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A 340B policy is the written description of how a covered entity runs its program. Joshua Free, PharmD, MBA, founder and president of Nelco Advisory, audits those programs every year, and explains where the policy and daily operations drift apart and how to close the gap.
What does your 340B policy say that your team isn't actually doing? Joshua Free audits 340B programs for a living, and the first contradiction he usually finds is a steering committee the policy describes and nobody has ever convened.
Joshua has sat in the operator, advisor and builder seats: retail and long-term care pharmacy, a health system where 340B reported up to him, chief pharmacy officer, and now Nelco Advisory and RxFusion. He walks host Muhammad Atif through why every entity should have an annual independent audit, why a TPA's yes on a claim is not proof, and why a policy written at procedure level is guaranteed to fall out of date.
He also covers the CMS Part D repository, the 2027 rebate pilot, where AI helps and where it confidently gets things wrong, and the one control to test this quarter.
Recorded 1 October 2026.
The three places 340B policy and practice most often drift apartWhy every covered entity should have an annual independent auditWhat "independent" should mean for a 340B auditHow to design internal audits around your known weak spotsWhy a TPA's qualification logic is not an auditWhy policy and procedure belong in separate documentsWhat to build for the CMS Part D repository and the 2027 rebate pilotHow to use AI in 340B without creating another black box
00:00 Cold open: where policy and practice first contradict
01:22 Welcome to 340B Pulse
01:50 Joshua's path: retail, long-term care and health system 340B
03:35 RxFusion and provider office dispensing
04:11 Nelco Advisory: audit, strategy and compliance support
06:06 Is RxFusion a TPA? How office dispensing works in the clinic
07:40 PrEP at the point of care
08:50 The first contradiction: a steering committee that never met
10:17 Why the gap exists: change, staffing or governance
11:53 What an annual independent audit should cover
13:34 Mock HRSA audits and choosing your risk position
15:08 Multi-site and multi-entity programs
17:09 Keeping TPA and EHR logic in line with policy
19:07 What proof to ask your TPA for
21:41 What changes should trigger a policy review
23:39 The CMS Part D repository and the 2027 rebate pilot
26:26 Where AI helps without becoming a black box
28:52 Rapid fire round31:02 Closing
Where do 340B policies and operations most often disagree? According to Joshua Free, the most common gaps are a policy that references a 340B steering committee that never meets, training standards that are missing or impossible to meet, and Medicaid carve-in or carve-out status that doesn't match practice.
Should 340B policy and procedure be in the same document? Joshua Free recommends keeping them separate. The policy sets governance and controls, while procedure documents change with daily operations, so a TPA interface update doesn't require going back to the policy committee.
What one 340B control should a covered entity test this quarter? Duplicate discount prevention. Joshua Free calls it one of the harder things to get right, one of the easier things to test, and an area that both HRSA and manufacturers look at closely.
