Generic Quality Framework for Medical Devices and three modules for continence, stoma and diabetic care have been registered in the Quality Register of the Dutch Health Care Institute

05

Jan 2018

At the beginning of 2016 patient organizations, health care providers, health insurers, suppliers and manufacturers of medical devices have started working together with the Dutch Ministry of Health, Welfare and Sport and Dutch Health Care Institute on the development of the Generic Quality Framework for Medical Devices and three specific modules, including:

The Generic Quality Framework for Medical Devices serves as a description of good healthcare care for the client. It provides tools for developing quality standards for users of specific categories of medical devices, with the aim to:

  • unambiguously and transparently improve the quality of the medical aids used at home;
  • describe how to choose the right device, that meets the patient's functional needs;
  • ensure a wide choice of good quality device and acceptable costs (efficiency);
  • be able to serve as a guideline for the supervision of the interpretation of the duty of care as referred in the Healthcare Insurance Act;
  • use unambiguous language: a glossary of terms has been drawn up for this purpose (Appendix 2).

Health insurers can use the Generic Quality Framework for Medical Devices in healthcare purchasing for 2018.

See full details in the Dutch here.

Subscribe to our newsletter delivered every second week not to miss important reimbursement information.

Related news

29

May 2019

In April 2019, the Ministry of Health, Consumption and Social Welfare announced the update of the common package of benefits of the Spanish national health system with the inclusion of cervical cancer screening, nipple and areola micropigmentation and update of orthoprosthesis catalog.

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

28

May 2019

The report includes an overview of funding framework and all (as of May 2019) decisions from ultimate payers and decisions makers in England (NHS England, one CCG), Germany (G-BA), Netherlands (Zorginstituut Nederland), Norway (“New Methods” framework) and Switzerland (Federal Office of Public Health). More than 1000 decisions are included.

Read more

24

May 2019

At the end of April 2019, the network of European HTA agencies, EUnetHTA, published the “Custom-made or customizable 3D printed implants and cutting guides versus non-3D printed standard implants and cutting guides for improving outcome in patients undergoing knee, maxillofacial, or cranial surgery.”

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

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

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

20

Mar 2019

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

Read more

11

Mar 2019

On February 5, 2019, the Federal Department of Home Affairs (FDHA) decided that in case of suspected infection or fever of unknown origin, positron emission tomography (TEP) will be considered mandatory services. Also, percutaneous electrical stimulation of the posterior tibial nerve (PTNS) was approved for incontinence indication. Furthermore, the reimbursement amounts relating to incontinence and ostomy materials will be reduced. List of Analyses was also updated.

Read more

22

Feb 2019

At the beginning of February of 2019, 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.

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

13

Feb 2019

In January 2019, the Ministry of Health, Consumer Affairs and Social Wellbeing of Spain has released an Order by which Annex VI of the Royal Decree 1030/2006 was modified. With this modification, the common catalog of ortho-prosthetic devices is updated with new products (wheelchairs, orthoses and special prosthetics).

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

24

Jan 2019

Dutch Healthcare Authority (NZa) has released key features of the DRG package for 2020, including complex chronic lung failure, stem cell transplant care and indexation of DRG tariffs.

Read more

11

Jan 2019

Federal Department of Home Affairs (FDHA) released changes in coverage of medical procedures, IVD tests and medical aids in Switzerland. They include extension of coverage for neonatal screening to severe congenital immunodeficiencies, extension of coverage under restrictions for TAVI, gene test for breast cancer, PET, PET / CT, local superficial hyperthermia during tumour treatment, external defibrillator and coverage for sub-urethral tapes for the treatment of stress urinary incontinence in women. Also, changes in the coverage for neonatal screening were introduced.

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

12

Dec 2018

In late October 2018, Assobiomedica, the body that represents the companies that operate in the medical device sector, published the fourth edition of the document “Public policies for the purchase of medical devices.”

Read more

10

Dec 2018

At the end of September of 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.

Read more

07

Dec 2018

On November 7, 2018, the Italian Ministry of Health announced the document which should serve as a tool for the acquisition of medical devices through tenders.

Read more

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.

Read more

15

Nov 2018

Adding the MammaPrint® to the standard risk assessment in patients with early-stage breast cancer has not demonstrated health gains compared to the current way of determining whether a patient needs chemotherapy. Dutch National Health Care Institute has concluded that the test is not eligible for reimbursement from the basic insurance package.

Read more

25

Sep 2018

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

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

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.

Read more

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.

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

22

May 2018

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

Read more

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.

Read more

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

Read more

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).

Read more

19

Feb 2018

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

Read more

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).

Read more

21

Dec 2017

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

Read more

13

Dec 2017

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

Read more

04

Dec 2017

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

Read more

25

Oct 2017

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

Read more

29

Aug 2017

Decree #968 introduced a number of additional products for which procurement will be limited to Russian-made products only. The List includes devices for blood transfusion, containers for storage and transport of blood, consumables for mechanical lung ventilation, consumables for plasmapheresis, consumables for cardiopulmonary bypass, urine, and fecal collectors.

Read more

25

Aug 2017

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

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

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.

Read more

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.

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

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).

Read more

06

Jul 2017

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

Read more

23

Jun 2017

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

Read more

21

Jun 2017

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

Read more

14

Jun 2017

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

Read more

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.

Read more

28

Apr 2017

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

Read more