ENT

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 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.

In November 2021, twelve clinical guidelines, relating to gastrointestinal, ENT, orthopedic, and other disease areas, were released in Russia.

The new version of the classification of procedure codes (CCAM v.68) applicable from 09/12/2021 was published in France. Multiple changes were introduced, including registration of 22 new procedure codes, changes of notes and tariffs for procedure codes, removal of two codes, and other changes. New codes are related to procedures on the gastrointestinal tract, surgical procedures, peripheral vascular procedures, etc.

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 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.

In August 2021, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (magnetic resonance therapy for knee osteoarthritis, laparoscopic removal of uterine fibroids with power morcellation, hysteroscopic mechanical tissue removal for uterine fibroids), and six new Medtech Innovation Briefings (PLASMA system with button electrode, Immunoscore, MMprofiler, Patient Status Engine, lung texture analysis, Colli-Pee). Also, five clinical guidelines were published.

In August 2021, 22 Russian clinical guidelines in the fields of ENT, cardiovascular, obstetrics and gynecology, orthopedics and others, were released. Furthermore, the order on the approval of the standard of medical care for adults with urolithiasis disease entered into force.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 6462 of April 21, 2021, Tuscany Regional Healthcare has published assessments of six medical devices of various therapeutic areas, including devices for the treatment of vaginal prolapse, cardiovascular conditions, an implant for vocal cord rehabilitation, and a cerebral embolic protective device.

On February 18, 2021, the updated List of Reimbursable Products and Services (LPPR) was published. It contains new devices included in the LPPR list in January-February 2021, as well as other modifications made during this period. The newly-included devices belong to the cardiovascular (TAVI), ENT (cochlear and brainstem implants), and diagnostic imaging (FFR) technology groups.

In February 2021, the National Institute for Health and Care Excellence (NICE) published one new medical technologies guidance (Leukomed Sorbact for preventing surgical site infection) and seven new Medtech innovation briefings (PROPEL sinus implants, URO17 for detecting bladder cancer, Faecal microbiota transplant, DOAC Dipstick for detecting oral anticoagulants, CytoSorb for reducing the risk of bleeding during cardiac surgery, and others).

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.