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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.
Narration (00:03)
Welcome to 340B Insight from 340B Health.
David Glendinning (00:12)
Hello from Washington, D.C., and welcome back to 340B Insight, the premier podcast about the 340B drug pricing program. I'm David Glendinning with 340B Health. Our guest today is 340B Associate Director of Policy and Compliance, Rebecca Swartz. It's that time of year again when 340B hospitals need to go through the annual recertification process with the Health Resources and Services Administration to ensure they can continue participating in 340B.
This year, that process started Monday, August 10th, and it will end on Wednesday, September 9th, providing just more than four weeks to complete the annual requirement. So this is a good time to have Rebecca on the show again to go over what hospitals need to know about recertification. Here's that conversation. I am speaking with Rebecca Swartz from our policy and compliance team here at 340B Health. Rebecca, welcome back to 340B Insight.
Rebecca Swartz (01:11)
Thank you so much, David, for having me.
David Glendinning (01:13)
So, Rebecca, not only are you on the legal and policy team here at 340B Health, but you also happen to be my next door neighbor at the office. So anytime I have a policy or compliance question, ⁓ I don't have far to go. And the questions we're asking today are about very important compliance issue, which is the 340B recertification process. So let's start with the most important question any
David Glendinning (01:30)
About
David Glendinning (01:40)
Journalists would ask, which is why. So why do hospitals need to recertify for three forty B eligibility every year?
Rebecca Swartz (01:48)
Yes, David, that is a great place to start. So the need to recertify comes from language written in the 340B statute. And the law's language describes validating eligibility, maintaining records. So it's pretty general, but it does explicitly say that. And that has become an annual process everyone calls recertification.
David Glendinning (02:11)
And so where does this recertification process, as we call it, generally r rank in what you would call the the broader concept of three forty B compliance?
Rebecca Swartz (02:22)
So it's exceptionally important. It's one of the central tenets of compliance. And HRSA holds a preparatory webinar before recertification every year. And they always preface the discussion by explaining that 340B program integrity is performed through five primary reps. And that is initial registration, documentation requests, audits, entity self-disclosures, and the annual recertification process. So it's very important.
Hirsa emphasizes the importance to program integrity. It really ensures that participating entities continue to meet those eligibility requirements. So for hospitals, that would be ensuring that you are either a public or private nonprofit hospital. And for those private nonprofit hospitals, you need to make sure that you have those agreements with a unit of state or local government. All hospitals accept critical access, need to make sure that they're meeting that.
minimum dish percentage threshold. And then if you have any registered child sites, you need to ensure that they're continuing to have reimbursable outpatient cost and charges.
David Glendinning (03:30)
Okay. So hopefully hospitals are listening when Hirsa gives that ⁓ rundown at the beginning of the webinar. But if they're not exactly paying attention, if recertification slips their mind or they don't understand the importance of it, what could happen to a hospital if they fail to recertify?
Rebecca Swartz (03:47)
It's a big deal. You could lose eligibility, which means you no longer have access to 340B pricing. And for some hospitals, this means millions of dollars at per year are lost. So a lot is on the line here. So just making sure that you prioritize the completion of recertification to ensure that you continue your eligibility. There's no lapse. that's really important to the the 340B savings that you're able to access.
And once you are ineligible, it could be more than a year before the next opportunity to register.
David Glendinning (04:24)
Certainly a lot at stake if you're going a year or more without those savings. We do know speak often with hospitals about how much they rely on those savings. And so this is clearly critical for their ability to continue taking care of patients the way they are now. Okay, so now everybody's sold. Rebecca, you have made it clear to them how important this is. So let's talk about the process itself. Please tell us a little bit about how 340B recertification works.
Rebecca Swartz (04:50)
Yes. So it typically lasts about a month from mid-August to mid-September. We like to also make sure that people understand that, you know, you have a month from start to finish. And for some hospitals with a lot of sites, that can be a pretty big lift. So, you know, a month might seem like a generous amount of time, but I think once you start the process, it'll become clear that, you know, depending on how many sites you have, what you need to update, you might use that.
Full time. So starting early is important. We'll probably be saying that a lot throughout the podcast. It involves logging into OPACE and accessing recertification tasks in the system. And from what I'm able to see, I don't really have great visibility into OPACE as a non-covered entity user, but it seems like HRSA does a good job laying out, you know, what their specific tasks are involved in recertification.
And at a high level, that is verifying the information for the parent site, any child sites, and any contract pharmacies are up to date and accurate. And then there's also this piece of certifying that you remain eligible and are in compliance with program requirements.
David Glendinning (06:03)
Okay. So when you say that there are people at the hospitals logging into OPACE, and I guess I'll just say ⁓ for the people that don't speak in acronyms, that is the Office of Pharmacy Affairs Information System, correct? Am I getting that right? Excellent. So if there is a parent site and multiple child sites, there might be a bit of a team here involved in this process. So who are the people at the hospital involved with the recertification process?
Rebecca Swartz (06:17)
That is right, yes.
Yes, I think that's really important to make sure that people understand that there are just two folks. so it's your authorizing official or AO, and then a primary contact, PC. And the authorizing official has legal authority here. That's going to be the only person that can actually attest to and submit that recertification, right? The primary contact can and certainly does, I think, oftentimes carry the load up until that point of.
attesting to and submitting the risk certification, but your AO is the only person at the organization that can submit it. And for the parent, you can only have one authorizing official, but each child site can have a different primary contact. So that might be something you want to explore depending on where people, you know, sit in the organization. And then it's important to understand that while those are the only two that have access to OPECE and can actually carry out the process.
you're probably going to be coordinating with a lot of other departments such as finance, compliance, administration, legal. Three forty B is very interdepartmental in that way.
David Glendinning (07:40)
Many of the hospitals you've worked with have been through recertification probably many of times. And with you helping members through the process, you've you've seen them go through it many times. So I imagine you've picked up on some best practices that these AOs and PCs can use. So what are some of the things they can be doing during this process to make it go more smoothly?
Rebecca Swartz (08:02)
Yes. So as we, you know, said before, start early and make sure that you have the necessary worksheets and other documentation ready to go before you sit down to do it. I will say, unlike initial registration, you can complete recertification in multiple sittings. It doesn't require you to do it in one session, but I think it's still
Helpful just to have everything up front or everything that you anticipate needing up front. Of course, there's sometimes surprises. We also recommend going through the parent first, the parent site record first, because the confirmations flow down to each child site. So that the information will flow to the child site records. And that just ⁓ makes it a bit easier for you in that way. And then, you know, if you have your primary contact, go through the records first.
And have the authorizing official review after, that can be a way to kind of divide and conquer. And oftentimes your primary contact is a bit more involved in the day-to-day operations of 340B. So they might be a little bit more, you know, savvy with opace and that type of thing. But for both of them, you know, watch out for emails, any return task from HURSA. Again, I I
Want to give Hursa a plug here. Like they're very good about communicating daily the status of recertification. So make sure that you're watching email closely to understand where you are in the process. And then another thing is to take screenshots of each screen. Even if you haven't updated the information, you know, irrespective of that, just take screenshots because you want to make sure that whatever the record shows.
To your understanding of the record today is what, you know, remains. Sometimes things don't update. You know, systems are fallible. So just make sure that you have record of that via screenshots in that way. If there are discrepancies, that's can be a helpful way for you to communicate to HURSA maybe what went wrong.
David Glendinning (10:08)
Said systems are fallible. We know people are fallible too sometimes. And ⁓ maybe the information doesn't line up correctly the way it should every time. So what happens if one of these reviewers logs into OPECE and comes across some kind of discrepancy or error in what they're seeing there?
Rebecca Swartz (10:28)
Don't panic, firstly, because it's common that you're going to be looking at a piece of you know documentation, whether that's your cost report, gen. I'm gonna say it's generally your cost report, and you're saying, ⁓ you know, our dish percentage is different than what it should be, or you know, this child site has fallen off. There's no longer both reimbursable outpatient cost and charges. That's okay.
Recertification is really there to make sure that your information is accurate, up to date. So it is the time to make updates to those necessary fields and upload supporting documentation. And also, though, you know, as much as recertification is there to verify, validate your information, it highlights the need to check and update OPACE throughout the year. So regular maintenance should be a part of your 340B policies and procedures. But
Again, don't panic. That's what recertification is built for, especially if you're not doing things last minute. It should be totally fine. So there's this feature in OPACE that will allow primary contacts to pull back recertification to correct an error or an omission after they've sent it to the AO for attestation. So there's a button that they will press. It's very clear. It says back to PC and it will allow the PC to make corrections.
add missing documents, make any additional changes, and then resend the recertification to the AO to review. And, you know, there's been times where, you know, you think you're ready and then you realize, ⁓ no, we're missing a worksheet. And this is a great way to ensure that you can do that without having to like submit it and then it being kicked back to you by HRSA in the end anyway.
David Glendinning (12:21)
Okay, good to hear there's a little bit of an undo button, so to speak, if they do run into a situation like that. You had mentioned in that last answer about the need to be updating OPACE throughout the year and not just during recertification. So I'm getting that recertification is not really the only opportunity to update the OPACE records.
Rebecca Swartz (12:43)
That's right. And you shouldn't solely rely on recertification. As we know, aside from critical access hospitals, the remaining five hospital types do have a dish percentage threshold that they need to meet. And so depending on when you file your Medicare cost report, you know, you need to be making sure that the most recently filed cost report still reflects an eligible dish percentage in
you know, correspondence with your 340B hospital type. So that's really important to be monitoring and making just ensuring that you remain eligible, right? And I I will say too that the change ref request functionality, it is locked during recertification. The only thing that you can update is your authorizing official. So should that person
you know, change sometime during recertification, or you find that you don't have the right person designated, you can and should use the change request feature for that reason. But otherwise during the recertification process, it is locked. because you're essentially it's one big change request in a way, right? That's sort of the purpose of recertification is to update your record. So yeah, I hope that
that helps kind of explain the role of recertification and then, you know, maintenance and throughout the year.
David Glendinning (14:09)
So they do have these change requests you can make throughout the year, but as you mentioned, recertification also a really good time to check the records and make sure everything is is up to date. You know, 340B teams at hospitals have so much to do. So why why can't they just wait until the next recertification opens to update those fields with any new info from their Medicare cost report or something along those lines?
Rebecca Swartz (14:36)
Great question. And I think the historical thought was that recertification, you could basically wait. If there weren't any eligibility concerns, you know, you remained a public or private nonprofit, and then you met that dish percentage. The thought was, you know, we're still eligible and then we'll just wait until recertification to update our records. Well, in 2023, HRSA rolled out this new feature.
With the change request, where they allowed you to make updates to your qualification information on a ruling basis. We didn't quite understand what the expectation was until we started seeing audit results. And the audits told us that HERSA does expect you to use the change request feature to update your OPACET records with the information from your most recently filed cost report.
regardless of whether there's an eligibility concern. So even if you remain, you know, compliant with the dish percentage, even your, you know, filing and cost reporting period dates need to match the most recently filed cost report in addition to your, you know, dish percentage. So I think there's understandably then confusion around what the expectations are, but we saw findings, we even saw hospitals appeal those findings and ultimately HURSA upheld the findings. So they're serious that.
You know, they want you to maintain accurate records throughout the year.
David Glendinning (16:05)
Yeah, and at the end of the day, if there are going to be audits, we we want hospitals to come away with those process with clean audits. So important to be using those change requests. Rebecca, this has all been really helpful information. What should hospitals do if they need more information than what we've covered here or they have concerns about the recertification process?
Rebecca Swartz (16:27)
I think it's understandable that hospitals would. Things are going to come up during recertification, even during your normal maintenance. So it's always good to tap into legal counsel, especially when your authorizing official is taking a look at those seven attestations of eligibility and compliance. You know, if you have concerns about being able to attest to any of those, consult legal counsel. 340B Health.
We're here for our members too. Remember that, you know, we have our recertification resource, a registration resource. They're very similar. ⁓ and then we have an annual webinar on recertification. So please refer to those resources. HERSA also has a resource on its website. The OPECE user guide is great as well. They have their annual recertification webinar. And then ⁓ any you know, unanswered questions.
We're here for you through our technical assistance calls. So please reach out to our team with any questions. And then ⁓ a PEX call center is also great. They are on standby at the ready to help as well.
David Glendinning (17:38)
Great. I'm glad to hear you are on call for all of those members. I'm also so glad you're on call for me. Anytime I have questions about any of this that I'm trying to communicate to our members, I ⁓ next time that happens, I can can take that short walk. Or if I'm feeling really lazy, I'll just knock on the office wall and we can chat. Rebecca, thank you so much for taking the time to be with us today and we'll hopefully catch up with you soon.
Rebecca Swartz (18:03)
Thank you so much, David. Appreciate it.
David Glendinning (18:05)
Our thanks again to 340B Health's Rebecca Schwartz. Please be sure to visit the show notes where we have some links to the resources that Rebecca mentioned. And if you are a 340B Health member going through recertification and need some help, please call the policy and compliance team so they can assist you. We will be back with our next episode in a few weeks. In the meantime, as always, thanks for listening and be well.
Narration (18:32)
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 at 340bhealth.org.