Audits and Regulatory Compliance

Any health care organization that is approved for participation in government programs agrees to comply with requirements in order to continue to receive benefits. In addition to regulations that govern the percentage of Medicare and underserved patients they must treat, organizations are also bound by requirements that impact pricing, vendors, procedures, reporting and inventorying of program-related supplies.

These regulations can change frequently, depending upon federal and state law makers, the health care environment itself, program budgets and other influencers. Because these indicators aren’t always predictable, future planning – although critical – is problematic.

In addition, when changes occur, it can be difficult to interpret new policies due to the complexity and technical language of regulations.

The Ponaman Healthcare Consulting (Ponaman) team is comprised of experts with extensive experience working within the safety net and public sectors. We are able to guide clients through complicated, new regulations – and can often accurately predict changes on the horizon. For instance, in anticipation of the 2012 Health Resources and Services Administration (HRSA) audits, Ponaman created a template that helped clients prepare to successfully complete the official examination. Additionally, Ponaman has developed an auditing methodology reflecting HRSA’s process. This process continues to be updated as we learn more from the HRSA audits and the lessons learned while supporting our clients through their experiences.

The following are key areas of focus in our audit process:

  • Review of split-billing systems, onsite retail pharmacies, and contract retail pharmacies.
  • Review of current 340B policies and procedures with a focus on process, accountability, Group Purchasing Organization (GPO) exclusion, Medicaid regulatory compliance, and integration with the corporate compliance plan.
  • Review of current 340B registrations to ensure completeness for parent versus child sites, accurate key contact and authorizing official information, and Medicaid billing and exclusion file reporting status.
  • Validation of patient, provider, and covered entity eligibility working in reverse from the purchases to the patient and provider-level eligibility.
  • Billing system and chart auditing to validate unmatched dispensations.
  • Verification of accumulator levels and conversion factor analyses.
  • Verification of National Drug Code (NDC) mapping.
  • Verification of availability of contracted and employed provider listings.
  • 340B and Wholesaler Acquisition Cost (WAC) account structure review.
  • Review of inventory distribution processes.
  • Validation of eligible employee/patient relationships.

In addition to customizing our approach to address each of our client’s unique needs, Ponaman can also develop a comprehensive assessment report to identify opportunities for improvement to ensure regulatory compliance. The team’s report includes its assessment findings as well as an outline of recommendations.

In the event that HRSA contacts you to undergo an audit, Ponaman can serve as your partner in preparing for and during the HRSA onsite auditing process to ensure the most optimal outcome. As part of this function, Ponaman performs the following tasks:

  • Assists with identifying the internal team members necessary to support the audit.
  • Assumes a project manager and facilitator role for the team’s audit preparation.
  • Coordinates the collection, review, transmission, and tracking of all requested information and data by the auditor in a timely, efficient manner.
  • Serves as the liaison between the HRSA auditor and internal team.
  • Serves as the onsite contact and representative on behalf of the covered entity throughout the onsite audit process. This includes coordinating responses to questions by the auditor, coordinating tours of the hospital and contract pharmacies, and ensuring a sense of confidence and support with the hospital team during the audit process.

In addition, the Ponaman team offers service options that include answers to regulatory questions that arise during day-to-day operations.

To learn more about how Ponaman can assist you with your audits and in maintaining program compliance and by following regulatory policies, contact us at 480-421-9965 or and we’ll gladly provide you the answers you need.

  • Ponaman Healthcare Consulting provides outstanding 340B consulting services with exceptional results. Successful outcomes do NOT usually happen by accident.
    Steven T. Ciampa

    Chief Financial Officer
    Porter Medical Center