Leech Tishman Nelson Hardiman understands the complex laws and regulatory hurdles impacting pharmacies in an era of rapid growth and change within the healthcare industry. Fueled in part by the digital health revolution, new prescription standards, as well as privacy and security requirements, compound the challenge for digital and brick-and-mortar pharmacies nationwide.
Our attorneys provide robust representation in navigating innovative products with the FDA, drug trials, and other drug-related activities. Our multidisciplinary healthcare team focuses on long-term strategies and solutions for pharmacies, including retail pharmacies, compounding pharmacies, and long-term care pharmacies, in business, litigation, and regulatory matters.
Our firm also represents re-packagers, pharmacy benefit managers (PBM’s), wholesalers, manufacturers, and individual pharmacists and pharmacy personnel, giving us experience across the broad spectrum of legal issues encountered within the pharmacy industry.
- Represented a national provider of pharmacy services and a patient in a federal lawsuit brought against an insurer for denial of IVIG treatments
- Handled multiple investigations and enforcement proceedings targeting pharmacies and pharmacists
- Formed and counseled nationwide telehealth entities, combining patient access to physicians and pharmacies in integrated platforms
- Advised on the formation of entities, business structures, and purchase/sale agreements for pharmacies and pharmacy-related entities
- Obtained favorable resolution for pharmacy client by appealing audit findings of the California Department of Healthcare Services
- Advised pharmacy clients on HIPAA and state patient data privacy and security requirements
- Advised pharmacy clients regarding licensure, certification and/or related matters
- Documented significant domestic and international IP licensing, manufacturing, marketing, and distribution agreements for pharmaceuticals, biologics, and related products
- Defended regulatory compliance issues, reimbursement disputes, and business litigation, including partnership disputes
- Worked with Management Services Organizations (MSOs) in connection with pharmacy business operations and other business arrangements
- Counseled clients regarding pharmacy acquisitions, handling CHOWs and regulatory approvals, as well as counseled clients on 340B program requirements for structuring cash flows in certain pharmacy acquisitions
- Researched and wrote comprehensive guidelines on behalf of a client that wanted to close a pharmacy and relinquish its license
- Handled recovery audits by governmental payors, including Medicare and Medi-Cal third party payor audits
- Developed 50-state regulatory model for physician-pharmacy online, direct-to-consumer sales for major public company
- Documented significant domestic and international IP licensing, manufacturing, marketing, and distribution agreements for pharmaceuticals, biologics, and related products
