Pharmacy & Pharmacy Benefit Management

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Hall Render attorneys have diverse and extensive experience addressing issues unique to pharmacies, pharmacy benefit managers and providers involved in drug dispensing and distribution.  Among others, we counsel retail pharmacies, mail-order pharmacies, pharmacy benefit managers, hospitals and long-term care providers regarding the full spectrum of pharmacy and drug-related matters.  We provide a broad range of...Read More

Hall Render attorneys have diverse and extensive experience addressing issues unique to pharmacies, pharmacy benefit managers and providers involved in drug dispensing and distribution.  Among others, we counsel retail pharmacies, mail-order pharmacies, pharmacy benefit managers, hospitals and long-term care providers regarding the full spectrum of pharmacy and drug-related matters.  We provide a broad range of pharmacy-related services to address provider and professional issues, including regulatory compliance and enforcement support, development and maintenance of compliance programs, Medicare and Medicaid reimbursement matters, private payor reimbursement matters, and fraud and abuse advice and litigation defense.

In carrying out these services, our attorneys provide advice to pharmacy and pharmacy benefit manager clients related to the following matters:  controlled substances (DEA and state); wholesale distribution, mail-order drugs, pharmacy and PBM contracting issues, pharmacy technology, security and EMR; e-prescribing and telemedicine; auto-dispensing; drug recalls; institutional and individual licensure/enrollment; payor certifications (Medicare, Medicaid, private payors); Medicare Part D compliance; 340B Program implementation and oversight; pharmaceutical pricing issues; infusion service; pharmaceutical environmental issues; supply chain (product and related services agreements); HIPAA/HITECH; immunizations; and patient safety and quality improvement.

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Areas of Focus

  • 340B
  • Auto-Dispensing
  • Compliance Programs
    • Assessment
    • Audit Advice
    • Education and Communication
    • Structure and Reporting
  • Controlled Substances Act (individual and institutional registrations, ordering, dispensing)
  • Drug-Seeking Patients
  • HIPAA/HITECH
  • Immunization Matters
  • Infusion Pharmacies and Services
  • Labor and Employment
  • Patient Safety/Quality Improvement
  • Pharmaceutical Environmental Issues
  • Pharmaceutical Pricing and Rebates
  • Pharmacy Benefit Management Contracting and Regulatory Compliance
  • Regulatory Compliance
    • Civil Monetary Penalties Law - Relationships with Beneficiaries
    • Food, Drug and Cosmetic Act
    • Fraud and Abuse - Federal and State Anti-Kickback Statutes
    • Medicare Part D
    • Pedigree Requirements/Counterfeit Drugs
    • Prescription Drug Marketing Act
    • Stark Law - Relationships with Physicians
    • Traditional Medicare and Medicaid
  • Regulatory Enforcement Support and Litigation
    • Centers for Medicare & Medicaid Services
    • Drug Enforcement Administration
    • False Claims Act Defense
    • Office of Inspector General
    • State Enforcement Agencies
  • State Licensing and Practice Hearings/Litigation
  • State Pharmacy and Pharmacist Enrollment/Certifications
  • Supply Chain (product and related services agreements)
  • Technology
    • E-Prescribing and Telemedicine
    • Electronic Medical Records
    • Security