Nephrology and Urology

The French National Authority for Health 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 in September 2022. Thirty-eight 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. Opinions concern cardiovascular and peripheral vascular, neurovascular and neuromodulation, orthopedic, endocrine, ENT, dermatological, and spine-related devices, as well as digital care and medical aids.

In July 2022, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (transcatheter tricuspid valve annuloplasty for tricuspid regurgitation, and transcatheter tricuspid valve leaflet repair for tricuspid regurgitation), one new Diagnostic Guidance (PLGF-based testing to help diagnose suspected preterm pre-eclampsia), and four new Medtech Innovation Briefings (ProciseDx point-of-care platform for IBD, RespiraSense for continuously monitoring respiratory rate, Lenus COPD Support Service, and cyanoacrylate glue for hernia mesh fixation). Also, five clinical guidelines were updated.

In June 2022, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (vertebral body tethering for idiopathic scoliosis, nerve graft for corneal denervation, and synthetic cartilage implant insertion for first metatarsophalangeal joint osteoarthritis). Also, four new clinical guidelines were published.

In March 2022, NHS England and NHS Improvement published the MedTech Funding Mandate (MTFM) policy for 2022/23, which will come into force on April 01, 2022. The MTFM launched in 2021 to support NICE-approved and cost-saving devices, diagnostics, and digital products. Commissioners must fund technologies included in MTFM.

On January 28, 2022, 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 2021. The medical technologies belonging to the cardiovascular, ENT, eHealth, gastrointestinal, neuromodulation, neurovascular, orthopedic, and other technology groups obtained positive status 1.

On January 20, 2022, the Academy of Medical Royal Colleges (AoMRC) launched a consultation on the latest set of guidance (List 3) of the Evidence-based Interventions (EBI) Programme. EBI program develops guidance sets (Lists) for tests, treatments, and procedures based on recommendations from the Expert Advisory Committee and NICE assessments. Proposed List 3 covers 17 interventions across a range of medical specialties, including cardiology, ophthalmology, urology, and others. The deadline for comments submission is March 31, 2022.

In early December 2021, the Danish Health Authority (Sundhedsdatastyrelsen) has published DRG tariffs, as well as psychiatric and rehabilitation rates for 2022. Later on, in mid-December 2021, the DRG tariff system (Takstsystem) guide for 2022 was also published. Among other changes, seven new DRGs, specifically in ENT, endoscopy, obstetrics, and gynecology fields, were introduced.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 20520 of November 22, 2021, Tuscany Regional Healthcare has published assessments of seventeen medical devices of various therapeutic areas, including devices belonging to neurology, as well as gastrointestinal, urology, cardiovascular, orthopedics, peripheral vascular, and other fields of care.

In early December 2021, NHS Accelerated Access Collaborative announced seven technologies that will be covered by the MedTech Funding Mandate (MTFM) in 2022/23: four for benign prostatic hyperplasia treatment (UroLift, GreenLight XPS, Rezum, and PLASMA system), and three for improving the patient experience during procedures (XprESS multi-sinus dilation system, Thopaz+, and Spectra Optia). Four technologies included in 2021/22 (placental growth factor-based testing, SecurAcath, HeartFlow, and gammaCore) will continue to be supported.

In November 2021, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (percutaneous implantation of pulmonary artery pressure sensors in chronic heart failure and coronary sinus narrowing device implantation for refractory angina), one new Medical Technologies Guidance (Synergo for non-muscle-invasive bladder cancer), one new Diagnostic Guidance (SeHCAT for diagnosing bile acid diarrhea), and four new Medtech Innovation Briefings (clonoSEQ for minimal residual disease, CerebAir for continuous EEG monitoring, 24/7 EEG SubQ for epilepsy, Paige Prostate for prostate cancer). Also, three new clinical guidelines were published, and six were updated.

In late October 2021, the BfArM (Federal Institute for Drugs and Medical Devices) has published the final version of the 2022 OPS procedure coding classification. The OPS, together with the ICD-10-GM (International Statistical Classification of Diseases and Related Health Problems, 10th revision, German Modification), forms the basis for the reimbursement systems in outpatient and inpatient care.

On October 7, 2021, the Treatment Council (Behandlingsråd), a new body for assessing treatments and health technologies that became fully operational in late May 2021, has decided to initiate its first assessment. It will concern the use of metal stents in the treatment of chronic ureteral strictures.