On December 26, 2021, the new health app was 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, 28 health apps are now available at the DiGA Directory.

On December 17, 2021, the Belgian Health Care Knowledge Center (KCE) published a health services research report “Evidence gaps for drugs and medical devices at market entry in Europe and potential solutions”. In this report, KCE examined the lack of comparative evidence health technology assessment (HTA) agencies and payers face in evaluating new medicinal products and high-risk medical devices at market entry.

On January 14, 2022, the Government of the Russian Federation released a Decree which approved the inclusion of three devices (implantable pulse generator for urinary/fecal incontinence, bioprosthetic aortic valve/xenoprosthesis, and vessels embolization material) in the List of Essential Implantable Medical Devices.

In December 2021, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclatures for private payers in England, published Bulletins 0181 and 0078 with changes to be implemented no later than February 01, 2022. Seven new procedure codes and four new diagnostic codes were introduced.

In spring 2022, a new reimbursement system for remote consultations will be launched with new reimbursement codes and conditions.

In December 2021, the National Institute for Health Research (NIHR) in England released two MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned improving continence in children and young people with neurodisability, and augmented trabeculectomy in glaucoma. 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.

In December 2021, nineteen clinical guidelines relating to cardiovascular, gastrointestinal, men’s health, peripheral vascular, and other disease areas were released in Russia.

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 December 2021. More than 15 recommendations were published in relation to the registration, modification of registration conditions, renewal of registration of devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular, orthopedic, ENT devices, as well as medical aids. Except for this, CNEDiMTS published an opinion about transitional coverage (a newly established pathway for reimbursement) for a cardiovascular device.

In December 2021, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (endobronchial nerve ablation for chronic obstructive pulmonary disease and transanal total mesorectal excision for rectal cancer), two new Medical Technologies Guidance (ClearGuard HD antimicrobial barrier caps, and Endo-SPONGE for treating low rectal anastomotic leak), and one new Medtech Innovation Briefings (FreeO2 automatic oxygen titration). Also, one new clinical guideline was published, and five were updated.

Dutch Healthcare Authority (NZa) has issued a draft release of the DRG package for 2023, including a new procedure code for intermittent pneumatic compression therapy, a new diagnosis code for guidance in early pregnancy after a fertility program, and several new DRGs for pediatric palliative care, lymphovenous anastomosis surgery and light therapy in inflammatory dermatoses.

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 mid-December 2021, 44 new procedure codes were introduced by the Code Service of the Finnish National Health and Wellbeing Institution (THL). The introduced codes are dedicated to substance abuse, psychological counseling and rehabilitation, palliative care, anesthesia, and sedation. No updates related to medical technologies were introduced.