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    v1.0.28
    OpenPayerPolicy UpdatesOphthalmology/OptometryAetna Indocyanine Green Angiography Coverage Updat…
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    CurrentAetnaPolicy 0111

    Indocyanine Green Angiography

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    Clinical policy governing medical necessity, experimental/investigational uses, and coding for indocyanine green angiography (ICGA) across ophthalmic and selected non-ophthalmic indications for Aetna members.

    Policy Summary
    PayerAetna
    PolicyIndocyanine Green Angiography
    Policy CodePolicy 0111
    Change TypeNo material changes in this revision
    Effective DateApr 19, 1996
    Last ReviewMar 23, 2023
    Next Review DateJan 25, 2024
    Key ActionObtain and document prior fluorescein angiography results or other required findings in the medical record to justify ICGA use as an adjunct and support medical necessity.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    7ophthalmic indications listed
    92240, 92242covered ophthalmic CPTs
    C9733covered HCPCS example
    numerousexperimental/investigational uses
    01/25/2024next review

    Coverage Criteria

    inv-01: Ophthalmic Indications - Medically Necessary when used as an adjunct to fluorescein angiography

    Covered when ANY of the following ocular conditions are present and documentation supports one of the specified findings:

    Ocular indications: Acute posterior multifocal placoid pigment epitheliopathy OR Exudative senile macular degeneration OR Hemorrhagic detachment of retinal pigment epithelium OR Monitoring of foveo-macular vitelliform dystrophy (Best disease) OR Retinal hemorrhage OR Retinal neovascularization OR Serous detachment of retinal pigment epithelium.

    Documentation must indicate one of: (1) evidence of ill-defined subretinal neovascular membrane or suspicious membrane on prior fluorescein angiography; or (2) presence of subretinal hemorrhage or hemorrhagic RPE (fluorescein angiography not required); or (3) current fluorescein angiography shows RPE does not demonstrate subretinal neovascular membrane. Physician documentation should support frequency and medical necessity.

    inv-02: Non-ophthalmic Medically Necessary Uses

    Covered when used intraoperatively or for sentinel node mapping in specified contexts:

    Non-ophthalmic uses:
    Policy Summary
    PayerAetna
    PolicyIndocyanine Green Angiography
    Policy CodePolicy 0111
    Change TypeNo material changes in this revision
    Effective DateApr 19, 1996
    Last ReviewMar 23, 2023
    Next Review DateJan 25, 2024
    Key ActionObtain and document prior fluorescein angiography results or other required findings in the medical record to justify ICGA use as an adjunct and support medical necessity.
    SourceLink
    On This Page
    Coverage CriteriaCodingProvider Actions, Documentation & Prior AuthorizationBackgroundDefinitions
    Intra-operative use for intracranial aneurysm surgery; Near-infrared angiography with ICG (eg, SPY Elite System) for breast reconstruction surgery (note: intraoperative imaging of tissue perfusion considered integral to the primary surgical procedure and not separately reimbursed); Use of ICG for sentinel lymph node mapping in cervical and endometrial cancer.

    CPT/HCPCS coding guidance available for covered ophthalmic and selected non-ophthalmic codes when selection criteria met.

    inv-03: Experimental and Investigational (Not Covered)

    ICGA is considered experimental and investigational for the following groups of procedures and conditions because effectiveness has not been established:

    Procedures listed as experimental: Use in various intraoperative surgical assessments including, but not limited to: anatomical dissection during robot-assisted radical prostatectomy; evaluation of anastomotic perfusion in colorectal surgery; evaluation of anastomotic leak/perfusion during or after esophagectomy; evaluation of residual parathyroid gland function and prediction of post-operative hypocalcemia after total thyroidectomy; evaluation of anastomotic stenosis of reconstructed SMA aneurysm; evaluation of perfusion of supra-clavicular artery island flap in head and neck reconstruction; guidance in redo ileocolic resection for Crohn's disease; identification of superficial temporal artery/vein in forehead flaps; ICG-assisted ILM peeling in macular hole surgery; intraoperative evaluation of flap perfusion in skull base reconstruction; microsurgical subinguinal varicocelectomy; prediction of postoperative thrombosis in internal jugular vein; prediction of wound complications in ventral hernia repair; prevention of surgical morbidity during esophagectomy, and others listed in the policy.

    Policy lists a non–all-inclusive set of procedures considered experimental/investigational.

    Conditions listed as experimental: Use in management of Behcet's disease, choroidal melanoma, critical limb ischemia, diabetic macular edema, drusen differentiation, macular schisis, parasagittal meningioma, pseudo‑Moyamoya disease, sarcoidosis, scleritis/posterior scleritis, spinal dural arteriovenous fistula, Vogt‑Koyanagi‑Harada disease, and other listed conditions.

    Policy states ICGA has not been demonstrated to add useful clinical information for these conditions.

    inv-04: Ophthalmology: Diagnostic and intra-operative use

    Covered/appropriate when ALL of the following are met

    Ophthalmic diagnostic ICGA: Prior fluorescein angiography has been performed and yields equivocal or insufficient information regarding choroidal neovascularization or the choroidal vasculature, and ICGA is needed to better define lesions prior to photocoagulation or other therapy.

    ICGA is typically used as a second-level diagnostic test contingent upon fluorescein angiography results.

    ICG-assisted intraoperative use: Use of ICG to stain the internal limiting membrane or assist ILM/ERM peeling may be considered in difficult cases where visualization is poor; surgeon should weigh potential facilitation of peeling versus reported risks of retinal pigment epithelium damage and other ocular toxicity.

    Evidence is inconclusive for routine intra‑vitreal ICG use; reports of dye persistence and ocular toxicity exist and use should be limited to selected difficult cases.

    inv-05: Surgical/vascular/neurosurgical intra-operative use

    Covered/appropriate when ANY of the following intra-operative objectives are intended

    Neurosurgical intra-operative ICGA: Microscope-integrated ICGA to assess vessel patency, detect residual aneurysm filling after clipping, or confirm patency of parent, branching, and perforating vessels in intracranial aneurysm surgery; provides real-time assessment when structures are visible in the operative field and may guide immediate clip correction.

    Series report high concordance with post‑operative DSA and cases where ICGA altered the surgical procedure.

    Spinal dAVF and perfusion assessment: Use of ICGA during spinal dural arteriovenous fistula surgery to identify fistulous points, feeding arteries, and draining veins and to confirm obliteration; and use to assess regional perfusion in revascularization procedures.

    Case series and pilot studies document visualization and quantitative perfusion metrics.

    inv-06: Reported clinically useful applications and study-derived thresholds

    Clinical scenarios and study-derived criteria where ICGA has been reported as useful:

    Mastectomy flap assessment: LA‑ICGA (eg, SPY) reported to predict mastectomy skin flap necrosis better than fluorescein angiography and clinical judgment; study-derived numeric perfusion thresholds reported (examples: SPY value <=7 associated with necrosis; regions <=25% perfusion often nonviable; regions >=45% perfusion survived ~98%).SPY <=7; <=25% perfusion; >=45% perfusion

    Studies report high sensitivity/specificity but also tendency to over‑predict necrosis; device/software heterogeneity limits standardization.

    Lower extremity perfusion assessment: ICGA provides rapid visual and quantitative measures (ingress, ingress rate, curve integral, end intensity, egress, egress rate) to evaluate regional foot perfusion and changes after revascularization.not specified

    Promising initial data; further validation required.

    Flap reconstruction and intraoperative perfusion guidance: ICGA (SPY and other systems) used to assess flap perfusion in breast reconstruction and other reconstructive procedures; can aid donor site selection and anastomosis assessment and has been associated with reductions in ischemic complications in some series.device-specific perfusion units reported

    Heterogeneity in devices and thresholds; standardization needed.

    Neurosurgery (ICG videoangiography): ICG videoangiography assists identification and management of cerebral vessels and venous anatomy, can alter intra-operative management in a subset of aneurysm and vascular cases, and complements other modalities (eg, DSA, micro-Doppler).not applicable

    Evidence from prospective/retrospective series; complementary tools often required.

    Other applications: ICG‑FA has been used to predict wound complications in ventral hernia repair with reported high sensitivity/specificity in a small study and to detect leaking spots in refractory DME enabling targeted photocoagulation in case series.not specified

    Small studies; further larger studies required for validation.

    inv-07: Coverage-relevant evidence summaries

    Summary of clinical findings relevant to coverage decisions

    Anastomotic perfusion assessment: Multiple cohort and prospective single‑arm studies report feasibility of ICG‑FA to assess colorectal and esophageal anastomotic perfusion; some studies report changes in surgical plan and lower leak rates, but randomized controlled trials are lacking or heterogeneous.evidence: cohort/retrospective studies; no definitive RCT evidence

    See multi‑center and systematic review findings.

    Prediction of wound complications (VHR): Small prospective blinded VHR study reported sensitivity 100% and specificity 90.9% for predicting wound complications using ICG‑FA, but sample size was small (n=15) and findings need validation.small study

    Preliminary promising data requiring larger validation studies.

    Flap/IJV thrombosis prediction: Preliminary feasibility data suggest ICG transit times or perfusion metrics may predict postoperative thrombosis or flap complications, but evidence is limited and exploratory.small feasibility studies

    Further research needed.

    Diabetic macular edema: ICGA was not identified as a management tool for diabetic macular edema in cited reviews and is not established as part of standard DME management.no supporting literature in cited reviews

    ICGA role in DME requires further investigation.

    inv-08: Evidence summaries (informational)

    Summary of evidence findings (no prescriptive coverage rules stated in these chunks):

    Colorectal surgery evidence: Observational studies and meta‑analyses report that intraoperative ICG‑FA can change the site of bowel division in a minority of cases and is associated with lower anastomotic leak rates in some series; however, data are predominantly non‑randomized and authors call for well‑designed RCTs.evidence level: observational/meta‑analysis

    Heterogeneity in dosing, devices, and AL definitions limits certainty.

    Sentinel lymph node mapping: Retrospective and pooled analyses indicate higher sentinel lymph node detection rates with ICG compared with blue dye or technetium‑99m in endometrial and cervical cancer, with high pooled sensitivity and NPV; findings support feasibility and potential advantage but rely on non‑randomized data.evidence level: retrospective and meta‑analysis

    ICG produced highest SLN detection rates in pooled studies.

    Intraoperative flap evaluation: Systematic analyses report high sensitivity (~90.9%) and accuracy for intra‑operative ICGA in flap perfusion assessment, suggesting objective utility, but conclude additional work is needed to document clinical impact and standardize thresholds.evidence level: systematic analysis

    Device and setting heterogeneity noted.

    CABG graft assessment: Randomized and pilot studies show ICGA/IFI provides semi‑quantitative intraoperative graft imaging with higher sensitivity than transit‑time flow measurement for detecting >50% graft stenosis/occlusion in some trials, but limitations include incomplete visualization and lack of quantitative flow metrics.evidence level: randomized/pilot studies

    IFI/ICGA may reduce early graft failures but is complementary to other assessments.

    Parathyroid perfusion and other emerging uses: Pilot and observational studies suggest ICG‑enhanced fluorescence may help identify and evaluate parathyroid gland perfusion and predict postoperative hypocalcemia risk; larger randomized trials are needed.evidence level: pilot/observational

    Promising but preliminary.

    inv-10: Evidence-based considerations for ICG-FA use

    Findings from observational studies and meta-analyses suggesting clinical benefit in colorectal/rectal surgery

    Evidence summary: Multiple observational studies and meta‑analyses report lower anastomotic leakage rates with intraoperative ICG‑FA in colorectal and rectal cancer surgery (examples: pooled AL 3.8% with ICG vs 7.8% without; ORs reported 0.44 and 0.33 in meta‑analyses). Benefits were most consistent for rectal/low colorectal anastomoses.

    Authors emphasize heterogeneity and need for larger RCTs despite pooled effect estimates.

    Limitations: Heterogeneity in study designs, ICG dosing, imaging systems, and definitions of anastomotic leak; predominance of observational data and limited RCT evidence limit definitive conclusions.

    Standardization and randomized trials recommended.

    Potential actionable scenarios: ICG‑FA has been reported to prompt intraoperative change of resection margin in a minority of cases (eg, 3.1%–13.3%) and may be particularly useful in low anterior resections/rectal surgery where AL risk is higher.

    May inform selective use rather than routine application until higher‑quality evidence available.

    inv-11: Summarized clinical evidence by application

    Evidence-supported contexts and limitations (based on cited studies and systematic reviews):

    Colorectal/Rectal cancer anastomosis: Multiple meta‑analyses and pooled studies report reduced anastomotic leak rates with intraoperative ICG‑FA (eg, pooled ORs 0.31–0.46), but heterogeneity, variable dosing and imaging systems, and inconsistent AL definitions are repeatedly noted.

    More high‑quality RCTs are needed to confirm benefit and establish standardized protocols.

    Esophagectomy/gastric conduit perfusion: Non‑randomized trials suggest ICG‑FA offers dynamic assessment of gastric conduit perfusion and may guide conduit site selection to decrease AL, but poor data quality and heterogeneity limit generalizability; randomized multicenter trials recommended.

    Evidence promising but not definitive.

    Bowel resection for recto‑sigmoid endometriosis: Small studies suggest qualitative and quantitative NIR‑ICG evaluations can predict bowel fistula with high sensitivity and reproducibility, but sample sizes are small and validation is needed.

    Preliminary evidence only.

    Skull base and flap perfusion assessment: Systematic review (7 studies, 104 patients) found intra‑operative ICG enhancement associated with post‑operative MRI enhancement but not predictive of rare complications (eg, CSF leak); larger multicenter studies required.

    Current literature insufficient to predict rare post‑operative outcomes.

    AVM localization and neurosurgical guidance: ICG‑VA with FLOW 800 can aid localization of deep‑seated AVMs and guide resections in case series, but evidence quality is very low and larger registries or studies are needed.

    Adjunctive use supported by case series.

    Head and neck / flap planning: Small case series demonstrate ICGA can map vessels to aid flap design and may improve flap survival; evidence remains preliminary.

    Further study required.

    Vascular reconstruction and limitations: Case reports indicate ICGA can assess perfusion but may not detect anastomotic stenosis or subtle flow issues; ICGA should be considered adjunctive to other assessments.

    ICGA complements but does not replace standard vascular assessment tools.

    Ophthalmology: NAION diagnosis: ICG combined with fluorescein angiography has been used to study optic disc perfusion in NAION, but guidelines and reviews state diagnosis is clinical and do not endorse ICG as a routine management tool.

    Imaging provides physiologic insight but does not change standard diagnostic approach.

    The policy lists numerous ICD-10 codes that are not covered for the indications described in this Clinical Policy Bulletin. Examples called out in the policy include malignant neoplasms (e.g., C16.*, C18.*, C43.*, C50.*, C56.*, C60.*, C61, C64.*, C67.*), parasagittal meningioma (C70.0 / D32.0), and systemic inflammatory conditions such as D86.* (sarcoidosis). The document also lists multiple diabetes-related retinopathy/macular edema codes and several ocular diagnosis codes (for example, H35.721–H35.729; H35.731–H35.739; H35.361–H35.369) among the codes referenced in the exclusions section.

    The policy states that intraoperative imaging of tissue perfusion during breast reconstruction (near-infrared angiography with ICG, e.g., Spy Elite) is considered integral to the primary surgical procedure and is not separately reimbursed, so it is not billed as a distinct, separately payable service when performed as part of the reconstruction.

    ICGA is described as a second‑level diagnostic test to be used when fluorescein angiography (FA) is equivocal or insufficient to define choroidal neovascularization; the policy notes that when FA already provides a definitive diagnosis (for example, identifying patients who are not candidates for photocoagulation or who clearly lack neovascularization), ICGA is unnecessary.

    The policy cites Stanga et al (2003) to note that ICGA was not recommended for certain ophthalmic conditions because it has not been shown to add useful clinical information. Specific conditions listed include scleritis and posterior scleritis, drusen differentiation, Behcet's disease, and sarcoidosis.

    The policy indicates that ICGA is not currently mentioned as a management tool in some ophthalmology screening/guideline reviews for diabetic retinopathy and diabetic macular edema; cited reviews and an UpToDate screening chapter do not list ICGA as a standard management modality for DME.

    Consistent with the exclusion above, the document states that ICGA is not described or supported as a management tool for diabetic macular edema in the cited reviews and summary literature.

    The policy and cited systematic review report no explicit, definitive exclusions in the skull‑base flap perfusion literature, but they emphasize limited evidence: none of the included studies were randomized, sample sizes were small, flap/defect types were heterogeneous, and standardized quantitative assessment was lacking. Authors call for larger multicenter trials to validate whether intraoperative ICG enhancement predicts post‑operative complications.

    The policy notes that although ICG fluorescence has been used for sentinel lymph node mapping, NCCN guidelines for breast cancer and melanoma (versions cited) did not mention ICG SLN mapping at the time of citation, indicating a lack of guideline endorsement in those guidelines.

    The policy summarizes systematic reviews and expert commentary indicating that routine use of ICG in all colorectal surgery is not clearly supported. Authors highlight heterogeneous studies, limited high‑quality evidence, and concerns that routine application could be excessive and not cost‑effective; selective use in higher‑risk scenarios (e.g., low colorectal anastomosis) is emphasized.

    The document states that UpToDate reviews and AAO resources do not identify ICG as a management or therapeutic option for non‑arteritic anterior ischemic optic neuropathy (NAION). Diagnosis of NAION remains clinical per AAO EyeWiki, and ICG is not recommended as a standard management tool for NAION.

    Across multiple intraoperative applications, the policy concludes that current literature is insufficient to demonstrate that intraoperative ICG enhancement reliably predicts flap necrosis or other postoperative complications (for example, CSF leak or meningitis in skull‑base reconstruction). Reviews also note that LA‑ICGA/ICG can over‑predict necrosis and that device/software heterogeneity and lack of standardized numeric thresholds limit generalizability.

    The policy includes an extensive list of procedures and conditions for which use of ICGA is considered experimental and investigational (not medically necessary), explicitly calling out many intraoperative surgical assessments (for example, anastomotic perfusion assessment in colorectal and esophageal surgery, skull base flap perfusion evaluation, ICG‑assisted ILM peeling for macular hole surgery) and multiple disease management uses (e.g., Behcet's disease, choroidal melanoma, diabetic macular edema, sarcoidosis, scleritis).

    The policy documents potential ocular toxicity with intra‑vitreal ICG use and persistence of dye: Nakamura et al reported that ICG used during macular surgery may persist in the macular region for up to 7 months, and case reports describe ICG‑related ocular toxicity after intravitreal use, supporting a cautious approach to routine intra‑vitreal application for ILM peeling.

    The policy highlights that ICGA may over‑predict areas of necrosis and can therefore lead to removal of viable tissue; coupled with heterogeneity in devices and lack of consensus on perfusion metrics, this limitation is cited as a reason for caution and for standardization before broad adoption.

    Systematic reviews and meta‑analyses cited in the policy indicate insufficient randomized controlled trial evidence to definitively conclude that ICG‑FA reduces anastomotic leak rates. Although observational meta‑analyses report lower leak rates with ICG‑FA, authors consistently call for large, well‑designed RCTs before routine adoption.

    Many of the cited reviews and meta‑analyses describe limitations of the evidence base rather than issuing explicit categorical 'not medically necessary' statements; the policy therefore characterizes these indications as having limited or preliminary evidence and many are described as investigational pending higher‑level studies.

    Within the excerpts reviewed, explicit blanket 'not medically necessary' declarations are not consistently present; rather, the document reports feasibility and promising detection rates for sentinel node mapping and other uses while noting lack of guideline inclusion (for example, NCCN) and the need for further validation.

    Because studies are heterogeneous in patient selection, imaging systems, ICG dosing, and outcome definitions, and because many data come from non‑randomized cohorts, the policy emphasizes that routine use of ICG for prevention of anastomotic leak or other outcomes cannot be uniformly supported without documentation showing how ICG changed intraoperative management; these evidence limitations may preclude broad coverage for some indications.

    The policy notes selective intraoperative uses where ICG has been proposed to predict or prevent rare postoperative complications (for example, CSF leak, meningitis, flap necrosis in skull base reconstruction), but current studies are underpowered, heterogeneous, and unrandomized; thus, evidence is insufficient to support routine predictive use of ICG for these rare complications.

    Coding

    Covered CPT Codes (ophthalmic) if selection criteria metCPTCovered
    92240Indocyanine-green angiography (includes multi-frame imaging) with interpretation and report.
    92242Fluorescein angiography and indocyanine-green angiography (includes multiframe imaging) performed at the same patient encounter with interpretation and report, unilateral or bilateral.
    Other related CPT codes (non-ophthalmic surgical context)CPT
    15740Flap; island pedicle requiring identification and dissection of an anatomically named axial vessel.
    15860Intravenous injection of agent (eg, fluorescein) to test vascular flow in flap or graft.
    Covered HCPCS CodesHCPCSCovered
    C9733Non-ophthalmic fluorescent vascular angiography [Spy Elite System].
    ICD-10 Codes (examples covered or noted)ICD-10
    H35.3210 - H35.3293Exudative age-related macular degeneration.
    H35.721 - H35.729Serous detachment of retinal pigment epithelium.
    H35.731 - H35.739Hemorrhagic detachment of retinal pigment epithelium.
    H35.361 - H35.369Drusen (degenerative) of macula.
    ICD-10 Codes Not Covered / Experimental contexts (partial list)ICD-10Not Covered
    C50.011 - C50.929Malignant neoplasm of breast (listed as ICD-10 not covered for certain indications).
    D86.0 - D86.9Sarcoidosis (listed as not covered/experimental for ICGA utility).
    Coding references (not specified)mixed
    affected codesNo explicit CPT/HCPCS/ICD-10 codes are provided in these chunks; literature discusses devices and procedures generically.
    Coding references presentmixed
    none specifiedNo explicit CPT/HCPCS/ICD-10 codes are listed in these chunks.
    No explicit billing codes in this excerptmixed
    No codes listed
    inv-40: SPY/LA-ICGA perfusion numeric thresholds
    SPY numeric threshold associated with flap necrosisSPY Elite value <= 7 correlated with flap necrosis (88% sensitivity, 83% specificity; excluding smokers/epinephrine cases: 83% sensitivity, 97% specificity).
    Low perfusion percentage linked to nonviabilityAreas <= 25% perfusion were not viable ~90% of the time in a mastectomy flap series.
    High perfusion percentage linked to survivalAreas >= 45% perfusion survived 98% of the time in a mastectomy flap series.
    inv-41: time to perfusion fluorescence
    Median time to fluorescence signalMedian 35 seconds (range 15–45 seconds) to visualization of perfusion fluorescence after ICG injection.
    Study device/contextReported in near-infrared (NIR) laparoscopy colorectal series using ICG (2.5 mg/ml).
    Clinical implicationRapid visualization supports feasibility with minimal interruption to operative workflow.
    inv-42: added intra-operative time
    Median added intra-operative timeMedian added time ~5 minutes (range 3–9 minutes) for the ICG perfusion technique.
    Feasibility noteTechnique described as readily achievable with minimal added intra-operative time in colorectal resections.
    Operational impactMay influence decision-making (e.g., site of bowel division) without substantial operative delay.
    inv-43: Typical ICG dose
    Typical ICG dosing range reportedICG doses commonly reported as 2.5–10 mg for intraoperative fluorescence angiography.
    Example concentration used in colorectal seriesReported use of 2.5 mg/ml concentration in some laparoscopic colorectal studies.
    Documentation recommendationLiterature notes need to document ICG dose and imaging settings due to variability across studies.

    Provider Actions, Documentation & Prior Authorization

    Prior Authorization

    Prior authorization for primary ophthalmic ICGA codes

    CPT codes 92240 and 92242 are covered when the policy's ophthalmic selection criteria are met; obtain prior authorization per payer process when required.

    • 92240 = Indocyanine-green angiography (includes multi-frame imaging) with interpretation and report.
    • 92242 = Fluorescein angiography and indocyanine-green angiography performed at the same encounter with interpretation and report.
    Prior Authorization

    ICGA after fluorescein angiography

    ICGA is intended as a second-level diagnostic test after fluorescein angiography when FA results are equivocal or insufficient to define choroidal neovascularization; providers should document prior FA results to justify ICGA use.

    • Use ICGA when fluorescein angiography is equivocal or further definition is needed prior to photocoagulation.
    • Documentation should indicate one of the specified findings from prior or current FA per the policy note.
    Note

    Prior authorization: not specified in these excerpts

    The document excerpts do not specify an explicit list of CPT/HCPCS codes that universally require prior authorization for ICGA; follow plan-specific authorization rules.

    • No payer-specific prior authorization instructions are provided in these sections.
    • Consult the full policy or plan documents for any local prior authorization requirements.
    Prior Authorization

    Prior authorization: evidence considerations

    Evidence gaps and lack of randomized controlled trials for many non-ophthalmic indications are noted; prior authorization decisions may consider the strength and quality of supporting evidence.

    • Reviewers may request justification and supporting literature for non-established indications.
    • Observational and cohort data are prominent; randomized trial evidence is limited.
    Prior Authorization

    Prior authorization may be required for non-established indications

    For indications supported mainly by non-randomized studies or preliminary data (e.g., some intra‑operative perfusion uses), payers may require prior authorization with clinical rationale and expected impact on intraoperative management.

    • Document how ICGA will change the operative plan (e.g., site of resection, anastomotic revision).
    • Provide study references or clinical rationale when evidence is heterogeneous.
    Note

    Prior authorization not specified in excerpt

    This excerpt does not specify that prior authorization is required for ICG procedures; check plan-level guidance for authorization requirements.

    • Guideline recognition (e.g., NCCN) is noted but no payer prior-auth list is provided in these chunks.
    • Providers remain responsible for verifying authorization with the member's plan.
    Prior Authorization

    Prior authorization — evidence-based justification

    If prior authorization is requested, reviewers should ask for an evidence-based justification including indication, how ICGA will alter intraoperative decisions (for example, to prevent anastomotic leak), and pertinent supporting documentation.

    • Provide indication (e.g., prevention of anastomotic leakage in rectal surgery) and specifics of intended intraoperative decision changes.
    • Include relevant literature or institutional data supporting proposed use.
    Prior Authorization

    Prior authorization reasonable for rare/high-risk uses

    For rare or high‑risk procedures (e.g., skull base reconstruction, deep AVM surgery) where sample sizes are small and evidence limited, prior authorization may be reasonable; include planned use details and intended decision impact.

    • Document flap type, defect location, and how ICGA findings will guide intraoperative management.
    • State expected outcomes to be influenced (e.g., prevention of CSF leak, flap revision).
    Prior Authorization

    Prior authorization for investigational/limited-use indications

    Given limited or preliminary evidence for some intraoperative applications (e.g., skull base flap perfusion, nerve-sparing prostatectomy), prior authorization may be appropriate when payers require demonstration of medical necessity; include clinical indication and supporting rationale.

    • Provide rationale demonstrating how ICGA is necessary beyond standard techniques.
    • Include prior attempts or alternative methods if applicable.
    Note

    Prior authorization note

    Consult the full policy or plan documents for any prior authorization requirements; this section does not list specific CPT/HCPCS codes requiring authorization.

    • Clinical Policy Bulletins assist in administering benefits but do not guarantee coverage.
    • Providers should verify authorization requirements with the member's plan.
    Step Therapy

    Stepwise diagnostic use relative to fluorescein angiography

    Use a stepwise diagnostic approach: perform fluorescein angiography first; reserve ICGA for cases where FA is equivocal or does not adequately define choroidal neovascularization prior to treatment.

    • ICGA is appropriate when FA results are equivocal or additional choroidal definition is needed before photocoagulation.
    • Document prior FA findings to justify escalation to ICGA.
    Step Therapy

    Stepwise diagnostic approach

    The implied sequencing is fluorescein angiography as first-line imaging, with ICGA reserved for equivocal FA results or when more precise choroidal visualization is needed to guide therapy.

    • Document why FA was insufficient and how ICGA will inform management.
    • ICGA may not be necessary when FA already provides definitive diagnostic information.
    Step Therapy

    No step therapy requirements are described; selective intra-operative use for high-risk patients is suggested in a cost-effectiveness con...

    No formal step therapy (prior authorization sequencing) requirements are described in these excerpts; selective intra‑operative use for high‑risk patients is suggested in cost‑effectiveness discussions.

    • Consider selective use for patients at high risk of complications (e.g., mastectomy flap necrosis) per literature.
    • Routine use is not uniformly endorsed in the absence of stronger RCT evidence.
    Note
    Note
    Note
    Step Therapy

    Step therapy / sequencing

    No explicit step therapy directives are provided in the excerpts; literature supports selective use in higher‑risk scenarios (e.g., low colorectal anastomosis) rather than routine application.

    • Document the specific clinical scenario that justifies ICGA use.
    • Provide evidence that ICGA will alter intraoperative management when requested by reviewers.
    Step Therapy

    Step therapy

    Step therapy is not specified in this section of the policy; providers should follow plan-specific prior authorization and clinical criteria where applicable.

    • No formal sequencing or lock-step requirements are stated for ICGA in these excerpts.
    • Verify any plan-level step therapy rules prior to scheduling.
    Note
    Note
    Documentation Required

    Required clinical documentation

    Physician documentation must support medical necessity and indicate one of the policy-specified findings (e.g., ill‑defined subretinal neovascular membrane on prior FA; subretinal hemorrhage or hemorrhagic RPE; or absence of subretinal neovascular membrane on current FA).

    • Documentation should support the frequency and necessity of the procedure.
    • Include which of the three policy note findings applies to the case.
    Documentation Required

    Document toxicity risk discussion

    Document consideration and discussion of potential ICG ocular toxicity when intra‑vitreal or intraocular ICG is used (including possible residual dye retention and retinal pigment epithelium damage), and record rationale if proceeding with ICG-assisted ILM peeling.

    • Note any informed consent discussion of ICG risks and alternatives.
    • Record prior ocular status that may influence toxicity risk (e.g., macular hole).
    Documentation Required

    Document perfusion measurements and operative decisions

    When ICGA is used intra‑operatively for perfusion assessment (e.g., SPY/LA‑ICGA), document quantitative perfusion measurements (for example SPY numeric values such as <=7 when applicable), identified poorly perfused areas, and any subsequent management decisions made based on imaging.

    • Record numeric perfusion values and correlate with operative findings.
    • Document changes in operative plan (e.g., resection margin adjustment) tied to ICGA results.
    Documentation Required

    Suggested documentation elements

    Include procedure details in the record: ICG dose and concentration (literature commonly reports 2.5 mg/ml or total doses 2.5–10 mg), timing to fluorescence (median ~35 seconds), imaging device used, findings regarding perfusion adequacy, and whether the surgical plan changed because of ICGA.

    • ICG dose used and dilution/concentration.
    • Device/system used for imaging and time to signal visualization.
    • Whether ICGA altered intraoperative management.
    Documentation Required

    Suggested documentation elements

    Recommended documentation includes operative notes describing ICGA use, timing of ICG injection, visualization times, any intraoperative decision changes (e.g., site of bowel division), and relevant outcomes such as anastomotic leak or flap complications.

    • Describe visualization interval after injection and any resection/revision performed due to ICGA.
    • Record short‑term outcomes relevant to the ICGA-guided decision.
    Documentation Required

    Documentation / Technical requirements

    Document technical details when applicable: the near-infrared camera/system used for localization, software/settings if available, and any quantitative or semi-quantitative metrics captured, since devices and protocols vary across studies.

    • Specify the imaging platform (e.g., PinPoint, SPY Elite, microscope‑integrated ICG-VA).
    • Include any software or measurement parameters used (ingress, egress, PxS).
    Documentation Required

    Suggested operative documentation elements

    When used intra‑operatively, document standardized operative elements: ICG dose (commonly reported 2.5–10 mg), timing of injection and visualization, imaging settings, intraoperative findings, and whether the operative plan was changed based on ICGA.

    • Record exact ICG dose and concentration administered.
    • Note imaging device, visualization time, and any intraoperative modifications prompted by ICGA.
    Documentation Required

    Required clinical documentation elements

    Clinical documentation should explicitly state the indication for ICGA, intra‑operative findings, and whether ICGA changed management (for example, modified anastomotic site), and include specifics of ICG dose and imaging system due to variability across studies.

    • Indicate whether the ICGA result led to resection, revision, or other management changes.
    • Provide precise dosing and device details.
    Documentation Required

    Recommended operative documentation

    For skull base flap perfusion assessments, document flap type, defect location, presence or absence of intraoperative enhancement, and postoperative outcomes (CSF leak, meningitis, MRI enhancement) because available studies highlight variability in these parameters.

    • Describe flap pedicle, defect location (anterior vs posterior cranial fossa), and timing of imaging.
    • Record postoperative surveillance and any CSF leak or infectious complications.
    Note

    Clinical Policy Bulletin administrative note

    Clinical Policy Bulletins are intended to assist in administering plan benefits and do not guarantee coverage; providers are responsible for treatment decisions and should consult plan documents for coverage specifics and any authorization requirements.

    • Verify member benefits and prior authorization requirements with the payer.
    • Maintain complete documentation to support medical necessity.
    Denial Risk

    Documentation expectations for ophthalmic ICGA

    Expect denial risk if the member's medical record does not document one of the policy-required ophthalmic findings (e.g., ill‑defined subretinal neovascular membrane on prior FA, subretinal hemorrhage/hemorrhagic RPE, or absence of membrane on current FA).

    • Ensure the medical record explicitly states which policy-specified finding justifies ICGA.
    • Lack of this documentation may lead to claim denial.
    Denial Risk

    Prior fluorescein angiography

    ICGA appropriateness for choroidal neovascularization evaluation depends on prior fluorescein angiography; using ICGA without documented equivocal or insufficient FA may increase denial risk.

    • Document FA results and why FA was inadequate before ordering ICGA.
    • If FA definitively rules out or identifies neovascularization, ICGA may be unnecessary.
    Note

    No explicit payer authorization or documentation rules are present in these excerpts; however, absence of specified administrative triggers means reviewers may request clinical justification or additional records during claim review.

    • Be prepared to supply operative notes, imaging reports, and documentation of how ICGA changed management if requested.
    Denial Risk

    Evidence-related denial risk

    Use of ICGA for indications lacking RCT support may be subject to denial or requests for additional information; provide study references and clinical justification when filing for such uses.

    • Attach pertinent literature or institutional outcomes demonstrating benefit when available.
    • Detail why alternative, established methods are insufficient.
    Denial Risk

    Evidence limitations may trigger coverage scrutiny

    Where indications rely primarily on low‑quality or non‑randomized evidence, payers may scrutinize coverage and request stronger justification; this could lead to denial if medical necessity is not well supported.

    • Provide objective intraoperative measurements and documentation tying ICGA findings to management decisions.
    • Highlight patient‑specific risk factors that justify selective ICGA use.
    Note

    Background sections contain no explicit procedural authorization or coverage preconditions; administrative processing may rely on plan-specific rules.

    Denial Risk

    Documentation variability risk

    Heterogeneity in ICG dosing, imaging systems, and definitions across studies may lead to inconsistent documentation and trigger requests for additional information during review; include precise dosing and device details in records.

    • Record exact ICG dose, dilution, device make/model, and imaging parameters.
    • Provide rationale for chosen protocol when it deviates from commonly reported practice.
    Denial Risk

    Evidence limitations may trigger coverage denial or requests for additional justification

    Variable imaging systems, dosing, and lack of objective fluorescence quantification in studies may result in requests for additional justification or potential denial for some indications; include objective measurements and clear operative decision links when possible.

    • Supply quantitative perfusion metrics (if available) and explain thresholds used to guide decisions.
    • Document any intraoperative changes prompted by ICGA.
    Denial Risk

    Evidence limitations that may affect coverage

    Small sample sizes, lack of randomized controlled data, and variable defect/flap types limit evidence for some intraoperative uses; these evidentiary gaps could form the basis for denial of claims for unproven indications until stronger evidence is provided.

    • For investigational intraoperative uses, provide prospective data or registry evidence where possible.
    • Be prepared to justify necessity in the context of limited published outcomes.
    Note

    Background

    Background: Fluorescein angiography visualizes retinal and some choroidal blood flow but has limitations imaging the choroid due to dye scatter and leakage. Indocyanine green angiography (ICGA) uses intravenously injected ICG dye and near‑infrared imaging to better visualize choroidal circulation and is used as an adjunct to fluorescein angiography for certain chorioretinal conditions.

    Definitions

    inv-85: Indocyanine green angiography (ICGA)
    DefinitionIndocyanine green angiography (ICGA) is a diagnostic study in which indocyanine green dye is injected intravenously and sequential imaging is performed to visualize retinal and choroidal circulation, often used as an adjunct to fluorescein angiography.
    Primary visualized structuresUsed to image retinal and choroidal vasculatures and to better define choroidal neovascularization.
    Adjunct roleEffective as an adjunct to fluorescein angiography when fluorescein results are equivocal or insufficient to define lesions prior to therapy.
    inv-86: ICG-assisted internal limiting membrane (ILM) peeling
    DefinitionICG-assisted internal limiting membrane (ILM) peeling: intraoperative staining of the ILM with indocyanine green dye during vitrectomy to facilitate recognition and peeling of the ILM and epiretinal membranes.
    Reported benefitsStaining facilitates ILM recognition and may improve completeness of membrane removal in difficult cases.
    Safety concernsReports of variable anatomical/functional outcomes and potential ocular toxicity (residual dye persistence up to 7 months; cases of pigment epithelial atrophy, retinal toxicity).
    inv-87: Indocyanine green angiography (ICGA)
    Technique descriptionICGA uses intravenous indocyanine green dye and near-infrared illumination to visualize choroidal and retinal vasculature, providing better choroidal imaging than fluorescein angiography due to reduced dye scatter.
    IndicationsUsed to evaluate ill-defined choroidal neovascularization, serous or hemorrhagic RPE detachments, retinal neovascularization, and retinal hemorrhage.
    Diagnostic sequencingTypically used as a second-level diagnostic test after fluorescein angiography when fluorescein results are equivocal or insufficient.
    inv-88: ICG-assisted ILM peeling
    ApplicationUse of ICG to stain the ILM during vitrectomy to aid peeling of ILM and epiretinal membranes, particularly when visualization is poor.
    Evidence summaryTechnique is popular among vitreoretinal surgeons but outcomes are heterogeneous and evidence is inconclusive regarding routine benefit.
    Risk documentationDocumentation should reflect informed consideration of potential ICG toxicity risks and rationale for intravitreal use.
    inv-89: LA-ICGA / SPY
    Definition/SystemsLA-ICGA / SPY refers to laser-assisted or device-based intraoperative ICGA systems (e.g., SPY Elite) that provide near-infrared fluorescent imaging and numeric perfusion measurements to assess tissue viability intraoperatively.
    Clinical useUsed to evaluate flap perfusion during breast reconstruction and other reconstructive procedures to identify poorly perfused areas in real time.
    Reimbursement noteICGA via devices like SPY may be considered integral to the primary surgical procedure in some contexts (e.g., breast reconstruction) and not separately reimbursed.
    inv-90: ICGA quantitative perfusion parameters
    ParametersICGA quantitative perfusion parameters include ingress (increase in pixel strength [PxS]), ingress rate (slope), curve integral (area under curve), end intensity (PxS at end), egress (decrease in PxS), and egress rate.
    Use caseParameters were used to quantify foot perfusion before and after lower extremity revascularization in a series of patients with severe ischemia.
    PurposeProvides rapid visual and quantitative information about regional perfusion to assess response to revascularization.
    inv-91: ICG-FA / ICGA
    DefinitionICG-FA / ICGA: Indocyanine green fluorescence angiography — intraoperative near-infrared imaging after ICG injection to visualize tissue perfusion and vascular flow.
    Reported intraoperative useApplied for anastomotic perfusion assessment in colorectal surgery and other visceral operations to guide transection level and assess vascular sufficiency.
    Evidence contextStudies report feasibility and potential reductions in leak rates but note need for further randomized trials and standardization.
    inv-92: NIR-ICG
    DefinitionNIR-ICG: Near-infrared indocyanine green imaging used intraoperatively to visualize perfusion; reported median visualization times ~29–35 seconds in colorectal series.
    Clinical impactNIR-ICG assessment resulted in intraoperative change of bowel division site in some patients (e.g., 5.8% in a 504-patient series).
    FeasibilityAchievable with minimal added intra-operative time (median ~5 minutes) and high technical success rates in reported series.
    inv-93: IFI (intra-operative fluorescence imaging)
    DefinitionIFI (intra-operative fluorescence imaging): system using ICG fluorescence to assess graft patency (e.g., in CABG) providing semi-quantitative morphological/functional imaging.
    Performance noteICGA/IFI showed higher sensitivity (83.3%) and specificity (100%) versus transit-time flow measurement for detecting >50% graft stenosis/occlusion in one randomized comparison.
    LimitationsIncomplete visualization in some pilots and lack of absolute quantitative flow measurement; technique is semi-quantitative.
    inv-94: ICGFA / intraoperative fluorescence imaging
    DefinitionICG-FA / intraoperative fluorescence imaging: intraoperative use of ICG with near-infrared imaging to assess perfusion and guide surgical decisions.
    Common reporting elementsStudies report ICG dosing, timing to visualization (~29–35 s), procedural findings (changes in transection site) and operative outcomes (leak rates).
    RecommendationStandardized settings, documentation, and dosing are emphasized due to heterogeneity across studies.
    inv-95: SLN detection metrics
    DefinitionSLN detection metrics: performance metrics include sentinel lymph node detection rate (DR) and bilateral optimal mapping (OM) used to evaluate SLN techniques.
    Performance with ICGPooled SLN detection rates with ICG were higher (overall DR ~94%, bilateral DR ~74% in endometrial studies) compared with blue dye or technetium-99.
    ApplicabilityICG SLN mapping has been applied across gynecologic, colorectal, ovarian, and urologic cancers in feasibility and pooled studies.
    inv-96: ICG-FA
    DefinitionICG-FA: Indocyanine green fluorescence angiography — intraoperative near-infrared imaging using ICG dye to visualize blood flow and lymphatic drainage.
    Typical dose guidanceMost studies suggest ICG doses in the 2.5–10 mg range for intraoperative applications.
    Evidence noteEvidence for some applications (e.g., GI SLN detection, liver tumor detection) remains limited by small prospective studies.
    inv-97: Sentinel lymph node (SLN) mapping
    DefinitionICG-NIRF: Indocyanine green near-infrared fluorescence angiography — intraoperative technique using intravenously injected ICG and NIR imaging to visualize perfusion and anatomical landmarks in real time.
    Example applicationUsed for NVB identification during robot-assisted radical prostatectomy and for colorectal anastomotic perfusion assessment.
    Safety/feasibilityReported as simple, non-invasive, and feasible with no ICG-related complications in a 91-patient prostatectomy series.
    inv-98: ICG-FA
    DefinitionICG-FA: Intra-operative indocyanine green fluorescence angiography used to visualize perfusion in real time during surgery.
    Evidence in colorectal/rectal surgeryMeta-analyses and observational studies report lower anastomotic leakage rates with ICG-FA (pooled AL 3.8% vs 7.8%; ORs reported favoring ICG), but heterogeneity and limited RCT data noted.
    Documentation needStudies emphasize standardized documentation of ICG dose, imaging system, and intraoperative decision changes due to variability across series.
    inv-99: ICG-VA with FLOW 800
    DefinitionICG-VA with FLOW 800: Indocyanine green video-angiography analyzed with FLOW 800 software (Carl Zeiss) used for intra-operative visualization and flow analysis in vascular neurosurgery/AVM cases.
    Reported utilityUsed to localize deep-seated AVMs and guide resection; provided unique localization insights in case series (e.g., aided localization in ~57% of cases reported).
    Evidence qualitySystematic review rated overall evidence as very low; larger registry-based studies recommended.
    inv-100: ICG-NIRF
    DefinitionICG-NIRF: Indocyanine green near-infrared fluorescence angiography using devices (e.g., SPY Elite) for intraoperative perfusion assessment and anatomical guidance.
    Clinical applicationsApplied in breast reconstruction flap assessment, reconstructive surgery, and other intraoperative perfusion evaluations.
    Device noteSPY Elite and similar systems provide real-time imaging and can produce numeric perfusion outputs; heterogeneity exists among devices and software.
    inv-101: Flap perfusion assessment
    DefinitionFlap perfusion assessment: intraoperative evaluation of blood flow to surgical flaps using ICG enhancement to assess perfusion and potentially predict postoperative viability.
    Study findingsSystematic review of skull base reconstruction (7 studies, 104 patients) found intra-operative ICG enhancement associated with post-op MRI enhancement (94%) but not predictive of rare complications (CSF leak rate ~11%).
    Performance thresholdsDevice-specific numeric thresholds (e.g., SPY value <= 7; percent perfusion cutoffs <=25% nonviable, >=45% likely viable) have been reported in mastectomy flap series.