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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.
(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)
- Thanks for listening to "340B Insight."
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For more information,
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(exciting music)
(narrator chanting indistinctly)