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340B Program Integrity Audits

Ponaman’s 340B Program Integrity Audits (PIAs) are designed to provide an independent, external audit of an entity’s 340B Program. Our 340B consultants have provided support for more than 123 HRSA audits. We use HRSA’s most recent audit data request list to prepare the organization’s team for a HRSA audit while completing a thorough 340B compliance check and identifying areas to maximize program savings.

Ponaman’s PIA process adjusts to meet HRSA’s most recent compliance standards, and includes the following key steps:

Compliance checks
- 340B Eligibility documentation and registration verification
- Medicare cost report/grant reviews
- 340B Policy and Procedure assessment
- 340B pharmacy purchasing process review
- Medicaid billing and state requirements review
- Evaluation of existing 340B monitoring/compliance measures
- Review basic third party administrator (TPA) configuration settings
- and more!
Staff Training
- Our process is designed to train each covered entity’s team for a HRSA 340B Audit, so an entity will be organized and ready to respond.
Program Optimization
- We will identify any missed opportunities related to maximizing 340B program savings while conducting the audit. Our goal is to ensure that covered entities are achieving the full potential of program savings.

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Understanding the 340B Drug Pricing Program

The 340B Drug Pricing Program is a federal program that allows eligible healthcare organizations to purchase outpatient drugs at significantly reduced prices. This program is designed to enable these organizations to stretch their scarce resources, providing more comprehensive services to vulnerable populations.

Healthcare entities such as hospitals, community health centers, and specialty clinics can participate in the 340B program. By leveraging the savings from discounted drug prices, these organizations can invest in additional patient services, improve access to medications, and enhance overall healthcare delivery within their communities.

Importance of Compliance in 340B Audits

Compliance is critical in the 340B Drug Pricing Program, as it ensures that organizations adhere to federal regulations and maintain eligibility for the program. Non-compliance can lead to severe penalties, including the loss of 340B privileges and financial repercussions.

Organizations must conduct regular audits to identify potential compliance issues and rectify them promptly. This proactive approach not only safeguards the organization’s participation in the 340B program but also enhances the integrity of their operations, ensuring that they provide the best possible care to their patients.

Key Steps in Conducting a 340B Program Integrity Audit

Conducting a 340B Program Integrity Audit involves several essential steps that ensure thorough evaluation and compliance. These steps include reviewing eligibility documentation, assessing policies and procedures, and verifying the purchasing processes of 340B drugs.

Additionally, the audit process should encompass a comprehensive review of Medicaid billing practices and existing compliance measures. By following these key steps, organizations can identify areas of improvement, optimize savings, and prepare effectively for HRSA audits.

Benefits of Independent External Audits

Independent external audits provide an objective assessment of a healthcare organization's compliance with the 340B program. These audits are crucial for identifying potential risks and ensuring that the organization adheres to the latest regulatory standards.

By engaging an external auditor, organizations benefit from specialized expertise and an unbiased perspective. This can lead to enhanced operational efficiencies, improved compliance rates, and ultimately, better patient outcomes as resources are maximized and allocated effectively.