• Government Pricing Strategy
    and Compliance

Working with clients to find strategic compliance solutions.

The federal sector is a significant market for most pharmaceutical manufacturers, including Medicaid, Medicare, VA/DOD purchasing, PHS sales, and federally-funded safety net providers.  This highly-regulated industry remains in the spotlight of federal focus and enforcement through changing administrations and varying political agendas. Accurate government price reporting is critical to the overall compliance profile of an organization. The significance of revenue generated from federal programs means that inaccuracies in mandatory statutory and regulatory price calculations have a material impact on net revenues.
 
At BDO, we help clients in complex matters that demand industry, regulatory, operational, financial, and strategy knowledge. With more than a decade of experience, we’ve worked with both branded and generic pharmaceutical, biotech, and medical device manufacturers of all sizes. Together, we address the operational and data complexities arising from government guidance, including: 
 
Assessments:
  • Methodology and documentation evaluations
  • Objective calculation review
  • Transactional and master data analytics
  • 340B eligibility review and class of trade assignment evaluations
  • 3PL data/calculation assessments
  • Accrual development and evaluations 
Restatements and Recalculations:
  • Methodology and documentation revisions
  • Pricing and liability calculations
  • Historical data validation and cleanup
  • 3rd party restatement validation 
Other Services:
  • Government compliance program development or change management
  • Advanced strategies and methodologies (e.g. discount reallocation, smoothing)
  • Impact modeling
  • Data cleansing
  • GP calculation outsourcing
  • Company training
  • Expert testimony and litigation