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Sustainability: The fifth and final pillar for 340B program compliance

By Craig Frost

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

During the last month, I have written about what we call the five pillars of 340B program compliance. Regardless of the solution that 340B program managers employ to ensure compliance for their covered entity, the approach a team takes must rest on these pillars to ensure success. In earlier blog posts, I have covered the pillars of standardization, accountability, visibility, and efficiency. Today’s topic is sustainability.

It is not uncommon for 340B program directors to say they depend on a few key people to keep their process on track. When one of those individuals takes a vacation, it can hit the pause button on a program’s forward progress. If a key person retires from the organization, the program loses institutional know-how. Churn and job changes are a fact of life in healthcare. Sustainability helps 340B programs achieve independence from constantly turning to and relying on one or two key people’s institutional knowledge. Sustainability means having a system in place to collect, retain and grow the program’s knowledge and move forward regardless of who leads or makes up the 340B team.

Each of the five pillars shares the weight of a solution for ensuring 340B program compliance. But sustainability is unique in its focus on the future. Sustainability is all about keeping things together for the next month, quarter, and year. While the other pillars (i.e., standardization, accountability, visibility, and efficiency) have implications for the future, they are mostly about managing the work that has already happened (e.g., looking at pharmacy service agreements or disproportionate share hospital percentages for DSH entities in the Medicare cost report). Sustainability ensures a 340B program can weather the storm to come.

Compliance software is one solution for providing a program with sustainability. A good solution will help a 340B program team define its process within the software. Software like this can also alert stakeholders to tasks, deadlines, and report on the status of all manner of compliance-related work.

Well-designed compliance software will also help a 340B program team cover every area of compliance that the U.S. Health Resources & Services Administration wants to see. If a 340B program team has a deficiency, compliance software will let them know about it. Sectyr’s SectyrHub 340B compliance software does this through a color-coded dashboard with key program metrics that change from green to yellow to red based on the status of supporting documents, tasks, audits, or policies. Compliance software forces a 340B program team to think about whether they have each compliance element met and guides them through the workflow required to achieve compliance. By automating 340B compliance processes and centralizing the management of dashboards, documents, audits, and compliance performance, everyone across the organization gains working knowledge of how to continuously comply with HRSA requirements. That, in turn, delivers sustainability.

Why turn to compliance software when there are consultants to help with sustainability?

According to a northeastern U.S. university health network’s 340B program manager, when it comes to sustainability, compliance software complements her 340B consultants. “SectyHub automatically alerts us to what HRSA would look for, and we can act on it because the system sends reminders for edits, renewals, whatever,” says the 340B program manager. She notes that SectyrHub 340B synchronizing daily with the OPAIS “has been huge” because her 340B consultant would not take on work like this.

With compliance software in place, a 340B program that cannot afford to have a consultant on staff full-time can continually control its compliance strategy. At least a third of the 340B program managers I speak with say getting up to speed on a 340B strategy and associated tasks was like a baptism of fire. Many managers have to learn to construct and assess their programs without help. If, for example, the previous 340B manager leaves under a black cloud, the new manager might take a year figuring out things while spending deeply on consultants to help draw a picture of what is necessary to stay compliant.

With compliance software ensuring sustainability, even if there is a change in 340B leadership, the covered entity is not taking a financial risk by wondering if something in its program is missing, overlooked, or noncompliant. That is because a program’s institutional knowledge, process, and policies reside in one place as one source of truth.

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