Medicare contractor covers AI-QCT plaque analysis for chest pain

Palmetto GBA found AI coronary plaque analysis reasonable and necessary for chest pain without known coronary disease. In a cited study, physicians changed plans for 57.1% of patients.

  • 2 an organization

    In the CLARIFY study that the contractor cites, the software matched the consensus of expert readers with 99.7% accuracy for stenosis above 70% in 232 patients.

  • Not rated a person

    Physicians changed plans for 57.1% of patients in CERTAIN, but no cited study measured patient outcomes against standard care.

Depth runs from 1, a convenience or time saved, to 5, a life or a livelihood preserved.

Status
Reported benefit.
Evidence

foundstudiedreportedclaimed

Two independent assessment reports support the benefit.

Compared with

Physicians' management plans for the same patients based on CT angiography alone (CERTAIN study). Measured.

The system’s part
Not isolated. The contractor relays studies that compare the software's readings with expert readers and invasive tests, and one crossover study of physicians' plans before and after seeing its results. No cited study compared patient outcomes with and without the software. The contractor defines the service as an artificial intelligence application and cites a deep learning study of Heartflow's plaque analysis.
Limits
Not yet checked.
Costs and harms
Not yet checked.
Later
Not yet checked.

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Benefit type
Improved Task Accuracy
System
AI-enabled CT-based quantitative coronary topography and coronary plaque analysis (AI-QCT/AI-CPA), chiefly Cleerly's platform, with Heartflow plaque analysis also in the evidence
Made by
Cleerly, Inc. and HeartFlow, Inc.
Used by
Medicare providers performing coronary CT angiography in Palmetto GBA's jurisdictions
Where
Alabama, Georgia, Tennessee, South Carolina, North Carolina, Virginia and West Virginia, United States
Stage
In routine use
Date
Kind
Aggregate result
Broad benefit
Estimating the Quantifiable Characteristics of Products, Events, or Information, Analyzing Data or Information
Collections
Scrutiny and findings
Last revised
31 October 2026

Sources

  1. Assessment report, by authors with no tie to the system.

    Palmetto GBA. Local Coverage Determination L39851: Artificial Intelligence Enabled CT Based Quantitative Coronary Topography (AI-QCT)/Coronary Plaque Analysis (AI-CPA). Original effective date 24 November 2024, revision effective 15 October 2026. CMS Medicare Coverage Database, Analysis of Evidence.

    Based on the potential improved diagnostic capabilities and role for change in management based on the study’s results, the use of AI-QCT/AI-CPA is reasonable for stable chest pain with no known CAD.

  2. Assessment report, by authors with no tie to the system.

    Wellpoint Federal (formerly National Government Services), Medicare Administrative Contractor for CMS. LCD L39863: Artificial Intelligence Enabled CT Based Quantitative Coronary Topography (AI-QCT)/Coronary Plaque Analysis (AI-CPA). Analysis of Evidence (Rationale for Determination)

    Based on the potential improved diagnostic capabilities and role for change in management based on the study's results the use of AI-QTC/AI-CPA is reasonable for stable chest pain with no known CAD.

Details

AI system

Workflow

The software ran only after the CT angiography had been completed and interpreted. Physicians received the software's measurements of stenosis and plaque alongside the CT angiography report.

Follow-up

Conditions for replication

The software is cleared or approved by the FDA. The patient has chest pain with no known coronary artery disease and falls within the covered risk or CAD-RADS categories.

Entry details

Sector

Healthcare (cardiology).

Purpose

Cleerly and HeartFlow built AI-QCT and AI-CPA software to measure coronary narrowing and the amount and type of plaque from coronary CT angiography.

Not yet checked: model, release, provider, role, configuration, inputs and outputs, autonomy, human oversight, AI contribution, beneficiaries, reach, distribution and access, duration, every measurement question, every money question, ownership and control, dependencies, cross-border connections, geopolitical implications, replication attempts, availability, institutional decision, grounds, action and result, success criterion, every evidence question, observed or intended, alternative assessments, related entries, other identifiers, category mappings.

Cite this record

Peter H. Vartanian. (2026). Medicare contractor covers AI-QCT plaque analysis for chest pain (AIBD-0745). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0745.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)

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