Katie Lapins, Principal

Katie has worked in the pharmaceutical and medical device industries in the areas of commercial and government contracting, compliance, finance and sales operations for over 10 years. As a consultant, Katie’s areas of primary focus are government programs, corporate compliance and commercial operations. Within these areas, she has developed policies and procedures, led assessments and conducted training for client employees. Katie’s experience within the industry includes government contract administration, pricing analysis, commercial operations, specialty pharmaceutical distribution agreements and commercial contract management (chargeback processing, rebates, administrative fees, membership and eligibility).

Government Pricing and State Program Compliance

  • Administration of Medicaid Drug Rebate Agreement, Federal Supply Schedule (Veterans Affairs) and Public Health Service contracts and modifications as necessary
  • Development and review of policies, methodologies and procedures associated with the government programs
  • Determination of impact of COT changes on government calculations
  • Government calculations and submissions (AMP, BP, PHS, ASP, Non-FAMP and FSS/FCP)
  • Audit of government calculations, submissions and payments
  • Voluntary disclosure for restatements including reconciliation, methodology documentation and impact analysis
  • PHS/340B program management including maintenance and validation of 340B eligibility
  • Validation, payment and tracking of Medicaid & SPAP rebates and dispute, as necessary
  • Training and education of operational employees, field sales and senior management in the requirements of government pricing program requirements

Corporate Compliance

  • Conduct corporate compliance assessments
  • Implementation of corporate compliance strategy and programs
  • Development of corporate compliance policies and procedures
  • Code of Business Conduct Development and Implementation
  • Assessment of third-party logistics companies

Commercial Contracts Compliance

  • Development and implementation of commercial contracting controls and policies
  • COT schema development, policies and procedures
  • Sample accountability audit
  • Commercial contract analysis (impact on government programs, profitability and structure)
  • Member, Pricing Committee
  • Member, Grants Committee

 

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