Federal & State Regulatory Compliance

• Represent pharmacies and pharmacy professionals in complying with State Boards of Pharmacy laws and regulations.
• Counsel on federal and state anti-kickback and anti-inducement laws, federal False Claims Act, Health Insurance Portability and Accountability Act (HIPAA) and Health Information Technology for Economic and Clinical Health (HITECH) Act requirements.
• Advise on matters involving controlled substances, including DEA registration requirements, state Prescription Drug Monitoring Program requirements, electronic-prescribing, telemedicine and auto-dispensing.

Audits, Investigations & Litigation

• Represent pharmacies and pharmacy professionals across the country in administrative actions brought by State Boards of Pharmacy.
• Represent pharmacy clients in inspections, investigations, and litigation initiated by governmental agencies, such as the FDA, DEA, OIG, DOJ and state regulatory and professional licensing agencies.
• Represent clients with matters relating to the alleged diversion of drug products, including prohibited diversion under the Controlled Substance Act and 340B drug discount program.
• Represent pharmacies in government and commercial payor reimbursement audits, proceedings and appeals.

Mergers, Acquisitions, Joint Ventures

• Represent pharmacies and private equity sponsors in acquisitions, divestitures, mergers and joint ventures, including structuring, negotiating and documenting the transaction, performing due diligence.
• Advise clients on network pharmacy agreements, pharmacy services agreements with hospitals and accountable care organizations, and 340B contract pharmacy services agreements.

Licensure & Registration

• Counsel resident and non-resident pharmacies on change of ownership, transfer matters and other federal and state approvals.
• Advise national and regional mail service and specialty pharmacy operations regarding the applicability of in-state and out-of-state licensing requirements.
• Assist private equity groups in conducting health regulatory due diligence of retail, mail order and specialty pharmacy companies, including advising on federal and state “change of ownership” requirements.