Craig Frost headshot

HRSA Audits: Scared or Prepared?


Benjamin Franklin, an American Founding Father and Statesman, is attributed as being the source of the memorable quote “By failing to prepare, you are preparing to fail.” 

Today, compliance risk in the 340B Program remains significant for most covered entities.  The capabilities of many covered entities to reach all members of their communities with needed services and resources remains under intense pressure.  Hospitals, community health centers and other care providers have experienced unprecedented demands of staff and resources to meet the community needs of a seemingly unrelenting global pandemic. 

The risk of 340B program value erosion is centered around compliance, either directly or indirectly.  All stakeholders in the program focus on risk, whether in a direct audit finding or by indirect program integrity concerns with respect to duplicate discounts, diversion or ceiling price calculations.  HRSA continues to ramp up its oversight of the program with plans to increase both remote and on-site 340B audits during the upcoming year.

Meanwhile program benefits are shrinking, especially with respect to current disputes over the contract pharmacy program.  In a climate of shrinking benefits and increased integrity audits, 340B program leaders must focus on program compliance and also be savvy to ensure they make the most of the program.  Ask yourself, can you demonstrate 340B Program compliance, right now, to your CFO or CEO in a complete and comprehensive manner?  Is your 340B Program prepared for a HRSA compliance audit tomorrow?  A combination of good planning, structure and tools will get you to a “Yes” on the previous two questions.

A best practice is to formulate a comprehensive compliance plan for the 340B Program.  Key elements of the compliance plan should include:

  • Standardization
    • Define standard processes and procedures for consistency and predictability
  • Efficiency
    • Centralize documents and records, automate processes, focus on highest risk elements
  • Accountability
    • Create oversight mechanisms, establish time-bound compliance expectations
  • Visibility
    • Establish KPIs that are reported and readily available to all stakeholders
  • Sustainability
    • Design compliance processes that are program specific and not dependent upon staff changes

SectyrHub® 340B is designed specifically to be the comprehensive tool to manage Continuous Program Compliance™.  At Sectyr, our sole focus and mission is compliance. SectyrHub 340B is an all-in-one toolset to manage all aspects of 340B Program compliance.

How does SectyrHub 340B Ensure HRSA Audit Preparedness?

  • All program compliance elements are visible on customizable dashboards with convenient, presentation ready reporting of program integrity.
  • 340B Program teams use tasking and workflows to reinforce team accountability and to communicate clear expectations.
  • Covered entity OPAIS data is checked daily against your documentation to ensure your program data matches your records.  Contract pharmacies, child sites, grantee sites and all other OPAIS data is automatically verified daily.  If a discrepancy is detected, you are notified, and the variance is noted on your dashboard.
  • All program eligibility requirements are managed in intuitive, guided workflows to manage documentation in a compliant state, 24×7. 
  • The details of eligibility requirements and oversight documentation are tailored to each type of covered entity and managed through SectyrHub’s rigorous process of establishing compliance through guided workflows.  All elements of compliance are tested and documented.
  • Internal and third-party audits are managed in the system.  Audit findings are tracked and trended, with corrective action plans tracked and tasked to members of your 340B team.
  • Risk focused auditing is enabled by AI-powered machine learning.  SectyrHub 340B increases the efficiency of internal audits by focusing auditors on the highest risk transactions.
  • A HRSA audit tailored workflow gathers all elements of a data request into one easy to use workflow to submit to the HRSA auditors.  Any audit findings and corrective action plans, as well as notices of disagreements, are tracked in the SectyrHub 340B workflow.
  • Medicare Cost Report tracking,  with eligible child sites crosswalks, are all tracked using the guided workflows.

Visit SectyrHub®340B to learn more about how Sectyr can help you achieve Continuous Program Compliance™.   Learn how your colleagues have achieved pro-active 340B compliance in an efficient manner with our easy-to-use solution.

Craig Frost, RPh, MBA, FACHE is President and COO for Sectyr.  He can be reached at