Commentary

Article

Five Steps to Ensure Accurate 340B Program Data

Hospitals and health systems proactively monitor and manage data accuracy with third-party administrators to maintain 340B program compliance and maximize benefits for vulnerable patient populations.

Many hospitals and health systems across the United States provide equitable, high-quality care to patients facing social and financial barriers. The 340B Drug Pricing Program supports these efforts by allowing eligible hospitals—known as 340B-covered entities—to stretch limited federal resources further, enabling them to better serve vulnerable populations and offer comprehensive services. Under the program, manufacturers that participate in Medicaid agree to provide outpatient drugs to covered entities at significantly reduced prices.¹

To maintain eligibility, hospitals must keep accurate records of patient appointments, prescriptions, and 340B-eligible locations. The Health Resources and Services Administration (HRSA) requires this documentation to verify compliance and confirm continued participation in the 340B program.

To manage this complex process, many hospitals and health systems rely on third-party administrators (TPAs). These external partners are responsible for processing, evaluating, and recording transactions related to 340B medications. TPAs also manage the flow of data needed to demonstrate compliance with HRSA requirements and maintain program eligibility.²

Despite their critical role, TPAs are not infallible. Errors in the data they manage can lead to delays, service disruptions, and even loss of 340B pricing. Many 340B departments routinely identify data errors that TPAs fail to detect or resolve. When these errors are not addressed promptly, hospitals risk losing out on the full financial benefits of the 340B program.

Data Error Causes

A magnifying glass focuses on colorful data visualizations. Image Credit: © pingpao - stock.adobe.com

A magnifying glass focuses on colorful data visualizations. Image Credit: © pingpao - stock.adobe.com

Given the vast volume of data involved, errors in the 340B eligibility process are not uncommon. These may stem from manual data entry, automation failures, misconfigurations, or interruptions in data flow. TPAs typically pull data into tables and apply hospital-specific rules and logic to determine 340B eligibility. However, if the rules or data feeds are flawed, miscalculations can occur. Until these errors are found and corrected, hospitals may be unable to realize the full savings offered by the program.

To catch such discrepancies, many hospitals employ internal auditing teams that sample a small number of prescriptions each month. However, with hundreds or thousands of prescriptions filled monthly, many errors still go unnoticed. Because TPAs rarely flag data problems themselves, the burden often falls on the hospital or health system to identify and address these issues. The types of data shared with TPAs include provider files, prescription records, drug utilization logs, location crosswalks to Office of Pharmacy Affairs Information System child sites, and drug purchasing files.

Five Steps to Address These Issues

To enhance data accuracy and strengthen collaboration with TPAs, hospitals and health systems can follow these strategies:

1. Monitor Data Transfers to the TPA

Hospitals and health systems can verify data transfers to the TPA from electronic health records and pharmacy dispensing systems on a daily basis. Information technology teams can automate these transfers and generate routine reports to confirm successful data delivery. Staff should examine file sizes and transaction counts regularly to detect anomalies. Significant deviations—such as a file reflecting only 10,000 transactions when the facility typically processes 100,000 prescriptions per month—should immediately trigger investigation. TPAs can also automate file receipt notifications and issue alerts for missing submissions. Staff must monitor system performance closely after software upgrades, as these changes frequently disrupt routine data feeds.

2. Open a Ticket With the TPA

Upon identifying an issue, staff should immediately open a support ticket through the TPA’s designated portal. This step initiates formal issue tracking and facilitates timely resolution. Organizations lacking a dedicated TPA account representative may encounter delays, making it essential to document the ticket number, submission date, and subsequent updates diligently.

3. Request Verification Data

Hospital or health system staff should request a report from the TPA confirming identification of the error. This verification process may require persistence, but it plays a vital role in ensuring the TPA investigates and addresses the issue appropriately. The report also assists in clarifying the root cause and informing the corrective course of action.

4. Rerun Missed Data

After resolving the error, staff should instruct the TPA to reprocess the affected data. In addition, they should request a summary detailing the nature of the issue, the corrective measures taken, and the resulting net changes in 340B data. This documentation promotes accountability and supports the recovery of any lost program benefits.

5. Prevent Recurrence

To prevent similar issues from recurring, hospital or health system staff should ask the TPA to explain the corrective steps taken and describe the safeguards implemented. Conducting regular meetings with the TPA and performing thorough internal audits will further strengthen program oversight. Although this level of vigilance may require significant effort, it remains essential for maintaining data integrity and ensuring continued 340B compliance.

Ensuring Smooth 340B Operations

About the Author

Susan Coultrip, MBA, ACE, is a 340B compliance and regulatory senior consultant for Clearway Health.

The 340B program plays a vital role in helping hospitals deliver high-quality care to underserved populations, but only when the systems that support it are functioning properly. A breakdown in data management can compromise eligibility and reduce the program’s impact.

Partnering with a specialty pharmacy that brings regulatory and compliance expertise to the table can improve efficiency and error detection. These partners help hospitals and health systems understand what data are required, identify errors early, and implement fixes quickly. With the right support, organizations can better leverage the 340B program to reduce medication access barriers, enhance patient satisfaction, and sustain services critical to the communities they serve.

REFERENCES
  1. 340B Drug Pricing Program. Health Resources & Services Administration. April 2025. Accessed May 10, 2025. https://www.hrsa.gov/opa
  2. Nikpay S, Halvorson L. Growing administrative complexity in the 340B program and the rise of third-party administrators. Health Aff Sch. 2023;1(5):qxad052. doi:10.1093/haschl/qxad052

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