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For 340B Program compliance, visibility is the third pillar

By Craig Frost

Craig Frost, President Sectyr®
Craig P. Frost, RPh, MBA, FACHE
President & COO, Sectyr

Managing a 340B Program is a difficult practice, and, too often, program directors rarely have the high-level visibility to spot trouble as quickly as they would like. In fact, if 340B Program directors can’t see something, then how can they manage effectively? When stakeholders ask if a covered entity’s program is compliant, directors often make an educated guess. These blind spots cause program directors to teeter between worry and exposure to lost revenue, fines or worse.

No covered entity would purposely manage a 340B Program by lurching from one HRSA audit to the next. Imagine relying on the auditor to tell a director what was wrong with a program, having the program team fix it, and then fall out of compliance for another reason before the next audit. But without sufficient resources, the circumstances begin managing the program. This sort of thing unintentionally happens when there’s a lack of visibility. Think of visibility as the scoreboard for a 340B Program. Visibility–as a pillar for supporting continual 340B Program compliance–is a tactic.

Either you’re manually keeping score, or you lean on technology. Without technology, you’re watching the “game,” while scribbling notes to yourself and hand-turning the score after every “play.” Scorekeeping might be fun to watch from your seat at Wrigley Field, which is one of two Major League Baseball parks where people still work in the scoreboard manually flipping metal sheets with painted numbers for runs, strikes, outs, etc. But keeping score by hand, well, Wrigley Field scoreboard operator Darryl Wilson once told a CBS reporter, “This is serious work, you’re gonna bleed in here.”

Visibility, scorekeeping through technology

With compliance software, a 340B Program director has a digital dashboard to keep score seven days a week, 365 days a year. A digital scoreboard gives a program director an automatic, up-to-the-minute look at the status of, for example, self-audits, OPAIS data, and tasks requiring attention. Compliance software stretches a team’s resources. That is a critical consideration because a TPA or consulting engagement does not typically include this kind of work. The expense of a consultant working for you in a full-time capacity can be considerable. The nature of a consultant’s work is typically episodic. In contrast, compliance software, like SectyrHub® 340B, is always on and gives a covered entity’s 340B Program stakeholders around-the-clock visibility into the program’s compliance performance. By way of background, SectyrHub 340B is a software platform that creates one source of truth for analyzing and tracking the 340B Program data required by auditors from HRSA.

Compliance software also tells 340B Program directors the status of their program including the financial risks. With real-time visibility of program compliance, directors can gain a better understanding of their level of exposure and mitigate the financial risk with timely, corrective measures. In this way, visibility underpins continuous program compliance. The visibility that comes from a system like SectyrHub 340B also supports accountability, which I mentioned in my last blog post. If a team member fails to complete an assignment, both the responsible person and the program director will have the visibility into what was missed. With a system like SectyrHub 340B, the status of every task is visible.

Craig Frost, RPh, MBA, FACHE, is the president and COO of Sectyr, LLC where he manages operations and facilitates an innovative team to develop and market tools that enable best practices for continuous compliance.

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Five Pillars of 340B Program Compliance