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Standardization, the first of the five pillars for 340B Program compliance

By Craig Frost

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

I think of quality in terms of management. Admittedly, I geek out a bit when it comes to learning and reading about management practices. Many management models mention standardizing processes as a core tenet. Standardization is a way for managers and staff to achieve consistent outcomes.

In healthcare, the stakes are often high. For instance, a surgical team will have a standard method for preparation. That way, if a variance comes up during surgery, everyone on the team is ready. In 1966, Avedis Donabedian, a health services researcher and physician, created a model for evaluating the quality of health care drawn from outcomes, processes, and structure. Elements of the Donabedian model are applicable to managing a 340B Program.

The team maintaining the 340B Program at a covered entity needs to ensure that policies, procedures, and audit plans are followed consistently across the organization. Standardization doesn’t mean a team never varies its approach. Rather, standardization helps the team achieve the covered entity’s desired outcomes–compliance and fiscal health.

An organization may have policies and procedures in place. But how well does the staff follow the policies and procedures and what sort of guardrails are in place to ensure compliance? Do managers have a way to see how closely people are adhering to the policies? If a program’s documentation or contracts require updating or amending, how quickly would a manager learn about that? Hopefully, it wouldn’t take a HRSA audit to trigger the manager to realize some element of his or her 340B Program was out of compliance.

Technology as a framework for standardization

A 340B Program manager recently told our company that compliance software is what “keeps our policies and procedures, documents, contracts, and everything in one place. The software alerts us when we need to make a change to reflect changes in OPAIS or on the HRSA website.”

Implementing a compliance software system standardizes the analysis and tracking of 340B Program data required by auditors from HRSA. Not all compliance software systems are equal, though. If standardization is the aim, a manager will also want a system that includes logic-based, 340B-specific workflows for monitoring recertifications and corrective plans. It’s important to have a tool for imposing a structure and for visible and well-defined workflows.

But our consultant does that

Healthcare consultants play an important and valuable role advising clients about 340B Program decisions, audits, compliance, and monitoring. But should an organization add a consultant to its staff permanently?

340B Program managers often write policies and procedures in an aspirational way but have little visibility into what’s being done and how. The challenge is not in defining the policies but in ensuring they are followed. Compliance software like SectyrHub 340B can help a program manager see how well coworkers are following policy and procedure the consultant has helped it establish. Compliance management systems also serve up reports on a program, which a 340B Program manager can make visible to executives–between annual audits or quarterly meetings. This isn’t work a 340B consulting engagement typically includes. But the job is no less important.

Ultimately, SectyrHub 340B enables covered entities to see that its policies and processes are being followed and applied consistently, reliably, and predictably. That’s a management model everyone can standardize around.

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