Government Programs Advisory & Managed Services

 

When a pharmaceutical manufacturer launches a product, over 50% of their US market could be government payors and providers, such as Medicaid (over 85 million Americans) and Medicare Part B and D (45 million). Plus, with over $40 billion spent each year across the 340B Program and the VA, the government market has become the largest for pharmaceuticals in the United States today. This creates significant challenges and risks for emerging companies. HELIO helps you navigate the complex legalities and compliance of these government health programs.

 

Watch a brief webinar with HELIO industry veterans Joe Skupen and Chris Coburn as they discuss lessons learned, expert advice, and where GP compliance is going.

  • GOVERNMENT EXPERTISE

    We have expanded our team in this emerging field, bringing on industry experts like Chris Cobourn, Joe Skupen and Mark Sabatelli, who collectively have over 85 years of experience in the industry, working with GP technologies and systems and leading GP compliance assessments for top tier pharmaceutical manufacturers.

  • TECHNOLOGY DRIVEN SERVICES

    HELIO also utilizes its AI-enabled technology solutions to automate complex processes and operations. HELIO’s proprietary smart matching technology has identified significant errors in areas such as Class of Trade (COT) assignment and 340B validation in an efficient manner that ensures accuracy and audability.

Government Programs Services

The field of Government Programs in the US today is a complex and ever-changing landscape. We know the risks, and understand the legislative initiatives that make GPs so challenging. With our expertise and guidance, you’ll have complete confidence in meeting all GP compliance requirements and certifying your pricing calculations.

GP Compliance Assessments and GP Enhancement

  • Comprehensive GP Compliance Assessments, including Parallel Calculations.

  • Compliance review of third-party providers that offer GP calculation services.

  • GP Compliance enhancements and efficiencies.

  • AI-enabled COT assignment and 340B validation.

  • Review of third-party service providers who use algorithms to perform COT assignment and 340B validation.

Class of Trade and 340B Validation

Bona Fide Service Fee and Fair Market Value

  • Comprehensive review of third-party arrangements, such as Pharmacy

  • Benefit Managers (PBMs), Wholesaler, Managed Care, and Group Purchasing Organizations (GPOs).

  • Bona Fide Services Fee review, including Fair Market Value, for the appropriate inclusion or exclusion in various statutory pricing calculations.

GP Recalculation

  • Advisory and calculation support for 3-year recalculations for Medicaid, 340B, ASP and VA/NonFAMP, including a mitigation plan, communication protocols, and support for internal and external counsel.

IRO and CIA support

  • Evaluation of processes, systems, documentation, and calculations to ensure that a company is prepared for the annual Independent Review Organization review.

  • Ensure the accuracy of product master data and identify potential risks due to discrepancies in the data between the CMS MDP system, the FDA, and a company’s sales data.

Product Master Reconciliation

Government Program Enrollment & Pre-Launch Support

  • Support emerging pharmaceutical and biotech companies to prepare for launch in the US and participation in the various Government Programs, including financial planning and analysis.

  • GP Calculations: AMP, BP, PHS/340B and VA

  • GP Medicaid Claims Processing & Dispute Resolution

  • Rebates Processing: TRICARE, Medicare Part D Coverage Gap

  • GPO Admin and Distributor Fee Processing

  • Commercial/PBM Rebate Processing

  • State Price Transparency

  • FMV & BFSF Support

  • Gross-to-Net Forecasting & Accrual Management

Ongoing Government Programs & Commercial Managed Services Support