Currentblue cross blue shield - kansasPolicy N/A

Real-Time Intrafraction Motion Management During Radiotherapy

Defines coverage stance for the use of frequent or continuous target tracking during individual radiotherapy sessions (real-time intrafraction tracking and respiratory gating) and who it affects (BCBSKS members and providers).

Policy Summary

Payerblue cross blue shield - kansas

PolicyReal-Time Intrafraction Motion Management During Radiotherapy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMar 1, 2019

Next Review DateN/A

Key ActionVerify member benefits and submit a predetermination (prior authorization) request when coverage is questioned.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2principal policy stances

2019-03-01last review

investigationalcoverage stance

5 mmmotion threshold

Calypsoexample FDA system

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Not Covered / Experimental

Coverage stance

Policy coverage determinations: A. Real-time intrafraction target tracking during radiotherapy to adjust radiation doses or monitor target movement during individual radiotherapy treatment sessions is considered experimental / investigational. B. Respiratory gating techniques for the delivery of radiotherapy are considered experimental / investigational.

These statements indicate noncoverage due to experimental/investigational status as per this policy.

Exclusions noted elsewhere in document: Policy does not address IGRT used as part of stereotactic (body) radiotherapy and does not address patient positioning/setup consistency approaches.

These uses are outside the scope of this policy.

Investigational / Not covered as standard

Coverage determination based on available evidence and guideline context:

Investigational determination: Real-time intrafraction target tracking and respiratory gating techniques have demonstrated ability to track motion and reduce planning target volumes or dosimetric exposure to organs at risk, but there is insufficient evidence from controlled clinical trials showing improved clinical outcomes (reduced toxicity or improved survival).evidence not sufficient

As a result, these techniques are considered investigational.

Experimental / Investigational

Coverage stance:

Experimental/Investigational Determination: Real-time intrafraction target tracking during radiotherapy to adjust radiation doses or monitor target movement during individual radiotherapy treatment sessions is considered experimental / investigational.

Applies to all diagnoses per policy text.

Respiratory Gating

Respiratory gating techniques for the delivery of radiotherapy are considered experimental / investigational.

Listed explicitly in policy revisions.

This policy specifically excludes discussion of IGRT when used as part of stereotactic (body) radiotherapy and does not address techniques intended solely to optimize patient setup or consistency of positioning for treatment planning or individual sessions. Real-time intrafraction tracking for the purpose of intra-session target monitoring or respiratory gating is the focus of this policy; uses that are part of stereotactic body radiotherapy workflows are outside its scope. IGRT used as part of stereotactic (body) radiotherapy is not addressed by this policy.

Use of real-time intrafraction target tracking or respiratory gating to adjust the intrafraction dose during an individual radiotherapy session or to claim improved clinical outcomes is considered investigational. Although tracking technologies can reduce planning target volumes and dosimetric exposure to organs at risk, there are no data from controlled trials demonstrating that making intrafraction dose adjustments or margin reductions based on real-time tracking improves clinical outcomes such as reduced toxicity or improved survival. Adjusting intrafraction dose or margins using real-time tracking or gating is investigational.

Beyond the experimental/investigational designation articulated in this policy, no additional, diagnosis-specific exceptions or qualified coverage pathways are provided. The policy applies the experimental / investigational designation to real-time intrafraction target tracking and respiratory gating for all diagnoses, and no further coverage clarifications are specified in the document.

Real-time intrafraction target tracking during radiotherapy and respiratory gating techniques for delivery of radiotherapy are designated as experimental / investigational by this policy. This designation replaces prior language describing the service as not medically necessary and is the operative coverage determination.

Rationale for the experimental/investigational designation is that, while technologies can track tumor motion and reduce planning margins or doses to organs at risk, current evidence is insufficient to show improved patient-important outcomes (reduced toxicity or improved survival). Studies are generally small, nonrandomized, or lack head-to-head comparative data demonstrating clinical benefit; therefore the policy concludes there is insufficient evidence of health benefit to support routine coverage. As noted in the revisions, the policy language was updated to explicitly designate these services as experimental / investigational.

Policy language was revised on 03-01-2019 to replace the previous phrasing that included 'not medically necessary' with an explicit experimental / investigational designation for real-time intrafraction target tracking during radiotherapy. The current operative policy statements (Items A and B) state that both real-time intrafraction target tracking and respiratory gating are considered experimental / investigational.

Coding and Regulatory Identifiers

Regulatory / device 510(k) identifiers discussedmixed

K060906	Calypso 4D Localization System clearance (prostate)
K080726	Calypso 4D Localization System clearance (other soft tissue)
K102024	Varian RPM respiratory-gating system clearance
K003330	Active Breathing Coordinator (ABC) system clearance
K092479	SDX respiratory-gating system clearance

Relevant CPT/HCPCS Codesmixed

32553	Placement of interstitial device(s) for radiation therapy guidance (e.g., fiducial markers, dosimeter), percutaneous, intra-thoracic, single or multiple.
49411	Placement of interstitial device(s) for radiation therapy guidance (e.g., fiducial markers, dosimeter), percutaneous, intra-abdominal, intra-pelvic (except prostate), and/or retroperitoneum, single or multiple.
55876	Placement of interstitial device(s) for radiation therapy guidance (e.g., fiducial markers, dosimeter), prostate (via needle, any approach), single or multiple.
77385	Intensity modulated radiation treatment delivery (IMRT), includes guidance and tracking, when performed; simple.
77386	Intensity modulated radiation treatment delivery (IMRT), includes guidance and tracking, when performed; complex.
77387	Guidance for localization of target volume for delivery of radiation treatment, includes intrafraction tracking, when performed.
A4648	Tissue marker, implantable, any type, each.
A4649	Surgical supply; miscellaneous.
A4650	Implantable radiation dosimeter, each.
C9728	Placement of interstitial devices(s) for radiation therapy/surgery guidance (e.g., fiducial markers, dosimeter), for other than specified sites, single or multiple.

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Diagnosis CodesICD-10Not Covered

ICD-10

Experimental / investigational for all diagnoses related to this policy.

AAPM Task Group 76 motion threshold

AAPM TG-76 motion thresholdMotion that exceeds 5 mm in any direction

Measurement methods referencedTumor motion commonly measured with fluoroscopy or 4D-CT

Context of thresholdRecommend motion management when tumor motion >5 mm or if significant normal tissue sparing can be gained

Provider Requirements and Prior Authorization

Prior Authorization

Predetermination / Benefits Verification

Verify member benefits and consider submitting a predetermination request prior to scheduling services. State and federal mandates and the member's contract provisions take precedence over this policy; coverage depends on the member's specific plan and benefits.

Contact Blue Cross and Blue Shield of Kansas Customer Service to verify benefits.
Submit a predetermination request when there is uncertainty about coverage.

Denial Risk

Prior Authorization Recommended — Investigational Procedures

Procedures related to real-time intrafraction motion management during radiotherapy (including realtime intrafraction target tracking and respiratory gating techniques) are designated experimental/investigational in this policy and are not considered proven to improve clinical outcomes compared with existing techniques.

Real-time intrafraction target tracking during radiotherapy to adjust doses or monitor target movement during individual sessions: considered experimental/investigational.
Respiratory gating techniques for delivery of radiotherapy: considered experimental/investigational.

Prior Authorization

Predetermination / Prior Authorization Guidance

If there are questions about coverage, contact BCBSKS Customer Service, your professional or institutional relations representative, or submit a predetermination request for review.

Submit predetermination documentation when seeking coverage for real-time intrafraction motion management procedures.
BCBSKS customer service can advise on plan-specific requirements and prior authorization processes.

Documentation Required

Preferred Alternatives

Preferred, guideline-based alternatives and motion-management strategies should be considered instead of investigational procedures when appropriate.

For prostate cancer: use IGRT techniques (CT, ultrasound, implanted fiducials, electromagnetic targeting/tracking, endorectal balloon) and highly conformal radiotherapy per NCCN guidance.
For lung cancer: manage respiratory motion when excessive (beam-gating with respiratory cycle, dynamic tumor tracking, or motion-encompassing targeting as appropriate).
For breast cancer: consider respiratory gating among other strategies (prone positioning, IMRT, wedges) when clinically indicated; real-time tracking is not specifically recommended by NCCN.

Billing Rule

Coding Informational Note

Coding listed below is provided for informational purposes only. Inclusion of a code does not imply coverage; refer to the member's contract and the policy 'Policy' section to determine medical necessity and coverage.

Codes in the coding section are not comprehensive and are for informational use only.
A procedure's medical necessity and coverage depend on adherence to the Policy section and member contract.

Denial Risk

Experimental / Investigational — Denial Risk

Procedures designated experimental/investigational under this policy may be denied for all diagnoses related to these services.

Real-time intrafraction tracking and respiratory gating techniques are experimental/investigational and subject to denial.
Confirm coverage via predetermination to reduce risk of claim denial.

Definitions and Technical Terms

Definition — frequent or continuous target tracking

Definition (real-time tracking)Frequent or continuous target tracking in the treatment room during radiotherapy with periodic or continuous adjustment to targeting made on the basis of target motion detected by the tracking system

Scope noteIncludes techniques that may or may not use radiographic images; considered a form of IGRT for this policy

ExclusionsDoes not address approaches to optimize patient setup consistency or IGRT used as part of stereotactic (body) radiotherapy

Definition — online vs offline intrafraction correction

Online correctionAdjustments or actions that occur at the time of radiation delivery based on predefined thresholds

Offline correctionTarget tracking without immediate intervention; adjustments reviewed or applied after delivery

Clinical relevanceOnline vs offline distinction guides whether intrafraction actions are immediate or delayed

Definition — real-time intrafraction target tracking technology examples

Examples (implanted devices)Implanted fiducials and electromagnetic transponders (e.g., Calypso Beacon) used to track tumor position during delivery

Imaging-based examplesFluoroscopy and 4D-CT sequences for temporal tracking of tumor motion

Surface and respiratory-based examplesSurface-marker tracking and spirometric breath-hold systems for respiratory-related motion

Definition — respiratory gating

DefinitionA technique that times radiation delivery to specific portions of the respiratory cycle or uses breath-hold to limit tumor motion and spare adjacent normal tissues

Intended benefitReduce irradiation of normal tissue to lower toxicity and facilitate dose escalation

Clinical evidence noteStudies show reduced PTV margins and organ-at-risk doses; largest nonrandomized breast study (N=401) showed dosimetric and some acute toxicity improvements but no survival benefit

Definition — intra-fraction localization and tracking examples

Included techniquesContinuous monitoring or tracking of target or patient motion during delivery (examples: 3D positional tracking, gating, 3D surface tracking)

Related CPT/HCPCS examplesCPT/HCPCS codes representing these techniques include 77387 and G6017

Typical useUsed to monitor intrafraction motion and may enable reduced PTV margins or intrafraction adjustments

Definition — implantable transponders / fiducial markers

DefinitionImplanted devices (e.g., Beacon transponders, fiducial markers, implantable dosimeters) used to localize or track targets during radiotherapy

Coding/placement examplesPlacement coded with site-specific CPT codes such as 32553, 49411, or 55876; supplies reported with A4648/A4650/A4649

Regulatory noteNo device-specific CPT exists for Beacon transponders; implantation coded by anatomical placement codes

OpenPayer

Real-Time Intrafraction Motion Management During Radiotherapy

Coverage Determination

Coding and Regulatory Identifiers

Provider Requirements and Prior Authorization

Background and Rationale

Definitions and Technical Terms