340B Compliance Insights: Expert Guidance for Healthcare Organizations

13 Oct How Should You Handle 340B Audit Remediation From Tasking to Closure?

Posted at 10:30 AM in Blog by Scott Ponaman

Handle a HRSA 340B audit as one engagement with five owners and three clocks. Name a single response owner the day the engagement letter arrives, decide who may speak to the auditor, answer the document request from records you already hold, respond to the Final...

Read More

06 Oct The 340B GPO Prohibition Is Still Law After the Court Vacated HRSA’s 2013 Policy

Posted at 10:30 AM in Blog by Scott Ponaman

The 340B GPO prohibition is the statutory rule that stops disproportionate share hospitals, children’s hospitals and free-standing cancer hospitals from buying covered outpatient drugs through a group purchasing organization. On March 31, 2026 a federal court vacated HRSA’s 2013 policy on how that rule applies...

Read More

22 Sep Registering, Recertifying and Keeping Your 340B OPAIS Records Straight

Posted at 10:30 AM in Uncategorized by Scott Ponaman

If you came here for the login, it is at the 340B OPAIS site and this post will not help you find it faster. What follows is for the person who has to keep the record behind that login accurate, because that record is read...

Read More

15 Sep Who Actually Qualifies as a 340B Patient After the Court Rulings

Posted at 10:30 AM in Uncategorized by Scott Ponaman

Two things are true at once and the gap between them is where compliance officers get into trouble. A federal court rejected HRSA’s narrow reading of who counts as a 340B patient. And HRSA still audits against the 1996 guidelines. If you are deciding today...

Read More

08 Sep What 340B ESP Asks For and How to Submit Without Losing Discounts

Posted at 10:30 AM in Uncategorized by Scott Ponaman

A pharmacy director asked us recently why a manufacturer had restricted their contract pharmacy access when nobody at the entity had done anything differently. The answer was a submission that had quietly stopped running four months earlier, when the analyst who owned it changed roles....

Read More

04 Sep 340B Audit Requirements and the Documents That Satisfy Them

Posted at 10:30 AM in Uncategorized by Scott Ponaman

Most audit-readiness material tells covered entities to be ready. It does not tell them what “ready” means in evidence. Below is the other version. For each thing HRSA reviews, the record that answers it, taken from HRSA’s published audit scope and process rather than from...

Read More

31 Aug Building a WAC Spend Recapture Workflow for Your 340B Program

Posted at 9:00 AM in Blog by Scott Ponaman

Every covered entity running a replenishment model buys some drugs at wholesale acquisition cost that should have been replaced at 340B pricing. Not because anyone did anything wrong, but because an eligible dispense did not accumulate, a mapping was missing, or a package never triggered....

Read More

26 Aug How to Evaluate 340B Consulting Firms and Audit Companies

Posted at 9:00 AM in Blog by Scott Ponaman

Most covered entities run this selection once every few years, which means the process is rarely practiced and the criteria are usually invented under time pressure. We sit on the other side of it constantly, and the pattern is consistent. Entities compare firms on price...

Read More

24 Aug When to Hire a 340B Program Consultant and What They Deliver

Posted at 9:00 AM in Blog by Scott Ponaman

Nobody hires a 340B program consultant because things are calm. They call when something changed and the program did not change with it. A merger. A new service line. A TPA switch. A finding. Or the slower version, where the program grew from four sites...

Read More

17 Aug 340B Audit Findings, Severity, and Remediation

Posted at 9:00 AM in Blog by Scott Ponaman

An audit letter is not the moment your program is judged. It is the moment your last three years of record keeping gets read back to you. Covered entities that come through well are not the ones with perfect programs. They are the ones who...

Read More