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… Read More »Who’s responsible for 340B program compliance?
Continuous Program Compliance
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.
One way to reallocate time is with compliance software. With software that automatically analyzes and tracks the data HRSA auditors require, managers gain efficiency while keeping their 340B program in good standing. With a software system keeping tabs on what must be done, 340 program managers can focus on strategies for enhancing their 340B program instead of shoring up compliance.
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.
By automating the management of documents with compliance software, a director can assign tasks to each responsible party and verify the owner completes the job. Accountability is further improved when each team member can see their tasks, what’s expected, and when it’s due. Visibility is equally important for compliance. And in my next post, I’ll explore the role visibility plays for compliance.
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.
Nearly every healthcare CFO whose organization participates in the 340B Drug Pricing Program is familiar with (and understands) the risks associated with non-compliance. What most misunderstand is the severity of the cost of non-compliance. For example, the U.S. Health Resources & Services Administration requires 340B Program participants to ensure pharmaceutical makers aren’t giving duplicate discounts on drugs provided to 340B covered entities. If a 340B covered entity unwittingly submitted such claims the organization would have to pay back, potentially, millions of dollars to the drug maker. A penalty hurts for two reasons: 1) the possible size of the repayment, especially since most covered entities run on a thin profit margin, hovering around three percent, and 2) the time lapse between the claim error and discount repayments (i.e., the covered entity has generally closed its books… Read More »Do you have real-time situational awareness of 340B financial risks?
Sectyr®, a leading provider of 340B Program management solutions, today announced the first release of the new SectyrHub® 330 HRSA grant compliance tool for Federally Qualified Health Centers and Look-Alikes. Guided workflows walk staff through all required elements of compliance and dashboards help highlight anything that needs to be addressed. Once full compliance is achieved it’s easy to maintain through innovative continuous compliance tasking that can be tailored to meet the needs of each health center.