Approval by the health insurance
For the first prescription, approval must first be obtained from the respective health insurance of the insured person. The approval must be granted by the respective health insurance before the treatment begins.
The health insurance companies provide information on the exact procedure of the approval procedure. In principle, the prerequisites listed in the legislation should be addressed, in which
1. it must be documented that it is a severe disease for which
2. it is demonstrated that a generally approved service that meets medical standards is not available; or
3. it is demonstrated, on the basis of a reasoned assessment, that in individual cases, taking into account the side effects to be expected and the state of the patient’s illness, a generally approved service in accordance with the medical standard cannot be applied,
4. it is demonstrated that the prescription of cannabis blossoms or extracts or medicinal products containing cannabis has a not entirely distant prospect of a noticeable positive effect on the course of the disease or on severe symptoms.
Prior authorisation is only required for the prescription of finished medicinal products containing cannabinoids which are already prescribable if they are to be used off-label. If the request is made as part of a specialized outpatient palliative care according to § 37b SGB V, this should be noted separately in the request in order to shorten the approval period.
The health insurance company must have decided about the application no later than three weeks after receiving the application. In cases where the health insurance company considers an expert evaluation, e.g. by the MDK (Medical Service of the Health Insurance), to be necessary, the deadline is extended up to five weeks. The deadline starts after the health insurance company has received the application.
In case of patients who are in specialised outpatient palliative care in accordance with § 37b SGB V, the period for approval by the health insurance is shortened to three days (§ 31 Subsection 6 Sentence 3 SGB V).
Reasons for refusal
A refusal by the health insurance company is legally possible “only in justified exceptional cases” (§ 31 Subsection 6 Sentence 2 SGB V).
Participation in a substitution register
§ 31 Subsection 6 Sentences 4 and 5 SGB V stipulates that the insured person must participate in a non-interventional substitution register. This results in particular obligations for the treating physician.