ModifiedUnitedHealthcarePolicy CS010KY.05

Breast Imaging for Screening and Diagnosing Cancer (Kentucky)

Kentucky-specific medical policy describing coverage, definitions, and evidence-based stance for various breast imaging modalities used to screen for and diagnose breast cancer; applies to providers and members in Kentucky.

Policy Summary

PayerUnitedHealthcare

PolicyBreast Imaging for Screening and Diagnosing Cancer (Kentucky)

Policy CodePolicy CS010KY.05

Change TypeMaterial updates: clarified guideline reference and removed 3 CPT codes

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization for breast MRI when individuals meet the specified high-risk criteria (e.g., lifetime risk ≥20%, prior thoracic radiation between ages 10–30, or qualifying genetic/family history).

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 Applicable Codes.

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

Kentucky-onlyjurisdiction

≥20%MRI threshold

3CPT codes removed

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.

Class IIIFDA device class (ABUS)

many studies limitedstudy limitations

Coverage Criteria

Medically necessary imaging

Proven and medically necessary imaging procedures:

Proven/medically necessary modalities

High-risk MRI criteria: Any one of the following qualifies an individual for breast MRI: prior thoracic radiation therapy between ages 10 and 30; lifetime risk estimated >=20% using family-history–based models (e.g., Gail, Claus, Tyrer-Cuzick, BRCAPRO); personal history of breast cancer not treated with bilateral mastectomy; personal history of Li-Fraumeni syndrome (TP53), confirmed BRCA1 or BRCA2 mutation, Peutz–Jeghers syndrome (STK11/LKB1), or PTEN mutation; family history criteria including at least one first‑degree relative with BRCA1/BRCA2 mutation; first‑degree relative with TP53 or PTEN mutation; at least two first‑degree relatives with breast or ovarian cancer; one first‑degree relative with bilateral breast cancer or both breast and ovarian cancer; or a first‑ or second‑degree male relative with breast cancer

Unproven / Not medically necessary

Unproven and not medically necessary due to insufficient evidence:

Unproven modalities: Automated Breast Ultrasound System (ABUS); Computer‑aided detection (CAD); Computer‑Aided Tactile Breast Imaging; Computed tomography (CT) of the breast, including cone‑beam breast CT (CBBCT); Electrical Impedance Scanning (EIS); Magnetic Resonance Elastography (MRE); MRI of the breast for individuals with dense breasts in the absence of defined high‑risk factors; Molecular Breast Imaging (BSGI/MBI, scintimammography); Positron Emission Mammography (PEM)

Listed as unproven and not medically necessary due to insufficient evidence of efficacy; for breast CT (including 3D rendering) and additional MRI indications, refer to Community Plan Radiology & Cardiology Clinical Guidelines - Breast Imaging Guidelines.

Modality-specific coverage considerations

Overall conclusions from the evidence reviewed:

ABUS shows good agreement with handheld ultrasound for BI‑RADS assignment and can detect malignant lesions in prospective studies, but available studies are limited by single‑center designs, small cancer volumes, and variable detection rates; evidence supports ABUS as a supplemental option in dense breasts with appropriate documentation.

CAD (ultrasound/MRI): CAD tools (e.g., S‑Detect) demonstrate reasonable pooled diagnostic accuracy (pooled sensitivity ~0.82, specificity ~0.83) for ultrasound lesion classification, but high‑quality prospective evidence that CAD improves patient outcomes or MRI performance is lacking.

CBBCT: Cone‑beam breast CT and contrast‑enhanced variants show promising sensitivity in small studies and some meta‑analyses, but overall evidence is heterogeneous, limited in size and quality, and inconclusive for routine screening or replacing standard imaging.

EIS/EIT: Electrical impedance techniques report variable sensitivity and specificity across studies and meta‑analyses, but evidence is insufficient to establish clinical benefit or impact on management compared with standard imaging.

High-risk MRI screening

Covered when aligned with established high‑risk indications per specialty guidance

MRI screening for high‑risk individuals: Screening breast MRI is appropriate for individuals meeting high‑risk criteria such as confirmed BRCA1/BRCA2 mutation carriers (and certain untested first‑degree relatives), other high‑penetrance genetic syndromes (e.g., TP53, PTEN, Peutz‑Jeghers), prior chest irradiation between ages 10–30, or an estimated lifetime breast cancer risk of >=20% using validated family‑history‑based models; recommendations are supported by ACR, ASBrS, and NCCN guidance.

Supplemental and emerging imaging

Supplemental imaging considerations where benefits are uncertain or variable

Supplemental imaging for dense breasts: Use of supplemental MRI or ultrasound in women with dense breasts may increase cancer detection but also increases recall and biopsy rates; routine supplemental screening based solely on density is not established and evidence of improved outcomes is inconsistent.

USPSTF finds evidence insufficient to determine balance of benefits and harms for supplemental MRI or ultrasound after a negative mammogram.

Emerging/adjunct modalities: Modalities including MRE, MBI/BSGI, scintimammography, PET/PEM, and contrast‑enhanced techniques (e.g., CEM) may increase detection in select contexts but carry limitations (radiation exposure for molecular techniques, limited prospective outcome data) and require further study before routine use.

ACR recommends against BSGI/MBI for screening due to radiation dose concerns; NCCN notes limited data for CEM and molecular imaging.

This policy does not address routine preventive breast cancer screening performed with conventional mammography. Routine screening mammography falls outside the scope of this document; the policy focuses on additional, supplemental, and alternative breast imaging modalities used for diagnostic evaluation or for screening in defined high‑risk populations.

Several procedures are described in the policy as having insufficient evidence of clinical validity or utility for routine screening or diagnosis. This includes cone‑beam breast computed tomography (CBBCT) and other breast CT techniques, which current systematic reviews and evidence assessments characterize as limited, heterogeneous, and inconclusive; further well‑designed, prospective studies are required before routine coverage for screening can be supported. The policy therefore treats CBBCT and other breast CT indications as investigational or limited and recommends referral to plan guidelines for any non‑research clinical use.

The policy limits routine annual MRI screening to populations meeting established high‑risk criteria and does not support MRI screening solely on the basis of breast density. Evidence does not demonstrate improved outcomes when MRI is used only because of dense breast tissue; major guideline statements and the USPSTF find insufficient evidence to recommend supplemental MRI for women with a negative mammogram regardless of breast density. MRI screening is covered when patients meet defined high‑risk indications (for example, prior chest irradiation or ≥20% lifetime risk) consistent with specialty guidance.

For breast computed tomography (including 3D rendering) or for additional indications for breast MRI beyond those detailed here, refer to the Community Plan Radiology & Cardiology Clinical Guidelines — Breast Imaging Guidelines. The policy update clarifies that plan‑level guidelines should be consulted for prior authorization and for CT/MRI indications not explicitly covered in this document.

Modalities described in this policy as unproven or not medically necessary due to insufficient evidence include: Automated Breast Ultrasound System (ABUS); Computer‑aided detection (CAD) when billed separately; Computer‑Aided Tactile Breast Imaging; Computed tomography (CT) of the breast (including cone‑beam breast CT); Electrical Impedance Scanning (EIS); Magnetic Resonance Elastography (MRE); MRI for individuals with dense breasts without defined risk factors; Molecular Breast Imaging (BSGI/MBI) and other scintimammography techniques; and Positron Emission Mammography (PEM).

Electrical Impedance Scanning (EIS) and computer‑aided tactile breast imaging are considered to have insufficient evidence to demonstrate effectiveness as adjuncts or replacements for established imaging. The literature is limited by low‑quality, uncontrolled studies, methodological bias, and heterogeneity; as a result these technologies are treated as investigational and not supported for routine clinical screening or diagnostic use outside research settings.

Breast Specific Gamma Imaging (BSGI) / Molecular Breast Imaging (MBI) are discouraged for routine screening. The American College of Radiology has recommended against use of BSGI/MBI for screening because of the relatively high radiation dose, and the policy designates these nuclear medicine techniques as not medically necessary for routine screening purposes.

Covered Indications

Breast MRI for high-risk individuals

Indication: Breast MRI for high‑risk individuals

Indications for breast MRI: Any one of the following qualifies an individual for breast MRI: prior thoracic radiation therapy between ages 10 and 30; lifetime risk >=20% estimated by family‑history‑based models (e.g., Gail, Claus, Tyrer‑Cuzick, BRCAPRO); personal history of breast cancer not treated with bilateral mastectomy; personal history of Li‑Fraumeni (TP53), confirmed BRCA1/BRCA2, Peutz‑Jeghers (STK11/LKB1), or PTEN mutation; family history criteria including at least one first‑degree relative with BRCA1/BRCA2 mutation; first‑degree relative with TP53 or PTEN mutation; at least two first‑degree relatives with breast or ovarian cancer; one first‑degree relative with bilateral breast cancer or both breast and ovarian cancer; or a first‑ or second‑degree male relative with breast cancer.

Breast MRI prior authorization is required when performed for individuals meeting these high‑risk criteria per payer rules.

Digital mammography for individuals with dense breasts (diagnostic)

Diagnostic use of digital mammography for individuals with dense breasts:

Digital mammography for density (diagnostic):

Coding and Billing

Applicable CPT and Category III codes (selected)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	Computed tomography, breast, including 3D rendering, when performed, unilateral; without 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 14

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Breast MRI and related codesCPT | HCPCSCovered

77046	Magnetic resonance imaging, breast, without contrast material; unilateral.
77047	Magnetic resonance imaging, breast, without contrast material; bilateral.
77048	Magnetic resonance imaging, breast, without and with contrast material(s), including computer-aided detection (CAD real-time lesion detection, characterization and pharmacokinetic analysis), when performed; unilateral.
77049	Magnetic resonance imaging, breast, without and with contrast material(s), including computer-aided detection (CAD real-time lesion detection, characterization and pharmacokinetic analysis), when performed; bilateral.
S8080	Scintimammography (radioimmunoscintigraphy of the breast), unilateral, including supply of radiopharmaceutical.

Device classification referencesmixed

FDA product codes (examples referenced)

Device regulatory classifications mentioned; cameras used for BSGI are Class I radiologic devices; ABUS devices are regulated as Class III (see policy text).

Previously Applicable CPT Codes (removed)CPTNot Covered

77065	Removed from Applicable Codes
77066	Removed from Applicable Codes
77067	Removed from Applicable Codes

Lifetime risk threshold for MRI

Lifetime risk threshold for breast MRI>= 20% lifetime risk by validated family-history based models (e.g., Gail, Claus, Tyrer-Cuzick, BRCAPRO)

Other high-risk MRI criteria (context)Prior thoracic radiation between ages 10–30; personal history of breast cancer (unless treated with bilateral mastectomy); specified high-penetrance genetic syndromes/mutations; strong family-history patterns

Use requirementMRI screening indicated when any one of the listed high-risk criteria is met

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Breast MRI for high‑risk individuals requires prior authorization. Submit documentation that the member meets high‑risk criteria (one or more): prior chest/thoracic radiation between ages 10–30; lifetime risk ≥20% by validated models (e.g., Gail, Claus, Tyrer‑Cuzick, BRCAPRO); personal history of breast cancer without bilateral mastectomy; or known high‑risk genetic syndromes/variants (BRCA1/2, TP53/Li‑Fraumeni, PTEN, STK11/Peutz‑Jeghers) or qualifying family history (first‑degree relative with BRCA1/2 mutation; ≥2 first‑degree relatives with breast/ovarian cancer; first‑degree relative with bilateral breast cancer or both breast and ovarian cancer; or a first/second‑degree male relative with breast cancer).

Prior authorization required for screening or diagnostic breast MRI when used for high‑risk screening as defined above.
If member has had bilateral mastectomy, breast MRI for screening is not indicated.

Prior Authorization

Prior Authorization May Be Required for Experimental Modalities

Prior authorization may be required for experimental or novel modalities. Requests for cone‑beam breast CT (CBBCT), breast CT, experimental breast imaging technologies, or other modalities with limited or inconclusive evidence may require prior authorization and are subject to denial if not supported by plan criteria.

Prior Authorization Details

Prior Authorization

Prior authorization required when MRI is for listed high‑risk indications

Prior authorization is required for breast MRI performed for high‑risk individuals meeting any of the listed criteria (see policy for full list); submit clinical documentation showing the qualifying criterion.

Qualifying examples include prior thoracic radiation ages 10–30, lifetime risk ≥20% by validated models, specified genetic mutations, personal history of breast cancer (unless bilateral mastectomy), or qualifying family history patterns.

Prior Authorization

PA recommended for CBBCT (investigational/limited use)

Cone‑beam breast CT (CBBCT) is considered investigational/limited use; prior authorization is recommended for non‑research clinical use given inconclusive evidence.

Meta‑analyses show promising sensitivity for CE‑CBBCT but overall evidence is limited and further large prospective studies are needed before routine coverage.

Prior Authorization

PA may be required for MBI/BSGI and specialized nuclear studies

Contrast and Imaging Modality Rules

Billing Rule

CAD is bundled with breast MRI CPTs 77048 and 77049 — do not bill separately

Do not separately bill computer‑aided detection (CAD) when performed with breast MRI codes 77048 or 77049; CAD is included with those MRI procedure codes and should not be billed for additional reimbursement.

Coding clarification: CAD is included with CPT codes 77048 and 77049; inclusion means no additional CAD reimbursement when billed with these MRI codes.

Billing Rule

Document contrast use for CBBCT — CE‑CBBCT shows higher pooled sensitivity/specificity

Limited studies report contrast‑enhanced CBBCT has higher pooled sensitivity and specificity than non‑contrast CBBCT; document whether contrast was used when requesting prior authorization or submitting claims.

CE‑CBBCT pooled sensitivity and specificity in meta‑analyses were higher than NC‑CBBCT, but study protocols and contrast administration varied across reports.

Not Covered / Exclusions

The following modalities are listed under the policy as not covered: Automated Breast Ultrasound System (ABUS); Computer‑aided detection (CAD) billed separately when it is included with an imaging CPT code; Computer‑Aided Tactile Breast Imaging (tactile imaging); breast computed tomography including cone‑beam breast CT and 3D rendering (unless plan guidelines permit); Electrical Impedance Scanning (EIS); Magnetic Resonance Elastography (MRE); MRI performed solely for breast density without defined high‑risk factors; Molecular Breast Imaging/Breast Specific Gamma Imaging (MBI/BSGI); and Positron Emission Mammography (PEM).

Routine use of EIS or tactile imaging for breast cancer screening or diagnosis is not covered outside of well‑designed research settings. The policy cites very low‑quality, uncontrolled studies and methodological limitations that prevent demonstration of clinical benefit, and therefore routine clinical adoption is not supported.

Routine clinical use of cone‑beam breast CT (CBBCT) or other breast CT technologies for screening or diagnosis is not covered outside of research or approved investigational protocols. Systematic reviews and evidence assessments identify limited, heterogeneous data and conclude that further large, prospective studies are needed before routine coverage can be recommended.

Routine screening with BSGI/MBI or scintimammography is not supported by current evidence and is discouraged due to the higher radiation dose associated with these techniques. Given ACR guidance recommending against their use for screening, the policy treats routine screening with these modalities as not covered.

Definitions

Automated Breast Ultrasound (ABUS)

DefinitionAutomated Breast Ultrasound (ABUS) systems are ultrasound imaging platforms that automate acquisition of volume data to provide 2D and 3D B‑mode images and are used as an adjunct to mammography.

Device characteristicsUse high-frequency broadband transducers to sharpen detail resolution and deliver broad contrast differentiation for volumetric breast imaging.

Clinical useStudied as a supplemental tool in women with dense breasts and compared prospectively to handheld ultrasound in diagnostic performance studies.

Regulatory noteAutomated whole-breast ultrasound devices are regulated by the FDA as Class III devices (see FDA product code ITX for device-specific records).

Breast Specific Gamma Imaging (BSGI/MBI)

Definition

Background and Evidence Summary

Mammography remains the standard modality for breast cancer screening and diagnosis, but its sensitivity can be reduced in women with dense breast tissue. Dense breasts both increase risk and can mask cancers on mammography; supplemental imaging such as ultrasound or MRI can improve detection in selected populations, although evidence of improved outcomes is variable and supplemental techniques are generally reserved for defined high‑risk or diagnostic indications rather than routine population screening.

Policy Summary

PayerUnitedHealthcare

PolicyBreast Imaging for Screening and Diagnosing Cancer (Kentucky)

Policy CodePolicy CS010KY.05

Change TypeMaterial updates: clarified guideline reference and removed 3 CPT codes

Effective DateJan 1, 2025

Next Review DateN/A

SourceLink

On This Page

MRE: Preliminary studies indicate MRE can quantify tissue stiffness and may improve diagnostic accuracy when added to contrast‑enhanced MRI, but larger validation studies are required before routine clinical adoption.

MRI for density‑only screening: Evidence does not support routine MRI screening based on breast density alone; robust data are needed to show improved outcomes when MRI is used solely for density‑based screening.

Digital mammography is considered proven and medically necessary for individuals with dense breast tissue when used for diagnostic indications.

This policy does not address routine preventive screening with conventional mammography; diagnostic mammography for symptomatic or work‑up indications is included.

ABUS supplemental use in dense breasts / second-look after MRI

ABUS may be used as a supplemental or second‑look technique with limitations:

ABUS supplemental/second‑look use: Consider ABUS as supplemental imaging in women with dense breasts or as a second‑look ultrasound after MRI when handheld ultrasound is insufficient; studies show comparable BI‑RADS agreement with handheld ultrasound and improved second‑look detection in some small series, but evidence is limited by study size and design.

Use with appropriate documentation; prior authorization may apply per plan.

CAD adjunctive use

CAD may be used adjunctively but lacks demonstrated patient‑outcome benefit:

CAD adjunctive use: CAD (e.g., S‑Detect) may be used as an adjunct to ultrasound interpretation to aid lesion characterization; meta‑analyses report pooled sensitivity and specificity around 0.82–0.83 for ultrasound, but CAD has not been shown to improve MRI or ultrasound patient outcomes or reduce breast cancer mortality.

CAD included in breast MRI CPT codes 77048/77049 when performed and should not be billed separately with those codes.

CBBCT limited/investigational use

CBBCT is investigational/limited and should be restricted to research or prior‑authorized use:

CBBCT limited/investigational use: Cone‑beam breast CT (CBBCT), including contrast‑enhanced variants, has shown higher sensitivity in some small studies and meta‑analyses but overall evidence is heterogeneous and insufficient to support routine clinical screening or replacement of standard imaging; use should be limited to research settings or require prior authorization for non‑research clinical use.

Refer to Community Plan Radiology & Cardiology Clinical Guidelines for guidance on breast CT and 3D rendering.

Tactile imaging/EIS investigational

Tactile imaging and electrical impedance techniques are investigational:

Tactile imaging / EIS investigational: Computer‑aided tactile breast imaging and electrical impedance scanning have low‑quality, heterogeneous evidence with variable sensitivity and specificity; they are considered experimental and should not replace standard diagnostic pathways outside of research settings.

Devices for EIS may have adjunct approvals tied to BI‑RADS categories, but clinical utility for routine screening/diagnosis is unproven.

MRE adjunctive use under evaluation

MRE is under evaluation as an adjunct to MRI:

MRE adjunctive use: Magnetic Resonance Elastography may augment contrast‑enhanced MRI by quantifying tissue stiffness and has shown improved diagnostic accuracy in small studies, but clinical benefit and validated indications remain under investigation and require larger studies before routine adoption.

Consider only with documentation and where research or specialty guidance supports use.

MRI screening for high-risk individuals

When MRI screening is appropriate:

When MRI is appropriate: Offer MRI screening to individuals with BRCA1/BRCA2 mutations (and certain untested first‑degree relatives), other high‑penetrance genetic mutations/syndromes, prior chest irradiation between ages 10–30, or an estimated lifetime risk >=20% using validated family‑history‑based models; these indications are supported by ACR, ASBrS and NCCN guidance.

Prior authorization required per payer policy when performing MRI for high‑risk screening.

Adjunctive ultrasound

Ultrasound as an adjunct when MRI is not feasible or for selected dense‑breast cases:

Adjunctive ultrasound: Consider whole‑breast ultrasound as an adjunct to mammography in women with dense breasts or as an alternative supplemental screening approach for high‑risk individuals who cannot undergo MRI; society guidance supports use in these contexts.

Evidence shows ultrasound may increase detection but can increase recall and biopsy rates.

Electrical Impedance Scanning adjunct use

EIS device approvals tie use to specific BI‑RADS categories but clinical benefit is unproven:

EIS adjunct use: Electrical Impedance Scanning devices have been approved as an adjunct to mammography for patients with lesions categorized as ACR BI‑RADS III or IV on mammography, but overall evidence is insufficient to support routine clinical use for screening or diagnosis outside of specified adjunct roles or research.BI‑RADS III or IV

Refer to device approvals and labeling for device‑specific indications and limitations.

CBBCT and other breast CT modalities have limited evidence — PA or additional clinical review may be required.
ECRI and recent systematic reviews characterize CBBCT/CT evidence as inconclusive for routine screening; use is investigational absent strong supporting documentation.

Prior Authorization

Prior Authorization May Apply for Specialized Modalities

Prior authorization may apply for specialized modalities such as Automated Breast Ultrasound System (ABUS), Molecular Breast Imaging (MBI)/Breast Specific Gamma Imaging (BSGI), and other adjunctive imaging. These modalities are considered unproven or limited by available evidence and may require prior authorization or additional review.

ABUS is FDA‑regulated (Class III) and may require PA; evidence is limited and study results are mixed.
MBI/BSGI are associated with higher radiation dose and ACR recommends against routine screening use — PA likely required and requests may be denied for screening indications.
Computer‑aided detection (CAD) is bundled with MRI CPTs 77048/77049 (no separate reimbursement).

Denial Risk

Denial Risk — BSGI/MBI Screening Limitations

Denial Risk for BSGI/MBI Screening: Molecular breast imaging (MBI/BSGI) for routine screening is not supported due to limited evidence and higher radiation exposure; such requests may be denied for screening purposes.

ACR recommends against routine screening use of BSGI/MBI because of relatively high radiation dose.
Requests for BSGI/MBI for screening should include justification and will be reviewed against plan criteria; absence of appropriate indication may result in denial.

Note

Conflicts with Plan‑Specific or Regulatory Requirements

When plan requirements conflict with this policy, federal, state, or contractual benefit terms govern. Check the member’s specific benefit plan and applicable regulatory requirements before authorization.

In the event of conflict, federal/state/contractual requirements supersede this policy.
Verify coverage and any plan‑specific prior authorization procedures before proceeding.

Billing Rule

Coding and Documentation Note

Coding and Documentation: Include applicable procedure and diagnosis codes on the prior authorization request. Note that computer‑aided detection (CAD) is included with breast MRI CPTs 77048 and 77049 — do not bill CAD separately when reported with these MRI codes.

Reference CPT codes 77046, 77047, 77048, 77049 as appropriate for breast MRI.
S8080 (scintimammography) and modality‑specific codes should be included when applicable.

Documentation Required

Required Clinical Documentation

Required Clinical Documentation: Prior authorization requests must include clinical indication and relevant imaging details to support medical necessity. Include prior imaging results, relevant history, risk assessment (including lifetime risk model and family/genetic history), and rationale for choosing the requested modality.

Provide prior mammography and ultrasound reports when available; indicate why standard imaging is insufficient if requesting supplemental or novel modalities.
For genetic/family history criteria, include genetic test results or pedigree documentation as applicable.

Documentation Required

Preoperative MRI — Documentation Expectations

Preoperative Breast MRI Documentation: For MRI requested in the preoperative setting, document the intended impact on surgical planning and acknowledge the higher likelihood of additional biopsies. Include prior imaging, lesion characteristics, and explicit clinical rationale for how MRI will alter management.

Preoperative MRI is associated with higher additional biopsy rates; documentation should describe the anticipated benefit to surgical decision‑making.
Include chronology of recent diagnostic imaging and any discordant findings prompting MRI.

Note

Screening Scope Clarification and Use of Standard Imaging First

Screening Scope and Imaging Sequence: This policy does not cover routine preventive mammography screening; standard imaging (mammography ± diagnostic ultrasound) should be used first. Supplemental modalities (MRI, ultrasound, MBI) are considered when indicated by risk profile or after standard imaging yields inconclusive results.

Routine screening mammography remains the primary screening modality; requests for supplemental imaging should include prior mammography results.
Prefer established supplemental modalities (breast MRI for high‑risk, targeted ultrasound) before experimental techniques; document why standard imaging is insufficient when requesting novel modalities.

MBI/BSGI and other specialized nuclear breast studies may require prior authorization per payer rules; check plan requirements before scheduling or billing.

NCCN notes limited data for molecular imaging and higher radiation dose; payer review may be required to justify use in nonstandard situations.

Prior Authorization

Refer to Community Plan guidelines and InterQual for PA on breast CT/extra MRI indications

For breast CT (including 3D rendering) and additional MRI indications, follow the Community Plan Radiology & Cardiology Clinical Guidelines and InterQual/plan‑specific criteria for prior authorization requirements.

Policy update explicitly instructs referencing the Community Plan Breast Imaging Guidelines for CT/3D rendering and additional MRI indications.

Billing Rule

CEM can increase detection but has iodinated contrast risks — document contrast and contraindications

Contrast‑enhanced mammography (CEM) can increase cancer detection in some high‑risk individuals but carries risk of iodinated contrast reactions; document contrast use and any related contraindications.

NCCN states CEM increases cancer detection in certain high‑risk patients but cautions about iodinated contrast reaction risk and limited data for routine use.

Breast Specific Gamma Imaging (BSGI), also called scintimammography or Molecular Breast Imaging (MBI), is a noninvasive nuclear medicine technique that uses intravenous radiotracers and a gamma camera to detect breast tissue with increased tracer uptake.

Clinical contextProposed primarily as an adjunct to mammography and physical exam to aid selection for biopsy in patients with palpable masses or suspicious mammograms; studies report relatively high sensitivity and specificity but limited evidence for outcome benefit in screening.

Regulatory/Guidance noteACR recommends against routine use for screening due to radiation exposure concerns; equipment (gamma cameras) are regulated as radiologic devices (see device classification).

Computer-Aided Tactile Breast Imaging

DefinitionComputer‑Aided Tactile Breast Imaging uses a tactile array sensor moved across the breast; the sensor data are processed into multi‑dimensional color images that display size, shape, hardness, and location of suspicious masses in real time.

Intended useDesigned as a bedside adjunctive tool to help detect and localize palpable or suspicious lesions; evidence is limited and quality of studies is low.

Evidence statusCurrent evidence consists of low‑quality, uncontrolled studies; modality is listed as unproven and not medically necessary for routine screening/diagnosis pending further validation.

Electrical Impedance Scanning (EIS)

DefinitionElectrical Impedance Scanning (EIS) detects abnormal breast tissue by applying small electrical currents and creating a conductivity map; malignant tissue typically conducts differently than normal tissue.

Intended roleDeveloped as a confirmatory adjunct to mammography to identify suspicious sites via surface probes or patches, with results displayed as conductivity maps.

Evidence & approvalPublished literature is insufficient to show EIS predicts clinical events or alters management; some devices are approved as adjuncts to mammography in specific BI‑RADS contexts but routine use is not supported.

Magnetic Resonance Elastography (MRE)

DefinitionMagnetic Resonance Elastography (MRE) is a phase‑contrast MRI technique that quantifies mechanical properties of tissue (elastic modulus) by applying a known stressor and imaging resulting deformation to measure tissue stiffness and viscoelasticity.

Physiologic basisBreast cancers typically have a markedly higher elastic modulus (estimated 5–20×) than surrounding fibroglandular tissue, allowing differentiation based on stiffness.

Clinical evidenceFeasibility studies show MRE can depict tissue stiffness and small prospective studies suggest adding MRE to contrast‑enhanced MRI can improve diagnostic accuracy, but larger validation studies are needed.

Positron Emission Mammography (PEM)

DefinitionPositron Emission Mammography (PEM) is a high‑resolution metabolic breast imaging modality that uses FDG tracer with detectors integrated into a mammography‑like system to acquire emission images immediately after mammography.

Clinical roleProvides metabolic imaging of the breast for patients unable to undergo MRI or when metabolic characterization is needed; evidence is limited and modality is listed among those considered unproven for routine screening.

ComparisonPEM offers higher resolution than standard PET‑CT for dedicated breast imaging but lacks sufficient evidence demonstrating improved screening outcomes when used adjunctively to mammography.

Automated Breast Ultrasound System (ABUS) — notes

Alternate definition/notesAutomated Breast Ultrasound System (ABUS) provides systematic volumetric whole‑breast ultrasound as an alternative or supplement to handheld ultrasound, particularly in women with dense breasts.

Study evidenceProspective comparative trials (e.g., Güldogan et al.) show ABUS and HHUS have comparable BI‑RADs assignment agreement, though ABUS may detect fewer total lesions in some series.

Regulatory noteABUS devices are regulated as FDA Class III devices; search FDA PMN/ product code ITX for device‑specific details.

S-Detect (CAD)

DefinitionS‑Detect is a software‑based computer‑aided detection (CAD) tool for ultrasound that analyzes lesion morphology to assist in distinguishing benign from malignant breast masses.

Diagnostic performanceMeta‑analysis of S‑Detect reports pooled sensitivity ~0.82 and pooled specificity ~0.83 for distinguishing benign vs malignant breast masses on ultrasound.

Clinical statusCAD may be used as an adjunct to conventional ultrasonography but current evidence has not demonstrated improved patient outcomes when CAD is added to MRI or ultrasound overall.

Cone‑beam breast computed tomography (CBBCT)

DefinitionCone‑beam breast computed tomography (CBBCT) is a CT‑based breast imaging modality available in non‑contrast and contrast‑enhanced variants (NC‑CBBCT, CE‑CBBCT) evaluated for breast cancer detection and characterization.

Diagnostic findingsMeta‑analyses show CE‑CBBCT often has higher pooled sensitivity and specificity than NC‑CBBCT and may have diagnostic performance superior to mammography in small studies, but evidence is limited and heterogeneous.

Clinical recommendationEvidence is insufficient for routine screening use; further large, prospective studies are required and clinical use may be investigational or subject to prior authorization.

EIS / EIT — adjunctive diagnostic technique

DefinitionElectrical Impedance Scanning (EIS) / Electrical Impedance Tomography (EIT) are adjunctive techniques that assess breast tissue electrical properties to aid lesion detection by producing conductivity/impedance maps.

Evidence summarySystematic reviews report variable pooled sensitivity and specificity; heterogeneity and methodological limitations mean evidence is insufficient to confirm clinical benefit or routine use.

Intended useDescribed as adjunctive to mammography in select device approvals, but routine diagnostic or screening use outside research settings is not supported by current evidence.

MRE — MRI-based stiffness measurement

Technique definitionMRE is an MRI‑based technique that applies mechanical stress and uses phase‑contrast imaging to measure tissue stiffness and viscoelastic properties of the breast.

Potential roleQuantitative stiffness measures may aid characterization of suspicious lesions and contribute to risk stratification in dense breasts.

Evidence caveatSmall studies suggest improved diagnostic accuracy when MRE is added to contrast‑enhanced MRI, but larger validation studies are required before routine adoption.

MRE — limited study evidence

Study resultsA prospective study (Siegmann et al., 2010) of 57 patients found that combining MRE with contrast‑enhanced MRI increased diagnostic accuracy versus MRI alone, though larger studies are needed.

LimitationsExisting studies are small and further research is needed to validate findings and identify patients who benefit most from combined MRE/MRI.

Clinical implicationMRE shows promise as an adjunct to MRI but remains investigational pending larger confirmatory trials.

MBI / BSGI — nuclear medicine techniques

DefinitionMolecular Breast Imaging (MBI) / Breast Specific Gamma Imaging (BSGI) are nuclear medicine techniques using radiotracers and gamma cameras to detect metabolically active breast malignancy.

Diagnostic summarySome studies and systematic reviews report relatively high sensitivity and specificity, with BSGI sensitivity similar to MRI and higher specificity than mammography/ultrasound in certain comparisons.

Limitations & safetyEvidence is limited by study design and applicability concerns; increased radiation exposure is an important consideration, and routine screening use is discouraged by some societies.

ABUS device regulatory note

Regulatory classificationAutomated breast (whole‑breast) ultrasound devices are regulated by the U.S. FDA as Class III devices.

ReferenceDevice‑specific information is available via FDA PMN searches using product code ITX; consult FDA device database for details.

ImplicationDevice regulatory status may affect prior authorization and device‑specific documentation requirements per payer policy.

ABUS — regulatory/device note

Regulatory note (duplicate)Automated breast ultrasound (ABUS) devices are regulated by FDA as Class III devices; see FDA PMN/product code ITX for device records.

Device lookupSearch the FDA device database by product name or product code ITX for approval/PMN details.

Clinical relevanceFDA classification underscores that ABUS is a regulated imaging device with specific device‑level documentation available.

BSGI regulatory note — gamma camera equipment

Regulatory statementBSGI is a diagnostic procedure and not regulated as a procedure by the FDA; however, the gamma camera equipment used to perform BSGI is regulated as Class I radiologic devices.

Equipment descriptionA scintillation (gamma) camera images the distribution of radionuclides using a photon detector to visualize tracer uptake in the breast.

ImplicationProcedure-level regulation differs from device regulation; equipment classification information is available in FDA device records.