Webinar Rewind: Virtual HRSA Audit: Part 1

Organizations across the globe had to pivot operations to account for changes resulting from the COVID-19 pandemic. This is no different for the Health Resources and Services Administration (HRSA). HRSA 340B program audits have gone virtual and this means the audit experience has changed, too. 

Cervey is dedicated to helping 340B covered entities maximize savings, ensure compliance, and optimize the performance of their contract pharmacies during COVID-19, including the virtual HRSA audit experience. That’s why we’ve included our recent webinar, “Understand and Prepare for a Virtual HRSA Audit Experience,” in our Webinar Rewind series where we break down our informative webinars into readable segments for 340B program managers, directors, buying committees, and CFO’s. 

Cervey’s Vice President of 340B Solutions Larry Crowder and Pharmacy Director of White River Medical Center Maggie Williams come together to discuss the new virtual 340B audits by HRSA in part 1 of Webinar Rewind: Understand and Prepare for a Virtual HRSA Audit. 

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Getting Started with HRSA Audit

Larry Crowder: 

Hello, my name is Larry Crowder. I'm with Cervey and with me today, I have Maggie Williams, she is the director of pharmacy of White River Medical Center in Batesville, Arkansas, and Maggie and I go way back. We've known each other for a long time, and I'm happy that she's on this call with me today because we're going to be talking about virtual HRSA audits, the differences of what the virtual audits look like versus what the onsite audit have looked like in the past. Maggie is an expert at this because she has had a virtual audit within the last month. I think it's going to be a big benefit to those of you who want to be prepared for your HRSA audit.

As I go through this slide presentation, Maggie is going to interject some things that she can bring to the table from her recent experience in the audit. Today's agenda we're going to review what you get initially, which is that HRSA letter that everybody loathes the day that that comes in, but the HRSA letter comes in first. And then how do you prepare for that on-site or virtual audit these days, and then preparing for them actually coming onsite, we're going to go through what they do, what expectations you should have and what you should do to be prepared for that. And then along the way, we're going to give recommendations for each of those areas.

The Dreaded HRSA Audit Letter

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Larry Crowder: 

The first thing you get is a letter from HRSA. HRSA is going to ask for approximately six months of data and give you about a month to upload these documents to a secure site they provide. One of the things they ask for is the detailed purchase history; you typically get that from your wholesaler. It's all your purchase history from the last six months for your 340B. Then they will ask for your usage files; that typically comes from your software vendors. If it's a contract pharmacy or your mixed use area, they're to ask for those claims or dispenses that made up your accumulations. Then they're also going to ask you for your policy and procedures. 

Then, they're going to ask you for the contracts for all of your contract pharmacy partnerships. The auditor will detail and make sure that those contracts were signed prior to you registering those contract pharmacies. They're going to ask you for your most recently filed Medicare cost report and they will want a signed copy. Then they focus on your government contract and nonprofit status. They're going to ask you for that documentation as well. We recommend that you keep hard copies of these contracts somewhere that's accessible and easy to get. You want to do that prior to getting the HRSA letter. You want to have one employee really in charge of keeping track of all these things, because something that you don't want to have happen is multiple employees and one of them doesn't realize that the other one hasn't done something.

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One Person With a Holistic View

Larry Crowder: 

You want to  have that one person of contact that everybody takes the new documents too. You want to practice running those reports that HRSA is going to request so that when you do get the letter, you're prepared and you're ready to run those reports quickly and get those back to them ASAP.  

Finally, you want to continually monitor that physicians list to make sure that you're routinely comparing the eligible physicians you have in your software with who's actually credentialed. 

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Maggie, can you speak to how long they gave you as far as getting a letter and what that process looked like for White River?

Maggie Williams:

Sure. We received our letter September 1st and then we had to have all of our documents submitted by October 13th. So, if you look at that, that's a six week timeframe, but I will tell you of course when you get the letter, it's a lot of information and we didn't have our call with our surveyors until I think it was September 17th. So, once you get the letter, there were a couple of weeks you weren't really sure how far and how hard to work on that information because some of it was unclear. Once we had our clarification call, we really only had a month to get everything ready. I would say if possible, start immediately when you get your letter, because it took us every bit of time to get that information. To give you an idea of the size of our facility, we're a 25-bed rural community hospital.

When he talks about the data you have to gather, those universes that you have to get are probably the hardest to gather and practice that before you get your letter, because there's going to be information you may not be able to pull. One of the things we had a hard time with was getting the actual administration date and who prescribed the med in our mixed use universe. We have dispensing machines. So, when we pull our information, it does not pull a physician across. Then we ended up pulling the attending, but during our audit, we were able to see who prescribed it. So, there's limitations to your data and it's better to find that out before you get a letter. I would say the hardest thing of all was the information to gather because it is a tremendous amount. We had three universes. We had our mixed use universe, our clinic universe, and then our contract pharmacy universe. So, we had to pull six months dispensing of all three of those universes.

Follow us to stay tuned for Part 2 of the Webinar Rewind series for “Understand and Prepare for the Virtual HRSA Audit Experience” here:

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Looking for the rest of the webinar series? Check out parts 2-6 below:

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