Cardiovascular devices

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 2022. Thirty 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, orthopedic, neurovascular, and neuromodulation and other devices, as well as medical aids.

On April 11, 2022, the Swedish Medical Technologies Product (MTP) Council released recommendations on devices for diagnosing atrial fibrillation via self-recording of electrocardiogram evaluated within the Orderly Introduction framework since 2020. MTP Council outlined that Coala Heart Monitor and Zenicor ECG could be used in certain types of patients only, whereas KardiaMobile, CardioMem CM 100 XT, and PhysioMem should be refrained from use.

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 2022. More than 15 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, orthopedic, and neurovascular devices, 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 2022. More than 25 recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration of devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular and peripheral vascular, orthopedic, neurovascular, and neuromodulation devices, as well as breast implants and medical aids. Except for this, CNEDiMTS published two negative opinions concerning transitional coverage of devices.

On March 17, 2022, the French National Authority for Health (HAS) published a standard for telemonitoring of patients with implantable cardiac devices (implantable defibrillators and pacemakers). In January 2022, the HAS also published standards for medical telemonitoring of four chronic pathologies (chronic respiratory failure, chronic heart failure, chronic renal failure, and diabetes). All these standards must be met by technologies in order to be reimbursed by the new reimbursement framework for telemonitoring, which is expected to enter into force in July 2022.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With regional decree 4229 of March 11, 2022, Tuscany Regional Healthcare has published assessments of two medical devices in the cardiovascular and ENT fields of care.

On March 10, 2022, the Ministry of Solidarity and Health published an Order in the Official Journal of the French Republic, which announced the transitional coverage for the Neovasc Reducer system. This is the first device to be covered under the new transitional scheme.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 2472 of February 10, 2022, Tuscany Regional Healthcare has published assessments of five medical devices of various therapeutic areas, such as cardiovascular and peripheral vascular areas.

On February 07, 2022, the Dental and Pharmaceutical Benefits Agency has announced the withdrawal of the assessments of the PhysioMem PM 100 and CardioMem CM 100 XT and the finalization of the assessments of the Zenicor ECG, Coala Heart Monitor Pro, and KardiaMobile. For the conducted assessments, it was outlined that the portable devices provide more limited information than standard ECG measurements; therefore, it was mainly estimated for atrial fibrillation.

In January 2022, the Basque Office for Health Technology Assessment (OSTEBA) released an HTA report aiming to assess and compare the efficacy, effectiveness, and safety of the mechanical circulatory support devices most used in the healthcare setting for the treatment and prevention of cardiogenic shock, including Impella® devices, intra-aortic balloon pumps, and extracorporeal membrane oxygenation.

On January 14, 2022, the Government of the Russian Federation released a Decree which approved the inclusion of three devices (implantable pulse generator for urinary/fecal incontinence, bioprosthetic aortic valve/xenoprosthesis, and vessels embolization material) in the List of Essential Implantable Medical Devices.

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 December 2021. More than 15 recommendations were published in relation to the registration, modification of registration conditions, renewal of registration of devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular, orthopedic, ENT devices, as well as medical aids. Except for this, CNEDiMTS published an opinion about transitional coverage (a newly established pathway for reimbursement) for a cardiovascular device.