In-vitro diagnostic tests

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

17

Jan 2020

The NHS in England is providing a new form of DNA test capable of quickly diagnosing rare diseases for critically ill babies and children, as part of its Long Term Plan to use world-leading technologies to improve care for the sickest infants. Read more

24

Dec 2019

In November 2019, the National Institute for Health and Care Excellence (NICE) published two new diagnostics guidance (for point-of-care creatinine devices and rapid tests for group A streptococcal infections), one new interventional procedure guidance (for irreversible electroporation for primary liver cancer) and two new MedTech innovation briefings (for Leukomed Sorbact for preventing surgical site infection and AmnioSense for unexplained vaginal wetness in pregnancy). Read more

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. Read more

09

Dec 2019

In Sweden, the Centre for Assessment of Medical Technology (CAMTÖ) leads the development of HTA cooperation in the healthcare region Uppsala-Örebro. In September 2019, CAMTÖ released an HTA report on PD-L1 positivity tested by McAb SP263 to guide immune checkpoint therapy in non-small-cell lung cancer. No safe conclusions could be drawn, but the wide range of positivity rates implies the difficulties in the standardization of PD-L1 expression and the need for better predictive biomarkers. Read more

04

Dec 2019

In November 2019, the two new mini-method assessments for ankyloglossia and rapid testing for chlamydia and gonorrhea were initiated by Oslo University. After the completion of the assessment procedure, the final reports would be available via a mini-HTA database. Read more