Diagnostic imaging

The French National Authority for Health 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 in May 2022. Thirty-one 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. Opinions concern cardiovascular and peripheral vascular, diagnostic imaging, interventional radiology, orthopedic, neurovascular and neuromodulation, endocrine and E-health devices, as well as medical aids.

In April 2022, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (intramedullary distraction for upper limb lengthening, liposuction for chronic lymphoedema). Also, one new clinical guideline on epilepsies in children, young people, and adults was published, and one for stroke and transient ischaemic attack in over 16s was updated.

In April 2022, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclatures for private payers in England, published Bulletins 0183 and 0080 with changes to be implemented no later than June 14, 2022. Eleven new procedure codes and nine new diagnostic codes were introduced.

In Q1 of 2022, Health Technology Wales (HTW) published one MedTech-related guidance on transcranial magnetic stimulation in depression treatment. A total of eleven Topic Exploration Reports (TERs) were released in Q1. Based on the TERs conclusions, HTW's Assessment Group decided to proceed with developing an Evidence Appraisal Report (EAR) and Guidance on one topic only - radiofrequency renal denervation for the treatment of resistant hypertension.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on April 1, 2022. The most significant changes concern the introduction of new additional flat rates for the observation and care of patients who are given certain medications, adjustment of EBM reproductive medicine definitions, and inclusion of several new codes for PET and PET/CT.

On March 31, 2022, NHS Digital released HRG4+ Local Payment Grouper for 2022/23 for use from April 01, 2022. In general, there are significant changes in base HRG design. A total of 120 new HRGs were created, and multiple HRGs were removed, so the total number increased by 62 from 2,838 to 2,900.

In February 2021, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclature for private payers in England, published Bulletins 0182 and 0079 with changes to be implemented no later than April 10, 2022. Three new procedure codes concerned robotic surgery in orthopaedic area, spinal procedures, and ophthalmology, and five new diagnostic codes were introduced.

In February 2022, the Finnish Coordinating Center for Health Technology Assessment announced the release of the seven accomplished rapid hospital assessments performed by the Helsinki, Tampere, and Oulu University Hospital. The accomplished rapid HTAs concern the diagnostic imaging, e-Health, endocrine, endoscopy, men’s health, neuromodulation technology groups.

On January 18, 2022, the Ministry of Health has awarded the Framework Agreement for the acquisition of 81 linear accelerators included in the High-End Technology Equipment Investment Plan. Furthermore, the National Institute of Health Management (INGESA) has also initiated the processing of the Framework Agreement that will facilitate the acquisition of the equipment in the fields of interventional cardiology, interventional vascular radiology, interventional neurovascular, digital brachytherapy, computed tomography, magnetic resonance imaging, PET-CT, SPECT-CT.

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.

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.

At the end of August 2021, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) has initiated a theme survey on digital image diagnostics to identify new and innovative technology that may become important in Swedish healthcare. This could lead to potential inclusion of the technology in the Orderly introduction of medical technologies framework. The suggestions could be submitted no later than September 24, 2021.