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340B Insight provides members and supporters of 340B Health with timely updates and discussions about the 340B drug pricing program. The podcast helps listeners stay current with and learn more about 340B to help them serve their patients and communities and remain compliant. We publish new episodes twice a month, with news reports and in-depth interviews with leading health care practitioners, policy and legal experts, public policymakers, and our expert staff.
Speaker 1 (00:04):
Welcome to 340B Insight from 340B Health.
David Glendinning (00:13):
Hello from Washington DC, and welcome back to 340B Insight, the podcast about the 340B drug pricing program. I'm David Glendinning with 340B Health. Our guest today is Tristan Greer, 340B program business Manager at Catholic Health, a system based in Buffalo, New York that provides care to patients in the western portion of the state.
(00:36):
Compliance with 340B rules and requirements is an important job for hospitals and a big part of Tristan's job at Catholic. One of the best practices 340B Health Systems used to maintain this compliance involves something called 340B internal audits. We wanted to hear from an expert to find out what these internal audits are and how they work. Before we go to that discussion, let's take a minute to cover some of the latest news about 340B.
(01:13):
The Pharmaceutical Research and Manufacturers of America and the National Association of Community Health Centers are heading up a new group that is pursuing legislative changes to 340B. 340B Health analysis of their proposal shows that the changes would reduce the number of hospitals in 340B, prevent many specialty drugs from being subject to 340B discounts and otherwise limit hospital's ability to rely on 340B to support patient care.
(01:41):
In a statement 340B Health president and CEO Maureen Testoni said, "This newest development is the latest in a long series of efforts by the pharmaceutical industry to back away from its obligations to healthcare safety net hospitals and their patients by advocating for Congress to reduce 340B eligibility." And Congresswoman Doris Matsui, a longtime champion of 340B hospitals, issued her own statement saying that, "This latest attack on the 340B program underscores our need to work together to strengthen the program, not further undermine it by sacrificing benefits for vulnerable patients." Visit the show notes to read the complete versions of both statements. 340B Health members will find a link to additional analysis of the pharma legislative proposal.
(02:43):
And now for our feature interview with Tristan Greer with Catholic Health, the federal government audits 200 covered entities per year to ensure their compliance with 340B rules and requirements, but hospitals also regularly conduct their own audits as part of their ongoing 340B compliance activities. Myles Goldman sat down with Tristan to learn how these internal audits work at Catholic and what the 340B team there has learned from conducting them. Here's that conversation.
Myles Goldman (03:13):
Thank you, David. I'm joined by Tristan Greer from Catholic Health. Tristan, welcome to 340B Insight.
Tristan Greer (03:21):
Thank you for having me, Myles.
Myles Goldman (03:23):
I'm excited to be talking to you today about internal audits. We've talked on this podcast before, a little bit about audits, but never specifically about this facet of the auditing process. So looking forward to diving further into the topic. And to just get us started, what is an internal 340B audit?
Tristan Greer (03:45):
So really Miles, an internal 340B audit is a compliance review and it helps ensure that your healthcare organization is meeting the requirements of the 340B program as those requirements are set out by HRSA. It's really a designated time that you set aside to ensure that your covered entity is continuing to deliver the important benefits of the 340B program. And there are certain compliance checks that you have to complete. And so the four main areas of eligibility that should be looked at are the eligibility to participate, which includes your percentage, your adherence to the GPO prohibition and things of that nature. The accuracy of the HRSA OPAIS website, ensuring that the address is listed for your contract pharmacies as well as your covered entities. Clinic locations are all accurate. The names that are listed on there, primary contact authorizing official, that those are completely accurate on the HRSA website. Also looking at diversions and making sure that 340B eligible drugs are not given to any 340B ineligible patients and also your duplicate discount.
Myles Goldman (04:56):
Well, thank you for providing that overview. I think it sets a really good baseline as we move forward to really understanding how this internal audit process works. And you kind of covered this a little bit, but let's talk about a little bit more. What are the benefits of conducting these audits and how frequently do you conduct them?
Tristan Greer (05:18):
Sure. So the internal audit really helps to ensure that your covered entity is maintaining what we like to call a strong environment of compliance. And it just allows for the continued success of the 340B program, both compliance-wise and financially-wise. And of course, these days we're seeing an increased scrutiny with the 340B program. And so our internal transaction level audits are completed monthly, meaning that when we say transaction level, we're talking about mixed juice as well as contract pharmacy level. And so we do those on a monthly basis. But our audits of our eligibility checks, which include our first OPAIS website accuracy, making sure that we're still eligible in terms of our [inaudible 00:06:05], things like that, we complete that on a quarterly basis. So it depends on what kind of audit you're completing to determine what the frequency of that audit should be.
Myles Goldman (06:14):
Well, and I think the segues done nicely into looking closer at what did your self-audit plan look like? Who on the team participates in the process and how do those different types of audits factor into it?
Tristan Greer (06:29):
Our team has really implemented both targeted and random transaction audits to ensure compliance with the program. And so depending on the size of your random sampling can often provide some value to your program. But I think really when you're trying to get into the nuts and bolts of your audit, really trying to get to the meat of it is really where you should complete your targeted auditing. I think the random auditing really is a guideway to determining where your issues are, where there's high compliance risk in your program. And so the targeting sampling can provide you with a greater assurance that your errors, any errors in your program will be detected. And there's a couple of things that you can look at here. You can look at specific providers, you can look at specific locations and you can look at specific drugs. And so the internal audits are really completed by our 340B analysts here at Catholic Health, but it's a whole team of people that kind of work when we find issues and resolutions.
(07:35):
So one of the things that we've done is we've created a contact list of all of the folks internally in inside of our organization that when we do find an issue, we can reach out to them and connect with them and figure out what the resolution of that issue can be, because while we are experts, we're not complete experts in everything. So we're not experts in revenue cycle, we're not experts in clinic operations. And so we really have to reach out and hone in on those folks that can really help us in helping us with our internal audits here.
Myles Goldman (08:08):
So let's continue to kind of move through this internal audit process. What materials do you need to gather prior to engaging in internal auditing?
Tristan Greer (08:18):
So that's a great question. Really, it depends on what kind of audit that you're doing. I mentioned before that there's kind of your quarterly eligibility and HRSA OPAIS check audits, and then you have your transaction-level testing. So with your quarterly and eligibility and HRSA OPAIS checks, you'll need copies of all of your contract PSAs. You'll also need a copy of your Medicare cost report in your trial balance. So I think referencing that Medicare cost report trial balance and crosswalking, being able to create a crosswalk from that with your internal EMR departments and locations is super helpful to determine, Hey, I didn't see that location before, that's a new location, let me reach out about that.
(09:00):
And then of course, with transaction level testing, you'll need access to your EMR. There's different applications within that EMR that you need to have access to. So there's the revenue cycle application. There's clinician notes that you need access to, more documentation that you need access to. So you need to make sure that you're connected with the appropriate folks that can get you that access to the appropriate levels of your EMR system that you need.
Myles Goldman (09:26):
And before, you were talking about a number of different elements that we need to gather before we even start the internal audit. So tell us a little bit more about how you keep organized in the process.
Tristan Greer (09:38):
Oh, that's a wonderful question. It's difficult. It's not easy to stay organized. 340B just touches so much within the organization that it often can become very overwhelming. The tips and tricks that I have learned throughout my time being a 340B manager is to really set a schedule for myself and to allow myself, and I think this is really important for our listeners to understand, space and grace. You really need to give yourself some space and give yourself some grace because everything is not going to be perfect when you find it. There's going to be issues that arise. And so deal with those issues one at a time and make sure that you're taking the time to really do a thorough review of whatever audit you're completing.
Myles Goldman (10:24):
How many claims are typically involved in these reviews and how do you make that determination?
Tristan Greer (10:30):
So that really depends on the size of your organization. So for example, if your health system audits 25, we'll say 25 records per month out of a total of 25,000 eligible dispensations, that's a 0.1% audit rate. And that's really not going to help you. It's really not going to help you get to a real resolution or to really find and be able to be good at detecting your errors. And so I think that folks should really consider your overall schedule and more importantly, the resources that you have available to your organization. So once you've developed a list of targeted areas, then you can determine the amount of records that need to be tested as well as the frequency of your testing.
(11:19):
And so I found that personally, there's certain months where I can go in and have to audit thousands of records. Why? Because it's the particular area of concern that I have at the time. So for me, the OR. The OR is a huge concern, the operating realm. And so you can go through thousands of drugs in order to really find out what your issue is. Is it a one-time-off situation or is the whole department have a problem? But then there's other months where I'm looking at maybe the infusion suite or specialty drugs where there's just a few of them. So you don't have to do as many ... you're not auditing as many records because those are kind of high-dollar, low quantity drugs when you're talking about the infusion suite or specialty pharmacy. So it really depends on what kind of audit you're doing and what you're finding.
Myles Goldman (12:16):
When HRSA does an official audit of a 340B hospital that has done its own internal audit, what does the agency expect to see?
Tristan Greer (12:26):
So I think really HRSA is really looking to see if you're saying that you're doing your audits, and especially the first thing that they're going to look at is your policies and procedures. What is it saying within your policies and procedures? What's the cadence of your internal audit plan? And then they're going to look to see documentation of that cadence. So they're not really looking to see necessarily what the findings were in that audit, just that it was simply being done. We audited X amount of records on X month or during X quarter, check mark, initials, signatures, whatever your covered entity has established within their policies and procedures.
Myles Goldman (13:05):
So when you're talking about records of you doing the internal audit, we're talking about an audit template and that type of thing, right?
Tristan Greer (13:11):
Exactly. And so one of the things that we have developed here at Catholic Health, we have an Excel spreadsheet, and so it has all the questions listed line by line in terms of patient eligibility in all the things that we should be looking for. And we've actually gone a step further and included that audit template within our policies and procedures. This is an example of the questions that we ask ourselves when we're completing our internal contract pharmacy and mixed-use audits.
Myles Goldman (13:44):
I want to broaden out a little bit in terms of just thinking about the internal audit process. How has it changed over the course of your career?
Tristan Greer (13:53):
I think it has changed and then it hasn't; so there's some yes, there's some no to that because ultimately, the basic fundamentals of our internal auditing process has not changed. But what has changed is how we're doing audits -- who are we getting on board to help us with these audits. TPAs have come and adjusted knowing that the covered entity of an added benefit to the 340B program for the TPAs to have these compliance departments that can help you walk through and kind of ask the appropriate questions when it comes to your covered entity. So that has changed. I think we're getting more people involved in and knowing the importance of these internal audits.
Myles Goldman (14:38):
Well, this is such an important topic, Tristan, for compliance with the program, which is of course, as we all know, really important. So I appreciate you taking the time today to really help us take a closer look at how this works and how other hospitals can be thinking about it. Thank you for joining us. Thank you for having me.
David Glendinning (14:58):
Our thanks again to Tristan Greer for walking us through, even crosswalking us through the 340B internal audit process. Hospitals take their commitments to 340B compliance very seriously, and we are appreciative of all the professionals such as Tristan, who understand what is required to get it right.
(15:17):
If you are attending the 340B Coalition Winter Conference in San Diego starting March 27th, we will see you there. When you visit the exhibit hall, be sure to stop by the podcast booth to say hello. We will be located across from 340B Health booth. You can pick up a pair of complimentary 340B Insight earbuds, and you might even catch us in action interviewing conference presenters and attendees. We've had some great recent episodes. We encourage you to check out. These include our discussions about how one state has been a leader in enacting 340B policy and about the 340B considerations involved with electronic health records system conversions.
(15:57):
We will be back after the conference with our next episode. In the meantime, as always, thanks for listening and be well.
Speaker 1 (16:10):
Thanks for listening to 340B Insight. Subscribe and rate us on Apple Podcasts, Google Play, Spotify, or wherever you listen to podcasts. For more information, visit our website at 340Bpodcast.org. You can also follow us on Twitter at 340B Health and submit a question or idea to the show by emailing us at podcast@340BHealth.org.
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