Veneto Region updates guidelines on brain, occipital nerve and vagal nerve stimulation therapy for Parkinson’s disease, drug-resistant chronic migraine, and drug-resistant epilepsy

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Jul 2017

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

The document is developed around questions that are specific for intervention and health condition, and defines criteria for the selection of the device and characteristics of the centres allowed to perform the implantation procedure. For each question, recommendations are given according to level of evidence (I–VI) and strength (A–E).

The main recommendations are listed below: 

  • Deep brain stimulation (DBS) for advanced Parkinson’s disease: It needs to be considered for adults diagnosed with Parkinson’s disease since 5 years, unresponsive to medical therapy, not presenting comorbidities or clinically relevant cognitive or psychiatric alterations, responsive to levodopa and presenting disabling motor symptoms (I - B).
  • Occipital nerve stimulation (ONS) for drug-resistant chronic migraine: It is not recommended (VI - D). Already at the end of 2014, the manufacturer (St. Jude Medical) producing the only ONS devices with indication for use in this condition, informed that the indications have been amended due to lack of reliable data showing effectiveness.
  • Vagal nerve stimulation (VNS) for drug-resistant epilepsy: It is indicated for patients (older than 12) presenting epileptic focal seizures with or without generalisation, unresponsive to medical therapy (at least two antiepileptic drugs), and not suitable for surgical treatments or in which the surgical treatments have failed (I - B).
  • Deep brain stimulation (DBS) for drug-resistant epilepsy: There is uncertainty around recommendations in favour or against this treatment for focal onset epilepsy in carefully selected adult patients, unresponsive to medical therapy (at least two antiepileptic drugs), not suitable for surgical treatments or in which the surgical treatments have failed, and not presenting severe cognitive impairment (II - C).

Criteria for the selection of the devices

  • Parkinson’s disease (IV - B):
    • Non rechargeable devices should be used when life expectation of the patient is less than 10 years, device replacement expected after 5 years, the patient is unable to manage the device;
    • Rechargeable devices should be used when life expectation of the patient exceed 10 years, device replacement expected within 5 years, the patient is able to manage the device;
  • Drug-resistant epilepsy: Only one device for VNS is on the Italian market (Therapy Pulse, Livanova); Only one device for DBS is on the Italian market (Activa PC 37601, Medtronic).

Main characteristics of the centres allowed to perform the implantation procedure

Previous experiences in performing the procedure; multi-disciplinary team able to assess patient’s eligibility; availability of properly equipped operating room and beds within the intensive care unit to manage complications; ability to follow the patient in all the phases of the therapy.

Access full document in Italian here.

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17

Jul 2019

On June 6, 2019, the Swiss Federal Department of Home Affairs (FDHA) has changed the Services Ordinance (OPre/KLV), which determines coverage of health care services in Switzerland. The changes regard mostly the reimbursement rules for various services. Furthermore, there are updates regarding the Health Insurance Law (LAMal/KVG), List of Analyses, List of Medical Aids and Equipment, and clinical coding.

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15

Jul 2019

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

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12

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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11

Jul 2019

On 17th June 2019, the company in charge of the development of the DRG system in Switzerland, SwissDRG SA, has announced the catalog version of SwissDRG 9.0/2020 (2017/2020). Eleven days later, the planning version of SwissDRG (2018/2020) has been published as well.

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10

Jul 2019

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

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08

Jul 2019

At the beginning of June 2019, the National Healthcare Institute (Zorginstituut Nederland, ZIN) has published an Overview of the healthcare services, which were excluded or included with restrictions into Basic Insurance Package. Percutaneous liver perfusion with melphalan in patients with metastases from a uveal melanoma was included with restrictions, whereas CardioMEMS PA Monitoring was included in the context of research only.

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03

Jul 2019

Notification to the Belgian Federal Agency for Medicines and Health Products (AFMPS) is a condition for obtaining reimbursement of compulsory medical insurance for implants and invasive medical devices for long-term use. Only devices that meet the notification requirements will be eligible for health care insurance.

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26

Jun 2019

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

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17

Jun 2019

On April 18, 2019, the Nomenclature was updated. The update brought changes in chapter V of Nomenclature, regarding the creation of new codes for ultrasound examination during pregnancy.

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11

Jun 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 cytoreductive surgery for colorectal peritoneal carcinomatosis, cytoreductive surgery for ovarian malignancies, therapeutic sialendoscopy, intra corporeal salivary gland lithotripsy, and others and diagnostic codes for tests for common and rare mutations.

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06

Jun 2019

Four updated pathways for gynecological cancers describe the whole process of management patients – from the first examination for suspicion of cancer to the follow-up and rehabilitation with the management of late effects.

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05

Jun 2019

HealthTech Connect, a new online resource provided by NICE to help identify and support new health technologies as they move from inception to adoption in the UK health and care system, was formally launched April 29th, 2019. The system, which is free to use, will help companies to understand what information is needed by decision makers in the UK health and care system, and clarify possible routes to market access.

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31

May 2019

Between the 3rd of June and the 15th of July, SwissDRG will be receiving the requests/suggestions regarding the DRG system in the country.

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23

May 2019

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

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22

May 2019

The report presents a summary of the reimbursement situation report for percutaneous tibial neuromodulation in overactive bladder. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden, and Switzerland.

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20

May 2019

With the regional decree of April 23, 2019, Tuscany Regional Healthcare has published assessments of six medical devices belonging to various therapeutic areas, including a system for monitoring in heart failure, TAVI, glaucoma drainage system, intravascular lithotripsy system.

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13

May 2019

On March 7, 2019, the Nomenclature was updated. The update brought changes in chapter V of Nomenclature, regarding the creation of new codes, deletion, and modification of existing codes. Changes mainly related to the in-vitro diagnostic testing.

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06

May 2019

Italian Ministry of Health, together with the national HTA agency, AGENAS, has published two Horizon Scanning reports in December 2018. Public consultations are open until May 25, 2019.

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03

May 2019

The 2019/20 national tariff payment system has been published and took on the 1st of April 2019. There have been no substantial changes to the proposed tariff consulted on during January and February 2019. Under the published tariff, blended payment will be the default payment approach for emergency care services.

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02

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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30

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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15

Apr 2019

The report presents a summary of reimbursement situation for sacral nerve stimulation. The following indications will be considered: urge urinary incontinence, retention of urine, faecal incontinence. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

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15

Apr 2019

With a regional decree of March 7, 2019, Tuscany Regional Healthcare has published assessments of seventeen medical devices belonging to various therapeutic areas.

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09

Apr 2019

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

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08

Apr 2019

In late March 2019, the Italian Minister of Health announced that the European Commission has decided to adopt the Italian national classification system for medical devices for the database at European level.

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02

Apr 2019

In late March 2019, the Italian Ministry of Health has published a new document on medical device governance. The document presents the guidelines for a new governance of medical devices, which aims at the efficient allocation of the NHS resources, the sustainability of innovation, the strengthening of supervision and the transparency of actions and reports concerning the procurement and use of medical devices.

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27

Mar 2019

On the Interterritorial Council that took place March 4th, 2019, the Working Plan for the Spanish Network for Health Technology Assessment was agreed and published. The working plan includes 22 health technology assessment reports, 7 monitoring studies, 9 clinical practice guidelines, and 1 evidence-based product.

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25

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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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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12

Mar 2019

On February 19, 2019, the Nomenclature was updated. The update brought changes in chapter V and VI of Nomenclature, regarding the creation of new codes for laser destruction of congenital port-wine stains, hearing aids and cone beam computed tomography.

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11

Mar 2019

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

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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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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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26

Feb 2019

In early February 2019, the entity that performs health technology assessment for medical devices in Italy, AGENAS, has called for the voluntary contribution of the clinical experts and/or reviewers, as well as for the participation of the manufacturers for announced that they’re working on several HTA projects on different medical devices and procedures, including bariatric surgery, continuous glucose monitoring, Elecsys®sFlt-1/PlGF test and others.

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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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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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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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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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01

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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31

Jan 2019

New material code for the dynamic hip system was added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in January 2019.

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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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28

Jan 2019

On December 27, 2018, the Belgian Official Gazette was updated. The update brought changes in chapter VIII of the Nomenclature, regarding the changing of the coding for flow reserve measurement.

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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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22

Jan 2019

In mid-June, 2018, the Catalan Agency for Quality and Healthcare Evaluation, AQuAS, published the Clinical Practice Guidelines for open-angle glaucoma.

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21

Jan 2019

Curafutura, an association of health insurance companies in Switzerland, started the initiative to change the current outpatient pricing structure (TARMED) in 2016. In late 2018, they let the public know that the new tariff structure for ambulatory medical benefits is almost ready to be submitted to the Federal Council.

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14

Jan 2019

In January 2019, the Danish Health Authority (Sundhedsstyrelsen) released a new national clinical guideline, which focuses on the choice between radical prostatectomy and the option of active monitoring of prostate cancer.

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11

Jan 2019

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

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09

Jan 2019

At the beginning of December 2018, the HTA entity of the Region of Tuscany has released a list of the upcoming assessments of the medical devices. Assessments include among others Impella ventricular assist device from Abiomed, Endocuff Vision colonoscope from Olympus, VascuFlex® Multi-LOC multiple stent delivery system from B Braun.

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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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03

Jan 2019

On November 30, 2018, the DRG-regulating body in Switzerland, SwissDRG, has notified the public that the tariff version of SwissDRG 8.0/2019 has been published.

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21

Dec 2018

Changes will be made in sixteen chapters of Nomenclature. In relation to medical technologies and in-vitro diagnostics, the most important changes include creation of new codes for ophthalmology, otorhinolaryngology, radiology, radiotherapy and nuclear medicine, clinical biology and genetic examinations.

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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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17

Dec 2018

In late November 2018, the Belgian Healthcare Knowledge Center (KCE) published a report with the title “Optimisation of RIZIV – INAMI lump sums for incontinence.” The primary aim of this report is to analyze the adequacy of the current payment model. The report was requested by the National Institute for Sickness and Disability Insurance (RIZIV-INAMI).

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12

Dec 2018

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

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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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07

Dec 2018

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

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04

Dec 2018

On 7th of November, 2018, the Italian Ministry of Health announced that the technical standards for magnetic resonance and its use are updated.

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03

Dec 2018

On 13th of November, 2018, one of the Swiss insurers’ association, curafutura, announced on their website that the new benefit structure, which will be the basis for the new fee structure in ambulatory settings, is ready. The company ats-tms SA prepared this benefit structure.

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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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28

Nov 2018

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

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27

Nov 2018

New national clinical guideline for spinal stabilization in adults with trauma contains a number of recommendations for stabilizing the spine in adults who have been exposed to a trauma.

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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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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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16

Nov 2018

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

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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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25

Oct 2018

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

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22

Oct 2018

On 6th of September, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI-HTA) has released a report on external stimulation of the trigeminal nerve for the prevention and acute treatment of an episodic and chronic migraine. The method was not recommended for inclusion into catalogue of hospital benefits.

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22

Oct 2018

The report presents a summary of reimbursement situation for gastric pacemaker stimulation. Two indications are considered: gastroparesis and obesity. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

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18

Oct 2018

The report presents a summary of reimbursement situation for cochlear implants for hearing loss. The only reimbursement within public / statutory health insurance systems is considered. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

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17

Oct 2018

On 3rd of October, 2018, the Italian Agency for Regional Healthcare Services, AGENAS, announced on their website that the reviewer volunteers are needed for reviewing the reports that should be published soon.

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11

Oct 2018

In the early July 2018, the authorities of the Italian region Veneto brought a decree that updates the regional guidelines for the management of patients with colostomy, ileostomy and urostomy that were published in January 2017.

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02

Oct 2018

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

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20

Sep 2018

Emilia Romagna Region published a preliminary information report on the LumiHeal™ KLOX system, a topical photo-converter system for the treatment of acute and chronic wounds.

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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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06

Sep 2018

Emilia Romagna Region published a rapid assessment report on the Medtronic’s Heli-FX™ EndoAnchor™ system. The authors concluded that published literature is of poor quality (mainly non-comparative studies) and mostly includes patients with abdominal aortic aneurysm. Data on the use of the device for thoracic aorta aneurysm repair are extremely limited.

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13

Aug 2018

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

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09

Aug 2018

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

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07

Aug 2018

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

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06

Aug 2018

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

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02

Aug 2018

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

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01

Aug 2018

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

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27

Jul 2018

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

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26

Jul 2018

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

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24

Jul 2018

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

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23

Jul 2018

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

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20

Jul 2018

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

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16

Jul 2018

The report presents a summary of the reimbursement situation for use of spinal cord stimulation. Indications include neuropathic and ischemic pain. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

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16

Jul 2018

The report presents a summary of the reimbursement situation for deep brain stimulation. Indications include Parkinson’s disease, dystonia, essential tremor, cluster headache, and epilepsy. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

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13

Jul 2018

The report presents a summary of the reimbursement situation for vagus nerve stimulation. Indications include epilepsy and depression. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

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05

Jul 2018

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

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04

Jul 2018

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

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04

Jul 2018

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

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25

Jun 2018

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

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20

Jun 2018

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

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19

Jun 2018

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

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13

Jun 2018

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

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12

Jun 2018

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

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11

Jun 2018

On 11th May, the Italian Ministry of Health announced from its website that five new Med Tech-related HTA documents are available for public consultation. See the details in the MTRC post.

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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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16

May 2018

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

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15

May 2018

On 26th April, the Italian national agency for regional healthcare, AGENAS, announced that five new HTA documents will be produced for medical technologies during the next months.

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14

May 2018

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

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10

May 2018

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

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09

May 2018

This is an updated version of the National Clinical Guidelines for the Treatment of Brain Metastases published in 2014.

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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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19

Apr 2018

Emilia Romagna Region published a preliminary information report on the Equistasi® device, a wearable proprioceptive stabilizer for rehabilitation of postural instability in Parkinson's disease, multiple sclerosis and athletes.

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16

Apr 2018

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

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13

Apr 2018

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

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11

Apr 2018

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

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10

Apr 2018

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

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04

Apr 2018

At the beginning of 2018, IACS, Institute of Health Sciences in Aragon Autonomous Community, has released a clinical practice guideline on the detection and management of Chronic Kidney Disease.

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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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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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27

Mar 2018

The background for updating the National Clinical Guideline for Treatment of Brain Metastases is that local treatment (stereotactic radiation therapy) has gained more space in the treatment of brain metastases.

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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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20

Mar 2018

In January 2018, the Galician HTA body, Avalia-T, released the technical review of The Vivistim® system, an implantable device for upper-limb rehabilitation after stroke. Evidence was found to be very limited to advice on the implementation of the technology.

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08

Mar 2018

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

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07

Mar 2018

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

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06

Mar 2018

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

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01

Mar 2018

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

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27

Feb 2018

The Danish National Board of Health has decided to resubmit the pool for the development of National Clinical Guidelines in 2018, so that more professional companies and healthcare environments could have the opportunity to develop clinical guidelines.

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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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13

Feb 2018

The background for updating the National Clinical Guideline for Treatment of Brain Metastases is that local treatment (stereotactic radiation therapy) has gained more space in the treatment of brain metastases.

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12

Feb 2018

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

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06

Feb 2018

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

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31

Jan 2018

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

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24

Jan 2018

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

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19

Jan 2018

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

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11

Jan 2018

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

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09

Jan 2018

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

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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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28

Dec 2017

Assobiomedica published a report presenting the status of the ventilation and monitoring equipment installed across the public and private hospitals at 2016. The scenario pictured by the analysis appears to be critical considering the high number of units older than 10 years.

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27

Dec 2017

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

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22

Dec 2017

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

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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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08

Dec 2017

Emilia Romagna Region announced the launch of two new series of documents, according to the new regional assessment framework for medical devices developed during 2017: rapid assessment reports and preliminary information reports.

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05

Dec 2017

Emilia Romagna Region published a preliminary information report on the CytoSorb® device, an extracorporeal cytokine adsorber for the reduction of circulating cytokines in the blood stream.

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01

Dec 2017

Emilia Romagna Region published a rapid assessment report on the cardiac cryoablation catheter (also known as cryoballoon) for atrial fibrillation (AF). The authors concluded that, compared to radiofrequency ablation, cryoablation is not linked to higher effectiveness but presents shorter procedural time.Emilia Romagna Region published a rapid assessment report on the cardiac cryoablation catheter (also known as cryoballoon) for atrial fibrillation (AF). The authors concluded that, compared to radiofrequency ablation, cryoablation is not linked to higher effectiveness but presents shorter procedural time.

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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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20

Nov 2017

Annual report from the Italian Society of Interventional Cardiology (GISE) shows increasing trends in procedural volume of percutaneous coronary interventions (PCI), transcatheter aortic valve implantations (TAVI), mitral clip implantations, closure of left atrial appendage (LAA) and patent foramen ovale (PFO).

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16

Nov 2017

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

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13

Nov 2017

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

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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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01

Nov 2017

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

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20

Oct 2017

The analyses were performed on the 2015 data from 16 Regions, on the basis of 35 indicators. According to the score assigned, Regions were classified as “compliant” (i.e., score ≥ 160 or between 140 and 160 with no critical values in any of the indicators) or “non-compliant” (i.e., score < 140 or between 140 and 160 with at least one critical value in one of the indicators). Overall results showed that the Country is split into two sections: Regions in the north were all compliant while those in the south, with the only exception of Basilicata, showed suboptimal performances.

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19

Oct 2017

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

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17

Oct 2017

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

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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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09

Oct 2017

Agreement on the national HTA programme for medical devices has been reached between the central and regional authorities during the last Assembly. The main player in this context will be the Cabina di Regia per l’HTA. The steering committee will produce policy recommendations about the use of the assessed technologies and monitor implementation by procurement organizations. Read about the scope of the framework in our blog post.

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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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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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06

Sep 2017

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

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05

Sep 2017

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

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04

Sep 2017

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

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31

Aug 2017

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

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30

Aug 2017

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

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23

Aug 2017

A list of scientific societies and technical and scientific medical associations appointed to release national guidelines will be defined in the next months by the Ministry of Health, following its decree issued on 2nd August 2017.

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22

Aug 2017

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

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21

Aug 2017

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

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11

Aug 2017

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

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10

Aug 2017

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

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09

Aug 2017

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

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07

Aug 2017

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

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04

Aug 2017

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

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27

Jul 2017

As of today, 11 Italian regions have specific regulations for health technology assessment. Medical devices are among the most commonly assessed types of technologies. Read English summary of the comprehensive report on HTA in Italy, developed by Agenas and SIHTA.

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25

Jul 2017

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

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24

Jul 2017

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

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21

Jul 2017

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

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18

Jul 2017

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

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17

Jul 2017

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

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13

Jul 2017

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

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11

Jul 2017

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

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03

Jul 2017

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

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27

Jun 2017

Assessments were directed by national HTA body AGENAS. They cover renal denervation for hypertension, next generation sequencing in oncology, robotic surgery, sling operation for urinary incontinence and vertebral disc replacement.

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22

Jun 2017

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

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20

Jun 2017

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

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15

Jun 2017

For 19 of the surgical procedures in which laparoscopic techniques are more common, such approach is used in less than 4 out of 10 cases. Differences in levels of use emerged between Northern, Central, and Southern Regions in which the laparoscopic procedures were used less often.

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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

New publication in Obesity Facts provides insights into cost-effectiveness of bariatric surgery in Italy ("Cost-Utility Analysis of Bariatric Surgery in Italy: Results of Decision-Analytic Modelling"). Bariatric surgery was found to be cost effective at 10-year and cost saving at lifetime time horizon.

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08

Jun 2017

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

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06

Jun 2017

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

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05

Jun 2017

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

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31

May 2017

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

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30

May 2017

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

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29

May 2017

An updated form for notification of medical technology to Italian national health technology assessment program has been released in May. Any stakeholder, including industry, can make notification, which will be reviewed and prioritize every six months.

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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

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

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15

May 2017

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

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10

May 2017

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

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09

May 2017

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

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08

May 2017

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

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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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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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27

Apr 2017

Assessment using HTA Core Model framework revealed that technology is safe, but evidence of efficacy is limited.

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26

Apr 2017

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

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24

Apr 2017

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

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19

Apr 2017

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

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