From medical devices last week, we are moving back to digital health applications (DiGAs), and how clinician fees are set for these services in Germany.
What are DiGAs?
Since 2020, clinicians can prescribe and SHI funds reimburse digital treatments and medical applications (DiGAs).
For every new DiGA, the BfArM assesses whether it offers a positive effect on patient care and meets the necessary requirements on data protection and information security, and quality. If the assessment was successful, the BfArM will include the product in the DiGA list. This means that clinicians can then prescribe the product and SHI funds will reimburse the costs.
If there is not enough evidence yet to demonstrate a positive effect on care, but the DiGA fulfills the other requirements of the Digital Health Applications Ordinance, then the BfArM can include it provisionally. The manufacturer then has 12 months to complete the necessary study for full inclusion.
Permanent inclusion in DiGA list
Currently, the DiGA list permanently includes 12 apps.
This includes the app Vivira for the treatment of osteochondrosis of the spine, and somnio for insomnia.
Provisional DiGA list
At the moment, the BfArM is testing 19 apps under the provisional inclusion. Amongst them are three DiGAs for adolescents between 12 and 17 years:
- Mawendo; for disorders of the knee cap
- Compagnion patella; for disorders of the knee cap
- Rehappy
Deletions from DiGA list
Since they set up the DiGA list in 2020, the BfArM has removed 2 apps, which are no longer available for prescribing.
What are the clinician fees for treating with DiGAs in Germany?
Clinicians working in the German outpatient sector are paid according to the “Uniform value scale” (German: “Einheitlicher Bewertungsmaßstab (EBM)“). This directory details all outpatient services that are reimbursed by the SHI funds, and their respective fees. All clinicians of SH-insured patients across all of Germany have to follow it and charge according to the EBM.
The EBM catalogue also covers the fees for clinicians for prescribing, tracking, and analysing the data received from DiGAs.
In May 2022, the KBV and GKV-SV have also agreed fees for DiGAs on the provisional list.
EBM codes for DiGAs:
- 01470 Issuing an initial prescription for a DiGA (€2.03); available once; valid until 31 Dec 2022
- 01471 Follow-up and evaluation of DiGA somnio (€7.21)
- NEW (from May 2022): 86700 Follow-up and evaluation of DiGA (€7.12); available up to twice per year, but not in combination with EBM position 01470
- NEW (from May 2022): 86701 Issuing an initial prescription for a DiGA to children or adolescents (€2.00); available once; valid until 31 Dec 2022
- NEW (from July 2022): 01472 Follow-up and evaluation of DiGA Vivira (€7.21) for general practitioners, internists with no specialization, orthopedists and specialists in surgery
Further reading related to DiGAs
- Digital treatments and medical applications (DiGA) – Assessment process in Germany
- Experience with DiGA fast track process in Germany after one year
- How are digital health applications assessed in Germany?
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