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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.
Monica Forero (00:12):
Hello from Washington DC and welcome back to 340B Insight, the podcast about the 340B drug pricing program. I'm Monica Forero with 340B Health filling in today for our host David Glendenning. Our guest today is Stephen Miller, 340B Health's Vice President of Pharmacy Services. Steve will walk us through the annual 340B recertification that the Health Resources and Services Administration has allotted hospitals roughly four weeks to complete. The period began on August 12th and will end on September 9th this year. It is an essential annual process that covered entities must take to ensure their continued eligibility for the program. David sat down with Steve to learn more about certification and what hospitals should know when completing it. Here's that conversation.
David Glendinning (01:00):
I'm here with Steven Miller, Vice President of Pharmacy Services for 340B Health. Steve, we have had you on the program before but it's been a while so I will say welcome back to 340B Insight.
Stephen Miller (01:13):
Thank you David. It's great to be back. It has been a little while, so if I'm a little rusty you can keep me in check.
David Glendinning (01:20):
All right, will do. So we're speaking because we're at that time of year when 340B hospitals are talking about re-certifying their eligibility for 340B, among all their other day-to-day responsibilities. We know we have many 340B veterans listening to the program, but not all of them are. So for the benefit of those who might be new to 340B, please briefly describe how hospitals are eligible.
Stephen Miller (01:49):
Yeah, I'm happy to give us a little bit of a reset. So hospitals that want to participate in 340B must be one of three types. They either can be a public hospital which is government owned or operated, they can be a public or private hospital with governmental powers or they can be a public or private nonprofit hospital that has a contract with state or local government to provide those low income healthcare services to low income individuals that don't qualify for Medicare or Medicaid. In addition, all of the hospitals that are participating in 340B, except for critical access hospitals, must meet a minimum disproportionate share adjustment percentage and that's kind of an indicator of their provision of those healthcare services to low income individuals. In addition, each hospital must have filed their last Medicare cost report with reimbursable outpatient cost and charges for any area or within purchase at 340B.
David Glendinning (03:02):
Thank you for that eligibility primer. That's important to set the stage here. And how does recertification fit into this 340B hospital eligibility picture?
Stephen Miller (03:14):
Absolutely. Most importantly, it's a statutory requirement. So the 340B statute actually says that the government must recertify every covered entity at least once a year in the 340B program. It also provides a mechanism for the participating hospitals to validate their eligibility with the government and to make sure that their records are accurate with the government.
David Glendinning (03:43):
We speak frequently on this show about 340B compliance issues. So really this recertification process is all about compliance with 340B rules, correct?
Stephen Miller (03:54):
Absolutely. It's a foundational element for 340B compliance for all of the covered entities and especially for the hospitals. It's also important that they complete recertification every year because if they miss it, there's not an opportunity to just automatically rejoin 340B, if you will. So if they miss the recertification period, the next opportunity if they're eligible is to register again in October and then wait the quarter to begin participating in January. If they're not eligible and have to wait on a cost report, then they could be out millions of dollars in savings to wait the, it could be up to 22 months before they could be enrolled in 340B again.
David Glendinning (04:40):
And of course not having access to those savings could mean significantly fewer resources for those hospitals to care for patients in need. With that very important factor in mind, how should hospitals approach this crucial process?
Stephen Miller (04:56):
First and foremost to start early, as soon as recertification opens, hospitals really want to be ready to go and it typically is mid-August, goes for four weeks usually, and you want to have all of your ducks in a row, so to speak, have your documentation available because you're going to have to upload information when you make changes or corrections in the system to do that. Secondly, you want to check, periodically and throughout the year you want to make sure your information is accurate in the Office of Pharmacy Affairs Information System where recertification occurs and you want to make sure that you're matching your obligations that are detailed in the 340B statute and the regulations that the government has put out.
David Glendinning (05:44):
Who are the cast of characters here for recertification? So who are the people at the hospital who will be taking on this recertification process each year?
Stephen Miller (05:55):
The most important one is the authorizing official. We often call that the AO and that person has legal authority for the hospital. Their signature, if you will, is binding on the hospital. Secondly, the primary contact is the kind of the doer, if you will. They have the ability to go in and make changes for the authorizing official to review and then confirm that those are accurate. They must be two different people and they're the only two roles that have the ability to log in for the hospital and to take these actions. The hospital has one authorizing official for the entire organization. So the Medicare provider number, the 340B ID, it extends across all of the participating locations and it must be the same individual. Each of those locations though can have a different person as the primary contact and some hospitals have the same one across the board, that's fine. Or they may have one for a handful of locations and a different one for another handful. There's different strategies for why they might do that.
David Glendinning (07:05):
Authorizing official and primary contact. So AO and PC, more 340B related acronyms to keep track of, but certainly important ones it sounds like. Once a hospital has those officials, those correct officials in place, how do they start the annual process?
Stephen Miller (07:22):
So the first step is they need to make sure that their login credentials are current, that they can actually log into OPAC and then once they log in, they're going to see all the organization locations listed in the recertification task. We're going to work through those starting with the parent site or the main hospital site, because if they make qualification or eligibility edits there and complete that, then they'll flow to all the associated sites. So that's an efficiency process. So absolutely always start with the parent sites, our recommendation.
(07:59)
Secondly, they're going to want to make sure that they track all the changes that they make so that they can make sure that they are retained in the system. So one way to do that is to take screenshots. And they want to make sure that their information is consistent across their supporting documentation, what's listed in OPAC and the various components of it across their full organization so that it's reviewed by HRSA just as a part of recertification. Or if at any other point in time then there's not a problem with there being an inconsistency.
David Glendinning (08:33):
So it sounds to me like these officials are just confirming or testing, I should say, that the information is all correct.
Stephen Miller (08:42):
It is that, but it can be more than that because HRSA also audits against this information. So they're going to check when you called up for a random audit, they're also going to check this is what you certified as being accurate during the last recertification, but this is not what you just provided to us as part of your audit. And so that can cause a finding, often a database finding, no repayment, that's still a pain. Have to go through the process, create a corrective action plan and then implement that and then prove it after the fact. So certainly better to avoid all that, get it rights first time and recertification and then not have to go through those extra steps as part of a audit.
David Glendinning (09:25):
Getting it right the first time. So hopefully all the information on OPAC in that database will be ship shape when they check it, but if the PC or the AO log on and they notice there are discrepancies or errors, how much of a problem is that going to be for the hospital?
Stephen Miller (09:43):
Not a problem at all because this is the great opportunity to make it right. You can change and update just about everything during recertification for the hospital. There are a couple of minor things that you cannot change during that time, but nearly everything you can change with supporting documentation. So it's a great opportunity to do that because you do have that four week window period of time and you can collaborate across the organization if necessary. Just don't wait till the last minute. Please don't do that. But it is an opportunity to make those changes during recertification.
Monica Forero (10:22):
Hi there. It's Monica Forero with a message from 340B Health's research department. Each year 340B Health partners with member hospitals who are using applied data, transformative technology and community-based insights to innovate their health equity efforts. We are currently seeking your stories to showcase in our annual health equity report. Please email podcast@340Bhealth.org if you're interested in helping us spread the good word about your hospital or health systems advancements in health equity. We appreciate your time and consideration. Please be sure to check out our 2023 health equity report that is linked in the show notes. And now back to the interview.
David Glendinning (11:05):
Good to hear that recertification provides that opportunity to correct some of those issues if they have not been noticed earlier. Any other best practices you can share from the hospitals you've spoken to that seem to be consistent at recertifying cleanly every year?
Stephen Miller (11:23):
Absolutely. The one that comes to mind almost always first is making sure that you've updated information that you can update earlier. So there are a lot of things you can change as part of a change request, because the change request feature itself is locked during recertification. Once it starts, you can't make those routine changes as part of a change request. However, you can do them during recertification, but having them done first can avoid errors. The AOs in a hurry, they press the submit button but they didn't make the corrections and then you've got a problem that you either need to wait until it's all done and change request or you have to wait for the registration period. Problem with waiting in any case is you can have an audit notification and then this time period is part of your sample and then you're out of compliance there as well.
(12:22)
I think the two sets of eyes piece is really important. It's not a requirement. So having the primary contact go through first, flag the things, put the changes in, and then talk with the authorizing official and making sure that they review those before submitting it. That a really important thing.
(12:43)
Having all of your documents in front of you at one time and doing it in one sitting is also a really helpful thing that we've heard from hospitals. Always take a screenshot of anything that you change. Again, there can be an electronic glitch, if all the little electrons are not aligned sometimes things don't save like you think they did and having that screenshot that you really to put it in can be a really helpful thing after the fact.
(13:10)
You don't want to skip any fields in the system. Make sure you go through each one, read the information that's there and compare it to the documentation that you have such as your last filed cost report, because anything that you click okay on, continue, it's going to save whatever was already there if you don't update it and change it.
(13:30)
Lastly, but maybe even most importantly is if HRSA has a question, a clarification or they need additional information, they're going to send that request back to the authorizing official. The PC doesn't necessarily see it or know about it, and so the AOs really got to be engaged until the completed notification comes through. Everything's done. If HRSA sends a request like that, it expires in five days. So AO is on vacation out of the country somewhere and they miss that five day, they've got to start all over with recertification. You don't want to do that. So make sure that AO is really making sure there are no pending tasks in the system until they get that completion notice. That's really important.
David Glendinning (14:20):
This has been great advice. What happens if a hospital runs into a quandary that we have not covered here? So how can 340B Health help hospitals that have recertification questions or encounter problems along the way?
Stephen Miller (14:36):
That's a great question, David. We have several really helpful resources available on our website. We have a section just for recertification and registration. We have just recently updated our recertification resource. So it goes through lots of screenshots of how things look, where to find information, to put it into the things that HRSA is looking for in recertification. There's a couple of things that are a little bit tricky, we think. So that resource is really, really helpful there.
(15:07)
We also have webinar every year before recertification starts. You can log on to the registration that was put out ahead of time or if you didn't register for the webinar, you can register now, after the fact, throughout the coming weeks you can do that and listen and watch the webinar, see the resources and be able to get some helpful information.
(15:31)
So if that's not enough, you still have questions, happy for you to reach out to me or to anyone on our team. We can schedule a technical assistance call to address any of the questions you have about recertification as you go through to process over the coming weeks.
David Glendinning (15:47):
Steve, we always appreciate you giving us a look under the hood to see how some of these crucial 340B compliance processes work, or I should say how they should work if they go smoothly. And I know our member hospitals appreciate the guidance your team provides throughout the year. So thank you for your time today.
Stephen Miller (16:05):
Absolutely. Glad to do it. And again, reach out anytime.
Monica Forero (16:09):
Our thanks again to Steve Miller for sharing his expertise with hospitals navigating the recertification process. If you desire more information, visit the show notes for a link to 340B Health's recent recertification webinar for member hospitals. We are also happy to address any lingering questions you may have about recertification and hear your ideas for future 340B operations and compliance episodes. We invite you to email those to podcast@340Bhealth.org.
(16:39)
We will be back with a new episode in a few weeks. As always, thanks for listening and be well.
Speaker 1 (16:49):
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.