- The G-BA, physicians, hospitals, SHI funds or patient organizations can request the assessment of a new method.
- If the request was accepted, the G-BA publishes the assessment topic. It also contacts clinical experts, manufacturers of devices, and patient groups to offer them a chance for commenting.
- Then, the G-BA itself or IQWiG assesses the benefit and medical need of the method based on all available studies in the relevant indication and patient population. This assessment focuses on the use of the method, both in hospitals and in the outpatient sector.
- In the next step, the G-BA or IQWiG assesses whether the method is economical and needed in the health care context. This is conducted separately for the inpatient and outpatient sector.
- When this assessment is concluded, the G-BA publishes the draft decision. Clinical experts, manufacturers of medical devices, and patient organizations etc. have another chance for commenting.
- Lastly, the final decision is published. There are 4 possible conclusions:
- The method should be reimbursed
- The method should be excluded
- The assessment will be suspended for a defined time
- Testing studies will need to be conducted