Continuous Monitoring (340B)
Definition
Continuous monitoring is a proactive compliance approach that replaces or supplements periodic audits with ongoing, regular review of program data and operations. Rather than discovering compliance issues once a year (or when HRSA comes knocking), continuous monitoring identifies problems as they occur, when they are still small and manageable.
A continuous monitoring program typically includes regular review of transaction data for diversion indicators, duplicate discount risk monitoring, OPAIS data accuracy checks, contract pharmacy performance reviews, and split-billing software configuration audits. The frequency and scope of monitoring activities are calibrated to the entity’s risk profile.
Continuous monitoring is particularly valuable for covered entities with complex programs, high transaction volumes, or multiple contract pharmacy arrangements. It creates a documented record of ongoing compliance oversight that is itself evidence of a mature compliance program—which HRSA views favorably.
Frequently Asked Questions
Why Continuous Monitoring (340B) Matters
Annual audits find problems that have been accumulating for a year. Continuous monitoring finds them while they are still small. For high-volume programs, even a few months of undetected compliance issues can generate significant repayment exposure. Continuous monitoring is the most cost-effective way to protect savings and program integrity.
How Virtue 340B Uses It
340B Continuous Monitoring is a core Virtue 340B service. We provide ongoing, structured oversight of covered entity programs, delivering regular reporting on compliance status, flagging emerging issues, and providing guidance on remediation—so our clients always know where their program stands.