Medical devices

Certain medical devices are financed within the DRG tariff but require explicit review to ensure that they are safe and effective. This mechanism is called “intra-DRG” (intra-GHS) coverage. On August 5, 2021, the new version of the intra-DRG list was published by the French Ministry of Solidarity and Health. No new devices were added to the list compared to the version of November 2020.

On July 16, 2021, NICE announced a new approach to prioritizing requests for NICE Scientific Advice. Because of the increased engagement, the waiting time for new scientific advice projects is currently several months. To address this, from December 2021, NICE will reserve priority slots in the work plan for companies developing high-priority technologies for the NHS.

On January 29, 2021, the Institute for the Hospital Remuneration System (InEK) has published the List of the requests for innovation funding (NUB) that were submitted by the hospitals in 2020. The medical technologies belonging to the cardiovascular, ENT, eHealth, gastrointestinal, neuromodulation, neurovascular, orthopedic, and other technology groups obtained positive status 1.

In November 2020, the National Institute for Health and Care Excellence (NICE) published one new interventional procedure guidance (for swallowable gastric balloon capsule for weight loss), five Medtech innovation briefings (for QuickChange Incontinence Wrap for urinary incontinence in men, Magseed for locating breast cancer lesions, Dexcom G6 for continuous glucose monitoring, and others). Also, one clinical guidance (for acute coronary syndromes) was updated.

New material codes and related conditions of reimbursement for anchoring and fixation implants for soft tissue were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in August 2020.

New material codes and related conditions of reimbursement for middle ear implants were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in August 2020.

In July 2020, new material code and related conditions of reimbursement concerning the endoscopic treatment of primary or secondary vesicoureteral reflux were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV).

New material codes and related conditions of reimbursement for an isolated iliac bifurcation endoprosthesis were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in June 2020.

In late April 2020, the European Parliament has postponed the come-into-force of the EU Medical Device Regulation (MDR) by one year. Medical devices can thus be placed on the market for another year under the previous regulations. The end date of the transition period will remain May 26, 2024.

New material codes for a locking stylus for extraction of endovenous electrodes and system with recovery lasso for the extraction of endovenous electrodes by femoral approach were added to the List of reimbursable devices of the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) in April 2020. Some reimbursement conditions were updated as well.

The Italian association of medical technology manufacturers, CONFINDUSTRIA dispositivi medici, published the results of a study in which they studied the average time the supplier of medical devices has to wait to get an invoice paid by the Italian hospitals. The differences vary between 35 days and 504 days.

On January 30, 2020, the Institute for the Hospital Remuneration System (InEK) has published the List of the requests for innovation funding (NUB), submitted by the hospitals until October 31, 2019. Out of 778 technologies, 201 (26%) received the positive status 1, which means that the evaluated procedure or medical device meets the NUB criteria and allows the hospitals to negotiate with the sickness funds for the innovation funding for these technologies.