Brachytherapy
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This clinical policy bulletin governs the medical necessity, experimental/investigational determinations, and coding guidance for brachytherapy (internal radiation) services provided to Aetna members.
Coverage Criteria and Evidence
Medical Necessity (externalized to eviCore)
Covered when ALL of the following are met per eviCore Radiation Therapy Clinical Guidelines
Providers must consult eviCore guidelines for specific selection criteria; eviCore guidelines are reviewed annually and may be updated.
Experimental / Investigational
Considered experimental and investigational (not supported):
Effectiveness has not been established for these interventions.
Evidence summaries informing coverage
Evidence summaries and conclusions relevant to coverage decisions:
Supports dosimetric equivalence but lacks clinical outcome data.
Limited sample size and short follow-up.
Short follow-up and guideline caution.
Feasibility data only.
Randomized evidence unfavorable for routine use.
Early benefit but no sustained long-term advantage.
Promising observational results but lacking RCT data.
Justifies cautious coverage and reliance on guideline/expert review.
Literature evidence summaries by anatomic/clinical indication
Evidence and outcomes reported in the literature for various brachytherapy indications (select findings):
Limited size and follow-up.
Observational evidence supportive but not definitive.
Small matched cohort data.
Early dose-finding evidence.
Promising outcomes but limited high-quality evidence.
Supportive observational data.
Limited and variable outcomes across studies.
Guideline-based caution.
Single-center small-sample data.
Evidence supports salvage/palliative use in selected patients but RCTs lacking.
Spinal and bone metastases (salvage/palliative use)
Evidence-based considerations and typical candidate scenarios (narrative criteria rather than rigid checklist):
Systematic reviews report analgesic benefit and an overall complication rate ~19%; guideline sources do not list brachytherapy as routine for bone cancers.
Base-of-tongue cancer (boost with EBRT)
Head and neck (base of tongue) boost:
Potential OS benefit for advanced T-stage based on retrospective registry data.
Endovascular/intravascular brachytherapy
Endovascular/intravascular and novel applications:
Novel applications with limited evidence and guideline non-endorsement.
Early-term reductions in restenosis not sustained long-term in some analyses.
Electronic brachytherapy
Electronic brachytherapy (EBT/Xoft Axxent) considerations:
ASTRO/ABS and systematic reviews note unproven advantages and measurement uncertainties for EBT.
Medically Necessary Indications
Aetna considers brachytherapy medically necessary for the following conditions:
See policy appendix for full list.
Experimental / Investigational (Not Covered)
Aetna considers brachytherapy experimental and investigational for the following and other non-listed indications:
Effectiveness has not been established for these indications.
The policy lists specific ICD-10 diagnosis codes and condition ranges that are not covered when the indication falls within the CPB exclusions. Examples include malignant neoplasm of pancreas (C25.0–C25.9), malignant neoplasm of bladder (C67.0–C67.9), malignant neoplasm of brain (C71.0–C71.9), and ranges representing hematopoietic malignancies (e.g., C81.00–C96.9 and related codes). These codes are cited in the policy appendix as examples of diagnoses for which brachytherapy is not considered a covered indication.
The policy states that the routine use of electronic brachytherapy (EBT) is not supported for indications where long-term efficacy and safety data are limited. Published EBT evidence is largely small, single-center, dosimetric or retrospective studies with short follow-up, and concerns about steep dose gradients and dosimetry accuracy have been raised. Guideline and consensus statements therefore advise that EBT (including surface EBT for non-melanoma skin cancers and EBT for APBI or vaginal cuff treatment) be used primarily within prospective clinical trials until higher-quality, long-term outcome data are available.
A phase III randomized trial of epi-macular brachytherapy (EMBT) for treatment‑naive neovascular age-related macular degeneration (n=494) failed to meet the pre-specified 10% non-inferiority margin versus ranibizumab monotherapy at 24 months. The EMBT arm had fewer injections but a higher proportion of serious adverse events (54% vs 18%). Based on these 2‑year effectiveness and safety data, EMBT is not supported for routine use as an alternative to anti‑VEGF monotherapy for treatment‑naive wet AMD.
Systematic reviews and randomized trials of endovascular/intravascular brachytherapy (EVBT/IVBT) for reduction of restenosis after peripheral angioplasty demonstrated early reductions in re‑stenosis at 6–24 months but no sustained benefit at longer follow‑up and an increased risk of new lesions. Given inconsistent long‑term outcomes and safety concerns, EVBT/IVBT cannot be recommended for routine use in peripheral arterial disease.
Major professional practice parameters and consensus reports (American Brachytherapy Society; ACR/ABS) do not list brachytherapy as a standard therapeutic option for pancreatic cancer. The NCCN likewise describes the role of intraoperative radiotherapy (IORT/HDR‑IORT) in pancreatic cancer as controversial and recommends such treatment only at specialized centers. These practice statements support excluding routine pancreatic brachytherapy outside specialized programs and study settings.
Several authoritative guideline reviews and widely used clinical summaries (NCCN, UpToDate) do not include brachytherapy among standard management options for multiple indications, including central nervous system tumors, bone metastases, and cardiac tumors. The absence of guideline endorsement in these contexts indicates that brachytherapy is not established as routine therapy for these conditions and may prompt requests for additional justification when proposed.
The policy explicitly states that brachytherapy is considered experimental and investigational for all indications not listed as medically necessary. Examples provided include bladder cancer, bone metastases, brain tumors, pancreatic cancer, spinal tumors and metastases, and other conditions where effectiveness has not been established. Requests for brachytherapy for these non‑listed indications are therefore treated as not medically necessary under this policy.
Clinical Policy Bulletins provide a summary of plan or program benefits and do not constitute a contract. They contain only partial, general descriptions of coverage; actual coverage decisions are governed by the member’s benefit plan, program provisions, and applicable medical necessity rules.
Electronic brachytherapy (EBT), including systems cleared by the FDA (e.g., Axxent), is specifically listed in the policy as an intervention considered experimental and investigational for breast cancer and all other indications because comparative effectiveness versus standard radioisotope‑based brachytherapy has not been established in the peer‑reviewed literature.
The randomized EMBT trial in neovascular AMD did not demonstrate non‑inferiority to ranibizumab using the pre‑specified 10% margin and showed a substantially higher rate of serious adverse events in the EMBT arm. Consequently, EMBT is not supported as a routine alternative to anti‑VEGF monotherapy for treatment‑naive neovascular AMD based on available 2‑year randomized data.
Consensus reviews and professional statements caution against routine adoption of electronic brachytherapy for several applications. Specifically, EBT is not recommended for routine use outside clinical trials for accelerated partial breast irradiation (APBI), non‑melanomatous skin cancers, or vaginal cuff brachytherapy because of dosimetry concerns, heterogeneous dose distributions, and limited long‑term randomized data.
Treatments identified in the policy as experimental or investigational are treated as not medically necessary. The document indicates that interventions such as EBT for breast and other indications, EVBT/IVBT for restenosis, EMBT for neovascular AMD, and other non‑listed uses lack sufficient evidence of effectiveness and therefore are not medically necessary under this Clinical Policy Bulletin.
Codes and Billing
| 19296 | Placement 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. |
| 19297 | Concurrent with partial mastectomy (List separately in addition to code for primary procedure). |
| 19298 | Placement of radiotherapy afterloading 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. |
| 20555 | Placement of needles or catheters into muscle and/or soft tissue for subsequent interstitial radioelement application (at the time of or subsequent to the procedure). |
| 41019 | Placement of needles, catheters, or other device(s) into the head and/or neck region (percutaneous, transoral, or transnasal) for subsequent interstitial radioelement application. |
| 49327 | Laparoscopy, surgical; with placement of interstitial device(s) for radiation therapy guidance (eg, fiducial markers, dosimeter), intra-abdominal, intrapelvic, and/or retroperitoneum, including imaging guidance, if performed, single or multiple (list separately in addition to code for primary procedure). |
| 49412 | Placement of interstitial device(s) for radiation therapy guidance (eg, fiducial markers, dosimeter), open, intra-abdominal, intrapelvic, and/or retroperitoneum, including image guidance, if performed, single or multiple (list separately in addition to code for primary procedure). |
| 55875 | Transperineal placement of needles or catheters into prostate for interstitial radioelement application, with or without cystoscopy. |
| 55876 | Placement of interstitial device(s) for radiation therapy guidance, prostate. |
| 55920 | Placement of needles or catheters into pelvic organs and/or genitalia (except prostate) for subsequent interstitial radioelement application. |
| A9527 | Iodine I-125, sodium iodide solution, therapeutic, per millicurie. |
| C1715 | Brachytherapy needle. |
| C1716 | Brachytherapy source, non-stranded, gold-198, per source. |
| C1717 | Brachytherapy source, non-stranded, high dose rate iridium-192, per source. |
| C1719 | Brachytherapy source, non-stranded, non-high dose rate iridium-192, per source. |
| C2616 | Brachytherapy source, non-stranded, yttrium-90, per source. |
| C2634 | Brachytherapy source, non-stranded, high activity, iodine-125, greater than 1.01 mCi (NIST), per source. |
| C2635 | Brachytherapy source, non-stranded, high activity palladium-103, greater than 2.2 mCi (NIST), per source. |
| C2636 | Brachytherapy linear source, non-stranded, palladium-103, per 1 mm. |
| C2637 | Brachytherapy source, non-stranded, ytterbium-169, per source. |
| C00.0 - C00.9 | Malignant neoplasm of lip. |
| C01 | Malignant neoplasm of base of tongue. |
| C50.011 - C50.929 | Malignant neoplasm of breast. |
| C61 | Malignant neoplasm of prostate. |
| C71.0 - C71.9 | Malignant neoplasm of brain. |
| C25.0 - C25.9 | Malignant neoplasm of pancreas. |
| C67.0 - C67.9 | Malignant neoplasm of bladder. |
| C81.00 - C96.9 | Malignant neoplasms of lymphoid, hematopoietic and related tissue (range examples). |
| D33.0 - D33.2 | Benign neoplasm of brain. |
| No codes listed |
| No codes listed |
Provider Actions, Prior Authorization, and Documentation
Ensure eviCore selection criteria are met
Brachytherapy coverage is determined using the eviCore Healthcare Radiation Therapy Clinical Guidelines referenced in this policy; providers must ensure the patient meets those selection criteria because prior authorization may be required according to those criteria.
- Medical necessity is determined according to eviCore Radiation Therapy Clinical Guidelines.
- eviCore guidelines are subject to annual review and may be updated without notice.
Obtain prior authorization for electronic brachytherapy (EBT)
Electronic brachytherapy (EBT) is described as an emerging modality with limited clinical data and uncertainties in calibration/dosimetry; obtain prior authorization when EBT is requested and be prepared to justify use given investigational concerns.
- ASTRO noted advantages of EBT are unproven and there are no accepted calibration standards.
- EBT (e.g., Axxent, INTRABEAM) lacks sufficient comparative evidence versus radioisotope brachytherapy.
Prior authorization advised for pancreatic IORT/HDR
Intraoperative radiotherapy (IORT) or HDR-IORT for pancreatic cancer is controversial and should only be performed at specialized centers per NCCN; prior authorization is advised and may require documentation of specialized-center delivery and rationale versus standard therapies.
- NCCN states IORT’s role in pancreatic cancer is controversial and appropriate only at specialized centers.
- Major brachytherapy practice parameters do not list pancreatic brachytherapy as a standard option.
Prior authorization for salvage or adjunct brachytherapy
When brachytherapy is proposed as salvage or adjunct therapy after standard treatments have failed, obtain prior authorization and submit documentation of prior therapies and reasons standard options are unsuitable.
- Justify salvage use with prior treatment history (e.g., recurrent disease after EBRT or contraindication to surgery).
- Evidence for spinal and bone metastases and re-irradiation is largely observational; documentation of intent and expected outcomes is needed.
Prior authorization to verify medically necessary indication
Prior authorization is implied for brachytherapy claims to verify that the treated indication is listed as medically necessary and not among the experimental/investigational exclusions; submit documentation supporting the specific indication.
- Clinical documentation should demonstrate the indication is among those listed as medically necessary (appendix) or provide justification if otherwise experimental/investigational.
- Interventions labeled experimental/investigational (e.g., EBT for breast, endovascular brachytherapy for restenosis) are not supported.
Follow Aetna policy and plan provisions for prior authorization
Consult the full Aetna clinical policy and the member’s plan program provisions for specific prior authorization requirements and processes; the policy summary does not enumerate all authorization rules.
- Policy history and program provisions may affect authorization requirements.
- Use Aetna resources and plan documents linked in the policy for authorization details.
No additional prior authorization stated here
This supplemental section does not state any standalone prior authorization requirements beyond referencing eviCore and plan provisions; follow external eviCore criteria and plan-specific rules for authorization determination.
- No additional prior authorization rules are specified in this section.
No step-therapy specified
No step-therapy instructions are provided in this portion of the policy; providers should follow indication-specific guidance and plan requirements where applicable.
- The policy does not specify a required sequence of therapies for brachytherapy.
Prefer anti-VEGF monotherapy first for neovascular AMD
Epi-macular brachytherapy (EMBT) did not meet the pre-specified 10% non-inferiority margin versus ranibizumab and had higher serious adverse events; anti-VEGF monotherapy remains the preferred first-line treatment for neovascular AMD.
- EMBT arm had higher rate of serious adverse events (54% vs 18%) and failed the 10% non-inferiority margin at 24 months.
Document trials of standard bridging therapies before CT-guided brachytherapy
When CT-guided brachytherapy is considered as a bridge to liver transplantation or locoregional therapy for HCC, document consideration of established bridging therapies (e.g., TACE) and rationale for selecting CT-guided brachytherapy.
- Comparative studies have evaluated CT-guided brachytherapy versus TACE for bridging before transplant; CTB may be considered for patients not suited for TACE.
Prefer standard therapies before brachytherapy; document prior attempts
Evidence typically positions brachytherapy as an alternative after external beam radiation, stereotactic radiosurgery, surgery, or systemic therapy are exhausted or contraindicated; document prior attempts of standard therapies or contraindications when seeking authorization.
- Provide documentation that standard therapies were attempted or are unsuitable for the patient.
- Rationale should include prior treatment history, contraindications, and expected palliative or salvage intent.
Provide prior treatment justification when alternatives are available
When alternatives exist (e.g., surgery, EBRT), prior treatment attempts or documented contraindications may be required to justify brachytherapy; include clinical history showing why standard options are not appropriate.
- Documentation should support that brachytherapy is selected because other modalities are contraindicated or have failed.
No sequencing requirements here
No step therapy or sequencing requirements are described in this supplemental section; follow indication-specific guidelines and eviCore criteria as applicable.
Follow eviCore radiation therapy guidelines
Follow the eviCore Healthcare Radiation Therapy Clinical Guidelines for medical necessity determinations and submit documentation consistent with those guidelines when requesting authorization.
- eviCore criteria are the authoritative selection criteria referenced by this policy.
Document pre-treatment biopsy and CT imaging for EBT skin cases
For EBT skin treatments, perform and document pre-treatment biopsy to confirm malignant diagnosis and obtain CT imaging to assess lesion depth for treatment planning.
- Document selection of appropriate surface applicator and depth used for prescription (e.g., 3–7 mm depth in cited series).
Reference trial inclusion criteria when applicable
Clinical trials using EBT IORT have enrolled selected patients (example: IRB-approved trials with age >45, unifocal tumors ≤3 cm, infiltrating ductal or DCIS histology); include trial eligibility criteria when relevant.
- Trial example: age >45, unifocal tumors ≤3 cm, uninvolved lymph nodes; 20 Gy to balloon surface in cited study.
Submit clinical and treatment planning documentation (operative notes, dosimetry)
Include operative notes, pre-treatment mapping/3-D planning, and post-implant dosimetry verification in the medical record; these items have been used in studies to document treatment planning and delivery.
- Examples: mapping biopsies for conjunctival disease, 3-D planning and immediate dosimetry verification for I-125 spinal seed implants.
Document prior treatments and detailed procedural justification
Document prior therapies and the clinical rationale for choosing brachytherapy (e.g., refractory disease after EBRT, inability to tolerate surgery), and include procedural details such as seed count, activity, and matched peripheral dose when applicable.
- For I-125 seed implants, document seed number, activity (reported 0.5–0.8 mCi), and matched peripheral dose.
- Describe expected intent (palliative vs curative) and anticipated outcomes (pain relief, QoL).
Document indication to match medically necessary list or justify exception
Support the treated indication with clinical documentation showing it is among the policy’s medically necessary list (e.g., breast, gynecologic, prostate, ocular melanoma) or provide justification if treating an indication classified as experimental/investigational.
- If the indication is not listed as medically necessary, include evidence and rationale to support use.
Background and Context
Background: Brachytherapy places radioactive sources within or near a tumor to deliver high, localized radiation doses while sparing surrounding tissue. It may be delivered alone or combined with external beam radiation and can be administered using radioactive isotopes (e.g., I‑125, Ir‑192) or electronic X‑ray sources (electronic brachytherapy). The policy references eviCore Radiation Therapy Clinical Guidelines for detailed selection and medical necessity criteria.
Definitions and Terms
Policy History and Revisions
Policy last reviewed on 06/06/2023 (document lists last review date).
Policy originally became effective on 03/08/2000.
Next policy review scheduled for 04/11/2024 as noted in policy metadata.
Prior authorization: This supplemental section does not list explicit prior authorization requirements. Providers are directed to the main policy, plan program provisions, and eviCore guidelines for any prior authorization procedures that may apply.
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