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Clinical Study Summaries

STUDY SUMMARY: HeartFlow Continues to Deepen Market Access

Policy Changes in the United States
Despite robust evidence supporting the use of invasive FFR to guide clinical decisions, FFR has been underutilized and in 2013, was estimated to be used in less than 10% of coronary revascularization procedures. The low utilization could be due to the invasive nature of the procedure, risk associated with rupturing plaques, lack of availability, and notably, the challenge of receiving reimbursements from health plans.14,15
 
Therefore, it is important that large insurers and payers in the United States support the use of HeartFlow FFRCT as part of the diagnostic and treatment pathway for CAD.
 
In June, Blue Cross Blue Shield Association’s (BCBS) Evidence Street issued a positive healthcare evidence review of Heart Flow’s technology, based on an assessment of its technical performance, diagnostic accuracy, and clinical utility in patients with stable chest pain at intermediate risk of CAD, who are being considered for ICA.16
 
The report concluded: “The available evidence provides support that use of CCTA with selective FFRCT is likely to reduce the use of ICA in individuals with stable chest pain who are unlikely to benefit from revascularization by demonstrating the absence of functionally significant obstructive CAD.”16
 
Furthermore, it was confirmed that there is sufficient evidence “to determine that the technology results in meaningful improvements in the net health outcome.”16
 
In addition, Aetna recently updated its coverage policy supporting use of HeartFlow’s FFRCT for persons with stable, recent onset chest pain of suspected cardiac origin and a clinically determined intermediate 10% to 90% risk of CAD.17
Most recently in July, New Jersey’s Horizon BCBS expanded its coverage to include the use of HeartFlow FFRCT for certain patient populations. Coverage by Horizon BCBS was soon followed by coverage through Anthem, Blue Shield of California, as well as BCBS of Alabama, Arizona, Idaho, Kansas, Kansas City, and Nebraska. These payer’s quick adoption of HeartFlow FFRCT suggests that other health plans may be receptive to expanding their coverage and improving FFRCT’s accessibility.
   
Current Procedural Terminology (CPT) Codes
In early July, Category III Current Procedural Terminology (CPT) codes were granted and released by the American Medical Association for the regulation of HeartFlow FFRCT (Table 3). As government payers and commercial health insurance companies use CPT codes when reviewing applications for reimbursement, this designation will simplify the compensation process for hospitals and clinics where FFRCT is implemented.18
 
The application for CPT code recognition of HeartFlow FFRCT was jointly submitted by the ACC, the Society of Cardiovascular Angiography and Interventions, and the Society for Cardiovascular Computed Tomography. This collaboration across societies indicates the clinical need for this diagnostic tool to advance current practice standards.18
 
Importantly, the designation of CPT codes indicates the utility of HeartFlow FFRCT to provide much-needed clinical data to offer guidance for improved care and greater implementation in practice. Healthcare facilities with FFRCT will be able to use these codes starting January 1, 2018.18
 
The designation of CPT codes for HeartFlow FFRCT offers the advancement of this clinical tool in practice to serve a greater population of patients with suspected CAD, reducing needs for additional invasive testing. With CPT codes, clinicians can easily order this tool for actionable insights, where clinicians can develop personalized strategies of care and improve clinical outcomes.18
 
Conclusion and Relevance
HeartFlow FFRCT is gaining traction in market access based on evidence from clinical and real-world studies validating its use in the diagnosis and treatment of CAD. Furthermore, NICE and ACC guidelines recommend use HeartFlow FFRCT to guide treatment. This technology is also recognized among insurers and multiple payers across the country. Moreover, HeartFlow can be successfully implemented by physicians and hospitals for reimbursements through established CPT code designations. Given the prevalence and burden of CAD, as well as the potential for HeartFlow FFRCT to improve clinical outcomes, streamline management of patient pathways, and reduce healthcare expenditures, FFRCT is well-positioned to become a vital diagnostic tool in the standard of care for patients at risk for CAD. 



 
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