The Commonwealth Fund has released international comparison of health care systems: UK and the Netherlands are leading in number of areas

19

Jul 2017

Researchers at the Commonwealth Fund 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 United Kingdom was high in the ranking in all areas, except health care outcomes. The Netherlands was also superior to other countries in relation to access and equity, but showed poor performance in administrative efficiency of the system.

Norway and Sweden showed the best among others performance in relation to health care outcomes, and worst – in relation to care process.

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 full report here.

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Jul 2019

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Jul 2019

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Jul 2019

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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.

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Jul 2019

On the 11th of June 2019, the Dutch National Healthcare Institute (Zorginstituut Nederland, ZIN) has published a position regarding the positively assessed indications and the appropriate protocols for Hyperbaric Oxygen Therapy (HBOT) that have been included in the basic package since 2009 in order to promote the appropriate use of this care. Health insurers can include this information and the quality criteria of the protocols when purchasing HBOT.

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Jul 2019

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Jul 2019

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Jul 2019

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Jun 2019

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Jun 2019

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Jun 2019

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Jun 2019

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Jun 2019

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Jun 2019

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Jun 2019

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Jun 2019

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Jun 2019

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Jun 2019

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Jun 2019

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Jun 2019

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Jun 2019

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May 2019

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May 2019

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May 2019

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May 2019

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May 2019

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May 2019

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May 2019

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May 2019

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May 2019

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May 2019

German IQWiG assessed vacuum therapy and published the report in late March 2019. Evaluation found statistically significant impact of therapy on wound healing, rate of reinterventions and length of hospital stay.

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May 2019

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May 2019

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May 2019

The colorectal cancer screening program became organized in Germany on April 19, 2019. Until now, only the breast cancer screening program was the only organized screening program. The Evaluation Committee has already updated the EBM catalog.

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May 2019

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May 2019

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May 2019

At the beginning of April 2019, the Federal Cabinet has adopted the draft of a "Law on the Establishment of an Implants Registry in Germany and other amendments to the Fifth Book of the Social Code” (Implants Registry Establishment Law, Implantateregister-Errichtungsgesetz, EIRD).

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May 2019

In Sweden, the Centre for Assessment of Medical Technology (CAMTÖ) leads the development of HTA cooperation in healthcare region Uppsala-Örebro. Currently, CAMTÖ is working on several assessments related to the medical devices and technologies such as equipment for 3D Printing, robot Intuitive daVinci Xi etc. After the completion of assessment procedure, the reports will be published at the web-site of Örebro County Council.

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Apr 2019

The Clinical Coding and Schedule Development (CCSD) group develop and maintains procedural and diagnostics nomenclature for private payers in England. New diagnostic codes concern circulating tumor DNA profile for the different type of cancers, myriad Prolaris test, PET Scan with florbetapir, etc. and a procedure code for robotic-assisted radical hysterectomy and lymphadenectomy. The codes are introduced with a recommended adoption date being the 1st of May 2019. The documents also contain a list of textual changes in codes and an updated list of unacceptable combinations of codes.

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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.

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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.

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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.

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Apr 2019

On behalf of the Institute for Quality and Efficiency in Health Care (IQWiG), a working group of the Hannover Medical School (MHH) has assessed the treatment outcomes in case of nasoalveolar molding (NAM) for cleft lip and palate. The report was published in February 2019.

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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.

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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.

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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.

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Apr 2019

The NHS Long Term Plan announced, on March 7, 2019, that the NHS will ensure that patients with type 1 diabetes will benefit from life changing flash glucose monitors from April 2019. This will end the variation patients in some parts England are facing. The new guidance sets out the criteria for flash glucose monitoring and the maximum amounts CCGs will be reimbursed for the ongoing costs of the flash glucose sensors.

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Apr 2019

In early 2019, the Memorandum of Understanding was signed to support HTA in Ireland, Scotland, and Wales. The Memorandum of understanding establishes a collaborative approach to the identification and assessment of new health technologies between Health Information and Quality Authority Ireland, Health Technology Assesment Group Ireland, Health Technology Wales, and the Scottish Health Technology Group. These bodies assess and give guidance on health technologies within their national healthcare systems.

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Apr 2019

In March 2019, the National Institute for Health and Care Excellence (NICE) published two new interventional procedure guidance (for Barnett Continent Intestinal Reservoir (modified continent ileostomy) to restore continence after colon and rectum removal and high-intensity focused ultrasound for symptomatic benign thyroid nodules), and three new MedTech innovation briefings (for system for ruling out coronary artery disease in people with symptoms of stable coronary artery disease, medical imaging software tool for kidney stone evaluation, incision management system for closed surgical incisions).

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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.

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Mar 2019

NHS Digital is launching a pilot to build the process that will enable partner services to connect to NHS login, providing a single way for patients in England to verify their identity and then use the login to access digital health and care services. The five selected partners represent the range of organizations who will connect with NHS login - from large, established organizations to new players in the market. The service will begin its activities in April 2019.

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Mar 2019

Since 2018 the cost weight for a number of day surgery DRGs has become equal to the cost weight of the relevant hospital DRGs. In 2019 the number of DRGs has been extended, and in total 39 day surgery DRGs are included in the list in 2019.

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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.

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21

Mar 2019

During November-December 2018, the Federal Joint Committee (G-BA) has introduced an organized screening program for the early detection of cervical cancer and initiated consultation procedure for prostate cancer screening.

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18

Mar 2019

New material code for voice prosthesis was added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in March 2019.

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14

Mar 2019

Key changes in the Norwegian DRG system in 2019 include novel payment schemes for dialysis treatment, emergency conditions that occur as outpatient or day case, digital services. Pilot DRG payment models will be implemented for selected medical quality registers and selected procedures for contract specialists.

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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.

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07

Mar 2019

In Norway, the mini-HTA for magnetic technology (Magseed) for breast lesions was released in February of 2018. The method was determined as efficient, safe and was recommended to be introduced as part of the clinical routine in the hospital.

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06

Mar 2019

More than 50 new DRGs were introduced in the Swedish system in 2019, while two have been deleted. The changes affected nursing care, psychiatry, hospital and day case services of different major disease categories. Important changes relate to cardiac ablation, placement of neurostimulator.

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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.

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04

Mar 2019

In early 2019, the Norwegian Institute of Public Health (NIPH) has published a health technology assessment report regarding the hyperbaric oxygen therapy for osteonecrosis. The results have shown that the efficacy and safety evidence of the procedure is too uncertain for now, and its economic evidence is also very limited. Further controlled, prospective studies are recommended.

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01

Mar 2019

Eleven new DRGs have been added in 2019, while three DRGs have been deleted. The significant changes have been made for disorders of the circulatory organs (MDC 5) and musculoskeletal, skeletal and connective tissue disorders associated with prosthetic surgery (MDC 8). They concern insertion of vagus stimulator, ablation of heart, percutaneous valve replacement, and others.

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28

Feb 2019

In January 2019, the National Institute for Health and Care Excellence (NICE) published six new interventional procedure guidance, three medical technologies guidance, and three new MedTech innovation briefings for liver function capacity test, a functional electrical stimulation (FES) integrated cycling system used to start muscle contraction to stimulate trunk and limb muscles in people with spinal cord injury, laser shoe attachment used as a walking aid and is designed to help prevent freezing of gait in people with Parkinson's disease.

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27

Feb 2019

In October of 2018, the Dental and Pharmaceutical Benefits Agency (TLV) has published a completed health economic evaluation regarding the clinical efficacy and cost-effectiveness MiniMed 670G in comparison to MiniMed 640G device. TLV concluded that the use of the MiniMed 670G can increase the patients’ quality of life due to reduced concern for hypoglycemia, increased comfort, fewer complications and also lead to potential cost benefits.

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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.

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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.

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19

Feb 2019

The NHS Long Term Plan, released on 7th of January 2019, will save almost half a million more lives with practical action on significant killer conditions and investment in world-class, cutting edge treatments including genomic tests for every child with cancer. Local NHS allocated £570 billion to fund the NHS Long Term Plan.

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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.

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15

Feb 2019

In January 2019, the German Institute for Quality and Efficiency in Health Care (IQWiG) has selected four medical topics from citizens' suggestions for scientific assessment in the form of HTA reports (depression in children, mHealth solutions for multiple sclerosis, elephantiasis, and pain in endometriosis).

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12

Feb 2019

On January 31, 2019, NHS England and NHS Improvement launched the statutory consultation on the proposed 2019/20 national tariff. The consultation period ends at midnight, at the end of 21 February 2019.

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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.

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08

Feb 2019

The Clinical Coding and Schedule Development (CCSD) group develop and maintains procedural and diagnostics nomenclature for private payers in England. New procedure codes concern robotic-assisted laparoscopic procedures, 2-dimensional radiotherapy, revision of anti-reflux operations, etc. The codes are introduced with a recommended adoption date being the 1st of May 2019. The document also contains a list of textual changes in codes and an updated list of unacceptable combinations of codes.

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07

Feb 2019

At the end of December 2018, the Federal Joint Committee (G-BA) decided that optical coherence tomography for the diagnosis and therapy control of several retinal diseases will be covered by the statutory health insurance.

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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.

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05

Feb 2019

In December 2018, the National Institute for Health and Care Excellence (NICE) published one new diagnostic guidance (for tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer), two new interventional procedure guidance (for transcutaneous neuromuscular electrical stimulation for oropharyngeal dysphagia in adults and bronchial thermoplasty for severe asthma), and four MedTech innovation briefings.

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Feb 2019

The Clinical Coding and Schedule Development (CCSD) group develops and maintains procedural and diagnostics nomenclature for private payers in England. In October/November 2018 new code for bilateral US Doppler vascular limb was added to the CCSD Schedule.

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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.

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29

Jan 2019

The Clinical Coding and Schedule Development (CCSD) group develops and maintains procedural and diagnostics nomenclature for private payers in England. In October/November 2018, five new procedure codes for laser correction of refractive error following non-refractive ophthalmic surgery, insertion of urethral catheterization device, injection of botulinum toxin for hyperhidrosis, laparoscopic and robotic-assisted pancreatoduodenectomy have been added to the CCSD Schedule.

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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.

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23

Jan 2019

In November of 2018, the completed mini-method assessment for decompression due to entrapment neuralgia for patients with chronic pain in the neck, shoulders, and head was released. The method was determined as poorly documented and was not recommended to be introduced as a part of the routine clinical practice.

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18

Jan 2019

Two mini-method assessments regarding intraepidermal nerve fiber density in skin biopsy and neurovascular structure-adjacent frozen-section (NeuroSAFE) during robot-assisted laparoscopic prostatectomy (RALP) were initiated by Oslo University Hospital in December of 2018. All finalized mini-method assessments are published in the National Database for Mini-HTA.

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15

Jan 2019

In December of 2018, the completed mini-method assessment for targeted deep sequencing panel for patients with varying types of hematological neoplasia was released by the Norwegian Institute of Public Health (NIPH). The method was determined as safe and efficient and was recommended to become a part of routine clinical practice.

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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.

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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.

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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.

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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.

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05

Dec 2018

At the end of October of 2018, DIMDI has published the preliminary version of the procedure catalogue for the coming year. MTRC will report about new procedures and other changes included in the catalogue after the release of the official version in the beginning of 2019.

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30

Nov 2018

The Clinical Coding and Schedule Development Group develops and maintains procedural and diagnostics nomenclature for private payers in England. In October, one new diagnostic code.

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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.

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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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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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19

Nov 2018

In the draft guideline for management of urinary incontinence and pelvic organ prolapse NICE recommended to offer a full range of non-surgical options to women with stress urinary incontinence or pelvic organ prolapse before any operations.

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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.

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14

Nov 2018

In October of 2018, the Norwegian Institute of Public Health (NIPH) has published a single technology assessment regarding the external ultrasound stimulation - Exogen™ in the treatment of femoral or tibial non-union. The objective of the assessment was to evaluate the efficacy, safety and health economic documentation for EXOGEN™ compared to surgical treatment for the management of patients with non-union of a fracture. The results have shown that the present documentation does not give evidence to assess the clinical or cost-effectiveness of EXOGEN™ for the treatment of non-union fractures compared to surgery.

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09

Nov 2018

Two mini-method assessments regarding the magnetic technology (Magseed) for labeling non-palpable breast lesions and robotic-assisted minimally invasive harvesting of muscle patches for reconstructive surgery were initiated in Norway this October of 2018. All finalized mini-method assessments are published in the National Database for Mini-HTA.

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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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06

Nov 2018

In September, the National Institute for Health and Care Excellence (NICE) published two new interventional procedure guidance for transurethral water jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia and intravesical microwave hyperthermia and chemotherapy for non-muscle-invasive bladder cancer, one medical technologies guidance for neuropad for detecting preclinical diabetic peripheral neuropathy and two new medtech innovation.

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02

Nov 2018

In August, the National Institute for Health and Care Excellence (NICE) published four new interventional procedure guidance for leadless cardiac pacemaker implantation for bradyarrhythmias, superior rectal artery embolisation for haemorrhoids, sutureless aortic valve replacement for aortic stenosis and transurethral water vapour ablation for benign prostatic hyperplasia, and four new medtech innovation briefings.

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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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26

Oct 2018

In October 2018, the Austrian HTA body, the Ludwig-Boltzmann Institue (LBI), published the update on the PET/PET-CT topic. The report was done together with the Berlin Technical University.

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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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03

Oct 2018

On the 14th of August of 2018, the Norwegian Institute of Public Health (NIPH) has published a health technology assessment report in relation to autologous hematopoietic stem cell transplantation (AHSCT) comparing with standard treatment for patients with systemic sclerosis. The results have shown that the transplant‐related mortality after AHSCT is high, but risk of organ failure and death is lower after two years follow‐up and beyond compared to standard treatment, AHSCT provides a significant improvement of skin involvement and lung function measured by forced vital capacity compared to standard treatment with cyclophosphamide injections.

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26

Sep 2018

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

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25

Sep 2018

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

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19

Sep 2018

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

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14

Sep 2018

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

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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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11

Sep 2018

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

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10

Sep 2018

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

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07

Sep 2018

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

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04

Sep 2018

At the end of June of 2018, the National Board of Health and Welfare (Socialtyrelsen) has published an updated version of the National clinical guidelines for heart care. The review was conducted for the inclusion of few updated recommendations regarding the management of the coronary heart disease, valvulopathy and arrhythmia.

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03

Sep 2018

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

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31

Aug 2018

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

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30

Aug 2018

Three mini-method assessments regarding the magnetic non-radioactive detection system SentiMag Sienna + of sentinel lymph nodes in breast cancer, cough reflex testing and emergency targeted ultrasound implementation were initiated by Oslo University Hospital in June of 2018. All finalized mini-method assessments are published in the National Database for Mini-HTA.

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29

Aug 2018

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

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28

Aug 2018

In June of 2018, the Norwegian Institute of Public Health (NIPH) has published a single technology assessment regarding the MicraTM Transcatheter Pacing System (Micra TPS) - a leadless pacemaker produced by Medtronic to reduce the rate of complications following pacemaker implantations through design and novel technology. The objective of the assessment was to investigate the clinical efficacy, safety and cost effectiveness of Micra TPS in patients indicated for single chamber ventricular pacemaker implantation. The results have shown that the current evidence is not sufficient to prove that the Micra TPS gives less complications than standard pacemakers, also the use of Micra appeared not to be cost-effective.

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27

Aug 2018

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

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24

Aug 2018

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

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23

Aug 2018

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

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21

Aug 2018

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

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16

Aug 2018

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

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10

Aug 2018

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

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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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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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18

Jul 2018

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

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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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13

Jul 2018

On the 14th of May of 2018, Norwegian RHF Decision Forum (Beslutningsforum) has recommended usage of the Flash Glucose Monitoring system - Freestyle Libre for the treatment and follow-up of children (less than 18 years) with type 1 diabetes and other types of diabetes.

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11

Jul 2018

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

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09

Jul 2018

Two mini-method assessments regarding brachytherapy for esophageal cancer and targeted gene deep-sequencing panels were initiated by Oslo University Hospital in May of 2018. All finalized mini-method assessments are published in the National Database for Mini-HTA.

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06

Jul 2018

Norwegian Institute of Public Health (NIPH) conducted a full health technology assessment (HTA) of Peptide receptor radionuclide therapy (PRRT) using 177Luthetium (177Lu-PRRT) on the request from payers (“New methods” framework for introduction of innovations in Norway).

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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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03

Jul 2018

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

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27

Jun 2018

Remote follow-up for chronically ill patients is included in a new trial that will start in Norway in autumn 2018. Six municipal cooperation projects received grants to participate in this trial in collaboration with the National Welfare Technology Program (Nasjonalt velferdsteknologiprogram).

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25

Jun 2018

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

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22

Jun 2018

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

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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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18

Jun 2018

On the 30th of May of 2018, Norwegian Institute of Public Health (NIPH) has published a report regarding effectiveness of shunt treatment for persons with idiopathic normal pressure hydrocephalus, which was earlier commissioned to NIPH by My treatment choices platform with the purpose to find and summarize key findings from systematic reviews about the effects of shunts in the treatment of idiopathic normal pressure hydrocephalus.

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12

Jun 2018

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

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08

Jun 2018

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

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07

Jun 2018

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

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06

Jun 2018

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

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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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01

Jun 2018

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

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31

May 2018

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

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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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28

May 2018

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

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25

May 2018

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

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23

May 2018

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

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22

May 2018

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

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21

May 2018

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

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18

May 2018

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

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17

May 2018

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

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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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08

May 2018

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

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07

May 2018

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

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03

May 2018

In April of 2018, the National Board of Health and Welfare (Socialstyrelsen) has published a report “Screening for severe combined immune deficiency”, which contains recommendation and assessment basis for the national combined immunodeficiency screening program (SCID).

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02

May 2018

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

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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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27

Apr 2018

On the 16th of April, 2018, the new classification of diagnosis codes (ICD-10-SE) was released by the National Board of Health and Welfare (Socialstyrelsen). Seventeen new diagnosis codes were added in 2018.

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25

Apr 2018

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

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24

Apr 2018

The report “Development Trend 2018” will help to provide a basis for analyzing the environment for eHealth and creating a frame of reference for understanding the eHealth development.

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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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18

Apr 2018

At the beginning of March, 2018, the National Board of Health and Welfare (Socialtyrelsen) has published the instruction with the amendments for coding of infected wounds. Several clarifications to the use of these diagnosis codes were implemented.

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17

Apr 2018

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

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13

Apr 2018

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

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12

Apr 2018

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

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06

Apr 2018

On the 22nd of March, 2018, the National Board of Health and Welfare (Socialtyrelsen) has published a preliminary version of National guidelines for endometriosis care. Socialtyrelsen is opened for comments and suggestions until the 31st of May, 2018.

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05

Apr 2018

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

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03

Apr 2018

At the end of January, 2018, the National Board of Health and Welfare (Socialtyrelsen) has published updated Guidelines for management of asthma and chronic obstructive pulmonary disease (COPD). The few recommendations on drug treatment and management of COPD were updated.

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30

Mar 2018

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

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29

Mar 2018

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

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28

Mar 2018

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

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26

Mar 2018

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

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23

Mar 2018

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

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22

Mar 2018

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

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21

Mar 2018

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

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19

Mar 2018

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

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15

Mar 2018

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

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09

Mar 2018

According to the recommendation of the National Board of Health and Welfare (Socialstyrelsen), hospitals and clinics should not offer screening for prostate cancer with PSA tests with or without other supplementary tests before tissue sampling. The recommendation is based on that the benefit of screening for prostate cancer with PSA tests does not outweigh the negative effects on a population level.

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07

Mar 2018

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

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05

Mar 2018

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

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28

Feb 2018

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

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26

Feb 2018

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

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22

Feb 2018

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

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20

Feb 2018

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

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19

Feb 2018

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

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15

Feb 2018

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

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14

Feb 2018

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

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12

Feb 2018

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

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09

Feb 2018

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

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08

Feb 2018

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

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02

Feb 2018

Ninety-two new codes have been implemented, including protein fractions and reproductive medicine tests.

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30

Jan 2018

Applications for creation of new codes, removal of code or changes to existing codes and code description can be submitted by the Norwegian Directorate of Health.

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25

Jan 2018

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

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24

Jan 2018

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

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23

Jan 2018

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

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22

Jan 2018

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

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19

Jan 2018

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

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17

Jan 2018

Since January 1, 2018, responsibility for managing the product regulations for medical devices is transferred from the Norwegian Directorate of Health to the Norwegian Medicines Agency.

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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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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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03

Jan 2018

The current guideline replaces the previous version of the document of 2010. The Norwegian Directorate of Health decided to update the guideline because new methods of treatment and rehabilitation of stroke became avaliable in recent years.

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26

Dec 2017

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

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25

Dec 2017

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

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22

Dec 2017

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

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21

Dec 2017

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

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20

Dec 2017

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

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19

Dec 2017

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

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18

Dec 2017

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

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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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12

Dec 2017

Eight new medical procedure codes for obstetric, urological, gynecological and vascular interventions will be added to the Swedish Classification of non-surgical medical interventions (KMÅ) in 2018.

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11

Dec 2017

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

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07

Dec 2017

Eight new surgical procedure codes for otorhinolaryngologic, colorectal and orthopedic interventions will be added to the Swedish Classification of surgical interventions (KKÅ) in 2018.

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06

Dec 2017

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

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04

Dec 2017

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

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29

Nov 2017

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

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28

Nov 2017

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

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24

Nov 2017

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

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23

Nov 2017

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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17

Nov 2017

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

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16

Nov 2017

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

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15

Nov 2017

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

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14

Nov 2017

Patients should not pay anything other than regulated out-of-pocket payments when they visit general practitioner or other healthcare professional, who have contract with public health authorities.

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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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07

Nov 2017

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

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03

Nov 2017

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

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02

Nov 2017

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

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31

Oct 2017

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

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26

Oct 2017

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

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25

Oct 2017

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

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24

Oct 2017

In June of 2017, the Ordering Forum RHF commissioned rapid method assessment for the Prosigna test. Only when the Norwegian Institute of Public Health receives documentation from the suppliers they carry out a quick method assessment. On 16th of the October, suppliers were requested to submit data to the Norwegian Institute of Public Health (NIPH) regarding clinical efficacy, safety and economics of Prosigna test.

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19

Oct 2017

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

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18

Oct 2017

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

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17

Oct 2017

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

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13

Oct 2017

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

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12

Oct 2017

Irreversible electroporation (IRE) is a new minimally invasive method for the ablation of tumors. Currently, this method is not used in Norway. The conclusion of mini-HTA stated that IRE should be included as part of the routine clinical practice in the hospital.

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11

Oct 2017

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

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10

Oct 2017

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

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06

Oct 2017

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

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03

Oct 2017

New procedure codes will be created for stem cell procedures, extracorporeal techniques (including hemodialysis and CO2 removal), surgical interventions, including growth-controlling spinal correction, transposition of peripheral nerve, interventions on veins, and percutaneous image-guided procedures (including code for pressure measurement in coronary arteries and additional code for drug-eluting balloon). Classification will be enabled from January 1, 2018.

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02

Oct 2017

On 25th of September, the Norwegian Decision Forum of “New Methods” had a meeting to review several medical technologies and IVD tests. Decisions were made in relation to the introduction of 2 new newborn screening tests, prehospital emergency thoracotomy, aortic valve replacement using sutureless stent Perceval, and digital breast tomosynthesis.

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29

Sep 2017

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

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28

Sep 2017

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

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27

Sep 2017

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

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26

Sep 2017

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

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25

Sep 2017

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

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22

Sep 2017

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

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20

Sep 2017

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

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19

Sep 2017

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

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14

Sep 2017

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

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12

Sep 2017

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

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08

Sep 2017

All significant innovations in Norway should undergo either national or hospital-based health technology assessment within “New Methods” framework. Guiding criteria for prioritization of topics for assessments were recently formulated by the administration of the program.

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07

Sep 2017

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

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06

Sep 2017

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

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04

Sep 2017

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

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01

Sep 2017

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

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30

Aug 2017

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

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28

Aug 2017

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

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25

Aug 2017

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

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24

Aug 2017

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

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22

Aug 2017

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

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16

Aug 2017

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

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11

Aug 2017

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

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10

Aug 2017

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

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10

Aug 2017

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

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10

Aug 2017

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

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07

Aug 2017

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

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03

Aug 2017

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

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02

Aug 2017

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

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01

Aug 2017

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

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26

Jul 2017

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

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25

Jul 2017

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

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24

Jul 2017

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

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21

Jul 2017

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

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20

Jul 2017

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

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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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11

Jul 2017

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

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06

Jul 2017

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

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05

Jul 2017

The guideline is based on recently updated and summarized research-based knowledge of the effects and side effects associated with the treatment. Both user experiences and research-based knowledge are emphasized in the assessments of the adverse effects that have been associated with the treatment.

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04

Jul 2017

The Government has given to the Swedish National Board of Health and Welfare (Socialstyrelsen) to see how much of the highly specialized care could be coordinated at the national level. The proposed model will be tested in autumn 2017 in two areas: the nervous system diseases and women's health and childbirth. These areas will be surveyed to see which individual care measures would be improved.

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03

Jul 2017

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

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29

Jun 2017

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

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29

Jun 2017

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

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26

Jun 2017

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

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23

Jun 2017

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

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22

Jun 2017

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

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21

Jun 2017

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

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21

Jun 2017

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

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20

Jun 2017

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

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19

Jun 2017

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

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16

Jun 2017

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

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14

Jun 2017

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

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14

Jun 2017

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

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13

Jun 2017

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

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12

Jun 2017

The Ministry of Health and Care Services has decided to transfer management tasks related to the medical device area from Norwegian Directorate of Health to the Norwegian Medicines Agency from 1 January 2018.

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09

Jun 2017

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

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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

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

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01

Jun 2017

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

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31

May 2017

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

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30

May 2017

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

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26

May 2017

Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) is working on three health technology assessment projects, related to medical technologies and in-vitro diagnostics, including diagnostics of prostate cancer, diagnostics of endometriosis and surgery for arm fractures in elderly.

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24

May 2017

The National Board (Socialstyrelsen) has developed a new national guideline for the treatment of stroke with a significant focus on mechanical thrombectomy. MTRC provides an overview of key recommendations, which concern diagnosis and treatment phase using medical technologies.

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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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19

May 2017

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

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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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15

May 2017

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

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12

May 2017

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

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10

May 2017

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

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09

May 2017

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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04

May 2017

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

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03

May 2017

Guidelines from Norwegian Directorate for Health have high impact and can be considered as commissioning guidelines. New criteria for screening for gestational diabetes and new fasting glucose threshold for diagnosis were determined.

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03

May 2017

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

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02

May 2017

The Forum of Norwegian payers made decision about introduction of three medical technologies: mechanical thrombectomy for stroke, baroreflex activation therapy for resistant hypertension and non-invasive prenatal testing for detection of trisomy 13, 18 and 21.

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01

May 2017

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

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28

Apr 2017

Three mini-HTAs were published since beginning of 2017: procalcitonin for diagnostic of bacterial infections, Per Oral Endoscopic Myotomy (POEM) for achalasia, and use of the Prosigna test (PAM50 ROR) for decisions on adjuvant treatment in breast cancer. These assessments can support introduction of methods at local hospital level in Norway.

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28

Apr 2017

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

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26

Apr 2017

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

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24

Apr 2017

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

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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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14

Apr 2017

Report found that Sweden has high regional variability in provision of cardiovascular procedures (PCI and CABG), but low to moderate variability in provision of orthopedic and obstetrics procedures compared with selected OECD countries.

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13

Apr 2017

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

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04

Apr 2017

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

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31

Mar 2017

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

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24

Mar 2017

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

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