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.
“Once we develop our program plan, SectyrHub does the thinking and reminding to keep us true to that plan, so we’re audit-ready,” remarks the program manager. “The alternative would be relying on Excel spreadsheets and calendaring tools, which wouldn’t automatically alert us to changes to OPAIS the way SectyrHub can.”
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.
“For anyone who’s considering LicenseTrak, I can say as a global user who oversees compliance this software puts licenses for pharmacies, pharmacists, DEAs, and other documents in one place and saves what would be weeks’ worth of work to track the same information in spreadsheets,” said the director of retail pharmacy operations for a Midwestern healthcare system.
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
“Five years ago, as the result of an accrediting survey, we found there was a lack of primary source verification for some of our employees,” said a pharmacy director for a large health system in the South Atlantic region. “At that time, for accreditation, we relied on a teammate who captured information with a homegrown system, paper, and computer spreadsheets.”
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?