Cancer

In late April and early May 2021, 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, fifteen health apps are now available at the DiGA Directory.

On April 20, 2021, the Dutch Healthcare Institute (ZIN) published an annual report on the progress of the conditional reimbursement program. In 2020, there were 13 ongoing projects under the program, six of which concerned medical technologies. Furthermore, in 2020, percutaneous transforaminal endoscopic discectomy for the treatment of lumbosacral radicular syndrome in lumbar disc herniation was included in the basic insurance package as regular care.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on April 1, 2021. Two new EBM codes for IVD tests were introduced, and reimbursement conditions for two IVD tests were amended.

In March 2021, the National Institute for Health and Care Excellence (NICE) published four new Interventional Procedure Guidance (transcervical ultrasound-guided radiofrequency ablation for symptomatic uterine fibroids, extracorporeal whole liver perfusion, free-functioning gracilis transfer to restore upper limb function, cytoreduction surgery with hyperthermic intraoperative peritoneal chemotherapy), two Medical Technologies Guidance (Danis stent for acute oesophageal variceal bleeding, Alpha-Stim AID for anxiety disorders), two Medtech Innovation Briefings (Sonata system for symptomatic uterine fibroids, Butterfly iQ+ for diagnostic ultrasound), and one Diagnostic Guidance (QAngio XA 3D QFR and CAAS vFFR imaging software for assessing coronary stenosis). Also, five clinical guidelines were updated.

In March 2021, Orders on the approval of the several standards of medical care entered into force, including standards for the provision of medical care for adults with gastrointestinal stromal tumors, cancer of the rectum, esophagus, cardia, biliary system, tracheal cancer, etc. For the diagnosis and treatment of diseases, patients will be provided with primary health care, specialized care, and laboratory testing.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 554 of January 18, 2021, Tuscany Regional Healthcare has published assessments of eight medical devices of various therapeutic areas, including devices for the treatment of cardiovascular conditions, personal diabetes management system, endoscopic devices, and pedicle screw system.

On January 28, 2021, the Innovation Committee at the Federal Joint Committee (G-BA) published the first overview of the 28 innovative projects on new forms of medical care that will be funded. The projects concerning the technologies belonging to the cardiovascular, eHealth, orthopedic, neurology, nephrology, and other technology groups received funding.

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.

In January 2021, the National Institute for Health and Care Excellence (NICE) published two new interventional procedure guidance (self-expanding implant insertion into the intersphincteric space for faecal incontinence and minimally invasive radical hysterectomy for early stage cervical cancer), two new medical technologies guidance (the PLASMA system for transurethral resection and haemostasis of the prostate, and the VAC Veraflo Therapy system for acute infected or chronic wounds), and six Medtech innovation briefings (Optilume for anterior urethral strictures, AI in mammography, AI for analyzing chest CT images, AcQMap for mapping the heart atria to target ablation treatment, and others). Also, two clinical guidelines were updated.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on January 1, 2021. The most significant changes include the increase of the reimbursement base rate and the introduction of many new surcharge fees in the area of radiotherapy services.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 19274 of November 24, Tuscany Regional Healthcare has published assessments of twelve medical devices of various therapeutic areas. See the list of evaluated devices in the post from MTRC.

In late October 2020, the BfArM (Federal Institute for Drugs and Medical Devices) has published the final version of the OPS 2021 (Operation and Procedure Keys) system. 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.