🇩🇪Germany

BfArM-Prüfungsrisiken bei CAM-Produkten

1 verified sources

Definition

Complementary medicines must comply with specific commissions (C/D/E); non-compliance in claims results in reimbursement denials or regulatory actions.

Key Findings

  • Financial Impact: €10,000+ pro Lizenzverstoß, Rückforderungen von Erstattungen
  • Frequency: Bei ungenehmigten Phytotherapie/Homeopathy-Anträgen
  • Root Cause: Fehlende Validierung gegen BfArM-Listen

Why This Matters

This pain point represents a significant opportunity for B2B solutions targeting Alternative Medicine.

Affected Stakeholders

Apotheker, Hersteller, Heilpraktiker

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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:

Related Business Risks

Verzögerte Abrechnung bei Heilpraktikern

30-60 Tage DSO (Days Sales Outstanding), 2-5% Kapitalbindungskosten pro Jahr

GoBD-Verstoß bei manueller Abrechnung

€5,000+ Bußgeld pro Verstoß, 20-40 Stunden/Monat für Nachbesserung

Verweigerte Erstattung durch fehlende HTA-Konformität

10-20% der Ansprüche unreimbursed, €500-2,000 pro verweigertem Fall

Betrug durch unkontrollierte Barzahlungen

1-3% revenue shrinkage; €2,000-€10,000/year per practice

Kosten für ärztliches Attest und Führungszeugnis

€100-200 pro Antrag (Ärzteattest €50-100, Führungszeugnis €13+)

Verlorene Rechnungen bei Paketabrechnung

€5,000+ per unbilled package cycle; 2% revenue leakage

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