Breast Biopsy Procedures
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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.
No material clinical or coverage changes in this revision.
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:
inv-10: Intra‑operative margin assessment (MarginProbe) — evidence summary
Intra‑operative margin assessment (MarginProbe) — Evidence summary:
Covered Indications
Coding — CPT/HCPCS/ICD-10
| 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). |
| 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. |
| 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). |
| 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. |
| No codes listed |
| No codes listed |
Provider Actions — Prior Authorization, Documentation, Billing
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 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.
- Provide device manufacturer/name (e.g., Magseed, Savi Scout), placement technique, and intended surgical plan when requesting authorization.
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.
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.
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.
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 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 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 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.
Contrast and Imaging Guidance Rules
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.
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.
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.
- Magseed compatible with MRI but can produce a bloom artifact up to 6 cm.
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
Frequency Limits
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.
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