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340B Program Management

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.

Who’s responsible for 340B program compliance?

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?

Sustainability: The fifth and final pillar for 340B 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.

Efficiency, the fourth of five pillars for 340B program compliance

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.

For 340B Program compliance, visibility is the third pillar

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.

Accountability, the second pillar for 340B Program compliance

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.

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

How SectyrHub helps health systems and consultants manage 340B

For more than 100 years, New Brunswick, N.J.-based Saint Peter’s University Hospital has served people across central New Jersey. Founded in 1907, Saint Peter’s is now a 478-bed teaching hospital that is part of the Saint Peter’s Healthcare System, a non-profit, acute care facility sponsored by the Roman Catholic Diocese of Metuchen, N.J. The Children’s Hospital at Saint Peter’s University Hospital operates one of the largest and most advanced neonatal intensive care units in the country as part of the hospital’s state-designation as a Regional Perinatal Center. Along with joining the 340B Drug Pricing Program in 2014, St. Peter’s University Hospital is also a Disproportionate Share Hospital, which the U.S. Health Resources and Services Administration defines as serving a significantly disproportionate number of low-income patients. “We’re in Middlesex County, which has a poverty rate about… Read More »How SectyrHub helps health systems and consultants manage 340B

Five value pillars of 340B Program compliance

For 340B Program directors, knowing in real time if their employer complies with the U.S. Health Resources & Services Administration’s requirements (and could pass a HRSA audit) is top of mind, all the time. That’s because maintaining their employer’s 340B Program benefit directly correlates to profitability. Complying with the program means focusing on ever-changing guidelines and regulations. Along with protecting profits and monitoring changing requirements, 340B Program managers also hear politicians, pharmaceutical makers and the press call for more oversight by the federal government. Drug makers are concerned how rapidly the program has grown. For example, in 2000 there were 8,100 participating hospitals and pharmacies. By 2020, the number participating soared to 50,000. According to HRSA, discounted purchases under the 340B Program hit $44 billion in 2021, a 16-percent uptick from 2020. While healthcare CFOs… Read More »Five value pillars of 340B Program compliance

Do you have real-time situational awareness of 340B financial risks?

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?