Episode Summary
In this episode of 340B Pulse, host Muhammad Atif speaks with Mark Capuano, PharmD, MBA, who leads 340B and supply chain work in corporate pharmacy at NYC Health + Hospitals, the largest public health system in the country, spanning 11 hospitals and a large FQHC network. Mark built his 340B career starting at NYU Langone in 2015, moved to NYC Health + Hospitals in 2021, and has now been through 10 HRSA audits combined across both systems. His central claim is one most audit checklists miss: the failures he has seen are almost never a single catastrophic gap. They are small, unmonitored logic drift an Epic build for a UD modifier or an actual acquisition cost calculation that quietly stops matching the rule it was built for left unchecked until an auditor's transaction trace exposes it. He walks through how HRSA's child-site structure turns location tracking into a yearly reconciliation project, what a strong transaction narrative actually requires from patient class down to provider credentialing, and why he still trusts an in-house team's judgment over a TPA's "system logic" answer.
Show Notes
- The true definition of audit readiness is not a fast binder, it is a program that can explain an ordinary day.
- Why most operators falsely assume a well-organized program and a well-controlled program are the same thing.
- The critical difference between a documentation problem and a workflow problem when something goes wrong in an audit.
- Why Medicaid billing is one of the most consistently tricky areas across a HRSA audit, since every state applies different rules.
- How HRSA's child-site structure turns an off-site clinic into a yearly reconciliation project against the Medicare cost report and trial balance.
- The true cost of unmonitored logic drift, like an Epic build for a UD modifier or an actual acquisition cost rule nobody is rechecking.
- Why Mark would rather tell an auditor "let me look into this and get back to you" than answer a nuanced question on the spot.
- How a single 340B transaction has to clear patient class, location eligibility, provider credentialing, payer status, and medication exclusions before it qualifies.
- Key Insights and Takeaways
- Mark Capuano, PharmD, MBA, leads 340B and supply chain work in corporate pharmacy at NYC Health + Hospitals.
- NYC Health + Hospitals is the largest public health system in the country, with 11 hospitals and a large FQHC network.
- Mark's 340B career began at NYU Langone in 2015, and he moved to NYC Health + Hospitals in 2021.
- He has now been through 10 HRSA audits combined across both systems, nine of them at NYC Health + Hospitals alone.
- The data request list that comes with a HRSA audit letter does not change dramatically year to year, so teams that assemble it ahead of time save significant time later.
- In mixed-use and split-billing settings, HRSA wants to see multiple layers of checks, including proof the patient was 340B-eligible in both the EMR and the split-billing software.
- When the same exception shows up across five claims, the team has to decide whether it is a one-off fix or a systemic issue that needs RevCycle, the Epic build team, compliance, or legal.
- Mark treats "the TPA handled that" as an answer that needs validation, not an answer that closes the question.
- The one mistake he says an organization never wants to make is billing Medicaid incorrectly, since that risks Medicaid fraud and False Claims Act exposure for the whole organization, not just the 340B program.
- Mark sees AI's near-term role as pulling disparate 340B claims data into one master warehouse so small cracks get caught before they grow into bigger problems.
- He still wants human validation before AI-prepared evidence goes to an auditor, even as that trust develops over time.
- He does not see the 340B program disappearing, since federal law ties Medicare and Medicaid participation to offering 340B pricing to covered entities.
- He does expect it to keep getting harder to generate the same level of 340B savings, with more transparency and data-sharing expected from covered entities going forward.
- His rapid-fire advice includes knowing that the emergency room is typically a mixed-use area and infusion centers are typically clean sites, two departments every 340B leader should understand well.
- His single best piece of advice after 10 audits is that the work is doable if you prepare, follow the data request list, and run real outside mock audits with a strong outside group.
- He closes with the reminder that a successful HRSA audit takes a village, since many of the documents an audit requires come from outside the pharmacy department entirely.