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340B covered entities are well aware that 340B program audits are on the rise and underway at many hospitals throughout the United States. If you attended the ASHP Midyear Clinical Meeting or you are a member of SNHPA and receive their 340B newsletters, it is hard to ignore the glaring theme that 340B oversight is a priority in 2012. While you may know that the chances for an audit of your organization are increasing, what hasn’t been communicated is the extent and depth of these audits and the risk areas that should be addressed.

Veridikal has participated in recent audits and is currently assisting clients prepare for upcoming audits by HRSA. Unlike pre-2012 340B audits, we are finding that 340B auditors are taking a much deeper dive into a hospital’s 340B compliance protocol. They want to see that the 340B covered entity has monitored and maintained their program as federally mandated. It’s not enough to just switch on a 340B split billing software and let it do the work for you.

What your hospital needs to be ready for:
  • Independent audits, in addition to internal audit procedures, have been suggested by the government. Independent auditors would not include software providers, wholesalers, claims administrators, or PBM’s
  • Audit data requests are extremely comprehensive and serve to test the reconciliation process is consistent with 340B regulations and, whether it is your contract pharmacy or hospital-based pharmacy, a clear 340B audit trail. Just providing reports from your split billing software will not suffice
  • A thorough review of policies and procedures will be conducted. Your written procedures are used as a blue print for auditors as they seek to understand discrepancy documentation, “grey area” opinion reports such as 340B MTM/Patient Definition, and monitoring roles, testing and internal audit reviews throughout the year
  • Interviews with several departments outside of pharmacy will include individuals that may not be heavily involved with your current 340B compliance program. These departments include your Medicaid Billing, Reimbursement, Finance, and Internal Audit. If these participants lack the necessary knowledge to help your hospital administer the 340B program, this may lead auditors to identify additional issues
While these are just some of the areas that need attention, the repercussions of a poor audit outcome range from fines to program dismissal. A comprehensive approach and compliance program must be in place or the consequences could be serious.

If you would like to find out even more about 340b Audits, we suggest reading more in this document or at the HRSA Website. You can also listen to a podcast about Veridikal's 340b Audit program here.

Client Testimonials

Anna Mangum

"SNHPA engaged Veridikal to create our standard set of Policy and Procedures that maybe used by Covered Entities. This project was very successful and the Veridikal professional team did an incredible job providing the necessary guideline principals, documentation, and supportive materials for our members."

Steve Smith

AVP Strategic Services Partners

"Quorum joint venture with Veridikal Health System is to focus on our hospitals with ambulatory pharmacies and 340b needed audit services. We want to provide the best solution set to our members with a professional team and company that has an impeccable track-record for success, Veridikal provides our team that support."

George Puckett

Vice President Pharmacy Software, Talyst

"Veridikal Technology, has been a great strategic technology partner for Talyst, they are focused on pharmacy solutions for mutual clients including the University of Kentucky for key HRSA and 340b Reporting. Veridikal has provided their integrated Pharmacy Solutions that have assisted our organization in looking at the complete book of business with custom reporting and business edits."

John Adams

Director of Pharmacy Services, Good Shepard Healthcare Systems

"Veridikal was engaged to come into our facility to evaluate our outpatient pharmacy operations. They not only identified a number of key operational issues but we discovered that we had not setup our wholesale accounts and key 340b program correctly. Their help was invaluable and has allowed our organization to ensure compliance while we captured additional savings opportunity with our emergency room visits and owned physicians networks listed on our cost report."

Brian Ward

Vice President, Business Solutions and Operations

"SunRx engaged Veridikal to provide an independent neutral audit for our 340b clients that require a third party validation of their 340b Policy & Procedures, workflow, and compliance. We selected Veridikal because of their active involvement in NCPDP 340b committees, Professional Staff, and conservative approach to the 340b programs. We trust their approach and quality of their work with our clients."

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