Compliance
Compliance & Best Practice Reviews:
- S•E•T Enterprises created an industry best practices model for government pricing requirements that reflects experience gained working with eight of the top ten pharmaceutical manufacturers.
- Conducted numerous compliance and best practice assessments based on the model resulting in development of policy and procedure manuals, pricing calculation validations and financial impact assessments.
- Served as quality assurance partner for numerous government pricing implementation projects.
- Performed industry staffing surveys and organizational design assessments based on industry best practices.
Government Pricing Audits:
- S•E•T Enterprises has conducted several hundred audits for industry leading pharmaceutical and vaccine manufacturers.
- S•E•T’s Audits scrutinized government pricing submissions for compliance with regulatory requirements as well as conformance to internal calculation methodologies.
- Audits covered Non-Federal Average Manufacturer Prices, Average Sales Prices, Average Manufacturer Prices, Best Prices and Federal Ceiling Price calculations.
- Developed and utilized proprietary government pricing models to perform independent third-party reviews of government prices for numerous pharmaceutical manufacturers to confirm the accuracy of existing calculations, verify the accuracy of proof-of-concept efforts, and confirm accuracy of new government pricing system implementation projects.
Government Pricing Restatements/Proforma Impact Analysis:
- S•E•T Enterprises identified the compliance gaps in existing government pricing calculations that required the restatement of multiple years of historical data.
- Developed pricing models utilizing multiple formats of historical transactional data to calculate restated government prices.
- Developed the models needed to determine the financial impact of the restated prices.
- Created and delivered the presentation to the appropriate government agency in support of the required reparations.
- Client received approval for the restatement and the proposed changes to the calculation methodology.
System Migration Support:
- S•E•T Enterprises developed Medicaid Best Practice Models including business processes, data elements, data relationships, and functional system requirements.
- The systems implemented based on these models reduced Medicaid Rebate liabilities by several million dollars annually, reduced and/or eliminated exposure to significant fines and penalties, provided accounting controls on over $500 million in Medicaid Rebate payments annually, and produced management reporting information critical to improving decision making processes.
- Provided support for migration from manual calculation process to automated government pricing systems (both inhouse and commercially available).
- Provided audit support for parallel processing periods, conducted gap analysis & data reconciliation support and documented the automated system implementation end state.
Pricing Methodology Optimization:
- S•E•T Enterprises developed government pricing methodology enhancements that improved stability in calculated government prices, reduced fluctuations in year-to-year comparisons which reduced calculated inflation penalties and improved financial revenue on sales to government entities.
- Developed presentations to the appropriate government agencies resulting in approval of the proposed methodology.
- Presented methodology overview to OIG auditors on behalf of manufacturers on numerous occasions resulting in clean audit results for my clients.