostate cancer (no evidence of metastatic disease).
Tumor characteristics consistent with focal / hemi-gland ablation candidacy as described in focal HIFU series and trials: unilateral or predominantly unilateral disease confined to one prostate lobe on multi-parametric MRI and/or transperineal mapping biopsy (no bilateral clinically significant cancer).
Risk stratification: patient with low- or intermediate-risk prostate cancer favored for consideration of focal ablation (e.g., Gleason Grade Group 1–2 or selected favorable intermediate-risk cases); low-risk patients should generally preferentially be managed with active surveillance per AUA guidance; ablation for high-risk disease is not supported by current evidence.
Prostate volume and anatomy amenable to HIFU delivery (prostate size within device limitations and absence of anatomic factors precluding adequate energy delivery).
Patient counseling and informed consent documenting that HIFU focal ablation is an emerging/novel therapy, uncertainty regarding long-term oncologic equivalence to radical prostatectomy or radiotherapy, and the potential need for subsequent salvage therapy or repeat ablation.
Follow-up plan in place including PSA monitoring, digital rectal exam, imaging (e.g., mpMRI) and scheduled post-treatment biopsies as used in focal-HIFU trials (to detect in-field and out-of-field recurrence).
Treatment performed in an appropriate clinical setting by experienced multidisciplinary team and preferably within a clinical trial or registry when available (NICE and guideline recommendations prioritize use in research settings).

Billing and Coding

Covered CPT Codes (when selection criteria met)CPTCovered

55880

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

CPT Codes Not Covered for Indications ListedCPTNot Covered

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.

HCPCS Codes Not Covered for Indications ListedHCPCSNot Covered

C9734

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

ICD-10 Codes Covered if Selection Criteria MetICD-10Covered

C61	Malignant neoplasm of prostate [radio-recurrent prostate cancer].

ICD-10 Codes Not Covered for Indications Listed (not all-inclusive)ICD-10Not Covered

B02.22	Postherpetic trigeminal neuralgia
C16.0 - C16.9	Malignant neoplasm of stomach [liver metastasis from stomach cancer]
C18.0 - C18.9	Malignant neoplasm of colon [liver metastasis from colon]
C22.0, C22.2 - C22.8	Malignant neoplasm of liver, primary [hepatocellular]

No codes listed in these chunksmixed

No codes listed

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Coverage Expectations

Prior authorization is recommended or required for many focused-ultrasound procedures and related indications. When requesting coverage for a covered indication (for example, CPT 55880 for transrectal HIFU ablation of malignant prostate tissue in radio‑recurrent prostate cancer), submit prior authorization to confirm the indication and provide the supporting clinical documentation described below. For indications or devices considered investigational/experimental (see policy), prior authorization should be obtained and requests should include detailed clinical rationale and supporting evidence; lack of high-quality evidence or missing documentation may lead to denial.

Prior authorization expected when billing CPT 55880 for covered prostate HIFU — confirm radio‑recurrent prostate cancer diagnosis and selection-criteria documentation.
Prior authorization recommended for MRgFUS in movement disorders — confirm whether treatment is provided under special governance/research arrangements (see NICE) and whether it is part of a research/audit program.
Prior authorization recommended for MRgFUS for metastatic bone pain — randomized trial evidence exists; prior authorization should document prior radiotherapy status (unsuccessful, contraindicated, or declined) and refractory pain.
Prior authorization advisable for indications with mixed or limited evidence (renal tumors, select breast cancer indications, adenomyosis, malignant biliary obstruction, cesarean scar pregnancy, osteoid osteoma, hepatocellular carcinoma) — include indication‑specific supporting data.

Definitions and Key Terms

HIFU — High-intensity focused ultrasound (HIFU)

DefinitionHigh-intensity focused ultrasound (HIFU): a method that focuses ultrasound to heat and ablate target tissues without injuring surrounding structures.

MechanismDelivers targeted high-intensity ultrasound to rapidly elevate temperature in a precise focal zone to induce thermal coagulative necrosis.

Guidance modalitiesImage guidance may be MRI (MRgHIFU/MRgFUS) or ultrasound (US-guided HIFU) depending on indication and device.

Applications (general)Investigated across oncology, gynecology, ophthalmology, and neurosurgical indications for focal tissue ablation and palliation.

Most actionableHIFU is a noninvasive thermal ablation technique that can be directed to a precise focal zone to ablate target tissue while sparing surrounding structures.

Background and Evidence Summary

Consistent with guideline and evidence summaries, the policy reiterates that major sources (NCCN, ACR, AUA) do not include HIFU among standard therapeutic options for many indications, and that NICE recommends MRgFUS for essential tremor only with special governance or in research. This guidance supports the policy’s investigational stance for many applications.

Because HIFU is characterized as experimental in guideline assessments and has limited regulatory approval for many uses in the United States, the policy advises that routine use outside of clinical trials or well-defined investigational programs is not supported. The coverage section requires documentation or trial enrollment for indications outside the single covered scenario (radio‑recurrent prostate cancer without metastasis).

Policy Revision History

2023-10-11policy_reviewLatest

Clinical policy reviewed; last review recorded on 10/11/2023.

2024-08-22scheduled_review

Next policy review scheduled for 08/22/2024 per policy metadata.

2008-10-24policy_effective

Policy originally became effective on 10/24/2008.

Policy Summary

PayerAetna

PolicyHigh Intensity Focused Ultrasound

Policy CodePolicy 0766

Change TypeNo material change

Effective DateOct 24, 2008

Last ReviewOct 11, 2023

Next Review DateAug 22, 2024

Key ActionObtain prior authorization when billing CPT code 55880 to confirm selection criteria for covered prostate HIFU.

SourceLink

On This Page

For investigational/experimental treatments (including many renal, some prostate, and other HIFU applications not explicitly covered), prior authorization is recommended and may be required; submit device/model, treatment protocol, and supporting literature.

Note

Clinical Trial Enrollment and Patient Selection

Clinical-trial enrollment and selection of appropriate patients are emphasized for many HIFU applications — trial participation should be prioritized when guidelines recommend it (e.g., prostate ablation, MRgFUS for Parkinson tremor).

Clinical-trial enrollment and patient selection recommended for prostate ablation — AUA and other guidance: consider ablation in select intermediate‑risk patients and prioritize clinical trials; low‑risk patients should preferentially undergo active surveillance.
Focal HIFU trials require detailed pre-treatment characterization (mpMRI and trans‑perineal template prostate mapping biopsies) and eligibility criteria (histologically proven localized disease, PSA/Gleason/T stage limits).
Research-only context for MRgFUS in Parkinson disease tremor — NICE recommends use only in research; absence of research context may lead to non-coverage.

Documentation Required

Governance / Research Arrangements

Governance and research-arrangement requirements may apply. For technologies with guideline-mandated special arrangements, confirm governance, consent, audit, or research oversight when submitting prior authorization.

NICE recommends special arrangements for clinical governance, consent, and audit or research for MRgFUS thalamotomy for essential tremor.
When NICE or other authoritative guidance restricts use to research (e.g., MRgFUS for Parkinson disease tremor), document IRB/registry participation or trial identifiers.
If governance/research arrangements are not documented, requests for these indications may be denied.

Documentation Required

Required and Suggested Clinical Documentation

Document baseline disease severity, prior therapies tried and failed, and indication‑specific diagnostic testing. For movement disorders, document tremor severity and prior medication trials; for prostate focal therapy, include PSA, Gleason score, mpMRI and mapping biopsies; for breast fibroadenoma include histologic confirmation.

Clinical documentation for movement disorders: baseline tremor severity (validated scale), failure of ≥2 medications (when applicable), target laterality and prior surgical history, and neurological exam.
Documentation in focal HIFU prostate trials: pre-treatment mpMRI, trans‑perineal template prostate mapping biopsies, histologic confirmation, PSA and Gleason score, and tumor localization (index lesion criteria).
Core needle biopsy with histological confirmation required for palpable breast fibroadenomas prior to HIFU; cytology/histology acceptable for some patients ≥25 years per trial protocols.
Suggested supporting documentation for breast fibroadenoma: core-needle biopsy results, size/US visibility, symptom description, prior conservative/surgical options discussed, and informed consent.
Suggested supporting documentation for adenomyosis, HCC, malignant biliary obstruction and other selected indications: prior treatments attempted, imaging and laboratory results, and rationale for HIFU versus standard therapies.

Documentation Required

Procedure, Device, and Outcome Documentation

When coverage is requested, include procedure and device details and outcome measures. For requests tied to clinical trials or registries, provide trial identifiers and planned follow‑up assessments.

Required clinical documentation: device make/model, procedure protocol, technical success metrics, baseline and planned follow‑up outcome measures (e.g., IOP for glaucoma, pain scores and analgesic use for bone metastases, PSA and biopsy results for prostate cancer).
Clinical outcome data to include in documentation: time to stent dysfunction and stent patency for biliary obstruction, recurrence rates and need for radical therapy for prostate focal ablation, pain response rates and BPI‑QoL for metastatic bone pain.
Documentation in trials: planned biopsy schedule (e.g., TPM at 36 months), validated patient-reported outcome instruments (IIEF, IPSS, EPIC, FACT‑P), and imaging follow‑up plans.

Step Therapy

Prior Therapies and Step-Therapy Expectations

Step-therapy and prior conservative or surgical therapy expectations vary by indication. For many conditions with established alternatives, documentation that standard therapies were tried and failed is expected.

Step before HIFU: for prostate cancer, standard options include active surveillance, radiotherapy, and radical prostatectomy; HIFU is generally investigational or reserved for trials except where policy lists covered circumstances.
Fail conservative therapy first: for essential tremor MRgFUS trials typically enrolled patients refractory to ≥2 medications.
Step therapy expectation: for glaucoma, medical therapy is usually first-line and incisional surgery second; HIFU or cyclo‑destructive procedures are considered when standard approaches fail.
Consider radiotherapy before MRgFUS for painful bone metastases when radiotherapy is the standard first-line palliative treatment unless radiotherapy was unsuccessful, contraindicated, or declined.

Denial Risk

Evidence Limitations and Denial Risk

Evidence limitations and gaps are important considerations for coverage decisions. Requests lacking high-quality comparative data, long-term outcomes, or safety reporting are at higher risk for denial.

Techniques currently do not permit sufficient tumor destruction for some indications (e.g., extra-corporeal HIFU for renal tumors) — these are considered experimental.
Evidence gaps may lead to denial: absence of comparative studies vs standard treatments, limited safety data, heterogeneous or low‑quality studies, or short follow‑up.
Evidence-based denial risk: documented inconsistent or limited comparative effectiveness (for example, mixed results versus cyclodiode for glaucoma) may trigger noncoverage if submission lacks strong supporting data.
Limited high-quality evidence may trigger denial for many off‑label or emerging indications (renal tumors, several oncologic uses, some gynecologic indications) unless provided within a trial or with robust rationale.

Billing Rule

Coding, Administrative Notices, and Where to Refer

Administrative and coding notices: codes billed for non‑covered indications per this policy are subject to denial. Refer to the full policy for complete lists of CPT/HCPCS/ICD-10 codes, coverage rules, and specific prior authorization instructions.

Support for covered indication: when submitting covered CPT/ICD‑10 codes (e.g., 55880 and C61 for radio‑recurrent prostate cancer), include the clinical evidence that meets selection criteria.
Coding-based denials: procedures billed with codes listed as not covered for the requested indication (see policy code lists) are subject to denial.
Prior authorization: refer to full policy for the explicit list of codes requiring authorization, submission addresses, and contact information.
No explicit provider authorization or coverage rules are present for some rare or emerging indications in this fragment — follow the full policy and payer-specific prior authorization portals for operational rules.

Radio-recurrent prostate cancer — definition and context

DefinitionRadio-recurrent prostate cancer: prostate cancer that has recurred after prior radiation therapy and is confined to the prostate without metastatic disease.

Evidence basisHIFU has been used as salvage therapy for biopsy-proven local recurrence after radiotherapy; published series report short- to mid-term cancer control but no RCTs in primary setting.

ConsiderationsSelection requires histologic confirmation of local recurrence and exclusion of metastatic disease; outcomes influenced by pre-HIFU PSA and Gleason score.

Guidance note (actionable)Aetna considers HIFU medically necessary for radio-recurrent prostate cancer in the absence of metastatic disease when selection criteria are met (supported diagnosis code C61).

Focal HIFU (INDEX trial criteria)

DefinitionFocal HIFU (INDEX trial criteria): treatment of a unilateral dominant (index) lesion guided by multi-parametric MRI (mpMRI) and trans-perineal template (TPM) prostate mapping biopsies.

Eligibility parametersTrial eligibility example: histologically proven localized low/intermediate-risk disease (PSA <15 ng/mL, Gleason ≤7, clinical stage ≤T2cN0M0) with contralateral side free of clinically significant disease.

Mapping requirementPre-treatment tumor localization requires mpMRI plus TPM biopsies to confirm unilateral index lesion and absence of clinically significant contralateral disease (Gleason ≥7 or core length ≥4 mm).

Outcome assessmentPost-treatment assessment includes targeted biopsies and TPM biopsies (e.g., at 36 months) to document absence of clinically significant disease.

Endpoints — Biochemical DFS and PSA nadir

Common endpointsBiochemical disease-free survival and PSA nadir are commonly reported endpoints across HIFU series.

Definition variabilityDifferent biochemical definitions used across studies (Phoenix, Stuttgart, ASTRO), limiting comparability of reported DFS and nadir results.

Reported rangesReported PSA nadirs in series ranged from 0.04 to 1.8 ng/mL; 5-year disease-free survival ranged roughly 61–95% across uncontrolled studies.

Most actionableWhen evaluating HIFU outcomes, compare definitions used for biochemical recurrence and PSA nadir across studies because heterogeneity affects interpretation.

Focal (hemi-gland) HIFU

DefinitionFocal (hemi-gland) HIFU: targeted ablation of a unilateral dominant tumor (index lesion) within the prostate using HIFU with pre-treatment localization by mpMRI and TPM biopsies.

Selection detailsIndex lesion approach treats unilateral dominant tumor provided contralateral prostate is free of clinically significant disease (e.g., Gleason ≥7 or core length ≥4 mm).

Outcome expectationsReported short-term outcomes include treatment-failure–free survival and need for repeat focal or radical therapy; example: Abreu et al reported ~73% 2-year freedom from treatment failure after hemi-gland HIFU.

Most actionableFocal HIFU protocols mandate precise pre-treatment tumor mapping (mpMRI + TPM) and scheduled post-treatment biopsies to verify absence of clinically significant residual disease.

MR-guided focused ultrasound thalamotomy

DefinitionMR-guided focused ultrasound thalamotomy: transcranial MRI-guided HIFU creating a focal thermal ablation in the thalamic ventral intermediate nucleus to treat medication-refractory essential tremor.

Efficacy evidenceRandomized, sham-controlled trial (Elias et al.) showed significant improvement in hand tremor at 3 months with benefits maintained at 12 months; RCT included patients refractory to ≥2 medication trials.

Limitations and patient factorsDurability beyond 12 months is uncertain; skull thickness/anatomy may make some patients unsuitable; procedure creates a fixed lesion (cannot be adjusted like DBS).

Most actionableMRgFUS thalamotomy is an evidence-supported option for medication-refractory essential tremor in selected patients but suitability requires skull-anatomy assessment and counseling about fixed lesion effects.

MRgFUS — Magnetic resonance-guided focused ultrasound

DefinitionMRgFUS (magnetic resonance-guided focused ultrasound): a noninvasive focused ultrasound technique using MRI for targeting and real-time thermometry to thermally ablate deep targets.

Indications studiedStudied for movement disorders (ET, parkinsonian tremor), intracranial targets (e.g., capsulotomy for OCD in pilot reports), and palliation of bone metastasis pain (including RCT evidence).

Evidence contextRCTs show benefit for tremor and for bone metastasis pain palliation; additional RCTs are needed for many intracranial targets and long-term durability assessment.

Most actionableMRgFUS requires MRI-compatible workflow and skull suitability assessment; evidence supports use for selected tremor and bone-pain indications under defined protocols.

Thalamotomy (focused ultrasound)

DefinitionThalamotomy (focused ultrasound): a fixed lesion in the thalamus produced by focused ultrasound to reduce tremor; unlike DBS, it cannot be adjusted after ablation.

Clinical implicationsProcedure creates irreversible lesioning; potential persistent adverse effects (e.g., altered sensation) reported in a minority of patients (permanent in ~14% in one editorial summary).

Patient selectionBest suited for patients with medication-refractory unilateral tremor and favorable skull anatomy; candidacy should consider inability to adjust therapy compared with DBS.

HIFU — general oncology definition and guidance

DefinitionHIFU: technology delivering focused ultrasonic energy to induce thermal coagulative necrosis in target tissues (extracorporeal or laparoscopic approaches reported).

Oncology applicationsStudied across primary bone malignancies, pancreatic cancer (often with chemotherapy), liver tumors (with/without TACE), and other tumor types, typically in nonrandomized series and some small RCTs.

Evidence caution (actionable)Most oncologic uses lack high-quality randomized comparative evidence; outcomes and complication rates vary by indication and technique—document indication-specific evidence when requesting coverage.

MRgFUS / MR-guided focused ultrasound

DefinitionMRgFUS / MR-guided focused ultrasound: uses MRI for targeting and real-time thermometry to perform thermal ablation; applied in trials for bone metastasis pain and movement disorders.

Trial evidencePhase III RCT in bone metastasis pain demonstrated superior pain response (64.3% vs 20.0% placebo) at 3 months; movement-disorder RCTs show tremor improvement versus sham.

Patient selection and monitoringRequires MRI-based planning, peri-procedural thermometry, and follow-up assessments (pain scales, tremor scores) to document effectiveness and safety.

US-guided HIFU

DefinitionUS-guided HIFU: high-intensity focused ultrasound guided by ultrasound imaging, used in studies for breast fibroadenoma, cesarean scar pregnancy, and other extracorporeal applications.

Study exampleMulticenter US-guided HIFU study for breast fibroadenoma reported mean volume reductions up to 72.5% at 12 months with mostly transient minor skin effects.

Actionable pointUS guidance allows outpatient procedures for superficial targets (e.g., breast fibroadenoma) but requires histologic confirmation prior to treatment as in reported studies.

MR-guided focused ultrasound (MRgFUS)

DefinitionMR-guided focused ultrasound (MRgFUS): a non-invasive, image-guided ultrasound technique that creates focal thermal lesions in targeted brain regions with real-time thermometry guidance.

Regulatory contextMRgFUS thalamotomy is supported by randomized sham-controlled evidence for essential tremor; some MRgFUS intracranial targets have FDA approvals while others remain investigational.

Most actionableMRgFUS intracranial procedures require multidisciplinary evaluation, skull-compatibility assessment, and discussion of irreversible lesioning vs adjustable alternatives (e.g., DBS).

US cycloplasty / HIFU cyclo-coagulation

DefinitionUS cycloplasty / HIFU cyclo-coagulation: application of high-intensity focused ultrasound to the ciliary body to reduce intraocular pressure via selective thermal ablation.

Study resultsProspective study (n=73) reported 78.3% success at 12 months (IOP reduction ≥20%) with no major intra- or post-op complications reported in short-term follow-up.

Actionable considerationEvidence is mixed versus other glaucoma procedures; documentation of prior standard therapies and expected endpoints is important when requesting coverage.

MRgHIFU / USgHIFU

DefinitionMRgHIFU / USgHIFU: image-guided HIFU approaches (MRI- or ultrasound-guided) that localize and monitor thermal ablation during treatment; choice depends on target location and acoustic window.

Feasibility limitsFeasibility depends on tumor location, ability to prepare adjacent organs (bowel/bladder), and absence of bone obstructing acoustic window; some lesions may be unreachable.

Most actionableAssess target accessibility and plan preparations (bowel/urogenital emptying/filling) to maximize treatable volume; document infeasibility when disease lies beyond transducer reach.

Malignant Biliary Obstruction (MBO)

DefinitionMalignant biliary obstruction (MBO): obstruction of the biliary tree due to malignancy; studies compared stent insertion alone versus stent plus HIFU ablation.

Meta-analysis findingsMeta-analysis of 6 studies (n=429) found pooled stent dysfunction rates 25.9% (stent alone) vs 18.0% (stent+HIFU) and longer time to stent dysfunction with HIFU (MD -3.15 days, p<0.0001).

Actionable noteEvidence suggests stent+HIFU may improve stent patency and OS versus stent alone in selected studies, but limitations (retrospective designs) warrant cautious interpretation and further RCTs.

Cesarean Scar Pregnancy (CSP)

DefinitionCesarean scar pregnancy (CSP): ectopic pregnancy implanted in the scar of a previous cesarean section; treatments compared included HIFU followed by curettage versus uterine artery embolization (UAE) plus curettage.

Meta-analysis findingsMeta-analysis (34 studies) reported HIFU groups had significantly reduced blood loss (SMD -1.45), fewer adverse events (OR 0.36), higher success rate (OR 1.56), and higher re-pregnancy rates versus UAE groups.

Most actionablePublished pooled data favor HIFU plus curettage for CSP on several short-term outcomes, but applicability depends on study quality and regional practice; document reproductive outcome expectations when requesting treatment.

High-intensity focused ultrasound (HIFU) is a noninvasive technology that focuses ultrasound energy to produce localized heating and thermal coagulative necrosis of target tissues while aiming to spare surrounding structures. The policy background describes HIFU’s mechanism and notes that clinical study to date has focused on multiple indications with variable levels of evidence and documented procedure-specific toxicities.

This policy excerpt does not specify prior authorization procedures within the provided text. The policy header contains effective and review dates; providers should refer to the complete policy or payer-specific administrative guidance for precise prior authorization requirements.