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 G-BA. The legal basis for this mandatory and deadline-bound benefit assessment is §137h of the German Social Code Book V (SGB V) as well as the Regulation on the Assessment of Methods for Medical Devices (MeMBV).
The assessment applies to those new examination and treatment methods (“Neue Untersuchungs- und Behandlungsmethoden”, NUB) meeting the following preconditions:
- A hospital submits the first application according to §6 (2) Hospital Reimbursement Act (“NUB application”) to the Institute for the Hospital Remuneration System (InEK).
- The technical application of the method is largely based on the use of a high-risk medical device. High-risk medical devices are those that are particularly invasive in nature. Either because the use of the medical device substantially interferes with essential functions, in particular of the heart, the circulatory system or the central nervous system, or because the medical device specifically affects essential organ functions by emitting energy or radioactivity.
- The method is based on a new theoretical-scientific concept. This means that the mode of action or the therapeutic indication differs substantially from other methods already introduced in inpatient care.
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 G-BA. This is done in agreement with the medical device manufacturer. The G-BA publishes the transmission form within two weeks, thus starting the procedure to supplement information. In this procedure, further hospitals and medical device manufacturers concerned can submit additional documents within four weeks. The G-BA 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 G-BA.
Because the §137 procedure is linked to the annual NUB procedure (with the submission deadline at the end of October), §137 assessments at IQWiG are usually only conducted during the winter.
Similar to other G-BA assessment procedures, the period to conduct the assessment is stipulated by law. The G-BA must decide on the benefit, harm or ineffectiveness within three months on the basis of the information submitted. Accordingly, the assessment at IQWiG must be completed within a few weeks. If neither benefit, harm nor ineffectiveness can be identified, the G-BA usually initiates a testing study to evaluate the benefit. For this purpose, if necessary IQWiG develops the key points of the study within the framework of its §137h assessment.
If, on the basis of all documents submitted and the assessment conducted by IQWiG, the G-BA 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.
If the G-BA decides that the benefit of the method is to be regarded as sufficiently proven, it then examines whether directives on quality requirements are to be developed. If, on the other hand, the harmfulness or ineffectiveness of the method can be regarded as sufficiently proven, the G-BA decides on the rapid exclusion of the service from inpatient services.
Production of assessments according to §137h SGB V (simplified):
- Transfer of all documents by the G-BA: 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, the medical device manufacturer, and, if applicable, further hospitals and manufacturers.
- Scientific evaluation: On receipt of the documents at IQWiG, the Institute will start with the assessment of 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: The G-BA 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.