Medical devices

On January 20, 2022, the Federal Joint Committee (G-BA) has initiated an evaluation procedure for early benefit assessment for the use of a stent retriever (pRELAX by femtos) to treat vasospasm of cerebral arteries after subarachnoid hemorrhage.

On December 9, 2021, the Danish Treatment Council (Behandlingsråd), during its meeting, approved three topics selected for developing the so-called major analyses (større analyser) in 2022. The approved topics include handheld focused ultrasound in emergency medicine, artificial intelligence (AI) as decision support for colonoscopy, and intelligent/high-tech beds for use in intensive care units.

In early-mid November 2021, the Federal Joint Committee (G-BA) has initiated an evaluation procedure for early benefit assessment for two new cardiovascular technologies (Revivent TC™ by BioVentrix and Trilogy™ Heart Valve System by JenaValve Technology) in heart failure, and aortic valve insufficiency and stenosis, respectively.

In late October 2021, the Treatment Council (Behandlingsråd) published three topics chosen for developing the so-called major analyses (større analyser) in 2022. The selected topics include patient-centered diabetes technology, hand-held focused ultrasound in emergency medicine, and artificial intelligence as decision support for colonoscopy.

Since October 2021, it is necessary to have the unique device identifier (UDI) of the various models and commercial references of the devices currently on the "intra-DRG" list in order to make it possible to collect and transmit the information relating to the use of these devices in health care establishments.

On September 1, 2021, the Institute for Hospital Remuneration Systems (INeK) announced the start of the application process according to §6 (2) KHEntgG (New Examination and Treatment Methods, NUB) for 2022.

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.