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 as well as privacy and security requirements compound the challenge for digital and traditional pharmacies nationwide. We also provide expert 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. We also represent re-packagers, pharmacy benefit managers (PBM’s), wholesalers, manufacturers in meeting Current Good Manufacturing Practice (CGMP) requirements, 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 multiple investigations and enforcement proceedings targeting pharmacies and pharmacists.
• TELEHEALTH Formed and counseled nationwide telehealth entities combining patient access to physicians and pharmacies in integrated platforms.
• 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.
• LICENSING AND PRODUCT AGREEMENTS Documented significant domestic and international IP licensing, manufacturing, marketing, and distribution agreements for pharmaceuticals, biologics, and related products.
• 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.
• NATIONWIDE ONLINE DRUG SALES Developed 50-state regulatory model for physician-pharmacy online, direct-to-consumer sales for major, now public company.
• LICENSING AND PRODUCT AGREEMENTS Documented significant domestic and international IP licensing, manufacturing, marketing, and distribution agreements for pharmaceuticals, biologics, and related products.