Subscribe
Share
Share
Embed
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 your host, David Glendinning with 340B Health. Our guest today is Steven Miller, 340B Health's Vice President of Pharmacy Services.
(00:30):
If you're listening to this episode, the day it came out August 14th, that means today is the first day of the annual recertification process for 340B hospitals. This year, the Health Resources and Services Administration will close recertification on September 11th, at 11:59 PM Eastern Time, to be precise. That gives hospitals four weeks to complete this mandatory process. We wanted to hear from Steve about some of the best practices hospitals should follow when navigating this year's recertification. But first, let's do a quick recap of some of the latest news about 340B.
(01:17):
340B Health was among the associations that submitted responses recently to an official Senate request for information, otherwise known as an RFI, about 340B. The RFI came from three Democratic and three Republican senators who had asked for information from stakeholders about a range of 340B policy issues. The request made clear that the senators are concerned about drugmaker restrictions on 340B pricing for drugs dispensed at contract pharmacies, among other issues.
(01:48):
The 340B Health comment letter to the senators asks Congress to enact measures to safeguard and strengthen 340B and avoid making changes that could undermine 340B. These include passing legislation to protect hospitals from unlawful drug-company restrictions and conditions, opposing additional burdensome and unworkable 340B hospital reporting requirements, and passing legislation that prohibits 340B-specific discriminatory payment policies by pharmacy benefit managers and payers. Please visit the show notes to read our press release on the Senate RFI as well as our full comment letter.
(02:36):
And now for our feature interview with Steve Miller on 340B recertification. Recertification is an annual process that is one of the crucial steps covered entities must take to ensure their continued eligibility for the program. Myles Goldman sat down with Steve to learn more about this process and how hospitals can go about completing it. Here's that conversation.
Myles Goldman (02:59):
Thank you, David. I'm joined by Steve Miller. To ensure everyone listening is on the same page, what is the purpose of the recertification process?
Steven Miller (03:09):
I often remind myself to think about what is the source of truth when I'm thinking about a particular topic and how it relates to compliance and those kinds of things. So with 340B things, we often think of the 340B statute as that source of truth, and that certainly is the case with recertification. The statute describes a method that the Health and Human Services secretary was instructed to implement, and that is now what we call recertification, but the purpose of it is really to confirm or validate that the covered entities' eligibility and accuracy of the information in the Office of Pharmacy Affairs database is complete and accurate. HRSA also uses that for the covered entities to make a pledge of their compliance with all 340B program requirements.
Myles Goldman (04:04):
I like that term, the source of truth. It sounds like something out of Star Wars or something like that.
Steven Miller (04:10):
Yeah, we could call it the sort of truth too, I guess.
Myles Goldman (04:13):
So the real purpose is to just make sure that they're following program compliance, right?
Steven Miller (04:18):
Right. That they're eligible, they continue to be eligible and that their information is accurate and that they are compliant.
Myles Goldman (04:26):
How should hospitals be preparing for recertification and when should they start?
Steven Miller (04:31):
Well, really they should start when they enroll in the program and register their hospital and child sites as participating in 340B, but you have to do this every year. So a good place to start is by looking at your policies and procedures and making sure that your day-to-day 340B operations align really closely with what you have written down in your policies and procedures.
(04:56):
After that, the most critical thing that hospitals can do is to make sure that all of their information that is listed in the Office of Pharmacy Affairs Information System, or OPAIS, is complete and accurate, and pay special attention to things like qualification information; eligibility information; demographic information, so addresses, names, phone numbers, contact information; and the Medicaid exclusion file.
(05:23):
Secondly, recertification also requires a lot of documentation if you make any changes or updates during the recertification, so you want to gather all those first before you actually open up recertification tasks to get started. Remember, recertification is the action of confirming that everything is right. It really shouldn't be about making routine changes, because the quarterly registration periods are really designed for that.
Myles Goldman (05:51):
What are the eligibility criteria that hospitals must meet for recertification?
Steven Miller (05:57):
Well, there's a list of things, Myles, and we'll just touch on those lightly, but first of all, hospitals that are participating in 340B have to be nonprofit hospitals. If they are a for-profit corporation, they cannot participate in 340B by definition in the statute. Secondly, nonprofit hospitals can be either public hospitals, so they're owned or operated by the government, or they can be private hospitals. If they are a private hospital, they have to have a contract with a unit of local or state government to provide healthcare services to those low-income individuals who don't qualify for Medicaid or Medicare services.
(06:35):
Next, all hospitals except for critical-access hospitals have to meet or exceed a disproportionate share adjustment percentage, which is on their Medicare cost report, and they want to be using the one that was last filed. For DSH, cancer and children's hospitals, they have to exceed 11.75%. For rural referral centers and sole community hospitals, they can equal or exceed 8% of that adjustment percentage to qualify, and as I said, the critical-access hospitals are exempt from that requirement.
(07:10):
All hospitals and child sites that are participating in 340B must have reimbursable outpatient cost and charges on that last filed cost report, and of course, we've already mentioned that this is about compliance, so HRSA is expecting the authorizing official who makes the submission for recertification to promise or pledge that they're going to be compliant with all 340B program requirements.
(07:36):
Once recertification opens, either the primary contact or the authorizing official will log into OPAIS and open up their dashboard and then look at their tasks, and there will be a recertification task pending. Once the primary contact or the authorizing official opens that recertification task, they want to find and check the parent hospital site first, and it's really important to start with the parent site and recertification, because once they make all of the changes or updates or confirm that everything is correct in the demographic information about the hospital and the qualification information, that will all transfer to all of the associated child sites, so they won't have to do it for each one. If you don't start with a parent, then you're going to have to do it for each one and it'll take much, much longer.
(08:32):
So after checking the demographic information, then they want to check the qualification information, and this is super important. You need to take that last filed cost report and make sure that all of the qualification information on the Medicare cost report matches what is in OPAIS. You cannot depend on the upload from CMS to go to OPAIS and to make all that information match at the time of recertification. It might or it might not, but don't even pretend that it might. Just automatically look at it and make sure that those fields all match.
(09:09):
So we're talking about the DSH percentage. We're talking about the Medicare cost report filing date, the Medicare cost reporting period, the control type and classification type for the hospital. All of those things are on your Medicare cost report, and they must match in recertification, because if they don't and you get an audit six months from now and you submit that information from your last cost report and it doesn't match what you attested to in recertification, you're going to get a finding. It's just important to do that right off the bat.
(09:40):
Next, you want to make sure that you check all of your other information for each child site after completing the parent site and make sure that that is accurate as well.
Myles Goldman (09:50):
Steve, if the hospitals find that the information doesn't match on their Medicare cost report, what can they do?
Steven Miller (09:58):
If it doesn't match, the most important thing that they would do in recertification is to make the changes in the recertification task, and then the system will prompt them to upload the supporting documentation, whether that's certain worksheets from the Medicare cost report that is showing: okay, the recertification default is showing a DSH percentage of 15%, but our last cost report is 18.3%. So even though it's not a change in eligibility, it is still a discrepancy between the last cost report and what is showing up in OPAIS. So they would change it to match what's in the last cost report, and then they would upload that worksheet that shows that figure.
(10:44):
The important thing also to remember is during recertification, the traditional change request process is locked for hospitals who are recertifying until after the recertification is approved by HRSA, so they can't go in and make routine changes. They would have to make all of those changes to anything that is not correct during the recertification process.
Myles Goldman (11:07):
Let's talk about the Medicaid exclusion file. Why is this a critical component of the recertification process?
Steven Miller (11:16):
The Medicaid exclusion file really ties back again to the statute, so the 340B statute has a requirement for the secretary to implement a mechanism for covered entities and other stakeholders to be able to prevent duplicate discounts, and that's where a manufacturer provides the 340B price a Medicaid agency is submitting a rebate for the same drug bill to Medicaid. The Medicaid exclusion file process of validating that information and recertification is an important part, because it has such a big consequence if it's wrong. So a manufacturer can be harmed by paying the discount twice, and the hospital is non-compliant if they don't have the information in there correctly.
Myles Goldman (12:07):
You mentioned the authorizing official a little earlier. Can you explain further about the importance of the AO?
Steven Miller (12:17):
The authorizing official is really the most important person from the covered entity or the hospital participating in 340B, because they are the only person who can do all of these things in terms of a final way. They have to have legal authority to bind the hospital or the covered entity in matters with the government. When they receive tasks or notifications from HRSA, they have to respond to those. The primary contact can enter information, they can make changes, they can submit comments on things in OPAIS, but only the authorizing official can submit those to HRSA for approval or finalizing whatever the item is, including change requests.
Myles Goldman (13:04):
Do hospitals ever fail to be re-certified, and what are the most common reasons if this occurs?
Steven Miller (13:14):
There are some hospitals every year that do not recertify. Fails is a little bit of a hard word there, because sometimes it's just a natural consequence because they no longer qualify, and that is the predominant reason is their eligibility DSH percentage has dropped on their cost report that has just been filed just before recertification starts.
(13:39):
The other reason can be a change in their type, so if they're a nonprofit hospital that's purchased by a for-profit corporation and they are no longer a nonprofit hospital, then they would no longer qualify. That is another reason that some hospitals do not recertify.
(14:00):
There are a very, very, very small number who just don't get all the information done on time, and then they have to work one-on-one with HRSA to complete it, and sometimes HRSA will allow them to go on and recertify late or sometimes they have to wait out a quarter and reenter the next quarter.
Myles Goldman (14:21):
Through any of the examples you just provided there, if the hospital is no longer eligible for 340B, when is their next opportunity to become eligible again?
Steven Miller (14:33):
Well, it depends on the reason that they drop. If it is eligibility that's tied to the Medicare cost report and their next cost report is not filed for another 12 months, then it's going to be 12 months plus another quarter, because once they register, then it's not effective until the following quarter.
Myles Goldman (14:53):
What are some of the most common errors hospitals make during recertification, and what are some of the best practices to avoid those?
Steven Miller (15:03):
The most common error that I hear from our members is that the primary contact or the authorizing official didn't check every single one of those qualification requirements, so the DSH percentage, the Medicare cost report filing date or the cost reporting period, the control type, any one of those things, or classification type. If they just think that if it's defaulted in, that it has to be right, but it isn't always. Something has changed or they filed an amended cost report, which has changed one of those numbers. So it's just really, really important to check that information based on what the last cost report is, including if there was an amended cost report filed.
(15:48):
The second thing is just double-checking, so two sets of eyes is a really good best practice here for recertification. The primary contact goes in and looks at everything first, makes any changes, comments, submits that to the authorizing official, and then the authorizing official reviews it again, making sure that everything is right, and that seems to work really well for hospitals.
(16:14):
After recertification is completed and HRSA has approved it, the next best practice is to go back into OPAIS and check that everything saved correctly, because we've heard from a few hospitals that they thought they made the change, but they didn't take a screenshot, and that's another best practice. Take a screenshot of every single page as you go through it, and particularly if you make changes, so you have something to go back to. And then if it didn't save, then you have something you can take to HRSA and say, "Look, here's a screenshot as we went through it and it shows the different number, and now it doesn't show that number that we changed it to," and they can help work through fixing those kinds of things.
Myles Goldman (16:57):
If a hospital has questions about recertification, what should they do?
Steven Miller (17:01):
Well, certainly they should go to our website and look at all the resources that we have on our website at 340Bhealth.org. There are a number of these resources and member tools. There's actually even a section for recertification and registration. Registration and recertification are really closely tied together.
(17:20):
Secondly, if they have questions they don't see the answers or they're not really sure they understand exactly what they need, they can reach out to us by email and set up a call with one of our staff experts. The info at 340Bhealth.org is as good a place as any to send that email. That's an easy one. You don't have to know somebody's name. Certainly you can reach out to me, but we have a number of staff that can answer these questions.
Myles Goldman (17:46):
I know this can be one of the more stressful times of the year for staff managing their 340B programs, so thank you, Steve, for taking the time today to help share best practices for successfully navigating 340B recertification.
Steven Miller (18:01):
You're more than welcome, Myles. We're always available to help.
David Glendinning (18:05):
Our thanks again to Steve Miller for all his great advice for hospitals on navigating the recertification process. If you are a 340B Health member and you missed our August 3rd recertification webinar, you can access a recording of the event. Please visit the show notes to learn more.
(18:23):
What operations and compliance topics would you like us to cover on this podcast? You can email your episode ideas to podcast at 340Bhealth.org. We will be back in a few weeks. As always, thanks for listening and be well.
Speaker 1 (18:44):
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.