Percutaneous heart valve repair and replacement

In February 2023, NHS England released the position statement on Transcatheter Aortic Valve Implantation (TAVI) and Surgical Aortic Valve Replacement (SAVR) for symptomatic, severe aortic stenosis in adults to support elective performance. Previously, NHS England was commissioning TAVI at high surgical risk. This new position statement sets criteria for intermediate and low-surgical risk patients who are eligible for TAVI.

On January 30, 2023, the Institute for the Hospital Remuneration System (InEK) published the list of the requests for innovation funding (NUB) that were submitted by the hospitals in 2022. The medical technologies belonging to the cardiovascular, eHealth, gastrointestinal, neuromodulation, neurovascular, peripheral vascular, orthopedic, and other technology groups obtained positive status 1.

In December 2022, NHS England launched a consultation on the preliminary 2023/25 NHS Payment Scheme, which is set for two years and will replace the National Tariff Payment System from April 2023. Two new cardiovascular categories (antibacterial envelope, mitral valve repair and replacement devices) are proposed for inclusion in the 2023/24 High Cost Device List (will be updated and reissued for 2024/25). The deadline for comments submission is January 27, 2023.

In the second half of December 2022, the Basque Office for Health Technology Assessment (OSTEBA) released a report aiming to evaluate mitral valve repair surgery as an alternative to mitral valve replacement.

In November 2022, the National Board of Health and Welfare released the Swedish version of the NordDRG system to come into force in January 2023, including the list of DRG codes, names, and cost-weights. A total of 77 new DRGs will be implemented. Key new DRGs were introduced in cardiovascular, gastrointestinal, and endoscopy fields, also for breast reconstruction and bone-anchored hearing implants.

On October 28, 2022, several Resolutions of the General Directorate of the Common Package of Benefits of the National Health and Pharmacy System were published concerning the use of the system for percutaneous repair of the mitral valve with clip, prioritization of patients with type 2 diabetes mellitus for the provision of glucose monitoring systems, and the use of glucose monitoring system with sensors (flash type) for type 1 diabetes mellitus in childhood and adolescence.

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 October 2022. Fourteen 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, neurovascular, orthopedic, and ENT devices, as well as medical aids.

On September 01, 2022, NHS England published an update of the Specialized Services Policy Pipeline (as of August 24, 2022). Two new MedTech-related Clinical Commissioning Policies were added to the work program (transcatheter edge-to-edge repair of the mitral valve, pectus surgery for really severe pectus), and no new policies were published. The status of ongoing policies was updated as well.

On September 01, 2022, NHS England published an update of the Specialized Services Policy Pipeline (as of August 24, 2022). Two new MedTech-related Clinical Commissioning Policies were added to the work program (transcatheter edge-to-edge repair of the mitral valve, pectus surgery for really severe pectus), and no new policies were published. The status of ongoing policies was updated as well.

In July 2022, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (transcatheter tricuspid valve annuloplasty for tricuspid regurgitation, and transcatheter tricuspid valve leaflet repair for tricuspid regurgitation), one new Diagnostic Guidance (PLGF-based testing to help diagnose suspected preterm pre-eclampsia), and four new Medtech Innovation Briefings (ProciseDx point-of-care platform for IBD, RespiraSense for continuously monitoring respiratory rate, Lenus COPD Support Service, and cyanoacrylate glue for hernia mesh fixation). Also, five clinical guidelines were updated.

In April 2022, the Dutch Healthcare Institute (Zorginstituut Nederland, ZIN) announced two projects which received a subsidy under the "Subsidy scheme for promising care" in 2022 for research of a transcatheter tricuspid valve repair in severe leakage of the tricuspid valve and precision radiation in epilepsy. In total, five projects will receive a subsidy in 2022.

On January 28, 2022, the Institute for the Hospital Remuneration System (InEK) has published the list of the requests for innovation funding (NUB) that were submitted by the hospitals in 2021. The medical technologies belonging to the cardiovascular, ENT, eHealth, gastrointestinal, neuromodulation, neurovascular, orthopedic, and other technology groups obtained positive status 1.