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340B Policies and Procedures: 5 Gaps Audit

340B Policies and Procedures: The 5 Gaps Audits Find and How to Close Them

340B program, 340B Compliance, 340B Policies /

By NorthArc Health, with Joshua Free, PharmD, MBA. Last updated 28 October 2026. 340B policies and procedures are the written rules a covered entity uses to govern its program: who oversees it, how claims qualify, how duplicate discounts are prevented, and how compliance is checked. They matter because HRSA audits the program against them. When […]

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Pharmaceutical packaging, financial strategy reports, and 340B workflow diagrams on an executive desk.

The 340B Rebate Model: Cash Flow, Claims Data, and Compliance Challenges

340B Compliance /

The 340B Drug Pricing Program helps eligible healthcare providers stretch limited resources to serve patients and communities in need. However, the proposed shift from upfront discounts to rebates for selected drugs could introduce new financial, technical, and compliance challenges for covered entities. Understanding the 340B Rebate Model Established in 1992, the 340B Program enables eligible

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340B claims data submission

340B Claims Data Submission: What It Actually Costs an FQHC Pharmacy

340B Compliance, 340B Contract Pharmacy, FQHCs /

340B claims data submission is the process of taking a dispensed prescription, generating a data file through a third-party administrator (TPA), and uploading it to a manufacturer portal within a fixed window, usually 45 days, to keep the 340B price on that claim. For a well-staffed hospital system, that process runs in the background. For

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340B audit readiness

340B Audit Readiness: The 7 Controls That Hold When Nobody Is Watching

340B program, 340B Compliance /

Most 340B programs can produce a binder in three weeks. Very few can explain what their controls were doing in the eleven months before the letter arrived. That gap is the whole subject of this article, and it is where 340B audit readiness either exists or does not. Everything below is drawn from an operator

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contract pharmacy restrictions

Contract Pharmacy Restrictions: 6 Rules That Actually Work

340B Contract Pharmacy, 340B program, Uncategorized /

Most coverage of contract pharmacy restrictions is written from the outside. It tracks lawsuits, manufacturer policy announcements, state legislation, and federal uncertainty. All of that matters. None of it tells you what happens inside a health center on the Monday morning after a new policy drops. Thomasyna Sweed knows that Monday well. She is Program

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multi-state 340B program

Multi-State 340B Program Management: How Health Systems Scale Without Losing Control

Multi-State 340B Program /

A multi-state 340B program is a single covered-entity operating model applied across hospitals, clinics, pharmacies, vendors, and state regulatory environments that do not match each other. It scales when the organization standardizes its compliance core, documents every justified local exception, and governs vendors on outcomes rather than service levels. That distinction sits at the center

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340B operations

340B Operations: The 7 Habits That Protect a Program Before Anything Goes Wrong

340B program, 340B Compliance /

Strong 340B operations are a set of small, repeatable habits: running the reports that show where prescriptions actually go, reviewing what failed to capture, checking wholesaler invoices against the 340B price, and owning the program rather than delegating it to software. Programs that build these habits absorb pricing and regulatory pressure. Programs that skip them

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Duplicate discount prevention

Duplicate Discount Prevention: What Actually Has to Work Behind the Scenes

340B program /

Duplicate discount prevention is the process of ensuring a covered entity never claims both a 340B discount and a Medicaid rebate on the same drug unit. It sounds like a narrow compliance task. In practice, it depends on data quality, billing accuracy, Medicaid decisions, vendor processes, and ongoing review working together, which is exactly why

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