(pleasant music)
- Welcome to "340B Insight" from 340B Health.
- 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 for this episode is Melissa Bruce
with UNC Health based in North Carolina.
On the show, we recently covered
the topic of navigating 340B audits
with one of the presenters
at the most recent 340B Coalition Conference.
We also wanted to speak with a 340B expert
on how hospitals can help prevent findings
for one of the key compliance violations
that auditors look for, duplicate discounts.
And that's where Melissa came in.
But first, let's take a minute
to cover some of the latest news about 340B.
(exciting music)
There is new federal legislation to end
drug company restrictions on access
to 340B pricing through contract pharmacies.
Congresswoman Doris Matsui,
a democrat from California
recently introduced the 340B PATIENTS Act of 2024.
It would clarify the 340B statute to bar drug makers
from imposing restrictions
or conditions on covered entities
receiving 340B discounted drugs,
regardless of where those drugs are dispensed
to the entity's patients.
If the bill were to become law,
it would end the restrictive policies
from the more than 30 drug companies
that now have them in place.
Visit the show notes
to read Congresswoman Matsui's announcement
and 340B Health's statement on the legislation.
State governments also continue to make progress
on the contract pharmacy dispute.
In one of the most recent developments,
a federal appeals court has cited
with Arkansas health officials
regarding a law preventing restrictions
on 340B contract pharmacies in that state.
The pharmaceutical industry had sued the state
over the constitutionality of the law,
but the court issued a decision, saying that
federal statute does not preempt state law in this case.
340B Health members can read more about the decision
and possible next steps in the court case
by visiting the show notes.
(exciting music)
And now, for our feature interview with Melissa Bruce.
Melissa is a 340B certified compliance analyst
for UNC Health.
She presented on a panel
at the 340B Coalition Winter Conference
about duplicate discount prevention.
This is one of the most important compliance requirements
for 340B hospitals, and it can be quite complex.
But UNC Health has been pursuing an innovative approach
to duplicate discount prevention,
and we spoke with Melissa about some of the lessons
the health system has learned during implementation.
Here's that conversation.
- I am speaking with Melissa Bruce
(atmosphere humming) (people chattering distantly)
here at the 340B Coalition Winter Conference,
and we are competing with the Ice Cream Social.
So, we're gonna try to keep our mind
on what we're here to talk about today,
and that is duplicate discounts.
So Melissa, welcome to "340B Insight,"
thank you for being here.
- Yeah! Thanks David, thanks for having me.
- Tell us a little bit if you could, about UNC Health
and the patients you serve there.
- Sure!
So, UMC Health is comprised of 14 hospitals
in over 700 clinics.
The 340B program management team,
that's who I'm a part of,
oversees the program compliance for 10 covered entities.
And we service all of North Carolina.
And kind of your basic patient mission for us
is going to be improving the health
and wellbeing of North Carolinians and others whom we serve.
- Wonderful.
Well, we've had episodes before
where we've focused on 340B audits, but we have not yet
done a deep dive on one very important element of that,
which is preventing duplicate discounts.
So, to start with,
what do we mean when we talk about duplicate discounts?
- So, a duplicate discount
is really when you have
drug coverage that can involve Medicaid rebates
that are paid out to states from manufacturers,
as well as providing the 340B discount to covered entities.
When we talk about duplicate discounts,
we're looking at making sure
that the covered entity has mechanisms in place
to prevent the duplicate discount
or the risk of an audit finding.
So, it's just really important to keep in mind
from a covered entity that
that responsibility lies within that covered entity,
and not necessarily with the manufacturer
or with the state Medicaid agency.
- Clearly, this is gonna be high
on the list of compliance concerns for covered entities,
and I understand there may be different factors at play
based on what state
a covered entity's operating in, correct?
- It can vary state by state,
and it's especially important to think through,
if you're a covered entity,
what are the requirements in your home state.
Another piece of that is if you have multiple border states,
or if you're in a high kind of pass through area
where you have a lot of tourists,
or maybe a high college town, where you will see
a lot of different states.
And so, it's really taking a look at how varied they can be,
what the requirements are,
and what type of Medicaid is even provided
within that state.
Let's say, if it's fee for service
and you have managed Medicaid,
how do you want to address those?
Do you wanna carve in or do you wanna carve out?
And really what that means is if you're going to bill
fee for service Medicaid, you're going to carve in
for your 340B drugs.
If you decide, hey, these particular states
that might be not necessarily state, you only have one claim
that you wanna carve out,
so you're choosing not to bill Medicaid and 340B drugs.
We have several states that are mandatory carve out states,
meaning that you don't have the option to bill Medicaid
and use 340B drugs for those patients.
And then, on the flip side, you have a couple states
that are mandatory carve in.
And so, that's a whole different level of complexity
because then you really have to focus on
understanding the EHR and billing requirements,
and you don't have a choice in the matter.
So, really understanding where are you at
for your covered entity, is at your home state?
Which is obviously the most important.
But as well as a border state, you might have
half your volume coming at the border,
and you really need to be able to understand
the billing requirements for both sides.
- Okay, so carving in, carving out,
fee for service versus managed care,
there's certainly, adding a bunch more terminology
to the list, which is not uncommon with 340B compliance.
You mentioned the complexity level before, how complex
can this actually get
for a system like UNC Health?
In terms of having systems
in place to prevent duplicate discounts?
- So, it can get very complex,
especially when you're looking at multiple child sites.
Because each child site needs to have
consideration for the Medicaid billing.
So, one big thing that we need to talk about
is the Medicaid exclusion file.
So, this is a requirement on OPAC for every 340B ID
within that program structure.
So if you are a large institution
and you have multiple child sites,
that it can vary from two child sites,
it could be 100 child sites,
that every one of the child sites
should be operationalizing Medicaid
the same from a compliance standpoint.
If you decide only half of them are gonna carve in
and then the other half are gonna carve out,
it really is understanding the compliance risk
associated with being able to audit for that,
and maintaining accuracy on the Medicaid exclusion file,
as well as ensuring that OPAC mirrors the operations
within those child sites.
So the complexities for UNCH,
it really is taking a look at the cross border areas.
So, we do have several that are going to be
right at the border.
So, when we talked about understanding
the different types of Medicaid
and really understanding the billing requirements,
is understanding that those particular border areas,
you need to know that patient volume.
Do you choose to carve in versus carve out?
The other side of this is really understanding
from a mixed use standpoint,
so this is the institutional claims
that are being billed, not the retail pharmacies,
how do you manage a carbon carve out list,
and what does that look like?
And then, from a retail pharmacy standpoint,
it gets a little bit easier
because you've got your bin and PCN,
and group lists that you still have to compile the data,
but it's a lot more easily identifiable.
And then if you do have to
implement a carve out list, that tends to be
a little bit on the easier side versus trying to figure out
different payers in the institutional area.
- When we think about the 340B hospitals
that 340B health represents, our members,
we're always on the lookout for ways to help
manage some of those types of complexities
within the program.
So, what kinds of processes
can hospitals implement to handle,
or perhaps reduce these levels of complexities
while still remaining compliant with all 340B rules?
- So, there's a couple of types of process
that can be considered.
So, you have manual workflows,
and these are really, when you talk about manual,
it really is manual.
It's reviewing Medicaid dispensations, it's taking a look at
how do you identify these payers?
How do you get into your EHR?
So, it's understanding within the EHR
or who in the organization can even help you say, hey,
this particular payer name is fee for service Medicaid.
If you don't know what that looks like
or even managed care organization,
sometimes the naming convention
can look like a commercial payer.
And really, this is where you get into collaborating
within your covered entity, is bringing out knowledge
and helping you close the gap.
Especially when we're looking at carve out lists,
preventing those 340B accumulations is imperative.
If you do not, and you're carving out
but the manufacturer thinks you're carving in,
this is a duplicate discount.
And so, you're trying to prevent that,
and you might need a little bit of help, and that's okay.
It really is just honing in on those experts.
And then another process is really taking a look at
a cadence check.
So if a weekly check becomes very cumbersome,
do you have resources?
Do you have somebody who is Excel-savvy?
And if you do and you start to get heavily Excel-based,
and this resource is fantastic,
but they're so great, they might get promoted.
And then what do you do?
And then another kind of option
which isn't gonna sound too pleasant,
is carving out entirely.
From a financial standpoint,
understandably so, it's likely not viable.
However, if you don't have a resource
to understand EHR configurations,
how do you apply those modifiers, or how do you go through
applying the 340B actual acquisition cost?
You might need to do a temporary carve out
just until you get that down.
Biggest piece on that to consider is,
while you might be losing out on 340B savings,
you are considering the compliance
for the entire program.
And so if it's a very short period of time,
you get somebody in place
and you get those modifiers set,
then you can get right back to carving in.
- I'm getting the feeling here
that there's another option at play,
and certainly based on your presentation here
at the conference, another option
besides either manual workflows or total carve out.
So, how did UNC health decide
to approach this complexity challenge?
- Yeah, so we really had to think outside of the box.
And it was talking through
various resources even within the team
and team's leadership of understanding
what was happening in our TPA,
what was happening in our EHR.
So, our approach was to take an automated workflow approach,
which is truly just streamlining those manual tasks.
So, what we did is took a look at our TPA dispensation file,
and that was really again using resources
within the covered entity, who is the expert?
Who manages the data that you might need?
And working with our director of revenue cycle
and identifying payers
that we consider either out of state Medicaid,
or there's third party billing services.
What shows up on the institutional claim
is not the name of the Medicaid payer,
it's the name of the service.
So, you might look at that
and not think it's Medicaid, but it really is.
And so, how do you build this carve out list?
So, we worked really hard
with a few different groups of people to create
a carve out list,
and then what we did is we decided we wanted to block
those list of payers from flowing to the TPA.
So, stopped 340B accumulations, we were able
to successfully get through one implementation.
We do have many more to go.
So, just keeping in mind thinking outside the box,
get the wheels turning,
the size of the covered entity is super important.
If you have just a small low bed dish
with no child sites,
so using automation if you don't have the resources
might not be the most appropriate.
But you can look at automating even an Excel file
if you're doing monthly audits, or if you're going through
and you're doing them quarterly, think different ways,
just get outside of the box, ask other people too.
Big thing is, is using your peers.
Find another covered entity that's similarly structured,
and ask them what they did.
- That process does sound very compelling.
The automation process for, as you say, covered entities
for whom it makes sense to to implement it.
At UNC Health, what benefits did you see
from moving to workflow automation?
- So, the first one is really taking a look at accuracy
and improving accuracy.
Accuracy is really important
because it instills reliability,
which then really shows your stakeholders
that what you're doing is valid,
and it really increases the trust they have with you,
especially if you're an enterprise level team.
If you're doing work on behalf of a covered entity client,
and letting them know that hey,
what we're doing increases accuracy,
which is gonna lower the risk
for duplicate discount finding.
Part of my preparation
for the presentation was really looking at HRSA's findings.
What audits they've completed.
And something that I just put into my presentation,
and wanted to kind of mention here is,
since 2015, it was very consistent trend,
that 15 to 20% of entities that were audited by HRSA
had duplicate discount findings.
So, really thinking through
how can you prevent them is super important.
Another benefit was improving workflow.
So, by improving workflow, you're taking out
any repeated tasks, you're becoming more efficient,
you're able to have better use of your resources,
you're really optimizing
so that you can meet the objectives.
And then finally, it's looking at time constraints,
and finding new ways that you can use those resources.
So, there might have been a project that's been pending.
Or something else
that you needed to kind of bring to the table,
and now you have this freed up resource
to be able to start a new project.
Or maybe there was another area within the program
that needs more attention.
That's not duplicate discount-related,
but equally important from a compliance standpoint.
- You mentioned those HRSA audit stats,
which I'm imagining are top of mind
when you're thinking about this.
So, how did you ensure
that the new process you put in place
was going to work as intended?
- So, we really took a look at who we needed to talk to,
and who was gonna be the most appropriate to,
from start to finish, be able to implement
and really understand our requests.
So, first and foremost was identifying
the right person who could update our logic.
And again, it's taking a look at that list of payers,
so that carve out list,
and then being able to understand how the logic truly works,
so that we could apply exclusionary filters.
Another big piece here, which,
it ended up being a vast majority of the work,
was validating how the new logic would work
if we implemented it.
So, what we did is we identified our covered entity
that we wanted to pilot our automation workflow with,
which just so happened to have gone through
a recent HRSA audit,
and started with test file information.
So, the prep work that we used for that HRSA audit,
it was an out-of-state Medicaid audit,
was our kind of test file that we used,
and then we were able to look at using that date range,
can we update the logic?
Give me what the new version of the logic would be.
(atmosphere humming) (people chattering distantly)
So, it's really just baseline testing
and validating, to look at
did the update and the logic work as intended?
Or were there inadvertent consequences?
Or, was more data removed from that file
that didn't need to be?
So, were some of those carve in payers
that was the data missing?
Or, did some of the payers still flow through
and we didn't need them to be?
So, really using that test case to make sure
that everyone understood how the change in logic
was going to be applied, and then making sure
that we continue that through go live.
- That's very interesting.
The idea of doing a dry run
with the previously audited site.
Any lessons that you learned from this process?
- So, I think the biggest thing that we really picked up
is that larger,
more complex sites
are going to need more validation.
So, we were kind of filtering through data,
we thought we understood how the logic worked,
and it ended up being that we needed more time.
Going through and looking at how secondary
or tertiary Medicaid payers, if there was some type of payer
reprocessing that was occurring, how did that look?
So, it really was looking at individually
from a covered entity instead of doing a mass rollout,
we needed to do one version,
so that we could understand really what was going to happen.
Another one was really understanding that
there was a need for frequent checks, especially at Go Live.
How often is data being sent to our TPA was a big thing
that I don't think we realized
when payer data flowed through, we assumed
it was going at the same time as our dispensation file,
and it ended up being a several week lag time.
So, we needed a larger amount of time in between
doing validation of the live data,
and so we really got into setting a precedent
for doing regular cadence checks after Go Live.
And then finally, the biggest thing,
I think two people think through things,
is that it is not a set it and forget a process.
Maintenance is key.
You wanna continue to check.
So, what if a new payer is added to the EHR?
What if a new state is billed?
What happens if the state billing requirements change?
What happens if one of your border states ends up
contracting with a completely different state
and you weren't aware of it?
So, you just really have to continuously check
and do maintenance is super important.
- After seeing this positive example from you
and hearing your presentation,
let's assume another health system out there is sold now
on the idea of implementing workflow automation.
What additional advice might you have for them?
- One thing I learned since my first conference,
is that when you talk to other people here,
it really highlights that you are not alone. (chuckling)
And you can actually have a conversation with somebody
and they know what you're talking about.
One of the biggest struggles I think that we had
was really communicating clearly and concisely
what we needed in a way that it was easily translatable
throughout the covered entity.
Words that we might use in the 340B space
we think means one thing
if you're talking to somebody in revenue cycle,
if you're talking to somebody,
maybe in your IT department,
but it means something completely different.
So, making sure that you're standardizing your terminology,
it's clear and concise, but also setting an expectation,
maybe have them repeat the ask back to you to make sure
that they truly understood what you were saying.
Another one is really engaging with peers.
I mentioned this earlier, is reach out
to another organization that's the same program structure.
If you use a consulting service.
We have 340B experts everywhere.
Reach out to somebody,
it's okay, it's one of those adages,
there's no stupid questions 340B is one of those things,
ask the questions.
And then finally, I think this is most important,
be patient and stay motivated.
I've been at the forefront of working on
this particular project,
and it took nine months to get one covered entity,
and you get through month three or month four,
and really making sure that you stay motivated,
and really understanding why you're doing what you're doing,
and that it is super important.
- Melissa, I enjoyed the opportunity
to look more closely
at such an important element of 340B compliance with us.
So, best of luck with the rolling this out
to additional sites,
and thank you for sharing your experience and your advice.
- Yeah!
It was great talking,
and I am so glad that you reached out about the interview!
- Our thanks again to Melissa Bruce
for helping us better understand
the complexities of duplicate discount prevention
and how 340B hospitals can navigate them.
We also thank her for sharing her great advice
and lessons learned with her fellow conference attendees.
And we wholeheartedly agree
that when it comes to 340B operations and compliance,
there are no stupid questions.
We hope that all of our listeners grant us
the same grace as well.
What questions do you have for us?
We invite you to send them along
so we can plan topics for future episodes.
Please contact us at podcast at 340bhealth.org.
We will be back in a few weeks.
In the meantime, as always,
thanks for listening, and be well.
(electronic music)
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(narrator chanting indistinctly)