{"id":"AIBD-0745","title":"Medicare contractor Palmetto GBA covers AI coronary plaque analysis for stable chest pain, citing better diagnosis and changes in management","summary":"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.","date_observed":"2024-11-24","date_basis":"event","date_precision":"day","benefit_status":"reported","source_collection":null,"source_entry":null,"account":"Palmetto GBA, a Medicare administrative contractor, issued a local coverage determination for AI-enabled coronary plaque analysis, effective 24 November 2024. The software applies artificial intelligence to coronary CT angiography to measure narrowing and the amount and type of plaque. The contractor covers it as reasonable and necessary for acute or stable chest pain with no known coronary artery disease, within set risk categories. In its rationale, the contractor cites the potential for better diagnosis and the changes in management seen in the DECODE and CERTAIN studies. In the CLARIFY study of 232 patients, Cleerly's readings matched the consensus of three expert readers with 99.7% accuracy for stenosis above 70%. In the CERTAIN crossover study, physicians changed management plans for 57.1% of 750 patients after seeing the software's results. The contractor notes that CERTAIN was not designed to compare this approach with standard care. It judged that benefit had not been established for high-grade stenosis or known obstructive disease, and it does not cover screening or surveillance.","category":"aggregate result","unexpected":false,"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.","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","model_version":null,"developer":"Cleerly, Inc. and HeartFlow, Inc.","deployer":"Medicare providers performing coronary CT angiography in Palmetto GBA's jurisdictions","location":"Alabama, Georgia, Tennessee, South Carolina, North Carolina, Virginia and West Virginia, United States","domain":"Healthcare (cardiology)","segment":null,"benefit_type":"Improved Task Accuracy","work_activities":["4.A.1.b.3","4.A.2.a.4"],"taxonomy_note":null,"registry_ids":{},"ratings":[{"group":"organizational","depth":2,"reason":"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."},{"group":"personal","depth":null,"reason":"Physicians changed plans for 57.1% of patients in CERTAIN, but no cited study measured patient outcomes against standard care."}],"ai_role":{"status":"unassessed","statement":"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."},"evidence":[{"kind":"assessment report","citation":"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. 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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.","title":"LCD L39851: Artificial Intelligence Enabled CT Based Quantitative Coronary Topography (AI-QCT)/Coronary Plaque Analysis (AI-CPA)","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39851&ver=18","date":"2024-11-24","written_by":"independent","quote":"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."},{"kind":"assessment report","citation":"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)","title":"LCD L39863: Artificial Intelligence Enabled CT Based Quantitative Coronary Topography (AI-QCT)/Coronary Plaque Analysis (AI-CPA)","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39863&ver=10","date":"2026-04-01","written_by":"independent","quote":"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."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sources[].id":{"state":"value_present","value":{"kind":"identifiers","identifiers":["AIBD-0745-source-0001","AIBD-0745-source-0002"],"role":"Existing evidence items, in their original order"},"provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"complete"},"sources[].language":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"sources[].relationship":{"state":"value_present","value":{"kind":"record_fields","fields":{"evidence":[{"kind":"assessment report","citation":"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.","title":"LCD L39851: Artificial Intelligence Enabled CT Based Quantitative Coronary Topography (AI-QCT)/Coronary Plaque Analysis (AI-CPA)","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39851&ver=18","date":"2024-11-24","written_by":"independent","quote":"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."},{"kind":"assessment report","citation":"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)","title":"LCD L39863: Artificial Intelligence Enabled CT Based Quantitative Coronary Topography (AI-QCT)/Coronary Plaque Analysis (AI-CPA)","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39863&ver=10","date":"2026-04-01","written_by":"independent","quote":"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."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sources[].upstream_sources":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"strategic_assessments[]":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"strategic assessments"},"summary":{"state":"value_present","value":{"kind":"record_fields","fields":{"summary":"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.","account":"Palmetto GBA, a Medicare administrative contractor, issued a local coverage determination for AI-enabled coronary plaque analysis, effective 24 November 2024. The software applies artificial intelligence to coronary CT angiography to measure narrowing and the amount and type of plaque. The contractor covers it as reasonable and necessary for acute or stable chest pain with no known coronary artery disease, within set risk categories. In its rationale, the contractor cites the potential for better diagnosis and the changes in management seen in the DECODE and CERTAIN studies. In the CLARIFY study of 232 patients, Cleerly's readings matched the consensus of three expert readers with 99.7% accuracy for stenosis above 70%. In the CERTAIN crossover study, physicians changed management plans for 57.1% of 750 patients after seeing the software's results. The contractor notes that CERTAIN was not designed to compare this approach with standard care. It judged that benefit had not been established for high-grade stenosis or known obstructive disease, and it does not cover screening or surveillance."}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["summary","account"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].autonomy_permissions":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].component_role":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].deployment_configuration":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].inputs_outputs":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].model_name":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].model_version":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].product_name":{"state":"value_present","value":{"kind":"record_fields","fields":{"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"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["system"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].provider":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"taxonomy_crosswalks[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"title":{"state":"value_present","value":{"kind":"record_fields","fields":{"title":"Medicare contractor Palmetto GBA covers AI coronary plaque analysis for stable chest pain, citing better diagnosis and changes in management","headline":"Medicare contractor covers *AI-QCT* plaque analysis for chest pain"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["title","headline"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"version":{"state":"value_present","value":{"kind":"identifiers","identifiers":["91c0b7377567764b089a933942dd11f74517b0c95851ae72b1bc954bf7a09179"],"role":"SHA-256 of the complete public record and its assessments"},"provenance":{"kind":"curatorial","basis":"SHA-256 of the public record, its assessments, and its displayed answers and notes, excluding its own identifier and the derived coverage summary.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"complete"},"workflow":{"state":"value_present","value":{"kind":"record_fields","fields":{"account":"Palmetto GBA, a Medicare administrative contractor, issued a local coverage determination for AI-enabled coronary plaque analysis, effective 24 November 2024. The software applies artificial intelligence to coronary CT angiography to measure narrowing and the amount and type of plaque. The contractor covers it as reasonable and necessary for acute or stable chest pain with no known coronary artery disease, within set risk categories. In its rationale, the contractor cites the potential for better diagnosis and the changes in management seen in the DECODE and CERTAIN studies. In the CLARIFY study of 232 patients, Cleerly's readings matched the consensus of three expert readers with 99.7% accuracy for stenosis above 70%. In the CERTAIN crossover study, physicians changed management plans for 57.1% of 750 patients after seeing the software's results. The contractor notes that CERTAIN was not designed to compare this approach with standard care. It judged that benefit had not been established for high-grade stenosis or known obstructive disease, and it does not cover screening or surveillance.","replication":{"produced_by":["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."],"must_hold":["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."],"echoes":[]}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["account","replication"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"}},"summary":{"total":91,"addressed":91,"known":28,"reviewed":2,"reviewed_complete":2,"reviewed_partial":0,"record_mapped":26,"review_not_assessed":63,"not_assessed":0,"complete":false,"by_state":{"value_present":28,"not_reported":0,"unresolved":63,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"d4bc29adea4057576dc4c33997e4194658ab017575d8899a52330a5dafa2943f"}