• 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 through FSS and national contracts,  and sales to federally-funded safety net providers at 340B discounts.  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 strategic pricing knowledge. With more than a decade of experience in government pricing compliance, 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 federal program participation requirements. Our focus areas include the following:
 
Assessments:
  • Methodology and Documentation Evaluations
  • Objective Calculation Review/Parallel Calculation testing
  • Transactional and Master Data Analytics
  • 340B Eligibility Review & Class of Trade Assignment Evaluations
  • 3PL Data/Calculation Assessments
  • Accrual Development and Evaluations
 
GP SME Support Services
  • GP Calculation Outsourcing
  • Periodic Parallel Calculation and GP Price Type Testing
  • Advanced Strategies and Operationalizing Complex Methodologies (e.g. Discount Reallocation, Smoothing)
  • GP Calculation Review/SME ad hoc support
  • FSS Contract Negotiation and Administration Support
  • Impact Modeling
  • Data Cleansing
 
Restatements and Recalculations:
  • Methodology and Documentation Revisions
  • Pricing and Liability Calculations
  • Restatements of Various GP Price Types (AMP, BP, URA, ASP, 340B, NFAMP and FCP)
  • FSS Contract Review and Voluntary Disclosures to the VA
  • Historical Data Validation and Cleanup
  • 3rd Party Restatement Validation
 
Other Services:
  • Government Compliance Program Development or Change Management
  • Company Training
  • Expert Testimony & Litigation