Retail and Specialty Pharmacies

Retail and specialty pharmacies look to Morgan Lewis’s interdisciplinary team of lawyers to advise on a broad range of issues—including healthcare regulatory, US Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), transactional, compliance, employment, and litigation. Our experience in working with a wide array of pharmacies and other healthcare organizations—such as payors, distributors, and pharmaceutical manufacturers—allows us to provide strategic, results-oriented legal and compliance advice to our pharmacy clients. We advise both large chains and community pharmacies, as well as specialty pharmacies that offer long-term care, infusion therapy, hospice, nuclear pharmacy, and other specialty services.

Scope of Services

• State and federal regulatory matters
  • State Board of Pharmacy regulatory and licensure issues, including responses to Board of Pharmacy enforcement actions
  • Cost effective state surveys to support regional or nationwide pharmacy initiatives
  • Pharmaceutical manufacturer arrangements, including rebate programs, drug and co-pay coupon programs, and patient adherence programs
  • Program enrollment matters, including those related to sales and acquisitions
  • DEA enforcement and controlled substance regulation
  • FDA regulatory matters related to prescription and over-the-counter drugs, including Drug Quality and Security Act compliance
  • Regulatory advice on food (private labeling), supplements and other OTC items , including recalls, state consumer protection issues, and FDA oversight
  • Pharmacy Benefit Management (PBM) and health plan arrangements
  • Medicare/Medicaid coverage and reimbursement issues, including administrative appeals, Zone Program Integrity Contractor (ZPIC), Recovery Audit Contractor (RAC), and Unified Program Integrity Contractor (UPIC) audit response, administrative appeals, and federal court actions
  • Contracting with Accountable Care Organizations, hospices, PACE programs, and long-term care facilities
  • 340B program matters
  • PBM and payor audits, including Medicare Part D prescription drug plan, Medicare Advantage, Medicaid managed care, and commercial plans
  • Privacy and data security/breach response matters, including HIPAA and HITECH
  • Stark Law, Anti-Kickback Statute, and other fraud and abuse counseling
  • Federal and state False Claims Act investigations and qui tam defense
  • Legal and regulatory counseling related to innovative pharmacy, optical and retail clinic business arrangements to increase efficiencies, enhance consumer experience and enhance care delivery
  • Compliance program implementation, corporate integrity agreements, exclusion screening and other credentialing, and government self-disclosures
• Purchasing arrangements with distributors, wholesalers, and manufacturers
• Customer accessibility/Americans with Disabilities Act issues
• Antitrust and competition law counseling and defense
• Employment and OSHA law issues
• Pharmacy industry mergers and acquisitions and dispositions

Pharmacy Industry Focus

Our pharmacy industry focus enables us to provide integrated legal guidance and manage a client’s interests with its various constituencies, including the government and payors, PBMs, patients, investors, business partners, and vendors.

Our team of lawyers includes nationally recognized thought leaders in healthcare regulatory, compliance, and enforcement matters. Our lawyers include a former deputy branch chief at the US Department of Health and Human Services (HHS) Office of Inspector General and a counselor at HHS on congressional investigations; several former FDA lawyers; a former Centers for Medicare and Medicaid Services (CMS) lawyer who counseled on new CMS healthcare regulations; a licensed pharmacist who has advised retail and specialty pharmacies for decades; and many former US Department of Justice and state attorney general prosecutors who regularly advise on False Claims Act and DEA enforcement matters.

We work with pharmacies, drugstore chains, and retailers with pharmacy operations to design, implement, and assess innovative programs and corporate compliance initiatives to prevent potential problems before they occur. Our lawyers use an empirical, risk-based approach to help clients focus their resources on the areas with the most significant risk. We regularly assist regional and national pharmacy operations to assess legal and regulatory issues across numerous jurisdictions (for example, through the use of legal surveys) to enable our pharmacy clients to run their operations in a compliant and cost-effective fashion.

Beyond our work helping clients, Morgan Lewis lawyers are active in the healthcare sector as thought leaders and in moderating discussions on pressing pharmacy compliance issues, including working with pharmacy trade associations and helping lead the National Association of Chain Drug Stores’ Retail Pharmacy Compliance Roundtable.