GPHA Clouds

Succeeding with HRSA 340B Audits: 4 Things you can do to Ensure Success

The HRSA audit process for 340B seems to be a mysterious process, where a lot of fear and anxiety reside. Having led Covered Entities through the HRSA 340B audit process, I thought I would give a little insight from these experiences as too what might help you to be successful.


1. Assess your Program, Create a Work Plan

You need to gather some baseline information about your program, prior to creating a plan to keep compliant with 340B. Many will point to free resources, such as Apexus tools and resources as a guide. Others rely heavily on software vendors. While these are tremendous resources, there is not a “one-size fits all” solution and the material takes a significant amount of time to navigate.

You need to drill into and extract specifically, items relevant to your program. This is accomplished faster if you have a resource experienced in 340B operations working with you. Simply put, hire a consultant that has actual HRSA audit experience to provide you with a baseline. I am not talking about 340B software vendors, nor am I talking about the free compliance “mock audits” these same vendors offer as “part of the software”. I am talking specifically about a pharmacy consulting group that knows both hospital and retail pharmacy business operations. You do not have to spend a ton of money to find a qualified resource, but you do need to make sure whatever resource you are investing in, will transfer as much knowledge to you as possible and ultimately provide you with a compliance work plan to help you stay compliant.

Why hire someone with experience? Most importantly, there is no substitute for actual experience with the HRSA 340B audit process.


2. Execute your Compliance Work Plan

Something you should not do, is hire someone to assess your 340B program and then do nothing with the recommendations for your compliance work plan. That seems a little silly, but the tendency is, particularly if your “mock audit” is clean, to do nothing. This is short-sighted in my view, because routineself-assessment has many tangible benefits, not realized from an annual mock audit. Here are some:

  • You will learn what is actually going on, versus what you think is going on. I would be surprised if you weren’t shocked.
  • You will identify compliance gaps and close them before you are audited.
  • This will result in your data being “clean” when preparing it for the audit.
  • You will likely be forced to address instances of non-compliance, familiarizing you with the concepts of internal corrective actions, self-disclosure and material breach.

The work plan that I have developed for my clients is hinged on some basic program fundamentals. We meet routinely (quarterly) to review our self-audits. This time is also set aside to clarify program requirements, 340B definitions, and news and assess our current policy and procedures.

3. Keep your Primary Contact and Authorizing Official Engaged

If you are an authorizing official or primary contact, your job is to be engaged and stay educated on 340B. This means that you participate or lead routine meetings. The HRSA auditor will expect that you have a working knowledge of your 340B “program universe”. You may be required to answer questions specific to your 340B program.

Take advantage of freely available resources, such as Apexus information. Also consider paid resources such as 340B Health and various conventions, such as 340B Coalition conferences.

4. Develop a Clear Audit Action Plan

An audit action plan is different than your compliance work plan. The audit action plan describes “when I get audited, this is what I do.”. It will contain who needs to be contacted about the audit, your key resources such as your authorizing official, primary contact, director of pharmacy, contract pharmacies, consultants, IT support staff and legal team. It will also describe who does what. As an example:

  • Who will navigate the HRSA auditor thru the medical record?
  • Who will provide cost report information?
  • Who will upload the data and documents the HRSA auditor needs?
  • Who will communicate directly with the HRSA auditor prior to audit?
  • Who will be present at the actual on site audit?

Having an audit action plan clearly defined may seem elementary, but really it is a great way for you to assemble your team and be assured you have a clear plan when you receive your email notification of audit.

In Conclusion

The old adage “an ounce of prevention is worth a pound of cure” holds true for 340B audits. A tremendous amount of resources are available to help you prepare for 340B HRSA audits.

By following these key principles I am confident you too will be successful with your 340B HRSA audit. You will likely know most of the gaps and or contentious (“gray areas”) of your program. This will put you in a good position to respond to questions that come up during your audit.

If you have further questions regarding what a 340B compliance work plan might look like for your facility, please do not hesitate to contact Tim Kerr, VP of Pharmacy Services I’ve developed many relationships with qualified resources over the years and would be happy to put you in contact with them if I cannot help you directly.




Posted by Tim Kerr on May 27, 2016 in Pharmacy Services.


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