In September 2024, the National Institute for Health and Care Excellence (NICE) published one new Interventional Procedures Guidance concerning single-step scaffold insertion for repairing symptomatic chondral knee defects.

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 September 2024. Five recommendations were published concerning the registration or modification of registration conditions/extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). Opinions concern endocrine and spine devices, as well as medical aids.

On September 18, 2024, the Organization for Outpatient Physician Tariffs (OAAT) AG announced that the comprehensive tariff system, including the TARDOC catalog of individual service tariffs and outpatient flat rates, is now available for review by interested parties. As emphasized by the OAAT AG, the new system has not been approved yet. After the partial approval by the Swiss Federal Council in June 2024, the implementation of the new system was postponed until January 2026.

Our goal at MTRC is to inform the decision-making of our clients and to support their market access activities. Below is a snapshot of our planned activities for the next two weeks. This can help our existing and prospective clients to better understand the potential scope of our support. From the week of October 7th, we are planning to work on 16 projects. Review the complete list of planned activities in this post.

The Danish Health Data Authority quarterly updates the Health Care Classification System (SKS). The updated version was published in mid-September 2024 to come into force on October 1, 2024. Eight new medical procedure codes and one new code for diagnostic investigations were introduced concerning obstetrics and gynecology, extracorporeal treatments, spine, cardiovascular, e-health, diagnostic imaging, and some other fields.

On September 2, 2024, NHS England published guidance for planning, designing, and implementing Community diagnostic centers (CDCs). The national CDC Program is in its third year and has approved 170 CDC sites across England. The guidance sets the next steps and best practices in developing CDCs, including minimum requirements for core diagnostic tests that CDCs must provide permanently.

On September 20, 2024, the Swedish Medical Technologies Product (MTP) Council commissioned the Dental and Pharmaceutical Benefits Agency (TLV) to perform a health economic evaluation of hybrid closed-loop systems for adults with type 1 diabetes. This evaluation is a part of the Orderly introduction framework, a staged process aimed at managing the national introduction of novel technologies. Based on the TLV assessment, the MTP Council will make recommendations to regions regarding the implementation of the technology and the criteria for use.

In August 2024, the National Institute for Health and Care Research (NIHR) in England released eight MedTech-related assessments in its Health Technology Assessment (HTA) Journal, which concerned automated devices for identifying peripheral arterial disease, left ventricular assist devices as destination therapy, cerclage suture type to prevent pregnancy loss, gynecological cancer surveillance in Lynch syndrome, multiparametric MRI in bladder cancer pathway, in-home monitoring for people with glaucoma, real-time ultrasound elastography of thyroid nodules, and AI-based software for analyzing chest X-ray images. 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.

On September 23, 2024, the Norwegian Directorate of Health released an updated version of the Norwegian Laboratory Code (NLK) system. Sixty-nine new codes were added, and 209 codes were changed.

On September 2, 2024, NHS England published service specifications for same-day emergency care (SDEC). The SDEC model allows patients to be assessed, diagnosed, and treated on the same day of arrival instead of being admitted to a hospital. The specification defines the scope, care pathways, patient selection, referral to SDEC, and requirements for staff and quality.

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 20315 of September 9, 2024, Tuscany Regional Healthcare published two new rapid HTA reports of medical devices in the orthopedics and surgical procedures areas.

On September 6, 2024, the new version of the Nomenclature of Medical Biology Acts (NABM 92) was released in France. Various changes were implemented, including the introduction of one new code, modification of the coefficient B rating for a number of codes, and deletion of Article 4 "Minimum quotations" from the general provisions section of the NABM with 18 codes of this section.