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Table 1 Assessment approaches of the G-BA and resulting consequences for provision prior to and after 2012

From: Evidence-based decision-making for diagnostic and therapeutic methods: the changing landscape of assessment approaches in Germany

  Outpatient Inpatient
Until 2011 Since 2012 a),b) 2000-2011 2012-2016 a),b) Since 2017
Before evaluation Not in benefit basket, i.e. provision not reimbursable Not in benefit basket, i.e. provision not reimbursable Provision allowed Provision allowed Provision allowed, unless method under § 137h
After evaluation
 Proven benefit Acknowledg-ment and inclusion in benefit basket Acknowledg-ment and inclusion in benefit basket Continued provision Continued provision Continued provision/ inclusion in benefit basket (§ 137h)
 No proven benefit + no ‘potential’ No acknowledge-ment, i.e. non-inclusion into benefit basket No acknowledge-ment, i.e. non-inclusion into benefit basket Exclusion from benefit basket Exclusion from benefit basket Exclusion/ non-inclusion (§ 137h)
 No proven benefit, but clinical studies expected (= ‘potential’) Suspension of the decision until studies available Suspension of the decision until studies available Suspension of the decision until studies available Suspension of the decision until studies available Trial implementation (under § 137e)
 Insufficient evidence, indication of possible benefit, no clinical studies expected/ planned (= ‘potential’) Approach not existent Trial implementation (under § 137e) Approach not existent Trial implementation (under § 137e) Trial implementation (under § 137e)
  1. a) The new regulations since 2012 complement the existing directives in the in- and outpatient care setting (§§ 135 and 137c SGB V)
  2. b) The term ’potential’ was introduced in 2012 in conjunction with the regulation under § 137e SGB V. This new assessment category requires a method to show potential being a valid diagnostic or treatment alternative to warrant the implementation of a trial. Additionally, the presence of a ’potential’ inhibits the exclusion of a method