Decisions about add-on reimbursement for medical devices in France in January 2019

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Feb 2019

The 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 January 2019. The decisions were brought for eighteen (18) medical devices.

Four (4) decision was released regarding prostheses:

  • LARS, Artificial ligament for the knee (application for renewal of registration, approved; application for amendment of the registration conditions, rejected due to the lack of clinical data provided)
  • DURASUL (insert and acetabulum), acetabular cup and monoblock insert in highly cross-linked polyethylene (canceled)
  • DURASUL (acetabulum), one-piece cup in highly cross-linked polyethylene (application for renewal of registration, approved; application for amendment of the registration conditions, rejected due to the lack of clinical data provided for one additional condition, approved for the other)
  • DURASUL (insert), highly crosslinked polyethylene insert, (application for renewal of registration, approved; application for amendment of the registration conditions, rejected due to the lack of clinical data provided for one additional condition, approved for the other)

Four (4) decision was released regarding cardiovascular devices:

  • ELUVIA, peripheral active release stent (paclitaxel) (application for renewal of registration, approved; application for amendment of the registration conditions (two new conditions), rejected due to the lack of clinical data provided)
  • ZENITH FENESTRATED, an aortic stent (application for amendment of the registration conditions, approved)
  • REVEAL LINQ, implantable cardiac monitor (application for registration, approved)
  • YUKON CHOICE PC, coronary stent coated with sirolimus (pharmacologically active product) (application for amendment of the registration conditions, approved)

Ten (10) decisions were released regarding other devices:

  • ERIS, modular electric scooter (application for registration, approved)
  • VISCO (cushion), viscoelastic memory foam cushion (application for renewal of registration, approved)
  • AXTAIR AUTOMORPHO PLUS, alternating pressure motorized air mattress pad with associated compressor (application for registration, rejected because the available clinical data do not establish the interest for this product)
  • SONALTO, pre-set listening assistant (application for registration, rejected because the available clinical data do not establish the interest for this product)
  • SORTEZ COUVERTS, lubricated male condoms (application for registration, approved)
  • SNAP Therapy System, negative pressure wound treatment system (application for registration, rejected because the available clinical data do not establish the interest for this product)
  • SIR-Spheres, microspheres made of Yttrium-90 (application for amendment of the registration conditions, approved)
  • MOBIDERM (standard), limb compression devices (application for registration, rejected)
  • ExEm Foam Kit FK05, preparation kit for the hyperechoic product (application for registration, approved)
  • FREESTYLE OPTIUM BETA CETONE, an electrode for measuring ketone (application for renewal of registration, approved)

See the full list of decisions in French here.

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The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in October 2018 concern various types of devices.

Read more

28

Nov 2018

The Health Data Agency published new DRG tariffs for hospital and outpatient care in the somatic and psychiatric area for 2019.

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26

Nov 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In October, eight new procedure codes for operations on joints, morcellation of uterine leiomyomas, transurethral water vapour and water jet ablation for lower urinary tract symptoms and transoral surgery have been added to the CCSD Schedule.

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23

Nov 2018

In October, the National Institute for Health and Care Excellence (NICE) published one new interventional procedure guidance for selective internal radiation therapy for unresectable primary intrahepatic cholangiocarcinoma, one updated medical technologies guidance endoluminal stent graft system designed for treating aneurysms and dissections of the thoracic aorta and one new medical technologies guidance for a titanium implant intended for use in people with chronic sacroiliac joint pain and three new medtech innovation briefings for device used for babies and children up to 30 kg who need mechanical ventilation, gammaCore for cluster headache and system that delivers warmed and humidified respiratory gases, including at high-flow rates.

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22

Nov 2018

In partnership with NHS England, NHS Improvement has set out some of the principal proposed changes to the payment system in 2019/20. The proposals include a change of the default way of paying for urgent and emergency care (moving away from episodic prices), recalculated market forces factor values and options for how the tariff might be used to fund the new NHS supply chain organisation.

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21

Nov 2018

On November 1, 2018, the European network for Health Technology Assessment, EUnetHTA, has announced that the patient groups’ input is required for a new Collaborative Assessment on a medical device for high-risk soft tissue sarcoma. The consultation is opened until November 30, 2018.

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20

Nov 2018

The Dutch Healthcare Authority advises to reward health care providers in specialist medical care on the basis of the health benefits for the patient.

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16

Nov 2018

The Health Data Agency published new DRG tariffs for hospital and outpatient care in the somatic and psychiatric area for 2019.

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08

Nov 2018

On October 26, 2018, the French High Authority for Health (HAS) has announced that the composition of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) has been renewed.

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07

Nov 2018

On October 26, 2018, the European Network for Health Technology Assessment has published the final report of femtosecond laser-assisted cataract surgery (FLACS) for the treatment of age-related cataract. The authors of this report are a group of experts from the Italian region of Emilia Romagna, together with Health Austria (Gesundheit Österreich, GÖG).

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01

Nov 2018

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in the period July-September 2018 concern various types of devices. In total, 52 decisions were published.

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30

Oct 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In July/August new codes for genetic tests, including 18S rRNA gene and sequencing and ELA2 Cyclic Neutropenia Genetic Screen were added to the CCSD Schedule.

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29

Oct 2018

In mid-October 2018, the French Ministry of Solidarity and Health has published an article which describes the change of the financing of the health care system and proposes medium-term strategies for this gradual change. The report has been developed by the Directorate of research, studies, evaluation and statistics (DREES) of this ministry.

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25

Oct 2018

In mid-September 2018, the Swiss Federal Council has placed in consultation the first group of actions that are intended to contain costs in the healthcare sector. The suggested measures will be discussed with all relevant healthcare stakeholders (tariff partners, Cantons, industry and patient associations). These measures should save hundreds of millions of Swiss francs in the long term.

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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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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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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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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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24

Sep 2018

The report presents a summary of reimbursement situation for placement of inferior vena cava filter to prevent pulmonary embolism. Permanent and optionally retrievable filters are considered. The only reimbursement within public / statutory health insurance systems is considered. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

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13

Sep 2018

In July of 2018, the Dental and Pharmaceutical Benefits Agency (Tandvårds-Läkemedelförmånsverket, TLV) has updated the product group codes for consumables for better understanding the range of the products. Editorial changes to the codes' descriptions were implemented. Seven new groups for stomach products, plates and bags of different types, which are especially intended for children have been included in the classification.

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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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13

Aug 2018

Six new DRGs have been added for 2019, including proton therapy, insertion of functional implants in the urinary tract or male genitals and replacement of processor in cochleart implant.

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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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17

Jul 2018

On the 5th of June of 2018, Dental and Pharmaceutical Benefit Agency (Tandvårds- och läkemedelsförmånsverket, TLV) has published a decision regarding inclusion of number of Verifine blood lancets produced by Mediq Sverige AB for diabetic patients to monitor the blood glucose levels into the list of pharmaceutical benefits with the price of SEK 23 per package.

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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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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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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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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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15

Jun 2018

In mid-May 2018, the Catalan Agency for Quality and Health Evaluation, AQuAS, has published an assessment of the efficacy of shoulder arthroscopy for different pathologies and the safety of the procedure for the treatment of shoulder disorders.

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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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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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05

Jun 2018

On the 14th of May of 2018, Dental and Pharmaceutical Benefit Agency (Tandvårds- och läkemedelsförmånsverket, TLV) has published a decision regarding inclusion of number of consumable medical devices for the treatment of asthma and chronic obstructive pulmonary disease (COPD) into the list of pharmaceutical benefits with the price of SEK 236.35 per piece.

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01

Jun 2018

European Med Tech and IVD Reimbursement Consulting Ltd. released a report, which identifies and provides an overview of the innovative payment schemes for medical devices and in-vitro diagnostic tests in European countries. The report was supported by the grant from the Med Tech Europe. Access the full version of the report at our web-site.

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29

May 2018

In April of 2018, Dental and Pharmaceutical Benefit Agency (Tandvårds- och läkemedelsförmånsverket, TLV) has published a number of consumable medical devices, which were excluded from the list of pharmaceutical benefits per manufacturers’ request.

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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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11

May 2018

On the 26th of April of 2018, Dental and Pharmaceutical Benefit Agency (Tandvårds- och läkemedelsförmånsverket, TLV) has published a positive decision for inclusion of Aurum Convex (one-piece range of colostomy, ileostomy and urostomy bags with Manuka honey) into the list of pharmaceutical benefits with the price of its comparators of 48.13 SEK per product.

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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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30

Apr 2018

On the 5th of April of 2018, Dental and Pharmaceutical Benefit Agency (Tandvårds- och läkemedelsförmånsverket, TLV) has published a positive decision for inclusion of VORTEX nozzle (spare part for VORTEX inhalation container) into the list of pharmaceutical benefits due to lower price of 45.42 SEK per product versus comparators.

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23

Apr 2018

In February of 2018, Dental and Pharmaceutical Benefit Agency (Tandvårds- och läkemedelsförmånsverket, TLV) has published a number of consumable medical devices, which were excluded from the list of pharmaceutical benefits per manufacturers’ request.

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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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11

Apr 2018

Eight reimbursement reports with the total size of 882 pages cover the most common radiotherapy modalities including brachytherapy, 3D conformal radiation therapy, stereotactic radiosurgery, stereotactic body radiation therapy, intensity-modulated radiotherapy (IMRT), volumetric modulated arc therapy (VMAT), image-guided radiotherapy, proton therapy. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 12 EU countries including Austria, Belgium, Denmark, England, Finland, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

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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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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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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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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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06

Mar 2018

Within the Work Package 4 of EUnetHTA Joint Action 3, femtosecond laser-assisted cataract surgery (FLACS) is currently under assessment by a team led by Emilia Romagna Region.

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01

Mar 2018

The Italian Ministry of Health published a report presenting the expenditure on medical devices for the national healthcare system at 2016. On a total healthcare expenditure for goods and services of 17.6 billion of Euros, 5.8 billion (33%) are related to medical devices.

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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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06

Feb 2018

Regional guidelines on the use of leadless pacemakers within the region have been released by the technical committee for medical devices in Veneto.

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31

Jan 2018

EUnetHTA analyzed HTA and reimbursement procedures in relation to pharmaceutical and non-pharmaceutical health technologies in EUnetHTA partner countries. About 59 HTA agencies and decision-makers provided country-specific information and outlined the process of HTA and reimbursement in 31 European countries.

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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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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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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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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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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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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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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

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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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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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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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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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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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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23

Oct 2017

On 13th of October of 2017, the Ministry of Health of Poland commissioned Agency of Health Technology Assessment and Tariff Systems (AOTMiT) to assess the benefit of angioplasty of arteries of lower extremities (femoral and popliteal) with drug-eluting balloons.

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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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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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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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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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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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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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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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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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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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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 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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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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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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04

Aug 2017

The List determines devices (generic lines), which can be procured for provision of care within Program of State Guarantees in Health Care. Number of surgical implants, orthopedic implants, hemostatic materials, glue for surgical wounds, connector for spine drain, penile prosthesis, plates for facial surgery, surgical mesh, peritoneal catheter were added to the List.

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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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31

Jul 2017

The previous regional guidelines on brain stimulation therapy for advanced Parkinson’s disease, drug-resistant chronic migraine, and drug-resistant epilepsy, published in 2014, have been updated by the Regional Technical Commission for Medical Devices considering the new evidence on the specific groups of patients and some modifications in the indications for use of some devices. Check out indications for different neurostimulator technologies. These recommendations will form the foundation for reimbursement of devices in the region.

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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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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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14

Jul 2017

Report provides overview of procedure coding, payment mechanism, reimbursement tariffs and policy considerations for mechanical and pharmacomechanical (AngioJet, Boston Scientific) thrombectomy, catheter-directed and ultrasound-enhanced catheter-directed (EKOS, BTG) thrombolysis in iliac, femoral and popliteal veins in 11 European countries.

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13

Jul 2017

Current version of the DRG manual for hospital and day case care was approved in December 2016 by the Russian Federal Fund for Mandatory Medical Insurance (FFOMS). Since then, FFOMS has issued two updates of the DRG manual, mainly focused on use of organizational coefficients for DRGs in oncology, criteria for DRG for infections of upper respiratory tracts, change of definitions of frostbite.

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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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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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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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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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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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08

Jun 2017

Administrators of the “New Method” program, which is focused on managed introduction of innovations into Norwegian system, have initiated technology assessments of 10 technologies and now have requested manufacturers to make submission of clinical and economic evidence.

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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

BCG published an overview of the study, including survey and interview of several thousand med tech professionals and executives. Among recommendations of the new study are focus on value-based health care, digitalization and low-cost products and services. The study strengthens the importance of market access for Med Tech companies.

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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

AETSA aimed to establish recommendations for clinical practice on hip arthroplasty in patients with osteoarthritis through a systematic appraisal of evidence. High-level recommendations for hip arthroplasty and selection of type of implants were made.

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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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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

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

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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

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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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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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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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

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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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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