Diabetes

Between late May and early September 2023, two 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, 49 health apps are currently available in the DiGA Directory, and six health apps were delisted from the Directory.

On July 07, 2023, the Ministry of Health and Prevention announced the implementation of the transitional period for innovative technologies following the experiment under Article 51 of the Social Security Financing Act.

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 13989 of June 29, 2023, Tuscany Regional Healthcare has published assessments of nine medical devices in the cardiovascular, peripheral vascular, diagnostic imaging areas, and surgical procedures.

On July 1, 2023, the National Institute for Health and Disability Insurance (INAMI-RIZIV) updated the conditions of reimbursement for continuous glucose monitoring (CGM) and intermittently scanned CGM (isCGM, commonly called flash glucose monitoring, FGM). Full coverage by health insurance became available to more patient categories.

In May 2023, the National Institute for Health and Care Excellence (NICE) published one new Interventional Procedure Guidance (intramuscular diaphragm stimulation for ventilator-dependent chronic respiratory failure from high spinal cord injuries), two new Diagnostic Guidance (MRI fusion biopsy systems for diagnosing prostate cancer, automated ankle-brachial pressure index measurement devices to detect peripheral arterial disease), and three new Health Technology Evaluations (Digitally enabled therapies for adults with anxiety disorders / with depression, and point-of-care tests for urinary tract infections). Also, four clinical guidelines were updated.

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 March 2023. Fifteen recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular and peripheral vascular, endocrine, endoscopy, gastrointestinal, surgical, and diagnostic imaging devices, as well as medical aids.

In mid-December 2022, the Danish Health Data Agency (Sundhedsdatastyrelsen) published an update of the Health Care Classification System (Sundheds-væsenets Klassifikations System, SKS). The most significant changes include: 11 new diagnosis codes, 27 new procedure codes, and eight additional codes (Tillægskoder) were added. The newly added procedure codes mainly concern the obstetrics and gynecology, surgical procedures, endocrine, gastrointestinal, and radiology fields, and some other technology groups.

On October 28, 2022, several Resolutions of the General Directorate of the Common Package of Benefits of the National Health and Pharmacy System were published concerning the use of the system for percutaneous repair of the mitral valve with clip, prioritization of patients with type 2 diabetes mellitus for the provision of glucose monitoring systems, and the use of glucose monitoring system with sensors (flash type) for type 1 diabetes mellitus in childhood and adolescence.

On May 31, 2022, the French National Authority for Health (HAS) published the final positive opinion on the coverage of the endoscopic gastroplasty with the ENDOMINA triangulation platform under the Innovation package (Forfait innovation).

On May 09, 2022, the updated List of Reimbursable Products and Services (LPPR) was published. It contains new devices included in the LPPR list in April 2022, as well as other modifications made during this period. New devices that were introduced in the LPPR list belong to the endocrine and gastrointestinal technology groups.

In March and April 2022, 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, thirty-three health apps are now available at the DiGA Directory.

In March 2022, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance (endoscopic balloon dilation for subglottic or tracheal stenosis, intramedullary distraction for lower limb lengthening, endoscopic full thickness removal of gastrointestinal stromal tumors of the stomach, percutaneous insertion of a cystic duct stent after cholecystostomy, and liposuction for chronic lipoedema), four new Medical Technologies Guidance (myCOPD, UroShield, Prontosan for wounds, and 3C Patch for diabetic foot ulcers), one new Diagnostic Guidance (terminated assessment of Freelite assays for multiple myeloma), and six new Medtech Innovation Briefings (Genedrive MT-RNR1 ID System, icobrain for multiple sclerosis, Al for analyzing chest X-ray images, and others). Also, three new clinical guidelines were published, and six were updated.