Nelson Hardiman understands the myriad laws and regulatory hurdles impacting pharmacies in an era of rapid growth and change for the healthcare industry. Fueled in part by the digital health revolution, new prescription standards and privacy and security requirements compound the challenge for digital and traditional pharmacies nationwide.
Our healthcare team, including attorneys from our transactional and litigation practices, focuses on long-term strategies and solutions for pharmacies, including retail pharmacies, compounding pharmacies, and long-term care pharmacies, in business and regulatory matters. We also represent re-packagers, pharmacy benefit managers (PBM’s), wholesalers, and individual pharmacists and pharmacy personnel, giving us experience across the broad spectrum of legal issues encountered by the pharmacy industry.
Our Work Includes:
- Benefits Dispute Represented a national provider of pharmacy services and a patient in federal lawsuit brought against insurer for denial of IVIG treatments.
- Board of Pharmacy Handled investigations and enforcement proceedings.
- Business Transactions Advised on the formation of entities, business structures and purchase/sale agreements for pharmacies and pharmacy-related entities.
- California Department of Healthcare Services Obtained favorable resolution for pharmacy by appealing audit findings of the California Department of Healthcare Services.
- HIPAA Consulted on HIPAA and state patient data privacy and security requirements.
- Licensure and Certification Advised on licensure, certification and/or related matters with respect to pharmacies.
- Litigation Defended regulatory compliance issues, reimbursement disputes, and business litigation, including partnership disputes.
- Management Service Organization (MSO) Worked with MSOs in connection with pharmacy business operations and other relationships.
- Pharmacy Acquisitions Counseled on pharmacy acquisitions, handling CHOWs and regulatory approvals; counseled on 340B program requirements for structuring cash flows in certain pharmacy acquisitions.
- Regulatory Compliance Researched and wrote comprehensive guidelines on behalf of a client that wanted to close a pharmacy and relinquish its license.
- Reimbursement Handled recovery audits by governmental payors, including Medicare and Medi-Cal Third party payor audits.