CurrentAetnaPolicy 0228

Cardiac CT, Coronary CT Angiography, Calcium Scoring and CT Fractional Flow Reserve

Aetna's clinical policy governing medical necessity, coverage, and investigational determinations for cardiac CT (including coronary CTA), coronary artery calcium scoring, and CT-derived fractional flow reserve. It applies to Aetna members and providers submitting claims for these imaging services.

Policy Summary

PayerAetna

PolicyCardiac CT, Coronary CT Angiography, Calcium Scoring and CT Fractional Flow Reserve

Policy CodePolicy 0228

Change TypeNo material changes

Effective DateApr 9, 1998

Next Review DateFeb 22, 2024

Key ActionObtain prior authorization and document pre-test probability, prior testing, and calcium score when requesting cardiac CT/CTA or CT-derived FFR.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

64-sliceminimum scanner specification for covered coronary CTA

CAC=0 & ≥5yconditions permitting repeat calcium scoring

BMI>40listed contraindication (except with 3rd gen DSCT 120-kv)

Cleerly codesidentified as experimental / not supported

98%approx pooled sensitivity of CCTA

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78%reduction in per-patient testing when CCTA used as gatekeeper

Coverage Criteria — Cardiac CT, Coronary CTA, CAC, CT‑FFR

Medical Necessity — Coronary CT Angiography and Cardiac CT

Covered when ANY of the following indication groups are met (grouping mirrors policy numbering):

Group 1: Rule out obstructive coronary stenosis in symptomatic persons: Rule out obstructive coronary stenosis in symptomatic persons with a low or intermediate pre-test probability of coronary artery disease or atherosclerotic cardiovascular disease by Framingham risk scoring, Pooled Cohort Equations, or ACC criteria.see Appendix for scoring

Includes symptomatic persons with a positive stress test (>=1 mm ST segment depression).

Group 2: Asymptomatic intermediate-risk with equivocal stress test: Evaluation of asymptomatic persons at an intermediate pre-test probability of coronary heart disease or ASCVD who have an equivocal or uninterpretable exercise or pharmacologic stress test or resting ECG changes (eg, LBBB, pathologic Q-waves, RBBB with LAFB) in which CAD is a possible etiology.intermediate pre-test probability per Framingham or Pooled Cohort Equations

Guideline note: AHA recommends against routine stress testing for asymptomatic adults.

Group 3: Pre-operative assessment for high-risk non-cardiac or non-coronary cardiac surgery: Pre-operative assessment for persons scheduled to undergo high-risk non-cardiac surgery (per ACC definition) or planned non-coronary cardiac surgeries, as an alternative to invasive coronary angiography when initial noninvasive assessment is preferred.low or intermediate pretest risk for obstructive CAD for non-coronary cardiac surgery

High-risk non-cardiac surgery examples: emergent, aortic/major vascular, peripheral vascular, prolonged procedures with large fluid shifts.

Group 4: Suspected coronary anomalies in young persons: Detection and delineation of suspected coronary anomalies in persons younger than 40 years with suggestive symptoms (eg, angina, syncope, arrhythmia, exertional dyspnea) or infants with specific signs.age <40 for typical symptoms; infants per listed signs

Includes congenital indications and evaluation of in-stent stenosis and calculation of CT-FFR when CTA shows CAD of uncertain functional significance or is non-diagnostic.

Group 5: Cardiac morphology and structural indications: CT angiography for cardiac morphology including pulmonary vein mapping, pre-TAVR aortic valve annulus assessment, evaluation of aortic erosion after ASD device, anomalous pulmonary venous drainage, complex congenital heart disease, suspected native/prosthetic valve dysfunction when echocardiography is inconclusive, Kawasaki disease, and symptomatic post-heart transplant recipients.indication-specific

Includes coronary vein identification for biventricular pacemaker placement and pulmonary vein evaluation for AF ablation.

Calcium Scoring — Covered Indications

Calcium scoring covered when ALL of the following are met (or as noted):

Primary screening indications: Single CAC scan by low-dose multi-slice CT, electron-beam (ultrafast) CT, or spiral (helical) CT is medically necessary for: (1) asymptomatic persons age >=40 with diabetes; OR (2) asymptomatic persons with intermediate (10% to 20%) 10-year risk of cardiac events by Framingham Risk Scoring or Pooled Cohort Equations.age >=40 with diabetes OR 10-year risk 10-20%

Repeat CAC criteria: Repeat calcium scoring is medically necessary only if ALL of the following are met: member's most recent coronary artery calcium (CAC) scan result was zero; AND the most recent CAC scan was at least 5 years ago; AND discovery of coronary calcium would change management.CAC = 0 and >= 5 years since prior scan

Experimental and Investigational (Not Covered)

The following are considered experimental and investigational (not covered):

Patient contraindications / populations not supported: Cardiac CT angiography for persons with BMI > 40 (except when 3rd generation DSCT 120-kv tube voltage is utilized), inability to image at desired heart rate (<80 bpm) despite beta-blocker administration, persons in atrial fibrillation unless rate-controlled and 3rd generation DSCT 120-kv used, and persons with extensive coronary calcification or prior Agatston score >1000.BMI>40 (except with advanced DSCT); HR>=80 despite meds; AF unless rate-controlled with advanced scanner; Agatston>1000

Technology / applications not established: Use of cardiac CT angiography with less than 64-slice scanners, routine serial or repeat calcium scoring (except when repeat criteria met), broad CTA screening of asymptomatic persons (including routine screening of asymptomatic heart transplant recipients), assessment of atherosclerotic burden or 'vulnerable plaque', and use of the Cleerly Coronary Report or certain AI prioritization/triage tools are considered investigational/not medically necessary.<64-slice scanners; serial CAC without meeting repeat criteria; certain AI/software tools

Cleerly Coronary Report specifically listed as lacking evidence of improved health outcomes.

Initial diagnostic use / Rule-out testing

Clinical scenarios where CCTA is most useful

Preferred use: Patients with low-to-intermediate pre-test probability of obstructive CAD and low coronary calcification (including CAC = 0) where CCTA is employed primarily as a rule-out test due to its high negative predictive value.pre-test probability low-to-intermediate; CAC low (including zero)

CCTA requires ECG gating, heart-rate control (often with beta-blocker) and is most informative when calcification is minimal; newer scanners can reduce radiation exposure.

Selective referral for ICA

CCTA as gatekeeper to invasive angiography

Gatekeeper strategy: Use of CCTA to triage patients referred for invasive coronary angiography can substantially reduce per-patient testing and selective catheterization based on CTA findings, with comparable major adverse cardiovascular event outcomes in trial follow-up.N/A

CONSERVE trial reported a 78% reduction in per-patient testing and lower revascularization rates with a CCTA-selective catheterization strategy.

Management and outcomes

Prognostic and outcome implications

Impact on management and outcomes: CCTA identifies non-obstructive and obstructive atherosclerosis leading to initiation of preventive therapies (eg, aspirin, statins, beta blockers) and lifestyle interventions; randomized trials and meta-analyses (SCOT-HEART, PROMISE and pooled analyses) associate CCTA with improved preventive therapy initiation and reductions in non-fatal myocardial infarction in some analyses.N/A

CCTA may increase rates of ICA and revascularization in some settings while reducing MI in others; provider management changes follow CCTA findings.

Acute chest pain evaluation

Emergency department and acute chest pain evaluation

ED use: In low-to-intermediate risk ED patients without known CAD, CCTA shortens length of stay and time to diagnosis, permits safe discharge when negative, and may reduce costs, though it can increase downstream invasive angiography and revascularization rates.Patients without known CAD presenting with acute chest pain and appropriate risk strata

Trials include ROMICAT II, CT-STAT, Litt et al; high NPV allows ruling out ACS in properly selected patients.

Clinical coverage context and evidence summaries

Clinical evidence and guideline-derived contexts where CCTA, FFRCT, and CAC scoring are described:

CCTA as diagnostic gatekeeper: Randomized trials and observational studies demonstrate CCTA can identify or exclude CAD and may reduce unnecessary invasive angiography; trials show mixed effects on hard outcomes and no definitive superiority over functional testing for all presentations.

Supported by PROMISE, SCOT-HEART, CONSERVE and other studies.

FFRCT use-case: HeartFlow FFRCT is supported as a noninvasive physiologic assessment for patients with stable, recent-onset chest pain and clinically intermediate risk (10%–90%) when adequate CCTA (>=64-slice) data are available; FFRCT may avoid invasive angiography in selected patients.clinical risk 10%-90%

NICE consultation and device summaries referenced; FFRCT not recommended for acute coronary syndrome or recent stent/bypass in some guidance.

CAC / EBCT role: CAC scoring detects subclinical calcified plaque and may inform risk assessment for selected intermediate-risk individuals but is not supported for routine screening of asymptomatic low-risk adults; guideline statements recommend selective use when risk-based treatment decisions remain uncertain.

AI-assisted CCTA — Evidence and limitations

Evidence and coverage-relevant findings summarized for AI-assisted CCTA tools

Evidence summary: Retrospective and sub-study analyses of AI-assisted CCTA tools (eg, Cleerly/AI-QCT) demonstrate high diagnostic performance versus core-lab QCA/FFR with rapid analysis times and FDA 510(k) clearance for Cleerly; however, there is a lack of evidence that use of the Cleerly Coronary Report improves patient health outcomes and prospective outcome trials are lacking.

CREDENCE sub-analyses report high per-patient sensitivity and rapid analysis (~10 min); prospective outcome data are needed.

CAV surveillance imaging

Noninvasive imaging for cardiac allograft vasculopathy (CAV)

Imaging options: CT coronary angiography, IVUS, MRI, PET, and echocardiography have roles in CAV surveillance; CTCA can be an alternative to invasive coronary angiography in experienced centers, although IVUS during ICA remains the gold standard when discrepancies exist.

Systematic review and society statements support noninvasive modalities as alternatives in select settings.

Post-Heart Transplant Surveillance — Imaging Considerations

Non-invasive imaging modalities may be used as alternatives to invasive coronary imaging for detection of cardiac allograft vasculopathy when appropriate.

Non-invasive imaging options: Transthoracic echocardiography, CT, MRI, and PET have demonstrated good-to-excellent accuracy for identifying CAV across multiple studies and may be considered as alternatives to invasive coronary imaging with IVUS when clinically appropriate.

Invasive coronary imaging with IVUS during ICA remains gold standard; noninvasive modalities reduce procedural risk and expense in experienced centers.

AI-assisted CAC assessment on non-gated chest CT

AI-based CAC scoring applied to non-gated chest CT (including LDCT) can provide risk category assessment concordant with manual Agatston-based scoring in studies.

AI-CACS performance: AI-CACS demonstrates good correlation and agreement with manual gated CACS (eg, correlation rho = 0.893, kappa = 0.679) and concordance rates around 80.6% in a 901-patient study; accuracy for dichotomous risk categories bounded by 0,100,400 was high across scanner types.

AI enables opportunistic CAC quantification on non-gated CT without additional radiation, but validation across settings is ongoing.

LDCT for lung cancer screening with CAC assessment: Low-dose chest CT (LDCT) is sensitive for coronary calcium; a negative LDCT for CAC may obviate dedicated gated CT. Qualitative categorical CAC scoring on LDCT correlates broadly with Agatston categories when performed by cardiac imaging experts; AI tools may improve reproducibility but require further validation before replacing gated numeric scoring.

Authors recommend reporting qualitative CAC categories on all LDCT for lung cancer screening; AI promising but needs more evidence.

Services considered investigational or excluded include serial or repeat coronary artery calcium (CAC) scoring except when explicit repeat criteria are met, and coronary CT angiography (CCTA) performed for general screening of asymptomatic persons (including routine testing of asymptomatic heart transplant recipients). The policy specifically cites use of CCTA for broad screening, assessment of atherosclerotic burden, and monitoring of atheroma as not supported by current evidence. Additionally, automated plaque characterization and certain AI-driven post-processing tools including the Cleerly Coronary Report are listed as lacking evidence of improved health outcomes and are considered investigational.

Limitations and relative contraindications for performing contrast-enhanced CCTA include irregular heart rhythms, known high coronary calcification (eg, CAC scores >= 400 or higher thresholds cited in some analyses), and borderline tachycardia defined as heart rate >80 beats/min despite pre-treatment. The policy also notes baseline renal impairment and known IV contrast allergy as factors that limit appropriateness or increase risk.

Specific contraindications called out where CCTA is generally not appropriate include acute myocardial infarction, routine screening of asymptomatic patients with low-to-intermediate risk of CAD, evaluation of coronary artery stents less than 3 mm, and evaluation of asymptomatic patients post-coronary artery bypass grafting (CABG) within 5 years or post-stent placement within 2 years.

Routine use of electron-beam CT (EBCT) or CT calcium scoring for population screening of asymptomatic individuals is not recommended because evidence is insufficient to demonstrate that screening reduces coronary events or death. Reviews and technology assessments have concluded EBCT/CAC screening lacks established clinical utility for broad asymptomatic screening, with questions remaining about target populations, thresholds, and impact on management.

The policy identifies a lack of evidence that the Cleerly Coronary Report improves patient health outcomes. While Cleerly has received FDA 510(k) clearance, the document highlights limitations of available studies (retrospective analyses, post‑hoc CREDENCE substudies) and states that prospective outcome data demonstrating improved clinical outcomes are not yet available.

Qualitative assessment of coronary artery calcium on low-dose, non-gated chest CT (eg, LDCT for lung cancer screening) by general radiologists is less accurate and reproducible than dedicated gated CT numeric scoring. The policy notes that AI-assisted methods show promise to provide quantitative CAC on non-gated studies and to improve reproducibility, but additional validation is required before these tools can replace gated numeric scoring in routine practice.

The cited reference segments in this policy provide supporting evidence, literature reviews, and device summaries but do not by themselves establish explicit additional coverage exclusions beyond those stated in the policy. They are presented as supporting documentation for the policy determinations.

Clinical Policy Bulletins are developed to assist administration of plan benefits but are not contracts or guarantees of coverage. Coverage remains subject to the specific member plan provisions and program disclosures; providers retain responsibility for clinical decisions and should verify benefits against the member's plan.

Coding — Covered and Not Covered Codes

Covered CPT/HCPCS for CTA and CT-FFR when selection criteria metCPTCovered

0501T-0504T	Noninvasive estimated coronary fractional flow reserve derived from coronary CTA data using computation fluid dynamics physiologic simulation software analysis of functional data to assess the severity of coronary artery disease.
75571	Computed tomography, heart, without contrast material, with quantitative evaluation of coronary calcium [not covered for serial or repeat calcium scoring].
75572	Computed tomography, heart, with contrast material, for evaluation of cardiac structure and morphology (including 3D image postprocessing, assessment of cardiac function, and evaluation of venous structure, if performed).
75573	Computed tomography, heart, with contrast material, for evaluation of cardiac structure and morphology in the setting of congenital heart disease (including 3D image postprocessing, assessment of LV cardiac function, RV structure and function and evaluation of venous structures, if performed).
75574	Computed tomographic angiography, heart, coronary arteries and bypass grafts (when present), with contrast material, including 3D image postprocessing (including evaluation of cardiac structure and morphology, assessment of cardiac function, and evaluation of venous structures, if performed).
75580	Noninvasive estimate of coronary fractional flow reserve (FFR) derived from augmentative software analysis of the data set from a coronary computed tomography angiography, with interpretation and report by a physician or other qualified health care professional.

Codes identified as not covered / experimental (e.g., Cleerly, plaque characterization software)CPTNot Covered

0623T	Automated quantification and characterization of coronary atherosclerotic plaque to assess severity of coronary disease; review of computerized analysis output, interpretation and report [Cleerly Coronary Report].
0624T	Automated quantification and characterization of coronary atherosclerotic plaque to assess severity of coronary disease; data preparation and transmission [Cleerly Coronary Report].
0625T	Automated quantification and characterization of coronary atherosclerotic plaque to assess severity of coronary disease; review of computerized analysis output to reconcile discordant data, interpretation and report [Cleerly Coronary Report].
0626T	Intraprocedural coronary fractional flow reserve (FFR) with 3D functional mapping of color-coded FFR values for the coronary tree, derived from coronary angiogram data, for real-time review and interpretation [Cleerly Coronary Report].
0710T-0713T	Noninvasive arterial plaque analysis using software processing of CTA data; includes data preparation/transmission, quantification of vessel wall structure and composition, assessment for lipid-rich necrotic core plaque, data review, interpretation and report.
0721T-0722T	Quantitative computed tomography (CT) tissue characterization codes (including interpretation and report); not covered for listed indications in the CPB.

HCPCS covered for calcium scoringHCPCSCovered

S8092

Electron beam computed tomography (also known as ultrafast CT, cine CT).

Example ICD-10 codes noted as covered when selection criteria metICD-10

E08.59	Diabetes mellitus due to underlying condition with other circulatory complications.
E10.59	Type 1 diabetes mellitus with other circulatory complications.
E11.59	Type 2 diabetes mellitus with other circulatory complications.
I25.10-I25.119	Atherosclerotic heart disease of native coronary artery.
I44.7	Left bundle-branch block.
I45.10-I45.19	Other and unspecified right bundle-branch block.
I48.0-I48.91	Atrial fibrillation codes (covered when rate-controlled and 3rd gen DSCT 120-kv is utilized).
Q21.1	Atrial septal defect.
Z13.6	Encounter for screening for cardiovascular disorders.

ICD-10 codes listed as not covered / contraindicatedICD-10Not Covered

I46.2-I46.9	Cardiac arrest (listed as contraindicated for CTA in this CPB).
Z91.041	Radiographic dye allergy status (contraindicated).
Z68.41-Z68.45	BMI 40.0 or greater (contraindicated unless 3rd gen DSCT 120-kv utilized).
Z48.21	Encounter for aftercare following heart transplant (listed as not covered for routine screening).

References to coding developmentsCPT

Category III CPT (example referenced)

Reference to issuance of a new category III CPT code for a coronary artery calcium population health solution (Nanox) — press release citation

FDA 510(k) device summaries (document IDs)mixed

K202280	Cleerly Labs v2.0 510(k) summary
K161772	HeartFlow FFRCT 510(k) summary

Referenced FDA 510(k) device summariesmixed

K202280	Cleerly Labs v2.0 510(k) No. K202280 (FDA)
K161772	HeartFlow FFRCT 510(k) No. K161772 (FDA)

inv-35: Calcium score / Agatston — Repeat CAC and CTA effectiveness

Repeat CAC permittedAllowed only when the member's most recent coronary artery calcium (CAC) scan result was zero AND the prior scan was at least 5 years earlier

CTA performance considerationCoronary CTA is less effective when Agatston (CAC) score is ≥600 (CORE-64 subset analysis showed decreased AUC and NPV)

Calcium scoring modalitiesValid modalities for CAC include low-dose multi-slice CT, electron-beam (ultrafast) CT, or spiral (helical) CT

inv-36: Heart rate for imaging

Target pre-scan heart rate

Provider Actions — Authorization, Documentation, and Workflow

Prior Authorization

Prior Authorization Required

Prior authorization is required when requesting cardiac CT/CTA and related CT calcium scoring or CT-derived FFR codes; coverage is contingent on member plan provisions. Clinical Policy Bulletins do not themselves establish coverage — providers must follow the member's plan benefits and any program disclosures. Prior authorization requirements depend on the member's plan and applicable administrative rules.

Prior authorization may be required for CCTA, CT calcium scoring (75571), contrast CCTA (75572/75573/75574), and noninvasive CT-derived FFR services (0501T-0504T, 75580).
Clinical Policy Bulletins are a partial description; check plan provisions and obtain PA when indicated.

Documentation Required

Prior Testing and Pre-test Probability

Document prior noninvasive testing and estimate the pre-test probability of coronary artery disease (CAD) when selecting CCTA. Use established tools (Framingham risk score, Pooled Cohort Equations) or ACC pre-test probability tables and record results in the chart to justify imaging.

Background — Rationale and Evidence Context

Coronary CT angiography (CCTA) is a contrast-enhanced, ECG‑triggered, multi-slice CT method that provides a noninvasive alternative to invasive coronary angiography for evaluation of coronary artery disease and coronary anomalies. It has high negative predictive value and is most useful as a rule‑out test in patients with low-to-intermediate pre-test probability or when other noninvasive tests are equivocal; image quality and applicability are influenced by scanner generation, heart-rate control, and patient factors.

Definitions and Terminology

inv-74: CCTA / Cardiac CTA

Definition — CCTA / Cardiac CTAContrast-enhanced cardiac computed tomography angiography (CCTA) uses multi-slice CT with intravenously administered contrast and ECG-triggering to visualize coronary arteries as a noninvasive alternative to invasive coronary angiography

Technical adjunctsBeta-blockers and sublingual nitrates are commonly used pre-scan to lower heart rate and dilate coronary arteries to improve image quality

Scanner generationsHigher slice-count scanners (eg, 64-slice and above) shorten scan time and improve spatial resolution, reducing artifacts

inv-75: CT-derived FFR (HeartFlow / software-based)

Definition — CT-derived FFR (HeartFlow)Noninvasive estimated coronary fractional flow reserve derived from coronary CTA DICOM data using computational fluid dynamics physiologic simulation software (eg, HeartFlow FFRCT)

Revision History and References

This policy references coding and device summaries, including FDA 510(k) summaries for Cleerly Labs (K202280) and HeartFlow FFRCT (K161772), and cites a broad reference list informing policy development. The reference list segment itself does not contain standalone 'not medically necessary' rulings but supports the policy's clinical conclusions and code group assignments.

The references and literature cited in the policy do not include step therapy rules for imaging. The document notes that step‑therapy sequencing is not applicable to the stated cardiac CT and CAC policy elements and that no prescriptive step‑therapy requirements are provided in the referenced sections.

1998-04-09policy_effective

Policy originally became effective.

2024-02-09last_review

Policy Summary

PayerAetna

PolicyCardiac CT, Coronary CT Angiography, Calcium Scoring and CT Fractional Flow Reserve

Policy CodePolicy 0228

Change TypeNo material changes

Effective DateApr 9, 1998

Next Review DateFeb 22, 2024

Key ActionObtain prior authorization and document pre-test probability, prior testing, and calcium score when requesting cardiac CT/CTA or CT-derived FFR.

SourceLink

On This Page

Referenced: USPSTF, ACC/AHA guidance; evidence limited for routine population screening.

Technical and patient limitations: CCTA utility is affected by scanner generation, high coronary calcification, arrhythmia, high heart rate, renal impairment and contrast allergy; newer dual-source and wide-detector scanners expand eligibility (eg, AF, high BMI) but may change radiation exposure and require experienced centers.

Scanner specification (>=64-slice) is a minimum for covered coronary CTA; high CAC (eg, >=400–600 or >1000) and HR >80 despite preparation reduce diagnostic accuracy.

Desired heart rate for diagnostic cardiac CT angiography is under 80 beats per minute (use beta-blockers or calcium channel blockers as needed)

Advanced scanner exception3rd generation dual-source or modern wide-detector scanners may permit imaging with less strict HR control in selected cases

ECG-triggering roleECG-triggered acquisition and heart-rate control improve image quality and reduce motion artifacts

inv-37: Heart rate — Borderline tachycardia

Borderline tachycardia definitionHeart rate > 80 beats per minute despite pre-treatment (eg, beta-blocker) is considered borderline tachycardia and may limit CCTA utility

Implication for appropriatenessPersistent HR >80 may render study non-diagnostic or necessitate alternative testing or advanced scanners

Documentation recommendedDocument efforts at rate control and reasons if HR remains >80 prior to scan

inv-38: Coronary artery calcium score — Levels impacting CTA

CAC threshold where CTA performance decreasesCoronary artery calcium (CAC) scores ≥400 are associated with reduced CCTA diagnostic performance

Higher CAC impact notedIn CORE-64 subset analysis, CTA performance decreased notably in patients with CAC ≥600 (AUC and NPV were lower)

Clinical implicationHigh CAC should be considered when selecting CCTA; invasive angiography may be preferable if burden is prohibitive

inv-39: CAC score threshold for non-diagnostic CCTA

Non-diagnostic CCTA cutoffA calcium (Agatston) score of >1000 is commonly used as the cutoff above which CCTA is often non-diagnostic and contrast CTA may be withheld

Guidance sourceCalcium scores greater than 1000 have been taken as a relative contraindication for CCTA (Maurya et al; Lin)

Alternative actionConsider invasive coronary angiography when CAC burden suggests non-diagnostic CCTA

inv-40: CAC risk category cutpoints

CAC risk category cutpointsRisk categories for CAC used in studies and AI-CACS are bounded by scores: 0; 1–100; 101–400; >400

AI-CACS performanceAI-based CAC scoring on non-gated chest CT showed concordance (≈80.6%) and kappa ≈0.679 versus manual Agatston-based categories

Clinical useThese categorical cutpoints are used for opportunistic risk stratification and reporting on chest CT/LDCT studies

Record prior stress test results (exercise or pharmacologic) and whether results were equivocal or uninterpretable.
Document the calculated pre-test probability (e.g., Framingham or Pooled Cohort Equations) or ACC age/gender/symptom category.

Prior Authorization

Prior Authorization Considerations for HeartFlow FFRCT

HeartFlow FFRCT should be considered only when a diagnostic-quality CCTA from a 64-slice (or greater) scanner is available and when used for patients with stable, recent-onset symptoms. Prior authorization and documentation should note availability of prior CCTA and the clinical indication for FFRCT.

HeartFlow FFRCT requires prior CCTA DICOM dataset from 64-slice or higher equipment.
Not recommended for acute coronary syndrome or within 1 month of MI, recent stent, or CABG per guidance — document clinical status.
Document that FFRCT is intended to inform need for invasive angiography or revascularization.

Documentation Required

CAC Threshold Affecting CCTA

High coronary artery calcium burden may render contrast-enhanced CCTA non-diagnostic. Calcium scoring can be used as part of a pre-scan assessment to determine scan feasibility and avoid contrast administration when images are unlikely to be diagnostic.

Calcium scores greater than 1000 are commonly considered a relative contraindication to performing contrast CCTA because images are often non-diagnostic.
Calcium scoring or a scout scan may be performed prior to contrast injection to assess whether CCTA will be feasible; if prohibitively high, consider invasive coronary angiography instead.

Note

CT Angiography for Post‑Transplant CAV

In experienced centers, CT coronary angiography can be an alternative to invasive coronary angiography for detection and surveillance of cardiac allograft vasculopathy (CAV). When used, document center experience and rationale for noninvasive approach.

CT coronary angiography may be considered for post‑heart transplant surveillance in experienced centers, particularly when high-quality scanners (e.g., dual-source) are available to manage high heart rates.
If non-diagnostic or results are discordant with clinical concerns, invasive angiography with IVUS remains the gold standard and should be considered.

Documentation Required

Screen for Stress Test Contraindications

Before selecting CTA, screen for contraindications to exercise or pharmacologic stress testing and document any contraindications or inability to perform stress testing that support choosing CTA first.

Document contraindications to exercise stress testing (e.g., acute MI, unstable angina, uncontrolled arrhythmia, severe aortic stenosis, inability to exercise, uninterpretable ECG).
Document contraindications to pharmacologic stress testing (e.g., active bronchospasm for adenosine/dipyridamole, significant conduction disease for dobutamine) when relevant.

Denial Risk

Contraindications Potentially Affecting Authorization

Contraindications that may affect authorization when considering CCTA should be identified and documented. Presence of listed contraindications may justify alternative testing or denial of CCTA if not clinically appropriate.

Contraindications potentially affecting authorization include acute myocardial infarction, unstable angina, inability to cooperate with scan, significant renal impairment (low GFR), known iodinated contrast allergy, irregular heart rhythms, and prohibitively high CAC.
Screen and document heart rate control efforts (beta-blockers/calcium channel blockers) and rhythm regularity prior to authorization.

Billing Rule

Use of Post-processing Software

When post-processing software (e.g., Cleerly Labs) or AI-assisted quantitative CT is used, a trained medical professional must perform and review user-editable segmentation and validate results. Software outputs are adjunctive and should be corroborated by qualified reader interpretation.

Ensure users are appropriately trained in the software; document user qualification and review of final edited segmentation.
Recognize that some applications (Cleerly) are considered investigational for improving outcomes and may be subject to denial for experimental indications when used beyond supported contexts.

Documentation Required

User Training and Result Validation

When AI-assisted or other post-processing tools are used, the operator must be trained and must validate the final results; the software is adjunctive and does not replace clinical judgment.

Document who performed the post-processing, their training, and that results were reviewed and finalized by a qualified clinician.
Do not rely solely on unedited software outputs for clinical decision-making or authorization justification.

Documentation Required

Pre-scan Clinical Documentation & Justification

Documentation should include pre-scan clinical factors that affect image quality and patient risk, and should justify the chosen imaging modality. Appropriate documentation supports medical necessity and authorization decisions.

Pre-scan documentation: calcium score (if performed), heart rate and rate-control medications used, renal function (GFR), contrast allergy status, BMI/technical considerations.
Clinical documentation to justify imaging: symptoms, prior test results, pre-test probability calculation (Framingham, Pooled Cohort Equations, or ACC criteria), and intended clinical management impact of the test.

Documentation Required

FFRCT Documentation Requirements

FFRCT can be accepted as a noninvasive method of documenting ischemia around the time of revascularization when appropriately documented; ensure source CCTA is available and include FFRCT interpretation with the clinical record.

Document the indication for FFRCT, the availability and quality of the prior CCTA dataset, and how FFRCT results will be used in management (e.g., decision for ICA/PCI).
Record that registries allow FFRCT as acceptable documentation of ischemia in the context of PCI decisions.

Documentation Required

Pre-test Probability Assessment Expected

Pre-test probability assessment is expected and should be documented in the medical record. Use ACC tables or validated risk calculators and record the result when requesting CCTA.

Include the chosen method for pre-test probability (ACC criteria table, Framingham Risk Score, or Pooled Cohort Equations) and the numeric or categorical result.
Pre-test probability documentation supports appropriateness (e.g., low or intermediate pre-test probability indications for CCTA).

Note

References — No PA Stated

Some sections of this Clinical Policy Bulletin are reference-only and do not impose prior authorization or documentation requirements themselves. Providers should not assume references alone constitute authorization rules.

The References section lists supporting literature and does not state PA requirements.
No authorization or denial rules are present in reference-only citation blocks — check the policy statements and plan provisions for actionable rules.

Note

Clinical Policy Bulletin Disclaimer

Clinical Policy Bulletins are developed to assist in administering plan benefits but do not constitute an offer of coverage or medical advice. Providers remain responsible for treatment decisions and must follow plan terms; claims are subject to plan provisions.

Clinical Policy Bulletins do not constitute coverage guarantees; review member benefits and plan documents.
Providers are independent and responsible for clinical decisions; administrative coverage depends on plan terms and prior authorization when required.

Note

Imaging Pathway Considerations

Consider the diagnostic pathway implications when choosing CCTA. Evidence supports CCTA as an alternative to functional testing in select patients and as a gatekeeper to invasive coronary angiography, but model-based findings and trial data should be weighed in clinical decision-making.

CCTA may be preferred prior to invasive coronary angiography in selected stable chest pain patients (gatekeeper strategy) and may reduce downstream ICA in some pathways.
Simulated diagnostic pathway models suggest CCTA (with or without AI-QCT) could reduce invasive angiography, but these are model-based and require clinical judgement.

Documentation Required

Assess Scan Feasibility Before Contrast CTA

Assess scan feasibility before administering contrast for CTA. Use calcium scoring or a scout scan to estimate coronary calcification and decide whether contrast-enhanced imaging will be diagnostic.

If calcium burden appears prohibitively high on scout or non-contrast images, withhold contrast and consider alternative testing or invasive angiography.
Document the feasibility assessment in the record to support authorization and medical necessity decisions.

Documentation Required

Consider Stress Testing Prior to CT

Consider appropriateness of stress testing prior to CTA when indicated. If stress testing is contraindicated or not feasible, document reasons for proceeding directly to CTA.

When stress testing is appropriate, consider exercise or pharmacologic testing first; if contraindicated or uninterpretable, document and consider CCTA.
Record contraindications to stress testing (see AHA/ACC lists) when used to justify CTA as initial testing.

Step Therapy

Step therapy sequencing is not specified in this portion of the policy. No step therapy rules are provided in the references or appendix sections of this Clinical Policy Bulletin.

No step therapy requirements are specified for imaging modalities in this CPB segment.
Providers should follow plan-specific step therapy rules if present in the member's benefits.

FFRCT provides physiologic assessment from CCTA and may help avoid invasive angiography when applied to appropriate patients

Regulatory referenceHeartFlow FFRCT has an FDA 510(k) summary (No. K161772) cited in the policy references

inv-76: Lifetime attributable risk (LAR)

Definition — Lifetime attributable risk (LAR)Estimated lifetime cancer risk attributable to radiation exposure from CT imaging; varies by patient age, sex, scan protocol, and scanner generation

Magnitude examplesLAR estimates vary widely (eg, 1 in 143 for a 20-year-old woman to 1 in 3,261 for an 80-year-old man for standard cardiac scans); dose reduction techniques lower estimates

ImplicationRadiation risk considerations influence modality choice, particularly in younger patients and women

inv-77: Calcium score (CAC)

Definition — Calcium score (CAC)Quantitative Agatston-based measure of coronary artery calcification obtained from gated CT used to detect subclinical atherosclerosis and inform pre-test stratification for CCTA

ModalitiesCAC scoring may be obtained by multi-slice CT, electron-beam (ultrafast) CT, or spiral/helical CT

Clinical limitationHigh CAC burden reduces CTA diagnostic accuracy and may necessitate alternative testing

inv-78: FFR / FFRCT

Definition — FFR / FFRCTFractional flow reserve (FFR) is the invasive physiologic ratio of maximal blood flow in a narrowed artery to flow in a normal artery; FFRCT is the CT-derived noninvasive computational estimate from CCTA images

Clinical utilityFFR-guided strategies improve revascularization outcomes compared with angiography-alone approaches; FFRCT offers noninvasive physiologic data from CCTA

Requirement for FFRCTFFRCT analysis requires high-quality CCTA acquisition (typically ≥64-slice) for reliable computation

inv-79: CAC / EBCT / UFCT

Terminology — CAC / EBCT / UFCTCoronary artery calcium scoring encompasses methods including electron-beam CT (EBCT/ultrafast CT) and multi-slice CT (MSCT); EBCT is highly sensitive but less specific

Clinical implicationsDifferent acquisition technologies influence sensitivity, specificity, and comparability of Agatston scores

Reporting noteDedicated gated cardiac CT numeric scoring is preferred over qualitative LDCT assessment for clinical decision-making

inv-80: Electron-beam CT (EBCT) / Ultrafast CT

Definition — EBCT / Ultrafast CTElectron-beam CT (EBCT), also called ultrafast CT, is a historical rapid-acquisition modality used for CAC scoring with high sensitivity but limited specificity for predicting events

Comparative noteEBCT scans are faster and were used as early gold-standard for CAC but multi-slice CT is now common in clinical practice

Evidence guidanceGuidelines have recommended against routine EBCT screening in asymptomatic populations pending outcome data

inv-81: Multi-slice CT (MSCT) / Spiral (helical) CT

Definition — Multi-slice CT (MSCT) / Spiral CTCT technologies using multiple detector rows or helical acquisition (multi-slice or spiral/helical CT) used for CCTA and CAC quantification; increasing detector rows improves temporal resolution and image quality

Scanner impactAdvances from 4-slice to 64-slice and current wide-detector scanners improved scan time, resolution, and reduced artifacts

Clinical relevanceMinimum recommended scanner for covered coronary CTA is 64-slice to ensure diagnostic quality

inv-82: Cleerly Labs

Cleerly Labs — product typeA web-based, user-editable post-processing software for analyzing CCTA data to quantify coronary plaque and stenosis and generate an interactive Coronary Report

Intended use and limitationThe software is intended for use by trained medical professionals and not to replace clinician judgment; interpolated data and editable segmentation require user validation

Regulatory noteCleerly v2.0 has an FDA 510(k) summary referenced in the policy (K202280), but evidence of improved clinical outcomes from use of the Coronary Report is lacking

inv-83: Cleerly Labs / Coronary Report

Cleerly Coronary Report — capabilityAn AI-assisted Coronary Report that performs coronary artery segmentation, plaque quantification, and stenosis assessment as an interactive report for clinician review

User responsibilitiesUsers can edit lumen and vessel-wall segmentation and must validate outputs; the report is supportive data, not a standalone diagnostic decision

Regulatory referenceCleerly Labs v2.0 510(k) No. K202280 is cited in the policy references

inv-84: HealthCCSng (Nanox.AI)

HealthCCSng — functionAn FDA-cleared AI software (HealthCCSng) for automated quantitative CT tissue characterization to detect and quantify coronary artery calcium on non-gated chest CT

Clinical applicationEnables opportunistic CAC quantification and classification into risk categories on commonly ordered chest CTs without additional radiation

LimitationsPolicy designates AI-assisted tools adjunctive; they should not replace full clinical evaluation and outcome-improving evidence is still limited for some applications

inv-85: CAV

Definition — CAVCardiac allograft vasculopathy (CAV) is the leading cause of long-term graft dysfunction after heart transplantation

Diagnostic contextIVUS during invasive coronary angiography remains the gold standard for CAV diagnosis, but noninvasive modalities including CTCA can be alternatives in experienced centers

Policy implicationCT coronary angiography may be considered for CAV surveillance in experienced centers; discrepant noninvasive results may prompt invasive imaging with IVUS

inv-86: AI-CACS / HealthCCSng

AI-CACS / HealthCCSng — summaryAI-CACS (eg, HealthCCSng) are AI algorithms cleared to detect and quantify CAC on non-gated chest CT and stratify patients into CAC risk categories

EvidenceStudies (eg, Xu et al) show good correlation (ρ≈0.893) and concordance (~80.6%) with manual gated CACS categorization bounded by 0,100,400

Use-case noteAI-CACS enables opportunistic screening on LDCT but clinical validation across scanners and outcomes data remain areas for further study

inv-87: CT-derived fractional flow reserve (FFRct)

Definition — CT-derived fractional flow reserve (FFRct)A noninvasive physiologic estimate of coronary lesion significance computed from coronary CT angiography images using computational models and device-specific software

Evidence baseSupported by device summaries and systematic reviews/meta-analyses referenced in the policy (eg, HeartFlow and subsequent evaluations)

Clinical requirementFFRct analysis requires high-quality CCTA data (typically from ≥64-slice scanners) for reliable computation

inv-88: CT-derived fractional flow reserve (CT-FFR)

Definition — CT-FFRNoninvasive computational estimation of coronary physiologic significance derived from coronary CT angiography, used to identify ischemia-producing lesions

Regulatory citationsCT-FFR technologies are described alongside FDA 510(k) summaries and systematic review evidence in the policy references

Clinical roleCT-FFR may help guide need for invasive angiography or revascularization in appropriately selected patients

inv-89: Coronary artery calcium scoring (CAC)

Definition — Coronary artery calcium scoring (CAC)CT-based quantification (Agatston scoring) of coronary artery calcification used for risk assessment and pre-test stratification prior to CCTA

Clinical interpretationCAC quantifies calcified plaque burden but does not measure physiologic significance; high scores reduce CCTA accuracy and influence test selection

Reporting practicesDedicated gated CT numeric Agatston scoring is the standard; opportunistic LDCT/AI methods may provide categorical risk assessments but are not fully equivalent

Most recent policy review completed.

2024-02-22next_review_scheduled

Next scheduled policy review date.