Policies and Procedures (P&P)
Definition
Policies and procedures (P&Ps) are the written operational framework for a covered entity’s 340B program. HRSA expects covered entities to have written P&Ps that address all major compliance areas, including patient eligibility determination, diversion prevention, duplicate discount prevention, contract pharmacy management, split-billing software oversight, vendor management, and staff training.
P&Ps must accurately reflect actual operations. A policy that describes a process the entity does not actually follow is potentially worse than having no policy at all, because it creates a documented gap between stated and actual practice that HRSA auditors will identify.
P&Ps should be reviewed and updated at least annually and whenever significant operational changes occur. They should be specific enough to provide operational guidance, not so generic that they could apply to any covered entity. HRSA auditors review P&Ps to assess whether the entity has a genuine compliance infrastructure, not just paperwork.
Frequently Asked Questions
Why Policies and Procedures (P&P) Matters
P&Ps are one of the first things HRSA requests in an audit. Well-written, current P&Ps that accurately describe actual operations demonstrate program maturity and compliance intent. Absent or outdated P&Ps are a red flag that often leads to deeper scrutiny.
How Virtue 340B Uses It
Virtue 340B reviews P&P quality and currency as part of every audit engagement. We identify gaps, outdated content, and misalignment between documented policies and actual operations, and we help entities develop P&Ps that are accurate, specific, and audit-ready.