In-vitro diagnostic tests

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.

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.

Predictive Analysis for Therapy (PATH) is a major collaborative project to optimize molecular predictive diagnostics in the Netherlands. The project focuses on the molecular analyses that are important for the treatment choice of cancer patients.

In June 2019, the Dental and Pharmaceutical Benefits Agency (TLV) has published a completed health economic evaluation regarding the cost-effectiveness of the comprehensive genomic profiling test for all solid tumors FoundationOne CDx. TLV believes that in most cases, the use of FoundationOne CDx is more expensive in comparison to current treatment methods. However, it has greater sensitivity and accuracy in the diagnostics.

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.

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.

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.

In April 2019, the Andalusian Agency for Evaluation of Health Technologies, AETSA, has released a report updating the map of genetic tests available in the Spanish National Health System.

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).

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.

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.

In Finland, the Health Care Services Selection Council is responsible for making recommendations regarding the research, treatment and rehabilitation methods. Currently, PALKO is working on the only one assessment related to in-vitro diagnostics - screening for a Serious Combined Immune Deficiency (SCID) from newborn heel. In final report, the Council will conclude whether the procedure is a part of publicly funded services or not.