Consultation procedures

With the exception of certain cases defined in the Rules of Procedure, the plenum decides on the initiation of a consultation procedure and commissions a subcommittee or working group with its execution. In some fields the prerequisite is a request for consultation submitted by a party defined by law as entitled to do so.

For example, such a request is necessary to initiate a methods assessment procedure. This request may be submitted by the G-BA impartials, the Central Federal Association of Health Insurance Funds, the National Association of Statutory Health Insurance Physicians (KBV), the National Association of Statutory Health Insurance Dentists (KZBV), the German Hospital Federation (DKG), or the patient representatives. All associations of statutory health insurance physicians and dentists, as well as the federal associations of hospital funding providers, can also submit requests. The SHI Healthcare Provision Act grants the right to submit an application for the testing (German only) of a new method to manufacturers of medical devices whose use significantly depends on the application of a new examination or treatment method, as well as companies that, as providers of a new method, have an economic interest in its provision at the expense of statutory health insurance.

The G-BA responds to internal and external suggestions of services for which quality standards should be developed. The Healthcare Provision Act also assigned a new responsibility in 2012 for testing methods that show potential. This also allows manufacturers of medical devices and other providers to submit requests.

The assessment of medicinal products is not normally initiated by a formal request. Here, the G-BA takes action based on its responsibility to update its directives regularly. Changes in the status of scientific research and in the market situation can trigger reassessments and thus changes to directives. Such procedures often start based on advice from scientific associations, the G-BA member organizations, or the G-BA staff office. In the area of medicinal products, an explicit right to submit a petition is found only in decisions on the inclusion of medical devices or OTC drugs that are normally excluded by law from the SHI catalogue of services. In these cases, the G-BA takes action in an administrative procedure upon request by manufacturer, and takes its decisions on a case-by-case basis. The approach for the early benefit assessment of pharmaceuticals with new active ingredients is different as well. In this case, the assessment procedure starts by law as soon as the medicinal product is approved for the German market and offered for sale.