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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