Cardiovascular devices
24
Mar 2022
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.
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11
Mar 2022
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.
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15
Feb 2022
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.
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26
Jan 2022
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.
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19
Jan 2022
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.
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27
Dec 2021
On December 17, 2021, NHS Digital released HRG4+ Consultation Grouper for 2022/23. This release is used to support the NHS England and Improvement consultation process for the 2022/23 National Tariff Payment System. In general, there are significant changes in base HRG design. A total of 120 new HRGs were created, multiple HRGs were removed, and the grouping logic was updated significantly. This Consultation Grouper will be superseded by the 2022/23 Local Payment Grouper in March 2022, for use from April 01, 2022.
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22
Dec 2021
The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 20520 of November 22, 2021, Tuscany Regional Healthcare has published assessments of seventeen medical devices of various therapeutic areas, including devices belonging to neurology, as well as gastrointestinal, urology, cardiovascular, orthopedics, peripheral vascular, and other fields of care.
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09
Dec 2021
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.
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08
Dec 2021
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 November 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, peripheral vascular, neurovascular, dermatological, and endocrine devices, as well as medical aids.
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07
Dec 2021
On November 9, 2021, the Belgian Health Care Knowledge Center (KCE) published the health technology assessment report "Remote monitoring of patients with cardiovascular implantable electronic devices (CIED)". Analysis of efficacy and safety of remote monitoring showed an advantage in various aspects. Cost-effectiveness analysis indicates that remote cardiac monitoring of ICDs and PMs is cost-effective compared to monitoring based on in-clinic visits.
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01
Dec 2021
In late November 2021, the INeK (Institute for the Hospital Remuneration System) has published the DRG catalog (Fallpauschalen-Katalog) with the list of DRGs and add-on reimbursement categories (ZEs) for 2022. Seven new DRGs and seventeen ZE categories were added to the catalog in 2022.
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26
Nov 2021
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.
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