Bleakley Platt & Schmidt, LLP handles a wide range of pharmacy matters, including corporate transactions; establishing, buying, and selling pharmacies; regulatory advice; pharmacy audits and investigations; and litigation matters. Our clients include pharmacies, pharmacy management companies, and physician groups in the development and operation of physician-owned pharmacies and dispensaries. Our firm’s health care practice includes a pharmacist-attorney.
Our health law practice provides comprehensive pharmacy services by working closely with attorneys across a range of the firm’s practice areas as needed to represent the pharmacy industry in diverse areas, including:
Regulatory Matters
- the development of pharmacy compliance plans, including New York State Medicaid compliance program regulations
- compliance with the Controlled Substances Act and Drug Enforcement Administration (DEA) regulations, including diversion control, prescription fraud monitoring, DEA red flags, and opioid prescriptions
- compliance with the Stark law, Anti-Kickback Statute, and other federal and state laws related to physician referrals, kickbacks, fee-splitting, the corporate practice of medicine, and pharmacy and dispensing laws
- compliance with Medicare and Medicaid standards, pharmacy state laws, and board of pharmacy rules
- compliance with Health Insurance Portability and Accountability Act (HIPAA) requirements, including the need for Business Associate Agreements (BAAs) with vendors, and data privacy and cybersecurity requirements
Corporate Matters
- the purchase or sale of a pharmacy, including selling a pharmacy to a chain store
- opening a new pharmacy, including corporate formation and lease negotiation
- the preparation and filing of applications with boards of pharmacy, the DEA, enrollment in the Medicaid and Medicare Programs, and filing related applications in connection with the opening of a pharmacy, the purchase or sale of a pharmacy, the purchase or sale of stock, or a pharmacy relocation or renovation
- assistance with ownership structures, corporate governance, employment and contractor agreements, pharmacy joint ventures, and space and equipment lease arrangements and agreements
- pharmacy management company formation, contracting, and ongoing compliance matters
- the preparation of shareholder agreements and employment agreements in connection with the opening a new pharmacy or the purchase of an existing pharmacy or change in ownership
Litigation
- the defense of regulatory actions brought under federal and state law as well as professional conduct proceedings
- breach-of-contract claims and other commercial litigation
- enforcement of intellectual property rights, including trademark infringement
For representation, please contact Robert Braumuller at 914-287-6185 or rbraumuller@bpslaw.com.
