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.
No material clinical or coverage changes in this revision.
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:
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:
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:
Policy lists a non–all-inclusive set of procedures considered experimental/investigational.
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
ICGA is typically used as a second-level diagnostic test contingent upon fluorescein angiography results.
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
Series report high concordance with post‑operative DSA and cases where ICGA altered the surgical procedure.
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:
Studies report high sensitivity/specificity but also tendency to over‑predict necrosis; device/software heterogeneity limits standardization.
Promising initial data; further validation required.
Heterogeneity in devices and thresholds; standardization needed.
Evidence from prospective/retrospective series; complementary tools often required.
Small studies; further larger studies required for validation.
inv-07: Coverage-relevant evidence summaries
Summary of clinical findings relevant to coverage decisions
See multi‑center and systematic review findings.
Preliminary promising data requiring larger validation studies.
Further research needed.
ICGA role in DME requires further investigation.
inv-08: Evidence summaries (informational)
Summary of evidence findings (no prescriptive coverage rules stated in these chunks):
Heterogeneity in dosing, devices, and AL definitions limits certainty.
ICG produced highest SLN detection rates in pooled studies.
Device and setting heterogeneity noted.
IFI/ICGA may reduce early graft failures but is complementary to other assessments.
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
Authors emphasize heterogeneity and need for larger RCTs despite pooled effect estimates.
Standardization and randomized trials recommended.
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):
More high‑quality RCTs are needed to confirm benefit and establish standardized protocols.
Evidence promising but not definitive.
Preliminary evidence only.
Current literature insufficient to predict rare post‑operative outcomes.
Adjunctive use supported by case series.
Further study required.
ICGA complements but does not replace standard vascular assessment tools.
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
| C9733 | Non-ophthalmic fluorescent vascular angiography [Spy Elite System]. |
| H35.3210 - H35.3293 | Exudative age-related macular degeneration. |
| H35.721 - H35.729 | Serous detachment of retinal pigment epithelium. |
| H35.731 - H35.739 | Hemorrhagic detachment of retinal pigment epithelium. |
| H35.361 - H35.369 | Drusen (degenerative) of macula. |
| C50.011 - C50.929 | Malignant neoplasm of breast (listed as ICD-10 not covered for certain indications). |
| D86.0 - D86.9 | Sarcoidosis (listed as not covered/experimental for ICGA utility). |
| affected codes | No explicit CPT/HCPCS/ICD-10 codes are provided in these chunks; literature discusses devices and procedures generically. |
| none specified | No explicit CPT/HCPCS/ICD-10 codes are listed in these chunks. |
| No codes listed |
Provider Actions, Documentation & 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.
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: 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 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.
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 — 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 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 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.
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.
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.
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.
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.
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 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.
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.
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).
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.
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.
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 / 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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
Background sections contain no explicit procedural authorization or coverage preconditions; administrative processing may rely on plan-specific rules.
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.
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.
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.
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
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