Reimbursement

Transitional coverage of certain products and services (prise en charge (PEC) transitoire), according to article L165-1-5 of the Social Security, is a newly-established pathway to obtain reimbursement for CE-marked medical devices intended for the treatment of rare or serious diseases, or compensation for a disability. The coverage is provided for 12 months with an opportunity for renewal before submitting an application for inclusion in the List of Reimbursable Products and Services (LPPR).

In late May 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 0177 and 0074 with changes to be implemented not later than August 01, 2021. Five new procedure codes related to diagnostic imaging, ENT, breast reconstruction, and gynecology, and nine new diagnostic codes were introduced.

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in May 2021. Recommendations concern orthopedic devices, cardiovascular, peripheral vascular, and neurovascular devices, medical aids, and pulmonary artery pressure sensor.

The application portal for inclusion in the Health App Directory at the Federal Office for Drugs and Medical Devices (BfArM) in Germany has been online since May 27, 2020. The first reimbursable health apps were introduced on the Directory in early October 2020. As of May 27, 2021, a total of 74 applications were received, 51 of which for provisional listing and 23 for final listing. Fifteen applications (20%) were introduced on the Directory.

In late April and early May 2021, three more health apps were introduced in the Directory of digital health applications (DiGAs) at the Federal Office for Drugs and Medical Devices (BfArM) and thus became reimbursable. These apps can be prescribed by physicians and psychotherapists and will be reimbursed by health insurers. In total, fifteen health apps are now available at the DiGA Directory.

Transcatheter aortic valve implantation (TAVI/TAVR) in severe aortic stenosis treatment across all surgical risk groups was being evaluated within the "New Methods" framework since 2019. On April 26, 2021, the Decision Forum for "New Methods" made a positive coverage decision for TAVI/TAVR to treat patients with severe aortic stenosis across all surgical risk groups.

In April 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 0176 and 0073 with changes to be implemented not later than August 01, 2021. Four new procedure codes related to men's health and breast surgery and one new companion diagnostic code were introduced.

On April 22, 2021, the List of reimbursable implants and invasive medical devices, maintained by the National Institute for Health and Disability Insurance (INAMI), was updated with the corresponding Nominative lists of brand-specific devices. Two new Nominative lists with reimbursable devices used for peripheral vascular interventions were introduced.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on April 1, 2021. Two new EBM codes for IVD tests were introduced, and reimbursement conditions for two IVD tests were amended.

On March 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 not later than May 01, 2021. NLK system is used for activity-based reimbursement by the Norwegian Health Economics Administration (Helfo) in outpatient settings since 2018.Thirty-four new codes were added in medical biochemistry and medical microbiology areas.

On March 17, 2021, NHS Digital released HRG4+ 2021/22 Local Payment Grouper. In general, there were no significant changes in the HRG logic for 2021/22, and no new HRGs were introduced. Two new ICD-10 codes for COVID-19 were incorporated into the grouping logic in addition to three codes already included in the consultation grouper. Furthermore, three new Main Speciality Codes (MSC) and 25 new Treatment Function Codes (TFC), which were introduced in April 2020, became mandatory to use in Grouper from April 2021. These codes concern a wide specter of areas of care.