Nelson Hardiman represents pharmacies, including retail pharmacies, compounding pharmacies, and long-term care pharmacies, in business and regulatory matters. In addition, we represent re-packagers, pharmacy benefit managers (PBM’s), wholesalers, and individual pharmacists and pharmacy personnel. Nelson Hardiman’s experience extends to a wide range of business, regulatory, and strategic challenges for the pharmacy industry, including:
- Business Transactions
- Formation of entities and business structure for pharmacy-related entities
- Management Service Organization (MSO) relationships
- Purchase and sale of pharmacies
- Regulatory Defense
- Board of Pharmacy investigations and enforcement proceedings
- Drug Enforcement Administration (DEA) investigations, audits, and hearings
- Food and Drug Administration (FDA) investigations and enforcement actions
- Reimbursement recovery audits by governmental payors, including Medicare and Medi-Cal
- Third party payor audits
- Compliance
- Pharmacy, PBM, and compounding compliance counseling
- HIPAA and state patient data privacy and security requirements
- Litigation
- Reimbursement disputes
- Business litigation, including partnership disputes