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.
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.
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
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
Whether you’re a veteran 340B Program manager or entering the field, the 340B landscape is complex and constantly changing. Keeping up with new requirements, regulations, and technology is one part of the job. Accounting for the status of an organization’s level of compliance is another piece. But monitoring 340B compliance status should not be a manual process. If that’s happening, 340B Program managers can fall behind on what really matters–directing their team, spotting risks, and finding opportunities for the program. Sectyr’s SectyrHub 340B software serves as the “air traffic control” for a 340B compliance program. With ever-changing 340B Program requirements, a 340B Program team can be overwhelmed by handling paperwork and records to maintain compliance. Increased scrutiny of the 340B Program by media, Congress, and drug makers only makes keeping up with requests and, potentially,… Read More »How to take the complexity out of 340B Program compliance
When asked what’s top of mind for a 340B Drug Pricing program manager, she said, “Knowing if I’m compliant today and if I would survive a HRSA audit without issue if that occurred next week.” The program manager went on to say that “Maintaining and protecting our 340B benefit is extremely important to our profitability.” Maintaining compliance every day and guarding profitability takes a complex balance of foresight and fortitude. Navigating the requirements requires equal parts insight and resources. To help bring that insight, we’re launching a 10-part blog series today that aims to examine not only the challenges to complying with the 340B Program but also strategies and tactics for making it easier to do so. Continually complying with the U.S. Health Resources and Services Administration requirements is a linchpin for avoiding the financial… Read More »The 340B Program problem: Achieving around-the-clock compliance