MTRC released the report on innovation payment schemes in Europe

01

Jun 2018

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19

Oct 2018

In mid-August 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI), has published a health technology assessment in which they have assessed the efficacy and safety of stereotactic radiotherapy (Cyberknife®), proton beam therapy and irreversible electroporation (Nanoknife®) for localized prostate cancer (PCa). It was concluded, there is inadequate and insufficient evidence to show that three evaluated technologies have either a positive impact on survival and quality of life or the ability to prevent or delay prostatectomy.

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18

Oct 2018

In May 2018, the French National Authority of Health, HAS, has published an update of the assessment of coronary stents.

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16

Oct 2018

The board of directors of the entity that runs and manages the Swiss DRG system, SwissDRG SA, decided to verify the conditions necessary for the foundation of the outpatient tariff agency in late September 2018.

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15

Oct 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) has published HTA of meniscal allograft transplantation for post-meniscectomy syndrome in Austria. It was concluded that there is not enough evidence demonstrating benefits in order to include MAT into the Austrian benefit catalogue.

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09

Oct 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) has published HTA of allogeneic mesenchymal stem cells for Crohn’s disease-associated complex perianal fistulas. Currently, inclusion into Austrian catalogue of benefits was not recommended with reevaluation in 2022.

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08

Oct 2018

MTRC expands the coverage of EU countries with its core service of reimbursement analysis (procedure coding, payment model, reimbursement tariffs). Work is done by MTRC personnel, supported by local reimbursement experts. Contact us, if you want to learn more.

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08

Oct 2018

On the 3rd of September 2018, an association of 4 Swiss health insurers, curafutura, published their opinion on the proposed reform of payment mechanism for inpatient and outpatient services.

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05

Oct 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) has published an evaluation of baroreceptor activation therapy for treatment-resistant hypertension. The authors concluded that there is no sufficient evidence to conclude on effectiveness or safety of BAT and thus inclusion of the procedure into the Austrian benefit catalogue is not recommended. There are currently three RCTs going on, and their results may bring new evidence.

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04

Oct 2018

The article "Congenital heart defect repair with ADAPT tissue engineered pericardium scaffold: An early-stage health economic model", published in Plos One presented the cost effectiveness of tissue engineered bovine tissue pericardium scaffold (CardioCel) for the repair of congenital heart defects in comparison with surgery using xenogeneic, autologous, and synthetic patches over a 40-year time horizon from the perspective of the UK National Health Service.

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04

Oct 2018

On 13th of August, 2018, the association of Swiss insurers, santésuisse, published an announcement in which they state that the control of the invoices received saves the premium payers’ costs up to CHF 3 billion.

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02

Oct 2018

On 24th of August, 2018, the company that maintains DRG system in Switzerland, SwissDRG SA, has announced that the planning version of SwissDRG (version 8.0 (2018/2019)) and the planning version of TARPSY (version 2.0 (2018/2019)) have been published.

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01

Oct 2018

In mid-August 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI), has published an evaluation of efficacy and safety of carbon ion beam radiotherapy (CIRT) for twelve oncological indications.

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28

Sep 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) has published an assessment of left atrial appendage closure to prevent stroke to determine national coverage of the procedure. Considering this evidence, the authors do not recommend the inclusion in the hospital benefit catalogue, neither for percutaneous left atrial appendage occlusion nor for surgical closure using a special clip.

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26

Sep 2018

In the second half of July, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance for low-intensity pulsed ultrasound to promote healing of fresh fractures at low risk of non-healing, fresh fractures at high risk of non-healing, superior capsular augmentation for massive rotator cuff tears, transaxial interbody lumbosacral fusion for severe chronic low back pain and two new Medtech Innovation Briefings for remote ECG interpretation consultancy services for cardiovascular disease and mechanical thrombectomy devices for acute ischaemic stroke.

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25

Sep 2018

The Innovation Credit focuses on the development of promising and challenging innovations with an excellent market perspective. This may involve the technical development of a new product or process or the clinical development of a drug or device. For technical development projects, there is still sample budget available and applications can be submitted.

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24

Sep 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) released an assessment of the subcutaneous implantable cardioverter defibrillator to determine coverage of the service. Authors concluded that evidence is insufficient to make conclusions about the comparative effectiveness of subcutaneous and transvenous ICDs. However, a substantially lower risk for lead complications in patients treated with subcutaneous ICD.

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21

Sep 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) has published an HTA report on efficacy and safety of endobronchial valve implantation for emphysema. The authors have concluded that the intervention is more effective but less safe than standard therapy in selected patients with severe emphysema. Inclusion in the national service catalogue is only recommended with restrictions.

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19

Sep 2018

In 2019 the regulation for “conditional reimbursement to the basic insurance” (Voorwaardelijke toelating tot het basispakket) will be replaced by the Subsidy Scheme for Promising Care. The goal is to make promising treatments, medical technologies, tools and medicines available for patients even faster. The Dutch Healthcare Institute is preparing for the implementation of the new subsidy scheme in the coming months.

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17

Sep 2018

On 20th of July, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI) has published an update of the HTA of high-intensity focused ultrasound (HIFU) for the treatment of prostate cancer. The report did not find the evidence of benefits of the treatment vs comparative treatments. The inclusion of the method hospital benefit catalogue was currently not recommended.

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14

Sep 2018

In July of 2018, the Federal Joint Committee (G-BA) has initiated the discussion regarding the establishment of the minimum quantity requirements for the surgical treatment of breast cancer and bronchial carcinoma. As the quality of surgery is directly dependent on the quantity, the number of operations performed at hospital and on the designated surgeon, the objective is to understand the importance of the experience and routine practice of the operations to reach the successful treatment outcomes and to determine a minimum number of operations, which should be performed in hospitals to gain enough experience.

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12

Sep 2018

Clarifications about coding of CytoSorb procedure and use of Flow Diverter in Switzerland were released by SwissDRG.

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11

Sep 2018

At the end of June of 2018, the Federal Joint Committee (G-BA) has commissioned to the Institute for Quality and Efficiency in Health Care (IQWiG) to provide an update of the Disease Management Program (DMP) for Diabetes Mellitus type 2 in order to perform a systematic research, make a selection of guidelines based on methodological criteria and extract guideline recommendations relevant for the treatment of Diabetes Mellitus type 2. The final report is expected to be released on the 31st of December, 2019.

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10

Sep 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In July new codes for aminoglycoside induced deafness testing, Intra-Operative PTH profile, cytokine panels and lymphocyte immunophenotyping, streptococcus pneumoniae by PCR, OCT for cardiology, contract-enhanced ultrasound and faecal immunochemistry test were added to the CCSD Schedule.

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09

Sep 2018

MTRC performs the analysis using administrative databases. Reporting of procedure volume is done according to the established procedural classifications (e.g., OPCS in England, OPS in Germany). Data are available for Austria, Belgium, England, France, Germany, the Netherlands, Sweden, and Switzerland. In other countries, it might be possible to obtain data from patient registries or clinical societies.

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07

Sep 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In July new codes for percutaneous paravalvular leak closure, endoscopic vacuum therapy for colorectal anastomotic leakage and phonomicrosurgery for vocal cord lesions, nodules, polyps, or cysts were added to the CCSD Schedule.

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03

Sep 2018

A national ‘pause’ has been announced in the use of surgical mesh/tape to treat stress urinary incontinence and for urogynaecological prolapse where the mesh is inserted through the vaginal wall. A Mesh Pause Clinical Advisory Group (CAG) was established. Further recommendations and CAG guidance on implementation of the pause has been published.

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31

Aug 2018

In the first half of July, the National Institute for Health and Care Excellence (NICE) published one new Diagnostics Guidance for biomarker tests to help diagnose preterm labour in women with intact membranesand one new medtech innovation briefing for airglove air warming system for venous access.

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29

Aug 2018

At the beginning of July of 2018, the Institute for Quality and Efficiency in Health Care (IQWiG) has published a final report regarding the benefit assessment of allogeneic stem cell transplantation (ASCT) in aggressive B-cell non-Hodgkin's lymphoma (B-NHL) and in T-cell non-Hodgkin's lymphoma (T-NHL). IQWiG concluded that the benefit of ASCT in B-NHL and T-NHL is unclear for now, as no meaningful studies are available.

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27

Aug 2018

This guide offers useful guidance on emergency patient flow to identify a large cohort of patients who can safely be treated on the same day, reducing admissions and improving the patient experience.

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24

Aug 2018

In the second half of June, the National Institute for Health and Care Excellence (NICE) published two new interventional procedure guidance for laparoscopic ventral mesh rectopexy for internal rectal prolapse and MRI-guided focused ultrasound thalamotomy for treatment-resistant essential tremor, and two new medtech innovation briefings for negative pressure wound therapy for closed surgical incision wounds and ocular response analyzer to measure corneal hysteresis.

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23

Aug 2018

At the beginning of July of 2018, the Federal Joint Committee (G-BA) has commissioned to the Institute for Quality and Efficiency in Health Care (IQWiG) to provide an assessment of potential harm and benefits of biomarker-based tests for or against adjuvant chemotherapy in primary breast to understand its efficacy in comparison with the previous standard examinations in women who do not require chemotherapy due to a low/intermediate risk of relapse. The final report is expected to be released by G-BA at the end of 2018.

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22

Aug 2018

INAMI/RIZIV launched a call for projects via the application of negative pressure wound therapy in home nursing until August 31, 2018. Funding for a project depends on the number of treatment periods started, with a maximum of €1,000 per patient.

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21

Aug 2018

A national ‘pause’ has been announced in the use of surgical mesh/tape to treat stress urinary incontinence and for urogynaecological prolapse where the mesh is inserted through the vaginal wall. This pause takes the form of a high vigilance restriction, and all cases should be postponed immediately if it is clinically safe to do so.

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16

Aug 2018

Hundreds of patients each year will benefit from fourteen new innovative treatments that will now be routinely available. These treatments include several devices and procedures: keraprosthesis for corneal blindness, left atrial appendage occlusion, selective dorsal rhizotomy and total pancreatectomy with islet transplantation for chronic pancreatitis.

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15

Aug 2018

At the beginning of July 2018, the Swiss agency for therapeutic products, Swissmedic, has released an announcement about the upcoming changes about upcoming changes relating to the issuing of Export Certificates (FSC) and Manufacturing Certificates (MC).

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10

Aug 2018

An article “An early analysis of cost-utility of baroreflex activation therapy in advanced chronic heart failure in Germany” was published in the BMC Cardiovascular Disorders. The study concluded that Baroreflex activation therapy (BAT) using the Barostim neo™ device (CVRx Inc., Minneapolis, MN, USA) compared with optimized medical management in patients with advanced chronic heart failure (NYHA class III) who were not eligible for treatment with cardiac resynchronization therapy, can be cost-effective from a statutory health insurance perspective in Germany over a lifetime horizon. The ICER was €27,951/QALY (95% CI €21,357–82,970).

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10

Aug 2018

In April 2018, a national HTA program has been launched in order to re-evaluate benefits presently covered by the mandatory health insurance.

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09

Aug 2018

On June 29th, 2018, the company that maintains DRG system in Switzerland, SwissDRG SA, has announced that The planning version of SwissDRG (version 8.0 (2017/2019)) and the planning version of TARPSY (version 2.0 (2017/2019)) have been published.

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07

Aug 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In June, new codes for genetic testing,including single gene tests and gene panel tests, next generation sequence and molecular profiling tests were added to the CCSD Schedule.

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06

Aug 2018

In April 2018, the French National Authority for Health (HAS) proposed an updated nomenclature in LPPR for foot orthosis and heel cup.

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02

Aug 2018

The French National Authority for Health (HAS) published new set of decisions about add-on reimbursement for medical devices in June. They concern orthopedic devices and endobronchial valve.

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01

Aug 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In June, new codes for laparoscopic pelvic lymphadenectomy, robotic assisted total knee replacement, abdominal (mesenteric) and limb angiogram were added to the CCSD Schedule.

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27

Jul 2018

The French National Authority for Health (HAS) published new set of decisions about add-on reimbursement for medical devices in May. They concern pacemakers, orthopedic devices, radiofrequency ablation system, vagus nerve stimulator and some other devices.

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26

Jul 2018

At the beginning of June 2018, the Federal Department of Home Affairs published an update of the Services Ordinance (Ordinanza sulle prestazioni, OPre). This update concerns many different fields, including the list of laboratory tests.

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24

Jul 2018

On 8th of June 2018, the company in charge of the development of the DRG system in Switzerland, SwissDRG SA, has announced the catalogue version of Swiss DRG 8.0/2019.

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23

Jul 2018

The French National Authority for Health (HAS) published new set of decisions about add-on reimbursement for medical devices in April. They concern orthopedic prostheses, neurostimulators and some other devices.

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20

Jul 2018

On 18th of June, 2018, the Federal Department of Home Affairs issued the latest update of the list of medical aids and equipment. This update will come into force on 1st of January, 2019. However, this list will be updated a few times in 2018.

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18

Jul 2018

In the first half of June, the National Institute for Health and Care Excellence (NICE) published one new interventional procedure guidance for Intranasal phototherapy for allergic rhinitis and one new medtech innovation briefing for lung volume analysis in emphysema.

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16

Jul 2018

Starting with 19th of June, 2018, HIV self-test kits can be bought in pharmacies and druggists all over Switzerland.

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11

Jul 2018

In the second half of May, the National Institute for Health and Care Excellence (NICE) published two new interventional procedure guidance for low-level laser therapy for preventing or treating oral mucositis caused by radiotherapy or chemotherapy and endoscopic bipolar radiofrequency ablation for treating biliary obstruction caused by cancer.

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05

Jul 2018

Payment-for-performance schemes in health care remain controversial as there is no solid evidence that they improve quality of care. A new study, published in Health Policy by Herbst et al, did not show any positive long-term effects of the implementation of P4P on quality of care. The program was implemented within the integrated contract framework between one ophthalmological clinic and one statutory health insurance company in Germany.

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05

Jul 2018

In spring 2018, the Belgian Healthcare Knowledge Center, KCE, has published a rapid HTA report of MammaPrint® test for personalized management of adjuvant chemotherapy decisions in early breast cancer. The report complements evaluation of the clinical utility of the test from the EUNetHTA’s assessment with health economic evaluation in a Belgian context. Estimates show approximate mean chemotherapy-related costs in Belgium of €11 411 without considering sick leave costs and of €15 044 when the latter are included. KCE came to the conclusion that given the uncertainties surrounding the limited data on the clinical utility of MammaPrint®, no reliable incremental cost-effectiveness ratio could be calculated.

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04

Jul 2018

MedTech Europe has published a paper with reflections on how to facilitate the dialogue between industry and funding and reimbursement decision makers, in order to create an innovation-friendly environment for healthcare in Europe. MTRC report on innovative payment schemes is cited in the paper.

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04

Jul 2018

A change in the Services Order (Ordinanza sulle Prestazioni, OPre), regarding surgery in general, will come into force on January 1st, 2019. This change makes it possible to reimburse a number of surgeries in hospital settings in exceptional circumstances because in general, these procedures should be performed in out-patient settings.

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03

Jul 2018

In April of 2018, the Institute for Quality and Efficiency in Health Care (IQWiG) has published an update for the report V14-03 “Systematic guideline search and appraisal, as well as extraction of relevant recommendations, for a disease management program (DMP) for osteoporosis” from 2016 in order to find additional evidence on integrated concepts of medical and physical rehabilitation. However, no new information was identified and included into the report.

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29

Jun 2018

The Ludwig Boltzmann Institute (LBI-HTA), the Austrian HTA body, develops health technology assessments of medical technologies to support decision-making about coverage of these methods in Austrian public reimbursement system. MTRC summarized the list of reports to be published by LBI-HTA until the end of 2018.

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25

Jun 2018

MTRC has developed reimbursement overviews for 14 EU countries. Overviews cover stakeholders, money flow, payment model, DRG system, innovation funding, coverage with evidence development, the role of health technology assessment, funding frameworks and reimbursement pathways. Reports are delivered in PowerPoint. Video explanations are available as well.

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25

Jun 2018

NHS England will fast track clinical trials and improve access for patients. As a result, patients will benefit from quicker access to clinical trials and the NHS will become a more attractive place to undertake research.

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22

Jun 2018

On the 23rd of May of 2018, the Institute for Quality and Efficiency in Health Care (IQWiG) has published an update version of the report “Colorectal cancer screening in persons with familial risk”, which was commissioned to IQWiG by the Federal Joint Committee (G-BA) in October of 2017 to provide an answer, whether people under 55 years of age with a family history of colorectal cancer benefit from a screening test. Like the previous report, the current one therefore concluded that the benefit of screening for under 55-year-olds with a family history of colorectal cancer is unclear.

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20

Jun 2018

On 28th of May, 2018, the Swiss Medical Tariff Commission (CTM-MTK) has agreed with the hospitals association (H+) on a transitional solution for the application of TARMED, which will last until July 31st, 2018.

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19

Jun 2018

On the 29th of May of 2018, the Institute for the Hospital Remuneration System (InEK) has published a joint document with G-DRG proposals for 2019. According to the decision made on the basis of § 17b KHG, the names of the applicants and procedure proposals for 2019 were provided.

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13

Jun 2018

The list of the laboratory tests is based on the Services Order (Ordinanza sulle Prestazioni, OPre) of the September 29th, 1995; the latest update is in force since January 1st, 2018. The list contains the services whose costs are covered by the obligatory healthcare insurance (assicurazione obbligatoria delle cure medico-sanitarie, AOMS). With the latest update, there are 1931 tests on this list.
See the list of the January 2018 modifications in Italian here.
See the full list of current laboratory tests in Excel format (in French, German and Italian) here.
Subscribe to our newsletter delivered every second week not to miss important reimbursement information.

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12

Jun 2018

At the end of April, 2018, the National Healthcare Institute (Zorginstituut Nederland, ZIN) has published an Overview of the healthcare activities, which were excluded or included with restrictions into Basic Insurance Package.

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08

Jun 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In April new codes for continuous glucose monitoring, vestibular and quantitative sensory testing were added to the CCSD Schedule.

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07

Jun 2018

In May of 2018, the Federal Joint Committee (G-BA) approved two additional indications for application of PET/CT for management of malignant lymphomas for coverage within statutory health insurance. As the procedures were included into Directive for methods and examinations and Directive methods of the contract medical care, they are now reimbursed in both hospital and out-patient settings.

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06

Jun 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In April new codes for therapeutic arthroscopic operation of temporomandibular joint, pelvic angiogram and diagnostic small-bore needle arthroscopy were added to the CCSD Schedule.

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04

Jun 2018

Report includes analysis for the following procedures: radiofrequency ablation, endoscopic plication and suturing, injection of bulking agents and endoscopic augmentation of the lower esophageal sphincter using hydrogel implants. 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.

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04

Jun 2018

Report includes analysis for the following procedures: surgical clipping, endovascular placement of a flow diversion device, endovascular coiling and stent-assisted coiling. 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.

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01

Jun 2018

On the 9th of May of 2018, the addendum H18-01 to the report H16-02C “Ultrasound-guided high-focused ultrasound (USgHIFU) therapy for malignant neoplasms of the pancreas” commissioned by the Federal Joint Committee (G-BA) at the beginning of March of 2018, was published by the Institute for Quality and Efficiency in Health Care (IQWiG) on its web-site.

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31

May 2018

In the first half of May, the National Institute for Health and Care Excellence (NICE) published one new interventional procedure guidance for percutaneous balloon valvuloplasty for fetal critical aortic stenosis and three new medtech innovation briefings for patient position monitoring system for intracranial stereotactic radiosurgery, 3D/QFR imaging software to assess coronary fractional flow reserve non-invasively and point-of-care tests for diagnosing group A beta-haemolytic streptococcus (strep A) throat infection.

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30

May 2018

In mid-May 2018, the Basque office for Health Technology Assessment, OSTEBA, has published a rapid assessment report on treating prostate cancer with high-intensity focused ultrasound. The article is published under EUnetHTA framework.

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28

May 2018

The call for a tender to select an organization to run the pilot study “Liposuction for the treatment of lipedema” was announced by the Federal Joint Committee (G-BA) on the 8th of May of 2018. The deadline for the requests is the 26th of June, 2018, 14:00.

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25

May 2018

On the 26th of April of 2018, the Federal Joint Committee (G-BA) has announced the call for a tender for the pilot study “Transcorneal Electrical Stimulation in Retinitis Pigmentosa” in the Official Journal of the European Union. The deadline for the requests is the 22nd of June, 2018, 14:00

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23

May 2018

On the 26th of April of 2018, the Federal Joint Committee (G-BA) has commissioned to the Institute for Quality and Efficiency in Health Care (IQWiG) to provide a rapid report regarding the current state of medical knowledge on synchronous balneophototherapy in atopic eczema. The identified results of the current state of medical knowledge would form the basis for the further G-BA’s assessment of adequacy, appropriateness and economic benefits of the researched method.

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22

May 2018

Flash Glucose Monitoring (FGM) is covered care for four groups of diabetic patients who are already eligible for reimbursement of real-time continuous glucose monitoring (RTCGM). This is stated in the 'Flash Glucose Monitoring' assesement of the Dutch National Health Care Institute

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21

May 2018

NHS Digital has published experimental statistics on patients that have had a procedure for urogynaecological prolapse or stress urinary incontinence including those where mesh, tape or their equivalents have been used

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18

May 2018

In the second half of April, the National Institute for Health and Care Excellence (NICE) published one diagnostic guidance on adjunctive colposcopy technologies for assessing suspected cervical abnormalities, four Interventional Procedure Guidance for robot-assisted kidney transplant, nerve transfer to partially restore upper limb function in tetraplegia, prostate artery embolisation for lower urinary tract symptoms caused by benign prostatic hyperplasia and microinvasive subconjunctival insertion of a trans-scleral gelatin stent for primary open-angle glaucoma, and two new MedTech Innovation Briefings for sleep mask for diabetic retinopathy and diabetic macular oedema and disinfecting cap for needleless connectors.

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17

May 2018

The cardiothoracic surgery report from the 'Getting It Right First Time' (GIRFT) programme sets out twenty recommendations to improve the way cardiothoracic surgical services are organised and delivered in England.

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16

May 2018

National Institute for Sickness and Disability Insurance (RIZIV/INAMI) reimburses some or all of the non-implantable medical devices provided by the pharmacist or in some cases by a supplier. In May 2018 the list of non-implantable medical devices has been updated.

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14

May 2018

Dutch Healthcare Authority (NZa) has published the DBC product structure and maximum tariffs for specialist medical care for 2019. Healthcare providers and health insurers can start using it for the contract negotiations for 2019. The most important changes include reimbursement for telemonitoring consultation and reimbursement tariffs

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10

May 2018

Between 28th of May and 9th of July 2018, SwissDRG will be accepting the requests/suggestions regarding the DRG system in the country.

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08

May 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In March one new code for non-invasive nasal airway remodelling was added to the CCSD Schedule.

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07

May 2018

On the 19th of April of 2018, the Federal Joint Committee (G-BA) was able to reassess previously excluded use of extracorporeal shockwave therapy (ESWT) in the indication of heel pain in plantar fasciitis on a current scientific basis and decided that ESWT will be used in out-patient settings in the future.

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02

May 2018

At the end of March of 2018, the Institute for Quality and Efficiency in Health Care (IQWiG) has released an updated version of the disease management program (DMP) “Coronary heart disease”, which was initially implemented in 2003.

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25

Apr 2018

In April 2018, Oleg Borisenko with support from the MTRC launched an international stipend and mentoring program. The objective of the program is to support medical students in developing countries with achieving maximum results in a medical profession. For the first round of the program (six months until Oct 2018), three students were selected. The program includes a stipend, bi-weekly meetings on different subjects (goal setting, evidence-based medicine, clinical epidemiology, medical experiment, marketing, publication standards and others) and a personal mentoring of Oleg Borisenko.

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25

Apr 2018

In the first half of April, the National Institute for Health and Care Excellence (NICE) published one new medtech innovation briefing for device that usesroutinely available datasets to help identify people who are at high risk of developing colorectal cancer.

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20

Apr 2018

On 5th of April, 2018, the Board of Directors of SwissDRG SA has given the director the mandate to establish, where appropriate, codifications by analogy in agreement with the Federal Statistics Office (FSO). The regulation from April of 2018 covers CytoSorb for removal of cytokines.

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19

Apr 2018

The CEO of MTRC co-authored the article "Cost–utility analysis of bariatric surgery", published in the leading European surgical journal, British Journal of Surgery. Analysis indicated that currently used surgical methods in England were found to be cost saving over the lifetime of individuals treated in England.

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17

Apr 2018

The Institute for Quality and Efficiency in Health Care (IQWiG) has selected four out of 31 themes for the future health technology assessments, which were proposed by the citizens at the web-site of ThemenCheck Medizin service and will presumably be published at the beginning of 2019. The next process of topics’ selection will start in August of 2018.

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16

Apr 2018

In February 2018, the DFI (the Federal Department of Home Affairs) has decided to make a change in the activity order (Ordinanza sulle prestazioni, OPre) concerning “out-patient before in-patient.” The modification is coming into force starting January 1st, 2019. Six procedures will be reimbursed only in out-patient settings.

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13

Apr 2018

NHS England has announced the selected technology for the central funding to accelerate access within NHS. These technologies include HeartFlow, Plus Sutures, Endocuff Vision and SecurAcath. This is the second year selection of the technology for the fast track innovation payment scheme in England.

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12

Apr 2018

In the second half of March, the National Institute for Health and Care Excellence (NICE) published one new medical technologies guidance for a portable digital system for managing chest drains.

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10

Apr 2018

New material codes for Ventricular Assist Device and Aortic Endoprotheses were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in April 2018.

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05

Apr 2018

The Federal Joint Committee (G-BA) has published two calls for tenders in the Official Journal of the European Union to select evaluator for two coverage with evidence development studies for pulmonary artery pressure measurement and monitoring using an implanted sensor to optimize therapy in NYHA class III heart failure and allogeneic stem cell transplantation for front-line treatment of multiple myeloma.

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30

Mar 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In February new codes for genetic tests and immunological tests for infections were added to the CCSD Schedule.

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29

Mar 2018

The NHS has selected 138 entrepreneurs to design and deliver new technological solutions and innovations in healthcare, including sickle cell disease and allergic reactions.

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28

Mar 2018

The Dutch Healthcare Authority (Nederlandse Zorgautoriteit) has published a draft version of the DBC package for specialist medical care for 2019 (RZ19a).

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26

Mar 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In February new codes for preparation and delivery of radiotherapy, knee resurfacing arthroplasty, balloon dilatation of the Eustachian tube and MRI-guided focused ultrasound (MRgFUS) thalamotomy for essential tremor were added to the CCSD Schedule.

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23

Mar 2018

Interstitial low-dose rate brachytherapy was commissioned to the Institute for Quality and Efficiency in Health Care (IQWiG) by the Federal Joint Committee (G-BA) in order to analyze the current knowledge on procedure.

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22

Mar 2018

In the first half of March, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedures Guidance (laparoscopic mesh pectopexy for apical prolapse of the uterus or vagina and mosaicplasty for symptomatic articular cartilage defects of the knee) and one new Technology appraisal guidance for autologous chondrocyte implantation using chondrosphere for treating symptomatic articular cartilage defects of the knee.

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21

Mar 2018

The Institute for Quality and Efficiency in Health Care (IQWiG) released the final report on the assessment of benefit for telemonitoring of cardiac implantable electronic devices compared to a standard treatment without telemonitoring in patients with ventricular tachyarrhythmias and / or heart failure. It was concluded that the benefits of the telemonitoring for patients with cardiac failure or heart rhythm disorders with a fast heart rate remain unclear.

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19

Mar 2018

In January 2018, the Institute for the Hospital Remuneration System (InEK) has published the List of the requests for innovation funding (NUB). Out of 705 requests for drugs and technologies, 171 (24%) received the positive status 1, and 72 of them were the requests for the medical technologies.

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15

Mar 2018

The German Federal Joint Committee (G-BA) has commissioned the Institute for Quality Assurance and Transparency in Health Care (IQTIG) to evaluate the guideline on minimally invasive heart valve interventions with minimum quality standards for hospitals that want to perform transcatheter aortic valve implantation (TAVI) or clip procedures on the mitral valve. The report has to be submitted by December, 2019.

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08

Mar 2018

In some cases, compulsory health care insurance reimburses an implant or an invasive medical device only if it is placed in a hospital that meets specific criteria.

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07

Mar 2018

In February, HAS published a set of decisions about add-on reimbursement of medical devices that were evaluated by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). These decisions concern cardiac pacemakers, devices for aortic root replacement, orthopedic devices (double mobility cups, porous high-density polyethylene implants) and other devices.

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05

Mar 2018

In the second half of February, the National Institute for Health and Care Excellence (NICE) published two new interventional procedures guidance (unilateral MRI-guided focused ultrasound thalamotomy for moderate to severe tremor in Parkinson’s disease and supraciliary microstent insertion with phacoemulsification for primary open-angle glaucoma) and one Medical technologies guidance for transanal irrigation system for managing bowel dysfunction.

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28

Feb 2018

This report calls for new approaches to scalling tried and tested health care innovations. It highlights the need to create the right conditions to spread this successfully across the NHS.

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26

Feb 2018

In the first half of February, the National Institute for Health and Care Excellence (NICE) published two new Medtech innovation briefings for a compression bandage for venous leg ulcers and insertable cardiac monitor for detecting suspected asymptomatic atrial fibrillation after cryptogenic stroke, one new interventional procedures guidance (aortic valve reconstruction with a new valve made from chemically treated cow pericardium) and one Medical technologies guidance for Memokath-051 stent for ureteric obstruction.

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22

Feb 2018

In March 2013, the National Association of Statutory Health Insurance Funds requested a benefit assessment of surgical lung volume reduction in severe pulmonary emphysema. The Joint Federal Committee (G-BA) decided on February 15th 2018 that the method will remain a benefit in the inpatient sector in Germany. The was supported by a health technology assessment provided by the Institute for Quality and Efficiency in Health Care (IQWiG).

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20

Feb 2018

The method was under assessment by the Joint Federal Committee (G-BA) previously but the assessment was paused due to insufficient evidence in 2008. The final decision will concern the reimbursement of the method in the outpatient sector. The Institute for Quality and Efficiency in Health Care (IQWiG) is mandated to provide a health technology assessment (HTA) report to support G-BA’s decision.

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19

Feb 2018

The deadline for acceptance of applications for conditional reimbursement in 2020 was announced by the is Zorginstituut Nederland, which is 15th of May 2018.

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16

Feb 2018

KCE performed health technology assessment of 3D high-risk printed medical devices. It provides description of evidence concerning efficacy, safety and cost-effectiveness of the 3D printed medical devices as well as legal issues (requirements to enter to the market, liability, data protection, patient’s rights, traceability, reimbursement, intellectual property rights).

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15

Feb 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In January new codes for Anti C1Q antibodies, soluble CD25, umbilical Cord Ph Level and several genetic tests were added to the CCSD Schedule.

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14

Feb 2018

The Dutch Healthcare Authority (Nederlandse Zorgautoriteit) has published a draft version of the DBC package for specialist medical care for 2019 (RZ19a).

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12

Feb 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In January new codes for robotic assisted laparoscopic pelvic lymphadenectomy, ligation of the intersphincteric fistula tract and eminectomy of temporomandibular joint were added to the CCSD Schedule.

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09

Feb 2018

In order to decide upon the inclusion of medical benefits into the German statutory health insurance, the Joint Federal Committee (G-BA) can commission the Institute for Quality and Efficiency in Health Care (IQWiG) with the preparation of health technology assessments (HTA). At the turn of the year, IQWiG published its 220th evaluation dossier since its foundation in 2004. G-BA followed IQWiG’s recommendations in 70% of cases.

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08

Feb 2018

In the second half of January, the National Institute for Health and Care Excellence (NICE) published two new Medtech innovation briefings for an amniotic membrane allograft for treating chronic wounds and minimally invasive percutaneous nephrolitholapaxy medium to remove kidney stones, and one new Clinical Guideline for assessment and management of oesophago-gastric cancer in adults.

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07

Feb 2018

The Ludwig Boltzmann Institute – Health Technology Assessment (LBI-HTA) released seven decision support documents in 2017. In these, three technologies were recommended for inclusion into the national benefit catalogue. The rest was preliminarily not recommended for inclusion. HTA by LBI-HTA have indirect but strong connection to decision making about funding by the Ministry of Health.

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25

Jan 2018

The German Institute of Medical Documentation and Information (DIMDI) opened the annual application process for procedure codes (OPS) in the inpatient sector. Applications can be submitted by medical societies and other associations within the German healthcare system Deadline for applications is February 28th 2018 and the new codes will be incorporated in the OPS version effective from 2019.

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24

Jan 2018

In December, HAS published a set of decisions about add-on reimbursement of medical devices that were evaluated by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). These decisions concern respiratory prostheses for total laryngectomy, mandibular advancement devices, some cardiovascular devices (transcutaneous bioprosthetic aortic heart valve, ventricular assist device, etc.) and other devices.

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23

Jan 2018

In the first half of January, the National Institute for Health and Care Excellence (NICE) published five new Medtech innovation briefings for in vitro diagnostic test for determining breast cancer subtypes, point-of-care creatinine tests before contrast-enhanced imaging, plasma EGFR mutation tests for adults with locally advanced or metastatic non-small-cell lung cancer, smartphone otoscope and sequencing panel for solid tumour cancers in children .

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22

Jan 2018

The Institute for Quality and Efficiency in Health Care (IQWiG) has analyzed the applications for approval of clinical trials at the Berlin Ethics Committee. The share of randomized controlled trials (RCTs) had risen to 86% in 2013. This trend is assumed to be an early response to increasing international legal regulations of medical devices requiring manufacturers to present higher standards of evidence.

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19

Jan 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In November new codes for allergy diagnostics, diagnostic profiles for certain diseases and detection of antibodies against Chlamydia were added to the CCSD Schedule.

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17

Jan 2018

Article “Cost-effectiveness analysis of bariatric surgery for morbid obesity in Belgium” published in the “Journal of Medical Economics” provides insights about economic outcomes of bariatric surgery in Belgium using Markov modeling. Over the 10-year horizon, bariatric surgery led to a cost increment of €3,788 and 1.4 additional QALY (€2,809/QALY) compared with optimal medical management. Over lifetime horizon, surgery led to 1.1 life years and 5.0 QALY gains and €9,332/patient average cost savings.

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11

Jan 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In November new codes for reconstruction of breast, open adnexectomy, transoral laser microsurgery and surgical correction of hallux valgus were added to the CCSD Schedule.

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10

Jan 2018

The Department of Home Affairs (EDI) in Switzerland decided upon the coverage with evidence development (CED) of two types of positron emission tomography as well as stereotactic radiotherapy (photons) of exudative age-related macular degeneration. The status is given to contested medical services for a specific period which is extended until evidence is complete.

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09

Jan 2018

The new Diagnosis Related Group (DRG) system, called “LKF system” in Austria came into effect on January 1st 2018. It is used for the reimbursement, documentation and cost data collection of inpatient and day case services in Austrian hospitals. Compared to the last version, the LKF system for 2018 includes two newly established procedure groups (Oncological Immunotherapy and Transcranial Magnetic Stimulation) as well as several new procedures and changes in the association of procedures to specific groups. See details in the MTRC report.

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05

Jan 2018

The generic quality framework and three modules of care describe the general requirements for medical devices for home-based application, included in the Health Insurance Act (Zvw). This framework is not intended for medical devices that fall under the Social Support Act (Wmo) and medical aids provided in intramural settings.

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27

Dec 2017

The further-developed tariff structure SwissDRG was approved by the Federal Council in Switzerland. The new tariff version for inpatient services will be effective from January 1st in 2018. The tariff structure SwissDRG defines how inpatient services in the acute care area of the hospitals and birthplaces are reimbursed within the framework of compulsory health care insurance in Switzerland.

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26

Dec 2017

A wireless sensor that better detects signs of sepsis in hospital patients, an app to help pregnant women monitor hypertension, and another that directs patients with minor injuries to treatment units with the shortest queues, are among the latest devices and technologies selected to join the NHS Innovation Accelerator (NIA).

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25

Dec 2017

The Institute for the Hospital Remuneration System (InEK) has opened the proposal procedure for integrating the medical and scientific expertise in the further development of the G-DRG system for the year 2019. Proposals, e.g. add-on payments, DRG re-grouping and changes in coding guidelines or cost calculation can be submitted until March 31st, 2018.

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22

Dec 2017

NICE recommends new tests to help diagnose asthma and a change in how medicines are offered.

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21

Dec 2017

The Dutch National Health Care Institute (Zorginstituut Nederland) published a position paper with results of 4-years observation of transluminal endoscopic step-up approach in patients with infected pancreatic necrosis. In accordance to this document the procedure fulfils the criteria ‘state of science and practice’. The method can be reimbursed within basic health insurance.

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20

Dec 2017

As part of its routine method evaluation, the Federal Joint Committee (G-BA) charged the German Institute for Quality and Efficiency in Health Care (IQWiG) with a benefit assessment of the use of negative pressure wound therapy (NPWT) compared to conventional methods of wound management in the inpatient sector in Germany. Currently, no restrictions exist for the use of NPWT in hospital settings. Based on the new evaluation report, the G-BA will re-assess the reimbursement status in the statutory health insurance.

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19

Dec 2017

In the second half of November, the National Institute for Health and Care Excellence (NICE) published two new interventional procedures guidance (for hypoglossal nerve stimulation for moderate to severe obstructive sleep apnoea and processed nerve allografts to repair peripheral nerve discontinuities).

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18

Dec 2017

The meeting Improvement of Patient Quality of Life and Access to Innovation: Two Priorities in Medical Device Evaluations was organized by HAS on 24th of November to discuss evaluation principles of medical devices in France with manufacturers. In connection to the meeting new and updated policy documents were released.

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15

Dec 2017

The Belgian Health Care Knowledge Centre and the Netherlands Organisation for Health Research and Care innovation have signed an agreement to invest 6 million euros in the pilot project Belgium-Netherlands Funding of International Trials (BeNeFIT) for conduction of comparative, practice-oriented clinical studies which is relevant to patients, caregivers and policymakers in Belgium and the Netherlands.

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14

Dec 2017

In the second half of November, French HAS published new set of decisions for add-on reimbursement: four positive decisions for orthopedic medical devices, two negative decisions for coronary stents and two positive decisions for cochlear implant and kit for wheelchair.

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13

Dec 2017

The changes of the DBC package for specialist medical care in 2019 (RZ19a) will include pediatric oncology, proton therapy, and telemedicine.

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11

Dec 2017

The German Institute for Quality and Efficiency in Health Care (IQWiG) has published its final plan for the benefit assessment of motor-driven movement splints (CPM) after interventions on the knee joint and on the shoulder joint. IQWiG was commissioned with this task by the Federal Joint Committee (G-BA). Two manufacturers and relevant associations had used the opportunity of commenting on the preliminary project plan.

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06

Dec 2017

The Institute for Quality and Efficiency in Health Care (IQWiG), in agreement with the relevant manufacturers' associations, has drafted a model contract to regulate the conditions under which information provided by manufacturers for the evaluation of medical devices is used by IQWiG and made available to third parties.

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04

Dec 2017

CEO of the MTRC, Dr. Oleg Borisenko will attend the "MedTech Access Leaders Forum" 5-7 of December in Berlin. Please, write to info@mtrconsult.com if you would be interested to arrange a meeting to discuss your market access needs in Europe. 

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04

Dec 2017

The Dutch National Health Care Institute considered that application of one-way endobronchial valves for endobronchial lung volume reduction fulfills the criteria of “state of science and practice” for patients with severe emphysema and insufficiency of drug treatment. Therefore, this procedure can be included into a basic package for appropriate indication.

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29

Nov 2017

Shockwave Medical, the manufacturer of the Coronary Lithoplasty® System for the treatment of calcified coronary artery stenosis, requested a consultation by the Joint Federal Committee (G-BA) to find out whether their device requires an early benefit assessment according to §137h of the Social Code Book V (SGB V). The G-BA decided that the technology is highly invasive and innovative and therefore will need to undergo benefit assessment to be granted innovation funding.

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28

Nov 2017

NHS England, Public Health England and Diabetes UK have teamed up with leading companies from the tech sector to fight against obesity and Type 2 diabetes using innovative digital products.

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24

Nov 2017

In the first half of November, HAS published a set of decisions about add-on reimbursement of medical devices that were evaluated by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). These decisions concern orthopedic devices (double-mobility cup, meniscal repair system), electrodes for radiofrequency ablation, portable oxygen concentrator, drug–coated balloons and other devices.

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23

Nov 2017

We have developed a one-day training in market access for IVD companies, covering essential areas of reimbursement, funding, health technology assessment, the role of clinical and economic evidence, stakeholder engagement. The seminar is based on the in-house expertise and extensive interview program with laboratory experts. During the course, both general aspects of market access and specific pathways for IVD tests in 12 European countries are reviewed. CEO Oleg Borisenko performs seminar on the client’s facility.

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23

Nov 2017

In the first half of November, the National Institute for Health and Care Excellence (NICE) published two new interventional procedures guidance (for total distal radioulnar joint replacement in symptomatic joint instability or arthritis and extracranial to intracranial bypass in intracranial atherosclerosis), one new diagnostics guidance for tests to identify people at high risk of ovarian cancer and four new Medtech innovation briefings.

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22

Nov 2017

The Austrian HTA body LBI-HTA performed a systematic review of health economic evaluations of Transcatheter Aortic Valve Implantation (TAVI) compared to medical treatment and surgical aortic valve replacement for inoperable and operable patients with high or moderate surgical risk. The result of the review have only limited transferability to Austria, and LBI-HTA concluded, that the currently applied selection of patients based on clinical parameters can be considered as good practice.

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17

Nov 2017

After successful trial application by a manufacturer (St. Jude Medical, now part of Abbott), the Federal Joint Committee (G-BA) decided to conduct a co-funded study to create evidence about the measurement and monitoring of pulmonary artery pressure using an implanted sensor called “CardioMEMS™ HF System” to optimize therapy in NYHA III heart failure. The G-BA released a trial guideline defining the key points of the planned study, including type and duration of the study, target population and control intervention.

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16

Nov 2017

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. New codes were added for trans-oral robotic surgery and joint replacement surgery.

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15

Nov 2017

A manufacturer (PQ Bypass) requested a consultation by the Joint Federal Committee (G-BA) about the eligibility of their medical device for an early benefit assessment according to §137h of the Social Code Book V (SGB V). The technology (PQ Bypass Stent Graft System) is a fully-percutaneous femoral-popliteal bypass procedure for peripheral arterial disease. The G-BA argued that the method is not based on the use of a high-risk medical device and therefore does not have to undergo a §137h assessment.

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13

Nov 2017

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. New codes were added for nitrogen washout test for lung capacity and fractional flow reserve CT measurement.

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08

Nov 2017

An international advisor group of 14 medical and health economic experts proposed 38 measures of how control the increase of healthcare costs in Switzerland. One third of the actions including the strengthening of HTA are already considered. The Swiss Federal Council now wants to develop concrete plans for the implementation of the new measures suggested in the report by the expert group, including global budgets for the outpatient sector, the introduction of medical boards, the encouragement of parallel imports of medical technology and implants and annual review of prices.

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07

Nov 2017

The article "Alfapump® system vs. large volume paracentesis for refractory ascites: A multicenter randomized controlled study" published in the Journal of Hepatology provides valuable insights into efficacy, safety and cost outcomes of the innovative method for managing refractory ascites.

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07

Nov 2017

In the second half of October, the National Institute for Health and Care Excellence (NICE) published two new clinical guidelines (for cataracts in adults and cystic fibrosis), and published two new Medtech innovation briefings for radiation dose monitoring software for medical imaging with ionising radiation and Promonitor for monitoring response to biologics in rheumatoid arthritis.

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06

Nov 2017

The Belgian Health Care Knowledge Center (KCE) performed assessment of use of static automated external defibrillators (AED) by bystanders for out of hospital cardiac arrest. The aim was to inform government, whether current practice of placing AED for public use should be supported or not. No strict recommendations were given due to insufficient evidence for this device in use by bystanders.

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03

Nov 2017

In October, HAS published a set of decisions about add-on reimbursement of medical devices that were assessed by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). These decisions concern orthopedic devices (foot prosthesis, bone graft substitute), TAVI using Sapien valve, liquid embolic system, remote monitoring system, wound dressing and home oxygen system.

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02

Nov 2017

Joint Federal Committee (G-BA) evaluated the use of diabetic foot syndrome with hyperbaric oxygen therapy (HBO) as a complementary treatment. Based on studies showing a faster healing process, the G-BA decided to include the method as a benefit in the outpatient sector and expand the indication for the method to a lower severity grade in the inpatient sector.

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01

Nov 2017

Patients who have undergone mastectomy for the breast cancer or as a preventive measure can now benefit from better reimbursement of autologous tissue breast reconstruction if it is performed in a hospital that has an agreement with INAMI.

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31

Oct 2017

The article "Patient Characteristics, Procedural and Safety Outcomes of Bariatric Surgery in England: a Retrospective Cohort Study—2006–2012" published in Obesity Surgery reviews the UK experience with bariatric surgery.

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31

Oct 2017

Following the request of a patient organization, the Joint Federal Committee (G-BA) evaluated the newborn screening for tyrosinemia type I by tandem mass spectrometry and decided to include the method into the relevant guideline. Before the method can be applied and reimbursed in the statutory health insurance (SHI) in Germany, the Genetic Diagnostics Act requires approval by the Genetic Diagnostics Commission (GEKO).

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26

Oct 2017

In the first half of October, the National Institute for Health and Care Excellence published one new Technology appraisal guidance (for autologous chondrocyte implantation for treating symptomatic articular cartilage defects of the knee) and four new Medtech innovation briefings for PleuraFlow Active Clearance Technology for maintaining chest tube patency, Mepilex Border dressings for preventing pressure ulcers, Thora-3Di for assessing asthma in children and Memokath-028, 044 and 045 stents for urethral obstruction.

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25

Oct 2017

In accordance with Health Insurance Act (Zvw) and Long-term Care Act (Wlz) the basic package of insured health care includes only health care that fulfills the criteria of “state of science and practice”. In September 2017, ZIN published opinion paper on the basis of reevaluation of the procedure. It was only recommended for coverage for non-resectable colorectal liver metastases. Other indications were not approved for coverage.

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19

Oct 2017

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. New codes were added for ophthalmology, skin surgery, treatment of anal fistula.

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18

Oct 2017

In the second two weeks of September, the National Institute for Health and Care Excellence published 2 new and 3 updated clinical, four new Interventional Procedures Guidance (for intramuscular diaphragm stimulation for ventilator-dependent chronic respiratory failure caused by high spinal cord injuries and motor neurone disease, ab externo canaloplasty for primary open-angle glaucoma, high-intensity focused ultrasound for symptomatic breast fibroadenoma), and 3 Medtech innovation briefings (Farco-fill Protect, Caris Molecular Intelligence for guiding cancer treatment and Aptiva for painful diabetic neuropathy).

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17

Oct 2017

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in September 2017. They include knee and hip prostheses, therapeutic shoes, coronary stents, heart valves, peripheral stents, and balloons.

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13

Oct 2017

SIRT is not routinely commissioned in England. In 2013 NHS England commissioned an evaluation of SIRT for colorectal liver metastases and intrahepatic cholangiocarcinoma within registry in England, complemented by systematic literature review and de novo economic analysis (Commissioning Through Evaluation). In July 2017, NICE prepared a final report for NHS England, which was made public on 12th of October 2017.

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11

Oct 2017

German Federal Joint Committee (G-BA) passed directives for co-funded trials to create evidence on two high-intensity focused ultrasound methods that showed potential benefit in the early benefit assessment process in relation to the innovation funding (NUB). Manufacturer refused to cover required contribution to trial costs and thereby risk exclusion of the methods from benefit catalogues in the German social health insurance.

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10

Oct 2017

At the beginning of August 2017, the French National Authority for Health (HAS) published a health technology assessment of systems for remote monitoring for implantable cardioverter defibrillators (ICD). The aim of this assessment was an update and clarification of arrangements for the provision of implantable cardioverter defibrillator systems (ICDS) to improve the quality of care for patients with ICD and to promote the deployment of effective solutions in the country.

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06

Oct 2017

The Joint Federal Committee (G-BA) resumes assessments of methods that have been intermitted due to missing evidence: LDR brachytherapy in localized prostate carcinoma and PET or PET/CT for malignant lymphomas as well as for interim staging in Hodgkin's lymphoma. Studies conducted in the meantime are expected to provide sufficient evidence base for the assessment about the inclusion of the methods into the social health insurance benefit catalogue in Germany.

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29

Sep 2017

After successful trial application by the manufacturer (Okuvision) of a stimulation technology (Okustim), the Federal Joint Committee (G-BA) decided on a trial guideline for a co-funded study defining the key points of the planned study, including type and time period of the study, target population and control intervention. Results from the trial will be evaluated and may lead to reimbursement of the method in both, the inpatient and outpatient sectors.

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28

Sep 2017

MTRC has analyzed timing of decision-making (negotiation about price, final ministerial decision and publication of the decision) after recommendation by CNEDiMTS about expected benefit (AS) and added clinical value (ASA) for invasive non-implantable medical devices reimbursed via LPPR list, title V. Since establishment of the title V program, 5 technologies were added to the List (stent retrievers for stroke; peripheral drug-coated balloons). Time from the recommendation by CNEDiMTS until the start of reimbursement varied from 7 to 13 months (9.4 months on average).

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27

Sep 2017

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. New diagnostic codes cover different indications and analytical methods.

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26

Sep 2017

Too little evidence was available to evaluate the efficacy and safety of liposuction for the treatment of lipedema in the inpatient sector in Germany. However, the Federal Joint Committee (G-BA) regards the method as a potential treatment alternative. It, therefore, plans a co-funded trial in cooperation with the manufacturer to create missing evidence with a start in 2018.

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26

Sep 2017

Austrian Ministry of Social Affairs engaged London School of Economics to undertake efficiency review of country’s social insurance system. Policy recommendations presented in the report include harmonisation of benefits (dentistry, non-medical services, medical aids and medical therapeutic devices), the introduction of an agency for quality assurance and modernisation of outpatient care.

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25

Sep 2017

Ministry of Health will close applications for proposals for inclusion of novel innovative tests into the List of Acts Outside Nomenclature in 2018 (Référentiel des actes Innovants Hors Nomenclatures, RIHN) 3rd of October 2017. RIHN provides early reimbursement for innovative tests, for which value is not yet validated to allow enlisting in the NABM Nomenclature.

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22

Sep 2017

On August 15th, the German Institute of Medical Documentation and Information (DIMDI) published the preliminary version of the new procedure catalogue for the inpatient sector in Germany. The final version of the catalogue will come into effect with the start of the year 2018. MTRC will report about new procedures and other changes included in the catalogue after the release of the official version in the beginning of 2018.

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21

Sep 2017

Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA) released results of a re-evaluation of percutaneous volume reduction of the intervertebral disk with a focus on chemolucleolysis. Based on current evidence, chemonucleolysis was recommended for inclusion into health benefit catalogue in Austria while percutaneous nucleotomy and percutaneous laser disc decompression were currently not recommended.

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20

Sep 2017

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. New codes were added for glaucoma surgery, myringoplasty and transforaminal epidural interventions.

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20

Sep 2017

CEO of the MTRC, Dr. Oleg Borisenko will be present at the 2nd Annual Medical Devices Sales and Marketing Conference, 28-29 of September in Cologne, Germany. Please, contact us at info@mtrconsult.com if you would like to arrange a meeting to discuss your needs with reimbursement and market access in Europe.

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19

Sep 2017

NHS Improvement together with providers of pathology (laboratory) services in England determined ways to integrate laboratory services to increase efficiency and reduce cost. The final proposal includes integration of pathology services of 105 English hospitals into 29 pathology networks, which would save NHS up to £200m annually.

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18

Sep 2017

Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA) released results of re-evaluation of leadless pacemakers for right ventricular pacing. Due to lack of comparative evidence vs conventional pacemakers, leadless pacemakers were not recommended for inclusion into health benefit catalogue in Austria.

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14

Sep 2017

In the first two weeks of September, the National Institute for Health and Care Excellence published one new (for diagnosis and management of endometriosis) and updated two clinical guidelines (for psoriasis and fertility problems). No health technology assessments were published.

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12

Sep 2017

On 6th of September, the Joint Federal Committee (G-BA) released announcement for manufacturers of OCT equipment to notify about their devices till 4th of October before G-BA makes the final decision about coverage of the procedure in out-patient settings within statutory health insurance. 

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07

Sep 2017

In 2016, Joint Federal Committee (G-BA) commissioned Institute for Quality and Efficiency in Health Care (IQWIG) for benefit assessment of telemonitoring systems in patients with implantable cardioverter defibrillators (ICD). In July 2017, IQWIG published a preliminary report. Due to lack of evidence, no benefit statement was made.

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06

Sep 2017

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in August 2017. They include different types of stents and stent-grafts for multiple indications (coronary, peripheral vascular), mechanical thrombectomy devices for stroke, medical devices applied for treatment of ulcer of venous origin, remote monitoring for Implantable Cardioverter Defibrillator Systems (ICDS).

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05

Sep 2017

Ludwig Boltzmann Institute HTA evaluated EST for GERD and found the current evidence insufficient to recommend its inclusion into health benefit catalogue. Reevaluation is recommended in 2022 when more evidence becomes available.

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04

Sep 2017

There is an ongoing process to change the structure of add-on reimbursement for peripheral vascular stents in France. In July 2017 CNEDiMTS issued additional clarifications about proposed reimbursement requirements for stents and stent-grafts. Read about proposed changes in our post.

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01

Sep 2017

In the second two weeks of August, the National Institute for Health and Care Excellence published three new Interventional Procedures Guidance for liposuction for chronic lymphoedema, radiofrequency treatment for haemorrhoids, biodegradable spacer insertion to reduce rectal toxicity during radiotherapy for prostate cancer.

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31

Aug 2017

New material codes for spinal distraction system and platinum surgical sealant for contact with lung tissue were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in August. Codes for application of intramedullary nails were changed and conditions of reimbursement for valvulotomy and percutaneous closure of the left atrial appendage were amended.

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30

Aug 2017

There is an ongoing process to establish add-on reimbursement for FFR guidewires. Earlier in 2017 two guidewires (Verrata & Verrata More, Philips Volcano; Pressurewire (Certus - Aeris – X), Abbott) received a positive assessment by the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) with moderate improvement vs. standard of care. In June 2017, COMET device also received a positive recommendation from CNEDiMTS (no improvement vs. already recommended devices) only on the basis of data about technical equivalency. This is unusual for brand-specific applications and may be an interesting precedent for further applications.

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28

Aug 2017

In the first two weeks of August, the National Institute for Health and Care Excellence published three new Medtech Innovation Briefings for Biopatch for venous or arterial catheter sites, Urethrotech UCD for difficult or failed catheterization and VEST external stent for coronary artery bypass grafts.

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25

Aug 2017

Since April 2016, procurement of a number of devices, which are reimbursed on top of HRG in England via High Cost Device List, was transferred from local level to the national level under NHS Supply Chain. NHS Supply Chain released a new set of questions and answers to the most common questions from the providers. The document provides substantial insights into specifics of the procurement process.

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24

Aug 2017

G-BA started review process for number of procedures for treatment of benign prostate enlargement in 2009. After publication of the results of rapid health technology assessment by the Institute for Quality and Efficiency in Health Care (IQWiG), G-BA was able to come to the conclusion in June 2017 about efficacy and safety of the thulium laser resection of prostate are well documented and procedure can be covered within statutory health insurance in Germany.

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22

Aug 2017

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. New codes were added for video-assisted anal fistula treatment, infracoccygeal sacropexy using mesh to repair uterine and vaginal vault prolapse.

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21

Aug 2017

New material codes for neurovascular self-expanding stent retrievers for clot removal (mechanical thrombectomy for stroke) and foam preparation for hysterosalpingosonography were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in July.

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17

Aug 2017

In 2017, PAE was evaluated by the Ludwig Boltzmann Institute – Health Technology Assessment (LBI-HTA) to define whether evidence for this minimally invasive procedure can be sufficient for inclusion into benefit catalogue. Within this research work, evidence in relation to efficacy and safety of PAE was assessed in comparison to transurethral resection of the prostate (TURP) and open prostatectomy. Based on the results of literature review, LBI-HTA did not recommend PAE for inclusion into benefit catalogue in Austria. LBI-HTA recommended re-evaluating PAE procedure in the 2021 year when new potential evidence is available.

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16

Aug 2017

In the second two weeks of July, the National Institute for Health and Care Excellence published one new (FebriDx for C-reactive protein and Myxovirus resistance protein A testing in primary care) and 3 updated Medtech Innovation Briefings, new Diagnostics Guidance for quantitative faecal immunochemical tests to guide referral for colorectal cancer in primary care and three new Interventional Procedures Guidance for laparoscopic insertion of a magnetic titanium ring for gastro-oesophageal reflux disease, transcatheter aortic valve implantation for aortic stenosis and hysteroscopic sterilisation by insertion of intrafallopian implants.

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11

Aug 2017

In the Netherlands, there is a possibility to test novel ways of delivering health care services (e.g. mobile diagnostic modules, online counselling, telemonitoring, screening/diagnostic for some complex conditions in primary care etc.) by establishing short (3 years) experiments between health provider and insurance company. After completion of experiment, analysis shall be performed about effect of the intervention. If it works, a new model can be population as novel type of care service in broader settings. See full list of ongoing small-scale experiment projects, extracted by MTRC.

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10

Aug 2017

The package will allow small and medium sized enterprises (SMEs) to develop and test new technologies in the NHS. This could include innovations such as digital technologies to help patients manage their conditions from home instead of a hospital, or to develop new medicines. Access to this funding will also speed up the time it takes to get new technologies from the lab to patients in the NHS.

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10

Aug 2017

The National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) reviewed indications for number of devices on the LPPR list and made recommendations about structure of the section in the LPPR list.

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10

Aug 2017

Article “Cost-utility analysis of bariatric surgery compared with conventional medical management in Germany: a decision analytic modeling” was published in the BMC Surgery. Surgery was found cost-effective at 10-year time horizon and cost saving over life time of operated cohort. Delay in provision of surgery led to reduction of gained health benefits.

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09

Aug 2017

Changes will be made in eleven chapters of Nomenclature. In relation to medical technologies and in-vitro diagnostics, the most important changes include changes in conditions for Stomatology, Radiotherapy and Nuclear Medicine codes, introduction of new codes for IVD tests, including diagnostics of tuberculosis and screening for EGFR mutation.

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08

Aug 2017

The Ludwig Boltzmann Institute – Health Technology Assessment (LBI-HTA) has published report with results of systematic literature review of application extracorporeal cytokine adsorption therapy (ECAT) for treatment and prevention of sepsis or systemic inflammatory response syndrome (SIRS). Considered evidence was assessed as insufficient to prove that ECAT is effective and safe procedure in patients with sepsis, septic shock and SIRS. Therefore, ECAT is currently not recommended for inclusion into the benefit catalogue.

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07

Aug 2017

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of 10 medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). They include microprocessor controlled knee prosthesis, transcatheter pulmonary valve, deep brain stimulation device, kit for self-monitoring of blood glucose and others.

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03

Aug 2017

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. Several codes were added to both procedural and diagnostic Schedules, including procedures for treatment of knee and hip osteoarthritis, robotic procedure, insertion of wireless pacemaker.

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02

Aug 2017

Dutch National Health Care Institute (Zorginstituut Nederland) has confirmed scope of surveillance on implementation of radioembolization with Yttrium-90 microspheres as salvage therapy for patients with non-resectable liver metastases of colorectal cancer origin in the Netherlands. The focus will be on evolution of cost and volume of procedures, concentration of care in few designated centers and implementation of clinical protocol for use of procedure.

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01

Aug 2017

The report aims on measuring baseline incidence and cost of inpatient falls prior to launch of falls improvement initiative of nineteen trusts for 2017/2018 financial year.

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28

Jul 2017

The Ludwig Boltzmann Institute – Health Technology Assessment (LBI-HTA) has published results of systematic literature review of evidence in relation to efficacy and safety of radiofrequency ablation for patients with metastatic spinal lesions. In conclusion, LBI-HTA recommended radiofrequency ablation of spinal metastatic lesions for inclusion in benefit catalogue with restrictions.

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26

Jul 2017

In the first two weeks of July, National Institute for Health and Care Excellence published four Medtech Innovation Briefings (Nasal Alar SpO2 sensor for monitoring oxygen saturation by pulse oximetry, Arctic Sun 5000 for therapeutic hypothermia after cardiac arrest, L-Dex U400 for lymphoedema after breast cancer treatment, FreeStyle Libre for glucose monitoring), new clinical guideline for Parkinson’s disease in adults, and updated diagnostic guidance for a new generation cardiac CT scanners.

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25

Jul 2017

Reinhard Busse et al. published article “Statutory health insurance in Germany: a health system shaped by 135 years of solidarity, self-governance, and competition” in the Lancet. Article provides valuable insights into history and current state of statutory health insurance system in Germany.

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25

Jul 2017

SwissDRG has released overview of planned update of DRG system (version 7.0) in 2018, including list of preliminary approved add-on reimbursement categories. Add-on will be established for endobronchial valves, proton therapy, autologous matrix-induced chondrocyte implantation at knee joint and intermitted hemodialysis for removal of proteins with molecular mass up to 60,000 Da.

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24

Jul 2017

HAS is the key decision-making body in relation to evaluation of sufficiency of clinical evidence to establish add-on reimbursement for medical devices, development of new procedure (CCAM) and clinical biology (NABM) codes in France. Annual report provides valuable insights into evaluation landscape for medical device and IVD tests. MTRC has extracted key facts related to assessment of medical technologies from the report.

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21

Jul 2017

Dutch Health Care Authority (NZa) has been working on developing tariffs for diagnosis-related groups (DBCs) to reimburse special medical rehabilitation care (medisch-specialistische revalidatiezorg, msrz). Originally, it was planned to roll out new payment model (DRGs with national tariffs) in 2019, however, NZa decided that more time is needed to collect cost data to determine appropriate tariffs.

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20

Jul 2017

New version 5.0 of the guidance “Allgemeine Methoden” provides basis for the scientific work of the Institute and its external experts. Multiple changes were made to existing sections, several new sections were added as well. Guidance provides brief overview of assessments performed in connection to benefit assessment for high class risk medical technologies, submitted for the innovation funding (NUB) for the first time.

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19

Jul 2017

Researchers evaluated care process, access, administrative efficiency, equity and health care outcomes in 11 countries on the basis of published health care statistics for 72 indicators. The best overall performers among European countries were the UK (ranked 1st), the Netherlands (3rd), Norway (4th), Sweden and Switzerland (6th). Germany (8th) and France (10th) were low in the ranking.

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18

Jul 2017

The treatment with autologous fat transplantation (AFT) may be a part of the basic health insurance package under certain conditions, including defects of the head and / or neck region, HIV-associated lipoatrophy and, and fibrosis (scarring), as recommended by the Dutch Health Care Institute (Zorginstituut Nederland).

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17

Jul 2017

The NIP test is a non-invasive prenatal test aimed at detecting Down's syndrome in fetus. This test is a screening performed using mother's blood sample from the 12th week of pregnancy. From 1 July 2017, non-invasive prenatal test will be reimbursed for all pregnant women.

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11

Jul 2017

Recently, CNEDiMTS at HAS issued positive recommendation for inclusion of HeartMate 3 ventricular assist device into add-on reimbursement catalogue (LPPR title III). No added value was established vs earlier version of device (HeartMate II), despite better safety profile demonstrated in the randomized controlled trial.

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06

Jul 2017

An assessment was initiated earlier this year. The Institute will evaluate compliance of dynamic fusion in lumbar spondylosis with the state of science and practice.

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03

Jul 2017

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of 8 medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). They include coronary stents, portable oxygen concentrators, Urolift device, spinal ganglion stimulator and insulin pumps.

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29

Jun 2017

The Head of NHS England has announced recently, that England will start a pilot of much deeper integrated care in 9 areas, covering about 7 million people. Integration will tighten up the links between hospital, GP and social care. Integration will be organized in the form of so-called "accountable care systems".

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29

Jun 2017

In last two weeks of June, National Institute for Health and Care Excellence published one Medtech Innovation Briefing (RIDASCREEN tests for monitoring infliximab in inflammatory bowel disease), four new interventional procedures guidance for vaginal vault prolapse and uterine prolapse and one new diagnostics guidance for multiple frequency bioimpedance devices to guide fluid management in people with chronic kidney disease having dialysis.

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27

Jun 2017

KCE is working now on development of research program for 2018 and proposals for research topics can be submitted by filling in an online form until 6 September, 2017. Proposal can also be submitted by the industry.

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26

Jun 2017

NHS Innovation Accelerator has initiated process of collection of applications for English innovation funding scheme. Selected devices and technologies will receive add-on reimbursement from NHS England for the period of 3 years. Applications will be accepted until 26th of July 2017.

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23

Jun 2017

An assessment was initiated earlier this year on the request from Dutch Hypertension Society and umbrella organization of 9 health insurance companies Zorgverzekeraars Nederland. The Institute will evaluate compliance of baroreflex activation therapy (BAT) for treatment of resistant hypertension with the state of science and practice.

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22

Jun 2017

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. Several codes were added to both procedural and diagnostic Schedules, including procedures on spine and endoscopy procedure.

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21

Jun 2017

The deadline for acceptance of applications for conditional reimbursement in 2019 by the Care Institute Netherlands (Zorginstituut Nederland) is 29th of June 2017. Conditional reimbursement for the period of up to 4 years can be available for promising technologies, which did not meet criteria for “state of science and practice” in the assessments of Zorginstituut Nederland.

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21

Jun 2017

In first two weeks of June National Institute for Health and Care Excellence published two Medtech Innovation Briefings (Neo Pedicle Screw System for spinal fusion surgery and device for securing cerebrospinal fluid drainage catheters) and updated two clinical guidelines for head injury and spondyloarthritis in adults.

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20

Jun 2017

In May 2017, CNEDiMTS at the National Authority for Health (HAS) issued positive assessment of Urolift for add-on reimbursement via LPPR list. Added value was found to be minor in comparison with transurethral resection of prostate (TURP). This assessment provides better results compared to the earlier one in January 2017. Add-on reimbursement might be established within about one year period.

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19

Jun 2017

NHS England has announced expansion of the NHS Diabetes Prevention Programme to cover another 25% of the population (Wave 2) in addition to the program, which has already covered about 50% of the population (Wave 1) and which was started last year. NHS Diabetes Prevention Programme is the program in England, which connects existing elements of health care system focused on prevention of diabetes and additional element of behavioral intervention for nondiabetic hyperglycaemia into a comprehensive program aimed on prevention of diabetes type II.

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16

Jun 2017

In March 2017, G-BA approved two additional indications for application of PET/CT for management of neck and head tumors in hospital settings after reevaluation of evidence by IQWiG in 2016. New indications concern decision making about need for neck dissection and laryngoscopic biopsy.

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14

Jun 2017

NCP is a program of centralized procurement of commonly used simple devices in the NHS in England. NHS Supply Chain makes procurement on behalf of all trusts and makes limited number of products available in its catalogue for order by individual trusts. The first products for centralized contracting in 2017 are couch rolls and blunt-fill syringes.

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14

Jun 2017

Recently the Institute for Quality and Efficiency in Health Care (IQWIG) published final report of evaluation extracorporeal shock wave therapy in patients with heel pain. On 31st of May, the Federal Joint Committee (G-BA) requested manufacturers for notification of their devices for extracorporeal shock wave therapy before final decision will be given.

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13

Jun 2017

The Care Institute Netherlands (Zorginstituut Nederland) has released information that real-time continuous glucose monitoring is now included into the basic health insurance package for two additional groups of patients suffered from diabetes: women with diabetes who wish to become pregnant and patients with type 1 diabetes with repeated severe hypoglycemia.

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09

Jun 2017

Eleven national population screening programmes are implemented in the NHS on the advice of the UK National Screening Committee (UK NSC), which makes independent, evidence-based recommendations to ministers in the 4 UK countries. The Screening Quality Assurance Service ensures programmes are safe and effective by checking that national standards are met. Changes in 2017 are related to KPIs for bowel, breast, and cervical cancer screening.

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06

Jun 2017

HAS published updated program that defines priority areas of work for 2017, including evidence review as part of developing new procedure codes for robotic surgery, endoscopic procedures, and technology assessments of remote monitoring, dialysis, coronary stents and others.

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05

Jun 2017

In second two weeks of May, National Institute for Health and Care Excellence has published two Medtech Innovation Briefings (collagen paste for anal fistulae and portable pulse‑echo ultrasound device to assist diagnosis of osteoporosis) one Interventional Procedure Guidance for endoscopic full thickness removal of non-lifting colonic polyps.

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05

Jun 2017

MTRC has developed a comprehensive introductory course in European market access. Course has duration between few hours and one day and takes place on your site. Topics include payment mechanisms, reimbursement pathways, role of HTA, economic argumentation and others. The cost is 5,000 euros irrespective of number of participants and duration of the course.

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01

Jun 2017

National Institute for Health and Care Excellence’s Scientific Advice service is launching an online tool to help developers of medical devices and diagnostics understand and generate the evidence needed to show their products are clinically and cost effective. This will help companies prepare for a dialogue with health technology assessment organisations and payers and potentially speed up time to market.

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31

May 2017

Although the report excluded medical technologies from scope, it includes useful information about the concept of innovative payment schemes, taxonomy, challenges of such approaches and provides an overview of international experience.

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31

May 2017

French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of 9 medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in May and April. Among others decision included MRI compatible and recharge free spinal cord stimulation devices, resorbable plates for osteosynthesis.

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30

May 2017

The Institute for Quality and Efficiency in Health Care (IQWIG) published final report of evaluation of extracorporeal shock wave therapy in patients with heel. Results demonstrated benefit of the extracorporeal treatment in comparison with placebo, ultrasound and iontophoresis.

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24

May 2017

In 2016, the Federal Joint Committee (G-BA) commissioned the Institute for Quality and Efficiency in Health Care (IQWiG) to perform evaluation of controlled active motion (CAM) in patients with rupture of the anterior cruciate ligament. The final report of assessment was published on May of 2017. No definite conclusion can be made in relation to comparative efficacy and safety of studied technologies due to lack of evidence.

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22

May 2017

Belgian Health Care Knowledge Center has released new clinical guidelines for evaluation and management of low back pain without serious underlying cause and radicular pain (including neurogenic claudication). It has number of implications for medical procedures, including transcutaneous electrical nerve stimulation, radiofrequency denervation, disk replacement, spine fusion and other.

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19

May 2017

In 2014, Federal Joint Committee (G-BA) commissioned Institute for Quality and Efficiency in Health Care (IQWiG) to conduct health technology assessment of different approaches for lung volume reduction in patients with severe pulmonary emphysema. And now IQWiG has published the final report. The main conclusion is that it was not possible to draw any conclusion about relative effectiveness of bronchoscopic and surgical methods due to lack of the data.

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18

May 2017

Guidelines focused on treatment for recurrent and metastatic cancer, neoadjuvant treatment and the most optimal diagnostic strategy.

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17

May 2017

At the meeting of 18th of April National Commission for Evaluation of Medical Devices and Health Technologies made decisions about add-on reimbursement of 17 medical devices. Ten decisions have been released to date for orthopedic, osteointegrated processing, cardiac and intravascular devices.

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16

May 2017

Cédric Carbonneil from the Ministry of Health published a letter in Value in Health in response to the article "New French Coverage with Evidence Development for Innovative Medical Devices: Improvements and Unresolved Issues" published in January 2016. Dr Carbonneil offers an interesting insights into background, rationale and direction of development of this important coverage with evidence development program for medical devices, in-vitro diagnostics and medical procedures in France.

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16

May 2017

Changes will be made in nine chapters of Nomenclature. In relation to medical technologies and in-vitro diagnostics, the most important changes include changes in conditions for two ophthalmology and endoscopy codes, new conditions for reimbursement of photodynamic therapy in dermatology, introduction of two new codes for IVDs, and creating of requirements for reimbursement of number of IVD tests in pregnancy.

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15

May 2017

In first two weeks of May NICE has published one Diagnostic Guidance, two Medtech Innovation Briefings, one Interventional Procedure Guidance, and has updated three Clinical Guidelines.

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15

May 2017

From November 1, 2017, patients practicing urinary self-drilling at home will enjoy better reimbursement conditions.

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12

May 2017

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. Several codes were added to both procedural and diagnostic Schedules, including multi-panel companion diagnostic test for cancer.

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10

May 2017

This post presents an extract from our reimbursement analysis for angioplasty of arteries of lower extremities with stenting using bare metal and drug-eluting stents for peripheral arterial disease in England, France and Germany. Procedure is reimbursed via combination of diagnosis-related group (DRG) and add-on reimbursement in England and France and solely via DRG in Germany.

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09

May 2017

A group of researchers from Belgium Health Care Knowledge Center (KCE) published an article about current state and development of organization and financing of urgent care in Belgium, including emergency departments, GP offices and telephone support.

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09

May 2017

National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) positively appraised Verrata and Verrate Plus guidewires for add-on reimbursement via LPPR title V. Level of added clinical value was considered moderate (ASA III) in comparison with management strategy, based solely on angiography data. This decision complements decision early this year in relation to St. Jude Medical’s (now Abbott) PressureWire FFR wires.

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09

May 2017

Ludwig Boltzmann Institute - HTA conducted a budget impact analysis on request from the Federal Ministry of Health and Women (BMGF) for testing of TSH as screening for hypothyroidism, urine culture as screening for asymptomatic bacteriuria and ultrasound screening for foetal anomalies.

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08

May 2017

Ministerial decree to enlist Medtronic's IN.PACT Admiral for the LPPR title V for add-on reimbursement was published on 6th of May 2017 in the Official Journal of French Republic. This is not only the first peripheral DCB on the List, but one of the first invasive non-implantable devices to get add-on reimbursement in France.

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08

May 2017

French National Authority for Health (HAS) has initiated an assessment of organizational impact of mechanical thrombectomy on the system of stroke management in France with objective to find the most adequate way of further introduction of the method into French health care system.

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05

May 2017

A new decree changed reimbursement approach for critical care in France. Before, it was reimbursed via daily supplements on top of base DRG tariff. New model introduces a mixed payment system with daily supplements and additional annual flat-rate fee, which depends on the size of the intensive care unit and activity in the previous year.

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04

May 2017

Check out reimbursement summary for the most established transcatheter mitral valve repair procedure in England, France and Germany. Reimbursement is established in Germany and France (for one indication). It is in process to be established in England and in France (for other indications).

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04

May 2017

Currently there are 10 ongoing mini-health technology assessments of medical technologies in Norway. After completion of evaluation, decision will be made about funding of these technologies at hospital level.

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03

May 2017

National Institute for Health and Care Excellence (NICE) in the UK issued one Interventional Procedure Guidance, one Med Tech Innovation Briefing and updated two of Clinical Guidelines in April 2017.

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01

May 2017

This post presents an extract from our reimbursement analysis for angioplasty of arteries lower extremities using plain and drug-coated balloons (DCBs) for peripheral artery disease in England, France and Germany. Plain balloon angioplasty is reimbursement via DRG solely and DCBs are reimbursement via combination of DRG and add-on reimbursement.

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28

Apr 2017

Suggestions for change of DRG system will be accepted by Dutch Healthcare Authority (NZa) by 1st of June 2017. If accepted, changes will be implemented in 2019.

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26

Apr 2017

German Federal Joint Committee (G-BA) has released information about results of benefit assessment (in connection to the §137h SGB V) for two methods: catheter-based lung denervation system for COPD and high-intensity focused ultrasound.

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26

Apr 2017

KCE issued a report, in which it reviewed provision of day surgery in Belgium, incentives for provision of day surgery in France and England and developed recommendations for incentive policy for day surgery in Belgium to policy-makers.

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24

Apr 2017

National Institute for Health and Care Excellence (NICE) in the UK issued two Interventional Procedure Guidance, one Medical Technology Guidance, five Med Tech Innovation Briefings and updated number of Clinical Guidelines in March 2017.

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24

Apr 2017

In Belgium, number of procedures and devices can only be reimbursed for the hospitals, that meet certain requirements. INAMI has released a new lists of hospitals eligible for reimbursement for a number of procedures and devices in cardiovascular, neuromodulation, urology and orthopedics areas.

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21

Apr 2017

SwissDRG has released the application form for suggestions for DRG change in 2017. Applications will be collected between 29th of May and 10th of July 2017. Approved changes will be implemented in 2019.

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20

Apr 2017

Belgian Health Care Knowledge Center (KCE) has issued report about organizational framework and evidence base for major trauma. Analysis is focused on Belgium, although organizational systems in England, Germany and the Netherlands were reviewed as well.

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19

Apr 2017

The French National Authority for Health (HAS) has released report about evaluation of cardiac defibrillation probes and proposed updated nomenclature.

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17

Apr 2017

Belgian Health Care Knowledge Center issued information about ongoing and planned health technology assessments of medical technologies and IVD tests. They include external cardiac defibrillators, bariatric surgery, OncoType for breast cancer, peripheral drug eluting balloons and others.

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13

Apr 2017

The procedure will be included into Prescribed Specialized Services. About 8000 patients can benefit from the treatment annually. Other stroke treatments are commissioned by Clinical Commissioning Groups.

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04

Apr 2017

NICE in the UK has released a consultation document in relation to the TAVI procedure (Interventional Procedure Guidance). Publication of the final guidance, which will replace the guidance from the 2012, is expected in July 2017.

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31

Mar 2017

NHS England has confirmed number of steps, included into the Cancer Strategy Implementation Plan: investment of 94 million pounds into linear accelerators and building up 10 new Rapid Diagnostic and Assessment Centres.

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24

Mar 2017

From 1st of April 2017 bariatric surgery will be fully transferred for commissioning by Clinical Commissioning Groups from national payer, the NHS England. English physicians are concerned that provision of surgery will face restrictions by local payers.

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