Cardiac pacemakers

In December 2020, Swedish Medical Technologies Product (MTP) Council decided to evaluate new technologies for self-monitoring of atrial fibrillation within the Orderly introduction framework. MTP Council commissioned the Swedish Dental and Pharmaceutical Benefits Agency (TLV) to perform a health-economic evaluation of Coala Heart Monitor Pro and KardiaMobile; however, other products may also be considered later.

On December 22, 2020, the Swiss Federal Office of Public Health announced the changes that will occur to the Services Ordinance (KLV/OPre). The changes concern the general part of the Services Ordinance (KLV/OPre), and all four of its Annexes, which define the coverage of services (List of explicitly evaluated services, List of Medical Aids and Equipment, List of Analyses, List of Medications with Tariff). The updates will enter into force on January 1, 2021. Updates concern among others bariatric surgery, Autologous Chondrocyte Transplantation, ultrasound focused therapy for neurological indications.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 19274 of November 24, Tuscany Regional Healthcare has published assessments of twelve medical devices of various therapeutic areas. See the list of evaluated devices in the post from MTRC.

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 November 9, 2020, in accordance with §137h Paragraph 6 SGB V, the Federal Joint Committee (G-BA) has initiated an evaluation procedure for endovascular implantation of a stent-graft with valve element in tricuspid valve insufficiency within the framework of the early benefit assessment.

In October 2020, a completed mini-method assessment for the coronary sinus reducer stent (Neovasc) implantation in refractory angina pectoris treatment was published within the New Methods framework. The Oslo University Hospital carried out the evaluation. The technology was recommended for routine use in hospitals.

In late September 2020, the Austrian version of the DRG system (LKF) 2021 model with the relevant supplementary documents was published in Austria. For 2021, the main changes include the addition of sixteen new procedure codes and the introduction of two new procedure codes for billing in the day-case settings, update of cases flat rates, and adjustments of the cases daily component calculation.

The French National Authority for Health (HAS) released new decisions about intra-DRG reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in July 2020. Decisions concern cardiac sutureless valve bioprostheses and implantable devices for the treatment of urinary incontinence.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 12735 of August 13, 2020, Tuscany Regional Healthcare has published assessments of eleven medical devices of various therapeutic areas, including peripheral nerve stimulator, catheter for renal denervation, EKOS technology and others.

In July 2020, the Austrian Institute for Health Technology Assessment (AIHTA) published updated evaluations of medical procedures previously assessed. Technologies that were revised are leadless pacemaker for right ventricle pacing and extracorporeal cytokine hemadsorption therapy in patients with sepsis or SIRS.

The French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of many medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in July 2020. Decisions concern drug-eluting coronary stents, TAVI, orthopedic appliances, wound dressing, stoma obturator, toric intraocular lens.

The Swedish Dental and Pharmaceutical Benefits Agency (TLV) is currently performing a theme survey for medical technology products for ischemic heart disease and heart failure. The submissions in relation to this survey will be closed on August 21, 2020

In July 2020, the Austrian Institute for Health Technology Assessment (AIHTA) published five decision support documents. The assessed technologies included implantation of a wireless pulmonary artery pressure sensor in patients with advanced heart failure, intrauterine ultrasound-guided transcervical radiofrequency ablation, percutaneous transvascular implantation of a coronary sinus reducing stent, radiofrequency-induced intravesical chemohyperthermia for non-muscle invasive bladder cancer, and Vascular photodynamic therapy with Padeliporfin (Tookad® solution).

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 9004 of June 18, 2020, Tuscany Regional Healthcare has published assessments of nine medical devices of various therapeutic areas.

The French High Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in May 2020 concern various types of devices, including cardiovascular devices (self-expanding intracranial stents, TAVI), CT navigation kit for CT-guided percutaneous interventions and medical aids. A total of 8 decisions were made.

The German Society for Neurology (DGN) has published a new version of the S1 guideline "Syncope." It is valid until January 2025.

The French High Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in April 2020 concern various types of devices, for example, cardiovascular and orthopaedic devices, diabetes management systems, and other types of devices. A total of 15 decisions were made.

With a regional decree 381 of March 23, 2020, Tuscany Regional Healthcare has published clinical guidelines on the appropriateness of use and indications on the variability of the consumption of the stents for the arteriopathy of the lower limbs, the carotid stents, and the coronary stents.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 3047 of March 2, 2020, Tuscany Regional Healthcare has published assessments of eight medical devices of various therapeutic areas.

The French High Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in February 2020 concern various types of devices, for example, cardiovascular and orthopaedic devices, diabetes management systems, and other types of devices. A total of 27 decisions were made.

On March 30, 2020, the French High Authority for Health, has published the opinion of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) regarding the Impella 5.0 device. The clinical added value was graded with level II (important) for the post-cardiotomy cardiogenic shock indication. After the negotiation with CEPS, Impella might be the first short-term VAD to enter add-on reimbursement list LPPR.

The French High Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in February 2020 concern various types of devices, for example, cardiovascular and orthopaedic devices, diabetes management systems, etc. A total of 6 decisions were made.

The French High Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in January 2020 concern various types of devices, mostly for cardiovascular and orthopaedic devices, and medial aids. A total of 29 decisions were made.

The HTA unit of the Lombardy region opens the possibility for the public to comment on the health technologies which are in the assessment phase. The call is open until February 28, 2020.

In early January 2020, the network of European HTA agencies, EUnetHTA, announced the final plan of the project OTCA24 “The 24-hour blood pressure measurement device Mobil-O-Graph® with the built-in pulse wave velocity algorithm ARCSolver® to measure arterial stiffness for the optimization of hypertension treatment and assessment of cardiovascular risk”.

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in December 2019 concern various types of devices, mostly for cardiovascular devices. A total of five decisions were made.

In late November 2019, new HTA activities were published on the website of regional HTA program of Lombardy Region, after a period of inactivity. Twenty-six (26) new technologies are currently in various stages of the HTA process, and they should all be completed in 2020.

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in November 2019 concern various types of devices, including orthopaedic, and cardiovascular devices. A total of twenty-four decisions were made.

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in October 2019 concern various types of devices, including orthopedic, cardiovascular devices, and hearing aids. A total of twenty-four decisions were made.

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in September 2019 concern various types of devices, including orthopedic, cardiovascular devices, and hearing aids. A total of eighteen decisions were made.

MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including cardiovascular technologies. This post provides some key facts about the HTA, funding and innovation payment landscape for cardiovascular devices in Europe.

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in July and August 2019 concern various types of devices, including orthopedic, cardiovascular, and blood glucose meters. A total of 29 decisions were made.

Explanation about the coding of selective intravascular radiotherapy (SIRT) with microspheres labeled with holmium-166, and of creation of intracardiac septal defect with implantation of an interauricular implant (percutaneous transluminal) in Switzerland was released by SwissDRG on July 26, and July 31, 2019, respectively.

In June 2019, the National Institute for Health and Care Excellence (NICE) published six new interventional procedure guidance, one new Medical technologies guidance for Endocuff Vision for assisting visualisation during colonoscopy, and two new MedTech innovation briefings (for Danis stent for acute oesophageal variceal bleeds, and The OPTIMIZER smart system for managing heart failure).

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in June 2019 concern various types of devices, including orthopedic, cardiovascular and diabetes devices, and cochlear implants. A total of 32 decisions were made.

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in May 2019 concern various types of devices, including orthopedic, cardiovascular and diabetes devices.

The Federal Joint Committee (G-BA) has signed a further contract for scientific monitoring and implementation of a trial study for NYHA III heart failure therapy optimization by means of continuous blood pressure measurement and monitoring using an implanted sensor in the pulmonary artery.

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in April 2019 concern orthopedic devices, coronary stents, ventricular assist devices, remote monitoring systems in cardiovascular field, cochlear implants, bronchial thermoplasty device.

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in March 2019 concern various types of devices, including orthopedic, cardiovascular (coronary stents), ENT and other products.

The report presents a summary of reimbursement situation for cardiac pacemakers. Both single- and dual-chamber pacemakers are considered. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

On February 19, 2019 the new “Catalog of Goods and Services” for the centralized purchasing platform was presented to the regional health authorities by the Minister of Health. This new catalog includes up to 25,000 items, including drugs and health products.

The French National Authority for Health (HAS) regularly publishes new (32 in total) decisions about add-on reimbursement for medical devices. The decisions made in February 2019 concern various types of devices, including multiple orthopedic, cardiovascular and other devices.