Cracking Cardiac AI Reimbursement: Category I CPT Codes & Beyond

Working through the labyrinthine pathways of healthcare reimbursement is arguably the most critical gatekeeper for any innovative medical technology. For AI-native health companies, particularly those operating in the complex cardiac space, securing favorable reimbursement isn’t merely a commercial aspiration. It’s the ultimate validation of clinical utility and economic value, directly dictating market penetration and investor returns. Without a clear and sustainable payment mechanism, even the most clinically advanced and FDA-cleared AI tool is destined to languish, unable to achieve widespread adoption and impact patient outcomes at scale.

The Bifurcated World of CPT Codes: Category I vs. Category III

The American Medical Association (AMA) CPT coding system is the bedrock of medical billing and reimbursement in the United States. For AI-native health companies targeting commercial viability, understanding the distinction between Category I and Category III CPT codes is paramount. Category III codes are temporary codes assigned to emerging technologies, services, and procedures. They allow for data collection on utilization and efficacy, offering a preliminary mechanism for providers to bill for novel services. While Category III codes signal innovation and can facilitate early adoption in specific settings, they often come with inconsistent payment rates, if any, and do not guarantee widespread commercial insurance coverage. Payers typically view them with skepticism, awaiting more strong evidence of clinical utility and cost-effectiveness. In contrast, Category I CPT codes represent established medical procedures and services that have demonstrated widespread clinical acceptance and utility. Securing a Category I code is a major milestone, signifying AMA recognition of a technology’s value and paving the way for consistent, albeit negotiated, reimbursement from Medicare, Medicaid, and commercial payers. The journey from Category III to Category I is arduous, demanding rigorous clinical evidence, proven patient benefit, and often, significant lobbying and advocacy efforts. For late-stage investors and market access specialists, the presence of Category I CPT codes for a cardiac AI solution dramatically de-risks the investment, signaling a tangible path to revenue generation and market scalability.

Case Studies in Cardiac AI Reimbursement: HeartFlow and Cleerly

The complex dance of clinical evidence, regulatory clearance, and reimbursement strategy is best illustrated by companies that have successfully navigated these waters. Two prominent examples in cardiac AI are HeartFlow and Cleerly, each tackling distinct aspects of cardiovascular diagnostics.

HeartFlow’s Strategic Pursuit of Category I CPT Codes

HeartFlow, an AI-native company, developed a non-invasive technology that creates a 3D model of coronary arteries from a standard CT scan, using computational fluid dynamics to calculate fractional flow reserve (FFR-CT). This innovative approach helps clinicians assess the physiological impact of coronary blockages without invasive procedures. Recognizing the critical importance of reimbursement, HeartFlow strategically pursued Category I CPT codes for its fractional flow reserve analysis. This was a multi-year endeavor that involved extensive clinical trials demonstrating improved diagnostic accuracy, reduced need for invasive angiography, and in the end, better patient outcomes. The AMA in the end assigned specific Category I CPT codes for FFR-CT analysis, including 75580 (Noninvasive estimated coronary fractional flow reserve (FFR) using data obtained from coronary computed tomography angiography). This code became effective January 1, 2024. AMA CPT Code Registry for FFR-CT This achievement was far-reaching for HeartFlow, providing a standardized billing mechanism and unlocking broader access to commercial insurance coverage. The Centers for Medicare and Medicaid Services (CMS) also established national average payment rates for these codes, further solidifying the technology’s commercial viability. For instance, for 2026, the national average payment rate for CPT code 75580 under the Medicare Physician Fee Schedule is $887 for the physician office setting (with a professional fee of $34), and $877 for the hospital outpatient setting (APC 5724). Also, HeartFlow Plaque Analysis is now covered by a new Category I CPT code 75577, effective January 1, 2026, for AI-powered plaque quantification and characterization. For 2026, the national average payment rate for CPT code 75577 under the Medicare Physician Fee Schedule is $1021 for the physician office setting (with a professional fee of $41). This successful reimbursement pathway has allowed HeartFlow to scale its operations and cement its position as a leader in non-invasive cardiac diagnostics. CMS Physician Fee Schedule Look-up Tool for CPT 75580

Cleerly’s Journey in Coronary Plaque Analysis

Cleerly represents another AI-native innovator focused on coronary artery disease, specifically on quantifying and characterizing coronary plaque from CT angiograms. Their AI-powered platform provides detailed insights into plaque burden and morphology, aiming to move beyond simple stenosis assessment to a more complete understanding of cardiovascular risk. Cleerly has successfully navigated key reimbursement milestones. Its ISCHEMIA software device, which provides noninvasive estimates of fractional flow reserve, can be billed using the Category I CPT code 75580, effective January 1, 2024. Plus, Cleerly has secured a Category I CPT code 75577 for its AI-QCT advanced plaque analyses, effective January 1, 2026. As of early 2026, Medicare covers AI plaque analysis under CPT code 75577 at a payment rate of about $1,000. This demonstrates that Cleerly’s AI-driven insights are gaining recognition for their value in guiding more personalized and effective treatment decisions.

The Path Forward: De-Risking for Investors and Market Access Specialists

For late-stage healthcare investors evaluating AI-native health companies, and for market access specialists tasked with commercialization, the takeaway is clear: reimbursement is not an afterthought, but a core strategic pillar that must be addressed from inception.

Key Milestones for Unlocking Commercial Insurance Coverage:

• Strong Clinical Evidence: Beyond regulatory clearance (e.g., 510(k) or De Novo), companies must generate compelling clinical evidence demonstrating improved patient outcomes, cost-effectiveness, and clinical utility in real-world settings. This often requires large-scale studies, potentially using real-world data to supplement key trial results.
• AMA CPT Code Assignment: The ultimate goal is Category I CPT codes. This requires demonstrating widespread clinical acceptance, a defined procedure, and clear benefits. Companies must engage with the AMA CPT Editorial Panel early and often, presenting strong data and clinical consensus.
• Payer Engagement and Policy Development: Even with Category I codes, commercial payers develop their own medical policies. Proactive engagement with major payers (e.g., UnitedHealthcare, Anthem, Aetna) is important to educate them on the technology’s value and influence positive coverage decisions. This often involves presenting health economic outcomes research (HEOR) data.
• CMS Coverage Decisions: For technologies impacting a broad patient population, securing positive coverage from CMS (Medicare and Medicaid) is far-reaching. This can involve pursuing National Coverage Determinations (NCDs) or demonstrating alignment with existing Local Coverage Determinations (LCDs). The pursuit of New Technology Add-On Payments (NTAP) for inpatient services can also bridge early payment gaps.
• Value-Based Care Alignment: Increasingly, AI solutions that demonstrate alignment with value-based care models, showing reductions in hospitalizations, readmissions, or unnecessary procedures, will find a more receptive audience among payers.

The commercial success of AI-native cardiac health solutions hinges on careful planning and execution of a reimbursement strategy. Companies like HeartFlow have demonstrated that with sufficient clinical rigor and strategic engagement with regulatory and coding bodies, the reimbursement barrier can be overcome, paving the way for widespread adoption and significant market impact. Investors and market access professionals must scrutinize this pathway with the same intensity applied to clinical efficacy and regulatory status, recognizing it as the true determinant of an AI-native health company’s long-term value.

Methodology and Source Note: This article synthesizes insights from expert interviews with reimbursement and regulatory specialists in the cardiac AI domain. Data points regarding CPT codes and CMS payment rates are based on analysis of publicly available information from the American Medical Association CPT code registry and the Centers for Medicare and Medicaid Services reimbursement schedules, current as of the article’s research date.