CurrentAetnaPolicy 0269

Breast Biopsy Procedures

Defines Aetna's coverage stance for minimally invasive image-guided breast biopsy procedures and related localization techniques for non-palpable or difficult-to-palpate breast abnormalities; applies to Aetna members and providers performing breast biopsy and localization procedures.

Policy Summary

PayerAetna

PolicyBreast Biopsy Procedures

Policy CodePolicy 0269

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionDocument lesion characteristics (non-palpable, deep, mobile, small, or clustered microcalcifications) and the image-guidance method to support medical necessity when submitting for authorization or claims.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6listed minimally invasive image-guided biopsy procedures considered medically necessary

4procedures considered experimental/investigational (examples listed)

07/16/1998effective date (document history)

04/26/2023last review date

03/14/2024next review date

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Coverage Criteria — Image-guided Breast Biopsy and Localization

inv-09: MIB to predict pCR — evidence summary

Image-guided minimally invasive biopsy (MIB) to predict pathologic complete response (pCR) after neoadjuvant systemic therapy (NST) — Evidence summary:

Multiple prospective and multicenter cohort studies and meta-analyses have evaluated the accuracy of image-guided MIB (primarily ultrasound-guided core biopsy) to identify breast pCR following NST. Early feasibility data (MICRA) and subsequent prospective studies demonstrated that obtaining representative post‑NST core samples is feasible but that false-negative rates (FNRs) are substantial in many series and vary by imaging response and tumor subtype.

Van der Noordaa et al (MICRA trial initial feasibility) reported that US-guided post‑NST biopsy was feasible; however, larger validation cohorts were required to determine FNR and clinical utility.

van Loevezijn et al (prospective multicenter single‑arm study) of pre‑surgical US-guided 14‑G core biopsies in patients with MRI rCR/rPR obtained a FNR of 37 % (29/78 FN among those with residual disease) and concluded MIB in their protocol was not accurate enough to reliably identify breast pCR; surgery could not be safely omitted based on biopsy results.

Li et al (2020) meta‑analysis of 9 trials (1,030 patients) reported pooled sensitivity 0.72 (95 % CI: 0.61–0.81) and specificity 0.99 (95 % CI: 0.89–1.00). Heterogeneity existed across studies; trials that did not restrict inclusion to clinical complete responders had higher accuracy than those limited to clinical CR.

Key limitations across studies include variable biopsy techniques (gauge, number of cores), variable imaging guidance and response assessment criteria (MRI vs ultrasound), small sample sizes in several trials, and heterogeneity in timing of biopsies and patient/tumor characteristics (molecular subtype impacts FNR).

Overall interpretation: Current evidence indicates that image-guided MIB can identify pCR in some patients, but sensitivity is insufficient and FNRs are unacceptably high in many series to allow routine omission of surgical resection after NST. Standardization of biopsy technique (marker placement, number/size of cores, imaging correlation), patient selection, and prospective validation in larger trials are required before MIB can replace surgical pathology to confirm pCR.

inv-10: Intra‑operative margin assessment (MarginProbe) — evidence summary

Intra‑operative margin assessment (MarginProbe) — Evidence summary:

MarginProbe is a hand‑held radiofrequency spectroscopy device FDA‑cleared in 2013 to assess margins on excised lumpectomy specimens intra‑operatively by detecting dielectric differences between normal and malignant tissue.

Several single‑center retrospective studies and comparative analyses have associated MarginProbe use with reductions in positive margin rates and re‑excision rates. For example, Coble and Reid (2017) reported a reduction in re‑excision rate from 15.1 % to 6.6 % and a 32 % reduction in overall tissue volume removed after instituting a MarginProbe‑guided targeted shaving approach compared with prior full cavity shaving.

Kupstas et al (retrospective chart review) reported a 50 % reduction in re‑lumpectomy rate (p = 0.039) after adoption of MarginProbe without increasing total tissue volume resected.

Systematic reviews (Gray et al 2018) found that MarginProbe and cavity‑shave techniques both lower positive margin rates, although there may be tradeoffs such as potential negative cosmetic effects and variable quality of evidence across studies.

Covered Indications

Coding — CPT/HCPCS/ICD-10

Covered CPT CodesCPTCovered

19081	Biopsy, breast, with placement of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; first lesion, including stereotactic guidance.
19082	Each additional lesion, including stereotactic guidance (List separately in addition to code for primary procedure).
19083	Biopsy, breast, with placement of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; first lesion, including ultrasound guidance.
19084	Each additional lesion, including ultrasound guidance (List separately in addition to code for primary procedure).
19085	Biopsy, breast, with placement of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; first lesion, including magnetic resonance guidance.
19086	Each additional lesion, including magnetic resonance guidance (List separately in addition to code for primary procedure).
19281	Placement of breast localization device(s) (eg, clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; first lesion, including mammographic guidance.
19282	Each additional lesion, including mammographic guidance (List separately in addition to code for primary procedure).
19283	Placement of breast localization device(s) (eg, clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; first lesion, including stereotactic guidance.
19284	Each additional lesion, including stereotactic guidance (List separately in addition to code for primary procedure).

1–10 of 23

1/3

Not Covered CPT CodesCPTNot Covered

0546T	Radiofrequency spectroscopy, real time, intraoperative margin assessment, at the time of partial mastectomy, with report.
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 requiring image postprocessing on an independent workstation.

HCPCS Covered CodesHCPCSCovered

C7501	Percutaneous breast biopsies using stereotactic guidance, with placement of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, all lesions unilateral and bilateral (for single lesion biopsy, use appropriate code).
C7502	Percutaneous breast biopsies using magnetic resonance guidance, with placement of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, all lesions unilateral or bilateral (for single lesion biopsy, use appropriate code).
G0279	Diagnostic digital breast tomosynthesis, unilateral or bilateral (List separately in addition to G0204 or G0206).

ICD-10 CodesICD-10

C50.011 - C50.929	Malignant neoplasm of breast.
C79.2	Secondary malignant neoplasm of skin [of breast].
C79.81	Secondary malignant neoplasm of breast.
D05.00 - D05.92	Carcinoma in situ of breast.
D24.1 - D24.9	Benign neoplasm of breast.
D48.60 - D48.62	Neoplasm of uncertain behavior of breast.
N60.01 - N60.99	Benign mammary dysplasias.
N63.0 - N63.42	Unspecified lump in unspecified breast [breast nodules].
R92.0 - R92.8	Abnormal and inconclusive findings on diagnostic imaging of breast.

Codes mentioned elsewhere in evidence sectionsmixed

No codes listed

Covered CPT Codes (additional mentions)CPT

No codes listed

Lesion size threshold — clinical thresholds

Lesion size thresholdLesions described as small (less than 2 cm) may warrant image-guided biopsy

ContextThreshold applies to non-palpable or difficult-to-palpate lesions (deep, mobile, clustered microcalcifications) identified by mammography

Palpable lesions noteFor larger, fixed, palpable lesions, image guidance is not medically necessary; palpation-guided biopsy is sufficient

Seeds per procedure — typical seed usage

Typical seeds used per procedureMajority of RSL procedures utilized 1 seed (86% in the McGhan series)

Provider Actions — Prior Authorization, Documentation, Billing

Prior Authorization

Prior authorization for covered biopsy/localization codes

Prior authorization may be required for covered biopsy and localization procedures per usual plan rules. When submitting for authorization, include the clinical indication and planned CPT/HCPCS codes for the biopsy or localization procedure.

Affected covered codes include CPT 19081–19086, 19281–19286 and related diagnostic mammography/MRI codes (e.g., 77046–77047, 77053–77067) and HCPCS C7501, C7502, G0279 when selection criteria are met.
Obtain prior authorization according to standard Aetna procedures when billing these covered biopsy/localization services.

Prior Authorization

Prior authorization for magnetic seed localization (operational note)

Newer localization technologies such as magnetic seed localization (Magseed) or SAVI SCOUT may have operational prior-authorization requirements or documentation expectations. Check payer-specific prior authorization pathways for these technologies and include device type and placement timing in the request.

Operational note: magnetic seeds (e.g., Magseed) and non-wire, non-incision (NWNI) reflector systems can be placed days before surgery — document placement date relative to surgery.

Prior Authorization Notes

Billing Rule

Bill using the covered CPT/HCPCS codes and document selection criteria

When any listed modality is billed, ensure the claim uses the covered CPT/HCPCS codes listed in the policy and that selection criteria are documented, since billing should reflect the covered codes.

Covered CPT examples include 19081–19086 and 19281–19288.
Covered HCPCS examples include C7501, C7502, and G0279.

Prior Authorization

No prior authorization specified for SAVI SCOUT in excerpt

The excerpt does not specify a prior authorization requirement for the SAVI SCOUT system.

Contrast and Imaging Guidance Rules

Billing Rule

Use MRI-guidance codes (19085/19086, 19287/19288, 77021) when MRI guidance criteria are met

MRI-guided biopsy/localization codes are listed (e.g., 19085/19086, 19287/19288, 77021) and should be used when MRI guidance selection criteria are met.

Use MRI guidance CPT codes for procedures performed under MRI guidance.
Document that MRI guidance selection criteria were met when billing these codes.

Billing Rule

No contrast-specific billing rules for tomosynthesis/biopsy in excerpt

The policy excerpts do not provide contrast-specific billing rules for tomosynthesis or biopsy procedures.

Billing Rule

MRI artifact considerations for magnetic seeds; no contrast rules specified

MRI compatibility limitations for magnetic seeds are noted (bloom artifact up to 6 cm); no specific contrast billing rules are provided for NWNI devices in the excerpt.

Not Covered / Experimental Procedures

PET‑guided breast biopsy techniques (for example, Naviscan) and three‑dimensional volumetric imaging/reconstruction methods are listed in the policy inventory as experimental, investigational, and not covered for the indications described. These techniques are flagged as not covered due to insufficient evidence of effectiveness.

The policy inventory and coding sections repeat that PET‑guided breast biopsy (Naviscan) is considered experimental/investigational and not covered for the listed indications; related imaging reconstruction techniques are similarly identified as not covered.

Additional experimental image‑guided localization and imaging reconstruction techniques are identified in the policy as investigational and not covered. The bulletin’s not‑covered lists and inventory reference these novel approaches as lacking established effectiveness.

The bulletin states that routine use of digital breast tomosynthesis (DBT) as a primary screening tool and tomosynthesis‑guided biopsy as standard practice is not supported by current evidence in the cited literature, and these uses are identified as not covered/unsupported for routine implementation pending higher‑quality outcome data.

Experimental PET‑guided biopsy and 3‑D volumetric imaging/reconstruction techniques are listed repeatedly in the inventory and not‑covered sections as examples of procedures considered investigational.

The policy inventory and not‑covered entries include experimental PET‑guided biopsy and 3‑D imaging reconstruction methods among techniques classified as investigational/not covered, reflecting the absence of sufficient evidence to support routine clinical use.

Background

Minimally invasive image‑guided breast biopsies are described as alternatives to needle localization core surgical biopsy for non‑palpable or difficult‑to‑palpate lesions. These methods generally offer shorter procedure time, less patient discomfort and cosmetic deformity, reduced mammographic artifact, and cost advantages; large‑core (11‑ or 14‑gauge) biopsies are preferred over fine‑needle aspiration because they provide more adequate tissue for pathology and allow differentiation of in‑situ from invasive carcinoma.

Definitions

Lesion descriptors — non-palpable or difficult-to-palpate lesions

Non-palpable or difficult-to-palpate lesions (definition)Lesions identified by mammography that are non-palpable or difficult to palpate because they are deep, mobile, small (<2 cm), or composed of clustered microcalcifications

Imaging contextThese lesion descriptors are the typical indications for image-guided minimally invasive biopsy as alternatives to needle localization surgical biopsy

Palpation-guidance exceptionFor larger, fixed, palpable lesions, palpation-guided biopsy is considered sufficient and image guidance is not medically necessary

ABBI — Advanced Breast Biopsy Instrument definition

ABBI — definitionAdvanced Breast Biopsy Instrument (ABBI): a stereotactically guided device allowing excision of a 2-cm core of breast tissue

Frequency Limits

DBT — frequency/limit entry

DBT frequency/limit entryDigital breast tomosynthesis (DBT) listed under frequency limits section of policy (no numeric frequency specified in excerpt)

Policy noteExcerpt does not provide a numeric limit or interval for DBT frequency; billing follows listed CPT/HCPCS codes and payer rules

Evidence contextDBT is FDA-approved as adjunct to standard mammography; large prospective outcome trials for routine replacement not yet established

Frequency limit — policy inventory entry

Frequency limit — entryPolicy includes an additional frequency-limits key-value entry without explicit numeric values in provided excerpt

Interpretation

Revision History and References

The policy history and review metadata are provided in the bulletin. The most recent review date shown is 04/26/2023, the effective date is listed as 07/16/1998, and the next scheduled review is noted as 03/14/2024.

Policy Summary

PayerAetna

PolicyBreast Biopsy Procedures

Policy CodePolicy 0269

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Contrasting assessments: The BlueCross BlueShield Technology Evaluation Center (TEC, 2013) concluded that radiofrequency spectroscopy for intraoperative margin assessment did not meet TEC criteria. UpToDate (Chagpar, 2019) notes studies associating MarginProbe with lower positive margin and re‑excision rates but highlights disadvantages including capital and disposable probe costs and lack of evidence that MarginProbe is superior to other strategies (e.g., cavity shave margins) in all settings.

Limitations and clinical considerations include single‑center and retrospective study designs, variability in operative workflow and surgeon technique, capital and per‑procedure costs for device and disposables, and absence of definitive randomized multicenter data demonstrating consistent clinical outcome improvements across practice settings.

Overall interpretation: Evidence suggests MarginProbe can reduce positive margin and re‑excision rates in some practice settings as an adjunct to standard margin‑assessment techniques, but heterogeneity of data, cost considerations, and incomplete demonstration of benefit over established approaches mean its routine, unconditional adoption is not yet supported; clinical judgment and site‑specific assessment of benefit, workflow, and cost are recommended.

Total seeds deployed (example series)1,148 seeds deployed in 1,000 procedures (McGhan et al) — demonstrates occasional use of >1 seed

Timing of placement76% of seeds were placed greater than or equal to 1 day before surgery in cited series

Minimum biopsy cores — study-suggested thresholds

Minimum cores associated with high NPVObtaining ≥5 biopsy cores in a select prospective study (with strict MRI criteria) resulted in 100% NPV and accuracy

Typical core counts in feasibility trialsMedian of 8 biopsies obtained (range 4–9) reported in MICRA feasibility series; median representative biopsies 4 (range 1–8)

Clinical implicationHigher core counts plus stringent MRI selection improved negative predictive value but larger validation studies are needed

Maximum recommended implantation depth — device recommendation and exceptions

Manufacturer recommended maximum implantation depthMarker implantation depth limited to up to 3 cm per manufacturer recommendation

Reported exceptionsIndividual reports noted successful detection at deeper implantations (3.3 cm and 5.0 cm) with probe palpation assistance

Operational limits and compatibilityDeeper implantation may reduce detection; probe recalibration, interference with paramagnetic instruments, and MRI bloom artifact are noted practical limits

Provide device manufacturer/name (e.g., Magseed, Savi Scout), placement technique, and intended surgical plan when requesting authorization.

Billing Rule

Non-covered CPT/HCPCS codes

Certain codes and proprietary device billing may not be covered for the indications described in this policy. Billing unsupported codes can trigger denials.

HCPCS / proprietary or unlisted device entries for some systems may have no specific covered code (e.g., entries noting Savi Scout / magseed with no specific CPT) — submit appropriate supporting documentation and prior authorization.
Examples of not-covered or unspecified-code situations should be confirmed with the plan before billing to avoid denials.

Note

Not applicable content in this excerpt

Not applicable: This excerpt does not establish global prior-authorization exclusions, step-therapy requirements, or other utilization-management mandates beyond the specific notes above. Providers should follow standard Aetna prior-authorization processes where applicable.

No step-therapy requirements are specified in this excerpt.
No blanket prior-authorization prohibition or universal coverage exclusion is stated in this excerpt.

Documentation Required

Clinical documentation to support necessity

Document clinical information that supports medical necessity when requesting authorization or when billing: include lesion characteristics, imaging findings, targeted lesion laterality, and rationale for the chosen biopsy/localization method.

Lesion size, palpability, imaging modality findings (mammogram, MRI, ultrasound) and reason image-guidance is required.
Planned procedure (CPT/HCPCS), device to be used (clip, seed, reflector), and expected number of lesions to be sampled/localized.

Documentation Required

Suggested documentation elements from clinical studies

When available, include study-derived or consensus-recommended documentation elements to strengthen the record: informed consent, placement confirmation imaging, number and type of cores or seeds, and pathology correlation.

Informed consent specific to the localization/biopsy device and procedure.
Placement verification: radiographic or ultrasound image documenting marker/seed/reflector position and specimen radiograph confirming retrieval when applicable.
Device details: type, manufacturer/model, lot number if available, date/time of placement, and any migration noted.

Documentation Required

Documentation elements for MIB after NST

For image-guided minimally invasive biopsy (MIB) performed after neoadjuvant systemic therapy (NST), include protocol-specific elements used in trials that evaluated pCR prediction: number of cores obtained, imaging response criteria, and correlation with surgical pathology.

Document pre-NST marker placement, MRI/US response (rCR/rPR), and imaging criteria used to select MIB.
Record number of cores obtained (trial medians/ranges reported: median 8 cores, representative biopsies median 4), biopsy guidance modality, and any technical limitations (e.g., marker not visualized).
Note that trials reported false-negative rates and that MIB alone may not reliably permit omission of surgery; document counseling and rationale if used for management decisions.

Documentation Required

Documentation suggested by study outcomes

Studies of newer localization and intraoperative margin-assessment techniques recommend documenting localization method, seed/reflector placement details (timing, depth, migration), MarginProbe or intraoperative assessment use, and margin outcomes to support clinical decisions and billing.

For magnetic seed/Magseed: placement depth, distance from target on imaging, any migration, and retrieval confirmation.
For SAVI SCOUT or reflector systems: placement date relative to surgery, imaging confirmation, number of reflectors (if bracketing), and specimen verification.
For MarginProbe: indication for use, device readings that prompted additional shavings, and resulting margin and re-excision outcomes.

Step Therapy

Step approach for intraoperative margin assessment

Step approach for intraoperative margin assessment: when MarginProbe or targeted shaving is used, document the intraoperative decision process, device findings that guided additional tissue removal, and comparison of device-directed shavings versus full-cavity shaving to support the operative record and coding.

Record whether MarginProbe prompted targeted shavings and the extent (number/volume) of additional tissue removed.
Document final margin status on pathology and any subsequent re-excision recommendations.
Include that use of MarginProbe is an adjunct to — not a replacement for — standard surgical judgment.

No prior authorization specified for SAVI SCOUT/RSL/ROLL/MarginProbe

No explicit prior authorization requirements are provided in the cited excerpts for SAVI SCOUT, RSL, ROLL, or MarginProbe.

Prior Authorization

Magseed/novel devices: provide clinical rationale and placement documentation if authorization required

Use of Magseed and other novel localization devices may require prior authorization depending on payer local policy; if requested, provide clinical rationale and documentation of device placement and intended surgical plan.

Magseed shown to have high placement and localization success in pooled analyses.
If authorization needed, include evidence of placement, intended use, and institutional preference.

Prior Authorization

No explicit prior-authorization thresholds for magnetic seeds in excerpt

No explicit prior authorization thresholds or numeric limits for magnetic seed localization or other NWNI devices are specified in this excerpt.

Magseed compatible with MRI but can produce a bloom artifact up to 6 cm.

Listed as one of the minimally invasive image-guided biopsy alternatives to needle localization core surgical biopsy for non-palpable lesions

Regulatory/context noteIncluded in Aetna’s list of medically necessary procedures when indications are met

RSL — Radioactive Seed Localization definition and context

RSL — definitionRadioactive Seed Localization: placement of a small radioactive seed into a non-palpable breast lesion preoperatively to guide surgical excision

Clinical outcomes (example)In McGhan series (1,000 procedures) negative margin at first operation was 97% for invasive carcinoma and DCIS; low complication and migration rates reported

Comparative contextSystematic reviews/meta-analyses report RSL as comparable or superior to wire-guided localization for margin status and re-operation rates in pooled analyses

RGL / ROLL — Radio-guided localization definitions

RGL / ROLL — definitionRadio-guided localization (RGL) / Radio-guided occult lesion localization (ROLL): techniques using radioguidance to localize non-palpable lesions for surgical excision

Evidence summarySystematic reviews combining ROLL and RSL studies found lower positive margin rates and fewer re-operations for RGL versus wire localization in pooled analyses

Study volumeLiterature reviews identified multiple studies (eg, 52 studies on ROLL/RSL with 27 meeting inclusion criteria in one review)

DBT / Tomosynthesis — definition and imaging description

DBT / Tomosynthesis — definitionDigital breast tomosynthesis (3-D mammography) acquires thin-slice images via an arc acquisition and reconstructs cross-sectional slices to produce thin-section views of the breast

Biopsy useDBT can be used to guide stereotactic or tomosynthesis-guided biopsies; tomosynthesis-guided biopsy is considered an acceptable alternative to mammographically guided biopsy for medically necessary indications

Evidence caveatPublished peer-reviewed literature has not definitively established accuracy and clinical utility for all DBT-guided procedures; evidence is evolving

SAVI SCOUT — device/system definition and mechanism

SAVI SCOUT — definitionSAVI SCOUT Surgical Guidance System: an FDA-cleared, non-radioactive system using an implantable electromagnetic wave reflector and a detector hand-piece/console to provide real-time guidance for localization and excision of non-palpable breast lesions

Placement timingReflectors can be placed up to 7 days before surgery in reported pilot studies

Clinical evidencePilot and feasibility studies report high successful placement and retrieval rates with favorable margin and re-excision outcomes, though larger trials are ongoing

SAVI SCOUT (SCOUT) — alternate definition entry

SCOUT (alternate entry)SCOUT (SAVI SCOUT): a non-radioactive, FDA-cleared implantable infrared/electromagnetic reflector system detected by a handheld detector to guide excision of non-palpable breast lesions

Key pilot findingsIn a 50-patient pilot, reflectors placed under mammographic or ultrasound guidance were removed successfully in all patients with high clear margin rates among cancers

Operational noteUsed as an alternative to wire localization; larger multicenter trials underway to validate pilot results

Radioactive Seed Localization (RSL) — additional definition context

RSL — additional contextRSL uses a small radioactive iodine seed (eg, I-125) placed into the lesion preoperatively; series report high success, low migration, and favorable margin outcomes

Operational advantagesRSL can be placed days before surgery and has been reported as easy to learn with low incidence of positive/close margins in large single-institution series

Comparative evidenceMeta-analyses and pooled studies indicate RSL may reduce positive margins and re-operations compared with wire-guided localization

MarginProbe — device definition (intraoperative dielectric spectroscopy)

MarginProbe — device definitionMarginProbe: a handheld intraoperative device using dielectric spectroscopy (radiofrequency/dielectric properties) to assess excised specimen margins and guide targeted additional shavings

Intended useIntended to reduce positive margins at initial surgery and decrease need for re-excision by testing specimen margins intraoperatively

Regulatory statusFDA-approved (2013) for intraoperative margin assessment

RSL / ROLL — combined definition entry

RSL / ROLL — combined entryRSL/ROLL: radio-guided localization techniques using radioactive markers or radiotracers to mark non-palpable breast lesions for surgical excision

Evidence summarySystematic reviews and meta-analyses report comparable or improved margin and re-operation outcomes versus wire localization in pooled analyses

Clinical implementationUsed as alternatives to wire-guided localization; selection may depend on institutional practice and resources

MarginProbe — additional definition entry

MarginProbe — additional entryMarginProbe is a handheld probe applying dielectric spectroscopy to excised specimens to detect malignant tissue near margins and guide immediate additional excision

Reported outcomesSingle-center series reported reductions in re-excision rates (eg, 57% reduction) and reduced specimen volume compared with full cavity shaving

Evidence limitationsSystematic reviews note mixed evidence and potential trade-offs in cosmetic outcomes and cost; further studies recommended

Magseed — magnetic seed localization definition

Magseed — definitionMagseed: a magnetic seed localization system (non‑radioactive) that uses an inducible magnetic marker detected by a handheld probe (eg, Sentimag) for pre-operative localization of non-palpable breast lesions

Performance metricsPooled analyses report high placement (94.42%) and localization (99.86%) success with low migration and retrieval failures in most series

LimitationsManufacturer recommends implantation depth up to 3 cm; MRI bloom artifact (up to 6 cm) and probe interference with paramagnetic instruments are documented concerns

MIB — definition for image-guided minimally invasive biopsy

MIB — definitionImage-guided minimally invasive biopsy (MIB): ultrasound- or image-guided core needle or vacuum-assisted biopsy targeting the tumor bed after neoadjuvant therapy to assess for pathologic complete response

Clinical roleUsed investigationally to predict pCR after neoadjuvant systemic therapy; current evidence shows variable false-negative rates and limited accuracy to omit surgery

Procedure detailsStudies report variable numbers of cores (median 4–8) and emphasize correlation with MRI response and marker placement

Magnetic seed localization — Magseed / magnetic seed definition

Magnetic seed localization — definitionMagnetic seed localization (Magseed): a non‑radioactive localization method using a magnetic seed and handheld detector to guide surgical excision; can be implanted days before surgery

Comparative findingsPooled studies report localization and retrieval success comparable to wire-guided localization with similar re-excision/clear margin rates

Practical notesLimitations include manufacturer depth recommendation (≤3 cm), MRI artefact, probe recalibration and instrument interference

NWNI — Non-wired non-ionizing techniques definition

NWNI — definitionNon‑wired non‑ionizing (NWNI) techniques: novel localization approaches (eg, reflectors, magnetic seeds, RFID tags) that do not use wires or ionizing radiation and can be placed days before surgery

Clinical advantagesAllow decoupling of localization from surgery, high localization success, and potential logistical benefits compared to wire or radioactive methods

Evidence statusPromising results in observational studies and pooled analyses but randomized trials and longer-term outcome data are limited

3D-SI — Three-dimensional surface imaging systems definition (Axis Three, Vectra XT examples)

3D-SI — definitionThree-dimensional surface imaging (3D‑SI) systems: noninvasive scanners (examples: Axis Three, Vectra XT) used to calculate breast volume and symmetry for pre-operative planning and cosmetic assessment

PerformanceValidation studies show excellent to substantial reliability versus water-displacement and MRI for volume measurement; intra- and inter-observer variability generally low

Clinical utilityUseful for reconstruction planning and objective cosmetic outcome assessment but requires further validation in larger cohorts

Definitions (link) — reference to master definitions link

Definitions resource linkPolicy links to a master Definitions page for additional terminology and device descriptions

Policy contextRefer to the Definitions link in the policy history for full list of terms used throughout the bulletin

LocationDefinitions accessible via the policy’s Definitions link (see Policy History section)

No explicit numeric frequency or periodicity provided in these chunks; follow payer billing rules and listed procedure codes

Actionable guidanceWhen frequency limits are required, consult full policy or payer prior authorization rules for any modality-specific limits