Avanti340B What If series: Enhancing GFI Responses
Executive Summary
The 340B Drug Pricing Program offers critical support to covered entities (CEs) by allowing access to discounted outpatient drugs, thereby expanding healthcare services to vulnerable populations. However, in recent years, drug manufacturers have intensified their scrutiny of purchasing patterns, issuing Good Faith Inquiries (GFIs) that question potential duplicate discounts or diversion activities. Responding to these inquiries can be time-consuming, complicated, and operationally disruptive—particularly for CEs without integrated data analytics and workflow tools.
What if there were a tool that empowered 340B entities to proactively investigate and resolve GFIs with precision and speed? What if entities had a tool that turned reactive GFI responses into proactive, data-driven compliance strategies? Avanti340B provides this capability. It enables covered entities to respond to manufacturer inquiries with confidence because it relies on verifiable data and a repeatable process.
Understanding the Challenge: Good Faith Inquiries in Context
A GFI is typically initiated when a drug manufacturer observes anomalies in a CE’s 340B purchasing behavior. Common triggers include:
Purchase volume anomalies for specific drugs
Unclear separation between outpatient and inpatient use
Suspicion of duplicate discounts
Covered Entities often struggle to respond due to:
Siloed or incomplete data across accounts
Limited internal resources for complete investigations
Lack of standardized workflows for inquiry resolution
The Avanti340B Advantage
Avanti340B is a data integration and workflow tool built specifically for 340B program stakeholders. It provides CEs with targeted analytics, automated audit trails, and structured processes to investigate and resolve GFIs effectively.
Core features include:
Crosswalk Reports that link 340B purchases to dispensing records
Purchasing Oversight with site-specific utilization metrics
Documentation Templates for standardized GFI responses
Actionable Alerts for anomalies in drug utilization trends
A Practical Example: Resolving a Good Faith Inquiry
Scenario:
A drug manufacturer contacts a hospital after detecting an increase in 340B drug purchases.
Using Avanti340B, the hospital takes the following steps:
Data Consolidation and Mapping
Follows Avanti340B specifications for pulling in dispensing, purchase, and accumulation records for the NDC in question.
Maps data and identifies any missing data.
Root Cause Identification
Cross references claims and purchase history.
Identifies that an issue began after a recent software update.
Response and Remediation
Prepares a clear, well-documented response to the manufacturer outlining the findings, impacted claims, and root cause.
Implements a system fix in the TPA interface.
Follow Up and Continuous Improvement
Flags similar NDCs for review using Avanti340B’s alerting system.
Initiates a quarterly internal audit workflow using Avanti340B templates.
Outcome:
The manufacturer acknowledges the hospital’s transparency and corrective action plan, resolving the inquiry without escalation. The hospital avoids penalties, maintains program integrity, and improves its internal processes.
Conclusion: Empowering Compliance with Confidence
GFIs are likely to increase in frequency and complexity as drug manufacturers continue to monitor 340B utilization. Covered entities must be equipped not only to respond, but to do so credibly and efficiently.
Avanti340B is not just a software—it’s a strategic compliance partner. By consolidating data, automating investigation workflows, and ensuring auditable, defensible responses, Avanti340B empowers 340B stakeholders to uphold both the letter and spirit of the program.
About Avanti340B
Avanti340B is a compliance and analytics platform purpose built for 340B covered entities and their partners. Our mission is to simplify 340B program management through intelligent technology, enabling healthcare organizations to serve their communities with integrity and confidence.
For more information, visit www.avanti340b.com or contact info@avanti340b.com.