Pharmacy

In 1998, we began working in pharmacy law. Today we assist pharmacies and DME providers in every aspect of regulatory and legal compliance. The unique legal issues facing community and compounding pharmacies, specialty pharmacies, and DME providers are a particular focus for us.

  • Audits by payers or PBMs
  • Board of Pharmacy
  • Civil investigatory demands
  • Consent agreements, decrees, and orders
  • Closed networks
  • Credentialing
  • Direct and indirect remuneration (DIR) fees
  • Disciplinary actions
  • DMEPOS and supplier billing standards
  • Drug Enforcement Administration
  • False claims: complaints by OIG, DCIS, and DOJ
  • FDA 503A and FDA 503B
  • Government audits by Medicare, Medicaid, or TRICARE
  • HIPAA and HITECH
  • Investigations by regulators, payers, or PBMs
  • Licensure
  • Marketing and lead generation agreements
  • Maximum allowable cost (MAC) disputes
  • Network contracting
  • Peer review panels
  • Recoupments
  • Reimbursement below cost (RBC) disputes
  • Telemedicine
  • USP 71, 795, 797, and 800
  • Zone Program Integrity Contractor (ZPIC) audits

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