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DESCRIPTIONThis policy discusses the use of real-time intra-fraction target tracking during radiation therapy (“real-time tracking”). These techniques enable adjustment of the target radiation while it is being delivered (i.e., intra-fraction adjustments) to compensate for movement of the organ inside the body. Real-time tracking, which may or may not use radiographic images, is one of many techniques referred to as “image-guided radiation therapy” (IGRT). For this policy, real-time tracking is defined as frequent or continuous target tracking in the treatment room during radiation therapy, with periodic or continuous adjustment to targeting made on the basis of target motion detected by the tracking system. This policy does not address approaches used to optimize consistency of patient positioning in setting up either the overall treatment plan or individual treatment sessions (i.e., inter-fraction adjustments), instead it deals with approaches to monitor target movement within a single treatment session. This policy will also not address technologies using respiratory gating.
In general, intra-fraction adjustments can be grouped into two categories: online and off-line. An online correction occurs when corrections or actions occur at the time of radiation delivery on the basis of predefined thresholds. An off-line approach refers to target tracking without immediate intervention.
During radiation therapy, it is important to target the tumor so that radiation treatment is delivered to the tumor but surrounding tissue is spared. This targeting seems increasingly important as dose-escalation is used in an attempt to improve long-term tumor control and improve patient survival. Over time, a number of approaches have evolved to improve targeting of the radiation dose. Better targeting has been achieved through various approaches to radiation therapy, such as 3-D conformal treatment and intensity-modulated radiation therapy (IMRT). For prostate cancer, use of a rectal balloon has been reported to improve consistent positioning of the prostate and thus reduce rectal tissue irradiation during radiation therapy treatment of prostate cancer. In addition, more sophisticated imaging techniques, including use of implanted fiducial markers, has been used to better position the tumor (patient) as part of treatment planning and individual radiation treatment sessions.
Intra-fraction target motion can be caused by many things including breathing, cardiac and bowel motion, swallowing or sneezing. Data also suggests that a strong relationship may exist between obesity and organ shift, indicating that without some form of target tracking, the target volume may not receive the intended dose for patients who are moderately to severely obese.
As noted above, the next step in this evolving process of improved targeting is the use of devices to track the target (tumor motion) during radiation treatment sessions and allow adjustment of the radiation dose during a session based on tumor movement. While not an exhaustive list, examples of some U.S. Food and Drug Administration (FDA) cleared devices are listed in the following section. Some of the devices are referred to as “4-D imaging.” One such device is the Calypso® 4D Localization System. This system uses a group of 3 electromagnetic transponders (Beacon®) implanted in the prostate to allow continuous localization of a treatment isocenter. The transponders are 8.5 mm long and have a diameter of 1.85 mm. The 3 transponders have a “field of view” of 14-cm square with a depth of 27 cm.
The Calypso 4D localization system obtained FDA clearance for prostate cancer in March 2006 through the 510(k) process (K060906). This system was considered equivalent to existing devices such as implanted fiducials.
Another system, the Cyberknife® Robotic Radiosurgery System, is a computer-controlled medical system for planning and performing image-guided stereotactic radiosurgery and precision radiotherapy. This system uses gold fiducials implanted in the prostate first to determine the absolute position of the target location, then to track 3-dimensional translation and rotation deviation from that location during treatment. (2) During treatment, the computer automatically adjusts the incident beam to compensate for target deviation. While the system can compensate for deviations of 10 mm, the larger the deviation, the greater is the uncertainty in the computer correction.
The Cyberknife Robotic Radiosurgery System obtained FDA clearance in September 2007 through the 510(k) process (K072504) for any location in the body when radiation therapy is indicated. This system was considered equivalent to existing devices.
POLICYReal-time intra-fraction target during radiation therapy to adjust radiation doses or monitor target movement during individual radiation therapy treatment sessions is considered not medically necessary.
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 HISTORY5/30/2008: Policy added
12/31/2008: Code reference section updated per 2009 CPT/HCPCS revisions
05/13/2010: Policy title changed from “Image-Guided Radiation Therapy for Prostate Cancer” to “Real-Time Intra-Fraction Target Tracking During Radiation Therapy.” Terminology used to describe the technology changed in the policy description and statement. Specific references to prostate cancer removed. Policy statement revised to state that this technology is considered not medically necessary, rather than investigational. Add new CPT codes 32553 and 49411. Revised the description of CPT code 55876. FEP verbiage added to the Policy Exceptions section.
04/13/2011: Policy reviewed; no changes.
02/24/2012: Policy reviewed; no changes.
04/03/2013: Policy reviewed; no changes.
SOURCE(S)Blue Cross & Blue Shield Association Policy # 2.03.10
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
Not Medically Necessary Codes