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Who’s responsible for 340B compliance?

Last May, we penned a blog series about what it takes to successfully comply with the 340B program. We posited compliance rests on five pillars, which are standardization, accountability, visibility, efficiency, and sustainability. Our aim with the posts was twofold:  Inform readers about each pillar but also clarify the roles people and technology play to ensure continuous compliance. In this post, we sum up our series and touch on the role compliance management software plays vis-à-vis consultants, and TPAs.

Act I:  Compliance Software and the Five Pillars

Compliance Management Software

An award-winning performance rests on a script that everyone works from. Consider that script a kind of standardization, which is the first pillar of continuous program compliance. Implementing a compliance software system standardizes the analysis and tracking of 340B program data required by auditors from the U.S. Health Resources & Services Administration. A 340B program team needs a software tool for imposing and maintaining a structure and for accessible and well-defined scripts, or workflows.

A 340B program manager can improve accountability, which is the second pillar, by automating the management of tasks with compliance software. A director should be able to assign tasks to each responsible party, regardless of what team they are on or what organization they work for. They should then be able to easily report on task status and verify that the task’s owner completes the job satisfactorily without having to jump between systems. Accountability is further improved when each team member can see their tasks, what is expected, and when it is due from within the same system used to store and manage compliance documents.

The third pillar of continuous program compliance is visibility. Think of visibility as the scoreboard for a 340B program. Are you relying on people or technology to keep score? With real-time visibility of program compliance, CFOs and managers understand their level of exposure and mitigate financial risk with timely, corrective measures.

While some program directors manage a 340B program without compliance software, they admit spending a lot of time juggling the intricacies. With technology that injects efficiency (the fourth pillar of program compliance) into the process, a 340B program can move from always looking back at what has (or has not) been accomplished to advancing the program in financially beneficial ways.

Job changes are a fact of life in healthcare. Sustainability (a compliance program’s fifth pillar) helps a 340B program free itself from relying on one or two key people’s institutional know-how. Like a Broadway play, every actor in a 340B program should have an understudy. Sustainability means having technology to collect, retain and grow the program’s knowledge regardless of who makes up the 340B cast. By automating 340B documents, audits, and compliance performance, everyone gains a working knowledge of how to continuously comply with HRSA requirements.

Act II: The role played by consultants, TPAs

For a 340B manager, compliance management software forms the critical triangle with consultants and TPAs. In addition to supporting audit preparation activities, compliance management software helps identify compliance deficiencies; it is a tool that consultants, TPAs, and 340B program teams can use to spot problems that arise between audits. It can help a consultant and client uncover and resolve issues before resulting in a fine, finding, or worse.

A 340B program manager for a Northeast university health network put it best when she said, “Sectyr’s compliance management software is complementary to our consultants because it synchronizes daily with the OPAIS; that’s 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. Savvy 340B program managers understand the value of tapping multiple resources (e.g., consultants, TPAs, and compliance software) to comply with HRSA regulations. But as any 340B consultant or TPA will offer, they are not responsible for paying a fine should a covered entity face a manufacturer payback, contract pharmacy underpayment, or penalty from HRSA. Consultants and TPAs are critical for helping a covered entity appropriately manage its 340B program and, thus, generate revenue. But what good is revenue if it is lost through documentation deficiencies or procedural errors?

Act III:  Bringing it all together

340B managers can maintain continuous compliance by standardizing processes and accountability with compliance management software. SectyrHub gives every actor visibility and sustains a 340B program through regulatory, organizational, contractual, or staffing changes. Technology, like SectyrHub, for maintaining continuous compliance is often mistaken for something third party administrators offer. While some TPAs offer similar services, health leaders say TPA-agnostic software like SectyrHub plays a unique role. While consultants and TPAs play important supporting roles, responsibility for program compliance ultimate rests with 340B managers who also need compliance management software to round out their cast.