New experiment "Reinforced home support systems for the elderly people" under Article 51 of the Social Security Financing Act in France

11

Nov 2020

On October 16, 2020, the Order of the Ministry of Solidarity and Health in relation to the new experiment on reinforced support for the elderly people (DRAD) was published in the Official Journal of the French Republic. The experiment offers a solution to elderly people with loss of autonomy who wish to stay at home, for whom "classic" support from home services is not more sufficient.

Article 51 of the Social Security Financing Act 2018 is the new scheme, which aims to improve cooperation between health actors and to decrease the partition of the health sector through innovative funding (for example, bundled payment) or innovation in the organization of healthcare. The projects eligible for funding via Article 51 has to improve access to healthcare, the efficiency of the system, relevance of prescription, and patient pathway. Thanks to this new approach, the innovative technologies can bypass one or more of the 63 regulations of social security financing laws, whether on the coordination of medical pathway, relevance, and quality of health, social or medico-social services, structuration of ambulatory cares and healthcare access. Experiments within this scheme are financed by the Innovation Fund for Health System (FISS, Fonds d'Innovation pour le Système de Santé), managed by the health insurance.

Since 2018, more than 60 experiments have been started under Article 51. In October, the new experiment on the home support of elderly people was added to the scheme. This alternative system offers integrated and reinforced coordination of the various professionals working with the elderly. It offers a base of additional services to the territory's existing offer, in a secure and suitable environment. The scope of the proposed experiment is national: it covers 19 departments and ten regions. The experiment is organized for three years, with a total cost of €21,381,820 (€1,004 per month and per patient).

The full details in French can be found here.

This news is just one of about 300 market access news collected by our team in the subscription services "HTA Alerts" and "Reimbursement Alerts" every two weeks from more than 80 organizations. Access our paid subscription services to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). First EU issues are available for download free-of-charge.

Not ready for a subscription service? Subscribe to our free-of-charge newsletter delivered every second week to get updates about key reimbursement developments in Europe (10-12 news every two weeks).

Related news

30

Nov 2020

In November 2020, the Innovation and Technology Payment (ITP) program for 2020/21 was released by NHS Accelerated Access Collaborative. ITP 2020/21 builds on the Innovation and Technology Tariff (ITT) and ITP 2019/20; eight products will continue to be supported. Additionally, two digital technologies received continued support through the Evidence Generation Fund.

Read more

16

Nov 2020

In November 2020, the new intra-DRG was published on the website of the French Ministry of Solidarity and Health. A new chapter was added for urogenital implants - “Implantable devices for the treatment of female stress urinary incontinence.”

Read more

02

Nov 2020

The Belgian Health Care Knowledge Center (KCE) is conducting research towards a faster, substantiated decision on the reimbursement of innovative medical products. The project started in 2019 and is still being conducted.

Read more

30

Oct 2020

On October 14, 2020, the French National Authority for Health (HAS) announced the ongoing update of the submission file guides to support companies who requested reimbursement for medical devices with a system of machine learning (artificial intelligence).

Read more

26

Oct 2020

On October 15, 2020, the French National Authority for Health (HAS) published the report “New techniques of bariatric surgery: identification, the status of advancement and opportunities to evaluate,” in which they outlined three techniques currently diffusing in France (SADI-Sleeve, Endosleeve, and Sleeve Gastrectomy with Transit Bipartition). All three methods are the subject of ongoing clinical studies, and the evaluation will be initiated at the end of these studies.

Read more

21

Oct 2020

On October 11, 2020, the French Ministry of Solidarity and Health published an Order in the French Official Journal relating to the coverage of CARMAT TAH by innovation package for the period of 48 months from the date of the beginning of the trial.

Read more

07

Oct 2020

On August 6, 2020, the Ministry of Solidarity and Health published an Order (of August 4, 2020) listing the rotational atherectomy systems ROTAPRO and ROTALINK PLUS of the company Boston Scientific under Title V of the list of reimbursable products and services provided for in Article L. 165-1 of the Social Security Code (LPPR List).

Read more

28

Sep 2020

At the beginning of August 2020, the French National Authority for Health (HAS) issued a favorable opinion on the inclusion of the genome detection of SARS-CoV-2 by gene amplification on saliva samples to the innovation package (forfait innovation) according to the article L. 165-1-1 of the social security code. The package is approved by the Ministry of Solidarity and Health, after consultation with HAS.

Read more

18

Sep 2020

In July 2020, the French National Authority for Health (HAS) issued an update of the methodological guide for the economic evaluation of medical technologies. The main changes aimed to improve the interpretation of the results and the uncertainty, to clarify technical points, and to integrate methodological changes that have occurred since 2011.

Read more

11

Sep 2020

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

Read more

08

Sep 2020

The NHS Innovation Accelerator (NIA) has launched its call for applications representing high impact, evidence-based innovations from September 01, 2020. The application deadline is October 16, 2020. NIA is an award-winning national initiative supported by England’s 15 Academic Health Science Networks (AHSNs), which helps dedicated innovations to spread more comprehensively in the healthcare system.

Read more

07

Sep 2020

The French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of many medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in August 2020. Decisions concern cartilage implant, energy return prosthetic feet, and Yttrium-90 microspheres.

Read more

31

Aug 2020

The procedure for applying the ‘subsidy scheme for promising care’ is opened again. The period for applying has started on July 22 and will last till September 22, 2020.

Read more

24

Aug 2020

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

Read more

18

Aug 2020

On the 28th of July 2020, in the Official Journal of French Republic (JORF), an Order for the inclusion of the web application MOOVCARE POUMON intended for the medical telemonitoring of relapses and complications in patients with non-progressive lung cancer in the French List of Products and Healthcare Services Qualifying for Reimbursement (LPPR) was published. The application is already included in the LPPR list in section 1, “Materials and treatments in the home, dietary products, items for dressings,” chapter 1, section 7, and a specific sub-section 7, which has been created for web applications and software for remote monitoring.

Read more

07

Aug 2020

The focus of the service is on reimbursement decisions (new procedure codes, DRG change, coverage decisions, innovation funding, clinical guidelines) in 14 European countries and globally. Only in Europe, 29 organizations are monitored. All news are classified by 31 Technology Group and alerts are sent every 2 weeks. This is a twin service for "HTA Alerts", where we track initiated or published HTAs from 56 organizations globally.

Read more

30

Jul 2020

In late June 2020, the Innovation Committee at the Federal Joint Committee (G-BA) published funding priorities on its website. For the first time, the decision on the funding priorities was preceded by a consultation process. Healthcare stakeholders who are not members of the Innovation Committee were asked to come up with suggestions for funding topics and criteria.

Read more

17

Jul 2020

The French High Authority for Health (HAS) develops national diagnostic and care protocols whose objective is to guarantee the quality and safety of care delivery within the French setting. In the first half of 2020, national diagnostic and care protocols have been developed for eighteen topics.

Read more

08

Jul 2020

On June 18, 2020, the Dutch Healthcare Institute (Zorginstituut Nederland, ZIN) announced four medical procedures which received a subsidy under the new innovative payment scheme: FFRct technique in the diagnosis of patients with chest pain; oral esketamine in patients with severe, non-psychotic, treatment-resistant depression; left atrial appendage closure in patients with atrial fibrillation and endolymphatic duct blockage in patients with uncontrollable Meniere's disease.

Read more

06

Jul 2020

The French High Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in June 2020 concern various types of devices, including total lumbar disc prostheses, arthroscopic meniscal repair system, vagus nerve stimulation system, and medical aids. A total of 10 decisions were made.

Read more

15

Jun 2020

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

Read more

01

Jun 2020

In spring 2020, the French High Authority for Health, HAS, has announced the call for public consultation with the purpose of developing a draft functional classification of the digital solutions (for example, health apps, web platforms). The call ends on June 30, 2020.

Read more

15

May 2020

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

Read more

11

May 2020

On April 27, 2020, the Italian Ministry of Health shared the invitation of the Italian “Alliance against cancer,” which is intended for all the interested companies that wish to participate in the CAR-T research project.

Read more

10

Apr 2020

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

Read more

07

Apr 2020

On March 5, 2020, the NHS Innovation Accelerator (NIA) announced the 11 high impact innovations that will enter the national accelerator in 2020. As outlined in the NHS Long Term Plan, the technologies that enter the award-winning NIA provide solutions that help prioritize areas for NHS.

Read more

06

Apr 2020

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

Read more

11

Mar 2020

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

Read more

09

Mar 2020

The “Subsidy for promising care” scheme makes it possible to obtain temporary financing for care that looks promising but is not yet reimbursed from the basic health insurance package. The deadline to apply for funding via this scheme is April 7, 2020.

Read more

27

Feb 2020

On the 17th of February 2020, the Innovation Committee at the Federal Joint Committee (G-BA) invited external stakeholders to suggest topics and criteria for future funding. Moreover, the submission of proposals for members of the new pool of experts was announced.

Read more

17

Feb 2020

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

Read more

10

Feb 2020

On January 30, 2020, the Institute for the Hospital Remuneration System (InEK) has published the List of the requests for innovation funding (NUB), submitted by the hospitals until October 31, 2019. Out of 778 technologies, 201 (26%) received the positive status 1, which means that the evaluated procedure or medical device meets the NUB criteria and allows the hospitals to negotiate with the sickness funds for the innovation funding for these technologies.

Read more

31

Jan 2020

Norway established in 2013 a framework “New Method” for the introduction of innovations into the health care system through either a national or hospital-based health technology assessment. In this framework, all innovations should undergo HTA before being funded. In January 2020, four new mini-HTA projects of medical technologies were launched in Norway: robotic-assisted procedures, ear reconstruction, continuous electroencephalography, among others.

Read more

20

Jan 2020

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

Read more

16

Dec 2019

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

Read more

25

Nov 2019

In October 2019, an extra subsidy round for Evaluation Research was opened on behalf of the Evaluation and appropriate use of care (Zorgevaluatie en Gepast Gebruik, ZE&GG) for diagnostics and follow-up/aftercare within both medical and nursing care. The submission deadline is on the 28th of November 2019.

Read more

22

Nov 2019

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

Read more

19

Nov 2019

Outcomes Based Healthcare and My Diabetes My Way have been selected as Health Data Research UK (HDRUK) Sandbox projects.

Read more

15

Nov 2019

In September 2019, the French High Authority for Health released an assessment report for analysis on DNA chips (ACPA) in different types of oncological conditions to determine its place in comparison with more conventionally used techniques. The ACPA allows to detect a large number of copy number of variations at the whole genome level, ploidy abnormalities, and heterozygosity losses; it is of interest as a cytogenetic technique with some specific advantages among existing technologies.

Read more

14

Nov 2019

In early September 2019, the Innovation Committee of the Federal Joint Committee (G-BA) has published an overview of new research projects in the area of health services to be funded by the Innovation Fund in the future.

Read more

08

Nov 2019

In September 2019, the French High Authority for Health (HAS) released an assessment report for gastric bypass, also known as omega loop in severe obesity. The evaluation aimed to compare omega-loop gastric bypass (OLGB) with Roux-en-Y Gastric Bypass (RYGB) in terms of efficacy and safety. OLGB cannot be determined as an alternative treatment to RYGB considering the safety aspects due to a lack of efficacy and safety data. The method should be studied in a framework of clinical research.

Read more

07

Nov 2019

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

Read more

06

Nov 2019

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

Read more

04

Nov 2019

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

Read more

31

Oct 2019

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

Read more

30

Oct 2019

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

Read more

29

Oct 2019

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

Read more

28

Oct 2019

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

Read more

24

Oct 2019

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

Read more

23

Oct 2019

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

Read more

22

Oct 2019

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

Read more

21

Oct 2019

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

Read more

18

Oct 2019

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

Read more

17

Oct 2019

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

Read more

11

Oct 2019

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

Read more

09

Oct 2019

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

Read more

07

Oct 2019

In September 2019, the French High Authority for Health (HAS) has released an assessment report regarding the evaluation of total or partial robotic-assisted nephrectomy, compared to open surgery and conventional laparoscopic surgery. Due to the lack of any prospective comparative studies reporting robust results with relevant judgment criteria and collected with appropriate follow-up time, HAS could not comment on the expected service or the expected service improvement of robot-assisted nephrectomy compared to open surgery or conventional laparoscopic surgery.

Read more

07

Oct 2019

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

Read more

03

Oct 2019

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

Read more

01

Oct 2019

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

Read more

01

Oct 2019

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

Read more

23

Sep 2019

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

Read more

21

Sep 2019

We have released the second part of the interview on the Market Access Insider channel on Youtube. The interview covered key stakeholders, procedure coding, principles of functioning of DRG system and add-on reimbursement for medical devices via LPPR List. Reimbursement pathways for devices, evidence requirements, pricing considerations, innovation funding (PHRC, PRME, forfeit innovation, Article 51, ETAPES program) were also discussed.

Read more

29

Aug 2019

The draft for a “Digital Supply Law,” approved by the Cabinet on July 10, 2019, promotes digitization in the health sector. Among other things, the law should help to accelerate the integration of digital applications into the standard care, to further develop and promote the use of the electronic patient record (ePA), to strengthen telemedicine and to connect more actors to the telematics infrastructure.

Read more

21

Aug 2019

Zorg van Nu information team published a brochure with regulations for stimulating digital care in the Netherlands. The brochure with the description of 16 schemes clearly explains which regulations are applicable for which e-health innovations.

Read more

13

Aug 2019

NHSX has officially launched in July 2019 bringing together teams from the Department of Health and Social Care and NHS England and NHS Improvement, to lead the largest digital health and social care transformation program in the world. With an investment of more than £1 billion pounds a year nationally and a significant additional spend locally, NHSX has been created to give staff and citizens the technology they need.

Read more

30

Jul 2019

The NHS Innovation and Technology Payment (ITP) 2019/20 program went live on April 1, 2019, and builds on the Innovation and Technology Tariff (ITT) and ITP 2018/19.

Read more

29

Jul 2019

In late June 2019, the Committee on Evaluation and Public Health (CEESP) of the French High Authority for Health (HAS) validated a second, provisional version, updating the methodological guide for the evaluation of effectiveness at the HAS.

Read more

23

Jul 2019

The French High Authority for Health (HAS) develops clinical guidelines and recommendations whose objective is to guarantee the quality and safety of care delivery within the French setting. In the second quarter of 2019, clinical guidelines/recommendations have been developed for 16 topics.

Read more

15

Jul 2019

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

Read more

10

Jul 2019

After having identified the eligibility conditions for teleconsultation and teleexpertise in 2018, the French High Authority for Health (HAS) published a series of documents in late June 2019, for the operational deployment of eHealth services. Each of the new modalities of practice is discussed: teleconsultation, teleexpertise, and teleimaging. Also, the HAS proposed an information document to be given to patients before a teleconsultation.

Read more

26

Jun 2019

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

Read more

14

Jun 2019

A syndicated report (>80 pages) includes the overview and statistics of 16 key innovation funding and coverage with evidence development schemes in seven European countries: Austria, Belgium, England, France, Germany, the Netherlands and Switzerland. The price of the report is €1600.

Read more

12

Jun 2019

On the 24th of April 2019, the French Technical Agency for Hospital Information (ATIH) has released a technical note in connection with the 2019 DRG changes. Several key updates in relation to the financing of hospitalization benefits as a change of DRGs for fractional flow reserve, package to finance the rehabilitation and infusion costs of the pulmonary system and implementation of two innovative packages for PULSANTE and WISE CRT devices were outlined.

Read more

07

Jun 2019

In France, there is a fast-track pathway, which provides reimbursement within the framework of the prospective medico-economic study, aiming at demonstrating benefits to patients or reduction of expenditure of health care system. On the 19th of April, the French National Authority for Health published two opinions regarding the inclusion of two devices into innovation package - eCLIPS: for treatment of cerebral aneurysm, Nuvaira™ Lung Denervation System for chronic obstructive pulmonary disease and asthma.

Read more

29

May 2019

The report includes all published reimbursement decisions for IVD tests in 2018 in European countries with established frameworks for out-patient reimbursement laboratory tests (Belgium, France, Germany, Netherlands, Switzerland).

Read more

23

May 2019

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

Read more

17

May 2019

In 2013, Norway established a framework “New Method” for the introduction of innovations into the health care system through either a national or hospital-based health technology assessment. In this framework, all innovations should undergo HTA before being funded. In April of 2019, the NIPH has released an HTA report for patent foramen ovale closure, antiplatelet or anticoagulation therapy alone for management of cryptogenic stroke commissioned by RHF Forum. Based on this HTA, the RHF Forum will make a decision regarding further implementation of current treatment method.

Read more

08

May 2019

In 2013, Norway established a framework “New Method” for the introduction of innovations into the health care system through either a national or hospital-based health technology assessment. In this framework, all innovations should undergo HTA before being funded. In April of 2019, the new mini-HTA regarding above cuff vocalization (ACV) was initiated by Oslo University Hospital. After completion of the assessment, hospital management will make a decision about funding of studied technology.

Read more

29

Apr 2019

The Innovation Fund in Germany was created in 2015 for the period from 2016 to 2019, with the primary aim to improve health care for policyholders and patients in statutory health insurance (SHI). In March 2019, the governing parties have agreed in the coalition agreement that the innovation funding should be continued at least until March 2021 with an annual budget of €200 million.

Read more

26

Apr 2019

On the 14th of March of 2019, the Dutch National Health Care Institute has opened a project submission period in a framework of subsidy scheme called “Promising care.” This scheme makes it possible to obtain temporary financing for a maximum of 6 years for those treatment methods that look promising but are not yet reimbursed from the basic package. The period for submitting project ideas for promising care is from March 14 to May 14, 2019.

Read more

25

Apr 2019

The Swiss innovation agency, InnoSuisse, reminds that the deadline for the application for financing of truly innovative projects is May 20, 2019. The Swiss Federal Council has ensured additional funding of CHF 24 million for 2019 and 2020 for the “Impulse digitalization programme.”

Read more

23

Apr 2019

The Academic Health Science Networks in partnership with the Association of British HealthTech Industries (ABHI) launched a report of the MedTech landscape aimed at accelerating the entry, adoption, and spread of innovations for the benefit of patients and commercial success.

Read more

16

Apr 2019

The 13 innovations joining the NHS Innovation Accelerator were announced on March 5, 2019, as part of an event to launch the fourth year of this award-winning national accelerator.

Read more

12

Apr 2019

On the 16th of February of 2019, the approval for financing of WISE CRT system in a framework of “forfait innovation” program was released in the Official French Gazette. This financing is provided for the 48-months period; it includes the amount of €25,600 and cannot be combined with other benefits. It is fully covered by the compulsory health insurance schemes.

Read more

09

Apr 2019

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

Read more

29

Mar 2019

Norway established in 2013 a framework “New Method” for the introduction of innovations into the health care system through either a national or hospital-based health technology assessment. In this framework, all innovations should undergo HTA before being funded. Currently, 13 ongoing mini-HTA projects are conducted in Norway: robotic-assisted procedures, microwave ablation, and tonsillectomy devices, among others.

Read more

22

Mar 2019

The Dutch Healthcare Authority (NZa) wants to contribute to stimulating the right care in the right place by making it possible to deploy e-health applications more broadly. In 2019 NZa will examine the possibilities for declaring e-health with the focus on district nursing and long-term care. Also, a large part of the e-health projects is in the pilot phase and the Dutch ‘Care for Innovation’ organization developed a step-by-step plan for a systematic approach for e-health introduction.

Read more

13

Mar 2019

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

Read more

05

Mar 2019

In mid-February 2019, the French High Authority for Health (HAS) has published the new guideline to clinical evaluation of connected medical devices in France.

Read more

20

Feb 2019

On January 31st, 2019, the French High Authority for Health (HAS) has published a new assessment of transcatheter aortic valve implantation (TAVI). The objective of this assessment was to clarify the level of requirements of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in terms of minimal clinical data to provide for the registration of a new TAVI on the LPPR, for the acceptance of a new indication for a TAVI already registered on the LPPR and for renewal of registration of a TAVI registered on the LPPR.

Read more

18

Feb 2019

Promising care must find its way to patients more quickly through inclusion in the basic health insurance. That is why the Dutch Ministry of Health, Welfare and Sport has adjusted the promising care with the new subsidy scheme. Dutch Healthcare Institute (Zorginstituut Nederland, ZIN) carries out the scheme in collaboration with the Dutch Organization for Health Research and Development (Nederlandse organisatie voor gezondheidsonderzoek en zorginnovatie, ZonMw). The scheme will replace existing procedure with conditional reimbursement of medical technologies.

Read more

11

Feb 2019

In January 2019, the Institute for the Hospital Remuneration System (InEK) has published the of medical devices and procedures approved for innovation funding (NUB). Out of 709 applications for drugs and technologies, 180 (25%) received the positive status 1, and 69 of them were the requests for the medical technologies.

Read more

06

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 made for eighteen medical devices.

Read more

30

Jan 2019

In late 2018, the French Ministry of Health announced that the telemedicine pilot project “ETAPES” will be maintained for four more years.

Read more

07

Jan 2019

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in December 2018 concern various types of devices (orthopedic, neurostimulators, drug-coated balloon and others). The decisions were brought for ten (10) medical devices.

Read more

19

Dec 2018

The French National Authority for Health (HAS) regularly publishes new decisions about add-on reimbursement for medical devices. The decisions made in November 2018 concern various types of devices. The decisions were brought for twenty-two (22) medical devices.

Read more

06

Dec 2018

In October of 2018, InEK has published the list of the devices, previously (in 2018) eligible for innovation funding via NUB, and which will be integrated into DRG payment system since 2019. Only two devices will be transferred into the DRG catalogue.

Read more

29

Nov 2018

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

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.

Read more

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.

Read more

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.

Read more

18

Oct 2018

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

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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).

Read more

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.

Read more

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).

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

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).

Read more

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.

Read more

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.

Read more

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.

Read more

19

Apr 2017

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

Read more