
Government Pricing
Government pricing compliance and reporting for pharmaceutical companies to reduce regulatory risk and protect brand equity.
Overview
Model N's Government Pricing is a cloud-based solution designed for pharmaceutical manufacturers that need to maintain compliance with government pricing and reporting requirements. It addresses the risk of calculation errors that can result in millions of dollars in overpayments or overcharge penalties, as well as the broader compliance risks that can lead to significant fines and brand damage.
The solution supports the structuring of price and rebate incentives across channels, customers, and geographies, while providing the audit trails, reproducibility, and reporting capabilities required to meet regulatory obligations on a monthly and quarterly basis.
Key Benefits
- Aligns commercial and government pricing by constructing auditable, reproducible, version-controlled methodologies for government pricing policies.
- Ensures timely payments and reporting by accurately calculating every transaction, price, rebate, and adjustment that could affect monthly and quarterly reporting cycles.
- Reduces noncompliance risk through full reproducibility, a complete audit trail, and built-in reporting and analysis capabilities.
Product Features
- Inflation Reduction Act compliance: Calculates Medicare Part B and Part D inflation rebates per unit, integrated with master data for processing potential inflation rebates.
- Regulatory Update Packs (RUPs): Delivers software and documentation updates to keep calculations and processes aligned with the latest regulatory changes and current guidance.
- Support for complexities: Allows definition of product blending for relabels, authorized generics, linked National Drug Codes (NDCs), and custom packs.
- Bundle reallocation: Handles complex discount bundle situations through configurable reallocation rules.
- Formula builder: Supports preconfigured price types or custom price type modeling through a flexible formula builder.
- Government price reporting management: Covers monthly and quarterly reporting requirements for average manufacturer price (AMP), best price (BP), average sales price (ASP), federal ceiling price (FCP), non-federal average manufacturer price (NFAMP), and U.S. Public Health Service (PHS) pricing.
Available Add-Ons
- Model N Alerts Management: Promotes cross-functional communication and awareness of important events across the organization. Alerts are fully configurable to meet the specific needs of each organization.
- Discount Reallocation Management (DRM): Supports compliance with bundled drug sales mandates outlined in the Deficit Reduction Act. Enables execution of complex contracting strategies with confidence that resulting discounts will be properly reported, and allows reallocation of discounts from one set of transactions — by product, customer, or timeframe — to a different set of products, customers, or timeframes.
Platform Context and Related Products
- Government Pricing is part of Model N's Revenue Cloud for Pharma, which covers sales and marketing, finance and contracting, and legal and regulatory functions.
- A related product, State Price Transparency Management, automates compliance with state-level price transparency regulations.
- The broader Model N platform serves pharmaceutical, medtech, and high-tech industries, and has been in operation for more than 25 years.
Meta
Domain
Quality, Compliance & RegulatorySubdomain
Regulatory Information Management (RIM)Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
Pharma
Development stage(s)
ManufacturingPost-Market & RWE
Target user(s)
QA / Regulatory AffairsCommercial / Market Access
Compliance standard(s)
21 CFR Part 11GxP