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Innovation in European healthcare – what can Sweden learn? - LIF

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Implementation and use of <strong>in</strong>novations<br />

<strong>in</strong> the outpatient sector (SHI)<br />

Who is entitled to make an application?<br />

• The <strong>in</strong>itial condition for the <strong>in</strong>itiation of a<br />

discussion procedure is the<br />

correspond<strong>in</strong>g application from bodies<br />

entitled by law to submit an application<br />

• These are normally<br />

– the responsible national<br />

confederations of regional<br />

associations of service providers,<br />

– the GKV national confederations of<br />

regional associations of health<br />

<strong>in</strong>surance funds<br />

– the organisations recognised <strong>in</strong> the<br />

Ord<strong>in</strong>ance on Patient Participation<br />

or the neutral members of the G-BA<br />

What must an application for exam<strong>in</strong><strong>in</strong>g a<br />

method conta<strong>in</strong>?<br />

• A complete application to exam<strong>in</strong>e the<br />

criteria of benefit, medical necessity and<br />

cost-effectiveness for an diagnostic and<br />

therapeutic method must conta<strong>in</strong>:<br />

– A description of the diagnostic or<br />

therapeutic method to be exam<strong>in</strong>ed,<br />

– The <strong>in</strong>dications and objectives to be<br />

exam<strong>in</strong>ed,<br />

– A detailed justification, based on<br />

<strong>in</strong>formation for the relevant <strong>in</strong>dication, on<br />

the benefit, medical necessity and costeffectiveness,<br />

each supported by scientific<br />

literature and <strong>in</strong> comparison to methods<br />

already provided,<br />

– Information on the relevance of the<br />

method,<br />

– Information on the urgency of the<br />

evaluation<br />

61

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