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Coronary imaging (FFR, IVUS)

An overview of market access challenges for coronary imaging procedures (FFR, IVUS) in European countries.


Procedure coding

Typically, procedure coding for coronary diagnostic imaging, including intravascular ultrasound (IVUS) and wire-based fractional flow reserve (FFR) measurement, is well-established in European countries. For example, in Denmark, SKS codes for coronary IVUS differ depending on the use of Doppler (SKS code UXUC85 – for the procedure without Doppler, SKS code UXUC86 – for the procedure with Doppler).

Procedure codes for coronary imaging are supplementary and are used in addition to coronary angiography or percutaneous coronary interventions. For example, in France, procedure codes for coronary IVUS (CCAM code DDQJ001 “Ultrasound and/or coronary intra-arterial Doppler ultrasound, during a transcutaneous vascular procedure”) and FFR measurement (CCAM code DDQF202 “Coronary fractional flow reserve [FFR] measurement during coronary arteriography”) are supplementary ones.

Digital FFR (e.g., based on coronary computed tomography angiography) is not specifically coded in most European countries.


Payment mechanism

In most EU countries, coronary imaging diagnostics (IVUS, FFR) are reimbursed solely via the diagnosis-related group (DRG) mechanism. 

In many countries (e.g., England, Germany, the Netherlands, Switzerland), FFR or IVUS can change the allocation of diagnostic and therapeutic PCIs to DRGs with higher tariffs than for stand-alone procedures. For example, in England, elective PCI with insertion of 1-2 drug-eluting stents is allocated to the HRG EY41D “Standard Percutaneous Transluminal Coronary Angioplasty with CC Score 0-3” with a tariff of £1,885, whereas when the procedure is performed with wire-based FFR measurement, it is allocated to the HRG EY40D “Complex Percutaneous Transluminal Coronary Angioplasty with CC Score 0-3” with a higher tariff of £2,287.

In some countries (e.g., France, Belgium), devices for coronary imaging diagnostics (IVUS, FFR) attract additional reimbursement, paid on top of the DRG tariff. For example, in France, there are seven LPPR categories for individual brands of FFR measurement guidewire with a tariff range from €379.99 to €400.


Policy considerations

Coronary imaging diagnostic procedures, including IVUS and wire-based FFR measurement, can be considered under coronary artery disease and acute myocardial infarction policies from payers or national decision-makers in the countries where such frameworks exist. 

Coverage policies for non-invasive coronary imaging and digital image assessment methods are under development in many European countries. For example, in the Netherlands, Fractional Flow Reserve Computed Tomography (FFR-CT), which is currently not covered under basic health insurance, was awarded the "Subsidy scheme for promising care" (coverage with evidence development program) in 2019 and will be assessed for coverage at the national level upon the completion of the study (approximately in 2025). 


Health technology assessment

Due to established reimbursement in European countries, invasive coronary imaging rarely becomes a subject of HTA. In contrast, novel non-invasive and digital methods of analysis of coronary angiograms are frequently considered for HTA.

For example, in 2021, the National Institute for Health and Care Excellence (NICE) published an updated Medical Technologies Guidance on HeartFlow FFRCT, initially published in 2017, which recommended this method as an option for patients with stable, recent-onset chest pain who are offered coronary computed tomography angiography (CCTA). Based on the current evidence and assuming access to appropriate CCTA facilities, using HeartFlow FFRCT may lead to cost savings of £391 per patient.


Future challenges 

Invasive coronary diagnostics has established reimbursement and funding in most European countries. New health technology assessments are unlikely. 

Novel methods of non-invasive coronary imaging or digital methods of assessment of coronary angiograms might need to develop specific procedure codes and adjust payment mechanisms to leverage their unique technology or cost profile fully. 

An important topic is the improvement of access and increasing number of simultaneous use of coronary diagnostics (FFR, IVUS) and percutaneous coronary interventions, which impacts the treatment outcomes and changes the number of patients and eligibility criteria for different PCI options.

MTRC has experience with more than 11 projects related to coronary imaging (FFR, IVUS) in Europe

News and insights

Recommendations about add-on reimbursement for medical devices in France in March 2023

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in March 2023. Fifteen recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular and peripheral vascular, endocrine, endoscopy, gastrointestinal, surgical, and diagnostic imaging devices, as well as medical aids.

2022/23 MedTech Funding Mandate policy published in England

In March 2022, NHS England and NHS Improvement published the MedTech Funding Mandate (MTFM) policy for 2022/23, which will come into force on April 01, 2022. The MTFM launched in 2021 to support NICE-approved and cost-saving devices, diagnostics, and digital products. Commissioners must fund technologies included in MTFM.

MedTech-related health technology assessments from NIHR in September 2021

In September 2021, the National Institute for Health Research (NIHR) in England released two MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned non-invasive imaging software for coronary stenosis assessment (QAngio XA 3D/QFR and CAAS vFFR) and quantitative fetal fibronectin test to predict preterm labor. HTA Journal publishes research reports on the effectiveness, costs, and broader impact of health technologies for those who use, manage, and provide care in the NHS and informs National Institute for Health and Care Excellence (NICE) guidance.

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