Ensure 340B Program Compliance with Year-Round Oversight for Covered Entities

Unlike a single-point-in-time audit, our Continuous Monitoring Service offers ongoing quarterly reviews of all 340B claims and purchasing activity, with cumulative insight and an annual mock HRSA audit built in. This approach helps covered entities maintain compliance with 340B requirements year-round rather than discovering issues months after they occur, ensuring better program participants can participate in the 340B program with confidence.

We match 340B drug purchases to dispensed claims each quarter to validate accumulations, ensure inventory control, and detect anomalies—building a defensible audit trail over time. This process verifies that drug manufacturers provide proper 340B pricing, ensures discounted drugs reach only eligible patients, and maintains compliance with 340B ceiling price requirements throughout your participation in the 340B program.

We request 340B captured claims, purchasing history, provider rosters, and patient encounter reports from your organization. We'll also coordinate secure EMR access to review a  claim sample remotely. This streamlined approach ensures we can effectively audit covered entities while minimizing disruption to your pharmacy services and patient care operations.

Our continuous monitoring service supports all types of 340B covered entities including hospitals, 340B health centers, federally qualified health centers, rural health clinics, and other eligible healthcare organizations. We help ensure these covered entities comply with 340B program requirements while maximizing their ability to reach more eligible patients through proper program management.

Our quarterly monitoring ensures proper compliance with the 340B requirements governing covered entity and contract pharmacy arrangements. We review 340B contract pharmacy pricing, validate that only eligible patients receive discounted drugs, and ensure your organization follows the rules for 340B program participation across all pharmacy services locations.

Our monitoring includes detailed review of patient eligibility criteria, verification that 340B drugs are only dispensed to eligible patients, and validation that your organization follows proper procedures to offer 340B pricing to qualified individuals while preventing 340B drugs to ineligible patients from receiving unauthorized discounts.

We review your participation in the 340B prime vendor program to ensure compliance with purchasing requirements and proper inventory management. Our monitoring validates that drug manufacturers provide the required 340B discount through the prime vendor program and that your organization maximizes savings while maintaining compliance with outpatient drug pricing requirements.

If we identify potential compliance issues, we provide immediate guidance on corrective actions within the critical adjustment window. Our team helps you understand the 340B drug pricing requirements, implement necessary changes, and document remediation efforts to prevent future violations and ensure ongoing participation in the 340B program while maintaining covered entity compliance.

Our monitoring stays current with evolving 340B rules and regulations from the Health Resources and Services Administration. We ensure your program aligns with the latest guidance from HRSA's 340B office, including requirements of the 340B drug pricing statute established under the 340B law and any new restrictions on 340B program operations.

We carefully review the interaction between your  program’s administration and the Medicaid drug rebate program to prevent duplicate discounts. Our monitoring ensures proper handling of 340B drugs billed to Medicaid, validates that you exclude 340B claims appropriately, and maintains compliance with Medicaid rebate program obligations.