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DESCRIPTIONIntraoperative radiotherapy 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.
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. 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.
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.
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 Nervous/Mental Conditions, 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 Medically Necessary, “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.
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.
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.
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.