In-vitro diagnostic tests
16
Mar 2023
MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Horgan et al. completed a survey of the status of Next-Generation Sequencing (NGS) in Europe and globally. Based on the feedback from 62 experts, a framework for implementation of the NGS is proposed along with in-depth discussion about current aspects of demand-and supply-side issues, governance and strategy, clinical standardization, awareness and education, equipment used, reimbursement and funding.
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08
Mar 2023
On February 23, 2023, the Innovation Committee at the Federal Joint Committee (G-BA) published the decisions, recommending the transfer to standard care for another three completed projects. The projects relate to preventing the family risk of colorectal carcinoma, shared decision-making in the hospitals, and digitally supported drug therapy management.
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03
Mar 2023
In February 2023, the National Institute for Health and Disability Insurance (INAMI-RIZIV) announced the completion of a pilot project for gene expression profiling (GEP) tests in early-stage breast cancer, which ran from 2019. The pilot showed significant benefits, and INAMI-RIZIV launched a reimbursement for certain tests under the specific agreement (GEP convention) with healthcare providers.
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24
Feb 2023
In February 2023, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclatures for private payers in England, published Bulletins 188 and 084 with changes to be implemented no later than March 23, 2023. Five new procedure codes (concerning interventional radiology, robotic surgery, and radiotherapy) and one new diagnostic code were introduced.
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13
Feb 2023
On January 31, 2023, the Order approving Addendum 11 to the National Convention for Laboratory Directors was published in the Official Journal of the French Republic. The Addendum implements financial measures provided for by the Social Security Financing Act – reduces the reimbursement tariffs for the tests registered in the main reimbursement catalog for IVD tests in France Nomenclature of Medical Biology Acts (NABM).
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10
Feb 2023
On January 24, 2023, the Swedish National Board of Health and Welfare recommended introducing a national screening program for spinal muscular atrophy (SMA) in newborns. It will identify children with a homozygous deletion in the SMN1 gene and 1–3 copies of the SMN2 gene. SMA testing must be included in the existing newborn screening (so-called PKU test). The launch of the new screening program is expected in the summer of 2023.
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08
Feb 2023
On January 23, 2023, the Norwegian Directorate of e-Health released an updated version of the National Laboratory code (NLK) system and associated tariffs for state and private laboratories to be implemented no later than March 1, 2023. Twenty-four new codes were added, 179 codes were changed, and 23 codes were terminated.
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16
Jan 2023
The revised EBM (German Uniform Evaluation Standard) catalog came into force on January 1, 2023. The most significant changes concern introducing the EBM codes for several IVD tests and further promoting outpatient (day case) surgical services.
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12
Jan 2023
In December 2022, the National Institute for Health and Care Excellence (NICE) published one new Medical Technologies Guidance (Memokath 051 Ureter stent for ureteric obstruction) and one MedTech Innovation Briefing (PromarkerD). Also, two new clinical guidelines were published, and one was updated.
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06
Jan 2023
On December 16, 2022, a decision of the National Union of Health Insurance Funds (UNCAM) relating to the update of the NABM Nomenclature for IVD tests was published in the Official Journal of the French Republic. Various changes were introduced, including the inclusion of new codes, modifications of the existing ones, and tariff changes.
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13
Dec 2022
On November 23, 2022, the Norwegian Directorate of e-Health released an updated version of the National Laboratory code (NLK) system and associated tariffs for state and private laboratories to be implemented no later than January 1, 2023. Eighty-six new codes were added, 207 codes were changed, and 27 codes were terminated.
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05
Dec 2022
On November 17, 2022, the Ministry of Health and Prevention published the Order in the Official Journal of the French Republic on the extension of the national newborn screening by laboratory diagnostics to seven more diseases (inborn errors of metabolism).
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