Percutaneous mitral valve procedures

On June 19, 2024, the Order SND/606/2024, of June 13, came into force. This Order, among other things, amends Annexes I, II, III, VI, and VII of Royal Decree 1030/2006, of September 15, which establishes the Common Package of Benefits of the National Health System and the procedure for its update. The changes mostly concern in-vitro diagnostics, ENT, pulmonary and airways, cardiovascular, and some other fields.

On January 30, 2024, 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 2023. The medical technologies of cardiovascular, ENT, extracorporeal, gastrointestinal, neuromodulation, and other technology groups obtained positive status 1.

On July 17, 2022, the Austrian Institute for HTA (AIHTA) published four decision support documents, which provide recommendations regarding the inclusion of new medical interventions in the catalog of individual medical services of the performance-oriented hospital financing (Leistungsorientierten Krankenanstaltenfinanzierung, LKF) model, as well as three updates to previous decision support documents.

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 April 2023. Twenty-three 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, orthopedic, nephrology and urology, and surgical devices, as well as medical aids.

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.

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.

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 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.

In November 2021, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (percutaneous implantation of pulmonary artery pressure sensors in chronic heart failure and coronary sinus narrowing device implantation for refractory angina), one new Medical Technologies Guidance (Synergo for non-muscle-invasive bladder cancer), one new Diagnostic Guidance (SeHCAT for diagnosing bile acid diarrhea), and four new Medtech Innovation Briefings (clonoSEQ for minimal residual disease, CerebAir for continuous EEG monitoring, 24/7 EEG SubQ for epilepsy, Paige Prostate for prostate cancer). Also, three new clinical guidelines were published, and six were updated.

In late October 2021, the BfArM (Federal Institute for Drugs and Medical Devices) has published the final version of the 2022 OPS procedure coding classification. The OPS, together with the ICD-10-GM (International Statistical Classification of Diseases and Related Health Problems, 10th revision, German Modification), forms the basis for the reimbursement systems in outpatient and inpatient care.