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DESCRIPTIONIntraoperative radiation therapy is delivered directly to exposed tissues during surgery. It can be delivered by electron beams produced by linear accelerators (also called IOERT) or high-dose rate brachytherapy (HDR-IORT [intraoperative radiotherapy]).
Intraoperative radiotherapy (IORT) is designed to increase the intensity of radiation directly delivered to tumors. The tumor and associated tissues at risk for micrometastatic spread are directly visualized at operation. IORT is delivered directly to the tumor, and normal or uninvolved tissues are not exposed to radiation because they are removed or shielded from the treatment field. It can be delivered by electron beams produced by linear accelerators (also called IOERT), or high-dose rate brachytherapy (HDR-IORT). Most clinical experience involves IOERT.
IORT is performed with applicators and cones that attach to the treatment head of high-energy medical linear accelerators that are designed to direct radiation to defined surface structures. Most patients are subsequently treated with external-beam photon irradiation (EBRT).
The INTRABEAM® system was first approved for use by the U.S. Food and Drug Administration (FDA) for intracranial tumors in 1999 and was subsequently approved for whole body use in 2005. The INTRABEAM® spherical applicators are indicated for use with the INTRABEAM® system to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity or intraoperative radiotherapy treatments. The Mobetron mobile election beam accelerator designed for use in the operating room received 510(k) marketing clearance in 1998.
This policy does not address use of IORT for breast cancer; for that indication, see related policy Accelerated Breast Irradiation after Breast-Conserving Surgery for Early Stage Breast Cancer and Breast Brachytherapy as Boost with Whole-Breast Irradiation.
POLICYUse of intraoperative radiotherapy may be considered medically necessary in the following situation:
Use of intraoperative radiotherapy is considered investigational for all other oncologic applications.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/15/2012: Policy approved by Medical Policy Advisory Committee.
11/15/2013: Policy reviewed; no changes.
09/29/2014: "Radiation Therapy" changed to "radiotherapy" throughout policy. Intent of policy statement unchanged.
SOURCE(S)Blue Cross Blue Shield Association policy # 8.01.08
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.