Coverage Policy Manual
Policy #: 2009001
Category: Medicine
Initiated: January 2009
Last Review: November 2023
  Radiation Therapy, Real Time Intra-Fraction Target Tracking
Description:
Image-guided radiation therapy for prostate cancer is a technique used to adjust the targeting of radiation while it is being delivered (i.e., intra-fraction adjustments) to compensate for movement of the organ inside the body. Image-guided radiation therapy (IGRT) is defined as frequent or continuous “imaging” in the treatment room during radiation therapy, with periodic or continuous adjustment to targeting made on the basis of organ motion detected by the imaging.
 
In general, image guided adjustments can be grouped into two categories: on-line and off-line. An on-line correction occurs when corrections or actions occur at the time of radiation delivery on the basis of pre-defined thresholds. An off-line approach refers to imaging without immediate intervention. The intra-fraction (during a treatment session) adjustments are being done through on-line corrections.
 
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, have been used to better position the tumor (patient) as part of treatment planning and individual radiation treatment sessions. 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 three 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 1.85mm. The three transponders have a “field of view” of 14-cm square with a depth of 27 cm.
 
This policy only addresses image-guided techniques and devices defined as devices that adjust radiation doses during individual radiation treatment sessions for prostate cancer, including but not limited to image-guided systems that localize a radiation target using electromagnetic devices.
 
Coding:
 
HCPCS code G6017 has been developed to report this service.
 
G6017 Intra-fraction localization and tracking of target or patient motion during delivery of radiation therapy (eg,3d positional tracking, gating, 3d surface tracking), each fraction of treatment
Policy/
Coverage:
Effective May 2020
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
The use of real-time intra-fraction localization meets member benefit certificate primary coverage criteria when used with deep inspiration breath-hold irradiation for the treatment of left-sided breast cancer to minimize negative side effects from radiation therapy.
 
NOTE:
When this procedure is used with IMRT, the technical component of the code is bundled with the IMRT delivery code so we would expect only the professional component to be billed. When used with conventional or 3D conformal radiation, the global code is appropriate in the freestanding setting.  In the hospital, only the professional component should be billed.
 
 Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
The use of real-time intra-fraction localization for any other indication does not meet member benefit certificate primary coverage criteria.
 
For members with contracts without Primary Coverage Criteria the use of real-time intra-fraction localization for any other indication is considered investigational (or not medically necessary). Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Image guided radiation therapy to adjust radiation doses or monitor target movement during individual radiation therapy treatment sessions does not meet Primary Coverage Criteria because this therapy is the subject of ongoing clinical trials and is more costly than alternative services that produce equivalent results.
 
For contracts without Primary Coverage Criteria the use of image guided radiation therapy to adjust radiation doses or monitor target movement during individual radiation therapy treatment sessions is considered not medically necessary.
 
Effective Prior to May 2020
 
Image guided radiation therapy to adjust radiation doses or monitor target movement during individual radiation therapy treatment sessions does not meet Primary Coverage Criteria because this therapy is the subject of an ongoing trial (NCT01624623) and is more costly than alternative services that produce equivalent results.
 
For contracts without Primary Coverage Criteria the use of image guided radiation therapy to adjust radiation doses or monitor target movement during individual radiation therapy treatment sessions is considered not medically necessary.
Rationale:
Studies thus far have focused on movement of the prostate during radiation therapy sessions. This is considered an initial step in evaluating this technology. Dawson (2007) comments that clinically meaning thresholds for IGRT and replanning of treatment during a course of radiation therapy are not yet known. Even less is know about the impact of IGRT within a single treatment session.
 
These new devices do appear to provide accurate localization. Santanam and colleagues (2008) reported on the localization accuracy of electromagnetic tracking system (Calypso) and on-board imaging systems. In this study both the imaging system and the electromagnetic system showed submillimeter accuracy during a study of both a phantom and canine lung.
 
In a clinical study, Kupelian (2007) described differences found in radiation therapy sessions performed on 35 patients with prostate cancer.  In this paper, six of the initial 41 patients could not be studied because body habitus (A-P dimension) was too large to allow imaging. The results showed good agreement with x-ray localization. Displacements of 3 mm or more and 5 mm or more for cumulative duration of at least 30 seconds were observed during 41% and 15% of radiation sessions. The five clinical sites for the study developed individualized protocols for responding to observed intra-fraction motion. Clinical implications or clinical outcomes, either for control of disease or treatment complications, e.g. proctitis, were not reported.
 
Langen (2008) reported on 17 patients treated at one of the centers in the study noted in the preceding paragraph.  In this study, overall, the prostate was displaced by greater than 3 mm in 13.6% of treatment time and by greater than 5 mm in 3.3% of treatment time. While the clinical impact of this movement was not determined the authors did comment that potential clinical impact would depend on a number of factors including the clinical target volume (CTV).
 
Because IGRT generally uses IMRT to deliver radiation therapy to the prostate, the use of intra-fraction IGRT is unlikely to produce outcomes that are inferior to IMRT treatment.  However, there are no data that indicate that use of image guided radiation therapy described in this policy improves clinical outcomes over existing techniques. This technology is more costly than alternative services that produce equivalent therapeutic results.
 
2012 Update
A search of the MEDLINE database was conducted through August 2012.  The following is a summary of the key literature identified.
 
Kindblom et al. similarly showed electromagnetic tracking was feasible with the Micropos transponder system and that the accuracy of transponder localization was comparable to x-ray localization of radiopaque markers (Kindblom, 2009). Smith et al. successfully coupled an electromagnetic tracking system with linear accelerator gating for lung cancer (Smith, 2009). A currently registered trial is looking at the movement of the cervix during radiation therapy The 2009 National Comprehensive Cancer Network (NCCN) clinical practice guidelines for prostate cancer state “The accuracy of treatment should be improved by attention to daily prostate localization, with techniques such as IGRT [image-guided radiation therapy] using CT[computed tomography], ultrasound implanted fiducials, electromagnetic targeting/tracking, or an endorectal balloon to improve oncologic cure rates and reduce side effects”  (NCCN V.3.2010).  NCCN has also added IGRT to all 3D-CRT (conformal radiotherapy)/IMRT treatment regimens. NCCN is applying a broader definition of IGRT and is addressing inter-fraction (daily) adjustment rather than intra-fraction adjustments, which are the focus of this policy. Although NCCN states that unless otherwise noted, all recommendations are based on level 2A evidence, no specific citations are provided for basis of their conclusions.
 
Literature Review
In a retrospective analysis of data collected from the treatment of 21 patients with prostate cancer treated with Cyberknife, Xie et al. reported on the intra-fractional movement of the prostate during hypofractionated radiotherapy (Xie, 2008). The analysis included 427 datasets composed of the time it took for the prostate to move beyond an acceptable level (approximately 5 mm). The data suggest that it takes approximately 697 seconds for the prostate to move beyond 5 mm relative to its planned position and that motion of greater than 2 mm at 30 seconds was present in approximately 5% of datasets. The percentage increases to 8%, 11%, and 14% at 60, 90, and 120 seconds, respectively. They concluded that these movements could be easily managed with a combination of manual couch movements and adjustment by the robotic arm. As noted earlier, the clinical impact of these displacements and resultant adjustments in treatments needs to be explored in much greater detail.
 
Noel et al. published data showing that intermittent target tracking is more sensitive than pre- and post-treatment target tracking to assess intra-fraction prostate motion, but to reach sufficient sensitivity, intermittent imaging must be performed at a high sampling rate (Noel, 2009). They concluded that this supports the value of continuous real-time tracking. While this may be true, there is a major gap in the literature addressing the actual consequences of organ motion during radiation therapy. Li and colleagues analyzed data from 1,267 tracking sessions from 35 patients to look at the dosimetric consequences on intra-fraction organ motion during radiation therapy (Li, 2008). Results showed that even for the patients showing the largest overall movement, the prostate uniform equivalent dose was reduced by only 0.23%, and the minimum prostate dose remained over 95% of the nominal dose. When margins of 2 mm were used, the equivalent uniform dose was reduced by 0.51%, but sparing of the rectum and bladder was significantly reduced using the smaller margins. This study did not report on clinical outcomes, and data from a larger randomized cohort will be needed to verify these results.
 
Sandler and colleagues reported on 64 patients treated with IMRT for prostate cancer in the Assessing the Impact of Margin Reduction (AIM) study (Sandler, 2010). Patients were implanted with Beacon transponders (Calypso Medical Technologies, Inc., Seattle, WA) and were treated with IMRT to a nominal dose of 81 Gy in 1.8 Gy fractions. Patients in this study were treated with reduced tumor margins, as well as real-time tumor tracking. Patient-reported morbidity associated with radiotherapy was the primary outcome. Study participants were compared to historic controls. Study participants reported fewer treatment-related symptoms and/or worsening of symptoms after treatment than the comparison group. For example, the percentage of patients in the historic comparison group reporting rectal urgency increased from 3% pre-treatment to 22% post-treatment, no increase was observed in the current experimental group.
 
In a clinical study, Kupelian et al. described differences found in radiation therapy sessions performed on 35 patients with prostate cancer (Kupelian, 2007). In this paper, 6 of the initial 41 patients could not be studied because body habitus (A-P dimension) was too large to allow imaging. The results showed good agreement with x-ray localization. Displacements of 3 mm or more and 5 mm or more for cumulative duration of at least 30 seconds were observed during 41% and 15% of radiation sessions, respectively. The clinical sites for the study developed individualized protocols for responding to observed intra-fraction motion. This publication did not report on clinical implications or clinical outcomes, either for control of disease or treatment complications, e.g., proctitis. The clinical impact of these displacements and resultant adjustments in treatments needs to be explored in much greater detail.
 
Langen and colleagues reported on 17 patients treated at one of the centers in the study noted in the preceding paragraph (Langen2008). In this study, overall, the prostate was displaced by greater than 3 mm in 13.6% of treatment time and by greater than 5 mm in 3.3% of treatment time. Results for median treatment time instead of mean were 10.5% and 2.0%, respectively. Again, the clinical impact of this movement was not determined. The authors did comment that potential clinical impact would depend on a number of factors including the clinical target volume (CTV). In this small series, intra-fraction movement did not change a large degree during treatment. However, the likelihood of displacement did increase as time elapsed after positioning.
 
No relevant outcome studies have been published in the literature for any site including, but not limited to, prostate, lung, and breast. Additionally, there are few registered clinical trials of these techniques at this time, and none of a randomized design focused on showing how these additional procedures may improve clinical outcomes, including a decrease in toxicity to surrounding tissue.
 
NCT06124623-This prospective, observational study will evaluate the daily use of the Calypso 4D tracking system in patients treated with radiation therapy after radical prostatectomy for prostate cancer.  The study is ongoing with an estimated completion date of August 2013 (www.clinicaltrials.gov).
 
Practice Guidelines and Position Statements
The current National Comprehensive Cancer Network (NCCN) guidelines for prostate cancer do not mention the use of real-time intra-fraction target tracking or the specific use of the Calypso 4D Localization System (NCCN V.4.2011).
 
Summary
Because real-time intra-fraction target tracking generally uses IMRT to deliver radiation therapy, the use of real-time tracking is unlikely to produce outcomes that are inferior to IMRT treatment. However, there are no data that indicate that use of real-time tracking during radiation therapy to adjust the intra-fraction dose of radiation therapy or monitor target motion during radiation treatment improves clinical outcomes over existing techniques. In summary, this technology does not meet primary coverage criteria because it is more costly than alternative services that produce equivalent therapeutic results. Additionally, this technology is currently being studied in a clinical trial (NCT01624623).
 
2012 Update
A literature search was conducted using the MEDLINE database through February 2013. There were no randomized controlled trials identified that would prompt a change in the coverage statement.
  
2016 Update
A literature search conducted through January 2016 did not reveal any new information that would prompt a change in the coverage statement.
 
2017 Update
A literature search conducted through October 2017 did not reveal any new information that would prompt a change in the coverage statement.  
 
2018 Update
A literature search was conducted through October 2018.  There was no new information identified that would prompt a change in the coverage statement.
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2019. No new literature was identified that would prompt a change in the coverage statement.
 
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2020. No new literature was identified that would prompt a change in the coverage statement.
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2021. No new literature was identified that would prompt a change in the coverage statement.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2023. No new literature was identified that would prompt a change in the coverage statement.
CPT/HCPCS:
G6017Intra fraction localization and tracking of target or patient motion during delivery of radiation therapy (eg,3d positional tracking, gating, 3d surface tracking), each fraction of treatment
References: American Society for Radiation Oncology. (ASTRO).(2020) IGRT. Available from: https://www.astro.org/Daily-Practice/Coding/ Coding-Guidance/FAQ-IGRT/

Balter JM, Kessler ML.(2007) Imaging and alignment for image-guided radiation therapy. J Clin Oncol, 2007; 25:931-37.

Borst GR, Sonke JJ, denHollander S, et al.(2010) Clinical results of image-guided deep inspiration breath hold breast irradiation. Int J Radiat Oncol Biol Phys. 2010;78(5):1345–1351.

Dawson LA, Jaffray DA.(2007) Advances in image-guided radiation therapy. J Clin Oncol, 2007; 25(8):938-46.

Kindblom J, Ekelund-Olvenmark AM, Syren H et al.(2009) High precision transponder localization using a novel electromagnetic positioning system in patients with localized prostate cancer. Radiother Oncol 2009; 90(3):307-11.

Kupelian P, Willoughby T, Mahadevan A, et al.(2007) Multi-institutional clinical experience with the Calypso System in localization and continuous, real-time monitoring of the prostate gland during external radiotherapy. Int J Radiat Oncol Biol Phys 2007;67:1088-89.

Langen KM, Willoughby TR, Meeks SL et al.(2008) Observations on real-time prostate gland and motion using electromagnetic tracking. Int J Radiat Oncol Biol Phys 2008 (Epub).

Li HS, Chetty IJ, Enke CA et al.(2008) Dosimetric consequences of intrafraction prostate motion. Int J Radiat Oncol Biol Phys 2008; 71(3):801-12.

NCCN Clinical Practice Guidelines in Oncology. Prostate Cancer V.3.2010. Available online at: http://www.nccn.org/professionals/physician_gls/PDF/prostate.pdf. Last accessed December 2011.

NCT01624623. www.clinicaltrials.gov. Last accessed November 2012.

Noel C, Parikh PJ, Roy M et al.(2009) Prediction of intrafraction prostate motion: accuracy of pre- and post-treatment imaging and intermittent imaging. Int J Radiat Oncol Biol Phys 2009; 73(3):692-8.

Santanam L, Malinowki K, Hubenshmidt J et al.(2008) Fiducial-based translational localization accuracy of electromagnetic tracking system and on-board kilovoltage imaging system. J Radiat Oncol Biol Phys 2008;70:892-99.

Smith RL, Lechleiter K, Malinowski K et al.(2009) Evaluation of linear accelerator gating with real-time electromagnetic tracking. Int J Radiat Oncol Biol Phys 2009; 74(3):920-7.

Wong JR, Gao Z, Merrick S et al.(2009) Potential for higher treatment failure in obese patients: correlation of elevated body mass index and increased daily prostate deviations from the radiation beam isocenters in an analysis of 1,465 computed tomographic images. Int J Radiat Oncol Biol Phys 2009; 75(1):49-55.

Xie Y, Djajaputra D, King CR et al.(2008) Intrafractional motion of the prostate during hypofractionated radiotherapy. Int J Radiat Oncol Biol Phys 2008; 72(1):236-46.
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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