ModifiedUnitedHealthcarePolicy CS010.W

Breast Imaging for Screening and Diagnosing Cancer

This policy evaluates evidence and guideline recommendations for adjunct and advanced breast imaging modalities (CT, MRE, MRI, molecular imaging, ultrasound, scintimammography) to inform coverage and clinical-use decisions for screening and diagnostic evaluation of breast cancer.

Policy Summary

PayerUnitedHealthcare

PolicyBreast Imaging for Screening and Diagnosing Cancer

Policy CodePolicy CS010.W

Change TypeRevised high-risk MRI criteriaremoved several proven and unproven indicationscoding updates

Effective DateJan 1, 2026

Next Review Date

Key ActionDocument gene- and treatment-specific MRI screening start ages and timing criteria when requesting authorization for high-risk breast MRI.

SourceLink

POLICY UPDATE CHANGES

Diagnostic breast ultrasound was removed from the revised list of proven and medically necessary indications.

Digital mammography for individuals with dense breast tissue was removed from the revised list of proven and medically necessary indications.

Added MRI screening timing criterion: screening starting 10 years prior to the age of diagnosis of the earliest relative with breast cancer (regardless of degree of relativity) whichever comes first, but not before age 25.

Replaced prior thoracic radiation MRI criterion with guidance to start screening at age 25 or 8 years after treatment, whichever is later, for prior thoracic radiation between ages 10 and 30.

Revised list of genes and associated screening start ages for individuals with pathogenic variants (e.g., BRCA1/2 beginning age 25; TP53 beginning age 20; others with specified ages).

Automated breast ultrasound system, computer-aided detection (CAD), and electrical impedance scanning (EIS) were removed from the list of unproven and not medically necessary indications.

Removed CPT codes 76499, 76641, and 76642 from the Applicable Codes section.

3Unproven/not medically necessary removed

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Proven indications removed

severalGenes with updated ages

multipleModalities reviewed

Coverage Criteria and Indications

High-risk MRI screening criteria and gene-based ages

MRI screening is covered when ALL of the following are met for individuals at increased genetic or treatment-related risk:

ALL of the following

- ANY of the following
  - BRCA1 or BRCA2 (screening beginning at age 25)
  - TP53 gene mutation (Li-Fraumeni syndrome) (screening beginning at age 20)
  - ATM (screening beginning at age 30)
  - BARD1 (screening beginning at age 40)
  - CDH1 (screening beginning at age 30)
  - CHEK2 (screening beginning at age 30)
  - NF1 (screening beginning at age 30)
  - PALB2 (screening beginning at age 30)
  - RAD51C (screening beginning at age 40)
  - RAD51D (screening beginning at age 40)
  - STK11 (Peutz-Jeghers syndrome) (screening beginning at age 30)
  - PTEN (Cowden syndrome) (screening beginning at age 30)
Individual has a calculated lifetime risk of breast cancer ≥ 20% (based on validated models, typically family-history based)≥ 20%
Individual has a personal history of prior therapeutic or diagnostic chest radiation where cumulative dose and timing meet criteria: exposure to a cumulative chest radiation dose ≥ 10 Gy between ages 10 and 30 (screening starting at age 25 or 8 years after radiation, whichever is later).
- ANY of the following
  - Diagnosed with breast cancer before age 50
  - Personal history of breast cancer with dense breasts
  - Personal history with atypia or lobular carcinoma in situ (LCIS) — consider MRI, especially when other risk factors are present
Screening timing requirement: For individuals with a family member diagnosed with breast cancer, screening with MRI should begin 10 years prior to the age of diagnosis of the earliest relative with breast cancer (regardless of degree of relativity), whichever comes first, but not before age 25.

Specific Covered Indications

Breast MRI for high-risk screening

Breast MRI for high-risk screening: Women with BRCA mutations or other high-risk germline mutations, women with prior chest radiation between ages 10 and 30, women with a calculated lifetime risk >=20%, and selected personal-history cases are appropriate candidates for annual breast MRI screening per specialty society guidance.

ACR 2023 and ASBrS guidance support MRI screening in these populations.

Diagnostic imaging for recalled lesions

Diagnostic imaging for recalled lesions: For diagnostic evaluation of lesions recalled from screening mammography, CEM, MRI, DBT, and handheld ultrasound (HHUS) have demonstrated high sensitivity; modality selection should consider the tradeoff between sensitivity and specificity and the clinical scenario.

Systematic reviews/meta-analyses report CEM and MRI as highest sensitivity and DBT/DM higher specificity.

Supplemental screening for individuals with dense breasts or at increased risk

Services Not Covered / Discouraged

Breast-specific gamma imaging (BSGI) / molecular breast imaging (MBI) is designated as not covered for routine screening. The ACR practice parameter highlights insufficient evidence for screening use and raises concerns about the relatively high radiation dose, which supports exclusion from routine screening coverage.

Use of BSGI/MBI for routine screening is not supported by ACR and NCCN due to limited evidence of benefit and higher radiation exposure compared with mammography. The ACR specifically recommends against screening use because of the radiation dose and insufficient evidence of improved outcomes; NCCN similarly cautions about higher whole-body effective radiation and limited data for routine screening.

The revised policy removed diagnostic breast ultrasound and digital mammography for individuals with dense breast tissue from the list of proven and medically necessary indications. These removals are documented in the Summary of Changes for the 01/01/2026 revision.

Key Definitions and Abbreviations

Contrast-enhanced cone-beam breast computed tomography — CE-CBBCT

TermContrast-enhanced cone-beam breast computed tomography (CE-CBBCT)

DescriptionCone-beam CT of the breast using iodinated intravenous contrast; studies report pooled CE-CBBCT sensitivity ~0.899 and specificity ~0.788 compared with non-contrast CBBCT.

Evidence noteMeta-analyses show CE-CBBCT diagnostic accuracy comparable to breast MRI but additional large prospective studies are needed before routine clinical use.

Magnetic resonance elastography of the breast — MRE

TermMagnetic resonance elastography of the breast (MRE)

DescriptionMRI-based elastography technique that quantitatively depicts elastic (stiffness) properties of breast tissues and can show higher shear elasticity in known tumors.

Coding and Billing

Removed CPT CodesCPTNot Covered

76499	Removed from Applicable Codes
76641	Removed from Applicable Codes
76642	Removed from Applicable Codes

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization for MRI screening in non-high-risk scenarios

Prior authorization may be required for breast MRI when used for screening in women who do not meet defined high‑risk criteria. Requests for routine or supplemental MRI screening in individuals who are <20% lifetime risk or who do not meet gene‑ or history‑based high‑risk definitions should be reviewed against plan prior‑authorization requirements; such requests are at higher risk for denial if medical necessity is not documented.

Check plan-specific prior authorization rules and required documentation before scheduling MRI screening.
Provide medical record documentation demonstrating the clinical indication, risk assessment (e.g., lifetime risk percentage), and why alternative screening is insufficient.

Prior Authorization

Prior authorization for breast MRI (high-risk)

Prior authorization is required for breast MRI screening in individuals meeting high‑risk criteria per this policy (for example, qualifying pathogenic/likely pathogenic genetic variants, prior chest radiation in the specified age window, or lifetime risk ≥20%). Requests should document the specific high‑risk indication, gene and family history details, age at which screening will start, and the expected benefit.

Prior Authorization Notes

Note

Contrast Administration and Safety

Note

Background and Scope

Multiple adjunct breast imaging modalities have been studied to improve cancer detection beyond mammography, particularly for individuals with dense breasts or those at increased risk. Evidence quality and outcomes vary: contrast-enhanced modalities and MRI show higher incremental cancer detection but also increased recall and biopsy rates; other emerging technologies (for example, cone-beam breast CT and magnetic resonance elastography) show promising diagnostic metrics but lack large prospective outcomes data and require further validation. Clinical guidelines generally reserve MRI screening for clearly defined high-risk populations rather than for density alone.

Additional Definitions

inv-30: MBI / BSGI

TermMolecular breast imaging (MBI) / BSGI

Key pointReported sensitivity in systematic reviews is relatively high and, in some analyses, similar to MRI; specificity may be higher than mammography and ultrasound.

Radiation concernMBI/BSGI is associated with relatively high radiation dose; ACR recommends against its use for routine screening.

inv-31: ABUS and EIS

TermAutomated Breast Ultrasound (ABUS)

Policy changeDefinition of ABUS removed from the policy; automated breast ultrasound system was removed from the list of unproven/not medically necessary indications in the revision.

Policy Revision History

2026-01-01policy_revisionLatest

Revised list of proven and medically necessary indications including updated MRI high-risk criteria (start 10 years prior to earliest relative's diagnosis, not before age 25), revised prior thoracic radiation timing (start at age 25 or 8 years after treatment, whichever is later), and updated gene-specific screening start ages (e.g., BRCA1/2 at 25; TP53 at 20; ATM 30; BARD1 40).

2026-01-01removal

Removed diagnostic breast ultrasound and digital mammography for individuals with dense breast tissue from the list of proven and medically necessary indications.

Policy Summary

PayerUnitedHealthcare

PolicyBreast Imaging for Screening and Diagnosing Cancer

Policy CodePolicy CS010.W

Change TypeRevised high-risk MRI criteriaremoved several proven and unproven indicationscoding updates

Effective DateJan 1, 2026

Next Review Date

Key ActionDocument gene- and treatment-specific MRI screening start ages and timing criteria when requesting authorization for high-risk breast MRI.

SourceLink

On This Page

Supplemental screening for dense breasts or increased risk: Supplemental screening (MRI, abbreviated MRI, ultrasound, MBI, or CEM) can increase cancer detection in some groups but also increases recall and benign biopsy rates; consider supplemental modalities based on individualized risk and availability, and prefer MRI when feasible for high-risk individuals.

NCCN and EUSOBI guidance support supplemental screening in selected populations; MRI yields higher incremental CDR than ultrasound.

Molecular breast imaging (MBI/BSGI) for detection in dense breasts or MRI-ineligible high-risk individuals

MBI/BSGI for dense breasts or MRI-ineligible high-risk individuals: MBI/BSGI may detect mammographically occult cancers and can be considered when MRI is not possible for high-risk individuals, but ACR finds insufficient evidence to support BSGI for screening and recommends against its routine use because of relatively high radiation dose; SNMMI/EANM acknowledge potential utility in select populations.

Conflicting society guidance; use reserved for select clinical situations.

MRI screening for individuals at high genetic risk

MRI screening for individuals at high genetic risk: MRI screening initiation ages specified per gene and timing rules must be met (see gene-specific ages and family-history timing); documentation of these criteria is required for coverage decisions.gene-specific ages and family-relative timing rules

Policy revision (01/01/2026) specifies gene-based start ages and timing relative to earliest affected relative.

Evidence noteFeasibility studies confirm ability to measure tissue stiffness but clinical benefit and diagnostic role remain under evaluation; further research required.

Molecular breast imaging / breast-specific gamma imaging — nuclear medicine techniques using radiotracers to image breast tissue

TermMolecular breast imaging / breast-specific gamma imaging (MBI / BSGI)

DescriptionNuclear medicine techniques using radiotracers and dedicated gamma cameras to detect radiotracer uptake in breast tissue; reported to have relatively high sensitivity and specificity in selected studies.

LimitationsAvailable studies have methodological limitations, mixed populations, and do not establish improved outcomes when used adjunctively with mammography; radiation dose is a concern.

MBI / BSGI — Molecular breast imaging (MBI)/breast-specific gamma imaging (BSGI)

TermMBI / BSGI (Molecular Breast Imaging / Breast-Specific Gamma Imaging)

Clinical utilityStudies report sensitivity similar to MRI and higher specificity than mammography/ultrasound for lesion evaluation; may detect mammographically occult cancers in dense breasts or in MRI-ineligible, high-risk women.

Society guidanceACR finds insufficient evidence and recommends against BSGI/MBI for screening due to relatively high radiation dose; SNMMI/EANM recognize potential utility in select populations.

Automated Breast Ultrasound (ABUS) and Electrical Impedance Scanning (EIS)

TermAutomated Breast Ultrasound (ABUS)

StatusDefinition removed from this policy; ABUS is no longer listed in the Definitions section of the revised policy.

Electrical Impedance Scanning (EIS)Definition removed from this policy; EIS is no longer listed in the Definitions section of the revised policy.

Document gene name(s), mutation pathogenicity, and relation to member when family history is the basis for screening.
For prior thoracic radiation between ages 10–30, document treatment date; screening initiation follows policy timing (start at age 25 or 8 years after RT, whichever is later).
If screening start age is based on a relative’s age at diagnosis, document the relative’s age and relationship; policy may require screening to start 10 years prior to the earliest relative’s diagnosis but not before age 25.

Note

Check plan requirements

Before applying this policy, verify federal, state, and contract‑specific benefit requirements. In case of conflict, those requirements govern. UnitedHealthcare may also apply third‑party tools (e.g., InterQual) to assist coverage determinations.

Check the member’s plan contract and any state or federal mandates that may alter coverage.
Be aware that use of InterQual or similar criteria may affect prior authorization decisions and required documentation.

Denial Risk

BSGI/MBI screening discouraged

The American College of Radiology and other major guidelines recommend against using breast‑specific gamma imaging/molecular breast imaging (BSGI/MBI) for routine screening due to limited evidence and relatively high radiation dose. Requests for BSGI/MBI screening are generally not supported by this policy.

If BSGI/MBI is requested, include justification and prior imaging results; expect high denial risk for screening indications.
Consider alternative modalities (MRI, CEM, or ultrasound) when supplemental screening is clinically indicated and supported by guidelines.

Step Therapy

Stepwise use of adjunct imaging for dense breasts

When breast density is the only risk factor, routine adjunctive imaging (MRI, ultrasound, BSGI/MBI) is not routinely endorsed by some professional societies. Consider a stepwise approach: begin with mammography (DM/DBT) and reserve supplemental imaging for those with additional risk factors or persistent clinical concern.

For asymptomatic women with dense breasts and no other risk factors, document shared decision‑making if supplemental testing is pursued.
If supplemental imaging is requested for density alone, provide rationale (e.g., prior false negatives, strong family history despite calculated risk <20%) to support coverage review.

Electrical Impedance Scanning (EIS)Definition removed and EIS removed from the list of unproven/not medically necessary indications in this revision.

Removed automated breast ultrasound system, computer-aided detection (CAD), and electrical impedance scanning (EIS) from the list of unproven and not medically necessary indications.

2026-01-01coding_update

Removed CPT codes 76499, 76641, and 76642 from the Applicable Codes section.

2026-01-01supporting_information_updated

Updated Supporting Information (Clinical Evidence, FDA, References) and archived previous policy version CS010.V.