Pharmacy

Holland & Knight's Pharmacy Team provides comprehensive legal services tailored to a wide range of clients in the pharmacy industry. With a deep understanding of the complex and evolving legal landscape surrounding pharmaceuticals and healthcare regulations, our experienced attorneys deliver legal solutions to meet the distinct needs of our pharmacy clients.

Industry Experience and Know-How

Led by industry veterans who have experience as both in-house general counsel and outside counsel, our multi-disciplinary team serves as operational and transactional counsel to many of the nation's leading retail, mail order, specialty, compounding, long-term care, veterinary pharmacies, pharmacy benefit managers (PBMs), infusion centers, wholesalers and distributors. Our lawyers stay current with the latest developments and trends in the pharmacy sector, including federal and state law changes, policy issues, industry trends and evolving distribution models.

We provide forward-thinking advice and solutions to help a variety of clients active in the pharmacy sector, including:

• large and small retail, mail order, compounding and veterinary pharmacies
• large and small specialty and home infusion pharmacies
• large long-term care pharmacies
• large and small drug manufacturers
• private equity firms
• drug wholesalers and distributors
• group purchasing organizations (GPOs)
• 340B-covered entities
• reimbursement hubs, prior authorization programs, financial assistance programs and other pharma services companies

Regulatory Compliance: Federal, State and Local

Our attorneys assist pharmacies and related entities in navigating the intricate web of federal, state and local regulations governing the pharmacy industry. We monitor the latest changes in healthcare laws and regulations to help ensure that our clients remain in compliance with applicable regulations, licensing requirements and other relevant laws and guidelines, including state pharmacy laws, U.S. Drug Enforcement Agency (DEA) regulations, Medicare and Medicaid guidance, the Health Insurance Portability and Accountability Act (HIPAA), and fraud, waste and abuse laws, such as the federal Anti-Kickback Statute, the Stark Law, the Civil Monetary Penalty Beneficiary Inducement Prohibition and their respective state analogues.

Licensing and Permitting

Holland & Knight's Pharmacy Team provides guidance and support throughout the licensing and permitting process. Our attorneys assist with initial license applications and renewals. We have extensive experience advising clients on sequencing the submission of Board of Pharmacy, Medicaid, Medicare, DEA, national provider identifier (NPI) and accreditation applications reporting changes of ownership, name, location, directors or officers, to ensure that filings are made in a timely, compliant and efficient manner without disruption to operations. We assist our pharmacy clients with any issues related to licensure.

Contract Negotiation and Review

Holland & Knight's Pharmacy Team includes skilled negotiators who draft, review and negotiate the contracts crucial to pharmacy operations, including procurement, reimbursement, fulfillment and services agreements. We assist with contracts related to wholesalers, manufacturers, GPOs, PBMs, insurers, healthcare providers and other entities within the pharmaceutical supply chain or with which a pharmacy may enter into an agreement. We have extensive experience with privacy and fraud, waste and abuse laws to help ensure our pharmacy clients' business arrangements comply with applicable laws. Our goal is to protect our clients' interests and help them achieve their business objectives.

Business Formation and Transactions

Our lawyers provide comprehensive legal support for pharmacy startups, mergers and acquisitions (M&A) and other business transactions. Our team assists with entity selection, business formation, due diligence, change of ownership guidance and filing preparation, contract negotiations and all legal aspects of expanding or restructuring pharmacy operations.

Compliance Programs, Audits and Investigations

Our team assists pharmacies and related entities in establishing and implementing compliance programs and compliance-related policies and procedures. Our attorneys also aid clients in conducting internal compliance audits to identify potential issues and rectify any identified noncompliance. In the event of Board of Pharmacy, DEA, U.S. Department of Justice (DOJ) or U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) government investigations or Medicare or Medicaid audits, our experienced lawyers provide strategic counsel and representation, minimizing risks and doing our utmost to achieve optimal outcomes.

Dispute Resolution and Litigation

When disputes arise, we offer skilled representation in negotiations, alternative dispute resolution methods and, when necessary, litigation. Our litigators have extensive experience in handling pharmacy-related disputes, including contract disputes, PBM issues, licensing challenges, regulatory violations, reimbursement disputes, professional liability claims and False Claims Act defense.

Representative Experience

Our Pharmacy Team has extensive experience representing clients in connection with a wide range of issues, including:

• assisting with licensing filings
• advising clients on schedule for timely submission of change of ownership applications
• preparing and handling change of ownership filings
• drafting, reviewing, and negotiating contracts related to procurement, reimbursement, fulfillment and services
• providing regulatory advice to help ensure compliance with fraud, waste and abuse laws in connection with business arrangements
• providing guidance regarding HIPAA and privacy-related issues
• supporting business transactions (startups, mergers, acquisitions, sales, restructurings)
• conducting due diligence, assessing risk and advising on how to lower any identified risk
• preparing compliance-related policies and procedures to help clients establish a compliance program
• conducting internal compliance audits and assisting clients to remediate identified non-compliance
• providing strategic advice and handling governmental investigations and audits
• litigating pharmacy-related disputes
• defending clients in False Claims Act cases