In-vitro diagnostics

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.

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.

Health Information and Quality Authority (HIQA) develops national HTA guidelines to support decision-making in Ireland. In the third quarter of 2021, Health Information and Quality Authority published three reports in relation to in-vitro diagnostics, including newborn bloodspot screening, tests for hepatitis C and SARS-CoV-2.

In August 2021, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (magnetic resonance therapy for knee osteoarthritis, laparoscopic removal of uterine fibroids with power morcellation, hysteroscopic mechanical tissue removal for uterine fibroids), and six new Medtech Innovation Briefings (PLASMA system with button electrode, Immunoscore, MMprofiler, Patient Status Engine, lung texture analysis, Colli-Pee). Also, five clinical guidelines were published.

In August 2021, NHS announced rolling out genetic testing for monogenic diabetes and placental growth factor (PLGF) testing to rule out pre-eclampsia. These decisions are made in line with the NHS Long Term Plan committed to increasing access to genomic testing, improving diabetes care across the country, and investing in cutting-edge technologies.

On August 17, 2021, the National Institute of Public Health released a rapid HTA report on the evaluation of PD-L1 assays in urothelial carcinoma commissioned by the Ordering Forum. This assessment does not provide any conclusions on the effectiveness of various treatment strategies in the treatment of urothelial carcinoma in adults.