CurrentKaiser PermanentePolicy N/A

Intraoperative Radiation Therapy (IORT) — Coverage Criteria

Defines medical necessity and investigational uses of intraoperative radiation therapy (IORT) for Kaiser Foundation Health Plan of Washington members; affects providers requesting IORT for oncology indications.

Policy Summary

PayerKaiser Permanente

PolicyIntraoperative Radiation Therapy (IORT) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the last 6 months of clinical notes and supporting documentation when requesting IORT for case review and prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Rectal cancerMedically necessary indication

Breast cancerInvestigational for

2 RCTsKey trials reviewed

4 CPT + HCPCSProcedure codes

Coverage Criteria for Intraoperative Radiation Therapy (IORT)

Medically Necessary

Policy Summary

PayerKaiser Permanente

PolicyIntraoperative Radiation Therapy (IORT) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the last 6 months of clinical notes and supporting documentation when requesting IORT for case review and prior authorization.

SourceLink

On This Page

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Investigational Uses

Investigational/Not covered for other oncologic applications:

Investigational indications: IORT is considered investigational when used for all other oncologic applications, including but not limited to breast cancer, fibromatosis, gastric cancer, glioma, gynecologic cancers, head and neck cancers, neuroblastoma, pancreatic cancer, renal cell cancer, and soft tissue sarcoma.

Some requests may be approved on a case-by-case basis by the Medical Director.

Intraoperative radiation therapy (IORT) for oncologic indications other than rectal cancer with the specified features below is considered investigational. The policy specifies that IORT may be considered medically necessary only for rectal cancer with positive or close margins with T4 lesions or recurrent disease; all other tumor sites and oncologic applications are investigational and may be denied or require case-by-case review by the Medical Director.

Billing and Procedure Codes

Considered Medically Necessary when criteria met: CPT codesCPTCovered

19294	Preparation of tumor cavity, with placement of a radiation therapy applicator for intraoperative radiation therapy (IORT) concurrent with mastectomy (List separately in addition to code for primary procedure)
77424	Intraoperative radiation treatment delivery, X-ray, single treatment session
77425	Intraoperative radiation treatment delivery, electrons, single treatment session
77469	Intraoperative radiation treatment management

HCPCSHCPCSCovered

C9726

Placement and removal (if performed) of applicator into breast for intraoperative radiation therapy, add-on to primary breast procedure

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization and Case Review

Prior authorization and case review — IORT requests should include clinical documentation and will be reviewed for medical necessity; some investigational uses require additional review.

Prior authorization required for IORT requests.
Requests will be reviewed for medical necessity; some investigational indications may require additional Medical Director review.

Note

Provider Submission Requirements

Provider action: submit a complete request packet with required clinical documentation (see Required Documentation callout). Incomplete submissions may delay review or result in denial.

Include supporting pathology, imaging, and operative reports when applicable.
Clearly indicate the oncologic indication and prior treatments.

Documentation Required

Required Documentation

Required documentation — list of required clinical notes and documentation to support medical necessity for IORT requests.

Last 6 months of clinical notes from requesting provider and/or specialist
Relevant operative reports, pathology, and imaging reports
Documentation of prior treatments and rationale for IORT
Clinical staging and margin status (when applicable)

Denial Risk

Investigational Indications

Investigational indications — requests for IORT for oncologic applications other than rectal cancer with positive/close margins, T4 lesions, or recurrent disease are considered investigational and must include documentation/justification; some may be approved only on a case-by-case basis by the Medical Director.

IORT is investigational for: Breast cancer; Fibromatosis; Gastric cancer; Glioma; Gynecologic cancers; Head and neck cancers; Neuroblastoma; Pancreatic cancer; Renal cell cancer; Soft tissue sarcoma
Requests for investigational uses require explicit justification and may require Medical Director review

Background on Intraoperative Radiation Therapy

Intraoperative radiation therapy (IORT) delivers a high single dose of radiation directly to the tumor bed during surgery using techniques such as low-energy X-rays, electrons (IOERT), or intraoperative brachytherapy. The intent is to enhance local control by targeting the tumor site immediately while allowing shielding or displacement of adjacent normal tissues from dose exposure; IORT is typically delivered with applicators or mobile treatment units as part of a multidisciplinary surgical and radiation approach.

Definitions

IORT — definition

DefinitionIntraoperative radiation therapy (IORT) is the delivery of a large, single dose of radiation directly to the tumor site at the time of surgery using applicators or mobile linear accelerators; it may include intraoperative brachytherapy (temporary or permanent implantation of radioactive seeds).

PurposeGoal is to enhance local tumor control by delivering a high dose to the tumor bed while shielding adjacent normal tissues during the operative procedure.

Delivery methodsDelivered with applicators and cones attached to high-energy medical linear accelerators, mobile linear accelerators moved into the operating room, or via intraoperative brachytherapy techniques.

Typical use contextUsually applied after most or all of the cancer is surgically removed as part of a multidisciplinary approach for localized cancers at high risk of local recurrence or not completely resectable.

Advantages and considerationsAdvantages include immediate targeting of the tumor bed and protection of nearby healthy tissue; disadvantages include longer operative time and the need for specialized shielding and staff protection during treatment.

APBI — definition and relation to IORT

DefinitionAccelerated partial breast irradiation (APBI) is a radiation technique that targets partial breast tissue around the tumor cavity with fewer fractions as an alternative to whole-breast external beam radiotherapy.

Relation to IORTIORT is one APBI technique that delivers a single dose of irradiation directly to the tumor bed at the time of surgery—targeting the tumor cavity rather than the entire index quadrant.

Delivery modalities for APBI/IORTIORT/APBI techniques include low-energy X-rays (e.g., Intrabeam), intraoperative electron radiation therapy (IOERT), intraoperative brachytherapy, and other devices; techniques differ in invasiveness, operator proficiency, and treatment time.

Clinical rationaleAPBI is based on the observation that >90% of local recurrences occur at or near the tumor bed after breast-conserving surgery, supporting targeted partial-breast approaches.