Shannon Wiley focuses her practice on healthcare regulatory and transactional matters with a specific emphasis on the pharmaceutical industry specializing in specialty pharmacy, digital pharmacy and infusion providers. Shannon provides clients with legal guidance driven by a deep understanding of their business. She assists clients with transactional and regulatory matters involving ambulatory infusion centers, management relationships for health system pharmacies and infusion practices, home infusion, specialty pharmacy, digital pharmacy, limited distribution networks, pharmacy services agreements, the 340B program and associated contract pharmacy relationships, hub arrangements, data services arrangements, and GPO agreements. She also provides guidance on matters related to billing by such providers, such as advice Medicare Part B and Part D regulations. She advises clients on regulations such as the Anti-Kickback Statute, the Health Insurance Portability and Accountability Act (HIPAA), the Civil Monetary Penalty Law, corporate practice of medicine laws, pharmacy laws, FDA regulations such as the Drug Supply Chain Security Act and state laws related to the operations of pharmacies and infusion providers.

Shannon’s practice involves counsel related to:

• Specialty Pharmaceuticals – Assisting specialty pharmacies, drug manufacturers, and data aggregators with program development, contracting strategy and negotiation, regulatory guidance, and licensure issues.
• Infusion Providers – Assisting pharmacies, physician clinics, and ambulatory infusion centers with regulatory and operational issues related to an infusion business.
• Pharmacy Management and Collaborations – Assisting management companies, pharmacies, and health systems in structuring management arrangements, including associated contracting and regulatory analysis.
• Infusion Management and Collaborations – Assisting management companies, infusion providers, and health systems in structuring management arrangements, including associated contracting and regulatory analysis.
• Digital Pharmacies – Assisting technology providers, drug manufacturers, and pharmacies in navigating the operational and regulatory issues related to digital pharmacy offerings.
• Healthcare Transactions – Assisting strategic and financial buyers in identifying targets in the pharmacy, infusion, and digital pharmacy sectors, conducting diligence, and navigating the transaction process, as well as advisement for industry targets on their sell-side process.
• Drug Distribution – Providing supply chain regulatory guidance to specialty and retail pharmacies, pharmaceutical manufacturers, and wholesale distributors.
• Healthcare Contracting, Regulatory & Operational Matters – Providing counsel on healthcare operations, regulatory and reimbursement issues; assisting with drafting and negotiation of contracts such as drug purchase, enhanced service, data, and GPO agreements.