Fractional flow reserve (FFR)

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.

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.

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.

The Scottish Health Technologies Group (SHTG) is a national health technology assessment (HTA) agency providing advice to NHSScotland on the use of new and existing health technologies, likely to have a significant impact on healthcare. In the third quarter of 2021, SHTG published only one report in relation to HeartFlow fractional flow reserve computerized tomography (FFRCT). Currently, the SHTG is working on assessments of technologies in the field of diabetes, digital health, surgical procedures, and other topics.

At the beginning of September 2021, the Government of the Russian Federation released the preliminary version of the Program of State Guarantees for the period of 2022-2024. Major changes concerned the High-End Medical Care (HEMC) list I, where two new procedures in the cardiovascular and neurovascular field were added. The HEMC list II was expanded with the procedures in the field of radiotherapy, neurology, and neurosurgery, surgical procedures. The final version is expected at the beginning of 2022.

In March 2021, the National Institute for Health and Care Excellence (NICE) published four new Interventional Procedure Guidance (transcervical ultrasound-guided radiofrequency ablation for symptomatic uterine fibroids, extracorporeal whole liver perfusion, free-functioning gracilis transfer to restore upper limb function, cytoreduction surgery with hyperthermic intraoperative peritoneal chemotherapy), two Medical Technologies Guidance (Danis stent for acute oesophageal variceal bleeding, Alpha-Stim AID for anxiety disorders), two Medtech Innovation Briefings (Sonata system for symptomatic uterine fibroids, Butterfly iQ+ for diagnostic ultrasound), and one Diagnostic Guidance (QAngio XA 3D QFR and CAAS vFFR imaging software for assessing coronary stenosis). Also, five clinical guidelines were updated.

On February 18, 2021, the updated List of Reimbursable Products and Services (LPPR) was published. It contains new devices included in the LPPR list in January-February 2021, as well as other modifications made during this period. The newly-included devices belong to the cardiovascular (TAVI), ENT (cochlear and brainstem implants), and diagnostic imaging (FFR) technology groups.

On January 26, 2021, NHS Accelerated Access Collaborative published the MedTech Funding Mandate policy for 2021/22, which will come into force in April 2021. According to the NHS Long Term Plan, introducing a MedTech Funding Mandate will support getting innovative medical devices, diagnostics, and digital products to patients faster. Four technologies will be supported in 2021/22 - HeartFlow FFRCT, gammaCore, SecurAcath, and PIGF-based testing.

On June 18, 2020, the Dutch Healthcare Institute (Zorginstituut Nederland, ZIN) announced four medical procedures which received a subsidy under the new innovative payment scheme: FFRct technique in the diagnosis of patients with chest pain; oral esketamine in patients with severe, non-psychotic, treatment-resistant depression; left atrial appendage closure in patients with atrial fibrillation and endolymphatic duct blockage in patients with uncontrollable Meniere's disease.

On December 27, 2018, the Belgian Official Gazette was updated. The update brought changes in chapter VIII of the Nomenclature, regarding the changing of the coding for flow reserve measurement.

In the first half of May, the National Institute for Health and Care Excellence (NICE) published one new interventional procedure guidance for percutaneous balloon valvuloplasty for fetal critical aortic stenosis and three new medtech innovation briefings for patient position monitoring system for intracranial stereotactic radiosurgery, 3D/QFR imaging software to assess coronary fractional flow reserve non-invasively and point-of-care tests for diagnosing group A beta-haemolytic streptococcus (strep A) throat infection.

A 150-page reimbursement report covers angiography, intravascular ultrasound (IVUS), fractional flow reserve (FFR), cardiac computer tomography (CCT), optical coherence tomography (OCT) for angina and myocardial infarction in hospital settings. Stand-alone application of imaging / diagnostic methods and use in conjunction with percutaneous coronary intervention procedure was considered. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.