CurrentUnitedHealthcarePolicy MMP372.11

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

UnitedHealthcare Medicare Advantage policy MMP372.11 defines coverage criteria for FDA-approved noninvasive fractional flow reserve derived from coronary CTA (FFR-ct) as a post-processing software for clinically stable symptomatic patients with coronary artery disease, including clinical indications, exclusions, applicable CPT and ICD-10 codes, and references to CMS LCDs/LCAs and FDA indications.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy MMP372.11

Change TypeApplicable codes removedevidence updated

Effective DateMar 1, 2025

Next Review DateN/A

Key ActionProviders must ensure and document that the base CCTA study has been completed and interpreted before ordering FFR-ct; FFR-ct is a post-processing analysis of existing CCTA DICOM data.

SourceLink

POLICY UPDATE CHANGES

Removed CPT codes 0501T, 0502T, 0503T, and 0504T from Applicable Codes.

Updated Clinical Evidence and References sections to reflect current information.

75580Primary CPT code for FFR-ct

40-90%Stenosis window triggering consideration

1+LCD scenarios covered

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CPT codes removed (03/01/2025)

Coverage Summary

UnitedHealthcare Medicare Advantage policy MMP372.11 defines a covered_with_criteria stance for FDA‑approved noninvasive fractional flow reserve derived from coronary CTA (FFR‑ct). The policy effective date is 03/01/2025 and the last committee approval/last review date is 02/12/2025. The scope includes FFR‑ct as a post‑processing software analysis of previously acquired CCTA (CT DICOM) data for clinically stable symptomatic patients with coronary artery disease, with coverage conditioned on meeting specified clinical criteria and exclusions. Applicable Medicare Local Coverage Determinations/Articles (LCDs/LCAs), ACC/AHA guideline recommendations, NICE guidance, and FDA device indications/limitations are referenced in the policy and inform the coverage criteria.

Key thresholds / exclusions

Coronary artery stenosis40-90% (proximal or middle coronary artery)

High-grade stenosis exclusion>90% => proceed to catheterization

Non-obstructing stenosis exclusion<50% without new symptoms => exclusion

BMI>35 excluded per FDA

Recent MI≤30 days excluded

Medical‑Necessity Criteria

Medically Necessary / Covered Criteria for FDA-approved FFR-ct

FFR-ct technology is reasonable and necessary when ALL of the following criteria are met:

ALL of the following

Patient is a clinically stable symptomatic patient with coronary artery disease (CAD).
Supported by FDA indication and CMS LCDs/LCAs
FFR-ct is used as post-processing analysis of previously acquired CCTA (CT DICOM data) and interpreted by a qualified clinician.
FFR-ct is post-processing of CCTA per FDA and Overview
Used as an alternative to stress testing (not used in conjunction with stress testing unless CCTA quality was insufficient and an alternative study is needed).
CMS LCDs/LCAs note FFR-ct performed as alternative to stress testing

Applicable Codes

Covered / Applicable Procedure CodeCPTCovered

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

Relevant Diagnosis Code (for reference)ICD-10

R93.1

Abnormal findings on diagnostic imaging of heart and coronary circulation

Removed / Former CPT Codes (not to be used)CPTNot Covered

0501T	Removed from Applicable Codes (03/01/2025 policy update)
0502T	Removed from Applicable Codes (03/01/2025 policy update)
0503T	Removed from Applicable Codes (03/01/2025 policy update)
0504T	Removed from Applicable Codes (03/01/2025 policy update)

Provider Actions & Billing Rules

Documentation Required

CCTA completed and interpreted prior to FFR-ct

Providers must ensure and document that the base CCTA study has been completed and interpreted before ordering FFR-ct; FFR-ct is a post-processing analysis of existing CCTA DICOM data.

Prior Authorization

Delegate prior authorization may apply

For Medicare Advantage plans where a delegate manages utilization management and prior authorization requirements, providers must follow the delegate's prior authorization requirements.

Denial Risk

Claims may be denied if excluded conditions present

Background & Evidence

FFR‑ct is described as a post‑processing software analysis of CCTA DICOM data that estimates coronary fractional flow reserve to support functional evaluation of coronary artery disease in clinically stable symptomatic patients. The policy specifies FFR‑ct is performed on previously acquired CCTA images, interpreted by qualified clinicians, and intended as an alternative to stress testing. Coverage references CMS LCDs/LCAs for clinical scenarios (including the 40–90% coronary stenosis window in proximal or middle coronary arteries for intermediate‑risk patients), cites ACC/AHA guidance endorsing FFR‑CT in specified intermediate‑risk scenarios, cites NICE recommendations for HeartFlow FFRct, and incorporates FDA indications and limitations (including populations and conditions for which safety/effectiveness have not been evaluated).

Key Evidence

Definitions

Medicare Determinations

Type	Name	Effective	Number
NCD	Non-Invasive Fractional Flow Reserve (FFR) for Ischemic Heart Disease	No NCD exists
LCD	Non-Invasive Fractional Flow Reserve (FFR) for Ischemic Heart Disease (multiple MAC LCDs/Articles referenced)		Examples: L38771, L39075, L38613, L38615, L38278, L38839 (see policy for full list)

Revision History

2025-03-01material_changeLatest

Removed CPT codes 0501T, 0502T, 0503T, and 0504T from Applicable Codes (effective 03/01/2025).

2025-03-01revision_noteLatest

Archived previous policy version MMP372.10.

2025-03-01

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy MMP372.11

Change TypeApplicable codes removedevidence updated

Effective DateMar 1, 2025

Next Review DateN/A

Key ActionProviders must ensure and document that the base CCTA study has been completed and interpreted before ordering FFR-ct; FFR-ct is a post-processing analysis of existing CCTA DICOM data.

SourceLink

On This Page

Base study (CCTA) has been completed and interpreted prior to FFR-ct.

CMS LCDs/LCAs require base CCTA completed and interpreted before FFR-ct

One of the following clinical scenarios (per LCDs/ACC/AHA guidance)

No prior coronary disease and acute (anginal) chest pain: intermediate risk (troponin elevation) with a coronary artery stenosis finding on CCTA of 40-90% in a proximal or middle coronary artery.40-90%
Known coronary artery disease and acute (anginal) chest pain: intermediate risk (troponin elevation) with a coronary artery stenosis finding on CCTA of 40-90% in a proximal or middle coronary artery.40-90%
No prior coronary disease and stable (anginal) chest pain: intermediate risk with a coronary artery stenosis finding on CCTA of 40-90% in a proximal or middle coronary artery.40-90%
Known coronary disease and persistent stable (anginal) chest pain: indicated after any 40-90% stenosis finding on CCTA.40-90%

FFR-ct is not being used where turnaround time may impact prompt clinical care decisions (i.e., results delay would affect care).

CMS LCDs/LCAs and ACC/AHA note delays that impact care preclude use

FFR-ct is FDA-approved technology (used in accordance with FDA indication) and results will be used by qualified clinicians in conjunction with clinical history, symptoms, and other diagnostic tests.

FDA indications specify use by qualified clinicians in conjunction with other clinical information

Not Medically Necessary / Exclusions

FFR-ct should NOT be used when ANY of the following clinical circumstances are present:

ANY of the following

Unstable coronary syndromes or suspicion of acute coronary syndrome where MI or unstable angina have not been ruled out.
FDA and LCDs exclude ACS/unstable syndromes
Recent myocardial infarction within 30 days.≤ 30 days
FDA lists recent MI within 30 days as not evaluated
Prior placement of prosthetic heart valves.
FDA safety/effectiveness not evaluated for prosthetic valves
Prior placement of grafts in coronary bypass surgery (prior CABG).
FDA lists prior CABG as not evaluated; LCDs exclude prior grafts
Intracoronary metallic stent present.
FDA notes stents may cause artifacts; LCDs list intracoronary stent as exclusion
Status post-heart transplantation.
LCDs list heart transplant status as exclusion
Prior pacemaker or defibrillator lead placement.
FDA lists pacemaker/ICD leads as not evaluated
Newly diagnosed systolic heart failure with no prior left heart catheterization.
LCDs list newly diagnosed systolic heart failure without prior cath as exclusion
Non-obstructing stenosis (< 50% of all major epicardial vessels) on CTA or catheterization in the past 12 months without a new symptom complex.< 50%
LCDs specify <50% non-obstructing stenosis in past 12 months without new symptoms is exclusion
If CCTA image quality is insufficient or extensive plaque present such that high-quality CCTA is unlikely to be achieved (FFR-ct should not be ordered if CCTA imaging is suboptimal).
ACC/AHA and LCDs note suboptimal CCTA or extensive plaque precludes FFR-ct
Patients with BMI > 35, complex congenital heart disease, need for emergent procedures, ongoing clinical instability (e.g., cardiogenic shock, SBP < 90 mmHg, NYHA III/IV or acute pulmonary edema) per FDA assessment (safety/effectiveness not evaluated).BMI > 35; SBP < 90 mmHg; NYHA III/IV
FDA lists these populations as not evaluated for safety/effectiveness
Patients with significant arrhythmias or tachycardia that preclude CT acquisition, or coronary vessels with excessive calcification, intracoronary stents, prosthetic valves, or pacemaker/ICD leads (FFR-ct safety/effectiveness not evaluated).
FDA lists arrhythmias, excessive calcification and device leads as not evaluated
If higher grade stenoses (> 90%) are present on CCTA — study not medically necessary; proceed to catheterization.> 90%
LCDs and coverage rationale state >90% stenosis should proceed to cath
If low-grade stenoses (< 40%) are present — additional confirmatory FFR-ct not required.< 40%
LCDs state low-grade stenoses (<40%) do not require additional confirmatory data

Claims may be denied if the service is performed for patients meeting any excluded clinical circumstances or when CCTA data quality is inadequate. Examples of excluded conditions include: recent myocardial infarction within 30 days, presence of intracoronary metallic stent, prior CABG, placement of prosthetic heart valves, BMI > 35, or inadequate/suboptimal CCTA image quality.

Recent myocardial infarction within 30 days (≤ 30 days).
Intracoronary metallic stent present.
Prior coronary artery bypass graft (CABG) surgery.
Prior placement of prosthetic heart valves.
Body mass index > 35 (safety/effectiveness not evaluated).
Inadequate or marginal CCTA image quality (motion, blooming, misregistration) or extensive plaque making high-quality CCTA unlikely.

Billing Rule

Use applicable CPT 75580

Use CPT 75580 for claim submission for FFR-ct services. Previously used temporary/proprietary codes 0501T–0504T were removed effective 03/01/2025 and should not be used.

CPT 75580 is the correct claim code for FFR-ct.
Codes 0501T, 0502T, 0503T, 0504T were removed from Applicable Codes effective 03/01/2025 and must not be used.

Documentation Required

Retain supporting documentation

Providers are expected to retain or have access to appropriate documentation to support medical necessity and claims when requested.

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

2025-02-12last_review

Policy last committee approval / review date: February 12, 2025 (context for 03/01/2025 effective changes).

2025-03-01effective_dateLatest

Policy effective date for MMP372.11 (context for code removals and updates).