ModifiedColorado Rocky Mountain Health PlansPolicy 2026T0375LL

Breast Imaging for Screening and Diagnosing Cancer

Policy governing coverage and medical necessity criteria for breast imaging modalities (e.g., mammography, breast MRI, CT, molecular imaging, tactile imaging) for UnitedHealthcare Commercial and Individual Exchange plans.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyBreast Imaging for Screening and Diagnosing Cancer

Policy CodePolicy 2026T0375LL

Change TypeRevised coverage criteria (density and age clarifications)

Effective DateFeb 1, 2026

Next Review Date

Key ActionObtain and document breast density and validated lifetime risk (≥20%) to support approval for screening breast MRI; prior authorization may be required per member benefit plan.

SourceLink

POLICY UPDATE CHANGES

Revised coverage criteria for magnetic resonance imaging of the breast for individuals who are high risk for breast cancer, adding breast density requirement (heterogeneously or extremely dense) and specifying screening begins at age 40 for certain criteria.

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

Replaced phrase excluding MRI for dense breasts without defined risk factors with a broader statement excluding MRI for individuals who do not meet listed criteria.

2026-02-01Policy effective

25BRCA start age

40Dense-breast start age

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.

High-risk lifetime threshold

SeveralUnproven modalities

Coverage Criteria

Indications for breast MRI considered proven and medically necessary

Covered when ANY of the following high-risk criteria are met (screening start ages provided where specified):

High-risk MRI indications: Individual meets ANY of the following high-risk criteria: heterogeneously dense breasts (ACR BI-RADS Category C) or extremely dense breasts (Category D) (screening beginning at age 40); prior thoracic radiation therapy between ages 10 and 30 (screening starting at age 25 or 8 years after treatment, whichever is later); lifetime risk >= 20% as estimated by validated, family-history–based models (e.g., Gail, Claus, Tyrer-Cuzick, BRCAPRO) (screening beginning at age 40); personal history of breast cancer (unless treated with bilateral mastectomy); presence of specified germline mutations (examples and screening start ages include: ATM age 30*, BARD1 age 40*, BRCA1/BRCA2 age 25, CDH1 age 30*, CHEK2 age 30*, NF1 age 30*, PALB2 age 30*, PTEN (Cowden) age 30*, RAD51C age 40*, RAD51D age 40*, STK11 age 30*, TP53 age 20); defined family-history patterns (e.g., at least one first-degree relative with a 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; a first- or second-degree male relative with breast cancer).See node text

Screening may begin at the listed age or 10 years before the age at diagnosis of the youngest affected relative (up to third-degree relatives), whichever comes first, but not before age 25.

Procedures considered unproven and not medically necessary

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

Unproven modalities: Computer‑Aided Tactile Breast Imaging; Computed tomography (CT) of the breast (including cone‑beam breast CT); Magnetic Resonance Elastography (MRE); MRI of the breast for individuals who do not meet the high‑risk criteria listed in this policy; Molecular Breast Imaging modalities (e.g., Breast Specific Gamma Imaging, scintimammography, Positron Emission Mammography).N/A

Refer to Breast Imaging Guidelines section of the Cardiovascular and Radiology Imaging Guidelines for 3D rendering and additional MRI indications.

Coverage principles and modality-specific stance

Coverage aligns with professional society recommendations and evidence:

High‑risk MRI screening: Breast MRI (including abbreviated MRI) is usually appropriate for women at high lifetime risk (e.g., BRCA mutation carriers, prior chest irradiation, lifetime risk >=20%) and should be offered regardless of density.

ACR and ASBrS guidance support MRI for high‑risk groups and annual MRI per recommendations.

Supplemental screening for dense breasts: For women with extremely dense breasts, consider offering supplemental MRI or other supplemental imaging based on combined risk and density; EUSOBI recommends offering MRI every 2–4 years for women aged 50–70 with extremely dense breasts after counseling and shared decision‑making.interval 2-4 years for ages 50-70

ACR supports supplemental screening based on risk and density; EUSOBI provides specific age/interval guidance.

Use of ultrasound and CEM: Ultrasound and contrast‑enhanced mammography (CEM) can increase cancer detection in recall/diagnostic settings; CEM demonstrates high pooled sensitivity and may be considered when MRI is not feasible for high‑risk patients.

High-risk and supplemental imaging coverage

Covered when ALL of the following are met (policy revisions and referenced society guidance):

High‑risk MRI screening criteria (revised): Individual meets an established high‑risk definition (e.g., germline high‑risk mutation carrier, prior chest irradiation, or lifetime risk >=20% by validated family‑history models) AND has heterogeneously dense (Category C) or extremely dense (Category D) breasts — screening may begin at age 40 or 10 years earlier than the earliest affected relative's age at diagnosis (not before age 25).lifetime risk >=20%

Policy revision (02/01/2026) added density requirement and clarified age guidance.

Alternative supplemental options when MRI unavailable: For high‑risk individuals unable to undergo MRI, consider supplemental screening with contrast‑enhanced mammography (CEM) or molecular breast imaging (MBI); whole breast ultrasound may be used if contrast‑enhanced or functional imaging is not available.

NCCN and ACR guidance support CEM or MBI as alternatives when MRI is not feasible; CEM carries risk of iodinated contrast reactions.

Dense-breast supplemental MRI (EUSOBI)

EUSOBI recommendation for women with extremely dense breasts aged 50-70:

EUSOBI supplemental MRI recommendation: Offer screening breast MRI every 2 to 4 years for women aged 50 to 70 with extremely dense breasts after counseling and shared decision‑making.interval 2-4 years

Women should be informed of their breast density and counseled on benefits and risks prior to offering MRI.

Professional society positions

Society positions and limitations:

USPSTF stance: USPSTF (2024) states evidence is insufficient to determine the balance of benefits and harms of supplemental screening with breast ultrasonography or MRI in women with a negative screening mammogram result, regardless of breast density.

This position may affect considerations for supplemental screening in average‑risk populations.

SBI/ACR ultrasound role: Breast ultrasound can be considered as an adjunct in women with dense breasts or in high‑risk women who cannot undergo MRI.

SBI/ACR guidance supports ultrasound when MRI is not possible (2010 recommendation).

MRI of the breast for individuals who do not meet the policy's listed high‑risk criteria is not medically necessary. The policy explicitly lists high‑risk indications for breast MRI (for example, specified germline mutations, prior chest irradiation, and lifetime risk ≥20%) and requires those criteria be met for screening coverage; requests that do not meet those criteria may be denied. This statement replaces prior wording that excluded MRI only for dense breasts without defined risk factors and reflects the revised coverage rationale effective 02/01/2026.

Use of breast CT (including cone‑beam breast CT) and many molecular imaging techniques (for example, breast‑specific gamma imaging/MBI, scintimammography, and positron emission mammography) for routine population screening is not supported by current evidence and is considered investigational or not medically necessary. The literature is limited by methodologic concerns, small or single‑center studies, and lack of demonstrated improvement in clinical outcomes when these modalities are used for population screening.

The policy designates MRI of the breast for individuals who do not meet the specific, listed criteria as unproven or not medically necessary. The revised language (effective 02/01/2026) broadens and clarifies the exclusion so that MRI screening is covered only when members meet the policy's defined high‑risk and density requirements.

The policy identifies specific investigational modalities that are considered unproven or not medically necessary, including: computer‑aided tactile breast imaging, computed tomography of the breast (including cone‑beam breast CT/CBBCT), magnetic resonance elastography (MRE), and molecular breast imaging techniques such as breast‑specific gamma imaging (BSGI/MBI), scintimammography, and positron emission mammography (PEM). These modalities lack sufficient high‑quality evidence demonstrating clinical benefit for routine screening or widespread diagnostic use.

Routine use of Breast‑Specific Gamma Imaging/Molecular Breast Imaging (BSGI/MBI) and cone‑beam breast CT (CBBCT) for population screening has not been established as medically necessary. Professional assessments note relatively high radiation doses for some molecular techniques and study limitations (heterogeneous populations, risk of bias), so these modalities are considered investigational for routine screening pending larger, well‑designed outcome studies.

The policy revision effective 02/01/2026 replaces earlier exclusion language that specifically singled out women with dense breasts but without defined risk factors. The updated policy now excludes MRI for any individual who does not meet the criteria listed in the policy, while also adding an operational definition for breast composition (density) categories used in coverage determinations.

Covered Indications

Breast MRI screening for individuals at high risk

Breast MRI screening for individuals at high risk: Refer to coverage criteria: MRI screening indicated for individuals with heterogeneously or extremely dense breasts beginning at age 40; prior thoracic radiation between ages 10–30 (start at age 25 or 8 years post‑treatment); lifetime risk >=20% (screening beginning at age 40); personal history of breast cancer (unless bilateral mastectomy); specified germline mutations with listed start ages; and defined qualifying family histories.Age thresholds as listed

Screening can begin at listed age or 10 years prior to youngest relative's diagnosis (up to third‑degree relatives), but not before age 25.

Diagnostic and supplemental screening indications

Diagnostic work‑up after recall: For lesions recalled from screening, diagnostic modalities that may be used include contrast‑enhanced mammography (CEM), MRI, digital breast tomosynthesis (DBT), handheld ultrasound (HHUS), and diagnostic mammography; pooled analyses show high sensitivity for CEM and MRI in this setting.

Frequency and Interval Limits

MRI frequency — MRI every 1-4 years depending on risk and guideline

Recommended MRI screening intervalFrequency varies by risk and guideline; MRI screening is described in the policy as occurring every 1 to 4 years depending on individual risk and applicable society guidance.

Risk-dependent frequencyHigher-risk groups (e.g., BRCA carriers, prior chest irradiation, lifetime risk ≥20%) generally follow annual or guideline-specified MRI intervals within the 1–4 year range.

Dense-breast supplemental interval guidanceFor women with extremely dense breasts, EUSOBI supports offering MRI at multi-year intervals within the 1–4 year range (see EUSOBI 2–4 year recommendation).

MRI frequency detail — every 2-4 years (EUSOBI referenced interval for specific density group)

EUSOBI intervalEUSOBI recommends offering screening breast MRI every 2 to 4 years for women aged 50 to 70 with extremely dense breasts.

Coding

Applicable CPT/HCPCS Codesmixed

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 16

1/2

Device codes and classifications (informational)mixed

MUE (product code)	Digital mammography systems pre-market product code referenced by FDA
Class I / Class II	Device classification noted for BSGI cameras (Class I) and mammographic x-ray systems (Class II)

Age-based MRI screening thresholds for specific high-risk groups

BRCA1/BRCA2Begin MRI screening at age 25 for individuals with BRCA1 or BRCA2 mutations.

TP53 (Li-Fraumeni)Begin MRI screening at age 20 for individuals with TP53 gene mutation.

Other high-penetrance mutationsSelected mutations with specified start ages: ATM, CDH1, CHEK2, NF1, PALB2, PTEN — screening generally begins at age 30 or 40 as noted in the policy (see policy details).

Lifetime risk threshold — >= 20% as defined by risk models

Lifetime risk threshold>= 20% estimated lifetime risk as defined by validated models largely dependent on family history (e.g., Gail, Claus, Tyrer-Cuzick, BRCAPRO).

Screening start age for lifetime risk

Provider Actions and Requirements

Billing Rule

Applicable Codes and Coding Clarification

The following procedure and diagnosis codes are provided for reference only and may not be all-inclusive. Listing of a code in this policy does not imply that the service is covered, and inclusion does not guarantee reimbursement. Benefit coverage is determined by the member-specific benefit plan and applicable laws. Computer-aided detection (CAD) is included with breast MRI CPT codes 77048 and 77049; if CAD is performed with these codes, no additional reimbursement will be allowed.

Reference codes are informational only; verify member benefits for coverage determination.
CAD is bundled into breast MRI CPT codes 77048 and 77049 — do not bill separately for CAD.

Documentation Required

Medical Records Documentation and Documentation-Based Denial Risk

Benefit coverage is determined by the member-specific benefit plan document and applicable federal or state mandates. Coverage decisions may require review of the medical record to confirm that policy criteria are met. Documentation that is incomplete, inconsistent with the policy criteria, or absent may result in denial of the request.

Prior Authorization

Billing Rule

Codes listed are reference only; check plan for prior authorization

All listed breast imaging procedures and codes are provided for reference and may require prior authorization per the member’s benefit plan; check plan rules before billing or scheduling.

Listing of a code does not imply coverage or payment.
Verify prior authorization requirements for specified CPT/HCPCS codes with the member’s plan.

Prior Authorization

Prior authorization may be required for screening MRI outside high‑risk indications

Screening breast MRI may require prior authorization when requested outside high‑risk guideline indications; verify authorization requirements before scheduling.

Confirm high‑risk indication (e.g., BRCA mutation, prior chest irradiation, lifetime risk ≥20%) to support MRI authorization.
If MRI is requested outside these indications, obtain prior authorization per plan rules.

Contrast and Contrast-Enhanced Studies

Billing Rule

Breast MRI contrast coding and CAD clarification (77048/77049)

CPT codes 77048 and 77049 describe breast MRI without and with contrast and include CAD when performed; follow coding guidance that CAD is not separately reimbursed with these codes.

Use 77048/77049 for MRI breast studies without and with contrast (including CAD when performed).
Do not bill separately for CAD when submitted with 77048 or 77049.

Billing Rule

Document contrast use and follow administration standards for enhanced studies

Contrast‑enhanced studies (e.g., CE‑CBBCT, contrast‑enhanced MRI) may improve diagnostic sensitivity; follow established contrast administration standards and document contrast use.

Protocols for iodinated or MR contrast varied across studies; document type and protocol of contrast administered.
Contrast‑enhanced CT/MRI may provide higher sensitivity than non‑contrast studies in diagnostic contexts.

Not Covered / Investigational

The following investigational modalities are listed as not covered: computer‑aided tactile breast imaging, computed tomography of the breast (including cone‑beam breast CT), magnetic resonance elastography (MRE), and molecular breast imaging techniques such as BSGI/MBI, scintimammography, and PEM. These are classified as unproven due to low‑quality evidence, methodological limitations, and insufficient data demonstrating clinical utility.

Routine screening with CBBCT, MBI/BSGI, or scintimammography is not covered as standard screening modalities. Systematic reviews and evidence assessments report limited or inconclusive clinical validity and highlight the need for larger prospective studies before these techniques can be recommended for routine population screening.

Routine molecular imaging (for example, breast‑specific gamma imaging/MBI, sestamibi‑based scintimammography, or PEM) is not supported for general population screening because of higher radiation exposure for some techniques and limited evidence that adjunctive molecular imaging improves clinical outcomes compared with established screening strategies.

Definitions

Breast Composition Categories — ACR BI-RADS categories A-D (density levels)

ACR BI-RADS Category AAlmost entirely fatty.

ACR BI-RADS Category BScattered areas of fibroglandular density.

ACR BI-RADS Category CHeterogeneously dense — operationalized in the policy as qualifying (Category C) for density-based MRI screening from age 40.

ACR BI-RADS Category DExtremely dense — operationalized in the policy as qualifying (Category D) for density-based MRI screening from age 40; EUSOBI specifically recommends MRI every 2–4 years for ages 50–70.

BSGI / MBI — functional molecular imaging using radioactive tracer and gamma camera

DefinitionBreast Specific Gamma Imaging (BSGI) / Molecular Breast Imaging (MBI) is functional molecular imaging that uses an injected radioactive tracer and a gamma camera to detect areas of increased tracer uptake in the breast.

Background and Evidence Summary

Background: Digital mammography (including digital mammography and tomosynthesis) remains the generally accepted standard for population breast cancer screening. Magnetic resonance imaging (MRI) has demonstrated clinical utility and is considered proven and medically necessary for specified high‑risk groups — for example, carriers of BRCA1/BRCA2 and other listed germline mutations, individuals with prior chest irradiation, those with a lifetime risk of ≥20% by validated models, and certain family history patterns. The policy revision (effective 02/01/2026) also incorporates breast density (heterogeneously or extremely dense breasts, Categories C or D) into screening considerations and specifies age‑based starting points for many indications.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyBreast Imaging for Screening and Diagnosing Cancer

Policy CodePolicy 2026T0375LL

Change TypeRevised coverage criteria (density and age clarifications)

Effective DateFeb 1, 2026

Next Review Date

Key ActionObtain and document breast density and validated lifetime risk (≥20%) to support approval for screening breast MRI; prior authorization may be required per member benefit plan.

SourceLink

On This Page

Akwo et al. pooled sensitivities: CEM 95%, MRI 93%.

Emerging modalities investigational: Cone‑beam breast CT, MR elastography, molecular breast imaging/BSGI, scintimammography and related molecular techniques currently have limited or inconclusive evidence for routine screening use and generally require further large prospective studies before being considered standard screening modalities.

Multiple systematic reviews and society statements conclude insufficient evidence to support routine screening use for these modalities.

Akwo et al. pooled sensitivities: CEM 95%, MRI 93%.

High‑risk screening indication: Annual MRI is appropriate for women with BRCA mutations, other high‑penetrance gene mutations, prior chest irradiation, or lifetime risk >=20% per professional society guidance.

ACR and ASBrS recommend MRI for these high‑risk groups.

Dense‑breast supplemental screening: Consider supplemental MRI or other modalities based on breast density and individual risk; shared decision‑making is recommended for women with extremely dense breasts.

EUSOBI and ACR guidance cited.

Supplemental breast imaging indications

Indications for supplemental imaging: Supplemental imaging indications include high‑risk status (germline high‑risk mutations, prior chest irradiation, lifetime risk >=20% by validated models), extremely or heterogeneously dense breasts, and situations where MRI cannot be performed and alternatives (CEM, MBI, whole breast ultrasound) are considered.

Supported by ASBrS, NCCN, and SNMMI/EANM practice guidance.

Context for 2–4 year intervalRecommendation applies after counselling and shared decision-making and acknowledges limited immediate availability in some settings.

Policy alignmentPolicy cites EUSOBI as support for multi-year MRI intervals for density-based supplemental screening and incorporates this interval into coverage principles.

Policy indicates screening for lifetime risk ≥20% begins at age 40 (unless other start-age rules apply).

Supporting society guidanceASBrS and ACR guidance support MRI for women with estimated lifetime risk in the ~20%+ range; policy aligns with these recommendations.

Medical records may be requested to demonstrate the member meets clinical criteria for coverage.
Incomplete or missing documentation increases risk of denial.

Denial Risk

Denial Risk When MRI Criteria Are Not Met

Requests for breast MRI screening may be denied if the individual does not meet the policy’s specified high-risk or density criteria. Use guideline-based risk thresholds (e.g., lifetime risk ≥20% by validated models, relevant family history, prior chest radiation, or heterogeneously/ extremely dense breasts where specified) when determining eligibility. Prior authorization requirements and member benefit limitations still apply.

Denials likely when MRI screening is requested for individuals who do not meet the policy’s listed criteria (e.g., lifetime risk, genetic mutation family history, prior chest RT, or specified breast density categories).
Prior authorization may still be required; always confirm member-specific benefit coverage before scheduling.

Note

Member Benefit and Plan Documentation

Before ordering or performing supplemental breast imaging, verify the member’s benefit plan and any applicable mandates. In the event of conflict, the member-specific benefit plan document governs. This policy is informational and not a guarantee of coverage. UnitedHealthcare (and delegated plans) may require prior authorization and may use external tools or Medicare guidance where applicable.

Confirm member-specific benefit plan terms and state/federal mandates prior to authorizing services.
When benefit plan language conflicts with this policy, the member-specific plan governs.
Prior authorization may be required for MRI or molecular imaging screening — verify and obtain authorization when applicable.

Prior Authorization

Required Clinical Documentation to Support Coverage

Prior authorization and supporting documentation should include clinical information to demonstrate the member meets the policy criteria (e.g., calculated lifetime risk model results, genetic test results, detailed family history, prior chest radiation dates/doses, and breast density assessment). Keep documentation available for review; failure to provide adequate clinical evidence may result in denial.

Include objective risk estimates from validated models (Gail, Tyrer-Cuzick, BRCAPRO, Claus) when applicable.
Provide genetic testing results or detailed family history (relationships and ages at diagnosis) to support hereditary risk.
Document breast composition/density category and any prior chest radiation (dates and dose estimates) when relevant.
Retain and submit medical record evidence with prior authorization requests to avoid delays or denials.

Prior Authorization

MRI requests must meet documented high‑risk/density criteria or be authorized by plan

Breast MRI is required to meet documented high‑risk/density criteria or be authorized by the member’s benefit plan; policy revisions may change authorization determinations.

The 02/01/2026 policy revision added a density requirement (Category C or D) for certain MRI indications; verify documentation reflects these revisions.
If documentation does not support revised criteria, prior authorization may be denied or additional records requested.

Billing Rule

CEM increases detection but requires contrast risk documentation

Contrast‑enhanced modalities such as contrast‑enhanced mammography (CEM) increase cancer detection compared to mammography but carry risks (e.g., iodinated contrast reactions); document informed consent and contrast safety considerations.

Consider CEM when MRI is not feasible, but counsel patients on risk of iodinated contrast reactions.
Document patient counseling and any contraindications to contrast in the medical record.

Clinical contextBSGI/MBI has demonstrated relatively high sensitivity and specificity in some studies but carries higher radiation exposure and limited evidence for routine screening use.

Regulatory noteEquipment for BSGI is subject to device regulation; BSGI procedures themselves are not FDA-regulated as devices are used to perform the procedure.

Computer-Aided Tactile Breast Imaging (TI) — handheld tactile sensor generating multi-dimensional images

Technique descriptionComputer-aided tactile breast imaging uses a handheld tactile array sensor moved across the breast to generate multi-dimensional color images depicting size, shape, hardness, and location of suspicious masses.

Evidence stanceThe policy lists tactile imaging as unproven and not medically necessary due to insufficient evidence of clinical utility for screening or diagnosis.

CodingTactile imaging is represented by CPT code 0422T (per policy code list).

Magnetic Resonance Elastography (MRE) — technique quantifying tissue mechanical properties

Technique descriptionMagnetic Resonance Elastography (MRE) is a phase-contrast MRI technique that quantifies mechanical properties (e.g., elastic modulus) of tissues to differentiate malignant from normal tissue.

Evidence stanceMRE has shown feasibility and potential to increase diagnostic accuracy when combined with contrast-enhanced MRI, but larger studies are needed and MRE is considered investigational for routine screening.

Policy positionMRE of the breast is listed among unproven and not medically necessary modalities for routine use in the policy pending more evidence.

Positron Emission Mammography (PEM) — high-resolution metabolic imaging using FDG tracer

Technique descriptionPositron Emission Mammography (PEM) is high-resolution metabolic imaging for the breast using an FDG tracer with detectors integrated into a mammography system.

Clinical considerationsPEM and related molecular imaging techniques provide functional/metabolic information but are noted in the policy as unproven or not medically necessary for routine screening due to limited evidence and higher radiation dose concerns.

Policy updatePolicy updated PEM definition; device context and regulatory considerations for breast-specific gamma imaging devices are noted.

CBBCT — cone-beam breast CT; non-contrast and contrast-enhanced variants

DefinitionCone-beam breast CT (CBBCT) is a CT technique for the breast available as non-contrast (NC-CBBCT) and contrast-enhanced (CE-CBBCT) variants.

Diagnostic accuracyMeta-analyses report varying performance: CE-CBBCT may show higher pooled sensitivity and specificity compared to NC-CBBCT, but evidence is heterogeneous and not yet sufficient for routine screening recommendations.

Policy stanceCBBCT is considered investigational / not medically necessary for routine population screening pending further prospective studies.

MBI / BSGI — molecular breast imaging / breast-specific gamma imaging context and limitations

Clinical contextMBI/BSGI are nuclear medicine techniques that detect radiotracer uptake and can have sensitivity similar to MRI with higher specificity in some studies.

LimitationsMBI/BSGI studies are limited by radiation exposure and heterogeneous evidence; routine screening use is not established and policy classifies many molecular imaging techniques as unproven or not medically necessary for screening.

Device/regulatory noteBSGI equipment (gamma cameras) is subject to FDA device regulation (Class I devices), though the procedure itself is a diagnostic service.

MRE — magnetic resonance elastography investigational role in risk stratification

Investigational roleMRE measures tissue stiffness and has an investigational role in breast cancer risk stratification and lesion characterization pending larger validation studies.

Potential benefitSmall studies suggest adding MRE to contrast-enhanced MRI may improve diagnostic accuracy, but evidence is insufficient for routine adoption.

Policy classificationMRE is listed among modalities considered unproven and not medically necessary for screening/diagnostic use in the policy.

Breast Composition Categories — added definition operationalizing heterogeneously dense (Category C) and extremely dense (Category D)

Category C (heterogeneously dense)Operative policy definition: heterogeneously dense — one of the ACR BI-RADS density categories operationalized in the policy as qualifying (Category C) for density-based MRI screening beginning at age 40.

Category D (extremely dense)Operative policy definition: extremely dense — ACR BI-RADS Category D operationalized in the policy as qualifying for density-based MRI screening beginning at age 40 and referenced in EUSOBI guidance for ages 50–70.

Policy additionPolicy history notes addition of 'Breast Composition Categories' definition to clarify Categories C and D for coverage decisions.

PEM / BSGI device context — updated definition and FDA/regulatory context for device use

Updated definitionPolicy updates the definition of Positron Emission Mammography (PEM) and clarifies device context for breast-specific gamma imaging equipment.

Regulatory contextBSGI cameras are considered Class I radiologic devices; FDA regulation applies to equipment though the procedure is a diagnostic test.

Coverage implicationDespite device availability, PEM and other molecular imaging modalities are listed as unproven or not medically necessary for routine screening in the policy due to limited evidence and radiation concerns.