Government Drug Pricing Consulting

Navigate Complex Government Pricing Requirements with Confidence

Our Government Drug Pricing consulting services help pharmaceutical and biotechnology manufacturers manage the complex requirements associated with federal government drug pricing, reporting, compliance, and audit readiness.

We support manufacturers across the drug pricing lifecycle—from new product launch and pricing methodology development through ongoing calculations, reporting, audits, restatements, remediation, and system enhancements. Our approach combines regulatory knowledge, data analytics, operational controls, and cross-functional collaboration to help ensure accurate, consistent, and timely government price reporting.

Our Government Pricing Services

Federal Government Price Reporting

We provide calculation, review, validation, audit, and compliance support across key government pricing programs, including:

• Medicaid Drug Rebate Program (MDRP)

  Average Manufacturer Price (AMP)

  Best Price (BP)

  Unit Rebate Amount (URA)

  Quarterly pricing calculations and reporting

  Restatements and corrections

• Medicare Part B

  Average Sales Price (ASP)

  Data validation and reporting support

  Pricing and transactional data analysis

• 340B / Public Health Service

  340B Ceiling Price calculations

  Data validation and compliance review

  Pricing methodology assessment

• Federal Supply Schedule (FSS) / VA

  Non-Federal Average Manufacturer Price (Non-FAMP)

  Federal Ceiling Price (FCP)

  Quarterly price updates and realignments

  VA/FSS reporting support

• Medicare Inflationary Rebates

  Medicare Part B inflationary rebate calculations

  Medicare Part D inflationary rebate support

  Data analysis, validation, and reconciliation

Government Pricing Data & Analytics

Accurate government pricing depends on reliable transactional, contracting, and financial data. We help manufacturers establish analytical processes and controls to identify discrepancies and understand the drivers of pricing changes.

Our services include:

• Government pricing data validation and reconciliation

• Period-over-period variance analysis

• Analysis of discounts, rebates, fees, chargebacks, and other pricing components

• Identification and investigation of data discrepancies

• Historical pricing audits

• Restatement and financial adjustment calculations

• Root-cause analysis and remediation support

• Development of analytical tools and reporting dashboards

• Audit-readiness assessments and documentation

New Product Launch & Government Pricing Strategy

Government pricing requirements should be incorporated early in the product lifecycle. We support manufacturers in establishing appropriate government pricing methodologies and processes for new product launches, acquisitions, line extensions, and changes to product portfolios.

Our support can include:

• Initial AMP, BP, and ASP methodology and calculations

• New product government pricing setup

• FDA product listing and related data requirements

• Government pricing methodology documentation

• Launch readiness assessments

• Cross-functional coordination with Market Access, Commercial, Finance, Legal, and Compliance

• Assessment of government pricing implications of commercial pricing and contracting decisions

Government Pricing Systems & Model N Support

We provide functional and compliance support for government pricing systems, including Model N, helping organizations improve data integrity, system configuration, calculation processes, and internal controls.

Our capabilities include:

• Model N data and configuration assessment

• Government pricing calculation validation

• System functionality and process reviews

• Business requirements and functional design

• System enhancements and implementation support

• User acceptance testing (UAT)

• Calculation testing and validation

• Data integrity and reconciliation controls

• Process documentation and SOP development

Compliance, Audit & Remediation

Government pricing compliance requires ongoing monitoring and effective internal controls. We help manufacturers identify potential compliance gaps before they become significant reporting or financial issues.

Our compliance services include:

• Historical government pricing audits

• Compliance gap assessments

• Review of pricing methodologies and assumptions

• Identification of calculation and data discrepancies

• Restatement assessments and calculations

• Remediation planning and execution support

• SOP and policy development

• Quality-control framework development

• Internal control design and effectiveness assessments

• Audit preparation and response support

State Drug Price Transparency

In addition to federal government pricing programs, we provide secondary support for state pharmaceutical price transparency requirements.

Services may include:

• State price increase reporting

• New drug introduction reporting

• State-specific filing requirements

• Data preparation and validation

• Reporting calendar and compliance tracking

• Assessment of state-specific pricing transparency obligations

Cross-Functional Government Pricing Support

Government pricing impacts multiple functions across a pharmaceutical organization. We work collaboratively with:

• Market Access

• Commercial

• Finance

• Gross-to-Net Accounting

• Legal

• Regulatory Affairs

• Compliance

• Government Pricing

• Contracting

• IT and Data Management

Our objective is to create alignment between commercial decisions, transactional data, financial processes, government pricing methodologies, and regulatory requirements.

Our Approach

We combine government pricing expertise, data analytics, regulatory interpretation, process design, and quality controls to help manufacturers build sustainable compliance processes.

Whether you need support with a specific government pricing calculation, a historical audit, a new product launch, a Model N implementation, or a broader government pricing compliance program, our consulting approach can be tailored to your organization's needs.

Key Areas of Expertise

Federal Government Pricing | Medicaid AMP/BP/URA | Medicare ASP | 340B | FSS/VA | Non-FAMP | FCP | Medicare Part B & D Inflationary Rebates | Model N | Pricing Analytics | Compliance Audits | Restatements | New Product Launch | State Price Transparency | SOPs & Controls