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Who’s responsible for 340B program compliance?

Managing a 340B program and ensuring continuous compliance takes resources beyond consultants and third-party administrators. A 340B program manager can sign up a consultant to run an annual integrity audit and tap multiple TPAs to review transactions. But neither can help a manager achieve around-the-clock compliance.

For a 340B program manager, compliance management software forms a critical triangle with consultants and TPAs. Compliance management software offers up-to-the-minute tracking of where a program’s problems lie. While compliance software won’t fix a problem, it’s a tool that consultants, TPAs, and 340B program teams can use to spot problems. In fact, the 340B program manager for a Midwest university medical center recently told us that his compliance management software “does the thinking and reminding to keep us true to [our program] plan, so we’re audit-ready.”

There are many kinds of consulting engagements, of course. Some engagements cover the annual program integrity audit and may include scheduled quarterly or monthly reviews. Others may include retainers for on-demand consultation and on-going program optimization. The size and scope of the engagement largely depends on how much the covered entity can afford and its staff’s 340B knowledge. Regardless of the consulting engagement’s duration or scope, compliance management software can help a consultant and client uncover and resolve issues before resulting in a fine, finding, or worse.

In fact, the 340B program manager for a Northeast university health network believes Sectyr’s compliance management software (known as SectyrHub 340B) is complementary to her 340B consultants. She notes how synchronizing daily with the Office of Pharmacy Affairs Information System “has been huge” because a consultancy wouldn’t take on work like this. In the past, she says, her team would manually review up to 70 of these contracts each quarter. SectyrHub 340B flags OPAIS data discrepancies as they occur. 340B program managers like her understand the value of tapping multiple resources (e.g., consultants, TPAs, and compliance software) to comply with HRSA regulations.

As any 340B consultant or TPA will tell you, the responsibility for compliance rests with the 340B program manager. Consultants and TPAs, for a variety of reasons, come and go. None are responsible for paying a fine should a covered entity face a manufacturer payback, contract pharmacy underpayment, or penalty from HRSA.

To be sure, consultants and TPAs are critical for helping a covered entity appropriately manage its 340B program and, thus, generate revenue. But what good is the appearance of generating revenue if it is eventually lost through documentation deficiencies or procedural errors? Overall program compliance is outside the scope of a TPA agreement. And while overall program compliance and audit-readiness are typically within the scope of a 340B consulting engagement, the cadence is episodic.

In contrast, 340B managers can put in place continuous compliance by standardizing processes and improving accountability with SectyrHub 340B. This, in turn, gives stakeholders visibility into compliance, improves efficiency, and sustains a 340B program through regulatory, organizational, contractual, or staffing changes. Ultimately, program compliance rests with the 340B manager.