CurrentAetnaPolicy 0001

Transrectal Ultrasound

This clinical policy bulletin defines when transrectal ultrasound (TRUS) is considered medically necessary, lists procedures considered experimental/investigational, and provides related coding and background; it applies to Aetna members and providers who request coverage for TRUS-related services.

Policy Summary

PayerAetna

PolicyTransrectal Ultrasound

Policy CodePolicy 0001

Change TypeNo material change

Effective DateJul 21, 1995

Next Review DateJan 11, 2024

Key ActionVerify member-specific benefit and prior authorization requirements when billing TRUS-related procedures and document an appropriate diagnosis to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12Medically necessary indications listed

7Experimental / investigational items

01/11/2024Next scheduled review

03/06/2023Last review

Coverage Criteria for Transrectal Ultrasound (TRUS)

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inv-03: When MRI/US fusion–guided biopsy is supported by evidence

Coverage considerations when MRI/US fusion–guided biopsy is being considered:

Indications supporting use: Persistent clinical suspicion for prostate cancer after prior negative TRUS biopsies; elevated PSA or abnormal digital rectal examination with MRI-visible target lesions; clinical need to better detect or localize higher-grade/clinically significant tumors.clinical judgment based on PSA, PSA density, prior biopsy history, and MRI suspicion level

Studies (Vourganti; Kuru; Siddiqui) report higher detection of clinically significant and high-grade cancers with MRI/US fusion targeting compared with standard biopsy.

Optimal diagnostic prerequisites: Presence of a multiparametric prostate MRI with identified target lesions (T2-weighted imaging plus at least one additional sequence such as diffusion-weighted imaging or dynamic contrast enhancement), MRI interpreted by experienced genitourinary radiologist, and documentation of PSA and prior biopsy status.mpMRI performed with at least one additional sequence; 3.0T preferred in some series

Several studies excluded MRI-negative patients and reported improved detection when MRI lesions were present.

inv-04: Evidence summary and comparative effectiveness

Key evidence findings from randomized trials, cohort studies, systematic reviews, and multicenter studies:

Siddiqui et al. (prospective cohort): In a prospective cohort of 1,003 men undergoing concurrent targeted MR/US fusion and standard biopsy, targeted fusion biopsy detected 30% more high-risk cancers and 17% fewer low-risk cancers compared with standard biopsy; combining targeted and standard biopsies primarily added low-risk diagnoses.

Majority had prior biopsies; MRI-negative patients were excluded; MRIs read by experienced GU radiologists.

Systematic reviews/meta-analyses: Systematic reviews and meta-analyses indicate MRI-targeted biopsy detects more clinically significant cancers and fewer insignificant cancers than TRUS-guided biopsy, often using fewer cores; overall cancer detection may be similar in MRI-positive cohorts but significant-cancer detection is higher with targeted approaches.

Heterogeneity exists across studies in inclusion criteria, csPCa definitions, and techniques.

Randomized trials (mixed results): Randomized trials show mixed results: some RCTs found no significant difference in csPCa detection between limited-core MRI-targeted strategies and standard 12-core biopsy, while others (e.g., PRECISION) showed non-inferiority or superiority of an MRI-targeted pathway in biopsy-naïve men.

Examples include Baco (no difference) and Arsov/Tonttila (mixed findings).

Ahmed et al. (PROMIS multicenter paired-cohort): Using template prostate mapping biopsy as the reference standard in biopsy-naïve men (PSA up to 15 ng/mL), mpMRI sensitivity for clinically significant cancer was 93% versus 48% for TRUS-biopsy; mpMRI triage could avoid ~27% of primary biopsies and may reduce over-diagnosis of insignificant cancers.

576 men underwent mpMRI, TRUS-biopsy and TPM-biopsy in paired analysis.

inv-05: Evidence-based clinical scenarios for use of mpMRI and MRI-targeted biopsy

Findings from clinical studies describing when mpMRI or MRI-targeted biopsy may be preferred or informative

mpMRI as triage before biopsy: Using mpMRI as a triage test before first biopsy can allow approximately 27% of men to avoid primary biopsy while maintaining high sensitivity for clinically significant cancer; MRI-targeted biopsy can detect more clinically significant cancers and fewer insignificant cancers in some trials (eg, PROMIS, PRECISION).mpMRI suspicious lesion (eg, PI-RADS ≥3)

Supported by Ahmed et al. and Kasivisvanathan et al.

MRI-targeted-only strategy: In biopsy‑naïve men, an MRI-targeted-only strategy (biopsy only if MRI is suggestive) was non-inferior and in PRECISION showed higher detection of clinically significant cancer and fewer diagnoses of insignificant cancer compared with standard TRUS-guided biopsy.

See Kasivisvanathan et al. (2018).

mpMRI in repeat biopsy setting: In men with prior negative biopsies and persistent suspicion, mpMRI-targeted biopsy detects more intermediate/high‑grade cancers, fewer low‑grade cancers, and can reduce the number of repeat biopsies (e.g., MRI-targeted-only in PI‑RADS ≥3 reduced repeat biopsies by ~50%).PI-RADS ≥3

Boesen and related studies report these findings.

Limitations and operator dependence: Diagnostic performance depends on MRI protocol quality, reader experience, and study selection; some significant tumors may be missed by mpMRI and applicability to MRI‑negative populations is limited by exclusions in many studies.

Caveats discussed across multiple studies.

inv-06: Evidence-based diagnostic pathway findings

Evidence-based pathway findings reported in cited studies (PROMIS, PROMIS-derived modeling, PRECISION, systematic reviews):

mpMRI-first pathway: Modeling and economic analyses (eg, PROMIS-derived models) suggest an mpMRI-first pathway followed by MRI-targeted TRUS-guided biopsy (with up to two targeted biopsies) detects more clinically significant cancers and can be cost‑effective compared with TRUS-first strategies (reported sensitivity ~0.95 vs 0.91 and ICER ~£7,076/QALY in one model).

Findings sensitive to test costs, MRI-targeted biopsy sensitivity, and long-term outcomes.

mpMRI diagnostic accuracy: Paired studies report mpMRI sensitivity for clinically significant cancer around 93% with NPV ~89%, whereas TRUS-guided biopsy sensitivity is lower (~48%); a negative mpMRI does not exclude all clinically significant cancers (eg, ~27% negative mpMRI rate in PROMIS with some CS cancers found on TPM-biopsy).mpMRI sensitivity ~93%, TRUS sensitivity ~48%

PROMIS and validating paired-cohort data support these metrics.

Emerging modalities: High‑resolution micro‑ultrasound shows detection rates comparable to mpMRI-targeted biopsy in pooled analyses; MRI‑TRUS fusion and PSMA‑PET are promising adjuncts but require further randomized data to define their roles.

Micro‑US pooled detection ratios approximate parity with mpMRI-targeted approaches in systematic reviews.

Coding and Billing References

CPT/HCPCS codes referencedCPT

76872	Ultrasound, transrectal [TRUS combined with USG elastosonography plus contrast-enhanced USG not covered for staging of rectal cancer]
76873	Prostate volume study for brachytherapy treatment planning (separate procedure)
45341	Sigmoidoscopy, flexible: with endoscopic ultrasound examination
45342	Sigmoidoscopy, flexible; with transendoscopic ultrasound guided intramural or transmural fine needle aspiration/biopsy(s)
76870	Ultrasound, scrotum and contents
76856	Ultrasound, pelvic (nonobstetric), real time with image documentation; complete
76978	Ultrasound, targeted dynamic microbubble sonographic contrast characterization (non-cardiac)
76979	Each additional lesion with separate injection (List separately in addition to code for primary procedure)
76981-76983	Ultrasound, elastography
76376	3D rendering with interpretation and reporting of CT, MRI, ultrasound, or other tomographic modality with image postprocessing

1–10 of 12

1/2

ICD-10 codes referenced (covered and not covered)ICD-10

C61	Malignant neoplasm of prostate
C19-C21.8	Malignant neoplasm of rectosigmoid junction, rectum, anus and anal canal
C76.3	Malignant neoplasm of pelvis
C78.5	Secondary malignant neoplasm of large intestine and rectum
C79.82	Secondary malignant neoplasm of genital organs
D01.1-D01.3	Carcinoma in situ of rectosigmoid junction, rectum, anus and anal canal
D07.5	Carcinoma in situ of prostate
D12.7-D12.9	Benign neoplasm of rectosigmoid junction, rectum, anus and anal canal
D29.1	Benign neoplasm of prostate
D37.5	Neoplasm of uncertain behavior of rectum

1–10 of 20

1/2

Codes referenced in policy (not present in this excerpt)mixed

No codes listed

Covered CPT Codes (not specified in excerpt)mixed

No codes listed

inv-21: PSA threshold reference

PSA threshold (metastatic lesion consideration)PSA greater than 10 ng/mL (used to consider metastatic lesions of unknown source possibly originating from the prostate)

PSA influence on biopsy detectionElevation of PSA above 10 ng/mL noted to increase detection rate when TRUS-guided biopsy is performed

Clinical context referencePSA used alongside abnormal DRE or hypoechoic TRUS findings to suspect prostate carcinoma

inv-22: PSA thresholds referenced

PSA >10 ng/mLIndicates higher likelihood of prostate cancer; referral to interventional specialist recommended (Hoffman 2015) and used as a threshold in multiple studies

PSA 4–10 ng/mLConsidered a diagnostic 'gray zone' where repeat testing or additional evaluation may be advised (Hoffman 2015)

PSA <3.0 ng/mL + percent free PSA >18%In one population screening study, men with PSA <3.0 ng/mL and percent free PSA >18% had no prostate cancer diagnosed on biopsy during study follow-up

inv-23: PSA concentration upper limit (study enrollment)

Study enrollment upper limitMen enrolled in the cited multicenter confirmatory study had PSA concentrations up to 15 ng/mL

PopulationBiopsy‑naïve men with PSA ≤15 ng/mL in the Ahmed et al. study

ImplicationPSA upper limit defined eligibility for comparison of mpMRI, TRUS-biopsy, and TPM-biopsy

inv-24: PSA for active surveillance cohort

Active surveillance PSA criterionEligibility for the active surveillance cohort included PSA below 10 ng/mL

Additional AS criteriaOther enrollment criteria included clinical stage cT1c, life expectancy >10 years, ≤3 unilateral positive cores, GS=6, and greatest % cancer per core ≤50%

Use casempMRI/TRUS fusion biopsy assessed in men on active surveillance to detect clinically significant progression

inv-25: PSA density threshold (study eligibility)

PSA density thresholdPSA density less than 0.20 ng/mL² was an eligibility criterion for the active surveillance cohort (Pepe et al., 2017)

ContextUsed alongside PSA <10 ng/mL and biopsy characteristics to select men for confirmatory biopsy and mpMRI/TRUS fusion targeting

RelevancePSA density was a significant predictor in multivariate analyses in several studies of MRI/US fusion biopsy utility

inv-26: mpMRI negative rate threshold

mpMRI negative rate (PROMIS)In the PROMIS cohort, 27% of men had a negative mpMRI scan (i.e., no suspicious lesion)

ConsequenceUsing mpMRI triage could allow approximately 27% of men to avoid primary biopsy per the Ahmed et al. analysis

False negativesOf the mpMRI-negative group in PROMIS, a minority (17 of 158) were found to have clinically significant cancer on TPM-biopsy

inv-27: PROMIS primary CS definition

PROMIS primary clinically significant definitionClinically significant cancer defined as Gleason score ≥4+3 and/or maximum cancer core length ≥6 mm (as used in Ahmed et al./PROMIS)

Reference standardDefinition applied when comparing mpMRI and TRUS-biopsy against template prostate mapping (TPM) biopsy

ImplicationStudy-specific CS definitions influenced reported sensitivity and NPV of mpMRI versus TRUS-biopsy

Provider Actions, Authorization & Documentation

Prior Authorization

Prior authorization — Verify member plan requirements

Verify prior authorization requirements with the member's benefit plan before scheduling or billing TRUS-related services. The bulletin does not list explicit payer prior authorization codes for TRUS, MRI/US fusion biopsy, or related procedures; providers should confirm whether prior authorization is required for the specific CPT/HCPCS codes and services they plan to bill.

Providers should check member-specific plan provisions and any plan prior authorization lists or portals prior to service.
When using MRI/US fusion biopsy or advanced TRUS techniques, document clinical indications and prior testing (e.g., prior negative TRUS biopsy, rising PSA, abnormal DRE) to support medical necessity if prior authorization is requested.

Denial Risk

Non‑covered screening / observation diagnoses

Claims for TRUS performed for screening or routine observation encounters are listed as not covered. Do not submit TRUS claims with screening or observation diagnosis codes when seeking coverage.

Do not bill TRUS for ICD-10 Z12.12 (screening for malignant neoplasm of rectum), Z12.5 (screening for malignant neoplasm of prostate), or Z03.89 (encounter for observation for other suspected diseases and conditions ruled out) — these are listed as not covered in the policy.
If TRUS is performed, ensure the claim includes a covered, medically necessary diagnosis from the policy's list (e.g., C61, K60.3–K60.5, K61.0–K61.4, R36.1, R97.20).

Step Therapy

Not applicable — no step therapy / sequencing or insurer paperwork specified

Not applicable content in this policy window: there are no step‑therapy, sequencing mandates, or insurer‑specific paperwork requirements specified in the excerpts reviewed. Providers should treat mpMRI and MRI/US fusion approaches as clinical decision tools described in the evidence summaries rather than as plan-imposed sequencing rules.

The policy excerpts do not impose step‑therapy or sequencing requirements for mpMRI, MRI/US fusion biopsy, or TRUS.
No insurer‑specific specimen submission, special forms, or unique administrative paperwork requirements are listed in these excerpts.

Note

Not stated in this excerpt — administrative / coding specifics

Not stated in this excerpt: the bulletin does not specify explicit administrative denial triggers or an exhaustive list of affected billing codes for MRI/US fusion or TRUS biopsy beyond the CPT/ICD groups shown. Providers must rely on member plan benefit details and prior authorization confirmations for operational coverage decisions.

The policy lists CPT/ICD groups and examples but does not enumerate every possible code for MRI/US fusion platforms or some emerging techniques (e.g., high‑resolution micro‑US-guided biopsy) — confirm coding and coverage with the payer.
If clinical justification is required (e.g., for MRI‑targeted biopsy after prior negative TRUS), document the indication, prior test results, PSA trends, and mpMRI findings to support medical necessity.
Treat Clinical Policy Bulletins as an aid in administering benefits; they are not a complete statement of member benefits or prior authorization requirements.

Documentation Required

Required imaging and clinical documentation

Document the clinical indication and imaging details clearly in the medical record to support coverage and any prior authorization requests. Include prior biopsy history and relevant mpMRI details when applicable.

For mpMRI, document sequences used (T2 plus at least one additional sequence such as DWI or DCE) and magnet strength when available (e.g., 3.0T if used).
For MRI/US fusion biopsy, document mpMRI findings (e.g., PI‑RADS score or suspicion level), targeted biopsy results, and prior TRUS biopsy history (number and dates of prior negative biopsies).
Record PSA values, PSA density, and any prior management (e.g., antibiotics for prostatitis) that bear on the decision to biopsy.

Documentation Required

Definitions and Technique Descriptions

inv-53: Elastography / sono-elastography

Elastography descriptionTechnique measuring tissue stiffness (qualitative and quantitative) with colors superimposed on B‑mode ultrasound to identify areas of abnormal firmness that may correspond to cancer

ApplicationsUsed with linear scanners, endocavitary probes, and echoendoscopes; can calculate elasticity modulus from tissue deformation

Evidence statusPromising biomarker but prospective studies are needed to define clinical applications

inv-54: MRI-TRUS fusion

MRI-TRUS fusion definitionTechnique where pre-biopsy MRI-identified targets are integrated (fused) with TRUS images (out-of-bore) to improve localization and sampling during biopsy

MethodsFusion approaches include in-bore MRI, MRI-US fusion with dedicated devices, and cognitive fusion

Device examplesExamples of fusion devices with supportive data include Artemis and Urostation

inv-55: Multiparametric MRI (mpMRI)

mpMRI componentsMultiparametric MRI requires T2-weighted imaging plus at least one additional sequence such as diffusion-weighted imaging (DWI) or dynamic contrast-enhanced (DCE) imaging

Quality considerationsHigh-quality mpMRI often uses a 3.0T magnet; endorectal coil use is controversial

Clinical rolesmpMRI aids in detection of poorly differentiated tumors, extracapsular extension, staging, and as a triage tool prior to biopsy

inv-56: MRI/US fusion biopsy

MRI/US fusion biopsy descriptionBiopsy approach that fuses pre‑biopsy MRI‑defined targets with real‑time transrectal ultrasound to perform targeted prostate sampling, improving localization and sampling accuracy

TechniquesCan be performed out‑of‑bore with fusion software, in‑bore, or cognitively; used to map, target, and track lesions

Clinical benefitTargeted biopsies using fusion reported higher sensitivity for clinically significant disease and improved accuracy versus systematic biopsy alone

inv-57: Clinically significant prostate cancer

Variable definitions of clinically significant PCaDefinitions vary by study; examples include Gleason score ≥4+3 or Gleason ≥4+3 or maximum cancer core length ≥6 mm (Ahmed et al./PROMIS; Siddiqui et al.)

Impact on study outcomesDifferent CS definitions affect reported sensitivity, NPV and comparative performance of mpMRI and TRUS-biopsy

ExamplesPROMIS used Gleason ≥4+3 or core length ≥6 mm; other studies used presence of any Gleason grade 4 or greater

inv-58: MRI-guided biopsy techniques

MRI-guided biopsy techniquesThree techniques: in‑bore MRI-targeted biopsy (MRI‑TB), MRI‑TRUS fusion targeted biopsy (FUS‑TB), and cognitive registration targeted biopsy (COG‑TB)

Comparative findingsMeta-analyses found MRI‑TB superior to cognitive TB for overall detection; FUS‑TB and MRI‑TB had similar detection rates

Usage noteTechnique choice may depend on available equipment, expertise, and lesion characteristics

inv-59: Clinically significant cancer (csPCa)

Study-based CS definitionsClinically significant prostate cancer (csPCa) definitions vary; examples include Gleason ≥4+3 or core length ≥6 mm (Ahmed) and presence of at least one core with Gleason grade 4 or higher (Pepe et al.)

RelevanceStudy definitions determine sensitivity and specificity reported for diagnostic tests and should be considered when interpreting results

ReportingAuthors commonly state the CS definition used when reporting detection metrics

inv-60: MRI-targeted-only strategy

MRI-targeted-only strategyAn mpMRI-first approach where only men with MRI‑suspicious results (e.g., PI‑RADS ≥3) undergo targeted biopsy while MRI‑negative men avoid immediate biopsy (as in the PRECISION trial)

OutcomesPRECISION showed non‑inferiority and higher detection of clinically significant cancer with fewer diagnoses of insignificant cancer compared with standard TRUS biopsy

Implementation noteEffectiveness depends on MRI quality, reader expertise, and defined MRI-suspicion thresholds

inv-61: Clinically significant (CS) prostate cancer

Examples of CS definitions in studiesStudies use varying CS criteria, examples include Gleason ≥4+3, core length ≥6 mm, or presence of any Gleason grade 4; these examples are applied across PROMIS, PRECISION, and other trials

Effect on metricsDifferent CS thresholds influence reported sensitivity, specificity, and comparative detection rates between mpMRI and TRUS methods

RecommendationReview the CS definition used in each study when applying evidence to practice

inv-62: mpMRI

mpMRI roleMultiparametric MRI used as a triage and targeting tool for prostate cancer detection and to guide biopsy strategy

Triage benefitmpMRI before biopsy may allow some men to avoid biopsy while maintaining high sensitivity for clinically significant cancer (PROMIS/Ahmed et al.)

Targeting benefitmpMRI findings can be used to direct TRUS-guided biopsy and improve detection of significant tumors

inv-63: micro-US

micro‑US descriptionHigh‑resolution micro‑ultrasound imaging of the prostate (eg, PRI‑MUS protocol) intended to improve lesion detection comparable to mpMRI

Comparative dataSystematic reviews report micro‑US and mpMRI‑targeted biopsies have similar detection rates across PCa grades in pooled analyses

Guideline statusMicro‑US is an emerging technique and is not yet universally incorporated into major practice guideline summaries cited in the document

inv-64: MRI/US fusion biopsy (duplicate inventory entry)

MRI/US fusion biopsy (summary)Technique combining mpMRI with TRUS targeting to improve prostate cancer detection; discussed in multicenter and device studies showing improved detection of csPCa

Techniques overlapDescribed across multiple sources as using fusion software or devices to map and target MRI‑identified lesions during TRUS biopsy

Evidence baseMultiple prospective cohorts, RCTs, and meta‑analyses evaluate MRI/US fusion; results show higher csPCa detection but heterogeneity exists

OpenPayer

Transrectal Ultrasound

Coverage Criteria for Transrectal Ultrasound (TRUS)

Coding and Billing References

Provider Actions, Authorization & Documentation

Background and Context

Definitions and Technique Descriptions

Revision History & Policy Metadata