Intraoperative Radiotherapy

POLICY NUMBER

L.8.01.414

DESCRIPTION

Intraoperative radiotherapy (IORT) is delivered directly to exposed tissues during surgery and may allow higher radiation doses by excluding nearby radiation dose–sensitive tissues. Different IORT modalities are available that impact both the dose distribution and method of application. IORT techniques include electron beam IORT, high-dose rate brachytherapy based IORT, and low-energy x-ray IORT.

Intraoperative radiotherapy increases the intensity of radiation delivered directly to tumors. The tumor and associated tissues at risk for micrometastatic spread are directly visualized during surgery. 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.

In the United States, certain racial/ethnic groups continue to be at an increased risk of developing or dying from particular cancers. Notably, Black men have the highest rate of new cancer diagnoses and Black men and women experience the highest rate of cancer-related death. Additionally, American Indians/Alaska Natives are disproportionally affected by kidney cancer and also have higher death rates from this cancer when compared to other racial/ethnic groups.

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. 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 radiotherapy or intraoperative radiotherapy treatments. In 1998, the Mobetron® mobile electron beam accelerator, designed for use during surgery, was cleared for marketing by the FDA through the 510(k) process. Xoft® Axxent® electronic brachytherapy system is also available and was approved to deliver high dose rate X-ray radiation for brachytherapy in 2008.

This policy does not address the use of IORT for breast cancer; for that indication, see related policy Accelerated Breast Irradiation and Brachytherapy Boost After Breast-Conserving Surgery for Early Stage Breast Cancer .

POLICY

Use of intraoperative radiotherapy may be considered medically necessary in the following situation:

• Rectal cancer with positive or close margins with T4 lesions or recurrent disease.

Use of intraoperative radiotherapy is considered investigational for all other oncologic applications.

POLICY EXCEPTIONS

Federal 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 GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting. 

POLICY HISTORY

11/15/2012: 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.

08/18/2015: Medical policy revised to add ICD-10 codes.

11/05/2015: Policy description updated. Policy statements unchanged. Policy guidelines updated to add medically necessary and investigative definitions.

05/25/2016: Policy number A.8.01.08 added.

03/29/2017: Policy description updated regarding external-beam radiotherapy. Policy statements unchanged.

01/22/2018: Policy description updated regarding the classification of surgical resection margins. Policy statements unchanged.

08/13/2018: Policy description updated to remove information regarding external-beam radiotherapy and general surgical resection margin classification. Policy statements unchanged.

08/15/2019: Policy reviewed; no changes.

08/19/2020: Policy description updated regarding electronic brachytherapy systems. Policy statements unchanged.

08/31/2021: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

06/27/2022: Code Reference section updated to add new CPT code 0735T, effective 07/01/2022.

08/11/2022: Policy description updated regarding racial/ethnic groups at increased risk of cancer. Policy statements unchanged.

08/10/2023: Policy reviewed; no changes.

11/21/2024: Medical policy updated to change the policy number from "A.8.01.08" to "L.8.01.414." Policy reviewed. Policy statements unchanged.

SOURCE(S)

Blue Cross Blue Shield Association policy # 8.01.08 

CODE REFERENCE

This 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.

Covered Codes

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