It’s Not a Matter of IF but WHEN

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Apexus remarked in October 2023, “It’s no longer a question of whether you’ll be audited; it’s a matter of when.”  In the present 340B program climate, this assertion could apply to more than just HRSA audits. The increasing scrutiny around the program highlights the critical nature of compliance. Therefore, proactive compliance and comprehensive reporting are not just necessary – they could become legally mandated soon.

Numerous risks threaten a team’s 340B program, such as duplicate discounts, diversion, staff turnover, or lack of sufficient resources, to name a few. And the consequences that come with failing to manage these risks could be irreversible. Here are three key strategies to avoid these common pitfalls:

  • Teams need to have a comprehensive approach to compliance. The cornerstone of this approach is having a defined compliance plan each year. The plan should be outlined in detail, reviewed, and made accessible to all members of the team. The plan should also be reviewed with a multidisciplinary steering committee to verify there are no gaps or inconsistencies with existing organizational policies and procedures. Once the plan is laid out, it is imperative that leaders and staff adhere to the plan. Progress and compliance with the plan should be reviewed frequently, and reporting should be provided on a predetermined schedule.
  • Investing in people and processes is a sound strategy. As the adage goes, “You are only as strong as your weakest link.” This holds true for any team or process. Investing in your team and having adequate staff is essential. This will not look the same for every organization, so workload and available resources must be assessed accordingly. Once your team is determined, they should be supported and encouraged to acquire training and certification that help them perform their duties or enhance their subject matter expertise. The defining of your team goes hand-in-hand with process development. Knowing who is doing what and when is essential to maintaining and sustaining compliance. Processes should also be reviewed regularly to ensure adjustments are made appropriately.
  • Consider compliance technology investments as well. Teams don’t have to work single-handedly without support! Software technology can help teams automate routine tasks and assist with tracking the many requirements and to-dos. Creating efficiencies with software tools can help teams get more done in less time. Additionally, automated tracking serves as an insurance policy to ensure errors are not made or important details are not overlooked.

Sectyr® specializes in compliance software that implements a proactive strategy for program management. This strategy allows teams to stay continuously compliant. SectyrHub® 340B software automates and optimizes the many compliance requirements associated with the 340B program. This empowers 340B teams to feel confident in their compliance status and concentrate on the 340B program’s ultimate goal — serving communities.

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Craig Frost is President and COO of Sectyr.  He can be reached at Craig.Frost@Sectyr.com.

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