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    OpenPayerPolicy UpdatesRadiation OncologyExcellus Brachytherapy Coverage Update | OpenPayer
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    ModifiedExcellus Health Plan IncPolicy 6.01.30

    Brachytherapy After Breast-Conserving Surgery

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    This policy governs coverage of accelerated partial breast irradiation using interstitial or balloon brachytherapy after breast-conserving surgery, including clinical criteria for medically appropriate use and circumstances considered not medically necessary or investigational. It also addresses intra-operative and electronic breast radiotherapy.

    Policy Summary
    PayerExcellus Health Plan Inc
    PolicyBrachytherapy After Breast-Conserving Surgery
    Policy CodePolicy 6.01.30
    Change TypeModified
    Effective DateDecember 22, 2025
    Next Review DateNovember 1, 2026
    Key ActionVerify the member’s product benefit coverage before applying the policy criteria.
    SourceLink

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    POLICY UPDATE CHANGES

    Code 0394T was termed and replaced by code 77437.

    Codes 77436, 77438, and 77439 were added.

    4Codes affected by revision
    3New codes added
    0394TCode replaced
    ≥50 yearsMinimum age for invasive ductal carcinoma pathway

    Medical Necessity and Clinical Criteria

    Medically Appropriate APBI Brachytherapy

    Accelerated partial breast irradiation (APBI) using either interstitial or balloon brachytherapy of the breast (e.g., the MammoSite Radiation Therapy System) is considered a medically appropriate treatment option when EITHER pathway A or pathway B is met.

    EITHER pathway A or pathway B

    • Pathway A — all of the following

      • BRCA negative
      • Aged 50 years or greater>= 50 years
      • Diagnosis of invasive ductal carcinoma measuring less than or equal to 2 cm (pT1 disease)<= 2 cm
      • Negative margin widths are greater than or equal to 2 mm>= 2 mm
      • No lymphovascular space invasion
      • Estrogen receptor (ER) positive

    • Pathway B — applicable alternative APBI eligibility pathway

      • Meets one of the applicable professional-guideline APBI eligibility pathways represented below

    ASTRO — Invasive Breast Cancer

    ASTRO recommends PBI for patients with early-stage invasive breast cancer when ALL of the following factors are present:

    ALL of the following

    • Grade 1–2 disease
    • Estrogen receptor (ER)-positive histology
    • Age 40 years or greater>= 40 years
    • Tumor size 2 cm or less<= 2 cm

    ASTRO — Ductal Carcinoma In Situ

    For DCIS, ASTRO recommends PBI when ALL of the following factors are present:

    ALL of the following

    • Low- to intermediate-grade DCIS
    • Age 40 years or greater>= 40 years
    • Size 2 cm or less<= 2 cm

    NCCN — Invasive Breast Cancer

    NCCN reports acceptance of the updated ASTRO APBI consensus statement and identifies the following selected invasive breast cancer group:

    ALL of the following

    • Age greater than 50 years> 50 years
    • Estrogen receptor (ER)-positive invasive ductal carcinoma measuring 2 cm or less (pT1 disease)<= 2 cm
    • Negative margin widths of 2 mm or greater>= 2 mm
    • No lymphovascular invasion

    NCCN — Ductal Carcinoma In Situ

    NCCN allows PBI for the following selected DCIS group:

    ALL of the following

    • Age greater than 50 years> 50 years
    • Screen-detected low- or intermediate-grade DCIS measuring 2.5 cm or less<= 2.5 cm
    • Resected with margins of 3 mm or greater>= 3 mm

    American Society of Breast Surgeons — APBI Selection Criteria

    Outside of multi-institutional studies and institutional protocols, patients should be carefully selected for APBI and properly informed of the benefits and risks. The American Society of Breast Surgeons recommends the following selection criteria when APBI is used as the sole form of radiation therapy in lieu of whole-breast irradiation:

    ALL of the following

    • Patient is age 45 years or older>= 45 years
    • Tumor is invasive ductal carcinoma or ductal carcinoma in situ
    • Total tumor size, including invasive disease and DCIS, is 3 cm or less<= 3 cm
    • There is no tumor on ink for invasive tumors and invasive tumors with associated DCIS; for DCIS, the tumor is greater than 2 mm from the margin

    APBI using either interstitial or balloon brachytherapy of the breast (e.g., the MammoSite Radiation Therapy System) as a boost treatment in individuals treated with breast-conserving surgery and whole-breast external-beam radiation therapy is considered not medically necessary.

    Intra-operative breast radiotherapy is considered investigational.

    Electronic brachytherapy is considered investigational.

    The American Brachytherapy Society states that electronic brachytherapy should not be used for accelerated partial breast irradiation, nonmelanomatous skin cancers, or vaginal cuff brachytherapy outside prospective clinical trials at this time, in light of higher recurrence rates in a randomized breast trial, lack of mature prospective data for other sites, and dosimetry concerns. The ABS also states that partial breast irradiation can be offered to selected women with estrogen receptor-negative and/or HER2-amplified breast cancer and to women with DCIS, and should generally be avoided in women with extensive lymphovascular space invasion.

    ASTRO, in conjunction with AHRQ, does not recommend PBI for individuals with positive lymph nodes or positive surgical margins.

    ASTRO does not recommend PBI for individuals with known germline BRCA1/2 mutations or other relevant germline mutations, or for individuals younger than 40 years. Positive lymph nodes and positive surgical margins are also exclusions.

    For individuals with early-stage invasive breast cancer receiving PBI, electron IORT is not recommended unless it is part of a clinical trial or multi-institutional registry.

    kV IORT alone without whole-breast irradiation is not recommended unless it is part of a clinical trial or multi-institutional registry.

    See the consolidated American Brachytherapy Society electronic-brachytherapy position above: electronic brachytherapy is not recommended for APBI outside prospective clinical trials.

    The American Society of Breast Surgeons states that there is no evidence to support use of APBI in male patients.

    This boost-treatment rule is consolidated in the earlier coverage criterion: APBI using interstitial or balloon brachytherapy after breast-conserving surgery and whole-breast external-beam radiation therapy is considered not medically necessary.

    Billing Codes and Clinical Thresholds

    CPT CodesCPT
    19296Placement of radiotherapy afterloading expandable catheter (single or multichannel) into the breast for interstitial radioelement application following partial mastectomy, includes imaging guidance; on date separate from partial mastectomy.
    19297Placement of radiotherapy afterloading expandable catheter (single or multichannel) into the breast for interstitial radioelement application following partial mastectomy, includes imaging guidance; concurrent with partial mastectomy (list separately in addition to code for primary procedure).
    19298Placement of radiotherapy after loading brachytherapy catheters (multiple tube and button type) into the breast for interstitial radioelement application following (at the time of or subsequent to) partial mastectomy, includes imaging guidance.
    77316Remote afterloading brachytherapy, 1 channel, includes basic dosimetry calculation(s).
    77317Remote afterloading brachytherapy, 2-12 channels, includes basic dosimetry calculation(s).
    77318Remote afterloading brachytherapy, over 12 channels, includes basic dosimetry calculation(s).
    CPT CodesCPT
    19294Preparation of tumor cavity, with placement of a radiation therapy applicator for intraoperative radiation therapy (IORT) concurrent with partial mastectomy (list separately in addition to code for primary procedure).
    77424Intraoperative radiation treatment delivery, x-ray, single treatment session.
    77425Intraoperative radiation treatment delivery, electrons, single treatment session.
    77436Surface radiation therapy; superficial or orthovoltage, treatment planning and simulation-aided field setting (effective 01/01/26).
    77437Surface radiation therapy; superficial, delivery, ≤150 kV, per fraction (effective 01/01/26).
    77438Surface radiation therapy; orthovoltage, delivery, >150-500 kV, per fraction.
    77439Surface radiation therapy; superficial or orthovoltage, image guidance, ultrasound for placement of radiation therapy fields for treatment of cutaneous tumors, per fraction (effective 01/01/26).
    CPT CodesCPTExperimental
    0394THigh dose rate electronic brachytherapy, skin surface application, per fraction, includes basic dosimetry, when performed (termed 12/31/25).
    0395THigh dose rate electronic brachytherapy, interstitial or intracavitary treatment, per fraction, includes basic dosimetry, when performed (effective 01/01/26).
    HCPCS CodesHCPCSExperimental
    C9726Placement and removal (if performed) of applicator into breast for intraoperative radiation therapy, add-on to primary breast procedure.
    Q3001Radioelements for brachytherapy, any type, each.
    ICD10 CodesICD-10
    C50.011-C50.922Malignant neoplasm of the breast (code range).
    C79.81Secondary malignant neoplasm of breast.
    D05.00-D05.92Carcinoma in situ of the breast (code range).
    Z85.3Personal history of malignant neoplasm of breast.
    Current code revisionsCPT
    0394TTermed; replaced by code 77437
    77437Replacement code for 0394T
    77436Added effective 01/01/26
    77438Added effective 01/01/26
    77439Added effective 01/01/26
    ASTRO invasive breast cancer tumor size
    GuidelineASTRO
    ConditionInvasive breast cancer
    Tumor size≤2 cm
    ASTRO DCIS tumor size
    GuidelineASTRO
    ConditionDuctal carcinoma in situ (DCIS)

    Provider Guidance and Coverage Checks

    Documentation Required

    Confirm benefit and applicable coverage guidance

    Verify the member’s product benefit coverage before applying medical policy criteria. For Medicaid products, check New York State Medicaid eMedNY guidelines; for Medicare products, check applicable national or local Medicare coverage decisions when available.

    Denial Risk

    Avoid APBI boost after whole-breast radiation

    Do not use APBI with interstitial or balloon brachytherapy as a boost for a patient treated with breast-conserving surgery and whole-breast external beam radiation therapy. This use is considered not medically necessary.

    Denial Risk

    Intra-operative breast radiotherapy is investigational

    Policy Background

    This policy addresses interstitial or balloon brachytherapy as an alternative radiation approach after breast-conserving surgery. It includes accelerated partial breast irradiation directed to the tissue surrounding the tumor, the intra-operative setting, and use of a cavity evaluation device placed during surgery to facilitate later balloon catheter insertion after final pathology and staging are available.

    Treatment Definitions

    Breast-conserving therapy (BCT)
    Treatment typeMultimodality treatment
    SurgeryBreast-conserving surgery to excise the tumor with adequate margins
    RadiationWhole-breast external-beam radiation therapy
    Additional componentsSome patients also receive axillary lymph node dissection or axillary irradiation
    Accelerated partial breast irradiation (APBI)
    DefinitionRadiation directed to a segment surrounding the tumor rather than the entire breast
    Treatment schedule
    Policy Summary
    PayerExcellus Health Plan Inc
    PolicyBrachytherapy After Breast-Conserving Surgery
    Policy CodePolicy 6.01.30
    Change TypeModified
    Effective DateDecember 22, 2025
    Next Review DateNovember 1, 2026
    Key ActionVerify the member’s product benefit coverage before applying the policy criteria.
    SourceLink
    On This Page
    Medical Necessity and Clinical CriteriaBilling Codes and Clinical ThresholdsProvider Guidance and Coverage ChecksPolicy BackgroundTreatment Definitions
    > 2 mm for DCIS
  1. Sentinel lymph node is negative
  2. If multifocal disease is present, the combined area of tumor is 3 cm or less<= 3 cm
  3. Estrogen receptor-positive or estrogen receptor-negative tumor
  4. If lymphovascular invasion is present, it must be focal
  5. Patient has not been treated with APBI if there is a BRCA mutation or another genetic mutation that confers increased breast cancer risk
  6. There is no evidence to support use of APBI in male patients
  7. Patients with a history of ipsilateral breast cancer treated with radiation should be treated with APBI only as part of a specific clinical trial
  8. There is no contraindication to APBI in patients with a history of contralateral breast cancer
  9. Patient selection and counseling are performed in a multidisciplinary fashion, with collaboration between the treating surgeon and treating radiation oncologist
  10. It is preferred that all treated patients participate in a clinical trial or registry
  11. All patients are monitored regularly to identify adverse events and local recurrences
  12. Individual treatment decisions outside these parameters require appropriate discussion with the patient
    13. Tumor size
    ≤2 cm
    NCCN-selected invasive breast cancer tumor size
    GuidelineNCCN-selected group
    ConditionER-positive invasive ductal carcinoma
    Tumor size and stage≤2 cm; pT1 disease
    NCCN-selected DCIS tumor size
    GuidelineNCCN-selected group
    ConditionScreen-detected low- or intermediate-grade DCIS
    Tumor size≤2.5 cm
    American Society of Breast Surgeons total tumor size
    GuidelineAmerican Society of Breast Surgeons
    ApplicationAPBI as sole radiation therapy in lieu of whole-breast irradiation
    Total tumor size≤3 cm
    American Society of Breast Surgeons multifocal disease combined area
    GuidelineAmerican Society of Breast Surgeons
    ConditionMultifocal disease
    Combined tumor area≤3 cm
    American Society of Breast Surgeons DCIS margin
    GuidelineAmerican Society of Breast Surgeons
    ConditionDuctal carcinoma in situ (DCIS)
    Tumor-to-margin requirementTumor is greater than 2 mm from the margin
    NCCN-selected invasive cancer margin
    GuidelineNCCN-selected group
    ConditionInvasive cancer
    Negative margin width≥2 mm
    NCCN-selected DCIS margin
    GuidelineNCCN-selected group
    ConditionDuctal carcinoma in situ (DCIS)
    Resection margin≥3 mm

    Do not submit intra-operative breast radiotherapy as a covered service without addressing its policy status. Intra-operative breast radiotherapy is considered investigational.

    Denial Risk

    Electronic brachytherapy is investigational

    Electronic brachytherapy is considered investigational. Do not expect coverage under this policy for electronic brachytherapy.

    Denial Risk

    Verify product benefit coverage

    Confirm that the member’s product covers the service before applying the policy criteria. If the product does not cover the service, coverage may be denied and the medical policy criteria do not apply.

    Approximately four to five days
    FractionationFewer fractions with larger doses per fraction
    Interstitial breast brachytherapy
    DefinitionBrachytherapy using needles or catheters placed within the breast or tumor bed to guide radioactive sources
    Delivery techniquesLow-dose-rate or high-dose-rate delivery
    High-dose-rate scheduleTypically eight fractions given twice daily over four days
    Implant timingNeedles and catheters may be implanted during lumpectomy or at re-excision
    Balloon brachytherapy
    DefinitionBrachytherapy using a single radioactive source
    Target volumeSpherical or elliptical target volume
    Between treatmentsNo radiation remains inside the breast
    Intraoperative radiation therapy (IORT)
    DefinitionRadiation delivered directly to exposed tissues during lumpectomy
    Treatment deliveryMay provide all required radiation in a single fraction
    Postoperative radiationMay replace postoperative whole-breast external-beam radiation in early breast cancer
    TechniquesElectron beam IORT, high-dose-rate brachytherapy-based IORT, and low-energy x-ray IORT