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CurrentAetnaPolicy 0371

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.

Policy Summary

PayerAetna

PolicyBrachytherapy

Policy CodePolicy 0371

Change TypeNo material changes

Effective DateMar 8, 2000

Last ReviewJun 6, 2023

Next Review DateApr 11, 2024

Key ActionObtain prior authorization and document that the treated indication meets Aetna medical necessity criteria per the eviCore Radiation Therapy Clinical Guidelines.

SourceLink

2experimental interventions listed

Manycodes enumerated

eviCoreexternal guideline

95%NMSC local control

19%125-I seed complication rate

Coverage Criteria and Evidence

Medical Necessity (externalized to eviCore)

Covered when ALL of the following are met per eviCore Radiation Therapy Clinical Guidelines

eviCore-based medical necessity: Medical necessity for brachytherapy is determined according to the eviCore Healthcare Radiation Therapy Clinical Guidelines referenced in the policy.

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):

Experimental/Investigational interventions: 1) Electronic brachytherapy (e.g., the AccuBoost Technique, Xoft Axxent eBx System) for breast cancer and all other indications (including non-melanoma skin cancer); 2) Endovascular/intravascular brachytherapy to reduce restenosis following percutaneous renal angioplasty or peripheral (femoropopliteal) angioplasty.

Effectiveness has not been established for these interventions.

Evidence summaries informing coverage

Codes and Billing

Covered CPT Codes (if selection criteria met) / Related CPT codesCPTCovered

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.

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Provider Actions, Prior Authorization, and Documentation

Prior Authorization

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.

Prior Authorization

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.

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

Brachytherapy — definition

DefinitionA type of radiation therapy where the radiation device or source is placed within or close to the target site to deliver high-dose radiation to a localized area.

Also known asInternal radiation, implant radiation, interstitial radiation therapy

Typical sourcesSeeds, ribbons, or capsules (examples: I-125, Pd-103, Ir-192, Cs-137, Au-198)

Electronic brachytherapy (EBT) — definition

DefinitionRadiotherapy using a high dose-rate, low-energy x-ray source (examples: Axxent, INTRABEAM) intended to provide intracavity, interstitial, or surface brachytherapy without radioisotopes.

Potential advantagesReduced shielding requirements and portability; avoids radioactive isotopes

Policy History and Revisions

2023-06-06policy_reviewLatest

Policy last reviewed on 06/06/2023 (document lists last review date).

2000-03-08effective_date

Policy originally became effective on 03/08/2000.

2024-04-11next_scheduled_review

Next policy review scheduled for 04/11/2024 as noted in policy metadata.

Policy Summary

PayerAetna

PolicyBrachytherapy

Policy CodePolicy 0371

Change TypeNo material changes

Effective DateMar 8, 2000

Last ReviewJun 6, 2023

Next Review DateApr 11, 2024

Key ActionObtain prior authorization and document that the treated indication meets Aetna medical necessity criteria per the eviCore Radiation Therapy Clinical Guidelines.

SourceLink

On This Page

Evidence summaries and conclusions relevant to coverage decisions:

EBT dosimetry vs Ir-192: Dosimetric comparison (Ahmad et al) showed comparable PTV coverage and mean V100 between EBT and Ir-192, with EBT producing increased high-dose region at the balloon surface and significantly lower doses to ipsilateral lung and heart; this was a dosimetric study without clinical outcomes.

Supports dosimetric equivalence but lacks clinical outcome data.

EBT IORT (small trial): Small institutional IORT trial using EBT (Ivanov et al, n=11) reported feasibility, short procedure time, excellent cosmesis in 10/11 and no recurrences at mean 12-month follow-up; authors emphasize need for longer follow-up.

Limited sample size and short follow-up.

EBT for NMSC: Retrospective series (Bhatnagar & Loper; 37 patients, 44 lesions) using HDR-EBT reported no severe toxicities and good-to-excellent cosmesis at median 4.1 months; NCCN states insufficient long-term data to support routine use of electronic surface brachytherapy.

Short follow-up and guideline caution.

EBT for endometrial/vaginal uses: A multi-center feasibility study (Dickler et al, n=15) delivered vaginal EBT with limited acute toxicities; further research needed to assess efficacy and safety.

Feasibility data only.

EMBT for neovascular AMD: Phase III RCT (Dugel et al, n=494) failed to meet the 10% non-inferiority margin versus ranibizumab; EMBT arm had fewer injections but higher serious adverse events (54% vs 18%), leading to conclusion that EMBT is not supported for routine use in treatment-naive wet AMD.

Randomized evidence unfavorable for routine use.

Intravascular brachytherapy evidence: Cochrane review and meta-analyses (Andras et al and others) showed IVBT reduced restenosis at early time points (6–24 months) but benefits dissipated by 5 years and were offset by higher risk of new lesions; evidence insufficient for routine recommendation over other technologies.

Early benefit but no sustained long-term advantage.

CT-guided HDR for unresectable HCC: Single-center series (Collettini et al; 98 patients, 212 tumors) reported good local tumor control and median OS ~29.2 months; authors call for randomized comparisons with standard locoregional therapies.

Promising observational results but lacking RCT data.

Overall evidence quality: Published data for many brachytherapy applications (including EBT) are predominantly small, single-center, retrospective or dosimetric studies with limited long-term follow-up; guidance emphasizes need for prospective randomized studies before routine adoption.

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):

Conjunctival diffuse neoplasms (32P film): Small series (Marr et al) using intraoperative 32P film reported median prescription dose ~15 Gy (1 mm), 24-month recurrence-free survival 75% with some moderate/severe adverse events; further study needed.

Limited size and follow-up.

CT-HDR for unresectable HCC: CT-guided HDR brachytherapy series (Collettini et al) showed low local progression (8.5% of tumors) and median OS 29.2 months; authors recommend prospective randomized trials versus RFA/TACE.

Observational evidence supportive but not definitive.

CT-guided brachytherapy vs TACE (bridge to transplant): Matched small study (Denecke et al) reported higher tumor necrosis rates with CTB and comparable or lower post-transplant recurrence versus TACE; further evaluation warranted.

Small matched cohort data.

HDR intraluminal BT for extra-hepatic biliary cancer: Phase I trial (Mattiucci et al) established recommended dose (25 Gy in 5 fractions) with acceptable early OS; phase II data needed.

Early dose-finding evidence.

Skin cancers (surface HDR BT): Systematic reviews and series report high local control (median 95–97%) and favorable cosmetic outcomes for NMSC treated with HDR brachytherapy, but studies are small, heterogeneous, and non-randomized.

Promising outcomes but limited high-quality evidence.

Peri-operative HDR for keloids: Prospective series report 2-year local control ~94% with regimen 3x6 Gy (total 18 Gy) and symptom relief; further validation recommended.

Supportive observational data.

I-125 seed BT for pancreatic lesions: Meta-analyses and small series report pooled OS ~9–12 months and pain relief in ~80% of patients; evidence heterogeneous and further studies required.

Limited and variable outcomes across studies.

IORT/HDR-IORT for pancreatic cancer: Guidelines (NCCN) note IORT role is controversial and appropriate only at specialized centers; major brachytherapy practice parameters do not list pancreatic BT as standard.

Guideline-based caution.

CT-guided interstitial BT for pancreatic lesions (small series): Small series (Omari et al) reported local tumor control 92.3% and median OS 16.2 months with few complications in selected patients.

Single-center small-sample data.

I-125 interstitial BT for spinal metastases / MESCC: Multiple series report feasibility, pain relief, improved KPS, and variable local control; reported median D90 around 99 Gy in re-irradiation series with acceptable toxicity but data are retrospective and small.

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):

Spinal and bone metastases: Brachytherapy (e.g., I-125 seed implantation) may be considered as a salvage or palliative option for patients with spinal or bone metastases refractory to prior therapies or who cannot tolerate surgery/EBRT; reported benefits include pain reduction, improved performance status, and variable local control, but evidence is primarily observational.

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:

Base-of-tongue SCC boost: Registry analyses (NCDB) suggest that adding a brachytherapy boost to EBRT (with chemotherapy) is associated with improved overall survival for higher T-stage (T3–T4) base-of-tongue tumors; utilization has declined over time and data are observational.

Potential OS benefit for advanced T-stage based on retrospective registry data.

Endovascular/intravascular brachytherapy

Endovascular/intravascular and novel applications:

Endovascular brachytherapy for tumor thrombus/cardiac sarcoma: Small case series report potential palliative benefit and tumor reduction (e.g., EVBT combined with TACE and sorafenib for MPVTT; endovascular brachytherapy for primary cardiac sarcoma) but evidence is limited, single-center, and non-randomized; procedural hazards include vascular perforation.

Novel applications with limited evidence and guideline non-endorsement.

Intravascular brachytherapy for recurrent in-stent restenosis: Observational studies and meta-analyses report high procedural angiographic success (~99.8%) with variable target lesion failure or TLR rates at 1–2 years; may be considered for recurrent DES-ISR when other options are limited, but randomized data are lacking and long-term benefits are uncertain.

Early-term reductions in restenosis not sustained long-term in some analyses.

Electronic brachytherapy

Electronic brachytherapy (EBT/Xoft Axxent) considerations:

EBT indications and limitations: Consensus statements and systematic reviews caution against routine use of EBT for APBI, non-melanomatous skin cancers, or vaginal cuff brachytherapy outside clinical trials due to dosimetry concerns, lack of calibration standards, and absence of robust phase III randomized long-term outcome data; small studies report acceptable cosmetic outcomes but are non-randomized.

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:

Medically necessary indications list: Brachytherapy is medically necessary when used for: breast cancer (e.g., MammoSite), esophageal cancer, eye tumors (choroidal melanoma; small retinoblastomas <15 mm diameter and <8 mm thickness), genitourinary cancers other than bladder (including penile, prostate, urethral), gynecologic cancers (cervical, endometrial, vaginal, vulvar), head and neck cancers (buccal mucosa, lip, mouth, nasopharyngeal, salivary gland, soft palate, tonsillar fossa/pillar, base of tongue), respiratory and digestive tract cancers (including lung for palliation of obstructive intraluminal tumor, pelvic recurrence of colorectal cancer, pleural mesotheliomas, rectal/anal cancer), skin cancer when surgery and photon/electron RT are contraindicated, soft tissue sarcomas, and stenotic obstruction post lung transplantation refractory to other treatments.

See policy appendix for full list.

Experimental / Investigational (Not Covered)

Aetna considers brachytherapy experimental and investigational for the following and other non-listed indications:

Investigational indications list: Brachytherapy is considered experimental/investigational (not covered) for: bladder cancer; bone metastases; brain tumors; leukemia; lymphoma; multiple myeloma; palmoplantar pustulosis; pancreatic cancer; prevention and treatment of keloids; spinal tumors and spinal metastases; subfoveal choroidal neovascularization secondary to AMD; and other indications not listed as medically necessary.

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.

Covered HCPCS/C Codes (if selection criteria met)HCPCSCovered

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.

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ICD-10 codes covered if selection criteria met (examples and ranges)ICD-10Covered

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.

ICD-10 codes not covered for indications listed in the CPB (examples)ICD-10Not Covered

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.

Covered/Medically Necessary Indications (examples, not codes)neutralCovered

No codes listed

Experimental and Investigational Indications (examples, not codes)neutralNot Covered

No codes listed

Accelerated Partial Breast Irradiation (APBI) — key parameters

APBI target margin1–2 cm (treat lumpectomy bed plus a 1–2 cm margin)

Common delivery methods for APBIMulti-catheter interstitial, balloon catheter (MammoSite, CONTURA), conformal external beam, IORT

Purpose of APBIEnable higher dose to a smaller volume over shorter periods compared with whole-breast radiotherapy

Prior Authorization

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

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

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.

Prior Authorization

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.

Prior Authorization

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.

Step Therapy

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.

Step Therapy

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.

Step Therapy

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.

Step Therapy

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.

Step Therapy

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.

Step Therapy

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.

Documentation Required

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.

Documentation Required

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).

Documentation Required

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.

Documentation Required

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.

Documentation Required

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).

Documentation Required

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.

Evidence caveatInsufficient comparative evidence versus radioisotope-based brachytherapy; dosimetry and calibration concerns noted

Accelerated Partial Breast Irradiation (APBI) — definition

DefinitionRadiation approach treating only the lumpectomy bed plus a 1–2 cm margin, allowing higher dose over shorter periods

Delivery methodsMulti-catheter interstitial, balloon catheter brachytherapy (MammoSite, Axxent EBT, Contura), conformal external beam, and IORT

Clinical roleOption for selected early breast cancer patients to reduce treatment duration compared with whole-breast RT

Electronic Brachytherapy (EBT) — technical notes

DefinitionUse of miniature x-ray sources operating at low kilo-voltage energies (<100 kV) to deliver brachytherapy doses without radioactive isotopes.

Practical characteristicsPortability and reduced shielding requirements; steep dose gradients increase dosimetry sensitivity

Clinical recommendationEvidence is limited (mostly small, single-center studies); cautious use recommended pending more prospective long-term data

Radioactive plaque brachytherapy (I-125) — definition

DefinitionAttachment of a radioactive plaque (e.g., I-125) to the sclera at the base of an ocular tumor to deliver approximately 40–45 Gy to the tumor apex.

IndicationsUsed for choroidal melanoma and selected retinoblastomas when tumor size/location permit

Size constraints (retinoblastoma)Tumor generally must be <15 mm diameter and <8 mm thickness to be a brachytherapy candidate

Intraoperative radiotherapy (IORT) — definition

DefinitionRadiation delivered during surgery either by external beam (IOERT) or high-dose-rate brachytherapy (HDR‑IORT).

Clinical roleUsed in select settings as single-fraction boost combined with surgical resection and (neo)adjuvant therapy

GuidanceRole in pancreatic cancer is controversial and generally limited to specialized centers per NCCN

I-125 seed implantation — definition

DefinitionAn interstitial brachytherapy technique using iodine‑125 radioactive seeds implanted into tumor tissue to deliver high localized radiation doses.

Reported procedural parametersReported seed counts 7–62; seed activity ~0.5–0.8 mCi; matched peripheral doses (MPD) reported 80–140 Gy in series

Clinical useDescribed as a salvage/palliative option for spinal metastases or MESCC with reported pain relief and functional improvement

Electronic brachytherapy (EBT/eBx/Xoft Axxent) — summary

DefinitionA brachytherapy approach delivering radiation via an electronic X‑ray source rather than radionuclide sources (examples: eBx, Xoft Axxent).

Common applicationsUsed for APBI, non‑melanomatous skin cancers, vaginal cuff treatments, and IORT in some series

Evidence and cautionsLacks phase III randomized trial data for many applications; ABS/consensus statements advise restricted use and further study

Intravascular/Endovascular brachytherapy (VBT/ICBT/EVBT) — definition

DefinitionDelivery of localized radiation within vascular structures (e.g., coronary arteries, portal veins, cardiac chambers) to reduce restenosis or treat intravascular tumor obstruction.

Clinical outcomesProcedural angiographic success reported ~99.8% in meta-analysis; target lesion failure/TLR rates vary with notable recurrence at 1–2 years in some series

Routine useEvidence shows early benefit that may dissipate by 5 years; not recommended routinely for peripheral arterial disease due to inconsistent long-term outcomes

Brachytherapy — alternate names and overview

SynonymsAlso known as interstitial radiation, intracavitary radiation, or internal radiation therapy.

MechanismPlacement of radioactive sources within or adjacent to tumor tissue to deliver high localized doses while sparing surrounding normal tissue

Indications overviewUsed alone or with EBRT and surgery for a variety of anatomically localized tumors when appropriate per policy/guidelines

Radiation necrosis (RN) — definition and relevance

DefinitionSymptomatic tissue injury after re‑irradiation characterized by necrosis; may require surgical intervention in some cases.

Incidence contextRates vary by tumor type and technique; meta-analysis reported mean symptomatic RN rates for recurrent intracranial tumors (examples: HGG 3.3%, meningioma 17.3%, metastasis 22.4%).

Clinical implicationRisk of radiation necrosis is an important consideration in re‑irradiation planning and patient counselling

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.