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The new regulation to investigate potentially beneficial diagnostic and therapeutic methods in Germany: Up to international standard?

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  • Olberg, Britta
  • Perleth, Matthias
  • Busse, Reinhard

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.

Suggested Citation

  • Olberg, Britta & Perleth, Matthias & Busse, Reinhard, 2014. "The new regulation to investigate potentially beneficial diagnostic and therapeutic methods in Germany: Up to international standard?," Health Policy, Elsevier, vol. 117(2), pages 135-145.
    • Handle: RePEc:eee:hepoli:v:117:y:2014:i:2:p:135-145
    DOI: 10.1016/j.healthpol.2014.04.018
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    References listed on IDEAS

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    1. Henschke, Cornelia & Sundmacher, Leonie & Busse, Reinhard, 2013. "Structural changes in the German pharmaceutical market: Price setting mechanisms based on the early benefit evaluation," Health Policy, Elsevier, vol. 109(3), pages 263-269.
    2. Reinhard Busse & Tom Stargardt & Jonas Schreyögg, 2005. "Determining the “Health Benefit Basket” of the Statutory Health Insurance scheme in Germany," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 6(1), pages 30-36, November.
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    1. Beck, ACC & Retèl, VP & Bhairosing, PA & van den Brekel, MWM & van Harten, WH, 2019. "Barriers and facilitators of patient access to medical devices in Europe: A systematic literature review," Health Policy, Elsevier, vol. 123(12), pages 1185-1198.
    2. Fuchs, Sabine & Olberg, Britta & Panteli, Dimitra & Perleth, Matthias & Busse, Reinhard, 2017. "HTA of medical devices: Challenges and ideas for the future from a European perspective," Health Policy, Elsevier, vol. 121(3), pages 215-229.

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