Enabling innovative laboratory diagnostics for patients
In vitro diagnostics play an important role in the early detection and prevention of diseases. They enable precise diagnosis, with companion diagnostics representing the key to the right therapy. In addition, successful therapies are evaluated with the help of in-vitro diagnostics. The VDGH is committed to the use of innovative diagnostics along the entire patient pathway.
Digital health applications
Since October 2020, digital health applications (DiGA) have been available to patients as a new form of care. The Federal Institute for Drugs and Medical Devices uses a fast-track procedure to review the applications for their intended purpose and positive effects on care, among other things. Together with twelve other associations and the GKV-Spitzenverband, the VDGH negotiated the framework agreement in accordance with Section 134 SGB V. The VDGH is working hard to ensure that DiGAs are also opened up for in-vitro diagnostics, as the Digital Act 2024 already made possible for medical devices in risk class IIb.
Placing on the market ≠ Reimbursement
In the inpatient sector, the "prohibition proviso" applies. As long as the Federal Joint Committee does not issue a directive that excludes a method from statutory health insurance, it may be provided. Conversely, in the outpatient sector, the "reservation of permission" applies. After market approval (CE marking), reimbursement must be initiated separately, as there is no automatic system for in-vitro diagnostics in the German system. In addition to professional medical associations, medical societies and the sponsoring organizations themselves, the VDGH has the exclusive right to submit applications for the inclusion of advice on the inclusion of new laboratory medical, human genetic and tumor genetic services in the reimbursement catalog of statutory health insurance.
Individual companies are not entitled to submit applications to the self-administration. On request, we advise our members in the innovation process.
The VDGH is an institution entitled to submit comments to the Federal Joint Committee. The association provides input for the evaluation of laboratory-based examination and treatment methods as well as for the further development of early detection measures and disease management programs.
Complex self-administration apparatus
The German healthcare system is characterized by a complex reimbursement system. Proof of successful evaluation of medical methods using in-vitro diagnostics is becoming increasingly important for inclusion in the statutory health insurance benefit catalog. The various regulations are based on the Fifth Social Security Code, the procedural rules of the Evaluation Committee and the procedural rules of the Federal Joint Committee as the central institution of self-administration.
Reimbursement channels compact
Together with the medical technology associations BVMed, SPECTARIS and ZVEI, the VDGH has developed a reimbursement guide for the various settings. The central document "Access to the German reimbursement system - a guide for manufacturers of medical devices and diagnostics" is available to everyone. Exclusively for member companies, four additional modules are available that offer an in-depth analysis of the reimbursement structure in the outpatient and inpatient sectors. In addition, the testing procedure and market access for digital care offerings are explained in detail.