PHP127 - Clinical and Health Economic Evidence Requirements for Obtaining Health Insurance Coverage for Innovative Medical Devices in Germany

Abstract

Reimbursement Pathways  Seventy-nine million Germans have either statutory health insurance (SHI ~ 90% of the German population) or private health insurance (PHI ~ 10% of the German population) coverage.  With a healthcare expenditure on medical devices of 25 billion euros in 2012 Germany remains the largest medical device market in the EU and the third ranked in the world, behind the USA and Japan.  Any medical device intended for the German market must bear a CE mark before it can be sold or put into service [1].  According to the German statutory rules in the inpatient care setting all (innovative) procedures are permitted with the reservation of prohibition (‚Verbotsvorbehalt‘) [2], and in the outpatient care setting all (innovative) procedures are prohibited until they have been officially approved (‚Erlaubnisvorbehalt‘) [3].  Hence hospitals are allowed to apply all innovative medical devices in an inpatient setting once they have received marketing approval for Germany (CE mark), whereas a positive voting from the federal joint committee (G-BA) is required for medical devices applied by physicians in the outpatient setting.  The reimbursement of inpatient services in Germany is based on a diagnosis-related group (DRG) system. Hence the reimbursement of a medical device in the inpatient setting depends on adequate coding options (procedural codes = OPS codes, medical indication coding = ICD-10 codes) on the DRG grouping systematic and on the adequate reimbursement value of the related DRG.  If all these preconditions are met a new medical device is already reimbursed adequately. If one or all preconditions are not met specific applications (OPS, DRG and/or NUB applications) can be made at the institutes responsible for the DRG coding and coverage, which are the German Institute of Medical Documentation and Information (DIMDI) and the Institute for the Hospital Remuneration System (InEK).  Whereas OPS and DRG application are focusing on the procedural coding and the DRG grouping, NUB applications are focusing on determining an extra rate, which will be reimbursed on top of an existing DRG fee. Such NUB applications can be prepared by the MD manufacturer but they can only be submitted by German hospitals that are also responsible for the NUB extra rate price negotiation. OPS=German Procedure Coding; DRG=Diagnoses Related Groups; ;MD = Medical Device; NUB=New Diagnosis & Therapy Methods; EBM=Statutory Health Insurance Physician Fee Schedule, GOA=Private Health Insurance Physician Fee Schedule; TAS = Therapeutic Appliance Schedule; IGeL=Individual Health Services Clinical and Health Economic Evidence Requirements