Assessments according to §137h SGB V
The Act to Strengthen the Provision of Health Care (GKV-VSG), which was introduced in 2015, mandates that certain examination and treatment methods with medical devices used in the hospital setting are subject to an assessment by the . This applies to medical device methods for which the following preconditions are met: A hospital submits the first application according to §6 (2) Hospital Reimbursement Act to the Institute for the Hospital Remuneration System (InEK) (“NUB application”), the method is largely based on a high-risk class medical device, and the method is based on a new theoretical-scientific concept.
The hospital submitting the first NUB application for such a method, at the same time also submits documents on the scientific state of knowledge to the . The publishes the transmission form within two weeks, thus starting the supplementary procedure. In this supplementary procedure, further hospitals and medical device manufacturers concerned can submit additional documents within four weeks.
The decides within three months whether the benefit or the harmfulness or ineffectiveness of the method is to be regarded as sufficiently proven. The scientific assessment on the basis of the documents submitted is usually conducted by IQWiG on behalf of the .
Similar to other assessment procedures, the time period to conduct the assessment is stipulated by law. Accordingly, the IQWiG assessment has to be completed within a few weeks.
If, on the basis of all documents submitted and of the assessment conducted by IQWiG, the decides that neither the benefit nor the harmfulness or ineffectiveness of a method can be regarded as sufficiently proven, it can commission IQWiG to conduct a systematic literature search. This is done to ensure that all relevant studies are considered in the preparation of the testing directive. IQWiG conducts this search in the form of an addendum.
Production of assessments according to §137h SGB V (simplified):
- Transfer of all documents by the : With the commissioning of an assessment according to §137h SGB V, the documents are transferred to IQWiG. The documents include the ones provided by the applying hospital and, if applicable, further hospitals and medical device manufacturers concerned.
- Scientific evaluation: On receipt of the documents at IQWiG, the Institute will start with the assessment of their content. Medical experts may be consulted to consider current every-day health care. The process is completed with the preparation of the assessment according to §137h SGB V.
- Optional: Within the consultations on a testing directive, the can commission IQWiG to conduct a systematic literature search to ensure that all relevant studies are considered. This search is conducted in the form of an addendum.