Elucid Announces CCTA Reimbursement to be Doubled with CMS Rule

BOSTON–(BUSINESS WIRE)–Elucid Bioimaging, Inc. has announced a final rule from US Centers for Medicare & Medicaid Services (CMS) that will significantly increase the reimbursement for cardiac computed tomography angiography (CCTA). The new rule, which goes into effect January 1, 2025, will double the amount paid to hospitals and outpatient clinics who perform cardiac CT scans from $175 to $357.13, allowing more hospitals, particularly those in non-urban areas, to be able to offer this service, reducing disparities in care.

“We are pleased to hear the final decision, aligning Medicare reimbursement more appropriately with the value CCTA provides in identifying and combating cardiovascular disease. We believe this could help bring CCTA and novel, impactful technology like PlaqueIQ™ to more patients”

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The increase comes after six years of advocacy work by the Society of Cardiovascular Computed Tomography (SCCT) and is due to a reclassification of CCTA into a higher ambulatory payment classification (APC) as part of the CY25 Hospital Outpatient Prospective Payment System (HOPPS) final rule. Payment rates for the CY 2025 OPPS/ASC final rule were based on claims with dates of service between January 1, 2023, and December 31, 2023, processed through June 30, 2024, and is better reflective of the value CCTA provides in cardiac care. In addition, CCTA prominence has increased dramatically in recent years due to the evidence-driven inclusion of CCTA as the only level 1A guideline for stable chest pain in the 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain and continuously expanding database of clinical evidence showing the efficacy of CCTA in research settings and clinical practice. ^{1, 2}

This reimbursement increase for CCTA follows recent decisions from five of the seven Medicare Administrative Contractors (MACs) to provide coverage for AI-enabled quantitative coronary plaque analysis, expanding accessibility to over 70 percent of eligible Medicare patients across the United States. Those decisions further recognize the importance of new technologies like Elucid’s PlaqueIQ™ that can help non-invasively quantify and classify coronary artery plaque and its components such as lipid-rich necrotic core (LRNC), giving potential insights into high-risk plaques that are key drivers of risk of heart attack and stroke.³ In addition, use of the software has the potential to enable earlier identification of higher-risk plaque before presence of symptoms or major adverse events.

“We are pleased to hear the final decision, aligning Medicare reimbursement more appropriately with the value CCTA provides in identifying and combating cardiovascular disease. We believe this could help bring CCTA and novel, impactful technology like PlaqueIQ™ to more patients,” said Kelly Huang, PhD, CEO of Elucid. “Elucid is a proud supporter of SCCT, who has worked incredibly hard to advocate for reimbursements that would make CCTA more economically viable for outpatient and ambulatory care. We also are grateful to CMS, the American College of Cardiology (ACC), and the American College of Radiology (ACR) for their longstanding work to increase payment that more appropriately covers the costs of performing cardiac CT. The momentum in coverage of technologies to help clinicians better identify and risk stratify cardiovascular disease could help save lives and improve treatment pathways.”

Elucid’s FDA-cleared PlaqueIQ is the first FDA-cleared non-invasive image analysis software that can quantify and classify plaque morphology based on ground-truth histology, the gold standard for characterization of plaques. PlaqueIQ is designed to give physicians new, clinically validated information to help stratify patients and inform patient-specific treatment pathways.

Cardiovascular disease (CVD) is the most common cause of death and disability globally, largely driven by myocardial infarction (MI) and ischemic stroke caused by atherosclerosis (plaque build-up and rupture in the arteries).⁴ The cost of CVD in the U.S. alone is approximately $219 billion per year, which includes the cost of healthcare services, medications and premature death.⁵ Moreover, the total cost of CVD is estimated to more than triple for people over 80 and more than double for people ages 65 to 79 by 2035.⁶

About Elucid

Elucid Bioimaging, Inc. is a Boston-based AI medical technology company dedicated to developing technology designed to provide physicians with a more precise view of atherosclerosis (coronary plaque buildup), the root cause of cardiovascular disease. The company’s PlaqueIQ™ product is designed to help physicians prioritize and personalize treatment based on actual disease, rather than population-based risk of disease. PlaqueIQ is the only FDA-cleared computed tomography angiography (CTA) algorithm that quantifies plaque morphology validated against ground truth histology, the gold standard for characterization of plaque, as indicated by renowned pathologists. PlaqueIQ equips physicians with critical information regarding the type and amount of plaque in arteries that can lead to heart attack and stroke. Elucid is also pursuing an indication for FFRCT, derived from its plaque algorithm, to help identify coronary blockages and the extent of ischemia non-invasively. For more information, visit elucid.com.

References:

¹ Gulati, M., Levy, P.D., et. al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. Updated December 11, 2023. Available from: https://www.ahajournals.org/doi/10.1161/CIR.0000000000001029#core-R169.

² Hosbrook, S., Falk, R. Increase in CCTA exams expected to mirror TAVR growth trend. AuntMinnie.com. December 26, 2023. Available from: https://www.auntminnie.com/clinical-news/ct/article/15659819/increase-in-ccta-exams-expected-to-mirror-tavr-growth-trend#:~:text=A%20steady%20increase%20in%20the,CCTA%20cases%20over%2012%20months.

³ Martinet, W., Coornaert, I., et. al. Regulated Necrosis in Atherosclerosis. Arteriosclerosis, Thrombosis, and Vascular Biology. 2022;42(10):1283-1306.

⁴ World Health Organization (WHO), Cardiovascular diseases (CVDs). 2017 23, April 2020. Available from: https://www.who.int/en/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds).

⁵ Centers for Disease Control and Prevention, Office of Policy, Performance, and Evaluation, Health Topics – Heart Disease and Heart Attacks. August 17, 2021. Available from: https://www.cdc.gov/policy/polaris/healthtopics/heartdisease/index.html.

⁶ American Heart Association. Cardiovascular Disease: A Costly Burden for America – Projections Through 2035. 2017. Available from: https://www.heart.org/-/media/Files/About-Us/Policy-Research/Fact-Sheets/Public-Health-Advocacy-and-Research/CVD-A-Costly-Burden-for-America-Projections-Through-2035.pdf.