Establishment of an Implants Registry in Germany

02

May 2019

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

The goal of the Registry is to improve the safety and quality of implantations for both privately and publicly health insured. By scientific assessment of the collected data, such as the lifetime of implants in the body, conclusions can be made, inter alias about the quality of the implants and the quality of the implanted devices.

Essential regulations of the EIRD include:

  • The German Institute for Medical Documentation and Information (DIMDI) will take over the central data collection as registrar. The start-up financing will be provided by the federal government, ongoing operations will be financed by fees
  • The Robert Koch Institute will establish an independent trust, which will pseudonymize all personal data
  • The telematics infrastructure will be used for transmitting the data records
  • In order to ensure the validity of the register, the registration will be obligatory for Health Care Institutions, statutory and private health insurances and all patients
  • Manufacturers will be obliged to register their products in the register's product database. In case of implanting device reporting violation or the use of implants, which were not registered in the product database, the law will provide an exclusion of payment
  • Comprehensive transparency requirements are included, such as annual reports from the Registry office and the Federal Institute for Drugs and Medical Devices (BfArM)
  • The expense incurred by the health care institutions due to the obligatory registration will be reimbursed
  • The framework conditions for the data transfer of existing registries are regulated
  • The actual beginning of the reporting obligation for the individual types of implants depends on the existence of all technical prerequisites for the receipt of the registration and will be specified by corresponding ordinance
  • It is expected that hip and knee endoprostheses and breast implants will be the first ones registered from mid-2021

The bill also contains provisions to speed up the procedure of the Federal Joint Committee (G-BA) for the evaluation of examination and treatment methods in contracted care. For this purpose, the previous timeframe for the G-BA will be shortened from three to two years.

The law does not require the approval of the Federal Council. The announcement is scheduled for the end of the current year. In addition to the law, a statutory ordinance will be worked out in order to regulate details of the Implant Registry operation.

The full details in German can be found here.

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06

Feb 2020

The Federal Joint Committee (G-BA) has updated the nationwide requirements for disease management programs (DMP) for patients with type 1 diabetes mellitus. The current DMP contracts must then be adjusted to the new requirements within one year of the decision coming into force. Around 225,000 legally insured patients are currently enrolled in a DMP for type 1 diabetes.

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04

Feb 2020

In January 2020, the Reimbursement Commission made changes to the Healthcare Implementation Communique in Turkey. The main changes relate to the addition of new laboratory test codes, procedure codes, new devices related to the ophthalmology, and price changing of materials related to interventional radiology.

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03

Feb 2020

The HTA unit of the Lombardy region opens the possibility for the public to comment on the health technologies which are in the assessment phase. The call is open until February 28, 2020.

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30

Jan 2020

From January 2020, the "Oncotype DX Breast Recurrence Score" test is reimbursed by the health insurance companies at an extra budget of 3,296.50€. This is explicitly the only test that the Federal Joint Committee (G-BA) has included in the contracted medical care.

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29

Jan 2020

New material code for a set of nets for the repair of prolapse (for vaginal placement) was added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in January 2020.

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27

Jan 2020

The Swiss Services Ordinance (KLV/OPre) is the document that defines the health care services which are covered by the compulsory health insurance in Switzerland. It is updated annually (with more frequent updates possible); thus, the 2020 version is released. Changes concern autologous transplantation of chondrocytes, extracorporeal photopheresis, transcatheter aortic valve implantation, ultrasound therapy focused on the pallidum, thalamus and subthalamus, CAR-T cell therapies, tomography with positron emission (PET/CT), stereotactic radiation therapy (photons) of wet age-related macular degeneration.

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22

Jan 2020

With a regional decree of December 18, 2019, Tuscany Regional Healthcare has published assessments of thirteen medical devices belonging to various therapeutic areas.

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21

Jan 2020

The Clinical Coding and Schedule Development (CCSD) group develops and maintains procedural and diagnostics nomenclature for private payers in England. New procedure codes concern removal of pectus bar, open surgical correction of pectus deformity of the chest wall, intradermal injection into the scalp, nerve and neurolytic root block with or without image guidance, facet joint injection with or without image guidance and diagnostic code for gustatory testing. The codes are introduced with a recommended adoption date being the 1st of May 2020. The documents also contain a list of textual changes in codes, unacceptable combinations, and inactivated codes.

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20

Jan 2020

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

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16

Jan 2020

New material codes for implantable non-rechargeable neurostimulator, electrodes, and extensions for stimulation of the dorsal root nodes were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in December 2019.

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13

Jan 2020

In mid-December 2019, the Swiss Federal Department for Home Affairs (FDHA) has decided that two new autologous cell therapies (CAR-T therapies) for the treatment of leukemia and lymphoma will be reimbursed by compulsory health care insurance.

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06

Jan 2020

At the start of the organized program for the early detection of cervical cancer on January 1, 2020, several new services will be added to the EBM (Einheitlicher Bewertungsmaβstab, German Uniform Evaluation Standard).

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30

Dec 2019

On November 7, 2019, the Nomenclature was updated. The update brought changes in chapter V of Nomenclature, regarding the creation of new codes and modification of existing codes.

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25

Dec 2019

In December 2019, the Swiss Medical Tariff Commission (MTK/CTM) has published their recommendations regarding the knee Autologous Chondrocyte Implantation (ACI). The CTM recommends covering the costs of the implant for knee ACI until the end of 2024.

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20

Dec 2019

At the end of November 2019, the company in charge of the development of the DRG system in Switzerland, SwissDRG SA, has announced the tariff versions (2020/2020) of the DRG and the add-on reimbursement catalog.

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16

Dec 2019

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

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12

Dec 2019

With the support of Aaron.ai, the first health application from the project “KBV Future Practice” ("KBV-Zukunftspraxis") was launched in Germany. About 50 medical practices are now testing the smart telephone assistant in their daily work. The evaluation of the practical tests is carried out by the Charité.

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10

Dec 2019

The Clinical Coding and Schedule Development (CCSD) group develops and maintains procedural and diagnostics nomenclature for private payers in England. New procedure codes concern injection eustachian tuboplasty, extracorporeal shockwave therapy for carpal tunnel syndrome, robotic-assisted laparoscopic excision of recto-vaginal endometriosis, and diagnostic codes for alpha-melanocyte stimulating hormone, NK cell inhibition panel, XR whole spine, and others. The codes are introduced with a recommended adoption date being the 1st of February 2020. The documents also contain a list of textual changes in codes, unacceptable combinations, and inactivated codes.

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05

Dec 2019

In late October 2019, the DIMDI (German Institute of Medical Documentation and Information) has published the final version of the OPS 2020 (Operation and Procedure Keys). The OPS, together with the ICD-10-GM (International Statistical Classification of Diseases and Related Health Problems, 10th revision, German Modification) forms the basis for the reimbursement systems in outpatient and inpatient care.

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02

Dec 2019

The National disease management guideline for chronic heart failure with recommendations for diagnostics and therapy has been revised. It is now available free of charge on the internet pages of the Medical Center for Quality in Medicine.

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29

Nov 2019

On September 16, 2019, the Nomenclature was updated. The update brought changes in chapter V of Nomenclature, regarding the creation of new codes and modification of existing codes.

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27

Nov 2019

On behalf of the Federal Joint Committee (G-BA), the Institute for Quality and Efficiency in Health Care (IQWiG) investigated whether wearing a lower jaw protrusion splint (Unterkieferprotrusionsschiene, UPS) is beneficial for obstructive sleep apnea.

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22

Nov 2019

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

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21

Nov 2019

In order to promote the video consultations, the National Association of Statutory Health Insurance Physicians (KBV) and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) have agreed on several new regulations. Thus, a video consultation will also be possible if the patient has not been previously treated by the doctor. For psychotherapies, the video consultations were reopened.

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14

Nov 2019

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

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12

Nov 2019

The Clinical Coding and Schedule Development (CCSD) group develops and maintains procedural and diagnostics nomenclature for private payers in England. New procedure codes concern scar revision, robotic-assisted thymectomy, prophylactic oophorectomy/ hysterectomy, percutaneous electrical nerve stimulation, delivery of fraction of proton beam therapy for non-ocular adult tumors and diagnostic codes for myriad breast and ovarian cancer panel 101 test, clinical exome sequencing MPLA test, and others. The codes are introduced with a recommended adoption date being the 1st of February 2020. The documents also contain a list of textual changes in codes and inactivated codes.

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11

Nov 2019

On the 19th of September 2019, the Federal Joint Committee (G-BA) concluded on the possible applications and limits of non-invasive molecular genetic tests (NIPT) at the expense of the statutory health insurance (SHI). The decision provides that a NIPT can be used in justified individual cases and after medical consultation.

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07

Nov 2019

In late September 2019, the DIMDI (German Institute of Medical Documentation and Information) has published the final version of the ICD-10-GM 2020 (International Statistical Classification of Diseases and Related Health Problems, 10th revision, German Modification).

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01

Nov 2019

New material codes for an implantable sensor for continuous measurement of glucose in interstitial fluid and embolization equipment were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in October 2019.

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31

Oct 2019

Reimbursement of optical coherence tomography (OCT) for diagnosis and therapy control in retinal diseases will be available from October 2019 via the EBM (Einheitlicher Bewertungsmaβstab, German Uniform Evaluation Standard).

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28

Oct 2019

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

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24

Oct 2019

On behalf of the Federal Joint Committee (G-BA), the Institute for Quality and Efficiency in Health Care (IQWiG) investigated whether a systematic test of newborns for sickle cell disease (SCD) in Germany would make sense.

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17

Oct 2019

The insurance company AOK Saxony-Anhalt concluded that patients are much less frequently prescribed an antibiotic after the examination via a rapid test for a bacterial cause of the infection. In more than 40% of the tested patients, the doctors waived the antibiotics prescription.

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14

Oct 2019

The German Research Foundation (DFG) has launched a new Artificial Intelligence (AI) imaging priority program "Radiomics: Next Generation Medical Imaging" (“Radiomics: Nächste Generation der medizinischen Bildgebung”). More than 8 million euros will flow into the program in the next three years. The program will be coordinated by the University Hospital Freiburg.

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11

Oct 2019

New material codes for extraction catheters were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in September 2019.

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10

Oct 2019

The fee negotiations for the coming year are over - the National Association of Statutory Health Insurance Physicians (KBV) and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) agreed on an increase in the monetary conversion factor for all medical and psychotherapeutic services in the amount of 1.52 percent. GKV-Spitzenverband and KBV have also agreed to sponsor the video consultations.

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08

Oct 2019

After a long time since the introduction of Healthcare Implementation Communique (SUT) for the first time (2007), the Reimbursement Commission made important changes to the SUT. The main changes relate to higher reimbursement fees for medical devices (reimbursement fees increased depending on the category from 5% to 100%).

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03

Oct 2019

In order to diagnose pre-eclampsia in pregnancy, two new markers were included in the EBM catalog in early October 2019. The statutory health insurances then will take over the costs for the determination of the PIGF concentration and the sFlt-1 / PIGF quotient. In addition, another tumor marker for ovarian cancer will be included in the EBM.

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30

Sep 2019

At the beginning of August 2019, North Rhine-Westphalia presented the plans for “Virtual Hospital,” a digital platform that will bundle specialist expertise nationwide and make it more accessible.

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26

Sep 2019

A positive conclusion regarding the model project “Rhineland-Palatinate breathes through - telemedicine for healthy lungs” (“Rheinland-Pfalz atmet durch – Telemedizin für eine gesunde Lunge”) was drawn by the Mainz Ministry of Health.

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23

Sep 2019

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

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19

Sep 2019

The Institute for Quality and Efficiency in Health Care (IQWiG) has presented its second final report on the benefit assessment of vacuum therapy in wounds healing. The previous final report for vacuum therapy in the wounds healing by secondary intention was published by IQWiG in late March 2019.

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13

Sep 2019

Patients suffering from recurrent or long-lasting depression can be treated within a structured treatment program (Disease Management Program, DMP) in the future. The Federal Joint Committee (G-BA) decided on the 15th of August 2019 the details on the content of the new DMP after more than three years of consulting.

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10

Sep 2019

At the beginning of August 2019, the Dutch Healthcare Institute (Zorginstituut Nederland, ZIN) has published an Overview of the applications of healthcare products and activities for conditional entry into the Basic Insurance Package. Two applications for heated intraperitoneal chemotherapy in ovarian cancer and GAG therapy in bladder pain syndrome were considered.

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06

Sep 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 hip replacement, endoscopic ablation, multiple arthroscopic operations on the ankle, collagen paste for closing an anal fistula and diagnostic codes for tests for next generations sequencing molecular intelligence, and others. The codes are introduced with a recommended adoption date being the 1st of November 2019. The documents also contain a list of textual changes in codes, inactivated codes, and an updated list of unacceptable combinations of codes.

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29

Aug 2019

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

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26

Aug 2019

New material codes for hearing aids were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in August 2019.

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22

Aug 2019

With the preventive program for pregnant women, "Hello Baby," premature births and infection-related birth complications should be minimized. Now, the program has been established nationwide: 60 health insurance companies offer to their approximately 6.5 million insured since July 1, 2019, the additional tests contained therein.

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15

Aug 2019

Domestic use of motor-driven moving splints (continuous passive motion, CPM) after interventions at the knee or shoulder joint remains covered by statutory health insurance. This has been determined by the G-BA (the Federal Joint Committee).

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12

Aug 2019

The test for severe combined immunodeficiencies (SCID) is part of neonatal screening since July 1, 2019, in Germany. At the beginning of July 2019, the Swedish National Board of Health and Welfare (Socialstyrelsen) has stated that health care should offer screening for the severe combined immunodeficiency (SCID) as approximately two or three children per each year can be diagnosed and treated for the fatal disease with the test available.

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09

Aug 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 mastectomy and immediate reconstruction of the breast, coronary intravascular lithotripsy, angioplasty, insertion of a stent, portal vein embolization, and others and diagnostic codes for tests for primary hyperoxaluria panel, myeloid panel, and hereditary angioedema. The codes are introduced with a recommended adoption date being the 1st of August 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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26

Jul 2019

On July 12, 2019, the Swiss Medical Tariff Commission (MTK/CTM), announced that the new tariff structure for the ambulatory sector, TARDOC, is ready to replace TARMED. The Medical Professional Association (FMH) and curafutura, the other involved partners, delivered TARDOC to the Federal Council for approval. The entry into force is scheduled for January 1, 2021.

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25

Jul 2019

Glioblastoma is an aggressive brain tumor with a low survival rate, usually occurring in late adulthood. The standard treatment consists of surgery, followed by radiation and chemotherapy. The Institute for Quality and Efficiency in Health Care (IQWiG) has examined possible benefits of tumor-treating field (TTF) therapy - new treatment based on electrostimulation in patients with glioblastoma.

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22

Jul 2019

The reimbursement for the partial surgical removal of enlarged palatal tonsils has now been confirmed. Thus, contract physicians can bill this service from July 1, 2019. A decision to amend the EBM has been taken by the Valuation Committee.

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18

Jul 2019

In late June 2019, the Federal Joint Committee (G-BA) took its first decision on the use of biomarker-based tests. Patients with breast cancer in the early stages, in which the risk of relapse cannot be determined with certainty, can be provided in the future with a biomarker test as a statutory health insurance (SHI) benefit.

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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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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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28

Jun 2019

The German Institute for Quality and Efficiency in Health Care (IQWiG) has investigated whether patients suffering from non-Hodgkin lymphoma have (better) chances of recovery in case of allogeneic stem cell transplantation. IQWiG concluded that the benefit of allogeneic SCT is unclear.

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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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21

Jun 2019

On the 7th of May 2019, the new evaluation for bone-anchored prosthesis has been commenced in a framework of New Method, which provides a way for a managed introduction of innovations into Norwegian health care system. The proposal for the assessment was submitted by Oslo University Hospital in order to receive an opportunity to offer this method to achieve overall money saving and medical benefits as nowadays, only conventional prostheses are offered, and patients are sent to Gothenburg to receive the treatment, that is financed by the Norwegian health service.

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20

Jun 2019

Disease management programs (DMPs) should be updated on a regular basis in order to adapt them to the current medical knowledge level. The Institute for Quality and Efficiency in Health Care (IQWiG) has thus researched current evidence-based guidelines on diabetes mellitus type 2, summarized their recommendations and checked the need for DMP update.

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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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07

Jun 2019

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

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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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30

May 2019

The Federal Joint Committee (G-BA) has signed a further contract for scientific monitoring and implementation of a trial study for NYHA III heart failure therapy optimization by means of continuous blood pressure measurement and monitoring using an implanted sensor in the pulmonary artery.

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29

May 2019

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

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29

May 2019

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

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28

May 2019

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

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27

May 2019

Statutory health insured with chronic back pain can benefit in the future from a structured treatment program (Disease Management Program, DMP), as the Federal Joint Committee (G-BA) outlined on 18th of April the substantive requirements for the new DMP.

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24

May 2019

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

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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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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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16

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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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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09

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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07

May 2019

NHS England is inviting nominations for additions to, and removals from, the high-cost drugs and devices lists for the next national tariff come into effect in April 2020. All submissions must be submitted by May 31, 2019.

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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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01

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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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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29

Apr 2019

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

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25

Apr 2019

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

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24

Apr 2019

In April 2019, the Catalan Agency for Quality and Healthcare Evaluation, AQuAS, published a quick report with indication criteria for cochlear implants in children.

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18

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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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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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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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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20

Mar 2019

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

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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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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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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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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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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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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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14

Dec 2018

In mid-November, 2018, the European HTA agency, EUnetHTA, published the ultimate project plan of the assessment on “Custom-made or customizable 3D printed implants and cutting guides versus non-3D printed standard implants and cutting guides for improving outcome in patients undergoing knee, maxillofacial, or cranial surgery”.

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13

Dec 2018

In mid-November, 2018, the Catalan Agency for Quality and Healthcare Evaluation, AQuAS, published their evaluation of bilateral cochlear implants in children and adults. The authors provided a list of criteria a patient has to fulfil in order to have a cochlear implant prescribed.

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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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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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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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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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21

Nov 2018

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

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20

Nov 2018

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

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16

Nov 2018

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

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08

Nov 2018

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

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07

Nov 2018

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

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01

Nov 2018

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

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30

Oct 2018

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

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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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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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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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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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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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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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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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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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09

Aug 2018

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

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07

Aug 2018

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

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06

Aug 2018

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

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02

Aug 2018

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

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01

Aug 2018

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

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27

Jul 2018

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

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26

Jul 2018

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

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24

Jul 2018

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

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23

Jul 2018

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

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20

Jul 2018

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

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17

Jul 2018

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

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05

Jul 2018

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

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04

Jul 2018

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

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04

Jul 2018

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

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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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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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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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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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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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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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16

May 2018

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

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14

May 2018

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

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11

May 2018

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

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10

May 2018

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

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08

May 2018

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

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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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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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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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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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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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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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30

Mar 2018

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

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28

Mar 2018

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

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26

Mar 2018

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

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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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13

Nov 2017

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

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03

Nov 2017

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

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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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31

Jul 2017

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

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25

Jul 2017

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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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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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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19

Jul 2017

Researchers evaluated care process, access, administrative efficiency, equity and health care outcomes in 11 countries on the basis of published health care statistics for 72 indicators. The best overall performers among European countries were the UK (ranked 1st), the Netherlands (3rd), Norway (4th), Sweden and Switzerland (6th). Germany (8th) and France (10th) were low in the ranking.

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18

Jul 2017

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

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17

Jul 2017

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

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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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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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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

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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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

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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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

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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01

May 2017

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

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26

Apr 2017

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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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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