ModifiedColorado Rocky Mountain Health PlansPolicy MMP372.12

Non-Invasive Fractional Flow Reserve (FFR) for Ischemic Heart Disease

Policy governing clinical use and coverage of noninvasive fractional flow reserve derived from coronary CT angiography (FFR-ct) for evaluation and management of patients with coronary artery disease; affects clinicians submitting claims to Colorado Rocky Mountain Health Plans (UnitedHealthcare Medicare Advantage).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyNon-Invasive Fractional Flow Reserve (FFR) for Ischemic Heart Disease

Policy CodePolicy MMP372.12

Change TypeClinical evidence, FDA, and references updated

Effective DateMar 1, 2026

Next Review Date

Key ActionObtain and document a completed, interpreted CCTA showing 40–90% stenosis in a proximal or mid coronary artery before requesting FFR-ct and include CPT 75580 on the claim when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Updated Clinical Evidence, FDA, and References sections to reflect the most current information.

Updated list of documents available in the Medicare Coverage Database to reflect the most current information.

75580CPT code listed for FFR-ct

Class IIAAHA/ACC recommendation strength

1,400Patients randomized in FORECAST RCT

82.2%Pooled accuracy (Faulder et al. 2024)

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Coverage and Medical Necessity Criteria

Medical Necessity Criteria

Covered when ALL of the following are met

FFR-ct general coverage criteria: (1) FDA-approved FFR-ct technology is used; (2) patient is clinically stable and symptomatic with coronary artery disease (not for unstable coronary syndromes); (3) base coronary CT angiography (CCTA) has been completed and interpreted prior to FFR-ct; (4) target lesion on CCTA demonstrates 40-90% stenosis in a proximal or mid major coronary artery (see clinical presentation–specific notes); (5) none of the exclusionary clinical circumstances are present (see exclusions); (6) FFR-ct is not used in conjunction with stress testing unless the CCTA is insufficient quality for FFR-ct and an alternative study is needed.stenosis 40-90%

If stenosis >90% proceed to invasive catheterization; lesions <40% do not require FFR-ct.

Covered Clinical Presentations

Covered indications by clinical presentation (per LCD guidance)

Indication subsets

a) No prior coronary disease — acute (anginal) chest pain: Intermediate-risk patient (e.g., with troponin elevation) after CCTA shows 40-90% stenosis in a proximal or middle coronary artery.
b) Known coronary artery disease — acute (anginal) chest pain: Intermediate-risk patient (e.g., with troponin elevation) after CCTA shows 40-90% stenosis in a proximal or middle coronary artery.
c) No prior coronary disease — stable (anginal) chest pain: Intermediate-risk patient after CCTA shows 40-90% stenosis in a proximal or middle coronary artery.
d) Known coronary disease — persistent stable (anginal) chest pain: Patient with known CAD after any CCTA finding of 40-90% stenosis in a proximal or middle coronary artery.

AHA/ACC recommended indications

AHA/ACC guideline recommends FFR-CT for diagnosing vessel-specific ischemia and guiding revascularization decisions in the following patient groups:

AHA/ACC recommended scenarios: FFR-CT is recommended (Class IIA, Level of Evidence B-NR) for: (1) intermediate-risk patients with acute chest pain and previously unknown CAD with 40-90% stenosis on CCTA in a proximal or mid coronary artery; (2) intermediate-risk patients with stable chest pain and previously unknown CAD with 40-90% stenosis on CCTA in a proximal or mid coronary artery; (3) intermediate-risk patients with acute chest pain and known CAD with 40-90% stenosis on CCTA in a proximal or mid coronary artery; (4) patients with known nonobstructive CAD with stable chest pain and 40-90% stenosis on CCTA.stenosis 40-90%

Guideline notes that FFR-CT should not be ordered when CCTA imaging is suboptimal, extensive plaque prevents high-quality CCTA, or delays in results could impact patient care.

FFR-ct should not be used together with stress testing except when the CCTA base study is of insufficient quality to permit FFR-ct and an alternative study is required. The CCTA must be completed and interpreted before FFR-ct is performed. FFR-ct is also not appropriate for patients with unstable coronary syndromes or when urgent or time-sensitive evaluation is necessary.

Specific clinical circumstances that exclude FFR-ct include prior placement of prosthetic heart valves, prior coronary artery bypass grafts, presence of an intracoronary metallic stent, status post heart transplantation, recent myocardial infarction within 30 days, prior pacemaker or defibrillator lead placement, newly diagnosed systolic heart failure without prior left heart catheterization, and non‑obstructing stenosis (<50%) on prior CTA or catheterization within the past 12 months in the absence of new symptoms. Additionally, FFR-ct should not be used when turnaround times could negatively affect prompt clinical care decisions.

FFR-CT should not be ordered when the quality of the source CCTA is suboptimal or when extensive coronary plaque is present such that a high‑quality CCTA is unlikely to be obtained. The ACC/AHA guideline explicitly cautions against FFR‑CT in these imaging circumstances and when any delay in obtaining results could affect patient care.

When CCTA image quality is insufficient for reliable FFR-ct analysis, clinicians should consider alternative diagnostic strategies (for example, stress testing) as indicated by clinical pathways and guideline recommendations.

FFR‑ct is intended for evaluation of lesions with intermediate anatomic stenosis on CCTA. It is indicated when a target lesion demonstrates 40%–90% stenosis in a proximal or mid major coronary artery on the interpreted CCTA. Lesions with anatomic stenosis > 90% are not medically necessary to evaluate with FFR‑ct and patients with such high‑grade lesions should proceed to invasive catheterization. Conversely, low‑grade stenoses (< 40%) do not require additional confirmatory FFR‑ct testing.

FFR‑ct is also not appropriate when other exclusion criteria (e.g., unstable presentation or implanted intracoronary devices) are present, or when its use would be concurrent with stress testing except as noted when CCTA quality is insufficient.

The clinical evidence base for FFR‑ct is limited primarily to observational studies, registries, and nonrandomized cohort designs. Systematic reviews and meta‑analyses have pooled results from prospective and observational studies but are influenced by variable follow‑up durations, heterogeneous outcome definitions, and potential overlap of patient populations across datasets.

Published reports and guideline summaries note conflicts of interest among some study authors and potential bias; randomized controlled data are limited. Consequently, additional independent, large‑scale randomized trials and longer follow‑up are needed to further validate prognostic value and to define optimal use in specific populations (for example, heart transplant recipients).

Billing Codes and Coding Guidance

Applicable CPT CodesCPTCovered

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

Example Diagnosis CodeICD-10

R93.1

Abnormal findings on diagnostic imaging of heart and coronary circulation

Coding references and guidancemixed

No codes listed

Anatomic stenosis percent on CCTA — thresholds for using FFR-ct

Indication stenosis rangeFFR-ct is indicated for target lesions on CCTA demonstrating 40–90% anatomic stenosis in a proximal or mid major coronary artery.

Severe stenosis (>90%)Lesions with >90% stenosis on CCTA are not appropriate for FFR-ct; proceed directly to invasive coronary angiography/catheterization.

Minimal stenosis (<40%)FFR-ct is not necessary for low-grade stenoses (<40%) on CCTA as functional assessment is unlikely to change management.

Anatomic site requirementTarget lesions should be in proximal or mid segments of major coronary arteries as specified in coverage criteria and LCD guidance.

Prior Authorization, Documentation, and Operational Guidance

Prior Authorization

Prior Authorization Required — FFR‑CT (CPT 75580)

Prior authorization is required for CPT 75580 (FFR‑CT). FDA‑approved FFR‑CT technology is considered reasonable and necessary when used as a post‑processing analysis of a completed and interpreted CCTA and when clinical criteria are met (see policy clinical criteria). Ensure correct coding and that the service is billed as a noninvasive estimate of coronary fractional flow reserve derived from CCTA data with physician interpretation and report.

Affected code: CPT 75580
FFR‑CT is post‑processing of existing CCTA DICOM — base CCTA must be completed and interpreted prior to FFR‑CT
Do not use FFR‑CT in conjunction with stress testing unless the CCTA is insufficient quality for FFR‑CT and an alternative study is needed

Prior Authorization

Follow Delegate Prior Authorization Process When Applicable

If a delegate (e.g., delegated utilization management vendor) administers prior authorization for the member’s UnitedHealthcare Medicare Advantage plan, providers must follow the delegate’s prior authorization process and requirements. Verify delegate-specific submission portals, documentation checklists, and decision timetables to avoid delays or denials.

Background and Rationale

FFR‑ct is a computer‑assisted post‑processing analysis of previously acquired coronary CT angiography (CCTA) DICOM data that estimates changes in intracoronary pressure to assess the hemodynamic significance of coronary stenoses. Its purpose is to help clinicians determine vessel‑specific ischemia and to guide management decisions, including whether invasive angiography or revascularization is indicated, serving as an alternative to stress testing in appropriate, clinically stable symptomatic patients.

The technique is intended to be used after a completed and interpreted CCTA and is recommended by the ACC/AHA guideline for selected intermediate‑risk patients with 40–90% stenosis in proximal or mid coronary arteries as a means to inform revascularization decisions.

Key Definitions

FFR-ct — definition

DefinitionNoninvasive fractional flow reserve deduced from computed tomography (FFR-ct) is a computer-assisted post-processing software analysis of previously acquired coronary CT angiography (CCTA) DICOM data to estimate changes in blood pressure within coronary arteries and evaluate the hemodynamic significance of stenoses.

PurposeProvides quantitative and qualitative analysis to support clinicians in assessing functional significance of coronary artery disease from CCTA images.

Data sourceUses previously acquired CCTA DICOM data; FFR-ct is a post-processing analysis rather than a separate imaging acquisition.

Invasive FFR threshold — reference standard

Reference standard thresholdInvasive fractional flow reserve (FFR) with a threshold ≤ 0.80 is considered hemodynamically significant and serves as the reference standard in diagnostic accuracy assessments.