Episode 16: Community Health Centers: Issues Facing FQHCs Today (Podcast) – Food, Drugs, Healthcare, Life Sciences

In this episode, Foley Senior Counsel Adam Hepworth talks with Trent Stechschulte of Equitas Health to talk about current hot issues…

In this episode, Foley Senior Counsel Adam Hepworth talks with Trent Stechschulte of Equitas
Health
 to talk about current hot issues related to
Federally Qualified Health Centers (FQHCs).

Adam Hepworth is a senior counsel and
health care lawyer with Foley & Lardner LLP. His practice
focuses on Medicaid and Medicare, internal audits and
investigations, health privacy laws, and compliance with health
care fraud and abuse laws. Adam has represented hospitals,
Federally Qualified Health Centers (FQHCs), and other providers in
numerous Medicaid administrative appeals. He argued Tulare
Pediatric Health Care Center v. State Department of Health Care
Services, resulting in a decision from the California Court of
Appeals recognizing the State’s obligation to pay FQHCs a
Medi-Cal per-visit rate that reflects their full costs when they
contract with an outside medical group.

Trent Stechschulte is the General Counsel
& Compliance Officer at Equitas Health. Trent received his
Bachelor of Arts degree in History from The Ohio State University
and a Juris Doctor from Cleveland-Marshall College of Law, where he
earned a Certificate in Health Care Law from the Center of Health
Law & Policy. At Cleveland Marshall College of Law, Trent was
elected Editor-in-Chief of the Journal of Law & Health.
Currently, Trent oversees the legal department and compliance
program at Equitas Health. As General Counsel, Trent regularly
works with the leadership, providers, pharmacists, and other
personnel on a wide variety of health care and corporate issues. He
is the Chair for Equitas Health’s Compliance Committee and
works with department Directors to carry out their Compliance
Plans.

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Please note that the  interview copy below is
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enjoy the show!

Adam Hepworth

My name is Adam Hepworth and I am an attorney with Foley
focusing on Medicaid and Medicare, compliance with health care
fraud and abuse laws, and administrative appeals. I work a lot with
federally qualified health centers or FQHCs, which are the topic of
this podcast. For those who aren’t familiar with them, FQHCs
are community health centers that receive a special status in
exchange for serving an underserved population and meeting a basic
set of requirements set forth by HRSA, the Health Resources and
Services Administration. FQHCs primarily serve low-income patients
who have Medicaid or are uninsured.

For today’s podcast, we will talk about hot issues for
FQHCs. They’ve emerged as a critical part of the pandemic
response, receiving significant government grants and other support
because of how well positioned they are to target the most
vulnerable individuals who needed health care, included COVID
testing and vaccines during the pandemic. We’re fortunate today
to have with us Trent Stechschulte, general counsel and compliance
officer at Equitas Health, an FQHC that serves tens of thousands of
patients each year in Ohio, Kentucky, and West Virginia, with 21
offices in 13 cities. Equitas Health is one of the largest LGBTQ
plus and HIV/AIDS serving health care organizations in the United
States. It also operates pharmacies serving patients in Ohio and
Texas. Trent has been with Equitas for about seven years. And
I’ve had the privilege of working with Trent recently in this
last year, including doing some presentations together. So I’m
excited to have him here.

Trent, welcome to the podcast.

Trent Stechschulte

Thank you, Adam, so much. And if you want, I think we can just
jump right in since we only have a short period of time. Is that
okay with you?

Adam Hepworth

So the first thing I wanted to talk to you about, Trent, is that
we’re now in a bit of a weird space where the country is really
starting to open up again after the pandemic, but some people are
still hesitant and a lot is happening remotely that would have been
in person just a couple of years ago. What are the biggest
operational and legal hurdles that are challenging your FQHC in our
current transition period?

Trent Stechschulte

That’s a really good question, and it goes back to what you
said before is that FQHCs predominantly serve Medicaid populations
and the uninsured population, so budgets and cash flow have always
been a challenge for FQHCs. At the beginning of the COVID pandemic,
a lot of FQHCs were nimble and were able to transition to
telehealth quite quickly, but it’s not surprising that many
could not because they don’t have the capital investment for a
telehealth infrastructure or the ability to hire talent to really
operationalize that type of program. So as we’ve gone over-as
regulatory health lawyers-FQHCs were expected to track and
operationalize Medicaid waivers, Medicare waivers, licensure
waivers, and other regulatory waivers that their businesses were
built on. So, the health care community, of course, nurses,
providers, MAs were very nimble and quick to this. The legal
community, lawyers like you, Adam, and the law firm of Foley, were
impressive in giving guidance in real time and you actually saw
that guidance in real time impacting health centers.

Most in-house lawyers like me were scrambling just to stay
organized and create some sort of compliance framework for those
waivers, and that’s something that we’re still dealing with
on a day-to-day basis. The response to COVID from my perspective
was this, constant messaging around the changes, meetings about how
to appropriately operationalize the changes, and conversations
around what waivers will stay forever and will go away once the
public health emergency goes away. At the beginning, we did not
know how long the lockdowns would last, how long the waivers would
remain, what the real impact of COVID would have, and the worry was
whether we should be changing our business model and I think
that’s what a lot of community health centers are dealing
with.

So, with the professional boards lifting a lot of the rules
around practicing for telehealth, that’s what we’ve been
talking about. But one thing that I think that we’re not
talking about enough is the impact that the COVID had on behavioral
health and how important it was for telehealth to open up in the
behavioral health sphere, but also is the operational challenges
that many community health centers have that are dealing with
social workers and how to coordinate care with our high-risk
patients. So social workers are responsible for coordinating
housing, food assistance, health care education resources, ensure
that a patient has health insurance, and coordinate prescriptions
for some patients. Since COVID meant working with grantors on
understanding the best ways to serve patients, a lot of those grant
rules, like you said, changed. A lot of grants came through to
address this, but COVID already shocked the system that was dealing
with homelessness, poverty, and an issue where otherwise avoidable
infectious diseases were being spread around communities at much
higher rates than others.

Adam Hepworth

I mean, that’s really interesting. I just wanted to jump in
for a second because I heard you talking about social workers and
coordinating these other areas and I think some people might not
realize the extent to which FQHCs are involved in those sorts of
efforts. I’ve done some work in the past on the social
determinants of health, which I know we’ve chatted about too.
For those who don’t know what that term means, it’s defined
by U.S. government agencies as the conditions in the places where
people live, learn, work, and play that affect, basically, their
health and quality of life risks and outcomes. So the idea is that
medical care only gets you so far and that it’s things like
education, food security, housing, and public safety that sometimes
matter a lot more, particularly in the most vulnerable communities
that don’t have those. So I think it would be really
interesting to hear a little bit about how FQHCs are on the front
lines of addressing some of those issues because it might be news
to some people that a health care organization, a community clinic,
would be involved in those efforts.

Trent Stechschulte

Many of those public health priorities you’re talking about
are actually going to be stalling or are inflamed right now. For
instance, substance abuse and overdose deaths in Ohio are at its
highest rates. Our community health center offers a needle exchange
program, we have care coordinators and testing specialists on site.
The mental health concerns coming from the pandemic is really
inflaming that epidemic that’s running rampant across Ohio, but
also what we’re seeing is that community health centers are
being tasked with many of the prevention activities that otherwise
would be managed by health departments. So the health departments
are using their resources to respond to COVID, as they should, but
they’ve asked community health centers and other partners to
really manage the patients that are traditionally within the
department’s purview.

So one example in Ohio is a drastic, drastic increase in
syphilis. At this time, we are unsure why, but now we are starting
to see congenital syphilis and babies born with syphilis, something
that is so rare is now happening with almost alarming regularity.
So our staff is working on the departments of health like that, but
when you talk about social determinants of health, we talked a lot
about telehealth, right? And so telehealth, for sure, it’s
opening many doors for community health centers, but it’s also
moving us towards health care being a privilege if the only way to
access that health care is through telehealth. There are so many
people that we try to reach that we do not have the ability to
access with technology.

We’ve talked about, and I think even you on a podcast have
talked about the aging population and finding unique ways to have
them access technology, but what we’re seeing is we’re
trying to reach out to the transgender teen that’s kicked out
of their parents’ house and has no phone, or the drug abuser
that has no cell phone number or reliable cell phone number, or the
recently unemployed service worker that couldn’t afford a
monthly fee to keep their phone and is no longer seeing their
primary care doctor for diabetes management. So when you talk about
social determinants of health, yes education, yes poverty, yes
where live, even race is a social determinant of health, but now
we’re starting to see that access to technology is also a
social determinant to health.

Adam Hepworth

That’s so interesting, and when you’re taking on these
new roles and the public health departments are understandably
overwhelmed by all the COVID responses, do you think this is
triggering long-term systemic change or do you think it’s
something where things will just go back to the way they were in a
few years after hopefully COVID is behind us and public health
departments return to doing the things they were doing before?

Trent Stechschulte

Well, one, I don’t think telehealth is going to go anywhere.
I think there may be some regulatory changes around what you can do
through telehealth, but I think a renewed focus on funding for
things like syphilis and HIV is really important. Ohio had a very
aggressive goal at decreasing the transmission rate of HIV and AIDS
by 90% by 2030, and not that the numbers are going up, but they are
stalling out, which is concerning. At this point-and I mean,
you’re a corporate health lawyer, many of the people listening
to this podcast may be corporate health lawyers-the civil monetary
penalties along the anti-kickback statute does allow some
exceptions for FQHC to provide incentives, but most of those
incentives may encourage patients to seek low cost preventative or
primary care, and at some point, we need to have a conversation
where public health departments are subsidizing technology or
subsidizing more incentives for these low-income patients,
right?

So I think that what this has shown is that though telehealth is
reaching more people, there are still a lot of populations falling
through the cracks, and just to kind of underscore how important
community health centers are at this time, I want to give a
specific example because I don’t want everyone just to think
I’m talking in platitudes here. So last week, we had a story
where a 22-year old lost a serving job at the beginning of the
pandemic, has since contracted HIV because he was worried he
couldn’t afford PrEP, which is pre-exposure
prophylaxis-it’s just a once a day pill that if taken daily is
99% effective at protecting against HIV.

He was jobless without insurance, did not think he can afford
it, but to us, it’s very inward. What should we have done
better with marketing? How could we have reached him where we could
have given him that PrEP without him being worried about the cost
of it? How can community health centers reach out to show how even
if you lose your job and insurance, there are still options for you
to stay safe? Adam, to your point, that’s a lot of the creative
thinking that we’re constantly going over with each other.

Adam Hepworth

It’s heartbreaking, but powerful, to have a concrete example
like this to understand the stakes of some of the things we’re
talking about. You mentioned something that I think is a recurring
tension in health care, which is on the one hand, you have these
fraud and abuse laws that are concerned with incentives to patients
because they’re concerned with overutilization and unnecessary
care and in safeguarding against those harms to the delivery
system. But on the other hand, we have these trends of whole person
care and addressing the social determinants of health and providing
a more comprehensive package of health and non-health services to
patients to really be more effective in our outcomes. And those two
things sometimes come into conflict, so you have this weird
situation where innovative Medicaid waiver programs, or other
government efforts like accountable care organizations, want you to
be doing comprehensive care management outreach to patients, but
without particular waivers of fraud and abuse laws, you’re
running against the traditional health care regulatory regime.

It would be interesting to hear how you feel that tension. To
pivot that way, one thing I wanted to ask you about was during the
pandemic, something that was very striking was the speed with which
government actors came in and tried to give regulatory flexibility
to health care providers, to waive a lot of the traditional fraud
and abuse laws, or to increase reimbursement, or to make it easier
to use technologies like telehealth. I know that that was hugely
important to probably all health care providers, but especially to
FQHCs. Could you talk a little bit about what that was like, and
then also the lessons learned?  What do you think needs to be
made permanent as we move forward?

Trent Stechschulte

I did mention this a little bit earlier about the sprint of
operationalizing all of these changes, the sprint of trying to
educate patients on this technology and how to access this
technology, and listen, we serve a very diverse patient population
when it comes to payers. We have young employed folks with private
insurance and we have Medicaid folks. We serve a lot of different
patient populations, so we were extremely effective on the
telehealth process in our social workers, which I think are a super
integral part of our health care space and really helped with
organizing and helping patients address those changes. Right? So
we’re still dealing with it. We didn’t have a lot of
patients fall out of care-thank goodness-but we did have some fall
out of care, so that’s something that we’re constantly
catching up on.

The second question about which I think should stick around is
obviously the patient and provider site rules. The provider site
rules, meaning providers can be wherever they want when seeing
patients and patients can be outside of the service area or in
scope service area for hearses purposes. And what I mean by that is
FQHCs were really built around the premise that certain areas of a
city or a rural area are underserved, and so community health
centers were established to address the needs of this community.
Now with telehealth, we are seeing a lot of the patients within our
scope, meaning in our service area, but we’re also seeing a lot
of patients that move away that don’t want to lose their
provider, that see us, Equitas Health specifically as an LGBTQIA
plus service site where they can go and not feel stigmatized for,
for instance, behavioral health.

So I think there needs to be some sort of changes around the
in-scope and out-of-scope expectations for FQHCs, and I think that
other community health centers are feeling the same, that a lot of
patients are moving away and they want to be seen by their
provider.

Adam Hepworth

And this is really, I think, related to the explosion of
telehealth that we’ve touched on a few times, because 20 years
ago, if you moved to a different state, I think that would be the
end of it. You couldn’t continue to see the same primary care
provider you had, but now we’re in this world where telehealth
accelerated so much during the pandemic that it’s actually
possible to keep that relationship going. So, I’m curious…did
Equitas make major shifts in its capacity and delivery of
telehealth during this time that were accelerated beyond what
anyone was expecting? Am I on base with what’s causing this
here or am I missing something?

Trent Stechschulte

No, no. You’re exactly right, and I think that we are seeing
a lot of patients that were moving away. I mean, that’s
causing-just from a compliance standpoint-that’s causing a
separate headache where we have to make sure that the patients
we’re seeing, our providers are licensed in those states. So
for instance, if a patient goes up to Michigan, one state away, our
provider must be licensed in Michigan to see that patient sitting
there. So if you don’t have a workflow in place where
you’re checking with the patient every step of the way where
they’re at or where they’re living, that’s where you
get into a little compliance issue, but that’s not what
we’re talking about here.

But, yes, what I’m seeing is that patients that otherwise
were traveling an hour or an hour and a half to come to Equitas
Health can now see our providers through telehealth. We’re
getting a lot more patients that want to come to us because
we’re more accessible now through telehealth. We’ve
consistently grown throughout my last seven years at Equitas
Health. We continue to grow, but it hasn’t been where all of a
sudden we’re getting a huge influx in patients. It’s just
slow growth and we’re seeing that patients are choosing us
instead of having to choose a provider that may be on the
corner.

Adam Hepworth

And when you had to make those changes suddenly to
operationalize an expanded telehealth program, was there anything
you think was unique about it being an FQHC? I know you’ve
already said you tend to be a cash strapped organization. These are
low-income patients. That creates its own barriers. How did you
confront those challenges?

Trent Stechschulte

So I’ll give you one example. We had a lot of concerns
around public transportation being shut down, even patients that
could do telehealth still had to pick up their prescription
somehow. So a lot of the waiver rules and certain insurance
carriers and PBMs lifting their delivery restrictions was huge. So
now that we can deliver prescriptions to patients that we otherwise
couldn’t deliver patients to was important because now our
patients can receive their medication that they otherwise either
couldn’t or were stopped from doing. So we actually had our
pharmacist calling saying, “Hey, listen, this patient
can’t get here. Can we drive the patients to them? What’s
the legal risk of doing that? Are we insured? Is that a fraud,
waste, and abuse issue?” So we had to analyze each one of
those instances and it is, delivering medication was a big one.

Another one just to kind of piggyback off that that I think is
worth noting is that the virtual visits and the e-visits being
reimbursed were huge for FQHCs because a lot of those short 10 to
15 minute conversations or virtual visits can happen. And I think
it actually helps with over utilization of services because instead
of telling patients they have to come into the clinic, these
virtual visits can address the patient’s care needs. And so
we’re not filling up our providers’ schedules on a daily
basis with patients that otherwise could be dealt with through
short virtual visits.

Adam Hepworth

That’s really interesting. So I work with a lot of FQHCs in
California where the state Medicaid agency started reimbursing
telephone visits under an emergency state plan amendment to FQHCs
during the pandemic. It was really a lifeline for a lot of these
clinics who that was the only way they could reach some patients.
Some patients don’t have the technology to do a whole
audiovisual encounter, but they can get on a phone call and do a
telephone visit. And I was wondering what’s your experience
with that in Ohio and the other states you serve?

Trent Stechschulte

That’s actually interesting you brought that up because we
did have some questions early on where, what happens when you do
audiovisual for half the visit and then the other half has done by
just telephone because the internet goes down or the technology
fails. And so we have run into a lot of issues with that because
you have templates and you have certain things built into your EMR
and your operations just to make sure that a lot of this risk is
kind of absorbed, right? And so you don’t have your providers
having to make all these choices, so if it is an audiovisual
template that they’re using, but they switched over to a
telephone visit, there’s a lot of training that needs to go on
around switching that to a telephone visit.

So you are right. It helps us be very flexible, especially with
the more vulnerable populations, I do think that offering different
ways to get health care will be really beneficial to FQHCs and
their patient population.

Adam Hepworth

I want to transition to a different area just because I know you
have an experience there that I think is really interesting and
valuable. So you’re the general counsel at Equitas Health, but
you’re also, I know, very involved with the 340B efforts of the
National Association of Community Health Centers, and 340B is just
a super-hot topic today, particularly for FQHCs. It was less than a
year ago that the association of FQHCs sued the Department of
Health and Human Services to compel an administrative dispute
resolution process for 340B controversies with manufacturers to
handle certain alleged violations. And even since that lawsuit,
there’s been a number of important developments in 340B that I
think are putting pressure on the 340B providers like FQHCs. So
because you have such unique insight into this issue, would you be
willing to just give us a little bit of a reality check or an
update on where some of those issues stand today?

Trent Stechschulte

Of course, and honestly, it may be helpful just to start to
underscore the importance of 340B. Many safety net providers depend
on the discount provided by the 340B program to fund their
services. And the program was built with the understanding that
FQHCs are required to accept patients regardless of their ability
to pay, and with such high Medicaid population, the discount became
essentially essential for continuing to care for patients. So, yes,
I do serve as on the executive committee of the Ryan White’s
HIV/AIDS 340B committee, or RWC 340B, and we do talk a lot about
this. And I know I do have some colleagues at Equitas Health that
serve on various boards and executive committees nationally. But
there has been a lot of activity around the 340B program.
That’s been happening for years, but recently there has been a
lot of pressure.

So the first would be the contract pharmacy exclusions, so
within the last couple of years, there’ve been manufacturers
explaining that they will only provide 340B discounts through one
contract pharmacy for each covered entity. It’s a strange
restriction, right? It’s essentially saying that covered
entities cannot get a discount if they contract with pharmacies
that serve their patient population, right? It is very rare that
any FQHC have all of their patients use one pharmacy. Sometimes
there’s a CVS and Walgreens across the street from one another,
right? The manufacturers know that, and it’s something not
contemplated by the statute. And these manufacturers are hoping to
ensure that they do not have to provide the discount that’s
required by law.

Another push has been manufacturers trying to get pay and claim
information for fills at contract pharmacies. There’s no rules
requiring that covered entities provide that level of data to
manufacturers, and it’s one of those things where it’s just
another line of we want to collect this information to try to find
a reason why we want to exclude that. And actually, manufacturers
have been excluding specific high priced drugs from the 340B
program. Again, something not contemplated by the statute in a
bizarre requirement because discounts should not be based on the
price of the medication.

So the government, as you said, the government has reacted to
the manufacturers by saying that they do not have the authority to
enforce the contract pharmacy rules. HRSA and HHS even went as far
as to say that manufacturers are violating the statute. Hospitals
filed a lawsuit demanding HHS order manufacturers. Grantees filed a
lawsuit. And so at the same time, there’s litigation around the
administrative dispute resolution process or ADR process. So in
January-and I believe the first rule came in 2010-in January HHS
implemented the long awaited ADR process that resolved the
overpayment process to hospitals and covered entities, and again,
there was immediate manufacturer push back on that.

So all of these processes are currently being worked out through
the court in various ways. There’s several manufacturers and
lawsuits going on at one time, and then you have the issue of
modifiers, specifically PBM modifiers, and the ongoing concerns
with discriminatory reimbursement. So PBMs and manufacturers
through their provider manuals are requiring that covered entities
identify their 340B claims on the front end so they know how much
340B stock each covered entity is utilizing them. They’re doing
this, we think, because they’re hoping to reimburse
discriminately, meaning PBMs and manufacturers are actually
reimbursing covered entities at a lower rate, depending on whether
they’re a 340B provider. Some of them are doing this at the
application process, meaning in order to join the network, you have
to note whether you are dispensing 340B drugs, and if you do,
they’re going to give you reduced reimbursement from a state
level.

There have been several states and advocates that have gotten
anti-discrimination language on the books-states like Ohio, Utah,
West Virginia, Oregon, South Dakota, Minnesota, Montana,
Tennessee-the laws vary based on whether they apply to just
contract pharmacy, whether they must outright prohibit
discriminatory reimbursement. But one issue that many policy folks
in these states are running into is the confidentiality provisions
and the payer agreements and applications themselves. So we’re
saying, what I’m telling you right now, we’re telling
lawmakers. And when they asked to see the agreements, we’re
saying we cannot share the agreement with you because it would
violate the contract if we did so.

So we always say that the argument that we don’t have proof
that discriminatory reimbursement is happening should not curtail
lawmakers passing a rule prohibiting it, because either which way,
it should be prohibited. And if they don’t pass a rule, Adam,
quite honestly, if they don’t pass a rule, it’s almost like
they’re implicitly encouraging these manufacturers or PBMs to
put in place discriminatory reimbursement. So that’s a very
high-level review of the attacks on the 340B. And it’s keeping
community health center CEOs awake at night. It’s keeping
HIV/AIDS service providers awake at night quite a bit. This is
probably the biggest attack that we’ve had on a 340B program in
quite some time.

Adam Hepworth

I mean, even just hearing your summary, it’s complicated and
it’s multifaceted. I know you don’t have a crystal ball,
but I wonder, do you think if this gets resolved, it’s going to
be through the courts through litigation, or do you think
there’s going to need to be federal congressional action or
maybe the state laws will do it, or is it just something where
it’s just fought on many fronts and you have to take it issue
by issue?

Trent Stechschulte

Yeah. I do think there probably may be statutory clarification
from a legislative standpoint with the contract pharmacy exclusion
or the medication exclusion. The claim identification issues and
the ADR process will likely be worked out through litigation. The
discriminatory reimbursement is already being handled by state
legislatures. The problem is, is it’s how applicable is it to
Medicare and the federal Medicare program? And so that’s where
I think a lot of litigation will work that out.

Adam Hepworth

Yeah. Because we’ve talked about commercial payers, but I
know that a lot of Medicaid programs and Medicare also pay a
different rate for 340B drugs. So those are eating into the health
center margins as well on the federal government side.

Trent Stechschulte

Exactly, and so a lot of it is grassroots efforts. So, for
instance, here in Ohio, Equitas had a wonderful grassroots effort
with the local community health center association and grantees and
making the case to the department of Medicaid and the lawmakers.
And it was very successful. And we’re seeing that repeated in
other states, just because once you provide the basic gist of PBMs
shouldn’t be able to discriminatory reimburse FQHCs, they look
at it and they don’t even think it’s happening. That’s
why they’re asking for the contract language because
they’re saying, “They were not doing that.” So,
it’s all about advocacy and at the state and local level, and
it’s working.

Adam Hepworth

Okay. That’s very, very interesting to hear. I think our
time is wrapping up here. So I want to thank you, Trent. It’s
been an absolute pleasure to speak with you today. I’ve been
working with FQHCs since the beginning of my career at Foley and
they are one of my favorite provider types, both because of the
critical mission that they serve and the really interesting complex
of legal issues that surround their operations. And I think we got
a taste of that today with the sort of depth and breadth of the
experiences that you shared. So it’s always a treat to talk
with individuals in the FQHC community, and I’m really happy
that we had this chance to chat.

Trent Stechschulte

I appreciate it, Adam. And it’s always nice, and again, you
and Foley and attorneys like you in law firms like Foley make
FQHC’s job so much easier because of how well you responded to
the COVID pandemic. And I sometimes don’t think that we
celebrate law firms enough in that regard, is how amazing the legal
community’s response to the COVID pandemic was. And so again,
thank you so much for everything you and Foley does.

Adam Hepworth

Thank you. That’s very kind.

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