In-vitro diagnostic tests

In late November 2021, the INeK (Institute for the Hospital Remuneration System) has published the DRG catalog (Fallpauschalen-Katalog) with the list of DRGs and add-on reimbursement categories (ZEs) for 2022. Seven new DRGs and seventeen ZE categories were added to the catalog in 2022.

In November 2021, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclature for private payers in England, has published Bulletins 0180 and 0077 with changes to be implemented no later than February 01, 2022. Four new procedure codes related to neurology, spinal procedures, cancer pharmacotherapy, and ophthalmology, and three new diagnostic codes were introduced.

In October 2021, the Scottish Health Technology Group released two Innovative Medical Technology Overviews for e-health technologies. The topics were asynchronous digital dermatology appointment service (DDAS) and the Dxcover™ Brain Cancer Liquid Biopsy. Regarding DDAS, the authors concluded that the Scottish health boards should provide more data to allow for further performance and economic analyses of the DDAS. Regarding Dxcover™, the SHTG concluded that it was cost-effective, but further work to confirm its accuracy, effectiveness, safety, and cost-effectiveness is required.

In November 2021, the National Board of Health and Welfare released an annual update of the Swedish procedure coding classification (Classification of Health Care Measures, KVÅ) that will come into force in January 2022. KVÅ includes two parts – medical procedures (KMÅ) and surgical procedures (KKÅ) divided into chapters based on anatomical principles. In 2022, six new surgical procedure codes will be introduced. Furthermore, structural changes will be made in Chapter V "Operations on the aorta, peripheral vessels, and lymphatic system," introducing two new sub-chapters with 318 new codes. A total of 53 new medical procedure codes (KMÅ) will be added.

In late October 2021, the BfArM (Federal Institute for Drugs and Medical Devices) has published the final version of the 2022 OPS procedure coding classification. 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.

In late September 2021, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclature for private payers in England, has published Bulletins 0179 and 0076 with changes to be implemented no later than January 01, 2022. Four new procedure codes related to gynecology, robotic surgery in the pulmonology area, and orthopedics, and four new diagnostic codes were introduced.

In October 2021, NHS England issued an updated version of the National Genomic Test Directory for 2021/2022, which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. Twenty new codes (test-indication combinations) were introduced in the cancer field, and 115 new codes were added for rare and inherited diseases.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on October 1, 2021. The most significant changes concern mainly IVD tests: extension of the newborn screening, the introduction of microsatellite instability testing, amendments of Oncotype DX® test reimbursement, the introduction of screening for hepatitis B and C as part of health check-up, as well as changes in reimbursement of radiation therapy services.

On September 15, 2021, the Evaluation Committee (Bewertungsausschuss) has decided to introduce in the EBM (German Uniform Evaluation Standard) the new code for Oncotype DX® testing. This change is introduced in the updated EBM version, which was published on October 1, 2021.

On September 23, 2021, 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 November 01, 2021. NLK system has been used for activity-based reimbursement by the Norwegian Health Economics Administration (Helfo) in outpatient settings since 2018. Thirty-nine new codes were added in medical biochemistry, clinical pharmacology, and medical microbiology areas.

In September 2021, the National Institute for Health Research (NIHR) in England released two MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned non-invasive imaging software for coronary stenosis assessment (QAngio XA 3D/QFR and CAAS vFFR) and quantitative fetal fibronectin test to predict preterm labor. HTA Journal publishes research reports on the effectiveness, costs, and broader impact of health technologies for those who use, manage, and provide care in the NHS and informs National Institute for Health and Care Excellence (NICE) guidance.

The Scottish Health Technologies Group (SHTG) is a national health technology assessment (HTA) agency providing advice to NHSScotland on the use of new and existing health technologies, likely to have a significant impact on healthcare. In the third quarter of 2021, SHTG published only one report in relation to HeartFlow fractional flow reserve computerized tomography (FFRCT). Currently, the SHTG is working on assessments of technologies in the field of diabetes, digital health, surgical procedures, and other topics.