PHOENIX, AZ- September 15, 2026 – Covered entities that align their fiscal year to the federal one are closing it this month, and for 340B programs the close is a documentation deadline as much as a financial one. Ponaman Healthcare Consulting, a 340B consultancy whose covered-entity clients range from disproportionate share hospitals to federal grantees, has set out what it advises entities to have on paper before the September 30 date, and what it advises them not to attempt in the time remaining.
In the firm’s experience across the entities it supports, program integrity reviews and compliance audits cluster around the fiscal-year close, which concentrates a year of 340B evidence-gathering into the weeks when pharmacy, finance and compliance staff are least available.
“An audit does not test how well you understand the rules, it tests records that already exist,” said Scott Ponaman, president of Ponaman Healthcare Consulting. “By the time an engagement letter arrives, the evidence is whatever it is. So the useful work in September is not fixing anything. It is finding out honestly what you can and cannot produce, and writing that down while you still have a choice about what to do next.”
Four Places Where a Control Exists and the Evidence Does Not
The firm identifies four areas where covered entities most often find that something they believe is operating cannot be demonstrated on paper.
The first is written policy. HRSA’s published audit procedures include a review of relevant policies and procedures and how they are operationalized, so a policy describing a process the organization has stopped following is a liability rather than a protection.
The second is the entity’s 340B OPAIS record. HRSA lists the accuracy of that record inside what an audit verifies, which makes an outpatient facility listing or contract pharmacy arrangement that no longer matches operational reality an audit exposure rather than an administrative untidiness.
The third is Medicaid exclusion. HRSA’s verification covers HRSA Medicaid Exclusion File designations, and whether those designations match current billing practice is a question that can only be answered by the 340B team and the revenue cycle team in the same room.
The fourth is patient eligibility. The determination process needs to be written down and applied consistently, because HRSA verifies the internal controls that prevent diversion, including how an entity defines whether a patient is inpatient or outpatient.
HRSA sets out its audit scope, procedures and self-disclosure process on its program integrity page.
Correcting the Record Rather Than Repairing It
Ponaman Healthcare Consulting advises against treating the fiscal-year close as an opportunity to improve the historical record. Where an entity identifies non-compliance, HRSA operates a published self-disclosure process, and the firm advises entities to consider that route with qualified advice rather than adjusting documentation in a way that cannot be explained later.
It also advises confirming current requirements directly with HRSA rather than relying on secondhand summaries, since 340B procedures and manufacturer conditions have both changed repeatedly.
The firm has supported 148 HRSA 340B audits, reports an 80% success rate in overturning 340B audit findings, and states that its clients are 67% more likely to have a HRSA audit without any 340B findings, figures published on its home page. Its existing guidance on audit preparation remains available as a published resource, alongside its note on protecting 340B savings during HRSA audits.
About Ponaman Healthcare Consulting
Ponaman Healthcare Consulting is a national 340B consulting firm working with covered entities including disproportionate share hospitals, critical access hospitals, federally qualified health centers, and other eligible grantees. The firm provides 340B program implementation support, compliance monitoring, program integrity audits, independent external audits, and HRSA audit support. Its team includes 340B consultants, auditors, and analysts supported by medical and legal specialists. Full service detail is available on the firm’s 340B services pages, including HRSA 340B audit support and program integrity audits.
Media Contact
Peta Russell Ponaman Healthcare Consulting [email protected] 480-421-9965 Media and speaking inquiries via the firm’s contact page
Media ContactCompany Name: Ponaman Healthcare ConsultingContact Person: Peta RussellEmail: Send EmailPhone: 480-421-9965City: PhoenixCountry: United StatesWebsite: https://ponaman.com/
