Transcatheter aortic valve implantation

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 2024. Twelve recommendations were published concerning the registration of medical devices or modification of registration conditions/extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). Opinions concern cardiovascular, neurovascular, ENT, and surgical devices, interventional radiology and endoscopy procedures, as well as medical aids.

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 February 2024. Fourteen recommendations were published concerning the registration of medical devices or modification of registration conditions with the extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). Opinions concern cardiovascular, neurovascular, neuromodulation, endocrine, and endoscopy devices, as well as medical aids.

On June 19, 2023, the Swiss Federal Office of Public Health (FOPH) published the changes that will occur to the Healthcare Benefit Ordinance (KLV/OPre) and its Annexes, which determines coverage of medical services in Switzerland. Key changes relate to introduction of two codes for genetic tests, several extensions of Coverage with Evidence Development, and updates in reimbursement conditions for transcatheter aortic valve implantation. The changes entered into force on July 1, 2023.

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.

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.

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 early-mid November 2021, the Federal Joint Committee (G-BA) has initiated an evaluation procedure for early benefit assessment for two new cardiovascular technologies (Revivent TC™ by BioVentrix and Trilogy™ Heart Valve System by JenaValve Technology) in heart failure, and aortic valve insufficiency and stenosis, respectively.

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.

In June 2021, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (laser lithotripsy for difficult-to-treat bile duct stones and percutaneous insertion of a closure device to repair a paravalvular leak around a replaced mitral or aortic valve), one new Medical Technologies Guidance (Plus Sutures for preventing surgical site infection), and four new Medtech Innovation Briefings (RapidAI for analyzing CT/MRI brain scans, WoundExpress, Magtrace and Sentimag, and SYNE-COV). Also, four clinical guidelines were updated, and two new published.

Transcatheter aortic valve implantation (TAVI/TAVR) in severe aortic stenosis treatment across all surgical risk groups was being evaluated within the "New Methods" framework since 2019. On April 26, 2021, the Decision Forum for "New Methods" made a positive coverage decision for TAVI/TAVR to treat patients with severe aortic stenosis across all surgical risk groups.

On October 30, 2020, the Swiss Federal Statistics Office (UFS) published the 2021 version of the procedure code (CHOP) nomenclature in French and Italian. The version in the German language was published in July 2020. The most important changes regard cardiovascular and peripheral vascular interventions.

On September 30, 2020, the Dutch Healthcare Institute (Zorginstituut Nederland, ZIN) published the position that transcatheter aortic valve implantation (TAVI) in patients with aortic stenosis and a high risk of surgery is eligible for reimbursement under basic health insurance package.