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HRSA’s Office of Pharmacy Affairs audited a record number of 340B covered entities in recent years, with the agency’s own audit data showing hundreds of findings annually against hospitals, health centers, and other covered entities enrolled in the federal drug pricing program. With audit activity showing no signs of slowing, and covered entities sitting on compliance infrastructures that were never designed to own 340B accountability in full, Ponaman Healthcare Consulting is calling on program managers and compliance officers to assess their audit readiness now. Before HRSA does it for them.

Key Facts: HRSA 340B audits, FY2024: HRSA’s Office of Pharmacy Affairs completed audits of covered entities across all entity types, with findings most commonly cited in duplicate discount prevention, eligibility documentation, and patient definition compliance. Per HRSA’s publicly available 340B Audit Findings Database. OPA audit scope: According to HRSA’s 340B Program Integrity initiative, the agency has committed to auditing a statistically significant sample of covered entities each fiscal year, with a stated focus on high-risk program areas including contract pharmacy arrangements and manufacturer restrictions. Ponaman Healthcare Consulting has supported 148 HRSA 340B audits across covered entity types. Hospitals, federally qualified health centers, and other safety-net providers. 67% of Ponaman-supported audits resulted in zero findings. Meaning the entity received a clean audit outcome. 80% success rate in overturning audit findings on appeal. A figure that reflects documented process infrastructure, not just legal arguments. A community health center client working with Ponaman achieved a 50% reduction in audit findings following a structured compliance review and program remediation engagement.

The Audit Environment Has Changed. Most Programs Haven’t HRSA’s 340B Program Integrity strategy, active since the mid-2010s and accelerating through the early 2020s, has produced a steady cadence of covered entity audits. The agency’s publicly available findings database shows that duplicate discounts, patient eligibility failures, and contract pharmacy documentation errors remain the most cited issues year after year. That’s not a coincidence. These are the exact areas where accountability diffuses across departments that were never designed to own 340B compliance. What the data doesn’t show is how many covered entities are operating on compliance programs that made sense when they were built but haven’t kept pace with regulatory changes, contract pharmacy restrictions, or the documentation standards HRSA now applies in the field. The advice that sounds confident in a presentation can quietly unravel under audit conditions. The gap isn’t usually intent. It’s infrastructure. Consider a federally qualified health center that enrolled in 340B years ago, built a reasonable set of internal controls, and hasn’t had a formal compliance review since. On paper, the program looks clean. In practice, patient definition documentation hasn’t been updated to reflect current HRSA interpretations, and contract pharmacy records have gaps that wouldn’t survive an OPA document request. The savings the program generated were real. So were the compliance gaps that had quietly accumulated. That scenario is more common than most program managers want to believe. Ponaman’s approach centers on what they call compliance infrastructure. Not a one-time checklist, but a documented, metrics-driven framework that maps accountability to specific roles, tracks KPIs against HRSA audit criteria, and creates a defensible record before an auditor ever walks in the door. Their team includes consultants, auditors, analysts, and medical and legal specialists who work across the full 340B program lifecycle: enrollment, implementation, compliance review, and audit support. For covered entities already under audit, Ponaman’s 80% success rate on overturning findings reflects that documented infrastructure. Because appeals won on paperwork, not arguments.

Executive Quotes “The assumption that a clean-running program is an audit-ready program is the most expensive mistake a compliance officer can make. HRSA doesn’t audit your intentions. They audit your documentation, your eligibility determinations, and your duplicate discount controls. If those records can’t tell the story on their own, your program’s track record won’t save you.” – Ponaman Healthcare Consulting “Sixty-seven percent of the audits we’ve supported ended with zero findings. That number isn’t about luck or auditor relationships. It’s about what was already in place before the audit started. The covered entities that come out clean are the ones who treat compliance as an ongoing operational discipline, not an emergency response. The ones who call us after an audit notice arrives are starting from a harder position. And it shows in the outcomes.” – Ponaman Healthcare Consulting

About Ponaman Healthcare Consulting

Ponaman Healthcare Consulting provides expert 340B drug pricing program consulting and compliance services to healthcare providers enrolled in or seeking to enroll in the HRSA 340B program. The firm has supported 148 HRSA audits across covered entity types, achieving a 67% zero-findings rate and an 80% success rate in overturning audit findings on appeal. Ponaman’s team of consultants, auditors, analysts, and medical and legal specialists works across every stage of the 340B program lifecycle. From enrollment and implementation through compliance review and audit defense. With a mission to help safety-net providers protect program savings and the patients who depend on them.

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Company Name: Ponaman Healthcare Consulting
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City: Phoenix
Country: United States
Website: https://ponaman.com/