Breast Imaging for Screening and Diagnosing Cancer (for North Carolina Only)
Clinical coverage guidance for breast imaging modalities used to screen for and diagnose breast cancer for UnitedHealthcare members in North Carolina. Applies to diagnostic breast ultrasound, breast MRI for defined high-risk groups, and other breast imaging technologies discussed in the policy.
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).
Added CPT codes 77048 and 77049 to the applicable codes list.
Added notation that CPT/HCPCS codes 0422T, 0633T, 0634T, 0635T, 0636T, 0637T, 0638T, 76391, 76498, 76499, and S8080 are not on the State of North Carolina Medicaid Fee Schedule and therefore may not be covered by the State of North Carolina Medicaid Program.
Updated Clinical Evidence and References sections to reflect the most current information.
Archived previous policy version CSNCT0375.04.
Coverage Criteria and Policy Statements
Medically necessary imaging
The following are proven and medically necessary:
Proven and medically necessary
- High-risk MRI criteria: One or more of: prior thoracic radiation therapy between ages 10 and 30; lifetime risk >= 20% estimated by family-history–dependent 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), or PTEN mutation; family history meeting any of: at least one first-degree relative with BRCA1/BRCA2 mutation; first-degree relative with TP53 or PTEN mutation; two or more first-degree relatives with breast or ovarian cancer; one first-degree relative with bilateral breast cancer or both breast and ovarian cancer; a first- or second-degree male relative with breast cancer
Exact list extracted from policy
Unproven / Not medically necessary
The following are unproven and not medically necessary due to insufficient evidence of efficacy:
Modalities described in policy as unproven, investigational, or insufficient evidence for routine use
Modalities — evidence summary and coverage implications
Summary conclusions from evidence in this document section:
Evidence limited; increased recall/biopsy rates noted
ECRI and systematic reviews find inconclusive evidence
Larger well-designed studies needed
Investigational pending validation
Balance of benefit and harms varies by subgroup
Consider adjunctive use only in select situations
Covered with criteria / Supplemental use only
Coverage stance and contextual criteria summarized from guideline and evidence statements in this section:
Synthesis from guideline recommendations and meta-analyses
Conditional/adjunctive scenarios
May affect coverage and prior authorization decisions
This policy does not address routine preventive breast cancer screening using conventional mammography. For guidance specific to breast computed tomography (CT) including 3D rendering or for additional indications for breast MRI, reference the Breast Imaging Guidelines section of the Community Plan Radiology & Cardiology Clinical Guidelines.
Cone-beam and other dedicated breast CT techniques have shown promising diagnostic sensitivity in small studies and meta-analyses, but the overall body of evidence is very low quality, heterogeneous, and primarily single-center or retrospective. The policy therefore states that breast CT/CBBCT remains insufficiently validated for routine screening or diagnostic replacement and that further large-scale prospective research is required before clinical usefulness is established.
Electrical impedance scanning (EIS/EIT) has demonstrated variable diagnostic accuracy across studies and systematic reviews, with methodological limitations and inconsistent clinical trial results. Because available evidence does not establish that EIS/EIT improves patient outcomes or reliably augments standard imaging, the technique is considered investigational pending larger, well-designed validation studies.
Molecular breast imaging techniques such as Breast-Specific Gamma Imaging (BSGI) / Molecular Breast Imaging (MBI) are not recommended for routine population screening. The ACR recommends against BSGI/MBI for screening given the relatively high radiation dose, and NCCN states routine molecular imaging is not supported; these modalities may be considered only as adjunctive options in select situations (for example, when MRI is contraindicated or unavailable) and are not endorsed for routine supplemental screening.
A subset of CPT/HCPCS codes referenced in this policy are not listed on the State of North Carolina Medicaid Fee Schedule and therefore may not be covered by the North Carolina Medicaid Program. Examples include codes such as 0422T, 0633T–0638T, 76391, 76498, 76499, and S8080; see the coding section and the Policy History for the complete list.
Automated Breast Ultrasound (ABUS) and Computer-Aided Tactile Breast Imaging are described in this policy as unproven and not medically necessary because current evidence is insufficient to demonstrate improved clinical outcomes or consistent diagnostic benefit when used as supplemental screening. These modalities are therefore not supported for routine use.
The available evidence does not support replacing standard screening or diagnostic modalities with breast CT (including CBBCT) or with electrical impedance scanning (EIS/EIT). Both classes of technology lack sufficient clinical validation and consistent outcome data; therefore, routine use of breast CT (CBBCT) or EIS/EIT as replacements for standard modalities is not supported by this policy.
Routine supplemental screening using molecular imaging modalities (MBI/BSGI) or routine supplemental screening with ultrasound or MRI after a negative mammogram is not supported by current evidence. Guideline statements (NCCN, USPSTF, ACR) note that while supplemental imaging can increase cancer detection, it also increases recall and biopsy rates and lacks clear evidence of outcome benefit when used routinely; thus these approaches are not endorsed as routine supplemental screening strategies.
Covered Indications and When Imaging Is Allowed
Breast MRI for individuals at high risk for breast cancer
Guideline- and policy-specified high-risk MRI criteria
Diagnostic breast ultrasound
Ultrasound CPT codes 76641 and 76642 listed in applicable codes
Dense breasts or diagnostic problem after mammography
Evidence shows incremental yield but increased recalls; use individualized decision-making
Adjunctive risk stratification or investigational use
MRE shows promise but requires further validation
Supplemental/adjunctive imaging for diagnostic evaluation or when MRI is contraindicated/unavailable
NCCN supports CEM or MBI when MRI unavailable
Liberman meta-analysis and guideline cautions
Reference external Breast Imaging Guidelines for breast CT including 3D rendering and additional MRI indications
Refer to the Community Plan Radiology & Cardiology Clinical Guidelines:
Policy history updated to clarify this external reference
Applicable Procedure Codes and Coding Notes
| 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. |
| No codes listed |
| 0422T | Not on NC Medicaid Fee Schedule |
| 0633T | Not on NC Medicaid Fee Schedule |
| 0634T | Not on NC Medicaid Fee Schedule |
| 0635T | Not on NC Medicaid Fee Schedule |
| 0636T | Not on NC Medicaid Fee Schedule |
| 0637T | Not on NC Medicaid Fee Schedule |
| 0638T | Not on NC Medicaid Fee Schedule |
| 76391 | Not on NC Medicaid Fee Schedule |
| 76498 | Not on NC Medicaid Fee Schedule |
| 76499 | Not on NC Medicaid Fee Schedule |
Provider Actions, Prior Authorization, and Documentation
Prior authorization and coding guidance
Providers should follow UnitedHealthcare Community Plan requirements for prior authorization for services referenced in this policy. Inclusion of procedure and diagnosis codes is for reference only and does not guarantee coverage or payment. Verify benefit-specific prior authorization rules before scheduling or performing services.
- Follow UnitedHealthcare Community Plan prior authorization procedures.
- When in doubt, obtain authorization prior to service delivery.
Coding does not guarantee coverage
Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage is determined by federal, state, or contractual requirements and applicable law. Inclusion of a code does not guarantee reimbursement or claim payment.
Routine screening with molecular imaging is not supported by evidence
Current evidence does not support routine screening with molecular imaging modalities (eg, breast-specific gamma imaging, sestamibi scintimammography, positron emission mammography) due to limited data and substantially higher whole-body radiation dose compared with mammography. These modalities may be considered in specific circumstances per guideline recommendations (for example when MRI is not possible), but are not recommended for routine population screening.
- Routine screening with MBI/BSGI is not supported by available evidence and is associated with higher radiation exposure.
- Consider molecular imaging only when clinically indicated and supported by guideline-directed exceptions.
Documentation and procedure standards for BSGI/MBI
When performing breast-specific gamma imaging (BSGI) or molecular breast imaging (MBI), ensure documentation meets procedure standards and quality controls. Follow appropriate documentation, recording, quality control, and radiation safety practices as outlined by professional society procedure standards.
- Document clinical indication, prior imaging findings, and how results will affect management.
- Adhere to radiation safety and quality control measures per society procedure standards.
Use adjunctive imaging before therapeutic decision-making
Scintimammography and other molecular imaging tests may require correlation with conventional imaging modalities and, when used to assess response to therapy, often need to be combined with other imaging studies before making therapeutic decisions. Use adjunctive imaging (eg, mammography, ultrasound, MRI) as clinically indicated prior to altering treatment plans based on molecular imaging alone.
- Conventional imaging should generally be performed before relying on molecular imaging for treatment decisions.
- For assessment of neoadjuvant chemotherapy response, combine scintimammography with other imaging modalities due to limited specificity.
Coverage may be denied for specific codes under NC Medicaid
Certain CPT/HCPCS codes referenced in this policy are not listed on the North Carolina Medicaid Fee Schedule and therefore may not be covered under the State of North Carolina Medicaid program. Providers should verify state-specific fee schedule coverage and obtain any required authorizations.
Contrast and Modality-Specific Imaging Rules
CAD included with MRI breast codes 77048/77049 — no separate payment
Computer-aided detection (CAD) is included with breast MRI CPT codes 77048 and 77049; there is no separate reimbursement for CAD when billed with these MRI procedures.
- Policy coding clarification explicitly states CAD inclusion and lack of additional reimbursement.
Contrast-enhanced CBBCT may show higher sensitivity/specificity in small studies
Small studies report that contrast-enhanced cone-beam breast CT (CE-CBBCT) may have higher sensitivity and specificity than non-contrast techniques, but protocols vary and the evidence is limited.
- Pooled sensitivity and specificity for CE-CBBCT in small meta-analyses were reported but additional large prospective studies are needed.
CEM/MRI can increase detection in higher-risk individuals but carry contrast-related risks
Contrast-enhanced mammography (CEM) and breast MRI may increase cancer detection in higher-risk individuals but carry risks related to iodinated or gadolinium-based contrast; consider when MRI is unavailable or contraindicated.
- NCCN notes CEM increases cancer detection in increased-risk individuals and carries risk of iodinated contrast reactions.
Definitions and Device/Modality Descriptions
Frequency and Follow-up Recommendations
Not Covered / Excluded Services
Automated Breast Ultrasound (ABUS) and Computer-Aided Tactile Breast Imaging are considered unproven and not medically necessary due to insufficient evidence of efficacy. When alternative modalities such as MRI or other advanced imaging are specifically indicated by the policy’s covered indications, those modalities may be used per criteria; otherwise the listed investigational modalities are not covered.
Routine use of breast CT (including cone-beam breast CT) for population screening or as a standard diagnostic replacement is considered investigational given the low-quality and inconclusive evidence base. Electrical impedance scanning (EIS/EIT) is also considered investigational. As such, these modalities are not covered for routine screening or diagnostic replacement.
Advanced and investigational breast imaging modalities lacking sufficient validation—such as certain breast CT techniques, EIS/EIT, and other novel technologies—are not covered for routine clinical use. Coverage decisions for these techniques require demonstration of clinical validity and utility in higher-quality prospective studies.
Investigational imaging technologies with inconsistent performance across studies and without clear evidence of improved clinical outcomes are not covered. This includes methods with substantial heterogeneity in published results and those still at an early research stage; use outside of approved research protocols is therefore not covered.
Routine investigational imaging approaches that have not demonstrated reproducible benefit, or that carry trade-offs such as increased radiation exposure without proven outcome advantage, are not covered. When imaging alternatives are appropriate, clinicians should follow the specified covered indications and accepted practice guidelines rather than adopt investigational modalities for routine care.
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