CurrentUnitedHealthcarePolicy CS010TN.W

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

Defines medical necessity and noncoverage determinations for supplemental and diagnostic breast imaging modalities (MRI, CT, MRE, MBI/BSGI, tactile imaging, PET/PEM, ultrasound, CEM) for Medicaid and CoverKids members in Tennessee, including high-risk screening indications and measures of insufficient evidence for certain modalities.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS010TN.W

Change TypeRevised coverage criteria

Effective DateApr 1, 2026

Next Review Date

Key ActionObtain authorization and include documented risk assessment and breast composition to demonstrate criteria are met.

SourceLink

POLICY UPDATE CHANGES

Added criterion requiring heterogeneously dense breasts (Category C) or extremely dense breasts (Category D) — screening beginning at age 40.

Added language that screening can begin at the listed age or 10 years prior to the age of diagnosis of the youngest relative (up to third-degree), whichever comes first, but not before age 25.

Replaced 'MRI of the breast for individuals with dense breast tissue not accompanied by defined risk factors' with 'MRI of the breast for individuals who do not meet the criteria [listed in the policy]'.

Added definition of 'Breast Composition Categories' and updated definition of 'Positron Emission Mammography (PEM)'.

Updated clinical evidence and references sections to reflect the most current information.

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Coverage Summary

Scope: This policy defines medical necessity and noncoverage determinations for supplemental and diagnostic breast imaging modalities (MRI, CT, MRE, MBI/BSGI, tactile imaging, PEM, ultrasound, CEM) for Tennessee Medicaid and CoverKids members, including high-risk MRI screening indications and statements about modalities with insufficient evidence. Application is to Medicaid and CoverKids in Tennessee.

Coverage stance and status: Mixed — MRI of the breast is proven and medically necessary for specific high-risk groups meeting the policy criteria; several novel modalities are considered unproven and not medically necessary. Policy is CURRENT and effective April 1, 2026.

Headline thresholds: Lifetime risk ≥ 20% (model-based: Gail, Claus, Tyrer-Cuzick, BRCAPRO) qualifies for MRI screening (typically beginning at age 40 per criteria). For family-history–based earlier start, screening can begin at the listed age or 10 years prior to the age of diagnosis of the youngest affected relative (up to third-degree), whichever comes first, but not before age 25. MRI screening begins at age 40 when heterogeneously dense (Category C) or extremely dense (Category D) breasts are present.

Key thresholds and quick facts

Risk threshold for MRI coverage>= 20% lifetime risk (model-based: Gail, Claus, Tyrer-Cuzick, BRCAPRO)

Minimum age allowed for early-start MRI screeningNot before age 25 (family-history rule)

Family-history earlier start ruleScreening can begin at listed age or 10 years prior to age at diagnosis of youngest affected relative (up to 3rd-degree), whichever comes first; not before age 25

MRI screening start for dense breastsHeterogeneously dense (Category C) or extremely dense (Category D): screening begins at age 40

Number of modalities listed as not medically necessary5

Policy covers breast MRI for defined high-risk groups (stat)1 (policy flag)

Medical-Necessity Criteria

Proven and medically necessary: Breast MRI for high-risk individuals

Covered when ANY of the following are met:

ANY of the following

Known deleterious genetic mutation
- Pathogenic or likely pathogenic mutation in BRCA1 or BRCA2 (screening beginning at age 25).
- Pathogenic or likely pathogenic mutation in TP53 (Li-Fraumeni syndrome) (screening beginning at age 20).
- Pathogenic or likely pathogenic mutation in PTEN (Cowden syndrome) (screening beginning at age 30*).
- Pathogenic or likely pathogenic mutation in PALB2 (screening beginning at age 30*).

Not Medically Necessary / Unproven

Not medically necessary / Unproven

The following procedures are considered unproven and not medically necessary due to insufficient evidence:

ALL of the following

Computer-Aided Tactile Breast Imaging
Computed tomography (CT) of the breast
Magnetic Resonance Elastography (MRE) of the breast
MRI of the breast for individuals who do not meet high-risk criteria listed above
Molecular Breast Imaging (e.g., Breast Specific Gamma Imaging, scintimammography, Positron Emission Mammography (PEM))

Coding

Included procedure codes (reference only)mixed

0422T	Tactile breast imaging by computer-aided tactile sensors, unilateral or bilateral.
0633T	Computed tomography, breast, including 3D rendering, unilateral; without contrast.
0634T	Computed tomography, breast, including 3D rendering, unilateral; with contrast material(s).
0635T	Computed tomography, breast, including 3D rendering, unilateral; without contrast, followed by contrast.
0636T	Computed tomography, breast, including 3D rendering, bilateral; without contrast.
0637T	Computed tomography, breast, including 3D rendering, bilateral; with contrast.
0638T	Computed tomography, breast, including 3D rendering, bilateral; without contrast, followed by contrast.
76376	3D rendering with interpretation and reporting; not requiring image postprocessing on independent workstation.
76377	3D rendering with interpretation and reporting; requiring image postprocessing on independent workstation.
76391	Magnetic resonance (vibration) elastography.

1–10 of 16

1/2

Coding clarificationmixed

77048/77049

Computer-aided detection (CAD) is included with MRI breast CPT codes 77048 and 77049; no additional reimbursement when CAD performed with these codes.

Device/product informational references (no coverage codes listed in this part)mixed

No codes listed

Provider Actions

Documentation Required

Medical record documentation required for medical necessity review

Patient medical record must contain relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures to support medical necessity. Documentation should be legible, maintained in the patient's record, and made available upon request.

Billing Rule

CAD inclusion billing rule

Computer-aided detection (CAD) is included with MRI breast CPT codes 77048 and 77049; do not bill separately for CAD when these MRI codes are reported.

Affected codes: 77048
Affected codes: 77049

Background and Evidence Summary

Background summary: Mammography remains the generally accepted standard for breast cancer screening and diagnosis. Supplemental imaging selection is based on individualized breast cancer risk and breast density; MRI is recommended for many high-risk groups while other adjuncts (ultrasound, CEM, MBI) may be considered in select situations when MRI is not possible.

Evidence landscape and limitations: Several novel modalities have limited or insufficient evidence for routine screening. Cone-beam breast CT (CBBCT) has mixed, small studies suggesting higher sensitivity in some analyses but requires larger prospective trials; overall evidence is low quality and inconclusive for screening. Magnetic resonance elastography (MRE) shows promise in differentiating tissue stiffness and may improve MRI diagnostic performance but evidence is limited and larger validation studies are needed. Computer-aided tactile breast imaging has very low-quality, uncontrolled studies with possible bias and unclear impact on outcomes. Molecular breast imaging / BSGI (including scintimammography and PEM) demonstrates relatively high sensitivity and specificity in some studies but carries higher radiation burden and lacks evidence showing improved outcomes for routine screening. Guideline positions vary: some societies support supplemental imaging in specific high-risk or dense-breast populations, while the USPSTF (2024) finds insufficient evidence to determine the balance of benefits and harms of supplemental ultrasonography or MRI after a negative mammogram, regardless of density.

Study / Guideline	Key finding
CBBCT vs mammography (Yang et al., 2024)	CBBCT sensitivity 0.92 and specificity 0.79 vs mammography sensitivity 0.77 and specificity 0.75; AUC CBBCT 0.93 vs MG 0.83, but limited sample sizes and heterogeneity — further large prospective studies needed
Komolafe et al. (2022)	Systematic review found DBT had improved diagnostic performance over CBBCT; CBBCT data limited and underrepresented — more prospective studies recommended
Uhlig (2019) systematic review/meta-analysis	Pooled CE-CBBCT sensitivity ~0.899 and specificity ~0.788; NC-CBBCT lower and high heterogeneity — encouraging but requires larger validation studies
Magnetic Resonance Elastography (MRE) studies (multiple, e.g., Patel 2022; Siegmann 2010)	MRE can quantify tissue stiffness and may improve MRI diagnostic accuracy (increased diagnostic performance when combined with MRI) and associate stiffness with risk in dense breasts; evidence limited and larger studies needed
Computer-Aided Tactile Breast Imaging (Tasoulis et al., 2014 and reviews)	Very low-quality evidence: higher sensitivity but much lower specificity versus clinical breast exam; uncontrolled studies with bias — insufficient to determine impact on outcomes
Molecular Breast Imaging / BSGI (systematic reviews/meta-analyses: De Feo 2022; Guo 2016; meta-analyses)	Limited literature shows relatively high sensitivity and specificity (similar to MRI in some reviews) but higher radiation burden and insufficient evidence to support routine screening; larger high-quality studies needed
SNMMI/EANM Practice Guideline (2022)	States MBI useful for detecting mammographically-occult cancers in women with dense breasts and in elevated-risk women who cannot undergo MRI
ACR practice parameters / appropriateness statements (2017; updates 2023/2024)	ACR recommends MRI (including abbreviated MRI) for high-risk women regardless of density; practice parameter notes insufficient evidence and recommends against BSGI/MBI for routine screening due to radiation
NCCN Guidelines (2021, 2024)	Acknowledges supplemental MRI/MBI/CEM/ultrasound can increase cancer detection but may increase recalls/benign biopsies; does not support routine molecular imaging for population screening but considers MBI/CEM when MRI not possible
USPSTF 2024	Concludes evidence insufficient to determine balance of benefits and harms of supplemental screening with ultrasound or MRI after a negative mammogram regardless of breast density
ACOG (2020)	Does not recommend routine use of alternative or adjunctive tests in asymptomatic women with dense breasts and no additional risk factors; supports further research
EUSOBI (2022)	Recommends informing women of breast density and offers screening breast MRI every 2–4 years for women 50–70 with extremely dense breasts, citing potential mortality reduction
SBI/ACR (2010) ultrasound guidance	Ultrasound can be considered as adjunct for dense breasts and for high-risk women who cannot undergo MRI
SNMMI (2010) & SNMMI/EANM (2022)	SNMMI earlier called for more study of BSGI; 2022 guideline supports MBI utility in certain dense/elevated-risk populations unable to have MRI
Evidence summaries in policy (overall)	Policy concludes mammography remains standard; several novel modalities (CT breast, MRE, tactile imaging, MBI/BSGI, PEM) have limited/insufficient evidence for routine screening use
Policy coding/definitions and device notes	Definitions note BSGI/MBI, PEM, tactile imaging, and MRE descriptions; codes exist but these modalities are listed as unproven/not medically necessary when criteria unmet

Definitions:

• Breast Composition Categories: ACR BI-RADS density levels A–D — Category A: almost entirely fatty; Category B: scattered fibroglandular density; Category C: heterogeneously dense; Category D: extremely dense.

• BSGI / MBI (Breast Specific Gamma Imaging / Molecular Breast Imaging): functional imaging using radioactive tracers and a gamma camera (also called scintimammography) to detect tissue uptake.

Revision History

2026-04-01material_revisionLatest

Added criterion requiring heterogeneously dense breasts (Category C) or extremely dense breasts (Category D) for MRI screening beginning at age 40; explicitly added breast composition categories to MRI screening criteria.

2026-04-01material_revision

Added language that screening can begin at the listed age or 10 years prior to the age of diagnosis of the youngest relative (up to third-degree), whichever comes first, but not before age 25 (clarified timing relative to family member diagnosis).

2026-04-01

Family history or personal history

Personal history of breast cancer with retained breast tissue (i.e., not treated with bilateral mastectomy).
Prior thoracic radiation therapy between ages 10 and 30 (screening starting at age 25 or 8 years after treatment, whichever is later).
Heterogeneously dense breasts (Category C) or extremely dense breasts (Category D) — screening beginning at age 40.
Family history criteria
- At least one first-degree relative who has a BRCA1 or BRCA2 mutation (screening beginning at age 40*).
- First-degree relative who carries a genetic mutation in TP53 or PTEN (Li-Fraumeni syndrome, Cowden syndrome, Bannayan-Riley-Ruvalcaba syndrome, or Peutz-Jeghers syndrome).
- At least two first-degree relatives with breast or ovarian cancer (screening beginning at age 40*).
- One first-degree relative with bilateral breast cancer, or with both breast and ovarian cancer (screening beginning at age 40*).
- First- or second-degree male relative (father, brother/half-brother, uncle, grandfather) diagnosed with breast cancer (screening beginning at age 40*).

Revised coverage criteria for MRI of the breast for individuals who are high risk for breast cancer

Revised coverage criteria — MRI of the breast for individuals who are high risk for breast cancer is proven and medically necessary when ALL of the following apply:

ALL of the following

Member meets one or more of the high-risk definitions listed under 'Proven and medically necessary: Breast MRI for high-risk individuals' (genetic mutation, personal history, prior thoracic radiation, family history, or breast density criteria).
High-risk definitions (one of)
- Known pathogenic/likely pathogenic genetic mutation associated with substantially increased breast cancer risk (see mutation list).
- Personal history of breast cancer with remaining breast tissue (not treated with bilateral mastectomy).
- History of prior thoracic radiation between ages 10 and 30 (screening starting at age 25 or 8 years after treatment, whichever is later).
- Family history meeting defined thresholds (e.g., first-degree relatives with BRCA mutation, multiple first-degree relatives with breast/ovarian cancer, male relatives with breast cancer).
- Heterogeneously dense (Category C) or extremely dense (Category D) breasts — screening beginning at age 40.
Documented rationale in the medical record supporting the member meets the high-risk criterion selected (risk-model score when used, genetic test results, radiation treatment dates, family relationship and ages at diagnosis, or breast density assessment).
Medical record documentation must be available upon request.

Revised Not Medically Necessary / Unproven Services

Policy revision clarified not medically necessary language to reference policy criteria rather than breast density alone:

MRI of the breast is considered not medically necessary for individuals who do not meet the criteria listed in the policy

Replaced prior language that specifically referenced MRI for individuals with dense breast tissue not accompanied by defined risk factors

Documentation Required

Document high-risk status and calculation method

Providers must document the member's high-risk status and the method used to determine it (for example, a named risk-estimation model such as Gail, Claus, Tyrer-Cuzick, or BRCAPRO, or family-history criteria including BRCA mutation status or number/type of affected relatives). Also document the member's breast density category (ACR BI-RADS Category C = heterogeneously dense or Category D = extremely dense) when requesting MRI screening.

Prior Authorization

Prior authorization likely required for MRI screening

Because MRI screening coverage criteria were revised, prior authorization is likely needed. When requesting authorization, include a documented risk assessment and the breast composition (density) to demonstrate that policy criteria for MRI screening are met.

Include documented risk assessment (e.g., model name or specific family-history criteria).
Include breast composition/density (ACR BI-RADS category).