Bußgelder bei fehlender G-BA Zulassung
Definition
Non-compliance with G-BA authorization proviso for outpatient settings results in non-reimbursable services and potential Betriebsprüfung fines.
Key Findings
- Financial Impact: €5,000-50,000 per audit violation; 100% loss on unauthorized billings
- Frequency: During tax/insurance audits (Betriebsprüfung)
- Root Cause: Lack of G-BA listing for devices/procedures in outpatient reimbursement
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Outpatient Care Centers.
Affected Stakeholders
Medical directors, Procurement managers, Compliance teams
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Financial Impact
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Current Workarounds
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Methodology & Sources
Data collected via OSINT from regulatory filings, industry audits, and verified case studies.
Evidence Sources:
- https://mdsdenmark.dk/navigating-medical-device-reimbursement-in-germany-what-manufacturers-need-to-know/
- https://value-dossier.com/en/reimbursement-of-medical-devices/
- https://www.iges.com/sites/igesgroup/iges.de/myzms/content/e6/e1621/e10211/e22175/e22650/e22652/e22723/AiM_Reimbursement_of_Medical_Devices_in_Germany_2020_21_ger.pdf
Related Business Risks
Verzögerungen durch Vorabgenehmigungsmanagement
DSGVO-Bußgelder bei EHR-Dokumentationsfehlern
Bürokratische Overhead-Kosten durch EHR-Implementierung
Kapazitätsverluste durch EHR-Dokumentationsengpässe
Verzögerte Abrechnung durch unvollständige EHR-Dokumentation
Manuelle Notfallprotokolle blockieren Kapazität
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