Intraoperative Radiation Therapy (IORT)
DESCRIPTION
Intraoperative radiation therapy (IORT) is delivered directly to exposed tissues during surgery and may allow higher radiation doses by excluding nearby radiation dose-sensitive tissues. The tumor volume and associated tissues at risk for micrometastatic spread are directly visualized at the time of the surgery. IORT can be delivered by electron beams produced by linear accelerators (intraoperative electron beam therapy) or high dose-rate brachytherapy.
Electronic brachytherapy (e.g., INTRABEAM®, Xoft® Axxent®) is a form of radiotherapy delivered using a miniaturized electronic x-ray source rather than a radionuclide-based source. This technology is currently being investigated,
POLICY
Intraoperative radiation therapy (IORT) for the treatment of cancer is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Intraoperative radiation therapy (IORT) when used for ANY ONE of the following is considered investigational:
For the treatment of other conditions/diseases
The use of electronic brachytherapy
MEDICAL APPROPRIATENESS
Intraoperative radiation therapy (IORT) is considered medically appropriate if ALL of the following criteria are met:
Electron beam or high-dose rate brachytherapy are used
Treatment is indicated for ANY ONE of the following conditions:
Retroperitoneal/intra-abdominal sarcoma with positive or close margins
Extremity, trunk, head/neck soft tissue sarcoma with positive or close margins
Colon cancer with T4 or recurrent cancer
Rectal cancer with positive or close margins with T4 or recurrent cancer
Breast cancer for ANY ONE of the following:
Invasive ductal carcinoma and ALL of the following:
50 years or older
Tumor 2 cm or less (T1 disease)
Negative surgical margin width of 2 mm or greater
No lymphovascular invasion
Estrogen receptor positive
BRCA negative
Low or intermediate grade ductal carcinoma with ALL of the following:
Tumor size 2.5 cm or less
Negative margin widths of equal to or more than 3 mm
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g., statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
The evidence for IORT using electronic brachytherapy is insufficient to determine its effect on treatment outcomes. Studies comparing outcomes of electronic brachytherapy with standard radionuclide-based brachytherapy are necessary.
SOURCES
American Society for Radiation Oncology (ASTRO). (2017). Accelerated partial breast irradiation: update of an ASTRO evidence-based consensus statement. Retrieved February 9, 2022 from https://www.astro.org/.
American Society for Radiation Oncology (ASTRO). (2019). Brachytherapy model policy. Retrieved February 8, 2023 from https://www.astro.org/Daily-Practice/Reimbursement/Model-Policies.
BlueCross BlueShield Association. Evidence Positioning System. (8:2023). Intraoperative radiotherapy. (8.01.08). Retrieved March 14, 2024 from https://www.bcbsaoca.com/eps/. (98 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Evidence Positioning System. (8:2023). Accelerated breast irradiation and brachytherapy boost after breast-conserving surgery for early-stage cancer. (8.01.13). Retrieved March 14, 2024 from https://www.bcbsaoca.com/eps/. (61 articles and/or guidelines reviewed) March 14, 2024
CMS.gov: Centers for Medicare & Medicaid Services. Palmetto GBA. (2021, July). Intraoperative radiation therapy (L37779). Retrieved February 9, 2022 from https://www.cms.gov.
Jin, L., Shi, N., Ruan, S., Hou, B., Zou, Y., Zou, X., et al. The role of intraoperative radiation therapy in resectable pancreatic cancer: a systematic review and meta-analysis. Radiation Oncology, 15 (1), 76. Abstract retrieved May 4, 2021 from PubMed database.
National Comprehensive Cancer Network. (2023, December). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Soft tissue sarcoma v.3.2023. Retrieved March 14, 2024 from the National Comprehensive Cancer Network.
National Comprehensive Cancer Network. (2023, December). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Pancreatic Adenocarcinoma v.1.2024. Retrieved March 14, 2024 from the National Comprehensive Cancer Network.
National Comprehensive Cancer Network. (2024, January). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Colon cancer v.1.2024. Retrieved March 14, 2024 from the National Comprehensive Cancer Network.
National Comprehensive Cancer Network. (2024, January). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Rectal cancer v.1.2024. Retrieved March 14, 2024 from the National Comprehensive Cancer Network.
Roeder, F., & Krempien, R. (2017). Intraoperative radiation therapy (IORT) in soft-tissue sarcoma. Radiation oncology, 12 (20), 1-18. (Level 4 evidence)
Tinkle, C. L., Weinberg, V., Braunstein, S. E., Wustrack, R., Horvai, A., Jahan, T., et al. (2015). Intraoperative radiotherapy in the management of locally recurrent extremity soft tissue sarcoma. Sarcoma, 2015, Article ID 913565. (Level 4 evidence)
U. S. Food and Drug Administration. (1989, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K891261. Retrieved June 30, 2009 from http://www.fda.gov.
U. S. Food and Drug Administration. (2012, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K121653. Retrieved December 9, 2015 from http://www.fda.gov.
U. S. Food and Drug Administration. (2014, January). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K133655. Retrieved December 9, 2015 from http://www.fda.gov.
ORIGINAL EFFECTIVE DATE: 8/1985
MOST RECENT REVIEW DATE: 4/11/2024
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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