title: The new regulation to investigate potentially beneficial diagnostic and therapeutic methods in Germany: up to international standard?
abstract: Funding of diagnostic and therapeutic methods in Germany's statutory health insurance (SHI) follows a dichotomy: in outpatient care, only methods with proven benefit are reimbursed while in inpatient care, all methods may be provided unless they are excluded due to proven harm or lack of benefit. In January 2012, a new section 137e was added to the Social Code Book V (SGB V), allowing for the inclusion of innovative and potentially beneficial diagnostic or therapeutic methods in the SHI benefit basket, while additional evidence regarding their effectiveness and safety must be gathered. In 2013, the Federal Joint Committee (G-BA) has specified the details of this new approach, which can be considered a variety of "Coverage with Evidence Development" (CED). Our comparison with CED schemes in selected countries reveals a dependence of the CED implementation on the encompassing healthcare system. However, we identify a clear legislative foundation, a definitive decision-making body, the possibility to obtain public funding, and the preference for high quality study designs as constituting factors of an emerging international standard for CED. In addition, it is necessary to ensure the suitability of circumstances and technologies for the successful application of CED in a clear and transparent way.
authors.affiliation: Medical Consultancy Department, Federal Joint Committee, Berlin, Germany; Department of Health Care Management, University of Technology, Berlin, Germany. Electronic address: britta.olberg@g-ba.de.
authors.forename: Britta
authors.initials: B
authors.lastname: Olberg
authors.affiliation: Medical Consultancy Department, Federal Joint Committee, Berlin, Germany. Electronic address: matthias.perleth@g-ba.de.
authors.forename: Matthias
authors.initials: M
authors.lastname: Perleth
authors.affiliation: Department of Health Care Management, University of Technology, Berlin, Germany. Electronic address: rbusse@tu-berlin.de.
authors.forename: Reinhard
authors.initials: R
authors.lastname: Busse
mesh_terms: D003657:Decision Making; D003933:Diagnosis; D019317:Evidence-Based Medicine / Q000331:legislation & jurisprudence / Q000592:standards; D005858:Germany; D033161:Government Regulation; D006291:Health Policy / Q000331:legislation & jurisprudence*; D006801:Humans; D007348:Insurance, Health / Q000331:legislation & jurisprudence; D038622:Internationality; D007883:Legislation, Medical; D009313:National Health Programs / Q000331:legislation & jurisprudence; D013812:Therapeutics
keywords: Coverage with evidence development; Decision-making; Diagnostic and therapeutic methods; German reform; Health policy