In-vitro diagnostic tests

12

Nov 2020

In late October 2020, the BfArM (Federal Institute for Drugs and Medical Devices) has published the final version of the OPS 2021 (Operation and Procedure Keys) system. 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. Read more

03

Nov 2020

NHS England has opened a consultation on the proposed approach to updating the National Genomic Test Directory set out in the consultation document. The deadline for comments submission is November 17, 2020. Read more

28

Oct 2020

In mid-October 2020, the Federal Joint Committee (G-BA) has decided that three more biomarker-based tests in breast cancer will be covered by the statutory health insurance. Since January 2020, the "Oncotype DX Breast Recurrence Score" test is already reimbursed in Germany with a tariff of €3,296.50. Read more

22

Oct 2020

The revised EBM (German Uniform Evaluation Standard) catalog for ambulatory reimbursement in Germany came into force on October 1, 2020. MTRC has compiled the selection of the most significant changes, concerning In-vitro diagnostics, telemedicine and vacuum wounds therapy. Read more

04

Aug 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 planning, insertion, and removal of high/low dose rate radioactive treatment (brachytherapy) into a prostate tumor, open/laparoscopic repair of Spigelian hernia, and others. The codes are introduced with a recommended adoption date being the 1st of August 2020. The document also contains a list of textual changes in codes and unacceptable combinations. There were no changes to the CCSD Schedule of Diagnostic Tests. Read more

29

May 2020

As part of efforts to increase the effectiveness of measures to prevent the spread of coronavirus infection, the Ministry of Health of Russia informed suppliers, manufacturers and executive authorities that, subject to the rules for submitting documents for registration of medical devices intended for the diagnosis of coronavirus infection, their registration will be carried out as soon as possible deadlines. Read more

25

May 2020

MTRC has released the new video on the Market Access Insider Youtube channel. Oleg Borisenko spoke to Mr. Andrea Zanella, CEO of DIANAX S.r.l. about market access for in-vitro diagnostic tests in Italy. Read more

09

Apr 2020

MTRC released the report on reimbursement of diagnostic testing for COVID-19 in six European countries (Belgium, France, Germany, Netherlands, Switzerland and Turkey). The report includes information about the availability of reimbursement, types of tests reimbursed, testing criteria. Download sample pages to assess the relevance of the report. Read more

25

Mar 2020

In February 2020, the Andalusian Health Technology Assessment Department published an assessment report on the evaluation of validity, clinical utility, and safety of the next-generation sequencing genomic platform FoundationOne® in non-small cell lung cancer and other solid tumors. It was observed that it is necessary to carry out new studies to confirm the diagnostic results and the clinical usefulness of the test due to the low quality of existing evidence. Read more

23

Mar 2020

Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) has issued an agreement document on March 17, 2020, providing principles for billing and funding the Coronavirus (COVID-19) Detection Tests. Previously in Protocol for Hospitals on March 10, 2020, it was outlined that COVID-19 tests performed outside the National Reference Center for Respiratory Pathogens at UZ Leuven have no specific nomenclature codes, and no reimbursement was provided, therefore, was paid by patients. The new agreement clarifies principles for reimbursement, but the invoicing for the tests still on hold. Read more

28

Feb 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 repair of femoral hernia requiring removal of previously inserted mesh, transurethral non-ablative radiofrequency of bladder, minimally invasive mitral valve repair, two-stage revision of total hip replacement for infection and others. The codes are introduced with a recommended adoption date being the 1st of May 2020. The document also contains a list of textual changes in codes, unacceptable combinations, and inactivated codes. There were no changes to the CCSD Schedule of Diagnostic Tests. Read more

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. Read more