ModifiedUnitedHealthcarePolicy CSOIOTN.U

Breast Imaging for Screening and Diagnosing Cancer (for Tennessee Only)

Policy governing coverage and medical necessity of breast imaging modalities (mammography adjuncts, ultrasound, MRI, and other technologies) for Tennessee Medicaid and CoverKids members. It specifies covered, unproven, and not medically necessary breast imaging services and applicable billing codes.

Policy Summary

PayerUnitedHealthcare

PolicyBreast Imaging for Screening and Diagnosing Cancer (for Tennessee Only)

Policy CodePolicy CSOIOTN.U

Change TypeCode removals and guideline cross-reference clarified

Effective DateJan 1, 2025

Next Review Date

Key ActionRefer to the Community Plan Radiology & Cardiology Clinical Guidelines Breast Imaging Guidelines for breast CT (including 3D rendering) and additional MRI indications; note CPT codes 77065–77067 were removed from the applicable codes list.

SourceLink

POLICY UPDATE CHANGES

Updated notation to clarify the Breast Imaging Guidelines section of the Community Plan Radiology & Cardiology Clinical Guidelines should be referenced for breast computed tomography (CT) including 3D rendering or additional indications for breast magnetic resonance imaging (MRI).

Removed CPT codes 77065, 77066, and 77067 from the applicable codes list.

Updated the Clinical Evidence and References sections to reflect the most current information.

>=20%MRI risk threshold

3CPT codes removed

TennesseeApplies to

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.

Preop MRI incremental biopsies

14.2–16.5/1000Supplemental MRI detection

Coverage Criteria and Modalities

Adjunct imaging/device guidance

Coverage and clinical guidance references for adjunct breast imaging devices. Consolidated guidance, evidence summary, and operational notes for device-specific adjunct technologies.

ANY of the following

Computer-Aided Detection (CAD) for mammography and ultrasound: Evidence is insufficient to show improvement in patient outcomes or breast cancer mortality when CAD is added to MRI, mammography, or ultrasound. Some studies and meta-analyses show potential diagnostic accuracy for specific CAD implementations (e.g., S-Detect for ultrasound) but are limited by small sample sizes, low-quality study designs, and retrospective methods. CAD may be used as a supplemental tool but is considered unproven and not medically necessary as a standalone screening enhancement.
Refer to clinical evidence summaries (chunks 19, 21) and FDA/device listings for product-specific information.
Automated Breast Ultrasound System (ABUS): Limited prospective data (small sample sizes) suggest ABUS may have higher detection rates than handheld ultrasound in certain second-look settings, but evidence is insufficient to establish improved patient outcomes or routine screening benefit. ABUS is considered investigational/unproven for general population screening and supplemental screening absent high-risk indications.
See Kim et al. 2016 summary (chunk 18).
Automated/Computer-Aided Tactile Breast Imaging: Current studies are very low quality, uncontrolled, and at high risk of bias; clinical impact on outcomes has not been demonstrated. Considered unproven and not medically necessary for routine screening or diagnosis.
See chunk 22.
Computed Tomography of the Breast (including cone-beam breast CT and 3D rendering): Available evidence is limited, heterogeneous, and of low quality. Systematic reviews and technology assessments (including ECRI) conclude there is inconclusive evidence of clinical validity or utility for screening. For breast CT or CBBCT and additional indications for breast MRI, refer to the Community Plan Radiology & Cardiology Clinical Guidelines Breast Imaging Guidelines for local policy alignment.
See chunks 24, 26 and policy history update (chunk 64).
Electrical Impedance Scanning (EIS)/Electrical Impedance Tomography (EIT): Evidence is limited and heterogeneous; some meta-analyses report modest sensitivity and specificity but studies are at high risk of bias with inconsistent methodology. Clinical benefit as an adjunct to mammography or as a screening tool is unproven and not medically necessary pending robust prospective trials.
See chunks 29 and 30.
Magnetic Resonance Elastography (MRE) of the breast: Feasibility studies show breast elastography can depict tissue stiffness, but clinical benefits for diagnosis or management remain unproven. Further research is required before routine clinical adoption for screening or diagnostic replacement.
See chunk 32.
Molecular Breast Imaging (MBI)/Breast Specific Gamma Imaging (BSGI) and other molecular modalities: These modalities increase radiation exposure relative to mammography. Current guidelines and evidence do not support routine use for population screening; emerging data suggest possible role as supplemental imaging in selected high-risk or MRI-ineligible patients but overall considered unproven for routine screening and subject to guideline-based exceptions.
See chunks 3, 43, 46.
Magnetic Resonance Imaging (MRI): MRI is proven and medically necessary for high-risk individuals meeting defined criteria (see Coverage Criteria). MRI for screening solely because of dense breasts without other high-risk features is unproven and generally not medically necessary according to multiple guideline statements; selective use should follow specialty guideline indications.
See chunks 2, 35, 36, 41, 43, 44, 45, 46.

Covered Indications and Specific Uses

Breast MRI for high-risk individuals

Breast MRI for high‑risk individuals (single top‑level indication): Indication: Screening MRI for individuals meeting any high‑risk criterion (see 'Breast MRI — high risk coverage'); document risk assessment or qualifying genetic/clinical history in the recordn/a

Top‑level covered indication derived from policy 'proven and medically necessary' list

ABUS for second-look ultrasound after MRI

ABUS as second‑look after MRI (single top‑level indication): Indication: Consider automated breast ultrasound (ABUS) as a second‑look ultrasound technique following preoperative breast MRI when handheld ultrasound is inconclusive or inadequate; document why handheld US is insufficientn/a

Evidence limited to small prospective studies indicating higher detection rates for ABUS in this specific use

Applicable Procedure Codes and Coding Notes

Applicable procedure codes (reference list)mixed

0422T	Tactile breast imaging by computer-aided tactile sensors, unilateral or bilateral.
0633T	Computed tomography, breast; including 3D rendering; when performed, unilateral; without contrast material.
0634T	Computed tomography, breast; including 3D rendering, when performed, unilateral; with contrast material(s).
0635T	0635T (listed in document as contrast; followed by contrast material(s)).
0636T	Computed tomography, breast; including 3D rendering; when performed, bilateral; without contrast material(s).
0637T	Computed tomography, breast; including 3D rendering; when performed; bilateral; with contrast material(s).
0638T	Computed tomography, breast; including 3D rendering, when performed, bilateral; without contrast; followed by contrast material(s).
76376	3D rendering with interpretation and reporting of computed tomography, magnetic resonance imaging; ultrasound; or other tomographic modality with image postprocessing under concurrent supervision; not requiring image postprocessing on an independent workstation.
76377	3D rendering with interpretation and reporting of computed tomography, magnetic resonance imaging; ultrasound; or other tomographic modality with image postprocessing under concurrent supervision; requiring image postprocessing on an independent workstation.
76391	Magnetic resonance (e.g , vibration) elastography.

1–10 of 19

1/2

Device regulatory references (no procedure codes listed in this excerpt)mixed

No codes listed

Previously listed CPT codes (removed)CPTNot Covered

77065	Removed from applicable codes list
77066	Removed from applicable codes list
77067	Removed from applicable codes list

Breast MRI risk threshold — inv-18

Risk thresholdLifetime risk >= 20% calculated by family-history–based models (examples: Gail, Claus, Tyrer‑Cuzick, BRCAPRO)

Examples of validated modelsGail; Claus; Tyrer‑Cuzick; BRCAPRO

Context of useThreshold applies for determining medical necessity of screening breast MRI for high-risk individuals

EUSOBI screening interval suggestion — inv-19

EUSOBI recommendationOffer screening breast MRI every 2 to 4 years for women aged 50–70 with extremely dense breasts

Target population

Provider Actions, Prior Authorization, and Documentation

Documentation Required

Follow community plan guidelines for breast CT/MRI

Follow the applicable Community Plan Radiology & Cardiology Clinical Guidelines for breast computed tomography (including 3D rendering) and for additional indications for breast magnetic resonance imaging (MRI). These community plan guidelines supersede or augment this policy where specified by federal, state, or contractual benefit terms.

Follow Community Plan Radiology & Cardiology Clinical Guidelines for breast CT/MRI

Documentation Required

Document MRI indication; MRI-triggered additional biopsies

Preoperative breast MRI is associated with substantially higher additional biopsy rates without a commensurate increase in cancer detection for many groups. When ordering preoperative MRI, document the specific clinical indication and rationale in the medical record to support the test and any downstream procedures it may prompt.

Document clinical indication and rationale for preoperative MRI to support medical necessity and potential downstream biopsies
Be aware that MRI-triggered additional biopsies are common and should be anticipated in consent and care planning

Prior Authorization Guidance

Note

Contrast and Imaging Protocol Notes

Note

Not Covered / Unproven Services

Breast CT and 3D breast CT rendering are identified as unproven/not medically necessary for routine screening or general diagnostic use. Automated Breast Ultrasound (ABUS) for population screening is considered unproven; molecular imaging modalities for routine population screening are similarly not supported by the evidence and are generally recommended against. These determinations are based on the policy’s evidence review and guideline references.

Breast CT (including 3D rendering) and Automated Breast Ultrasound (ABUS) are listed as unproven or not medically necessary for routine screening. The policy cites limited or inconclusive evidence for these modalities and directs clinicians to consult Community Plan Breast Imaging Guidelines for any consideration of CT‑based breast imaging.

Cone‑beam breast CT (CBBCT) and related CT approaches have mixed diagnostic accuracy results in systematic reviews and assessments; current evidence is insufficient to establish clinical utility for screening. The policy therefore treats breast CT and 3D rendering as unproven and not medically necessary outside of specified or guideline‑directed contexts.

Automated tactile breast imaging and electrical impedance scanning are unsupported by high‑quality evidence for routine screening. Studies are small, uncontrolled, or heterogeneous, with notable risks of bias and inconsistent reporting; consequently these modalities are considered investigational or not medically necessary for population screening.

Computer‑Aided Detection (CAD) tools and related software (including CAD for ultrasound or MRI) have not demonstrated consistent improvement in patient outcomes. CAD billed separately is listed as not medically necessary; note that CAD interpretation is included in breast MRI CPT codes 77048 and 77049 when performed.

Definitions and Device Descriptions

ABUS — inv-38

DefinitionAutomated Breast Ultrasound (ABUS): automated acquisition of volume data producing 2D and 3D B‑mode images used as an adjunct to mammography

Technical noteUses high‑frequency broadband transducers to automate volume acquisition and improve detail resolution

Clinical roleUsed as an adjunct to mammography and as a second‑look ultrasound technique after MRI

BSGI / MBI — inv-39

DefinitionBreast Specific Gamma Imaging (BSGI) / Molecular Breast Imaging (MBI): functional imaging using intravenous radioactive tracers and a gamma camera to detect focal tracer uptake in the breast

Procedure detailsPerformed after IV administration of radiotracer; intended as adjunct to mammography and physical exam

Frequency Limits and Interval Guidance

MRI — every 2-4 years — inv-60

Frequency recommendationMRI screening every 2 to 4 years

Applicable groupWomen aged 50–70 with extremely dense breasts per EUSOBI guidance

ContextRecommendation intended as a possible supplemental screening interval to reduce late diagnosis in extremely dense breasts

Frequency note — inv-61

Frequency noteNo additional frequency specified in this policy excerpt

ActionRefer to modality‑specific guidance or plan rules for other frequency limits

Context

Background and Evidence Summary

Mammography remains the standard screening modality for breast cancer. Additional imaging — including ultrasound, MRI, and newer modalities — is used to address limitations such as dense breast tissue, to further characterize findings, or to evaluate high‑risk individuals. Risk models and personal/family history guide the use of breast MRI and other supplemental imaging.

Policy Revision History

2025-01-01policy_updateLatest

Updated Coverage Rationale to clarify that the Breast Imaging Guidelines section of the Community Plan Radiology & Cardiology Clinical Guidelines should be referenced for breast computed tomography (including 3D rendering) and for additional indications for breast MRI; removed CPT codes 77065, 77066, and 77067 from the applicable codes list.

references_updated

Clinical Evidence and References sections were updated to reflect the most current information.

Material changes in this policy effective 01/01/2025 include an updated notation that providers should reference the Community Plan Radiology & Cardiology Clinical Guidelines Breast Imaging Guidelines for breast CT (including 3D rendering) and additional indications for breast MRI. The applicable codes list was updated to remove CPT codes 77065, 77066, and 77067.

Policy Summary

PayerUnitedHealthcare

PolicyBreast Imaging for Screening and Diagnosing Cancer (for Tennessee Only)

Policy CodePolicy CSOIOTN.U

Change TypeCode removals and guideline cross-reference clarified

Effective DateJan 1, 2025

Next Review Date

SourceLink

On This Page

Preoperative breast MRI

Preoperative breast MRI (single top‑level indication): Indication: Preoperative breast MRI may be used to evaluate extent of disease prior to surgery when clinically indicated; document indication and anticipated impact on management given higher rates of additional biopsies associated with preoperative MRIn/a

Onega et al. found increased additional biopsy rates with preoperative MRI without density‑based benefit; support documentation of rationale

Cone-beam breast CT

Cone‑beam breast CT (single top‑level indication): Indication: Cone‑beam breast CT (CBBCT) is considered investigational/unsupported for routine screening or diagnostic use due to limited and inconclusive evidence; if used, consider prior authorization or restrict to research settings and document rationalen/a

ECRI assessment and systematic reviews report inconclusive evidence and recommend further study

Computer-aided detection tools

Computer‑aided detection tools (single top‑level indication): Indication: CAD tools (including S‑Detect) may be used as adjunctive interpretation aids for ultrasound or mammography, but evidence does not show improved patient outcomes; when CAD is performed with MRI breast CPT codes 77048/77049, CAD is included in those codes and not separately reimbursedn/a

Policy cites limited evidence and coding clarification that CAD is included in MRI CPT codes

Preoperative and supplemental screening MRI

Preoperative and supplemental screening MRI (single top‑level indication): Indication: Use MRI preoperatively or as supplemental screening selectively based on clinical context (tumor staging, extent of disease, high‑risk status); avoid selecting patients for MRI solely on breast density without other risk factors; document expected benefit and how results will alter managementn/a

Zeng et al. systematic review shows increased detection and reduced interval cancers with supplemental MRI but higher recalls/biopsies; Onega et al. cautions against density‑only selection

Problem-solving or when MRI unavailable

Problem‑solving or when MRI unavailable (single top‑level indication): Indication: Consider molecular breast imaging (MBI/BSGI) or scintimammography as adjunctive problem‑solving tools when MRI is contraindicated or unavailable, recognizing higher radiation exposure and limited outcome evidence; use selectively and document rationalen/a

Meta‑analyses show acceptable sensitivity/specificity (~85%), but guidelines do not support routine population screening with these modalities

Adjunctive ultrasound

Adjunctive ultrasound (single top‑level indication): Indication: Handheld or automated whole‑breast ultrasound can be considered as an adjunct to mammography for women with dense breasts or to evaluate a specific mammographic finding; counsel regarding increased recall and biopsy ratesn/a

ACS and SBI/ACR guidance support ultrasound use in evaluating palpable findings and as adjunct in dense breasts

Electrical impedance scanning adjunct to mammography for BI-RADS III or IV lesions

Electrical impedance scanning adjunct to mammography (single top‑level indication): Indication: Electrical impedance scanning may be used as an adjunct to mammography for lesions categorized as BI‑RADS III (probably benign) or BI‑RADS IV (suspicious abnormality) on mammography; check device labeling and plan rulesBI‑RADS III or IV

Policy references FDA device approvals for adjunct use

Women aged 50–70 with extremely dense breasts

Shared decision-makingCounsel women on benefits and risks of mammography and MRI-based screening to support informed choice

Plan governance — inv-20

Governing precedenceFollow federal, state, or contractual benefit plan coverage terms when they differ from this policy

Action for providersCheck applicable federal/state/plan requirements before applying this policy to coverage decisions

Conflict resolutionIn event of conflict, federal/state/contractual requirements govern over this policy

Denial Risk

Inappropriate supplemental imaging may be denied

Use of supplemental imaging modalities (breast MRI, contrast-enhanced mammography (CEM), molecular breast imaging / breast-specific gamma imaging (MBI/BSGI), or whole-breast ultrasound) may increase cancer detection but also increases recalls and benign biopsies. Unjustified or non-guideline-concordant use of supplemental imaging may be denied.

Prior authorization or additional documentation may be required for supplemental imaging performed in lieu of standard modalities
Supplemental imaging that is not supported by guideline-based indications may be subject to denial

Billing Rule

Coding removal risk

Certain CPT codes for breast imaging were removed from the applicable codes list; billing with removed CPT codes (77065, 77066, 77067) may not be accepted. Verify current, supported CPT/HCPCS codes before claim submission.

Removed/obsolete codes: CPT 77065, 77066, 77067 — do not use for claim submission
Verify up-to-date code sets prior to billing

Billing Rule

Coding clarification: computer-aided detection (CAD)

Computer-aided detection (CAD) is included with the MRI breast CPT codes 77048 and 77049. When CAD is performed with these MRI codes, there is no additional reimbursement; do not bill separately for CAD with 77048 or 77049.

CAD is included with CPT 77048 and 77049 — no additional payment when CAD is performed with these codes
Do not submit separate CAD charges alongside 77048 or 77049

Documentation Required

Device and reporting information

Confirm device classification and reporting requirements for imaging modalities. Mammography systems are regulated under MQSA and are FDA Class II devices; Automated Breast Ultrasound Systems (ABUS) are FDA Class III devices; molecular imaging devices (gamma cameras) and procedures (e.g., BSGI) have specific device and reporting considerations. Ensure facility and device compliance with applicable FDA and MQSA requirements and include pertinent device/reporting details in imaging reports when required.

Mammography: MQSA-regulated, FDA Class II devices — comply with MQSA reporting and quality requirements
ABUS: FDA Class III — verify device approvals and applicable reporting
BSGI/MBI: consider device-specific radiation dose and reporting; follow regulatory/ACR guidance

Documentation Required

Reference plan-specific benefit terms

Listing a procedure or code in this policy does not guarantee coverage. Providers must reference the member’s federal, state, or contractual benefit plan terms when determining coverage. In the event of conflict, the federal, state, or contractual requirement governs.

Reference plan-specific benefit terms and state Medicaid/CoverKids rules for Tennessee when determining coverage
In case of discrepancy between this policy and benefit terms, benefit terms control

Note

Prefer standard imaging and primary mammography before adjuncts

Mammography (with or without targeted diagnostic ultrasound) remains the primary and preferred screening modality for average-risk women. Consider established, guideline-recommended standard imaging (mammography ± diagnostic ultrasound or MRI when indicated) before ordering newer adjunctive or supplemental modalities.

Primary mammography should be performed prior to adjunctive supplemental imaging for routine screening
Prefer standard imaging modalities (mammography ± ultrasound; MRI only when guideline-indicated) before newer CAD or supplemental modalities

Molecular breast imaging modalities (BSGI/MBI/scintimammography/PEM) are not supported for routine population screening by current guideline statements and evidence reviews. While these modalities can increase detection in selected scenarios and may be considered when MRI is contraindicated or unavailable, their routine use for screening is not recommended due to higher radiation exposure and limited outcome data.

Breast CT and 3D rendering remain categorized as unproven/not medically necessary for routine use. The policy history directs providers to the Community Plan Radiology & Cardiology Clinical Guidelines for specific CT and MRI indications, and it documents the removal of CPT codes 77065–77067 from the applicable list.

Evidence noteStudies report relatively high sensitivity and specificity but higher radiation burden; not supported for routine population screening

Tactile breast imaging — inv-40

DefinitionComputer‑Aided Tactile Breast Imaging: hand‑held tactile sensor that produces multi‑dimensional images representing size, shape, hardness, and location of suspicious masses

TechniqueClinician moves sensor across breast; data processed into color images in real time

Evidence statusInsufficient high‑quality evidence to support routine replacement of standard clinical exam or imaging

EIS — inv-41

DefinitionElectrical Impedance Scanning (EIS): technique mapping conductivity differences between malignant and normal tissue via surface probes

Regulatory/approval noteDevices are approved as an adjunct to mammography for lesions categorized BI‑RADS III or IV on mammography

Evidence statusStudy heterogeneity limits conclusions; additional well‑designed studies needed to determine clinical benefit as an adjunct

MRE — inv-42

DefinitionMagnetic Resonance Elastography (MRE): MRI technique measuring mechanical properties (elastic modulus) of tissue to distinguish malignant from normal tissue

MechanismApplies known stressor and measures resulting tissue deformation to quantify stiffness; cancers typically have higher elastic modulus

Evidence statusPreliminary data suggest improved diagnostic accuracy when combined with contrast‑enhanced MRI, but larger validation studies are needed

PEM — inv-43

DefinitionPositron Emission Mammography (PEM): high‑resolution metabolic imaging of the breast using FDG tracer, often integrated with mammography equipment

Clinical roleUsed for metabolic imaging when MRI is not possible; provides high‑resolution breast‑specific PET imaging

Evidence statusLimited evidence; molecular imaging modalities have higher radiation dose and are not supported for routine screening

Automated Breast Ultrasound System (ABUS) — inv-44

DefinitionAutomated Breast Ultrasound System (ABUS): an automated breast volume scanner used as a second‑look ultrasound technique

Comparative detectionSmall studies report ABUS detection rates that may exceed handheld ultrasound for second‑look exams (example: 94.7% vs 86.8%)

LimitationsEvidence limited by small sample sizes and study heterogeneity

CAD / S-Detect — inv-45

DefinitionComputer‑Aided Detection (CAD) / S‑Detect: software‑based morphological image analysis tools for ultrasound or mammography intended to assist interpretation

Diagnostic performanceMeta‑analysis of S‑Detect reported pooled sensitivity ~0.82 and specificity ~0.83, but studies were small and variable in quality

Coverage implicationCAD has not demonstrated improved patient outcomes when added to MRI or ultrasonography; use as adjunct with documentation and clinician judgment

Cone-beam breast computed tomography (CBBCT) — inv-46

DefinitionCone‑beam breast computed tomography (CBBCT): a CT‑based breast imaging modality evaluated for primary breast cancer detection

Evidence summaryMeta‑analyses show mixed results versus mammography or DBT; some small studies report higher sensitivity/AUC for CBBCT but evidence is limited and heterogeneous

Coverage stanceClinical utility not established; consider investigational or require prior authorization pending stronger evidence

Electrical Impedance Scanning (EIS) / EIT — inv-47

DefinitionElectrical Impedance Scanning (EIS) / Electrical Impedance Tomography (EIT): techniques measuring tissue electrical properties for lesion detection

Diagnostic metricsSystematic reviews report pooled sensitivity/specificity in the mid‑70s to low‑80s, but study heterogeneity limits confidence

ConclusionInsufficient evidence to support routine replacement of standard modalities; further large, well‑designed studies needed

Breast density — inv-48

DefinitionBreast density: characteristic that decreases mammography sensitivity and increases breast cancer risk

Screening implicationExtremely dense breasts may merit consideration of supplemental imaging; density should be disclosed to women and included in counseling

Guideline noteEUSOBI recommends offering MRI every 2–4 years for women 50–70 with extremely dense breasts (see related interval suggestion)

MBI/BSGI — inv-49

DefinitionMolecular breast imaging (MBI)/BSGI: functional nuclear medicine breast imaging using radiotracers (e.g., Tc‑99m sestamibi) with dedicated gamma cameras

Performance noteSystematic reviews report sensitivity similar to MRI and higher specificity than mammography/US in some studies, but with higher radiation exposure

Use caseMay be considered as adjunct/problem‑solving when MRI unavailable or contraindicated; not recommended for routine population screening

Electrical impedance scanning — inv-50

DefinitionElectrical impedance scanning: device approved as an adjunct to mammography for lesions categorized as BI‑RADS III or IV on mammography

Regulatory referenceFDA PMN listings referenced for device‑specific information

Clinical implicationApproved as adjunct; clinical benefit as routine screening adjunct remains unestablished

Policy does not provide further periodicity details for other modalities in this section