Taking Charge of Your Health

(murmuring audience) – [Speaker] Starting,
starting Mark? – Ah sure. I’ll catch up with you today. (murmuring crowd) Alright, good morning. I would like to welcome
everyone here with us today both here in the room and
joining us by webcast. To this public meeting
on expanding access to effective treatment
for opiod use disorder. Provider perspectives
on reducing barriers to evidence based care. This event’s being hosted
by the Duke-Margolis Center for Health Policy
and is supported by
cooperative agreement with the Food and
Drug Administration. I’m Mark McClellan,
I’m the director of the Duke Margolis
Center for Health Policy. And we’re pleased to have
this timely discussion on a very important, a
critical public health issue. As everyone here knows
there remains a crisis of opioid misuse, addiction,
and resulting morbidity and mortality in
the United States. Yet despite the high and
rising burden of the opioid epidemic millions of
Americans still lack access to quality evidence
based treatment. We’re here today because we
know that opioid use disorder is treatable and that
recovery is possible. We also know that although
there’s no one size fits all approach
to treatment there is strong evidence
demonstrating the effectiveness of FDA approved medications. Buprenorphine,
methadone, and naltrexone as a vital part of a
comprehensive treatment approach that also includes psycho-social
behavioral counseling and sustained recovery support. However, substantial
challenges remain both to patient access and
to provider utilization of these effective therapies. Just last week the
substance abuse and mental health services
administration released its annual survey of
drug use and health. The survey this year
included some positive news. Not only have we seen a
decrease in prescription opioid misuse and new heroin initiates, but more than 100000
Americans received treatment for opioid use disorder than
they had in the year before. However, the survey also
revealed some persistent gaps in our treatment of
substance use disorders. Of the estimated 2.1 million
people with opioid use disorders only 30% of those
individuals received treatment at a specialty facility or
a private doctor’s office. Additional studies
estimate that medications for opioid use disorder
treatment are routinely used in less than 50% of private
sector treatment settings and as many as 30
million people, many of them in rural geographic
areas live in counties without access to a single
buprenorphine provider. So as we’ll hear today
there are significant legal, regulatory, and payment issues and other practical
challenges that contribute to the gap in use of quality,
evidence based treatment. Addressing this treatment
gap will require cooperation and innovative approaches
across the healthcare system. Supporting development
access and adoption of medications for treatment
of opioid use disorder is a key priority for the US
Food and Drug Administration as part of it’s approach to
addressing the opioid epidemic. And the Duke-Margolis
Center for Health Policy is pleased to partner
with the FDA today to better understand
provider, patient, and health system
perspectives on how we can address barriers
to expanded access of these important medications. We hope that today
will serve as a forum for providers, clinical
experts, and other stakeholders within the healthcare
system to come together to learn from current
innovative models for treatment of
opioid use disorder. Identify barriers
to such treatment and discuss opportunities
to further reduce stigma and to expand
access to effective opioid use disorder
pharmacotherapies. As you probably can
tell from the agenda in your packets we have
a packed schedule today and we’re looking forward
to our speakers covering a lot of ground as
well the opportunity to engage with all
of you here today both in the room
and on our webcast on these important issues. To get us started I’d like
to introduce Greg Daniel our deputy director
for policy here at the Margolis Center. He’ll spend a few minutes
to quickly run through the day’s agenda, Greg? – Thanks Mark, good
morning everyone. I’d like to echo Mark’s
welcome to all of you for joining us today in
this important discussion. I’m Greg Daniel, deputy director
of the Duke-Margolis Center for Health Policy. Today we’re honored to be
joined by Dr. Janet Woodcock director of the Center
for Drug Evaluation and Research at FDA, who
will help us kick off the day with some
opening remarks. After that we’ll hear
from Admiral Brett Giroir who will be going over
HHS priorities and actions to address the opioid epidemic. Including expanding
access to treatment for opioid use disorder. Before we introduce them I
wanna spend a few minutes to quickly run through
today’s agenda. Following those opening
remarks we’ll hear from FDA’s Sara Eggers
presenting an overview of key findings from FDA’s
April 17th public workshop on patient focused
drug development for opioid use disorder. Then we’ll have a
few presentations
on the current state of knowledge on addiction,
clinical approaches for identification
and assessment of
opioid use disorder and evidence supporting
the use of medications for opioid use
disorder treatment. We’ll then move
on to session one which will be moderated by
Margolis Center director Mark McClellan who
will explore innovative and evidence based approaches to opioid use
disorder treatment. We’ll then take a small
break at 11:15 and come back and jump into session two
which will be moderated by Larry Greenblatt from the Duke University
School of Medicine. Where we’ll discuss
legal, regulatory, and practical barriers
to accessing treatment of opioid use
disorder by patients. We’ll then break for
lunch at 12:35, come back for session three at 1:35
which will be moderated by the Margolis Center
visiting fellow Regina LaBelle to discuss care
models and challenges for delivering
treatments to vulnerable and medically
underserved populations. After another quick break
at 2:40 we’ll moderate our last session, I’ll be
moderating that session. We’ll be discussing approaches to defining successful outcomes. So regardless of the treatment
for opioid use disorder what are the real
outcomes that we’re hoping to achieve and that we
can hopefully measure on how improved quality
measurement can lead to alternative payment
approaches is another topic. Improved quality and
access, outcomes related to all of those things will
be important to discuss. Before we get into
all of that just a few last
housekeeping comments. I wanna remind everyone that
this is a public meeting. We’re broadcasting
live online, everything will be on the record. We hope all of you will
be comfortable engaging in this really important
dialogue through out the day. For our speakers
and panelists we ask that you please disclose
any conflicts of interest from the get go so
that we can maintain a high level of
transparency here today. These are Mark’s and
mine as a heads up to speakers and panelists. Isha Sharma who’s sitting
right here in the front and Nick Fiori who is
not, will be keeping us all on schedule with
signs to indicate how much time is left
for your presentation. We want the audience here today, we’re gonna do some
interactive polling with the audience in
the room today as well as those of you who
are joining us online. For those of you in the
audience polls should be accessible via the
smart phone or web browser and I think that the, ah there’s a bitly web address up there. So right now if you’re in the
room take your smart phones or your computers out
and go to that website. For those of you who
are not in the room and are joining
us via the webcast the link should be
displayed in the chat box. If you go to the chat box
there should be a link there to access this portal. Many of the polling questions that we’ll get kicked
off with and throughout the sessions will
ask you to chose, questions about how you
perceive priority issues or barriers to opioid
use disorder treatment. And we understand that for
some of these questions there actually might
be more than one answer but bear with us, just pick
the one that is most important for those ’cause I
don’t think we are able to have multiple answers. So go ahead and pick the
one that best applies and then I think that what
we’re going to do right now is to kick things off with the
very first polling question. Hopefully you in
the room and online have accessed that site. So our first question, we know
that the opioid use disorder is an issue that
unites people across the country and we know
that many are coming to this conversation
with a wide variety of perspectives and
disciplines to help give us a sense of who’s joining
us online and in the room. We ask you to answer
this first question, which is which statement
best describes you? The choices are a
healthcare provider, another professional
who offers counseling or behavioral health services. C is a peer recovery
support specialist or recovery advocate. D is I’m a patient,
caregiver, or a advocate for people with OUD,
opioid use disorder. I’m a part of an
organization interested in opioid use
disorder treatment. Government, community
organizations, healthcare organizations,
payers, academia, and so forth, or other. So I’m gonna spend
a little bit of time for you to go ahead and answer and I think the results will
be popping up automatically? There they are, okay wonderful. We’ll give a few more minutes
for those of you to answer. Okay well this is
Washington DC so I suspect that second to last, this
any other organization that’s interested in this topic
would include policy folks other, I think much of
our Duke Margolis staff would be in there. But we do see a
swath of perspectives that are joining us for
this conversation today. You can expect more of these
kinds of questions throughout the day on issues that
are most important to all. During the sessions we’ll
also have designated time for Q and A. For those in the room you can,
we’re gonna have microphones on each end of the seating
so you can go ahead and toward the end of
each session line up there and the moderator will
get to you to engage with the panelists and
others in the room. For those joining via
the webcast feel free to submit any questions
throughout the day using the chat box, our staff
will relay those questions to the moderator. To keep things running
smoothly we will ask that you keep any questions
and comments short so that the panel has
time to get through as many questions and comments that you all bring as possible. Feel free to help
yourself to coffee and beverages throughout the day which are located right
outside of this room if you’re here with us. Lastly lunch will
be on your own. There are many restaurants
nearby that our staff can help provide a list
to you for some of those. And then with that
I’d like to ask Mark to come back up to introduce
Dr. Woodcock, thank you. – Greg thanks very
much, and thanks to all of you for
participating in the polling as well as the
rest of the event. I am very pleased to
introduce Dr. Janet Woodcock the director of Center
for Drug Evaluation and Research at FDA. There Dr. research not
only directs the center but also has been the
moving force behind a wide range of
initiatives to advance the critical path of developing
and using new medications and other medications
effectively. Ranging from the pre-market
and even pre-human setting to all the way up to more
effective post market use of medications to
meet the goal of safe and effective drugs
that are available to improve the health of all
people in the United States. Janet we look forward to
hearing more about these issues and how FDA is leading many
efforts to expand development and access to medications
for the treatment of opioid use
disorder, thank you. – Thanks very much, Mark
and good morning everyone. I’m really happy that
we’re having this meeting. I thank Duke Margolis
for really putting it on and I hope that we
can move this forward. The epidemic of opioid misuse
ongoing in this country is really a multifaceted
problem as you all know. FDA and in conjunction with HHS and many other
government agencies, state, local, and so
forth have been pursuing multi-part strategies
for mitigation. Because there’s not going to
be a single solution to this and its going to take time. A major effort at FDA
has been to decrease the number of people
who actually develop opioid use disorder by
reducing population exposure to prescription opioids. Which was clearly one of the
initiating factors for this. At the peak of prescribing
trends in about 2014, around 240 million
outpatient prescriptions were dispensed for
opioids in this country. And clearly that’s
an excessive amount. The proper amount
is not really known but that has come down since
but probably not enough. People when they get a
dispense prescription are still getting
many more tablets than we’ve seen are
needed post-operative or post procedure for
most of the people. And so adding up to
millions of units that are available for
misuse and diversion that are in the medicine
cabinets of Americans still. So we have to do more
to reduce exposure of the population to opioids which is a big
initiating factor. But even if we can
dramatically slow the rate of people developing
opioid use disorder we still have millions of Americans with established disease now. And for them our goal has
been to make effective and safe medication
available to treat withdrawal and to prevent relapse. And of course as
Mark said, a number of these are on the market. Now these are most
effective when dispensed as part of a
multi-disciplinary strategy to deal with each
individual’s situation and their root causes for
having an opioid use disorder in the first place. And the marketed
treatments are not ideal. Many people relapse. There can be tolerability
issues of various kinds. But the major problem, the
subject of this meeting, is that medical treatment
is often not even tried in opioid use disorder,
as Mark just said. And if you step back and
think about it, failure to attempt medical
treatment for a disease that is often fatal, that’s
not something you see very often in medical care. Where the major issue is
failure to attempt treatment for an often fatal disease. And you don’t see that
much outside of addiction. And most other fatal diseases,
we the medical community step in and we attempt
to treat these folk. Now many of the,
how could this be? Well many of the barriers
to effective treatment have been enumerated
numerous times. People have talked about them. There are restrictions
on prescribing. There’s a lack of physician
training and familiarity. We don’t have enough
physicians who know how to intervene appropriately. That’s been well documented. There’s stigma, and
that’s a lot of it. There’s reimbursement
problems and so forth. And probably there aren’t,
simply are not enough trained personnel of all
the different kinds that need to help
intervene when we have such a large number of
people in this country with a potentially
fatal illness. So today we’d like to explore
the barriers in more depth and try to get
from the community and the experts really
what are these barriers? What could be done to
mitigate these barriers? How could we move this forward? And so I’m not gonna
talk about that more because that’s the
subject of this meeting. I will say though, FDA’s also
working with drug sponsors to develop additional
treatment options for opioid use disorder. Because one of the
barriers is we don’t have a lot of convenient,
highly well tolerated, we don’t have a range of
treatments for people. We recently issued
draft guidance on end points, sort of
a pathway for sponsors to develop new treatments for
medication assisted therapy and we hope to
finalize that guidance and help hopefully attract
more sponsors into this area. The field has not been very
attractive for developers over the years as you all know. And so we have,
although we have safe and effective treatments
we have a limited range. And I think one thing
would be the case in a disease like this we
need a range of options that are convenient,
that are effective, that have different properties. People have many different
pathways to developing a substance use disorders and
they’re gonna need different types of interventions. And that’s true in many diseases that we treat with medication. So understanding the needs
of people with a disease is a central part
of what we call patient focused
drug development. And so we have started,
starting about six years ago, actually having meetings with
patients, day long meetings. And you’re gonna
hear about one we had with opioid use disorder
patients from Dr. Sara Eggers. But these meetings have
been very impactful in understanding that
the medical constructs that we often use to do
trials and create end points don’t take into account really
the needs of the patients. Both on the burden of disease,
the burden of treatment and also often the trials
don’t fit in with what the patient’s needs
are to actually enable them to participate. So as a result of those
meetings we have had we have started a very large program
that was initiated under the 21st Century Cures
Act and so forth, where we will be, and the
Prescription Drug User Fee Act where we will be putting
out a whole series of guidance’s on
how to collect valid and reliable information
from patients about what they care
about in the disease, what matters to them
about treatment, what they wanna have
treated, what are the most burdensome side
effects and so forth. What are their trade offs
between benefit and risk? How do they calculate
that as people who actually have
to assume the risks? So this, and we also
in this meeting, in this community we need
to hear from the providers because I think
unique in addiction and one of the barriers is there are additional burdens
on providers of care. And we need to
understand that better and hopefully we can
through meetings like this. Then hopefully develop therapies that can ease these burdens. Both on the providers of
care and on the patients so that more people can utilize
proven, effective therapy. So I hope both the increased use of medication assisted
therapy and development of additional choices
and modalities that meets the needs
of patients prescribers can be something that
one of the outputs of this meeting
that will help us as we craft pathways,
regulatory pathways to develop more therapies. So thank you all very
much for this, coming and helping us address this
really devastating epidemic. Thank you. (applause) – Janet thank you very much. Now I’d like to introduce
Admire Brett Giroir, the assistant
secretary for health at the US Department of
Health and Human Services. For those of you
who aren’t familiar with the assistant
secretary for health job, this is a big job
with a wide scope of responsibilities
related to protecting and improving the
health of the public and reflecting the importance
of the opioid crisis Admiral Giroir is
probably best known for leading the development of the HHS wide public
health policy recommendations and other activities. Overseeing 11 core
public health offices to protect and advance
the health and safety of our nation related
to the opioid crisis. In addition Admiral
Giroir serves as the senior advisor
to the secretary of HHS for opioid policy
and is responsible for coordinating these
efforts all across the administration to
fight the opioid crisis. His efforts have been critical. He’s right at the middle of
all of the activities related to opioids, and
we’re very pleased to welcome him here
today, Admiral. (applause) – So thank you Dr. McClellan. I’d like to thank the
FDA and the Duke Center for inviting me
here this morning. It really is a pleasure
to be here this morning. Its also good to be right
after everyone has had coffee and are wide awake
and ready to go. So I do look forward to
giving you an overview of where we are. As Dr. McClellan
said, when I came here to DC I expected to be the
ASH, the assistant secretary for health with all
those responsibilities. About six weeks later
the secretary organized the departments around
four major priorities and he put a single lead in
for each of those priorities. So I am the senior
advisor for opioid policy. Meaning I should be
your principal point of contact to get into HHS,
but also I’m responsible for coordinating and making
sure there’s synergism across a 1.5 trillion
dollar agency as diverse as the
Indian Health Service, the FDA, CMS, and how we
can all work together. All these slides are
gonna be available to you. So I’m gonna go through
’em pretty quickly. Don’t worry about taking notes. These are all public
release and available. So I wanna start out with
the level set where we are. Because you hear a lot of
numbers back and forth. On the graph slide this is
what was recently reported about a month ago as
the final 2017 numbers for substance abuse
overdose deaths in opioids. So in 2017 there were 72287
deaths, staggering amounts. The predominant number of
those were from opioids. So I wanna give you
sort of a different cut so you know where we are and
you know where to follow. Each month the National
Center for Vital Statistics puts out the rolling 12
month mortality rates, including the overall death rate and that for many
of the subclasses. What you see on the
left side of chart is the rolling 12 months
from February 2017 to February 2018, which is
really our most up to date data. It is six months behind. It is 99.8% complete, but
still even six months later there are .2% of fatalities
that have not been classified. The CDC uses an
algorithm to predict what the actual remainder
of those .2% are. So where we are, the latest
statistics said there were 71414 deaths. Those are predominantly opioids. Its up 5.1% from
the previous year and the overdose deaths due
to opioids increased 6.3% from the previous year. So again, we are in the midst of the greatest public
health crisis of our time. It is substance abuse and its
driven primarily by opioids. This is the latest map. I advise you to go there. If your state is in
blue you are improving. In other words your death rate
is going down year to year from that 12 month period. If you’re in yellow
you’re increasing and if you’re in orange
you’re in the throws of a major increase
still as we go on. Again, six months behind time
but this is our latest data in terms of mortality. Now if you look at that
its very interesting to see where the trends are. We wanna talk about opioids
and that is important. But if you look at the
mortality year to year the actual mortality
due to heroin actually decreased about 5%. The natural and
semi-synthetics which really are the pharmaceutical
agents primarily. The Oxycontin etc.
are down about 4%. Methadone down 6%,
but our big increases are really in the
synthetic opioids. This is the fentanyl, this
the carfentanil primarily that is being imported primarily
in the international mail via China either directly
to the United States or to Mexico and smuggled
across the border. That’s up 31%. Don’t forget about cocaine. Cocaine is up 24% with 14500
deaths associated with that. We see a lot of troubling
statistics, particularly in pregnant women,
and I’ll go over that. And finally the
psycho-stimulants. This is meth
primarily, but a number of other things put
in there, again up. So we have problems
across the board. Its clearly fentanyl
driving a lot of this but don’t forget cocaine,
meth, and psycho-stimulants. I pulled this out of the paper to give you an idea
of the problem. I’m a pediatric critical
care physician by training. Fentanyl was only
allowed to be used in our hospital system if you
were a critical care physician or you were an
anesthesiologist in the OR. That’s the respect we
have for this drug. But now you see on the
streets, just by good policing in Nebraska there was
118 pounds of fentanyl just seized in this one arrest which is enough to
kill 26 million people. And that’s just by good
policing in a truck in Nebraska. So this is a major, major issue. The FDA I know is teaming up
with customs and border patrol in a very synergistic
way to try to monitor the international mail
and do everything they can because our job is tough. Its gonna be even tougher
if we have shipments that kill, you know
a tenth or a quarter of the US population
strictly in a single car. So what are the
latest statistics? This is outta NSDUH and
I’m gonna, I can’t see that back monitor so I’m
gonna kinda turn around a little bit. Dr. McClellan talked
to you about this but the latest statistics
from the National Survey of Drug Use and Health
published last Friday. Its on the web and I’m
gonna give you a lot of statistics is that there
are 11.4 million people who misused opioids
in the past year. 11.1 of those are
pain relievers. Now misuse is defined as any use that is not indicated
by your physician. So if you’re using
it more frequently. If you’re using more, if you
don’t have a prescription and you use someone
else’s it all goes in the misuse category. 886000 people used heroin
and 562000 used both. 2.1 million people had
an opioid use disorder. So not just a misuse but
a DSM5 classification of an opioid use disorder
with about 1.7 million of those to pain relievers,
.7 million to heroin. Now very interestingly
still, 53% obtained their last pain reliever
from a friend or relative. So this is not you getting
prescribed the drug but you’re getting it out
of the medicine cabinet or someone saying you’re
having trouble sleeping, please use some of this. We have a major issue
in education we still have to overcome. 36% came from a
healthcare provider and if you look at
the sub statistics, very few are doctor
shopping anymore. I think the PD MPs have sort
of clamped down on that. Its usually a single
doctor that predominates with that and I highlight this ’cause its not
highlighted enough. The main reason for
opioid misuse is pain. 62.6% of people said
they misused it for pain. If we don’t solve the
pain crisis in our country we don’t develop new
therapies that are non opioid that are not addictive or use
adjunctive pain therapies, we are not gonna get
outta this crisis and so we are very
focused at HHS not just on opioid misuse but
on the flip side, how do we solve the pain crisis? I am also very
concerned and I know its not necessarily
the topic here, but we have an astronomical
rise in Hepatitis C cases. Primarily associated
with IV drug abuse. Probably a 300% increase
over the past five years. We don’t have good data
to know exactly how much but based on CD
trends that’s it. HIV, you know we
flattened across the board at about 38500 cases
but we’re seeing an increase in HIV
among IV drug abusers. So all the progress
we’ve made we’re actually at an inflection
point that we can see that rate going up again
in the United States. Very concerned about that. If you’re in a hospital
system I know you’re seeing a lot more things that
we used to see back in the 80s, endocarditis
from IV drug abuse. Skin and soft tissue
infections and of course the bugs are a lot meaner
now ’cause they’re resistant to just about everything. So very, very difficult
on the hospital systems. As a pediatric critical care
physician I’m very concerned about neonatal
abstinence syndrome. This is a very important
part about treatment because pregnant mothers
need MAT treatment in order to stabilize
their pregnancy, in order to avoid lots of the
problems we see in the babies and although we talk
about jittery babies who have diarrhea
and all those issues, and that’s very important,
we don’t talk about some of the problems of drug abuse
and pregnancy meaning you have a 25 weeker or a 26 weeker. So prematurity, preterm
birth and preterm death is very, very important. And as we found out from
some studies last month published in
Pediatrics, independent of prematurity, independent
of inter-uterine growth retardation, all
of that kind of stuff it looks like babies
were exposed to opioids in utero have
significant cognitive and psycho-social and executive function developmental delay. They’re gonna need
lots of interventions in the school systems. I’m really concerned
about this ’cause the NSDUH survey
shows that drug use in pregnancy is going
up substantially. From 2015 to 2017
illicit drug use went from 109000 women up to
194000 women using illicit drugs during pregnancy. Tobacco use and alcohol,
lets not forget about that ’cause those are still
terrible for the mom’s and they’re terrible
for the babies. So what is HHS doing? I only have a short time
here so I’m gonna run through a few things. I think all of you know
our five point plan that overall
describes the pillars. Strengthen public health
data and reporting. Very, very important,
we have to know where the epidemic is, we have
to know who’s dying when so we can bring resources. We have to know trends
that are going regionally so we can adequately respond. Advance the practice of pain
management, very important. We have to decrease
inappropriate use of opioids while preserving opioid
use for those patients, particularly those who
have intractable pain due to syndromes like
multiple myeloma, cancer pain, sickle cell disease patients
who need it intermittently while we’re looking
for other alternatives. Improve access to prevention
treatment and recovery. And we have focused on this
probably more than anything and I’ll give you
a few examples. And we absolutely support
medication assisted treatment as an evidence based
central component of therapy for people with
opioid use disorder. Whether that be naltrexone,
buprenorphine, methadone. They’re right for
different classes of people at different times in
their recovery cycle. But we are absolutely
supportive of that, 100%. Enhance the availability
of reversing medications. Naloxone, primarily
doesn’t cure your disease but it does absolutely give
you a second chance at life. Finally supporting
cutting edge research. So yesterday, actually
on Monday this is something outta
my group we published about 90 sub-strategies
to those five strategies and what we really did is we
took about the 700 efforts that are ongoing
within HHS right now. Understood where they fit
strategically under the pillars and then iterated
that specifically. Its kind of a geeky,
wonky document. Perfect for any academic
center who’s looking at policy but this really
outlines where we are in much more detail than
the five point strategy. My internal goal, everybody
asks me what success is. The secretary asked me
for what success is. This is not the
administration’s position, this is not the
president’s position, this is my position
is that my goal is to reduce drug
overdose mortality in the United States
by 15% by January 2021. From November 2017. There are a lot of
other appropriate goals but if we don’t reduce
mortality, save more people, give parents back
their children, give brothers back their
sisters, we are not gonna be able to declare even
an intermittent victory. So I am really focused on this
as at least one of our goals. So we have lots
of positive signs. At least since 2017. The number of opioid
prescriptions have
been reduced by 17%. If you look at morphine
milligram equivalents that’s down by 21% by all
the efforts we’re doing. By FDA, by the CDC
guidelines, by awareness, by PDMPs, by all the
things we are doing and actually we are on the
line to meet President Trump’s goal of reducing by 30%
by the end of his term. But again, we don’t
wanna throw the baby out with the bath water. We wanna make sure that
those who need opioids or prescription
medications get them while we’re reducing
inappropriate prescriptions. Since January 2017 the
number of unique patients receiving buprenorphine
monthly is up by 16%. Again, this matches the NSDUH
data of 100000 more people in treatment, and
since 2017 the number of naloxone prescriptions
dispensed have been up by 264%. Again, going in the
right direction. If you look at the NSDUH data
Dr. McClellan talked about this in 2017 there were
less and statistically significantly less
pain reliever misusers and statistically
significantly less people with pain reliever use disorder. Again, a very positive sign. And again this is another
geeky chart out of NSDUH but if you look at
the top bar that’s the overall everybody
12 and older. This is new use initiates of
heroin between 26 and 2017. We’ve had greater
than a 50% drop in those first users of heroin. Again, very positive signs. Now if you look at the 12
month overall rolling average this is not 2017
compared to 2016 but this is looking at
the number of deaths, the predicted number
of deaths by the CDC on those 12 month increments. We are not claiming victory. We have a huge way to go because
71000 deaths are too much. And again this is
six months behind but I wanna show this
because people think this is a futile effort
that we’re doing all this but we’re still losing. I think if you look at
this curve you can see that the overdose
mortality is tending to flatten out and some
indications we have is that mortality
is over the top and potentially going down. We’re not gonna let
up for one second on trying to further
treatment because 71000 is too big of a number. But don’t get fooled
that what we’re doing does not make a difference. ‘Cause I think we’re seeing
a difference nationally. Things that are
happening this week, and I’ll finish up in the
next two or three slides. This is heroin, prescription
opioid awareness and heroin week declared
by the president. Yesterday we put out
about 1.5 billion dollars in grant awards and
related to this topic. I just wanna say that
the SAMHSA state oriented response grants will
reimburse for treatment but we will only
reimburse for treatment that offers MAT as part of
their treatment program. It doesn’t mean that
every single center, like if you’re in a
faith based organization, that you have to do it. But you have to be associated
with another center and provide the meaningful
opportunity for patients to get MAT, that’s how
important we believe it is. I also wanted to say, and
I didn’t put it up here, as we clarify guidance from DEA, and I put this out in a
blog and we had many notices that it is now acceptable
to prescribe buprenorphine over tele-medicine. What it requires is
both people at the ends are registered with the DEA
but the person prescribing can have a waiver,
but the person at the
other end does not. So this is going to
be a tremendous tool as we move to take care
of people, particularly in rural areas who do not
have a waivered physician or prescriber to
prescribe buprenorphine. The Surgeon General put out a
report, just came out today. We’ve been working on
that, Spotlight on Opioids. And I also wanted to
announce that today the NIH is putting
out, actually yesterday it was put out, a
funding announcement for healing communities. This is a complete effort. Its gonna be
hundreds of millions of dollars over five
years with the goal of taking highly
affected communities and reducing overall mortality
by 40% within 3 years. Its an all of
government, all of local, all of state approach. We’re very excited about that
and its co-led by the NIH. Francis is working
on this personally as well as Nora Volkow
together with SAMHSA, Dr. Ellie McCance-Katz. And just to let you know
we have our next pain inter-agency task force
meeting next week. So very, very important
because we need to solve the pain problem. This is DOD, VA, and HHS
all working together. We invite public comment. Two last slides out of NSDUH. Now this not, well one
last slide out of NSDUH and one outta the
new literature. Now this struck me. Now when I talk to
addiction specialists they said this is not
surprising at all. This is not specific to heroin or opioid use disorder
but across the board. 20.7 million people needed
substance abuse treatment but 94.3% who needed
substance abuse treatment but did not receive
specialty treatment did not think they needed it. So the number one
reason why people are not getting treatment
is ’cause they don’t believe we need it. This sort of opened my eyes
to whole ‘nother educational destigmatizing kind of campaign and work that we
really need to do. ‘Cause no matter how
many resources we pour into the system, if we
can’t help people get that on ramp into treatment
and convince them that they need it, we’re
not gonna solve the problem. The second bit of
information I will leave you with was published by
Captain Chris Jones and Dr. Ellie McCance-Katz. Its online, its
not yet published. This is an addiction,
September 8th, 2018. What they did is survey, I think it was 6000, they
got 4000 responses of people who had recently
received their data waiver for prescribing. Now its not so recent that
they couldn’t have already had a portfolio of
people but they wanted to find out what are the
main reasons that they are not prescribing, or
how are they prescribing. So only 75% had
prescribed buprenorphine. So one outta four people who
had received their waiver and could be prescribing
buprenorphine had not ever prescribed it yet. And if you look
clinicians prescribing at or near their
limit was only 13.1%. Now this is important
data, we may need to expand the prescribing limits for people in a specialty center who are bumping up
against their limits. But what we’re seeing
here is there’s still a lot of capacity in the system. Particularly now that we
have the tele-medicine kind of buprenorphine
that we have to help physicians,
clinicians prescribe. And the number one reason
why they weren’t prescribing is because there was a
lack of patient demand. Patients are not
coming into the system which kind of matches very
nicely with the NSDUH data. But also time constraints and practice
insurance requirements and just the difficulty
of the patients. So this is a good
article please pull that. So that at the end of all
this data I do wanna say and I believe absolutely
and it was emphasized by Dr. McClellan is success
in recovery is possible. And its made much
more likely by safe and effective, proven
medication assisted treatment which is the focus
of this survey. Of this meeting. On the left side this is a
little boy named Stetson. He is an NAS baby who’s mom got into a medication assisted
treatment program, is in long term recovery,
and its sort of a life is good, happily ever after. So again I hope this is the
beginning of our conversation. If I can help in anyway,
I can be the single point of contact for you
or your organizations to reach into HHS. And again I really
appreciate the opportunity to share some thoughts with
you this morning, thank you. (applause) – Good morning everyone,
my name is Sara Eggers and I’m in the US Food and
Drug Administrations Cedar office of program and
strategic analysis. And as Dr. Woodcock
mentioned, we conducted a patient focused drug
development on OUD and I’m delighted to be here
today to share the insight of the people, the
individuals who have OUD who shared their experiences
and perspectives with us as well as the
loved ones that care about individuals with OUD. The standard disclaimer applies
and its even more fitting because I’m not trying
to represent anyone today but the people who have the
greatest stake in this issue. The few hundred
people who engaged with us through this meeting. This meeting was an opportunity through our patient focus
drug development program and Dr. Woodcock
explained that very well. What started out as a commitment in the 2012 Prescription
Drug User Fee Act, a commitment for FDA
to conduct 20 meetings on 20 different disease
areas has really blossomed into a multi-stakeholder
effort to continue to engage patients
and their loved ones and to develop more
systematic methodologies to get patients’ experiences,
needs, priorities, and experiences
captured meaningfully into drug development, into
evaluation of those products and into the appropriate
use of those products. On April 17th we conducted
a six hour meeting at our White Oak campus. The meeting was
conducted both in person, there was a webcast, and
we also had a docket open where people could submit,
anyone could submit comments. Whether they attended
the meeting or not. So we were really trying
to engage as many people and reach them through
whatever channels we could. This meeting was part of
the larger and broader ongoing efforts that
Dr. Woodcock described and really that we
heard from the HHS at trying to facilitate
the development of new treatments,
new formulations of
existing treatments and then to facilitate
the wider appropriate use of those treatments
to help people with opioid use disorder. The meeting was
supported enormously by the outreach and other
efforts from our colleagues NIDA and the many patient advocacy
and community organizations that helped us really
engage with a population that can be difficult to reach, that has needs and
organizing buses or telling us what
we need to know to make sure that
we were treating the participants with the
most respect that we could. So we very much thank them. We heard from a
spectrum of experiences from the individuals
and families who came. And we were very encouraged
by the strong turnout. We had over 100 individuals
and family members. Over 85 provided input through the interactive website, webcast and over 70 comments were
submitted through our docket. The participants
primarily were individuals with OUD, although we did
have some family members who provided input
as well individuals with OUD who are also caretakers
of loved ones with OUD. These participants varied
in age, race and ethnicity and their history of opioid
use and stage of recovery. For example people
have been battling with heroin addiction
for more than 30 years. People who developed OUD
following prescription use of medication. And people who started using
recreationally with pills in the last 10 years. So we really had
a wide spectrum. We also had a spectrum of
over arching perspectives on substance use. And this was, there were
a lot of perspectives that were capturing
at this meeting. Our discussion was
a town hall style and we had two
topics of priority. One was on experiences
with the health effects and the impacts of
OUD and the second was experiencing some
perspectives on approaches to treat OUD. For each of those topics
we had a kick off panel of individuals who had
shared their stories and then from that
we transitioned into a facilitated large group
discussion enabling anyone from the audience
to participate. So we are now
collating the input and pulling it all together
from the various sources. Each of our meetings results
in a patient focused drug development voice of
the patient report which we put on our website. These reports really intend
to capture participants experiences and perspectives
in their own words and our report for
this meeting is planned for release in later this fall. So I’m going to now present a summary of select
highlights from that report that I hope set the stage
for the discussion today and I’m very happy that
we are able to provide this input now in the
morning at the start of the discussion because
I think you’ll hear things that will continue
to come up throughout the day and having the
patient perspective captured is very important. So we first talked and
throughout the day participants talked about how they got to
where they were at this moment. Their complex journeys
of use, misuse, addiction, and recovery. They highlighted when they
were in the severe OUD being a prisoner to
intense withdrawals. Drug sick, as they termed it. The irritability, the
skin crawls and spasms, and the obsession with
getting the next hit. This all consuming obsession. They also shared the
devastating impacts more broadly to their jobs, their
careers, their relationships, their well being,
and their safety. They highlighted the
lasting impacts of OUD even in the various
stages of recovery. This lasts forever,
the scars, the insomnia that they feel, the
urges, stigma and the fear that they will be
a prisoner again. I wanna point out they had
mixed perceptions about their risk of overdose with
many in the room saying that they really took to
heart self harm reduction or harm reduction techniques. Always carried naloxone
and always made sure they used single needle and all that. There were others who said,
no today’s a different world and I am not safe even if I use. And then there
were, as illustrated in this bottom quote
here, the interplay with the disease
and their own sense of needing to take
care of themselves, if this was brought up. There are other quotes
that I’ve pulled here just select quotes to
highlight how they spoke about the physical and social
and physiological impacts. Really in concrete terms in ways that we might not describe them. So I think the quotes
are very important. We were particularly interested
in how they talk about what we called craving. They called it many
different things. They used the term craving. They also used urges,
feeding, obsession, etc. They talked about
craving as being more than a physical
craving for a substance that lasts well
beyond the drug sick and the feeling
changes over the time. So in the beginning its
this fight or flight to try to manage the
fear of withdrawal. But over time it can resurface with even the slightest trigger. And it was interesting
that one parent indicated that while
withdrawal is something that’s easy to see and easy
to wrap our minds around the long lasting craving is not. And that’s something parents
need to come to terms with. Here are a few quotes
that illustrate this. My mind telling me
to manage anxiety and this is how I will do it. The process of
doing, of preparing, of consuming, its
all wrapped up there. Its not just the
substance itself. And then another quote
to illustrate that. Even 10 years into her
recovery when one participant goes to the ATM even
today that can hit the sense of what she
felt when she was using and going to the ATM in
the middle of the night. There was a lot of discussion
about treatment goals. Over arching they stressed a need for an individualized,
holistic approach. This has been talked
about previously. But they’re saying this too. They had varying perspectives on the desired
outcomes of treatment. And for some abstinence and
being in a long term recovery is, complete abstinence
is their goal. But for others
they said that goal of complete abstinence
is either not feasible or not desirable for them. And they wanna focus
better on controlling or managing their use. A common element for all of
it was improved functioning, well being, and safety. And that was across the board. They also shared different
views on the role of MAT. With some accepting
the need to stay on it for the long term. Others hoping to detox off
of it once they are stable and some who said they
do not see a role for MAT in their treatment. Illustrated by the bottom quote. We did hear this
comment about exchanging the one addiction for another. But the top two quotes I
think are the bigger picture. The goal to manage things
the way that you can and the way that you
need to and facing that you have a disease. We did hear experiences with MAT with some highlighting
the benefits. You know controlling that rush or resisting,
resting the cravings and be able to regain
life and functioning. The discussion touched a
lot about the down sides. I’m gonna get into
the challenges and
barriers in a minute but the downsides being the
intolerable side effects or the side effects
that they have to take other
medications to treat. The long term need
and not addressing the underlying health
issue that they face. Some participants
did offer insight about why one treatment
worked for them at one point and then no
longer and then they switched to another and so we
did hear about that with some quotes here about,
we did hear about methadone saving lives and we
heard about what happens when they tried to
detox themselves. And then a quote that
I think illustrates the need to
continually reevaluate. They described the challenges and barriers to
MAT, lack of access. I’m not gonna go into detail
here, just to point out that they acknowledged these. Difficulty finding
treatments, long wait times, prohibitive costs, the strict
requirements being kicked out if you do one thing wrong. One person said if I hug
someone I can get kicked out. Unpleasant experiences or
concerns about safety, stigma. The interplay with the
withdrawal and craving. Addressing comorbid pain and
health needs at the same time and their need to come to
terms with the illness. Here’s one quote saying
it took eight weeks to get the appointment
and then when I did I had to go out and score
heroin in order to make it to the treatment facility. Again these are their own,
this is them speaking. They also gave insight, and
I think this is important, about how to better
help individuals. Raising awareness, integrating
MAT into primary care and holistic approaches. Making it easier,
reducing stigma. Keep developing
treatments or exploring the treatments, repurposing
treatments that are out there. Don’t forget the
underlying cause of why they started using
opioids in the first place and really try to create
situations of stability. Here are some quotes
that illustrate that. All options should
be on the table. We need to get rid of the stigma and we need to recognize
that individuals are in highly vulnerable
states and we need to help them where they are. So this input can help FDA and
others, including here today. Identify specific
areas of unmet need. Supporting medical
development programs. Informing understanding
of how to best assess the benefits of these
potential treatments and how to conduct the
benefit risk assessments and then to facilitate
wider and appropriate use of the medications. I also wanna point out
we had a meeting in July on chronic pain and
that meeting is I think, as informative as the OUD. So for more information
please visit the website. And you can also email our
team’s website, or our email. So thank you very much for that. (applause) – Thank you Sara for
providing the insight that you’re hearing
directly from patients. We’re gonna move on. Understanding the biological
basis of opioid use disorder and the clinical
armamentarium of therapies for treating this
disease is critical to our understanding of how we can advanced evidence
based approaches. Our next two presenters
will provide us with the basis for
understanding the current state of knowledge on addiction
and the clinical approaches for identification
and assessment of
opioid use disorder as well as the
evidence supporting the use of medications
for the treatment of opioid use disorder. Please welcome to the
stage Edwin Salsitz, attending physician at
Beth Israel Medical Center. As well as Lisa
Alexander, professor at George Washington
School of Medicine and Health Sciences
and president of the Physician Assistant
Education Association. (applause) – Thank you. Okay, okay. Good morning everyone
and I’d like to thank the organizers for inviting me. In particular, Isha
Sharma and Katie Greene in helping me with
all my logistics. Thank you very much. So I’m going to talk, I wanna
go back here for a minute. I’m going to talk about,
touch on a couple of topics. Some of them will
be talked about in more detail subsequently. I have no financial, no
disclosures, no conflicts. Everything we’re talking
about today really starts with this beautiful plant
that mother nature put on earth, the opium poppy plant. This is growing someplace
probably in Afghanistan. Has beautiful flowers. They bloom in the springtime,
perennial hardy plant. You can see there’s
something called the unripened seed pod which
is on your left hand side, lower left here. And if you cut into
the unripened seed
pod you get opium. And opium contains
morphine, codeine, and few other plant alkaloids. If you don’t cut into
the plant, let it ripen and shake it out
you get poppy seeds. And some poppy seeds can produce
a positive urine drug test for morphine and codeine. In talking about treatment
of opioid use disorder we have to mention some
very important names and the two most important names are Dr. Dole and Nyswander. Dr. Dole was a research
metabolic physician at Rockefeller University
and Dr. Nyswander was a psychiatrist trying
to help opiate addicted people in the 50s and
the 60s in New York City working in Harlem. They started studying
methadone for the treatment of opioid use disorder
in the early 60s and they were joined
by Dr. Mary Jane Kreek who is currently the chief of the addiction
laboratory at Rockefeller. And they had a couple of
interesting observations. Dr. Dole said that the reason
the heroin addicted folks were relapsing all the
time was that their brains lacked something that
the heroin provided. This was 10 years before the
endorphins were discovered. And what Dr. Nyswander observed
in trying to treat patients she says, you know they
seem to function better when they’re on heroin then
when they’re trying not to be on heroin. And these again may not sound
like much 53 years later but these were valuable
insights way back when. And here was the first
paper that they published on the treatment with methadone. Only 22 patients but results
like this had never been seen. People were doing well. They stopped craving
other opioids. They stopped relapsing
and the focus though was on getting ’em jobs. Getting ’em a GED if
they didn’t have it. Getting them to a job interview. Providing them with clothing
to go to that interview. In other words the
methadone was supposed to be a means to an end and
the end was improving function and rehabilitation. The big thing on that title
slide is a medical treatment. 53 years ago nobody
thought of addiction as a medical disease
or a medical problem with any sort of usual
medical solution. It was a character problem, it was a criminal
diathesis problem, but it wasn’t a medical problem. And that was really the
big breakthrough I think of Dole and Nyswander saying
yeah, this is like diabetes and it can be looked at that way and treated that way. So a little bit about
the neurobiology, the sagittal section
of the human brain. Looking at a blown up
version of, I’ll call it the limbic system
and prefrontal cortex,
frontal cortex. A dopaminergic rich
part of the brain and we’re not gonna talk
in detail about this but in a broad general
way the nucleus accumbens and dopamine levels in
the nucleus accumbens play a key role in how addiction
works in the brain. And this is a slide from Dr.
Eliot Gardner, who’s at NIDA. And I learned my
neurobiology from him. This is the rat brain. And rats and humans
have very similar areas of the brain that are
involved with addiction. And the only reason
I wanted to show this today is that when
it says the word opioids in red those are endorphins. There are dynorphins
and enkephalin so we make our own opioids,
the endogenous opioid system. And I think one of the thoughts that Dr. Dole had was
that after many years of short acting
opiate use like heroin or oxycodone the endogenous
system may be disrupted and that the methadone
or the buprenorphine now being a long acting medication
sitting on the receptor would normalize and
stabilize the brain. And those were the key words
that he used all the time. Normalize and
stabilize the brain. And he felt that until
that normalization and stabilization
occurred rehabilitation was not gonna be possible. This study came out
almost 20 years ago. It uses a technique called
phosphorus MR spectroscopy. And again maybe,
well I don’t know. I can’t do it that well
’cause there’s no mouse. But the white boxes
are normal controls. The box in the middle
are people who’ve been on methadone for approximately,
I think 150 weeks or so. And the ones all the way
over on the other side in the darker gray are
people who have been on methadone for 37 weeks. And this technique
is trying to look at certain brain metabolite
levels reflecting brain bio energetic status and brain cell
membrane integrity. And again without going
into a lot of detail you can see that as the patient
stay on methadone longer, the middle row, they
more closely resemble the controls than people who
have been on it less long. And as a matter of fact
in the bottom two boxes there is no
difference now between the longer term
methadone patients and the controls
in terms of some of these brain
bio-energetic molecules. And again the idea
here would be what the authors say is that the
nearly normal metabolite profile in long term methadone
subjects should suggest that prolonged methadone
maintenance may be associated with
improved neurochemistry. This is exactly
what Dole was saying but the science
wasn’t there yet. The techniques weren’t
available to show that. In other words, people
think that methadone, they don’t understand
the mechanism of action. But the mechanism of
action is to ameliorate the perturbations
caused by long acting, usually short term
opioid addiction. And another study that
was done in Philadelphia, 25 patients been on methadone for about four and a half years. Adequate doses,
they would come into the clinic and at
the trough level, before they got their
dose, they were shown some heroin cues. They wanted to, cue
induced craving. They showed them needles,
they showed them powder, they showed ’em
people injecting. And before they got their
dose, when the methadone was at the lowest level,
that’s the top line. You can see a lot of
orange, that’s lighting up in different areas
of the limbic system and they also on the craving
scoring card from zero to nine had increased craving. When they then got
their dose of methadone and the study was repeated
two to three hours at the peak level of the
methadone there was much less activation in those
parts of the brain that subserve craving
and addiction when they were shown those cues
and they scored lower on the craving scale. So this points out two things. Points out that methadone
is actually working and doing something
good in the brain but it also shows that
even people who’ve been on methadone for four
and a half years still are likely, or liable to get
craving in the right situation and they need to be
protected by continuing to take their methadone. And when people go
off methadone they are more vulnerable to relapse. Anyway vulnerability
to addiction, the usual genetic and
environmental combination. Culture plays a big part
in addiction liability, so does stress and
social determinants. What the Lancet calls
syndemics, are really a big part of what goes
on in addiction medicine. And I’m sure other speakers
will talk about it today. There are other things there
called exaggerated responses. I like to ask people,
what did it feel like the first few times
you used an opioid and you get this
verbatim response. I felt like the world was
perfect, under a warm blanket. And if you like an opioid
and it energizes you, you are vulnerable
to opioid addiction. Most people don’t like opioids. They get nauseous,
dizzy, they throw up. But just liking an opioid
makes you vulnerable. But ask people this
question, what did it feel like the
first few times? This is a slide on
sexual abuse and women and showing that depending
on the type of sexual abuse there are different risk
ratios or odds ratios of developing drug
or alcohol dependence and some psychiatric problems. We all know how harmful
sexual abuse can be. Besides patient
vulnerability it occurred to me that in this
epidemic of prescription opioid prescribing where
it quadrupled in 10 years, there was also
prescriber vulnerability. Where we thought this
was a reasonable thing to do based on a perfect
storm that occurred. Opiate agonist
therapy is complicated because not only does
it involve knowing the disease you’re treating
and the pharmacology of the agents you’re
using but involves issues that don’t come up in
the rest of medicine. Stigma, regulatory issues,
the political things around methadone
and buprenorphine. And also destitution or
severe psycho-social problems. Stigma, my wife’s opinion is
that methadone maintenance treatment is as
close to evil as you can get without killing someone. This is one of my long
term methadone patients, doing well no problems. Paying taxes, the whole thing. And I can’t convince
her otherwise. Saturday Night Live, Seth Myers. This is the Christmas show
a number of years ago. So Seth Myers says to
Mrs. Claus, you must be excited to see him
when he comes back. Mrs. Claus, by the
time he stumbles in at 6:00 a.m. Chris has eaten
roughly two billion cookies so he pukes for a solid day. She continues, he
then spends a week in a methadone clinic to come
down from the sugar high. This is coming out of
nowhere on a Saturday Night and I think about my
patient sitting there with his wife and kids
doing well, successful and they need that like they
need a hole in their head. I’ve written to
Saturday Night Live and haven’t gotten any response. But this is done all the time. With the concept that
being on methadone is futile, you’re an
idiot, its going nowhere. Time Magazine, 20 years
ago beautiful article about neurobiology of addiction and we thought like,
wow what an advance this is coming out of
NIDA, the whole thing. Buprenorphine was in
the development process. A few months later they came out with their article
about buprenorphine and they called it a
way out for junkies. There would be no
way this could happen with any other medical disease,
a pejorative term could used but there’s no political
correctness when it comes to the addiction space. Old terminology, they use
opioid substitution therapy in Europe and Australia. I think its very misleading. It leads right into, aren’t
you substituting one addiction of one drug for another? Why can’t we just
call it, you know, treating opioid use
disorder pharmacotherapy? Even MAT is a misnomer
’cause for many patients its not assisting the
counseling, it is the treatment and the people providing
the medical management are doing excellent
counseling even though its not called that ’cause
they’re not psychiatrists but they know what they’re doing and in many studies
you don’t see added improvement with counseling. This is an important
one, physical dependence does not necessarily
equal addiction. People who are doing well on
methadone and buprenorphine are not addicted to it. They’re physically
dependent but not addicted. Really important for the
patient and more importantly for the significant
other to believe that. How long should people
stay on this medication? If you look at the evidence
over the last 50 odd years the answer is
indefinitely, just like with hypertension,
diabetes, asthma. The relapse rates are
high when you get off. I’ve had people on
methadone in my own practice for up to 50 years now. Some of the original
Dole, Nyswander people. They’re doing well. Haven’t seen any
big organ problems or any other medical
issues that have come up. All treatments work
for some patients. No one treatment
works for everyone. A problem in addiction medicine is repeating the
same treatment over and over again even
though it doesn’t work without switching to a
different form of treatment. Why is all of this so important? Philip Seymour Hoffman, he was
a very successful AA patient for many years. He’d have years of
sobriety, go back to AA. And he was very into AA
and a very good member. But he had this severe
relapse a couple of years ago. It involved heroin. He was found with a
needle in his arm, heroin on the postmortem
toxicology, he died. I wonder if I could ask him now, do you think you
woulda been better off on buprenorphine then
trying to be abstinent? Maybe that would’ve
been a better strategy. He has a wife and two kids. So that’s why this
is all so important. Thank you very much. (applause) – Thanks so much, Ed. Good morning everyone. Thank you so much for being here and thank you for the kind
invitation to participate. I certainly think
that all of the topics that we’re covering today
are extremely important and I think that the materials that have been presented
and prepared for you in preparation and
conjunction with the meeting are absolutely essential. Much of what I’m going
to cover this morning is repeated in some of the
materials that you have with you and as I believe
I said earlier, we heard that the slides
will be available. Just a little bit
about my background. I am a primary care
physician assistant. I am an educator. I’ve been a PA for
almost 40 years so I’m one of the
very, very early PAs and I’ve had a career
in primary care. As we saw in the original
poll that we did earlier I think about one
in five right now in this audience are clinicians. And so what I’ll try to do today is not make this an
overly heavy talk using a lot of pharmacology
and clinical terms but I do think that
some of it is necessary to understand the scope of
the illness and the treatment. So as a starting point
lets think about the why. Ask ourselves why
are we doing this? We know that the use
of opioid agonists to treat OUD have been
studied extensively and they are generally accepted as standard medical practice. They’re highly effective
and it must be remembered however that it is
just not a pill. It is just not a
treatment that you go into a program and
are treated like, and talked about
for many many years with a particular agent. It has to be part of
a continuum of care. As a clinical providers or
public health folks we must take steps to make sure
that there’s prevention, there’s screening activities,
that there’s treatment, and there are follow up. This is a continuum of care. The Mu-opiod agonist
shown on the slide, methadone and
buprenorphine address the two top objectives. The long half life as
we know for methadone and buprenorphine contribute
to that third objective of the opioid blockade. Naltrexone on the other
hand is an antagonist. A Mu-opioid antagonist. So its been demonstrated
to reduce cravings and block the effects of
these illicit opioids. So when used in an
integrated approach I think we can all agree,
behavioral health is an essential,
essential component. MAT significantly
reduces the morbidity and the mortality and I’ll
show you some of the evidence. But before we do that a little
basic review of pharmacology. If my students knew that
was I was gonna cover pharmacology of opioid treatment in about two minutes
they would say, I’ll go to that lecture. So when we think
about the pharmacology we think about
methadone, buprenorphine, and naltrexone as we’ve heard. So the daily dosing of methadone
is in supervised settings. These are supervised settings
that have wrap around services if you will, and
they’re regulated at the federal and
the local level by a set of standards that
are absolutely essential. Methadone’s also on the WHO’s
list of essential medications and it is a synthetic
opioid as we know with a long half life. The buprenorphine is only
a partial opioid agonist that has a ceiling effect
different than methadone. But it is combined with
a naloxone antagonist to essentially serve as
the diversion strategy for illicit use. The available treatment
programs are not as controlled as we see. We are trying to get more
primary care providers as prescribers for buprenorphine so that it increases
access to treatment for those patients
who would be seen as suitable for this
particular strategy. And it does require
special training as we’ll talk about in
a little while regarding the data 2000 waivers. The last one, naltrexone is a full opioid
receptor antagonist. And again its available
through treatment programs and outpatient settings. No special training is required
for this particular agent. So that the basic
pharmacology now we’re gonna talk
about the evidence. So a recent PubMed
search revealed about
almost 1000 studies that looked at the big
three, if you will. The methadone,
buprenorphine, and naltrexone and this is a substantial
and extensive evidence base from which to draw conclusions
related to the effectiveness of these therapies. So I think we can
agree that the depth of clinical evidence is there and yet we still have
so many barriers. Whether its stigma,
access, and we can get into those in a little while. Specifically with methadone
the systematic reviews demonstrate the following. Improved retention in treatment. Reduced levels of criminality. Reduced rates of
injection drug use which is so important because it then impacts the blood
borne disease transmission which is essential
from a public health and clinical stand point. So in this country there’s
approximately 1600 opiod treatment programs
nationwide caring for approximately
350000 patients. So this ranges from clinics,
no clinics in Wyoming, to approximately 150
clinics in California. So the structured nature of these opiate
treatment programs serve a tremendous purpose and that
purpose is the structure. The structure of directed,
observed treatment, along with incredible
psycho-social wrap
around services that are essential
in the recovery of
individuals with OUD. However, there are some
studies that have been done in this country
that have studied the feasibility of
whether or not a patient can then maybe migrate to
community based methadone care without that structure
of a sanctioned program like they do in the
UK and in Canada. So this I think would be
an area to explore as well. Especially for patients
that have achieved a level of stability
in their life. So the next systematic
review that has demonstrated the effectiveness
of buprenorphine, the evidence demonstrates
the following. It increases time and treatment,
reduces illicit opioid use and reduces the use of
other illicit substances. But what you know is that
the prescription practices for buprenorphine are
controlled by specific training and so I’ll just get
to this real quick. We all know physicians
who are not trained in addiction psychiatry
or haven’t gone through the fellowship, they have
to do an eight hour program so that they are
allowed to prescribe. PAs and nurse practitioners
were given a time limited waiver or time limited
eligibility for the waiver and we now have a
large number of PAs and nurse practitioners who
are prescribing buprenorphine. Their training is
higher, they have to do an additional 16 hours. And so I think that is an
incredible augmentation to the pipeline of providers. We would, PA EA, myself
as a practicing PA would advocate for this to be a
permanent waiver eligibility process and not just
one that was piloted. So the last is naltrexone. Systematic reviews demonstrate that it assists in
maintaining abstinence from illicit opioids and
also it significantly reduces the cravings and we
know that naltrexone does not alleviate the
physical withdrawal symptoms. So naturally with any drug
therapy there are always risks. I’d suggest that you review
a British Medical Journal article from 2017 that talked
about mortality associated with treatment for OUD. One of the, I think
it was the editorial for that particular study used
the phrase, the golden month. Okay so in methadone
treatment the highest risk of mortality is in
the first four weeks. So for clinicians like
we think about sepsis and the golden six hours
of getting patients into treatment, its
the same for methadone. So treatment risks for mortality is always in the first
four weeks of treatment. During that induction
phase but also the first four
weeks after patients unfortunately leave treatment. We can, you’ll be able
to review these slides, but we can talk about
Long QT Syndrome but its a relatively
low risk unless patients are taking other medications
that convey a similar risk. And then the one risk that
often isn’t talked about is diversion risk. And that’s because
we reduce that risk by directly observed
treatment programs as I mentioned earlier. And so in summary when used in appropriately
selected patients we know that all three medications
approved for MAT are effective at preventing
relapse to illicit opioid use and also are increasing
retention to treatment. And like any treatment for
any chronic relapsing illness we need to individualize
that therapy. And so I would echo what
some of our other speakers have said, looking at
the patient profile and what’s going
to work for them. And I’ll share one
very small anecdote. I teach students. One of my students went to
a primary care setting down in a rural county in Maryland. He was working with the
only buprenorphine provider in the county. He was impacted
in a powerful way because he saw that there were
no mental health providers in that community. So how could you
prescribe buprenorphine without the services of
trained psychologists and he came back
and shared his story with his colleagues and it
made a tremendous impact. So I think that as a PA
I’m all about the team and I’m all about
working collaboratively and I think that these
medications provide hope to patients but we
can’t do it alone. So thank you very much. (applause) – Alright I’d like to
thank Edwin and Lisa for those very
informative presentations. Maybe you can take that
back, Lisa, to your students and give them a much
condensed course next time. I am very much looking
forward to moderating this next session which is going to feature experts who
are currently leading innovative models of care. These models are in
many cases combined with effective approaches for
improving opioid use disorder screening and
intervention as well as these integrated
treatment models because screening intervention
treatment and support for recovery of opioid
use disorder can occur in a variety of community
and health care settings. We’re also gonna
try in this session to identify lessons learned
and address challenges to broader implementation
that exist today. So we’re going to start
with brief remarks from each of our panelists and we can keep
those remarks tight. We’re gonna have time for
a moderated discussion and some questions and answers
time with the audience. That includes our
online audience. So those of you who
are joining us online if you have a question
please submit that and we’ll try to get to as
many of those as possible too. Looking forward to an
interesting discussion but before that I’d
like to ask everyone to respond to our
next polling question which will close at the end
of the panelist presentation. That question is, what
is the biggest challenge for health systems and
providers that would enable them to implement a
coordinated approach to opioid use
disorder treatment? And all these have been
raised as obstacles. I’m sure we’ll talk about them
during this session today. But we’re asking you to
pick a number one choice. Need for additional evidence
on which models work. Need for additional
funding resources. Need for additional
training or education. Need for additional
institutional support. Need for regulatory or legal
changes or something else. So please go to the
app, the instructions are on the screen if
you’re not still connected from earlier and
we’d like to ask you to pick the best one. We’ll come back to this,
tabulating the results after the remarks. So right now though
I’d like to get to the panel and I’d
like to ask all of them to come on up and sit at the
table so we can get going. First you’ll hear from
Coleen LaBelle the director of Boston Medical
Center’s office based addiction treatment program. Then Kathryn Cates-Wessel,
the chief executive officer of the American Academy
of Addiction Psychiatry. Then Gail D’Onofrio, professor
of emergency medicine and chair of the Department
of Emergency Medicine at Yale Medicine. And then Yngvild
Olsen, medical director at the Institute for
Behavioral Resources at Reach Health services. So Coleen let me
turn to you first. – Good morning, thanks
for having me today. Its a pleasure to be
here with all of you. So I’m gonna talk
just a little bit on the utilization of a
nurse care manager model. And expanding access
to buprenorphine and injectable
naltrexone treatment in our office based practices. I have no disclosures to report. So back in 2003 when
buprenorphine was actually FDA approved and hit pharmacy
shelves we began looking at how do we do this? How do we get providers
to take this on? ‘Cause our patients
are complicated. This is a complex
treatment population and so we looked at taking a
nurse care management model, integrating it into our
primary care medical setting. What did that look like? That was the ability to make
the nurse the glue person, that central person
that would be there to take care of the patients. To provide all that complex
care management wrapped around the provider
who had the waiver, to prescribe buprenorphine care. And an attempt in meeting
their social determinants of health and taking
care of the whole person. So what does the nurse do? What did they do then
and what do they do now? Its that frequent followup,
seeing that patient when and where they
need to be seen. Because the providers
are not in clinic all the time providing
care and management, addressing pharmacy issues,
prescription issues, doing that initial
assessment, the education. The treatment consents
and agreements. Dealing with pregnancy and
pain and criminal justice and Department of
Children and Families. In their housing, in
their social supports, and their insurance
barriers, and copays, and the different issues
that would happen. So that’s essentially,
that nurse took on that piece so sees the
patients more frequently with the providers as
little or as much involved as they wanna be in the
care of that patient. So when we integrated
it into other settings sometimes that
looked differently. So what happened is
we did it in Boston at Boston Medical Center. It actually worked
extremely well. And then the state
looked at this and said, wow maybe we should
look at expanding this into community health centers. So they put an RFR
out to model our model into community health centers
with us doing the training and technical support
for that model of care. So what happened
initially when we did this in 2007 as an RFR went out
and 14 health centers signed on and over time that
increased in small increments. It was really hard to get
providers at that point to take this on and to want
to treat those patients in their practice into
a community setting. But over time more
RFRs went out and more and more folks got
engaged and people saw that this was actually,
this was a populace they were taking care
of and it made sense and this provided wrap around
services for the patient as well as kept patients engaged and care and providers satisfied with the work they were doing. So now we’re servicing
34 health centers across the state of Massachusetts that
are funded under the bureau. There’s actually
43 health centers that have nurse
care manager models but some of them are funded
by HRSA and other measures so we don’t collect
data from them but we do provide
support to them. This cumulatively shows
you the numbers of patients that have been serviced in
the community health centers since we started the grant
in ’07 with 174 patients. Being serviced and now
greater than 16000 patients in the community health centers in the state of Massachusetts. This is just again
in the department of public health funded
sites, ’cause that’s the only sites we
collect the data for ’em. So there are actually more
patients being serviced. In doing this we looked
at utilization outcomes in this OBAT sites. So this shows you patients
in care less than 12 months and then patients in care
greater than 12 months and the longer folks are in care the more they
retain the decreases in emergency room
and hospitalizations
that we have seen. So patients did better, they have less costly
health outcomes. In addition we saw decreases in positive urine
toxicology screens. That being illicit cocaine
as well as benzodiazepines. So again, the longer
somebody was in care the better they did and
the less likely they were to in fact have
a positive urine. We also saw that patients
stayed in care greater than 55% were in
care at 12 months. Obviously our goal is
to keep people in care as long as we can and
we wanna improve that. And we’re able to keep
folks in care utilizing this wrap around nursing
care manager model. What also has happened
is Massachusetts is now sharing our experiences and we’ve been sharing
them with the HRSA grants and helping other states
get started through AHRQ, publishing our model
in that system. SAMHSA has dubbed it
the Massachusetts Model and recently started a
NIDA CTN clinical trial where this model is
being implemented into six health systems
across the country. And we’re actually into the
phase where we’re actually just started enrolling patients. So again others are looking
at the different models, different systems work
for folks depending on what resources one has. So again we need to
be flexible, we need to be open minded, we need to
change our systems of care. We need to address
more harm reduction, helping folks engage
in treatment when
and where they appear so we’re continuing to evolve with what we’re
doing in our care and trying to figure
out how do we get folks into care and how do we
decrease those barriers. But the nurses are at
many of these places where folks end up given its
the largest healthcare system of providers so utilizing them to the scope of their practice is a benefit to all of us. And so what makes things work? Models, systems of
care, reimbursement, but the most important
thing I think in my world is the people. This is my team that I am
so fortunate to work with. And they were actually
honored at The Boston Globe this year as a salute to nurses. But it just, its the
people that are passionate, that are engaged, that
wanna do this treatment, that wanna take care of patients that truly make the difference. And patients say
that being treated by their healthcare
team that treats them for their substance
use is actually the most important thing
to them in their lives. And that’s it, thank you. – [McClellan] Thank
you very much. (applause) – Hi, first of all I just
wanna say I feel humbled to be amongst this
group and I told Mitra, I’m not sure I’m the
right person for this but I do wanna say
also it is wonderful to hear everyone
talking so openly and honestly about
substance use disorders. I’ve been in the field
for 30 years its been a long haul so to hear
people talking about all the integral things
and how complex it is, its just very rewarding for me. So thank you for letting
me be part of this. So I’m a representative
of the American Academy of Addiction Psychiatry,
but even more so I’m gonna talk about
two initiatives that we are a part of and its not
just our organization. We are the convener, we are
the lead organization working with a large majority
of the people. Everyone at this table,
lots of other people in the audience. So I don’t want to leave
anyone out so I just wanted to make sure I clarified that. I have no, nothing
to disclose either. So the American Academy
of Addiction Psychiatry is made up predominantly
of psychiatrists who specialize in addictions. And that is our
mission, to focus on evidence based
practices looking at prevention
identification and treatment of all substances and
looking at the impact of co-occurring
mental disorders. And I wanna emphasize
that because more often than not we don’t talk
about mental health. And so that’s kind of
our niche in the area that we’re most interested in. Another thing that
we’re really focusing on is the need
for collaboration. And I mean everybody. Our primary focus has been
on health professionals but we know it goes
well beyond that. But we’re trying to stay as
much focused as possible. So when SAMHSA came
out with an opportunity to bring teams together and
to provide support system we jumped on. We said this is
where we wanna be. And so the model
is called providers clinical support system. Initially it was
called physician
clinical support system and then from there
it went to prescriber clinical support system. And actually through
our coalition and our steering
committee we went back to SAMHSA and we advocated
and we said its not just the physician, its not
just the prescriber, it has to be the full team. Its all about multidisciplinary. So just to give you
a sense of the nature of our coalition, this
is what it’s about. So what we’re about
is more than just that MAT waiver training. We do provide that
free of charge. Everything is free, free, free. If I don’t remember to tell ya. Everything of this is
provided free of charge. So we have all
kinds of resources. Who’s our target audience? All healthcare providers. Anyone, not just the prescriber. It takes a full team. And so we really
wanna emphasize that. Who are partner organizations? I’m not gonna go through
every single one of ’em. And you’ll see why. And we feel very strongly. So we have all the major
players in primary care. Who is the physician or
the nurse gonna go to? They’re not gonna come the
addiction psychiatry, trust me. You talk about stigma. They’re not gonna
go to those people. They’re gonna go to
their primary specialty. So the American
Medical Association. The American Dental Association. The International Nurses
Society on Addiction. The American College of
Emergency Physicians. So we went out and we brought
in all the addiction groups and the primary care groups. Multidisciplinary too. So collectively
we represent over a million health professionals. A huge coalition because we
feel very strongly that’s who people are gonna
listen to and that’s where they’re gonna go
to get their information. And that’s really
important to hear that. So what do we do? We provide webinars, we
provide online modules, we do the flip class, we do
podcasts, we do MAT chats we do O chats, we do anything
you could possibly think of to try to make it easy
for the health professional. They wanna do this in the middle of the night when they can’t
sleep, okay they can go online they can pull it up. They want to participate
in a live discussion, we can do that. So I think its really
important to be flexible and that’s a lot about
what we’ve been hearing is meeting people
and organizations and approaches in
where they are. You can’t just say
its gonna be like this and its a cookie
cutter for everybody. And so we recognize that and
we want to make it flexible. We have a tremendous
amount of resources online if you have not gone to our
website please, please, please do not waste your resources
and recreate the wheel. We have the best of the
best in the field out there so we have webinars,
we have everything you could possibly want. Also the other thing
that’s really big is our mentoring program. You could be matched up with
an addiction specialist. You could be matched up
with a pain specialist. You could be matched up
with a primary care provider who’s just been
providing medications and knows how to treat people
with opioid use disorders. Its all free, did I
mention that its free? So I think its really
important to know these are resources that
are already in play and available to everyone. So how much do we have? So just to give you some
general statistics we have a huge number of webinars
and materials, over 600. We also have small
group discussions. We find that health
provider professionals tend to like to have case,
clinical case discussions. And so those are private,
they’re up to 10 to 15 people on a call with an expert
on a specific topic. The clinicians can provide
a clinical case in advance and then the expert
can be prepared and then they can
discuss on the call, like a round table or journal
club that you would in a lot of other settings. That way they get that
kind of one on one. So we try to do those
probably twice a month. We have waiver trainings. Please, please, please do
not pay for waiver training. Its all free through this grant. Its for nurse practitioners. Its for physicians assistants,
its for physicians. We have eight hour online. We have half and half. We have eight hour live. So again if you don’t see
what you need let us know and we’ll try to meet
those needs as well. And then we have the
mentoring program that continues to grow and
makes it available to people. So again, a big part about
PCSS is bringing collectively the resources
together, the experts, and how can we bring
what we all do best and make it as best
for you as possible and easy for you as possible. Okay so we spent a lot of
time training the individuals. Okay the support
team, the prescribers. A lot of it on the prescribers but we also know there’s
a lot more involved and so I call it
connecting the dots. We need to go local. We need to find out
what you’re up against and what your challenges are. So in another part
of our initiative was an implementation project. We hear more and more. I’ll have a doctor call
me, take the waiver course and he’ll call and say, hey
Kathryn I’ve got the waiver, now what do I do? And I go, I don’t
know, what’d ya do? I mean you do what you,
I mean you prescribe, you take care of the patients. But they don’t really
know how to get started because their team
doesn’t know what to do. They’re not really
comfortable with a patient that has a substance
issue disorder. Its new to them. They’re billing office
doesn’t know what kind of work flow, I mean
its a systems issue. So how do I go back
and practically apply this in my setting? Providers don’t
work in a vacuum. Their team needs to be on board. So we said, okay well
why don’t we go out and find out what we
can do to help them. So we started out
with five states. Don’t ask me the criteria
of how we decided there were five states
because Yngvild is on one, Coleen is on a couple of ’em and we looked places
that we had champions, addiction champions and
we knew that settings that we could work in
easily to start out with. And so we chose five states,
we’re now in seven states. And we went in and we, first
thing we did is we identified one clinical site that had
to have the willingness to join effort with us. They bring on a
multidisciplinary team and we bring a technical
assistance team into them led by an addiction specialist. And the first thing we did
is we did a needs assessment. Looking at that local setting. What are your barriers? What are you strengths? What is it you’re dealing with? And then how can we
help you identify goals of how to overcome the barriers? And how to expand the use
of evidence based practices in addition to the use of MAT? And I say that because a
lot of people, particularly in community health centers, don’t say you
wanna increase MAT. Its really about substance use. And if you don’t get into the
substance use disorder piece and just focus only
on MAT they’re like, this is not gonna work. But then the more they
learn the more they realize that they have to
go beyond that. Here’s an example of one in
Pennsylvania that we did. They started out with
a mentor in PCSS. They require all
prescribers to take the, we have a core
curriculum on pain. Every prescriber has to
take the core curriculum. They have now gone
from two clinics with two people prescribing
and now they’ve gone out to 12 clinics and now
they’re integrating it into a large medical system. One of the prescribers, Dr. Peck is an OBGYN, she says I
find this more rewarding than delivering babies. And I’m like, wow that’s huge. And they said, this has
been a tremendous asset to them to moving forward. So STR grant, I’m gonna
talk quickly is a new grant that came out. We took the same model and
we took the same coalition. Don’t recreate the wheel,
build on, enhance expand, what we’ve learned through PCSS. Working with the addiction
technology transfer center ’cause they’re already
working in the states with the single state
agencies and we wanted to expand what we’re doing. Again, huge number, I love
coalitions, I love partners. Building on that, again,
expanding and making use of what we already know. So everybody at the
table is working with me on a lot of these. Thus far, within the
first 60 days we had to do a needs assessment of
every state and territory in the country. The first 90 days we
had to have system put in place with
prevention recovery and treatment consultants
in every state and territory in the country. World peace is next. But right now we’ve had
over 200 and some requests and that’s not only from
single state agencies with STR grants but individuals. So its really huge, we’re
getting a huge response from individuals
from a grandmother in Rhode Island who
wants to start a program for other grandparents
raising children who’s parents have an
opioid use disorder. So we have a huge
opportunity there. Again, technical assistance
is provided free of charge so if you know anybody that
need technical assistance go to STR-TA and you can
get that information. So workflow chart here,
I just wanna go through that there’s a process. That’s new for the field. Something to follow and
track where things are from the request to finally
completing the task. The other thing is we don’t
wanna duplicate efforts. So if somebody comes in
and they wanna mentor, we don’t recreate the
wheel and pay for a mentor. We send ’em over to PCSS and
say hey, we have somebody that wants a mentor and
then we close them out of the other system so
we’re not wasting resources. Huge issue, we got a lot of
things going on right now But we wanna make sure that
we’re using things effectively and filling gaps and not
recreating the wheel. So I won’t go through those. So anybody can put a request
in across the projects. Local is key. That doesn’t mean you have
to be in the room with them but you have to
understand their needs. Stigma is huge, huge, huge
and I’m gonna show briefly if I have a second,
a video that we did. SUD, the basics
of understanding. That’s a huge area, reason
why primary care providers don’t prescribe waiver. You tell me how to prescribe,
I really need to know how to manage this patient. I don’t know the basics of
substance use disorders. Collaboration is essential. Love, love, love. You have to, its everybody. It involves everybody. MAT is more than
just prescribing. Some people think, oh
you get the medication. You got naloxone and
you’re ready to go. Whoa, no you’re starting but
you’re not quite there yet. So its really
important to know that. Its not just one medication and different people
need different things so you have to look
at the individual and focus on that, not
just what is easiest for you to get out. Systems are needed. Simple, practical, templates,
business plans, charts are really, really important. Multidisciplinary team,
one size doesn’t fit all, mental health cannot be
ignored it takes time but its vital to
making real change. Together we can
make a difference. Now I don’t know if I have time to do the thing or, did I
go over my time to show the? Okay, so we did a
project on stigma and its talking about how we
can get health professionals to feel good about working. Because a lot of people say, well I don’t treat
those patients. Those are not my patients. And like well, you
have those patients you just don’t know it and
you’re not treating ’em. So we wanted to show
them kind of the reward and maybe we won’t but we did. On the PCSS there’s a
section on resources on educational and
it talks about stigma and it talks about how
rewarding it is to transform a person’s life. And how to be a
part of that process and so its not a big
deal but if you go onto the website for PCSS and
see there’s some videos from the patient’s
perspective and what it means to their recovery to have
someone who cares about them. Who’s non-judgemental
and who welcomes them and treats them like
any other patient and calls them by
their first name. Tom Hill’s a part of that. He’s been very involved with us. We also have the health
professional talking about how rewarding it is
and how meaningful and how much they enjoy
working with this population. So thank you very much. (light music) – My sort of first
memory of it was being there as a nurse with
30 patients all sick in a line out the door waiting
to be dosed with methadone. – It was quite frustrating,
’cause I didn’t know how to deal with
these men and women. There was a lot of guilt. I didn’t know how to
provide the best care. And a lot of blame. I’m embarrassed to say that
I often blamed the patient rather than me understanding
what was really happening. – It is a disease
like any other disease but unfortunately it is not
treated like any other disease. – It was not uncommon for
me to hear doctors talking about patients as
crazy or addicts or things like this and
realizing that there was a lot of stigma
within my community, the medical community. We have to really start having
open, honest conversations within the field of
medicine about how we are understanding addiction
in the first place. – Addiction is a
chronic medical disease, a disease of the brain. It is not a sign of moral
weakness or failure. – It truly is possible for all
of us to develop this disease which is what makes it so scary. – Once I started to
understand the neurobiology that there was a way
to actually understand what the drugs were
doing in the brain, then it was much easier
for me to treat them and to relate to them. – Particularly for opioid
use disorder we have excellent medications
that are available and that has to be the
foundation of treatment. We need high quality, evidence
based behavioral treatment. – In opioid use disorder
medication assisted treatment has been shown to
have great benefits. People realize that
medication assisted treatment is safe, that its reliable,
that it makes a difference. – I have changed
tremendously since working with this population. Despite the fact that
patients are very high risk its very rewarding
on a daily basis. – I see them doing well, putting
their life back together. Being able to get back
to their baseline. Being able to support
their families. Being able to take care
of their mental health. Being able to get
back into treatment. That really inspires me. – Their recoveries
are just as compelling as the recoveries that take
place in a cancer center or in a burn center,
or in any other traditional medical facility. I think I’ve had the
benefit of really kind of going on the journey
with them towards recovery. – [Speaker] For every
intervention that you do with a person you are
having a direct impact on their loved ones
and their family. For everybody who
doesn’t die unnecessarily that’s one more child that
still grows up with a parent. That’s very moving
and gratifying. (light music) (applause) – Thanks very much, Kathryn. Thank you very much and so
next we’ll hear from Gail. – Okay thank you very much. I’m happy, very
happy to be here. I have no disclosures
except one thing that Aetna has helped
us produce some videos that we’ve done for our
websites with NIDA and Yale. So most of you know
about emergencies. But we are the
24/7, 365 day option to help fight the opioid crisis. Most of us are seen as
people who actually work with immediacies,
whether that is anything that is life threatening
and its been somewhat of a struggle to see that
this is life threatening as well as the heart attacks and as well as the
strokes and the traumas. So emergency departments
and emergency physicians can do all these things. Identifying patients are
not really a problem. They hit us in the
head, they’re there. They’re there for overdose. They’re there seeking treatment. They’re there for infections
due to injection drug use, etc. So many of the times they really are right there in front of us. We can provide treatment. That treatment is not
only psycho-social, small interventions that we do, but also initiating medications
such as buprenorphine. And we can directly
link patients to care and
preventative services. So what is the evidence? We at Yale, a whole group
of us have completed this study and published
it in JAMA in 2015. We were looking at
different models of treatment for
patients that presented with opioid use disorder. So that you know these are
all patients who came in. Only 9% were overdoses. About 30% were seeking treatment and the rest were
identified during the course of the stay and what
we found with this is that if we
offered buprenorphine at the time of the visit along with a very, very
brief intervention of motivating patients
to care that people were much more likely to be
in formal addiction treatment at 30 days than they were if
we gave a brief intervention and a direct
referral on its own. Or if we just gave
them a referral which is more than standard care but based on their preference
on their insurance status. So we found that almost
80% of people went to the referral
that we gave them which was primary care
office based treatment along with our initiation
of buprenorphine. 50% of people were
initiated at that time. 50% received home induction
because they were not withdrawn. Which went very
well, very feasible. We also have one of our
team, Dr. Bush who’s a health economist that
able to show that relief for every dollar willing
is to pay things did well and this was very cost effective for engagement and
treatment as well as each day free
opiate illicit use. So now the latest research shows that we really should
do something with all this research and so
we have been doing it. We have implementation
projects, thank United for helping us with
that and we’re doing it everywhere on world. We’re doing it through
our national organizations and we really are
integrating it. At Yale New Haven
Hospital every single one of our attendings
have been waived. This is a big bar to
reach but we’ve done it. We also have Project Assert which are health
promotion advocates that help our team partner
with community resources and get people there. We have nurses on board, we
have advanced practice nurse practitioners and PAs as well. All of which are helping to
say this is a great patient. We should start
initiating something. So we know that this can work. We were fortunate to
even be in the head of The New York Times on
the front page just recently to show that EDs really
can make a difference. Dr. Andrew Herring
from Oakland California is really one of my big
heroes because he’s taken the research and he’s
done it in practice and he is offering this to all
of his patients who come in. There are many other
people who are doing this from Camden New
Jersey to Syracuse. All over the country
people are really working on doing this. So we’re part of a system of
a major comprehensive approach so one of those things
are access to care and the ED really offers
that access to care. In addition we often do
many other things such as talking to patients about
reducing their OD risks. We do safe prescribing. We share our data, we
try to reduce stigma in any way that we can. And so we have tried
often to reduce many of these barriers
and find solutions. I actually hate
that word barriers but we’re forced to
use it in many ways. We have two websites that are up and that’s for you
to please look at. One of those we
just created at Yale because we were waiting
for the other website to go up at NIDA but it
has just gone up this week. Its all the same data in
there and all the information so anything that
anybody needs to know to practice this in an
emergency setting are there. From our algorithms
to our home discharge with home induction to
videos that are there and these are the
ones that we had help with to film, a
filming crew came down. And those are
three minute videos on how do you talk to a patient
who doesn’t want anything? How do you talk to a patient
that you just saw overdose and doesn’t want treatment but there can be harm
reduction techniques? What’d ya do when it’s an
adolescent who comes in? Which is a little bit
of a longer video. And so just about
everything that you need. Frequently asked
questions are there. So please use those. There are many concerns
that emergency department practitioners have
and these are those. We’ve talked about them
some so I’m not gonna go into all of them, but
one is that addiction is a moral failing and of
course its not moral failing and the reality that
you can see here is that it is a
relapsing disease and we need to understand that and we know that we can do that. Another thing here is that,
and we can provide specific feedback to emergency
department personnel about what’s good is great because
in emergency medicine we only see failures, right. We only see the
people that come back. So we constantly are
telling our providers about patients who have
gotten into treatment who are really doing well
and that’s important. Diversion as you know,
is always people say, well I’m gonna divert. Well as far as we know yes
there are some diversion but it is less than
most other things and if you really look
at again, what was used in that SAMHSA of
misuse was not receiving a medication from a physician. Most all of the diversion
of buprenorphine is that so people will feel
better out in the street. If they feel better
the way I think of it and most of us in emergency,
is that’s one less time that they’ve used
an injection drug. That’s one less
time that you die. There is no other disease that if you mess up once you may die. You know, if you are diabetic
and you have diabetes and you come in
with hyperglycemia or there’s something that
set it off you’re generally not gonna die. We’re gonna help you,
we’re gonna get back and we’re gonna continue it. So this is just as
important as we are here. Other things are
that initiating, its hard to say this,
initiating buprenorphine in the ED, its crowded
and its chaotic. That’s very true
but this is quick and we can do this with the
protocols that we’ve outlined. You can do this
very, very quickly. In fact, you can get people
in and out very soon. If you use other
cocktails of medication without using evidence
based treatments you’ll be there forever and everybody
will be disappointed. So we give limited
supplies and we integrate this in our pathways. We have Epic or we people
have electronic health records and people are integrating
all this along. So again its not gonna
increase your length of stay. In terms of lack of referral
sites, many people think that there aren’t referral
sites yet when we go into the community we
finds tons of them. And as you can see there
are lots of doctors who have received their
waivers so they are there. So its a matter of one
person taking the time to collect that information. Patients will return, well
we have not found that. All of the people that
we know who are using it, we have not found that. Although if people
do return again, we know this is
relapsing disease and we will treat them again
and we do have protocols for people who have
chronic diseases who lack primary care on the outside
and often will see us and this is no different
than anything else. People will come
back for re-dosing. Actually we have not found that, neither has anybody
else who’s doing this in a concerted effort. So many patients
don’t want treatment. It is true that there
are patients who come in particularly
those after overdose because they’re kind of
dysphoric from the NARCAN that maybe they have been given. But we do talk to them. We do give them some
harm reduction strategies and in our emergency department
we actually hand them a NARCAN kit and we talk
to them about safe using, using with other people around, using with places that you
would have NARCAN available. And where they could
go for treatment should they decide to go for treatment. And then finally obtaining
a waiver is too difficult. Obtaining a waiver for us
is really a heavy lift. For emergency
physicians we have lots of things that we have
to do, stroke protocols and preparations for education that we have to do all the time. But it can be done and
everybody knows that its free! So its free, its free, its free! We’re doing it and we
have offered payment. In my institution I
happen to be the chair so its a little
easier, but I do offer a day for our community
docs who are working quite, you know 40 hours in the
ED which is 50 hours. For the academic docs
they go on their own time because they tend to
have more schedules that can be flexible. So while this is a problem, and when I go around
the country that is the number one problem. Its not only that you
have to take the program but the program is not tailored
for emergency physicians. We’re not people who
are gonna have people on a regular basis on our panel. We’re doing stuff in
the emergency department and what they learn
there is not really what they need to do. So we’re working on
doing special modules for emergency physicians. In addition to taking care
of patients who come in or need treatment we also
have patients who come in with major trauma,
even minor trauma who are on these medications. These medications are
really difficult when people do need management
of their pain. So there’s a lot that
emergency physicians need to know about it and its a lot
that we talk to people about. So some of the policy
things that we really need are enhanced training
that are specific for emergency medicine. It would be really nice
not to have a waiver as I go around physicians
will say to me, my goodness I can
open a chest without any special training than
my emergency training and now you’re requiring this. Or I can prescribe 1000
oxycodones in my lifetime and now I have to do this. And we’re also looking
forward to hopefully some of the availability of
some longer acting preparations so that we can use
those and that’s it. Thank you. (applause) – [McClellan] Thanks very
much, Gail and next is Yngvild. – And I know we’re
running behind so I think I’m gonna try
and talk really fast. So you’ve heard about the
number of different models. I’m gonna tell you
briefly about, oh and do I have to advance this? – [McClellan] The slide’s
up, that’s the other way. – Other way. Oh, ’cause I’m holding
it this way, that’s why. No. Ah, okay. Sorry, okay here we
go, here we go, okay. Alright so I’m gonna
address another model that actually now
really connects general
medical settings and specialty addiction
treatment settings. Otherwise known as kind of the
hub and spoke model of care. And right now
Vermont probably has the most well known such model. California is also embarking
and has been since 2015 on really expanding hub and
spoke models across their state. But I actually wanna go
back a little bit in time to 2006 because Baltimore
actually pioneered the hub and spoke
model at that point. Yeah, the white doesn’t
show up too well so my apologies. But essentially back in the
late 1990s to early 2000s Baltimore was ravaged
with a heroin, opioid epidemic and overdose. And when buprenorphine came
out in 2002 Maryland medicaid actually opted to add it
to its pharmacy benefit but only in general
medical settings. And so there was very,
very, very little uptake. Even with lots of
push and training and kind of everything
else people said, and there was research
done in Baltimore and elsewhere, that
some of the key barriers were that it was,
induction was too hard. It was too difficult
and it took too long. Sound familiar? That there weren’t enough
counseling services and essentially I think
kind of a nice way of really saying, we don’t
wanna treat those patients. We don’t want those
patients in our offices. And so the Baltimore
City Health Department in partnership with the
local addiction authority and an implementation
specialist essentially went to all the healthcare
facilities, hospitals, outpatient specialty
addiction treatment settings, all of the FQHCs in Baltimore. And the health commissioner
at the time said, we really need to do this. We have an epidemic
on our hands. We’ve got more heroin
overdoses than homicides. We really need to, and you
guys need to get on board. And what they ended up
doing is actually recruiting nine drug free, kind of
medication free specialty outpatient addiction
treatment centers and with state and federal
grant funds supported the inclusion and integration
of physicians, nurses into these addiction
treatment settings that had not had any medical
practitioners for decades. And they were able to
then actually get patients inducted and stabilized
on buprenorphine. And once that happened then with case managers really
actively linking people to then identified
primary care physicians, who essentially had been
told by their healthcare facility administrators now
you guys have to get waivered and we’ve gotta do this. And at the time because
these were stable patients the idea that like, oh I
don’t have to start them? Oh I don’t have to
like, manage all their difficult problems? Oh and you know,
there’s a case manager that’s gonna help me actually
kinda work through some of those challenges. There was a huge expansion in
access to effective treatment. At the same time the
initiative realized that this wasn’t
just about access, this was also about quality and that there were
clinical guidelines that were developed both
for the specialty addiction treatment centers as well
as for the practicing kind of primary care practices
because this idea that you can shift from an
acute detox kind of model of care to a chronic
maintenance model, that was new to this specialty
addiction treatment centers. And so the counselors
and the physicians, and even the
physicians and nurses in the primary care practices
really needed more education and more support around how
do I actually support somebody in recovery. How do I now actually take
care of this whole person and not just immediately
discharge them from care if they start using
opiates again or cocaine, or if they continue to
struggle with cocaine? What do I do I do about that? And ultimately that
really paid off. Between 2006 and 2009
the number of patients that actually were now being
treated across Baltimore with buprenorphine increased
from 577 to over 7500. And most impactfully, this
is a study from Baltimore that really shows that expansion that included both methadone
and buprenorphine really led to an overall,
over 50% reduction in heroin related
overdose deaths. So it had a population impact. So why am I sharing
this history with you? Well I think that there
are a couple lessons that I really take from this. So one is that
Baltimore actually had to quadruple its opioid
agonist treatment receipt. It wasn’t just the access, it was actually people
getting the medications. And we know that in
France that when you really dramatically expand
access and get people to take the medications
that’s when you see the reductions in the
overdose mortality. But I think it also
highlights that need for that quality of care. And we’ve heard some
of that this morning and I’m sure we’re gonna
hear more about that. And so those lessons,
Maryland and now Baltimore as well as learning from
Vermont and California are now embarking on building
out hub and spoke version 2.0. Using OTPs as hubs. Because there have been a
couple of financing changes in Maryland that have
led this to happen. So in 2010 Maryland
medicaid actually launched the OTP, sorry in
2013 Maryland launched the OTP health home initiative
that became available under the ACA and over 50%
of the OTPs in Maryland that have a health home
now are in Baltimore city. In 2015 medicaid also
added buprenorphine and Depot Naltrexone
reimbursement to its OTPs and changed the financing system that incentivizes now
more medical care. So OTPs are now really
paid for physician visits and nurse practitioner
visits, and other medical care that can be provided. And last year the
organization where I work, IBR where I see patients,
we got then a grant from the Baltimore
City Health Department to pilot this hub and
spoke model in Baltimore. So now that means that
patients have access to all three medications
and are able to choose which medication might work best for them when they
start treatment. So over the last six
months we’ve started over 100 new patients
on buprenorphine, 180 new patients on
methadone and a handful on Depot Naltrexone. According to also what
the patients want. And we have found that
between 25 and 30% of those patients who started
buprenorphine actually switched to methadone because
they really weren’t able to stabilize their
opioid use disorder on buprenorphine alone. Plus other wrap around
services we provide. But because of the
federal regulations and the restrictions around
methadone we can’t transition those patients to the
spokes that we’re working with like we do with our
buprenorphine patients. But the model has
enabled us to create a broader primary care
specialist network in which complex patients with multiple
substance use disorders and core current conditions
such as chronic pain, psychiatric conditions, can
obtain better coordinated care using our health home. Although its been difficult to engage traditional
mental health clinics, I will tell you. And we treat hepatitis
C, we provide some limited primary care
but there are currently no innovating financing
models for supporting OTPs becoming patient
centered medical homes. Actually as the
primary care homes for people who are
really difficult to engage in typical
primary care. And about 25% of our
patient population falls into that category because
they have often significant trauma histories that have, so they have
difficulty with trust. They’ve had bad experiences
with traditional primary care. They have multiple
substance use disorders and medical, and
psychiatric conditions that all together make
it really hard for them to navigate the traditional
primary care system. And we’ve seen a
significant culture change that’s been necessary,
both in the hub and in the spoke
to really embrace and think about ourselves
as part of a network where we’re co-managing
patient care and communication really
is critical to that. The high tech act many years
ago left out behavioral health clinicians and
providers from innovation in IT and so we’ve been
doing a lot of faxing, phone calls, lots of kind
of old fashioned ways of meetings to review
shared patients because we don’t
have the technology to actually be able to really
effectively share information even with the
appropriate consents. So we certainly
have had challenges but I think that the hub and
spoke model really presents another opportunity
to engage patients, improve their health,
and save lives. And we really look forward
in Maryland and Baltimore to continuing to expand on
hub and spoke version 2.0 so we can get back to,
in the era of fentanyl, more population based
impacts, thank you. – Thank you. (applause) Alright Yngvild,
all of our speakers. Thank you all very much. You covered a lot of ground
in a limited amount of time. We did start a little bit late. I promise we will have a break but I’m gonna go a little bit
past our scheduled break time to have a chance for
participation by some of you. First though, I think
we have the results for our, yes the
results for our survey. And it looks like
number one on the list is the need for additional
training and education. Ahead of regulatory
and legal changes, additional funding resources, and lower down additional
evidence on what works. I’ve heard a lot of evidence
today on models that do work. Let me start this by
first asking people who do have a question to
go to the microphones. Please keep them concise. But let me start
by asking you all, you’ve highlighted some
further policy steps but can I ask you to
highlight maybe one more, one really important
step to scale effective medication assisted
treatment models for opioid use disorders, one. – I would say to increase
the reimbursement, resolve the reimbursement
issue as in providing parity for substance use
disorder treatment as well as coverage
for all disciplines that have licensure to
provide this treatment so it doesn’t create
more barriers. – Okay thank you. Kathryn? – Require all
health professionals to have substitute training. It has to be integrated
into all training. – As I said my important thing is to start having
alternative ways of education besides
one for all people. ‘Cause its not gonna work. – In addition to all of
those, I think I would also advocate for
really re-looking at the regulatory
structure around opioid treatment programs. – Alright, a lot of comments
around regulatory issues. So we go to a couple of
questions from the audience. I have some from online. Please tell us who you are
when you ask the question and for any
responses lets please keep them concise
too, thank you. – [Peter] Hi my name
Peter Strumph I’m from Amygdala Neurosciences. I have a question, I guess
for Dr. LaBelle or Olsen. I was wondering,
patients being treated with buprenorphine, how
frequently do they come back? Everyday, once a week? And how has the introduction of Depot formulation
changed the practice? – I’ll answer first, Coleen. I’m not a doctor, just
for the record, nurse. So we see patients
weekly for the first four to six weeks until
they’ve stabilized. If they haven’t stabilized we
continue to see them weekly. Its really important to
stay engaged with them and help them with their
chronic relapsing disease. We decrease frequency as they
progress in their disease. Some people stay on
weekly for a long time or forever, other
progress rather quickly. We have not started
the Depot formula yet. We’re putting systems in place. We’re making sure
we have storage and security measures in place. As this comes into
people’s office practices, how do you keep it? How do you regulate it? How do you train staff on it? How do you put your
protocols in place? So we’re working through
pharmacy and that. But it will in fact
decrease the frequency in which you may
see folks depending on who we use it for, the
stable patients versus those that may be struggling. – I work in an OTP so
we’re really fortunate because we can actually
then see people, whether its once a day,
daily, to once a week to once a month. And it all really depends
on how people are doing in treatment and particularly with their opioid use disorder. The injectables, so
we’ve actually had a couple of patients
who have had the implantable buprenorphine. Most of them actually, the
two that we’ve had came to us on it. Its challenging because
the dosing limitation has been challenge. Many patients actually
are stable on higher doses than the eight milligrams
that are required for the implantable. And Maryland medicaid
while it has put the new injectable on its
formulary we also still are working through
the practical issues as well as it is gonna
be more expensive. And so having higher copays, and so right now we haven’t
really been using that. – Okay thank you, Michael. – [Mike] Hi I’m Mike Miller,
I’m the senior policy advisor for an organization
called Healthy Women. And we’ve been working with
some state legislatures around the country
collectively helping them figure out ways to address this. We put together a tool kit
actually to limit resources. But getting to the
video you guys showed, one of the first things
we have on our list is how to address stigma. And for not a technical audience but just sort of
lay conversation, if you guys could talk
about word choices. Because in putting
this together we tried to avoid using the words
addiction or abuse. Tried to go back to, you
know substance use disorder, opioid use disorder. Can you talk about
those word choices? I’m not advocating that
NIDA change its name but just how you manage that
or how you get to those? – Do you wanna take that one? – Sure, this is one
of the hardest things on our websites too we
have some better words to say than others. But we’re using the
wrong words, alright. So for example,
medication assisted
treatment is ridiculous. We don’t say that insulin is the medication assisted
treatment for diabetes. And diabetes has a lot of
behavioral issues resulting with it that
primary care doctors and others address with
any chronic disease. So it is a medication. We have shown time and time
again, there’s a huge crop of review that its the
medication that works with or without counseling. Does that mean that its not
good to have counseling? No, I’m not saying that. ‘Cause its good for a
lot of things, right? But it is the medication
and we are perpetuating that, SAMHSA has perpetuated it. So we’re asking that
it is medication for opioid use
disorder, alright. That is a better
way of saying it. That opiate agonist treatment
is methadone and buprenorphine and right now those are the
two evidence based treatments that have worked
and that have shown to decrease all case mortality. In terms of other things we like to say that people
return to use. Its not a relapse, its not a
failure, its return to use. We like to say that,
I’m trying to think of some of those other words. – [Mark] Anybody have
other favorite terms? – And the word abuse, I think
there is very good evidence. John Kelly has done
just a really innovative randomized trial that found
that mental health professionals treat and think about
people differently when you use the
word substance abuse compared to substance
use disorder. Addiction is a little
bit of a harder one. I also wear a hat
as the secretary for
the American Society of Addiction Medicine, and
we do use the word addiction because we actually
have a definition that is, its a primary
chronic brain disease. And so I think really
understanding kind of what addiction is
and how its defined is also kind of part of the key. There’s a big difference
between addiction and physical dependence. And I’m so glad that its
really made that point because we absolutely
very often find that even my patients
will get that confused and not understand
that the medication that they’re on, they will
develop physical dependence just like many other
medications that people take. Blood pressure medicines,
anti-depressants, right? And so that when they
would like to try and come off it we need to
do that in a monitored way and a medically monitored way. – Thank you, great discussion. I do have a question from
one of our web participants asking if one of
you could elaborate on some of the challenges
and successes associated with partnering with
non-medical groups in these integrated approaches. We’ve heard a lot about
that on this panel. Anyone wanna take that? – We work with a lot of
non-profession groups. We work with the recovery
community facing addiction and some other groups
that work with us. We find it, I think with the
most recent project we’re working with STR TA
we’re expected to have a prevention recovery
and treatment together. One of the first things
we all agreed we had to do is come up with
guiding principles. This is what we all agreed
on so any consultant that works on that project,
be it prevention recovery or treatment has to agree
on common approaches. One, its a brain disease. Someone in recovery
can be on medications and still be in recovery. So huge steps like that
where we all can agree on certain things, or somethings
we’re not gonna agree on but I think that
has been a huge step in bringing us together is focus on those areas where
we all agree on. – So I think some
of the struggle is the recovery
community, a lot of them are still focused
on the abstinence and we’re working on the
evidence of the medication. So we’re kinda battling that. So I think the more
we can engage them, the more we bring them
to the table we’re using a lot more recovery
coaches in Massachusetts. We’re really trying
to educate them on the science and
trying to get them to understand there’s
not one pathway. So bringing them to the
table, getting them involved, having them as part
of our coalitions. We’re also building
an ECHO type model for the inpatient addiction
treatment centers. Those that do detox and then the other step down
levels of care. And working with them
to talk with them and have them as
part of the panel to being the experts
to treating patients and working through cases. So I think its just about how
do we help them understand and how do we give
them these tools? And we need to
all come together. So its hard. – Yeah, great
examples that you also talked about during the panel. In terms of collaborations
with medical partners you all have described
a lot of those too, but I heard the comment
about difficulties with mental health
professionals and organizations. Any brief comment on
how to address that? – Its a great question
and its not entirely clear to me kind of why we’ve had such difficulty engaging with them. I will say that I think
that the education that we talk about in terms of
physicians needing education around addiction. All healthcare professionals
need training around addiction because I think part
of it is when there are social workers or
counselors or psychiatrists. Whoever the recovery
specialists, we
have them working in our program as well, that
people get various different educational experiences
and they have different life experiences. And so we can’t just focus on
the kind of medical schools. We really need to focus
on nursing schools and social work school and
all the curriculum kind of across the board. – Thank you. Time for one more
quick question please. – [Kaylin] No pressure, huh? Hi, I’m Kaylin Klie,
I’m family medicine and addiction
medicine in Colorado. And my question is
probably from all of your different
perspectives, especially those who are working across
multiple disciplines, how you have navigated some
of the particular privacy requirements around
substance use? This was highlighted when
I realized I was signing a release of information
with my patient to myself from family medicine to
addiction medicine, right. And so for those of you who
work across emergency room to primary care,
OTPs to the spokes, how are you navigating that? And if you have
any lessons learned that you would be
willing to share? – Anyone? – So we have patients
sign releases to as many places as
possible on the first visit. And the way we
explain it is really that you know, this is,
we are all about kind of holistic care, really
treating the whole person. We don’t necessarily,
we can’t necessarily do that ourselves within our
four walls and a roof. But that we then
coordinate care. And that its not, ’cause
a lot of times people have a lot of questions
about, you know, what are you gonna tell
this other provider? What information are you
going to give over here? And we really try
and make this about, this is about their health. And if we can also
be then advocates on their behalf in having
those conversations, that’s kind of the other
way that we message it. – Great, I’d like to
thank all of our panelists for this session on effective,
integrated approaches for opioid use
disorder treatment. Thank you you all very much. (applause) We are running a
little bit behind. If you could maybe take
an eight minute break or so and we’ll try to restart
around 11:35 this morning. Thank you. – I’m between you and lunch. Looking for my panelists. Here they come, okay. Welcome back, my name
is Larry Greenblatt and I’m a general
internist at Duke and I have dual
appointments as a professor of medicine and also professor of community and
family medicine. And I’m actively
involved with the opioid and prescription drug
abuse advisory committee in North Carolina and I’m
also a waivered physician as you wouldn’t be
surprised to hear. I’m very excited to be
moderating the second panel of the day, we have a
terrific group here. We’ve heard so much rich
conversation already. It’s gonna be a high
standard to try to keep up so I’m putting on the
pressure on my group here. We had a phone call and
I know that these folks have a lot of great ideas
and interesting things to talk about. In this session we’re
going to take a deeper dive into some of the
legal regulatory and practical barriers that
hinder greater healthcare, health system utilization
of medications for OUD treatment
and these barriers of course might
potentially interfere with access to treatment
for our patients. Some of the major
issues we’re hoping to address in this session
include major legal, regulatory, and cultural
barriers to access. The role of stigma in
limiting access to treatment and we realize we’ve heard
some these themes touched on already although I
think you’re gonna get a somewhat different
perspective from our panelists. We’re gonna talk about
patient perspectives and difficulties in navigating
the treatment system and also what gaps are there in the behavioral
health work force and payment policy that
interferes with treatment. So we’re gonna start
out with a poll. And we’ll discuss
the results following the panelists presentations. So at this time
I’m gonna ask you to use your cell
phone or your computer to answer the third question. I guess its on the
screen behind me and then you can also see
the questions on your device. So take a minute
and look at that. We’re gonna ask you about what is the most
significant opportunity to expand access for
medications for OUD? When we think about
what can policy makers and health systems do? So the answers are
in front of you. We’ll certainly address
many of these barriers today but we’re gonna pick
whatever comes up top and kinda try to explore
that a little bit more. So for now we’re gonna
go ahead and jump into our presentations
from our panelists. I wanna introduce them briefly. To my left is Tom Hill,
he’s vice president for practice improvement
at the National Council for Behavioral Health. Sharon Stancliff
is medical director for the New York State
Department of Health. Jessica Hulsey
Nickel we’ve all met on the phone but not in person, is the chief executive officer of the Addiction Policy Forum. And Sarah Wattenberg
is director of quality and addiction services at
the National Association for Behavioral Healthcare. So Tom I’m gonna turn it over
to you and let you present. – Good morning everybody. I’m gonna time myself. Because when we talked
on the phone I said, well maybe we can all
do it in six minutes so we’ll have more
time for conversation. And then I have to make sure
that I’m good for my word. So my name is Tom Hill,
what I’d also like you to know about me is I’m a person in long term recovery
from addiction. Yeah, I say addiction. I don’t say I’m an addict but I say that I’m
recovering from addiction. And I think that when
we look at people, when we look at
recovery in general and we look at people in
recovery from addiction, and people that are
looking for addiction, its really important to
look at how our services and systems and community
supports are in place because if they are in
place the likelihood of people getting into
recovery is much, much greater. And I think we often
have a tendency in this particular
disease to blame the people who are trying
to access the services but if they’ve been failed
by the system before or they’re continually
failed by the system we need to look at the
system and not the people who are accessing the system. Really, really important thing that we always look at
as we’re moving forward, that we don’t take cheap
shots when they’re people who need help the most. So today I wanna talk
about some regulations with medication assisted
treatment, especially OTPs as we talked about earlier. I’m gonna talk about
42 CFR part two and I’m gonna talk about
the Ryan Haight Act. So we talked about
the use of medications in combination with counseling
and behavioral therapies to provide a whole
patient approach to treatment of
substance use disorders. And research shows that a
combination of medication and therapy can successfully
treat these disorders. And I wanna add an
element of the third leg of the stool which
is recovery supports because the combination
of those three things is what enables people
to access a full life in recovery or at least
to consider themselves candidates for recovery. And in the past that wasn’t true for people who are medication
assisted treatment. So the idea of medication
assisted recovery, a new concept and something
to think about in a new way. So we talked about
terminology on that last panel and we talked
about the term MAT, medication assisted
treatment as being misleading and I sometimes think
that I’m not dyslexic, well I am dyslexic
but I think maybe TAM is the way to think about. Its treatment that’s
assisted by medication. And I think if we
think about it that way we don’t lose the treatment. We don’t lose the
psycho-social supports that are really, really
important part of the equation. Now some people will say
that just medication alone will save peoples
lives, it does. But medication with
the other supports will not only save
lives but enhance lives and have people fulfill
self actualized lives that they become
community citizens, family members, and productive
people all over again. So lets talk about opioid
treatment programs. To become an OTP a
program must be approved by the state opioid
treatment authority, that’s the SOTA, and
the approval process is different in every state. They need to registered by a
regional office of the DEA. They need to be
certified by SAMHSA the Center for Substance
Abuse Treatments division of pharmacological therapies. And they need to be
accredited by one of six SAMHSA approved
accrediting bodies. Those are four levels of
regulations and requirements that an OTP needs to go through and there’s a reason for that. So throughout the
evolution of OTPs since the 1970s, these quality,
these requirements have ensured quality measures
that monitor dispensing and dosing of methadone. Lower the risk of
diversion and overdose and ensure connections for
psycho-social therapies. The connections are all there. I don’t know why that happened. (light beeping) We’re just gonna
get rid of that. So another thing we’re
hearing right now is this idea of
decentralizing OTPs and dispensing methadone in
diverse primary care settings. And I think before we go too far with this idea we really
need to consider all the unintended consequences of dispensing controlled
substances without assurances of a four point part process
of approval, registration, certification, and accreditation
across federal, state, and private agencies. Those layers really
safeguard what the dispension of medication looks like. Especially the dispensing
of controlled substances. And so a wiser approach
may be to reinforce the infrastructure
of OTPs to be centers of excellence where patients can access all three medications to plant OTPs in areas that
desperately need them right now. And to make advances,
and we talked about the hub and spoke
model, to make advances in that model and applications
that are regionally focused that will fit a more
diverse regional and geographical areas. Especially rural areas, right? So I’m just gonna
talk about data 2000 but I think we covered that
enough in the last section so I wanna talk a
little bit about 42 CFR and this an issue that
has really galvanized the addiction field. And it raises hairs on the
backs of many, many necks. And its something I think
we need to talk about in terms of often the
elephant in the room. And so it came about to
ensure that a patient receiving treatment for
a substance use disorder and a part two program is
not made more vulnerable than an individual with an SUD
who does not seek treatment. And we know that
vulnerability of seeking or not seeking treatment is
one of the big issues here of whether people access service
or even look for services. So it applies to federally
assisted SUD programs. Its patient informed
consent must be obtained before sharing
information from a program that is subject to part two, and upon disclosure no
re-disclosure is permitted without the patient’s consent. And then there’s some
limited exceptions for disclosure without consent
like medical emergencies, scientific research,
child abuse reporting, things like that. So these regulations
came about in 1975. They were updated in 1987 and
then updated again in 2016. And the proposed rules
in 2016 were intended to modernize part two. Rules by facilitating
the electronic exchange of SUD information for treatment and other legitimate
healthcare purposes while ensuring appropriate
confidentially protections for records that might
identify an individual directly or indirectly as having
a substance use disorder. So we talk about stigma a lot. We use that word a lot in
all of our conversations. We rarely use the
word discrimination. And they’re not the same but
they’re intimately connected. And when we talk about
discrimination we have to talk about how, what
potential discrimination can happen as a result
of releasing records. Always has to be there,
especially in an age now where we’re going back to
criminal justice solutions or thinking about
criminal justice solutions that many of us
thought were long past. So the proposed rule is
intended to modernize part two. The addiction field is
divided on this issue of 42 CFR part two. The House passed a
bill earlier this year to align part two
with HIPAA regulations but the way its divided
is those opposing part two argue that it creates
unnecessary barriers to care. It impedes new models
of integrated care that rely on information sharing to support care coordination. It blocks electronic
information exchange and it hampers a recent focus
on performance measurement and value based payments. Now on the other
hand, others argue that a breach of privacy
information protections can lead to civil and criminal
consequences for patients. Including loss of employment,
housing, child custody, discrimination by medical
professionals and insurers, and arrest, prosecution,
and incarceration. So you see these are
two very differing sides of the fence, each has
their own point of view but we need to come
to some resolution in how these things are
going to be figured out as we move along. Because its often the
elephant in the room. Last thing I wanna talk
about is what we call the Ryan Haight Act. Its the Ryan Haight
Online Pharmacy Consumer Protection Act of 2009. It was designed to compact
the rogue internet pharmacies that proliferated
in the late 1990s selling controlled
substances online. Regulations were issued
at that time imposing a federal prohibition
on form only prescribing for controlled substances. So unfortunately the
exceptions did not align with direct to
patient service models in frequently sought areas
such as tele-psychiatry or substance use
disorder treatment. In addition there’s
a nationwide shortage of psychiatrists and board
certified addiction specialists along with the opioid
epidemic making tele-medicine services a vital
resource, especially in diverse geographic
areas and rural areas. So there’s two acts that
are currently on the Hill. One is Improving Access to Remote Behavioral
Health Treatment Act, and this would allow certain
community mental health centers and addiction treatment centers
to obtain DEA registration as a clinic. Would allow
tele-medicine providers to prescribe controlled
substances to patients present at those sites without the need for an in person examination. Think rural areas,
very, very important. And would expand
treatment sites beyond the current DEA
registered hospitals and specified
non-hospital clinics. So it would broaden the base. And then a coupled with
that is Special Registration for Tele-medicine
Clarification Act. So release simultaneously
and it directs the Attorney General
along with the Secretary of Health and Human
Services to within 30 days of passage of the act
release regulations regarding the issuance to practitioners
to use tele-medicine to prescribe controlled
substances without the in person team. So these amendments to the Ryan
Haight Act, National Council has been working diligently
for two years on. Really hopeful that
these things get passed and move along so that we
can open up tele-medicine in our field, especially in
areas where its direly needed. That’s what I’ve got. I think I’ve used my
time up and I’ll turn it over to my next speaker. (applause) – Good morning. I have no financial disclosures but I do have one disclosure. I’m actually only an
associate medical director at the AIDS Institute of the
New York State Department of Health but its a cool title. Associate Medical Director
of Harm Reduction in Health. I hope that kind of
comes through in some
of my slides here. So there’s not a huge
extensive body of literature on stigma and substance
use like there is with HIV and stigma, mental
health and stigma. So what I’m gonna do here
is tell you stigma is bad. Tell you a little
bit about that. Then I’m gonna talk a little
bit about what we know about trying to reduce stigma
and hopefully give you some fairly concrete examples
of that and part of why its a barrier
for us as providers. Providing care to people
that need the care. So stigma and substance
use, this is a review that happened of
it a few years ago. But we know its reduced
with poor physical and mental health. We know that its reduced
with poor access to services. For example in some substance
us programs providers, they’re the people
that really aren’t gonna work out very well and
these are the ones we like. We even know that there’s
internalized stigma both about myself but also
while I might inject drugs but I’m not like that
person over there that’s injecting those drugs. So its pervasive from
the general public which includes medical folks,
to people directly providing services to those that
need the services. And we know that
it has an impact on poor outcomes for people. Here’s a slide that
I also can’t see that actually does
discuss the discrimination versus stigma going on. And so this is specific
to the opioid crisis. This paper just
came out this year. So we’re looking at,
you know, people think that people that use opioids
are dangerous and criminal. So people begin to feel
like, hmm I’m dangerous and criminal and people
are gonna think that so I’m just actually
not going to go there. And people say well, the
actual outcome is I’m not gonna provide services,
I’m not gonna give this person who tests
positive in their urine a job even if it’s at McDonald’s. And then people begin to feel
like, well I’m not worthy. Why should I try to do this? I don’t wanna be
part of that label. I don’t wanna do anything
that will give me that label. So its on multiple,
multiple levels and you know I didn’t learn
much about substance use in medical school but the
funny thing is there wasn’t as much stigma, they forgot
to tell me that people that use drugs don’t
take their medicines. So until I heard about that
with HIV I was like, okay yeah so these people use drugs
but they do other things too. So there was a good
side to that, I suppose. So we already talked a little
bit about making changes to language and I think
that it makes a big deal. I get to say what I think MAT
means right here, I guess. So I think its medication
as addiction treatment which I got from Kelly
Clark the president of the American Society
of Addiction Medicine. Not to run down counseling. I need counseling, I’ll
probably need counseling. And people that have
had their lives really, really disrupted by drug
use can often really benefit from it, but what I
wanna say is that people that are using drugs
are not that helpless. We need to start changing
how we talk about them. Its not just that
people in recovery that are gonna carry the
message to providers. We’re not like trying
to get the people in recovery already
into treatment, they’re already in treatment. We need to make
providers feel like the people that are using drugs are valuable, interesting
people and they are. So you know, language is
certainly part of that. Addiction is sort
of on the line there but getting rid
of addict, abuser, and talk about
people who use drugs. Maybe people who inject drugs. Certainly junkie,
crack head, tweeker, those actually have no
place in our vocabulary. I know that people
that use drugs will talk about themselves as
having clean or dirty urine but I’m a professional, I’m
gonna talk about negative or positive urine. A lot of my patients are
gonna refer to themselves as junkies, as dope fiends,
but I’m a professional. I can hear what they’re saying. And sometimes we have
some really interesting discussions about it. Its like, clean is when
you have it together enough to get a shower every few days. Not when your urine doesn’t
have any drugs in it. And in fact I don’t know
if urine drug screens really measure stability at all. And that’s a question I
would like to ask of folks. People that use drugs have
major, major contributions to our world. And I think I could go on and
on but I’m gonna talk about a few that are really relevant
to where we sit today. It wasn’t public health people, well I guess you call
them public health people. It was like the first
public health people, that came up with
syringe exchange. It was, they called themselves
the junkie union in Holland. Like, people aren’t letting
us have access to needles. This is dangerous, so they
started needle exchange just before the
HIV epidemic hit. Some countries adopted
it sooner than others. Its become a major
public health measure. But that’s who came up with it. A needle exchange in Chicago
noticed what they were doing in Italy making
naloxone available so people that used
drugs in Chicago said, oh well people are
dying of overdoses we’re just gonna give them naloxone. They didn’t wait for
any laws to change. They didn’t ask any permission and they fortunately
didn’t get punished for it. But that’s where that came from. And then people on
methadone of course are stigmatized but the
way the first methadone treatment program in
a jail in this country at Rikers Island came about
is two of the patients that had been hired as
research associates said, gee why don’t we have
methadone not just detox but why don’t we have it
as actually as a place where we begin it
when people come in with substance use
disorders and send them out. So you know, like we’ve got
emergency room just do it. They just sort of
figured out how to do it. But those were people
that were on methadone and they’re highly stigmatized. And since tomorrow I’ll be
in Maryland I just wanna mention Dr. William
Halsted who is said to be one of the fathers
of modern surgery who was a founder of John
Hopkins School of Medicine who struggled with morphine and cocaine addiction
through his life. So you know, I think
we need to make these patients sound
much more interesting. We want the people that are
using drugs in our office and throw away those
treatment agreements where you sign to say you’re
not gonna steal anything or kill anybody while
you’re in the office. I have a really minimal
treatment agreement but those are
incredibly stigmatizing. So I think this is a direction
we need to start to go. If I could I’d work
in some of the fear that providers have
not only of the people that use drugs but of
the people that oversee the system, so I guess I’m
kind of working it in there. People are very
afraid of the DEA and they’re probably over
stigmatizing it, I don’t know but I just wanna throw that
in there because I want to. So finally I just wanna end with some social
media campaigns. In reducing stigma
that we know probably that the best thing
is good contact with the people that
are stigmatized. Whether its because
of their behaviors or because of how they
were born, whatever. The contact is important. We can’t always supply contact but I think we talked
about people going back to the emergency room to
say they’re doing well. I wanna send my patients
back to the detox where we finally got them
stabilized on buprenorphine. To say hi, I’m doing well. Send the people that are
doing really well back to the jail to say, I don’t
drop in and visit you all the time because
I’m on methadone now but seeing those
people is important. Changing our language and I love this social media campaign run by the New York City
Department of Health. You can see we’ve got one
on methadone who happens to be somebody I know, not
professional but socially. And then the other
one on buprenorphine. Throughout the subways,
and I’m hearing people that don’t know anything
about this stuff talking about these posters. And they’ve got vignettes
you can see on TV too. So I think getting some of
the positive images out there, whether its through
videos, through these, two minutes means I’ve
got until, eight minutes. ‘Cause I’m gonna end at six. So I am basically about done, but I think getting these
social media things out that are really
positive can help. Getting your patients to go back and talk to places
where they spent too much time before can help. And maybe people
will start to feel a little more comfortable
coming out of the shadows because its really
hard to do that. I know a lot of
people on maintenance that just don’t tell. So thank you very much. (applause) – Hi there. Moving forward. Hi my name’s Jessica Hulsey
Nickel and I’m the founder of the Addiction Policy Forum. We have a very interesting
network of members. We represent both
patients and families so we have folks in
long term recovery but we also have a
growing number of patients with an active use
disorder that are a member of our organization. We have lots of family members. Families who have a loved one
who is currently struggling. Families who have lost someone. All sorts of folks
that come together. Our goal and our aim is
to work towards a world where fewer lives are lost
and we have more resources and tools available to treat
and to survive this illness. We also are trying to build a
patient advocacy organization to really advocate for our
patients and where they stand. Even the, its not just
cancer and diabetes and Alzheimer’s and autism. Even the rare disease have had a patient advocacy organization. Like a whole national
organization of rare diseases. And then each of the
rare diseases have had their patient advocacy group. And yet we have 20 million
Americans struggling with this disease and
we need to be fighting for research funds, and
new medications, right? Not just the ones
that we have currently but new medications,
new developments. Make more information available. Better patient education,
all these pieces are a core part of what the
Addiction Policy Forum does. I wanted to come
at this from sort of a different
perspective and talk a little bit about
some of our families and about what happens
when we don’t get it right. About what happens
when, whether its stigma or lack of access,
lack of integration in our healthcare
system, what this means to so many of our families. So this is my friend
Amy and her son Emmett. Emmett loved to BMX bike riding. Super smart, was studying
computer science in college. His mom was the Sunday school
teacher at their church. He was a really good big brother to his two younger siblings. He started experimenting
with K2 Spice. Synthetic cannabinoids in
high school, early initiation. And he relapsed when
he was in high school and she did not know that. After she lost her
son at the age of 20 to an opioid overdose
she found out that he had seven
overdoses reversed in area hospitals, seven right. HIPAA did not
prevent notification of his primary care physician
or to college health services. They could have asked, hey
can we call your family? Can we call your mom? You just died and we
brought you back to life. There was a misinterpretation
of what the HIPAA laws were and we had seven opportunities to save Emmett that we missed. This is Courtney. Courtney’s dad Doug and
her mom Pam are amazing. Really, really close family. They tried everything that they
could to get Courtney help. She struggled with a
heroin use disorder. When their insurance
company told them that it was not life
or death so there would be no coverage for IOP,
intensive outpatient, or inpatient they got advice
from a local provider, a local stakeholder
that if they went across the border into Massachusetts
and that she was homeless that she could get public care. So on the advice of that person
they kicked their daughter out of the house so she
would be considered homeless for at least 48 hours,
and that night she died on the streets by herself. She was 20 years old. Terry and Annette like
some many others who have a heroin use disorder began
using when they were 12 and 13 years old. They came from homes with
an alcohol use disorder. A severe alcohol use disorder. They come from homes with
domestic violence and abuse that is a result often
times of having an AUD. And their illnesses
progressed very quickly into a heroin use disorder. In and out of prison and jail. My mom Annette went to
prison when I was four as a result of her
heroin use disorder. My dad was in and out of jail
for most of his adult life and ultimately homeless
in Los Angeles. My mom found a recovery path. I don’t say sobriety
and I don’t say recovery because I don’t think
its fair to sort of reject someone’s like,
give them credit card when you ultimately have
relapses on this path because this is a
complicated chronic illness. But she found wellness and
better healthcare through a methadone program. Methadone saved her life. I had 19 years with her
before she passed away at the age of 50 from
a sudden heart attack. We do not talk about the
long term health consequences of this disease. The long term health
consequences of
two heart attacks as a result of
cocaine use disorder. The long term
health consequences of untreated hepatitis C
because of IV drug use. My dad didn’t, he didn’t find
his way out of this disease. He died when he was 48
years old, homeless. Luckily I found him at the end. About every three
months I would sort of go figure out where
he was and clothe him and feed him and you
know, say a prayer and find him again when
the next time came around. But there were so
many opportunities. There were so many
missed opportunities for both of them when
they were young entering the criminal justice system,
within the healthcare system reaching out and seeking help. This is my why. This is why I do the
work that I do everyday. Addiction Policy Forum
is my love letter I write to my mom everyday. We can’t bring Courtney,
or Emmett, or Terry, or Annette back, but what
we can do is use our voices to make sure that we have
better care for those that are struggling
with this disease today and their families. So a little bit
about understanding
patient perspectives. And I’m gonna use
we terminology here because I love my members who
have an active use disorder today just as much as I
love my families who’ve lost someone, just as
much as I love my staff and my families who
are in recovery. We still have a lot of
struggles when it comes to accessing care,
to finding treatment. And I’ll go through
a little bit of them. First and foremost our
assistance for families. This is a pediatric
brain disorder, right. So this is an illness
that 90% of the time is going to begin
in adolescence. Yet we have created a treatment
program that’s largely made for adults. So technically we
have the only disease in America where we wait for it to worsen
before we intervene. Its sort of like waiting,
and let you be like okay, I am so sorry Susan,
but until you’ve had an amputation we’re not
really gonna address your type two diabetes, right. So we need to make sure that we have more resources available
when this illness begins and we need to take
on dangerous myths like rock bottom, right. We have an inherent
uneasiness about talking to even our own colleagues or loved ones about
their drinking, right. Our substances of first
use are alcohol, marijuana, and tobacco and yet
we have this like, well maybe it’ll
just go away instead of having systems and
training in place. Whether its in our
pediatricians exam room or within our families and care
givers at our school system. 90% of the time use
begins in adolescence and we need to make sure that
we are intervening there. The other piece about
a family component, when this is a disease that
begins when you’re largely an adolescent, we
need to make sure that families have the
right information, right? When we Google and we are
looking for help and information the first 83 pages
are of bad actors and patient brokers
that are more likely to take advantage of my
families than they are to connect me to treatment. We have to really take
on some of these myths and misinformation, that
we need a bed in Arizona. If this is cancer or
Alzheimer’s you don’t think, oh my gosh I hope I can
find that bed in Florida and liquidate my 401k
account quick enough, right. We find you, we find
healthcare, we find doctors. How do we change this
so our families know to find a physician? That we find someone within
the healthcare system that is going to help us
navigate this disease. Screen, detect,
and intervene early so we have better
health outcomes. That is what we need
to work towards. The other part of the, I
have three sons at home. Two are teenagers and one’s 10. And I can tell you from
first hand experience there is nothing more powerful
than a worried mom or dad. So if we start
equipping our parents with the right information
about how to prevent. This is a preventable illness. We can’t say that
about every disease that we’re struggling
with, but we can prevent substance use disorder. So if we start
equipping families with more information and
better information I think that we can start to see
much more informed families who are advocating on
behalf of their loved ones to demand better care. Now shifting a little bit
to the patient perspective. There’s some tricky
parts of this and I think we have to
sort of meet that head on. We as patients, we are not
always very well behaved, right? We are in an active
use disorder. We’re not always
the easiest patients to have on your hospital floor. But that is the same for
other patients, right? When you have cancer
or you’re in pain or you have the flu
even and you’re sick, not necessarily the best
behaved patients either. But making sure
that we talk about the physical
consequences and changes within our healthcare
system about our patients you understand, change
behaviors, change priorities. You understand that
this is a brain disorder and it is also treatable. We need as much culture
change and awareness within our healthcare systems
as we do within our families and within our criminal
justice system. The other tricky part of
this is we largely don’t think that we need help, right? We might have 20 million
people struggling today but about 95% of us don’t
think we actually have a problem and its usually
an intervening moment or a person that
is going to engage. So that means that
the levers that exist that can help for early
engagement need to be there. That’s parents and
families and employers. As we start to shift
this earlier on we have so much better outcomes. Navigation is very,
very tricky, right? And it also is,
you have a disease and illness that is affecting
the function of your brain. Your limbic system
and prefrontal cortex and yet I have to go
to either this OTP or this OBOT or
this doctor to get an MAT but I don’t
know how to get the psychiatry help I need. I don’t really know
where I’m supposed to get cognitive
behavioral therapy. Mind you I don’t
have a place to live or a job and the IOP
structure they just put me on means I’m not
really employable because I have to
show up for a nine to 12 session five days a week. We make this very
complicated for our patients. We don’t make this
as complicated for
other patient groups in other diseases, right. Other patients groups that
don’t have cognitive impairment. So how do we start to break
down those barriers in that? I wrote a word down here,
this is my speech for today. And I wrote one word
down and discombobulated. That’s what it feels like. Its like, not a linear path. I love hub and
spoke, its like here is how you get stabilized
on your methadone program. And here are all the things
that we have identified in the community because you
know what most patients need they don’t need one medication if they have an
opioid use disorder. If it was my mom today
and I had a chance to redo this I would
stabilize her on methadone and then I would move
her to buprenorphine and then I would probably do
a medically assisted detox so I could put her on a
long acting injectable of naltrexone, and then
I would make sure along the same time that I would
get her into a CBT program. Cognitive behavioral
therapy, maybe CBT for CBT. You can do it
online and at home. I’d make sure there’s a
contingency management component so we’re working with
that same reward system within her brain to reward
the good behavior change and make sure that there
are quick sanctions that aren’t about
losing her children and they aren’t about
going back to jail. I would make sure
that she had access to all the things that we
need and the layered approach similar to the things
that we started to do differently
with cancer treatment in like the 60s and 70s. We started sequencing
and combining treatments for better results. And we need to do the
same for our patients. We have so many
tools in the toolbox but we do nothing to
simplify or explain that to our patients
and their families that are trying to navigate
such difficult care. So that’s it, thank you so
much for having me today. (applause) – Hello everyone. I’m Sarah Wattenberg, I’m
from the National Association for Behavioral Healthcare. And we represent
large health systems that run more than 1000
programs in almost every state. I’m not gonna talk about
medication today per se, but about the system that
surrounds and supports the use of medication. With that, the first
thing I wanna say is to remind and or urge
everyone to understand that in order to strengthen
treatment for individuals with opioid use disorder
we need to bolster and sustain the entire
treatment system for all individuals with
all types of addictions. The fact is polysubstance
use characterizes most substance use disorders. 80% of people with an
opioid use disorder have another
substance use disorder and poly substance
use characterizes
most fatal overdoses. 88000 people a year die
from alcohol related deaths. And many emergency
department admissions and death from opioid
use involve alcohol. We also have something of
around 40 to 60% overlap between mental health and
substance use conditions. And opioid misuse is associated with higher rates of suicide. This is not to say that
we shouldn’t improve on broadening the use
of opioid medications. They are not used
enough, period. We should employ every technique and every strategy we
have to improve uptake for this evidence
based practice. However, if we focus on
opioid treatment alone we will not solve the problem
we are here today to solve. Similarly if focus
on addiction alone without addressing
mental health that too is not going to be enough
to solve the problem that brings us here today. The gold standard of
care for treatment for opioid use disorder
is to couple medications with psycho-social treatment
and recovery support services. This model is the one that
needs broad implementation. As we’ve heard, by
the time a person has developed an
addiction they are in need of more than just
medication to stabilize their physical dependence. People have lost their jobs,
houses, families, friends, and medication alone can’t
address those problems. Psycho social and
recovery support services are also needed. This means that we need to
support treatment models in which all medications
are available and in which all of these
psycho social services can be delivered. There are two
significant barriers to implementing this
comprehensive gold
standard of care. One is the workforce
and two is the financing and payment system. First to the workforce. HHS projects, sorry
the US Department of Health and Human
Services, projects a shortage of up to 250000
behavioral health practitioners by the year 2025. Sufficed to say we need
more of everything. Every discipline, every
degree, in every setting. But equally important
and a big problem is that we don’t really
know what we have in terms of workforce, and
therefore we don’t really know what we need. The HHS projections
do not account for geographical
distribution of providers. Which is a real
problem for rural areas where they are already
strapped for health providers and have high
rates of overdoses. The projections do
not include addiction medicine specialists,
peer counsel groups, community health workers,
or care managers. We don’t know the extent to
which mental health providers like social workers
and family therapists, provide addiction treatment. There is a misconception that
all mental health providers can or do provide
addiction services. Many do, but many don’t. One study showed that many
psychiatrists who medicate a patient for a mental
health condition do not necessarily medicate
that very same patient for their opioid use disorder. All of this is to
say that the stats and our understanding of the
workforce is very unclear. The other problem is that
even if we knew what we had, we don’t actually
know what we want. We don’t know what the
ideal workforce looks like. How many providers do we need? And how does that change
based on the treatment model, the setting, the region, and the availability
of medications? Not all addictions have
medications that can treat them. I can’t underscore enough
how important this is. We have a lot of money going
into communities right now to expand treatment but
if you don’t know who to train and how to train
and educate them, you really can’t expand your capacity. Payment policies are
the biggest threat to the workforce and
to treatment capacity for opioid use disorder. There are three main issues. First, payers do not
cover the continuum of providers and types
and levels of care. There are routine
limitations on residential and intensive outpatient
treatment even
where ACM criteria suggests that they are necessary and provide the best hope
for long term recovery. Many payers do not
cover medications for opioid use
disorder or do not pay for all types of
opioid use medications. There are medicare, commercial,
and state medicaid policies that still will not
pay for methadone and opioid treatment programs. Counseling sessions
are too limited. But counseling helps
people get onto medication, adhere to their
medication, assess risks and benefits of the
medication, help them get into mutual support groups,
all of which are associated with better longterm outcomes. Peer counselors and
community health workers are typically not even
eligible for reimbursement. Even though there is evidence
that they too contribute to longterm recovery. The second issue is that
when services are covered they are not covered for a
long enough period of time. Payers put time limits
on OUD medications that force patients
to taper off when that is not clinically desirable and could be
downright dangerous. Reimbursement
continues to be modeled on an outdated notion of
short term episodic treatment when in fact substance
use disorders are longterm chronic conditions. It can often take
five years for someone to settle into a relatively
stable period of recovery. Third issue is that providers
are not paid well enough. Historically behavioral
health providers have received far lower reimbursement rates
than other specialty providers with similar education,
training, and experience. Recent studies show
that these discrepancies continue to exist. This is true for psychiatrists
and social workers and other workers
in the workforce. Rates are so low that
addiction providers don’t wanna collaborate
with payers. They don’t take
medicaid, or medicare, and they don’t enroll
in insurance networks. A vicious cycle ensues
in which payers complain that they can’t find
qualified providers and qualified providers
drop out of the system because they are not
compensated fairly. Low rates have made it difficult to recruit a high
functioning workforce but without a high
functioning workforce that is accessible through
insurance, we’re not going to be able to expand
treatment capacity. On a happier note there are
some new payment methodologies that are emerging that
are trying to address some of these issues
and I think that we will hear about that
at our next session. Many of the issues that
I’ve talked about today and in fact that others
have talked about are in a paper that NABH
issued, its on their website. and the
paper is Pathways to Care. Thank you. (applause) – Thank you very much for
those wonderful presentations. Okay we’re getting
some questions. So lets go back to the poll. Can we bring that up? Alright so Sarah your
point there at the end. So the biggest issue that
folks agreed needed work was the examining coverage
and payment strategies for the kinds of services
that our patients need. So lets start there. We heard a lot about
recovery support. Something that I think maybe
doesn’t get talked about enough and is really important
for so many individuals with opioid use disorders and
other substance use disorders. And I was gonna just
turn to the group and ask, what ideas do you have? What models do you
have for how do we make these services available? How do we, you know,
parse them out so that we can make sure that these
individuals who provide these services are
adequately reimbursed? Because it seems like
much of what’s needed is kind of broad and diffuse
and not as nicely defined as the standard kind of
diagnosis and treatment visits for medical conditions. Anybody wanna? – Well I’ll start and
say, I mean we fund an awful lot of services
out there that are, I mean I’m from New
York and we fund a lot of services in New York. More so than many
states, I will admit. But we fund a lot of services
that are not evidence based. And you know I think
insurance companies balk, I’m not defending them,
but I think they can balk at what are we
actually paying for? So I think guidance on this
is what people actually need. I mean we know the
medications are there. We know that some
behavioral health services are more effective than others. We know that most people
need meds not beds. They need, they really need
good outpatient services instead we’re spending
a lot of money on inpatient services for people that do have adequate housing. So I would say that
there is a problem and that there’s too much paid for that’s really
not evidence based and switching over will be hard but I think that’s the
place we need to go. – And are you saying that
we need better research on these interventions,
or you think we have the research we just need
better payment policies? – I think we mostly
have the research. – We have the
beginnings of research but its been sort
of a resource issue. A lot of recovery services
came out of the grass roots on the community level. They’ve been evolutionary,
mostly in the past 20 years. We know that if somebody can go to the best treatment
in the world and if they leave
treatment and go back to a community where there
are no recovery supports their chances are not great. So we’re talking about
recovery housing. We’re talking about peer
support workers doing coaching. We’re talking about
non-clinical support groups. We’re talking about
collegiate recovery programs and recovery high schools. We’re talking about
recover employment programs to help people connect
back into their life into the community. So yeah we don’t have
evidence based practice yet. We have practiced based evidence because we know what’s
working on the ground we just have not had the gauge and the resources to
develop, promising to best evidence
based practices. But I think that is something
that is holding back the sort of full embracement
of recovery support services. Even though we know that they
do work over the long haul. – So a couple things
just to talk about why this is so critically
important to make sure that our patients
are successful. And we do have actually
an amazing amount of research about this,
but we usually just apply it to a different
population group. We know that pro-social
engagement and attachment are two important
protective factors for adolescents from
a variety of things, including developing a
substance use disorder. This is also why
recovery services or other programs whether
its a recovery high school or collegiate recovery
program, why that’s so incredibly important. Many times when you are
coming into recovery you have to make an
entirely new peer group. And that is not hard to do. Imagine today if
you left this room and you couldn’t
be friends with any of your current
peer group, you had to build it from scratch. Imagine on top of that,
if part of your issues that you had to work on
with your psychiatrist was some of your
family connections. Maybe abuse patterns
within your own family, some difficulties that
are there in the home. So this is a complicated road that you are on when
you are starting to complete treatments and build
your longterm recovery plan and the attachment of
pro-social engagement. Fancy words for saying
you need to belong to something that
is healthy to you and have other healthy
peer relationships. There are programs
that are low costs. There the clinical pieces with a peer recovery
support specialist. I agree we need to make sure
we’re following evidence and have clinicians
that are trained. That can be incredibly helpful, but for the long haul having
community organizations like recovery community
organizations, programs in your colleges,
your high schools, it doesn’t sort of
matter where this is but we need to make
sure that we have the longterm care to help
form positive attachments for 23 million folks
that are trying to navigate this disease
and the recovery phase. – I’ll just speak quickly
to the peer recovery and sort of ways to build
out that as a workforce. Part of the issue is
that different states credential people
differently, especially in the peer space. But more and more states
are now recognizing peers as eligible for reimbursement
under the supervision of licensed professionals. And I will just plug a
favorite program of mine, the Department of Labor
Apprenticeship Program is known for helping to
sponsor skill development in a range of job
classifications. And they have recently started to try and build out using
the apprenticeship program to train medical assistants,
certified nurses, and others in mental health
and substance use training. And its a great
program and it can lead to national
certification for peers and there are ways in which
they can help fund it, partnering with the employer. And I always think
about those programs when I think about developing
peer recovery coaches in hospitals because
hospitals work very closely with their unions and the
unions are very familiar with working with
Department of Labor in training people to raise
their level of skills. – Some of us work in the south
and we don’t have unions. That’s just a little
poke at North Carolina. So I’d like to have a few
minutes for questions. Here’s one that came up and I’m gonna encourage
folks if you have a question to line up at
either side on microphone but I’m gonna put
this one to Sharon but anybody can help
her out on this. Why is naltrexone
not used as widely as Suboxone, or buprenorphine,
given recent studies showing comparable effectiveness without physical dependence? – Well I think there’s a
couple things going on. The studies that have shown
comparable-ness showed that not on intend to treat but on the people
that actually– – [Larry] What
does that mean now? – Able to start it. So because you’re
required to have seven to 10 days of
abstinence from opioids before beginning Naltrexone
it can be really hard to get from here to there. And so in this clinical trial
where people were supposed to get this one
versus that one, many of the people couldn’t
even begin the naltrexone. So those that did
begin it that was fine for the period of time they
looked at them it did well but we still don’t have the
body of evidence showing that naltrexone reduces
mortality, reduces HIV, reduces hepatitis C. Maybe we will get there, but
for the moment we’re in crisis and so using the evidence
based medicines makes the most sense. That being said, there are
places such as Vermont, such as some of the
prisons that offer it, well not many of the prisons, but Vermont and
some other places that offer, Rhode Island
actually offer all three and they get really low uptake. Some of that might be
because the patients aren’t properly educated
about naltrexone but you know there’s myths
about all three medicines. But the interest just
hasn’t really been there. So even in places where
they’re all offered its just not getting the uptake. – Okay, lets take a question. – [Saira] Yeah hi, a comment
and a question for you on the– – If you could identify
yourself as well. – Saira Sultan of
Connect 4 Strategies. I actually did some work
in Alzheimer’s as well and a couple of you have made
references to Alzheimer’s. You know we pay for, there
may be not enough evidence at this point on some of
the other interventions. The social interventions,
which is very much a deal in Alzheimer’s as well, but we do cover the medications. And so to the point
about you know, is there enough evidence
on the medications there’s broadly sort of
wide spread agreement that there is strong
evidence for the medications. buprenorphine as well as
the others you’ve mentioned and yet we find states,
for example over and over limiting access
to the medications and cutting them off in not
evidence based ways, right? We stop them at 30
days, at 60 days, require more paperwork to
be able to stay on them. So that, I do think
there’s a policy focus on that piece that’s important because the evidence is there
to support rigorous use. My question is no
one today has talked yet about pharmacists. I wonder if there is
any roles you envision that pharmacists could
play in this space? Thank you. – I wanna just clarify, just
to make sure I understand your first comment. When you say states
are limiting duration of therapy, I imagine you
mean state medicaid programs? Because in general states
don’t control drug prescribing. State medicaid programs,
right okay very good. Okay a role for pharmacists. That’s something I could address but I’d be happy to
hear from our panelists. Okay I guess I’ll say something. Alright so I know
NIDA is investigating this possibility and I’m
personally am participating as a clinician in
a research trial. Right now its just a
simple feasibility study where our setup we have
three different practices that have each
partnered two clinicians with two retail pharmacists. Not hospital based or
clinic based pharmacists but retail pharmacists. We train them in how to do
MAT and they’re doing MAT under our supervision so I
have two that I work with. My patients who enroll in
this will get six months of treatment there and
specifically they show up there. They get a urine
drug test there. They’re checking our state PDMP. They go through a
check list looking for withdrawal, cravings,
they look to see has the person had any use,
any worrisome prescriptions and then they
communicate back with me and then we provide the
prescription or the medication. Its filled immediately
for the patient. The drop out rate so far
from what we’re seeing, we’ve had about 55
patients or so between the three practices
who’ve been enrolled. Only one has dropped out. Its amazingly low and
that individual had a parole violation,
he was one of mine. I don’t know why he
violated his parole but he cut off his ankle
bracelet, they caught him and then he could no longer
participate in the study because he was incarcerated. But he was doing
okay in the study. Not great, but its been
really quite remarkable to see how well it’s done. It was terrifying, I
think for the pharmacist to get started in this business but they were people who
volunteered and stepped up. And I think this
a potential model. I understand that
NIDA is gonna fund a full on randomized
control trial looking at a traditional model versus
a retail pharmacy based model. So stay tuned for that. – Could I just add a little? That’s really exciting stuff. On a lower level all over
this country pharmacists can provide naloxone to
people without them coming in with a prescription. Some places they
can sell needles. So in New York state
we’re trying very hard to get pharmacists educated,
not as exciting as that, because they may be the
source of information about these medications. They are partners in care. – And they often
have a standing order that they can operate under
when they identify somebody who’s for example may
be not getting insulin but buying syringes. Or somebody who is getting
a danger combination of an opioid with
a benzodiazepine. They can suggest you know
hey, you could really use some naloxone, I can
provide it to you under a state standing order and
train you or your family in how to use it. – Important partners. – Absolutely agree, yeah. And certainly clinical
pharmacists, you know can play a tremendous role. Okay we have very
little time left and I wanna allow
for your question and then we’re gonna wrap it up. – [Questioner] Just
a quick question. So sometimes we talk
about kind of recovery and treatment as being
two separate things and I wonder if you could
just comment on kind of how recovery and
treatment actually integrate across kind of the
continuum of services? – So I think the distinction
that’s often made is that treatment is
in a clinical arena and recovery is not. But I think, you know, like
when does recovery begin? So ideally it
begins in treatment. The difference between
a recovery plan and a treatment plan is
really sort of who generates it and who owns it. So if its, the recovery plan
is really more person generated with the assistance of
a peer or a professional but the person owns that
plan and sort of takes that plan with them as
opposed to a treatment plan that is sort of in
a treatment context. So I think its a
really good question. Where does one begin
and the other end? I think they definitely overlap. But we also have a lot
of people who don’t go to treatment and go right
into a recovery arena. So its complicated but
we’re thinking about it. We’re drawing a diagram for it. – So one of my favorite programs that we have a spotlight
series for our families where we spotlight
innovative things that are happening
all over the country in lots of different categories. And a program called
Aware Recovery Care, that Blue Cross Blue
Shield in New Hampshire and Connecticut
actually helped design with a provider on the ground. So its the home
visiting nurse model. Which we actually are
seeing an uptick in using that within child welfare cases. CPS cases that are
related to a parent’s substance use disorder. So you have that home
visiting nurse who is the like medical
home but in the house. But its not, I think
we make a mistakes when we disaggregate
treatment and recovery plans. When my grandma broke
her hip last year there wasn’t like the
treatment and the surgeon who replaced the hip
and a whole separate, oh you probably
should do these things or not do these things to make
sure that you can walk again. This an integrated plan to
make sure that the patient the patient outcomes
are positive, right. It is no different from
our patients that have a substance use disorder. So where recovery
care, its not just the connections to
the MAT provider. They might need to go to an OTP, they might be in an OBOT,
whatever that might be. It might be not a very
severe substance use disorder so maybe a medication’s
not necessary but they need to have counseling and some psycho-social
components that are there. But is that practitioner,
it is that nurse that builds the entire plan that is at least 12
months long if not longer. We know that our current
average dosage, 28 days is sort of this
mythical, magical number that you walk out of
an inpatient center and you’re magically fixed. But having sort of
the long term plans that combine
treatment and recovery for the holistic look at
what that patient needs to be healthy and well. That’s what I think our goal
needs to be moving forward. – Could I add one thing? – Okay this is the last word and then we’re gonna wrap it up. – Okay, I’ll let you
have the last word. – No no, you can have it. – I just wanna point
out that I have patients and colleagues and folks
at needle exchanges that actually don’t
like the word recovery because it just doesn’t include
what their experience is and so I think its a
great word for some people but I think that’s just
something to be aware of that it doesn’t
describe everybody that has stopped using
drugs and there are those that continue to
use drugs that use it on themselves,
so its a fluid word. – I wanted to thank my
four outstanding panelists for some really enlightening
thoughts and conversation and thank you for your attention and your great
questions as well. (applause) Greg are you gonna come up
and we’ll get some instruction about timing and
lunch and the like. Is he? – [Questioner] If you need
to like write you a question before the, ’cause I have one
pertaining to this right here. – Okay can you come up after? – [Questioner] Sure. – We’re between this
group and lunch, so come up and talk to us. Yeah, okay wanna just
make a few comments? – Yeah okay, thanks it was a
great panel, great session. I just wanna, we are gonna
go to lunch right now. As I said before,
lunch is on you own. There are a lot of restaurants
and areas right outside of the building
and I think we have a list at the table out there
of some of the restaurants. We’ll be reconvening back here
at approximately 1:35 sharp. I look forward to a
great conversation with the afternoon sessions. And if you want you’re
welcome to bring back food into this room as well. So have a great lunch
we’ll see you soon. – And welcome to the
moderated discussion about various populations
that are served in the opioid, need
service in opioid epidemic. I’m currently, my name’s
again Regina LaBelle. I’m currently a visiting fellow
at the Duke-Margolis Center for Health Policy
and also do work through LaBelle Strategies. So we spent the morning talking
about innovative approaches to opioid use disorder
treatment and access. And some of the
barriers that providers and patients may face. And so in this session
we’re really joined by some great people
who do excellent work among special populations
and many of whom are kind of
typically underserved or overlooked in
the opioid epidemic. So we have providers who are
working on delivering care to adolescents, pregnant
women, American Indian and Alaskan natives and then
incarcerated populations. So our panelists will
provide some brief remarks as we did earlier
today and we’ll check in on our audience polling. And then have at the
end of the discussion, have some moderated Q and A. And we’ll try to
keep everybody on, keep us back on schedule. So the polling question
that we wanted everyone to, we’d like everyone
to weigh in on is, it should come up now. Its basically recognizing
that there’s no one size fits all approach to opioid
use disorder care delivery. What’s the highest
priority issue that must be addressed first? So if you log in
this should come up and it has a
variety of responses to the question
that you can see. So everybody take
a look at that. And then the poll will
close and we’ll talk about the results following
our presentation. So I want to save a
lot of time in giving the broad, a lot of
detail about each of our esteemed panelists. So first we’re gonna
start with Marc Fishman who is the medical director
at Maryland Treatment Centers who focuses on issues relating
to juvenile populations. Kaylin Klie who’s an
assistant professor in the Department
of Family Medicine at University of Colorado. And she’ll talk about
pregnant and parenting women. Kailee Fretland a
clinical pharmacist with Indian Health Services. And then lastly
Jennifer Clarke who’s the medical director
for the Rhode Island Department of Corrections. So I’ll turn this over
to each panelist then for some remarks, thanks. – Well good afternoon. My name is Marc Fishman and
I’m an addiction psychiatrist. I am medical director at a
Maryland regional community behavioral health provider. So there I do both clinical
work and program administration. And then on the faculty at
Hopkins where I do research in SUD, mostly OUD. And I’ll focus in the
special population of youth or youts as they
say in Brooklyn. In both adolescents
and young adults. I’m not sure exactly
where adolescence actually ends these days. Does it go to 25, does it
go to 35, does it go to 75? But anyway, the idea
that its not so much a chronological cutoff right, but its a developmental span
that encompasses those issues that you all know too well. And why do we have to
care, well for a couple of reasons, one because in
this current opioid crisis young people, particularly
for this statistic, young adults 18 to 25 are
disproportionately effected by the crisis and are
the area in the life span that have the highest
per capital involvement both in illicit use, non-medical
use of prescription opioids and of heroin so they
really are at the forefront of this epidemic. And then the second reason and I think we heard
Jessica Nickel talk a little bit about it,
is that we think of SUD or we ought to be thinking of
SUD as developmental disorder of pediatric onset and where
do most people start using, its in their youth, in
their second decade of life. Mid teenage to young adult
years and SUD prevalence across all substances peaks
somewhere around age 20 at the beginning the third,
end of second decade, beginning of third
decade, so in the sense of our belief that
intervening early before the disorder progresses
to its most stage four or most severe forms,
the earlier you intervene in a chronic, progressive,
remitting, relapsing illness the better we can do. So that’s why we have to care. What are some of the barriers? Well young people are not
just short adults, right? They have their own
developmental needs. They are in some ways
similar to older adults but in some ways dissimilar. The issues of maturation
or immaturation as the case may be, the
sense of young peoples being invincible and
having waxing, waning, maybe mostly waning
motivation about care. Being disproportionately
I think burdened by how un-engaging
and uninviting and
how un-youth welcoming and youth friendly
care typically is. A sense of their
developmentally normative, but still problematic
pushback against what they see as the subjective
restrictiveness or intrusiveness of their parents or
other adult care givers involvement in their care. Their sense that I’m 18 and
one day I’m all growed up and this is none
of mom’s business, and I’ve got this and leave
me alone and the like. When they certainly,
as we know, do depend on developmentally on
the support of adults. And also a barrier
being that we don’t do as good a job, anywhere as
near a good a job I believe as for involving
families as we ought to. We talk about addiction
in treatment circles as a family disease but I
think mostly its lip service. And its hard to do. And there isn’t sufficient
training and competence. And its difficult to
have the dual agenda of dual stakeholders,
families and young people and one of the areas where
that particularly comes out is what I believe to be
an over rigid concern for confidentiality. Not to say that
confidentiality isn’t a core value of what we
do in addiction treatment. And investing in the
emerging autonomy of young people to carry
out their own journey into recovery,
also a core value, but I don’t think it
has to be incompatible to be able to empower
families to be involved and think through these
complex communication issues. And just to make a maybe over
simplified joke about it, what is the thing I hear
so much from families is little Johnny or little
Susie is living at home. Mom is paying for the treatment. Mom has dropped
them off at group and sitting in the parking lot and then calls the counselor
to say how’s little Johnny or Susie doing and they
get the stock answer, we can neither confirm nor deny that a person by that
name is receiving care at this institution. And I’m being silly
but the notion that we’re not only
not youth welcoming but we’re perhaps not
family welcoming as well and I think we can
do a better job. So just for the next minute or so talk about some
programming that we’re working at our center in
Baltimore to try to address some
of these barriers. Whether we’re successful or
not, you know stay tuned. But the notion that if we focus
on longer term enduring care as was talked about
before, and we think about this as a marathon not a sprint. That we don’t have surgically
curative approaches so that 28 day rehab does,
although maybe very useful and bed based care are a
necessary part of the continuum. By no means a sufficient
part of continuum. That is enduring
longitudinal treatment which we don’t really
have a model for, I think. When you think about young
adult and adolescent care in which a delivery system
quarterbacked by somebody. Maybe its a doctor,
maybe its a counselor, I’m agnostic but
quarterbacked over time in the sense of being able
to follow people waxing and waning, dropping
in dropping out which is the rule not
the exception over time just as we might manage
any chronic illness. With a reluctant and difficult to engage sick person
who isn’t always the best master
of their own ship in terms of seeking, utilizing, and making good judgements
about treatment. So three areas, we call this
youth opioid recovery services or YOURS just ’cause you’ve
gotta have a brand name, right. And so the three principles
for us are family engagement, so thinking through the issues of how to get families
involved and encourage them. Using assertive outreach. That is rather than
passively waiting for people to reach bottom
and come to get care and access clinic based
care when they’re ready, reaching out to them and
doing social marketing and chasing them, and
then third which is kind of a new thing
for us is adapting and adopting stuff
stolen if you will, from assertive community
treatment in chronic and persistent mental illness. Say for the treatment of
schizophrenia where we’re doing home delivery of long
acting injectable medications using either naltrexone
or buprenorphine and going into people’s
homes and saying, ding dong Vivitrol calling or
dingdong Sublocade calling, or you know that kind of thing. Just as you might
do with long acting injectable anti-psychotics. And on the assertive outreach,
you know it means calling and texting, and
Facebooking, and spending a lot of effort trying
to engage patients and their families. And on the family engagement
side it means paring it down to very
concrete elements and we focused for the
moment kind of the thin edge of the wedge, on
medication adherence. Not that medications
are the only tool or even the most important tool, but we certainly see relapse
prevention medications as critical in an
integrated, holistic kind of implementation. And one of the things
that’s clear to me in my experience over
time is that people who aren’t in treatment
or treatment providers get kind of bleary
eyed about what is it we do in treatment. You know, everybody sits
around and holds hands and talks about their feeling and who knows what the
secret handshake is. I’m being silly but
every mom or dad, but mostly moms have had the experience of
having to wrestle with a four year old with
a fever and an ear ache who didn’t wanna take
the pink medicine. And although it may be
different somebody who’s this height versus
somebody who’s 250 pounds and this height, its a
familiar kind of territory of negotiating medical
service utilization with a person who’s sick and
a person who is truculent and irritable and not themselves and doesn’t know
how to access care and needs guidance
of a mom or a dad. And so that’s kind
of a before we get to structural family therapy and other things that
are very difficult, although important, just the
basics of medication adherence as a starting point. Anyway, we’ve published
a small case series. We had some preliminary
positive results and we’re now in the field with a small randomized
control trial, and we’ll see. And if as I suspect,
we’ll see some benefit for at least a high
severity group of people. I mean it sounds
like a very expensive and very intensive
kind of intervention and just like ACT
is not for everybody with a mental illness,
parsing out who needs the step up to that level
of intensity, I don’t know but if we can demonstrate
that it has some merit then the next question is
well, how do you scale it? How do you pay for it with
medicaid pennies and the like? So anyway that’s a little
of where I’ve been thinking but just to come back
to first principles this is a really
critical target audience, target patient population. Gotta include families, I think
if you’re gonna reach them. Gotta think
developmentally in terms of specialty services
that target young people in a way that can
engage them different from the way that you target
adults and enough, go ahead. – Thank you, nice job. I’m gonna use my slides. And this guy goes
this way before– Oh, somebody beat
me to the punch. Well thank you so
much for having me and I have to thank my
colleague, my nurse practitioner and partner in crime at home, and nurse Anne Ahso for
interview in clinical practice. You that actually your
clinic nurse runs the ship and so she is manning
the ship today and I am indebted to
them for taking care of our patients in my absence. So I get to talk with you
a little bit about pregnant and mothering women. And I just wanted
to start with a few, although I sometimes
feel like we get a bit, a little fatigued
with watching all the climbing graphs
related to opioid use and overdose death, I think
that there’s some really important data that’s come
out of our work in Colorado and of several other
states regarding the specifics of substance
use in pregnancy. So a few select highlights
and data points. We talked a little
bit about in one of the earlier
presentations, really about the high rates of trauma,
co-occurring trauma in people with
substance use disorder. And we see even higher rates
of co-occurring childhood sexual abuse, childhood
physical and emotional abuse, neglect, and intimate
partner violence. Either previous or ongoing
for women, pregnant women with substance use disorder. We also see women who have
with a substance use disorder and specifically
opioid use disorder, sometimes unpredictable
fertility. So its very normal for a woman
with an opioid use disorder and or alcohol use disorder
to stop menstruating. And so she believes that
she cannot become pregnant and so has very low uptake
of reproductive healthcare. Many woman are dismayed
when their menses return within the first couple
months of being sober. Kind of a return to health
that’s not always welcomed but really many women
because they have not had a need in their mind for
reproductive healthcare have not had utilization
of contraception during their time of active use. The recommendations
that you see here have been widely accepted
by almost every group that is interested in
providing prenatal care and perinatal care to women,
is universal screening. And so universal
screening should mean a conversation not a
urine or biological sampling toxicology test. There still persists
kind of this idea in some groups and
in some practices that we should start
just including a
urine toxicology test with women’s first
prenatal care visit. And that’s in existence and
it is fraught with problems. Urine is not perfect. It has many false positives. And it serves for many
women, especially women that I’m taking care
of now will describe, you know that really scared
me and so I never went back. I didn’t go back
for prenatal care because I saw those
results come up and I didn’t want my provider
to talk with me about them. So when we have
toxicology testing that precedes a
screening conversation or a screening tool
validated electronic or paper and pencil tool,
I feel like sometimes we’ve already shot
ourselves in the foot with keeping that
woman engaged in care. The recommendation,
as for almost all of the people groups that
we’ve been talking about today is use of pharmacotherapy. Not recommendations
for detoxification. There still persists
some programs that offer detoxification
for pregnant, for women in pregnancy and the difficulty has been
obtaining follow up data to see really if
we use the endpoint of delivery as our target,
as we’ll see in a moment, hopefully a quick moment
if I can keep myself, speed myself up. You’re
gonna have to tell me when I’m bumping
up against time. That really if we don’t extend
and in fact increase support into that postpartum
period we sometimes are at higher risk for
losing a person either to treatment, having that
person fall out of treatment but also potentially at higher
risk for overdose death. Not only after
detoxification from opioids but also as detox is the only
intervention in pregnancy. And then all care providers. So I love the
multidisciplinary vibe that we’ve had going today. Really that everyone
has a stake. And our program in
Colorado we’ve really kind of had no wrong door
as our tagline, right. That however this
woman shows up, whether its in an incarcerated setting,
if its with social services, if its in the
emergency department, however she appears on
the radar that really there’s no wrong way
that she can present to be able to be funneled
into treatment services as she chooses. Okay some of the
barriers, you know stigma for pregnant women I
would kind of posit, is even greater than
stigma in general for people who use substances. I’ve even heard from
other treatment providers that you know, talking
about their own feelings of taking care of a
pregnant woman, you know how can she do
this to that baby? Doesn’t she care about the baby? And I wish that pregnancy
was the cure, right? So pregnancy cures one thing and that’s infertility, right. So pregnancy for the
rest of us doesn’t cure what ails us, right. Its a motivator, its often
a very strong motivator to make behavioral
changes or health changes that we’ve been meaning to
for a long period of time but its not the cure and we
shouldn’t confuse pregnancy particularly pregnancy
as a temporary state, with treatment, right. It can never substitute
for treatment just because its a strong motivator. Okay many women, I’m gonna
skip down a little bit, but many women
associate any detection of use with immediate
removal of custody. And so they’re, for
many women actually that I take care of
they were removed from parental custody
and they maybe are first or second
or third generation of people who’ve had some kind of social service
involvement in their family. And so for them the reality
is if the social worker knocks on your door, you
may be leaving that day with whatever you toss in a bag. And that’s a very
frightening reality if you are now the
parent and wanting to maintain custody not only of maybe your current pregnancy but other children at home. And so this is from
Colorado, some other states have also been
recently publishing their mortality data and
so I have the honor really of sitting on our
Colorado Maternal Mortality Review Committee. And so we review every
death in pregnancy and one year postpartum
that occurs in Colorado. To really try to make
sense of what happened and then come back with
system and provider, and patient care recommendations so that death isn’t in vain. And what we’ve found is
similar to other states. Our number one cause
of maternal mortality was and continues to be
accidental drug overdose. And I really think
of this as like kind of the warning sign, right. So when we’re seeing
women die in pregnancy or one year postpartum
who are probably at the peak of their
motivation for change and maybe at the
peak of their ability to access services, there really is something going on
that we’re missing, right. So if we have all of our
kind of data about increasing access to care for pregnant
women but this continues to be a leader of maternal
mortality it makes us kind of need to re-look
at how are we doing with really bringing
women into treatment and life saving
treatment at that. So this timing is
everything really is true for postpartum women. So this concept of the
fourth trimester, so ACOG, has come out with new
recommendations really that we should not let
someone have a baby and then see her six
weeks later in clinic. We should see her
much more quickly, especially when we
think about the risks within those first couple
weeks for mood changes, difficulty with breast
feeding, pain, right. And so that’s a start. But we can see for our
women who died from overdose that really that
fourth trimester needs to extend to the
full year postpartum. And so when you look at
this graph that green and blue portion are
deaths that occurred within a month to one year postpartum. And in fact the further
you get out from delivery the higher the risk
seems to be for relapse. So this makes us
question how are we doing with having pregnant women
as a priority population? Most states have
said we really want to have women be, you know
no barriers to treatment. They can be first in line. In fact it sometimes truly
means cutting the line for admission to a
methadone treatment program or buprenorphine care. But so far the data has
not been as reassuring as we had hoped. And we’re indebted to
Dr. Turplin who published some really important
data showing that although we
have many mandates that women should be
able to access treatment their utilization of
treatment is no more likely than if they were not pregnant. And so what we need is further
integration of services. Really making it
impossible for someone to show up pregnant with
an opioid use disorder and not access, or at least
know where to access services. So comprehensive and
integrated services continue to be where we’re all headed. And this needs to include
reproductive health. So when women are using
substances in pregnancy I would say almost 0%
initiated substance use during that pregnancy, right. What’s happening is women
are using substances, becoming pregnant,
often unintentionally, and then continuing on and
showing up as these numbers. A quick note, these are some
of the integrated model cares that are out there but
really for women who are pregnant and as we’ve
spoken about, you know pregnancy thank goodness is not
a permanent state. So women move in and out
of these circles, right. We have some really
beautiful integrated service treatment
models that across the nation that I think
we could learn from. But taking the best parts
of all of those programs and trying to come up with any
even more extensive network of care providers,
much like we have for things like
reproductive psychiatry, so mood disorders in
pregnancy and postpartum. I think really needs
to be our next step. We also need more research
about naltrexone in pregnancy. This is one of the
recommendations that has come out
recently that we really just need to know more so that
we can offer pregnant women potentially an
expanded armamentarium of medication
assisted treatment. And then continued policy
reform that continues to remove language and
remove punitive measures for pregnant women
who use substances so that they’ll have
decreased barriers and decreased difficulty
accessing care as they’re ready. Thank you very much. (applause) – Alright, good afternoon
and thank you guys for having us here
as a panel discussion and this has been a
very valuable afternoon with the multidisciplinary
discussions, discussing the
opportunities and barriers. My name is Kailee Fretland,
I’m a clinical pharmacist for the Indian Health
Service and I’m here today on behalf of Indian Health
Service representing the Indian Health Services
National Committee on Heroin, Opioids
and Pain Efforts. I have no disclosures. The mission of the Indian
Health Service is to raise the physical, mental,
social, and spiritual health of American Indians and Alaska
Natives to the highest level. So who is Indian Health Service? I wanna give you just
a brief overview. So Indian Health
Service serves members of 573 federally
recognized tribes within the United States. This is approximately 2.3
million American Indians and Alaska Natives. Of these IHS is divided
up into 12 regional or geographic areas
providing these services. And these are provided at
either federal facilities or tribally run
healthcare facilities and make up a mixture of
healthcare clinics, hospitals, there’s 134 Alaska village
clinics, health stations and urban programs. So we’re a diverse program. The American Indian and
Alaska Native people have long experienced,
I apologize this is really difficult
to see this slide. But the American Indian
and Alaska Native people have long experienced
lower health status when compared to
other Americans. Lower life expectancy and
the disproportionate disease burden exists because
of broad quality of life issues rooted
in economic adversity and poor social conditions. The Indian Healthcare
System approach to opioid use disorder
treatment must be grounded in principles
of trauma responsive care and social
determinants of health. Similar to what we’ve
already heard today. This slide captures a depiction of the impact of historical
and vicarious traumas, poverty, as well as common
stereotypes inflicted on the American Indian
and Alaska Natives and the potential impact
on their health outcomes. The IHS awareness of these
factors is interwoven into our opiate strategies
to foster autonomy. The higher burden of health
disparities increases the risk among American
Indian and Alaska Natives for serious persistent
mental illnesses and increases the risk of
substance use disorders. We have well published
data from the CDC. This particular data
comes from, was reported for 2015 but it
indicates in 2015 that American Indians
and Alaska Natives had the highest drug
overdose death rates. For metropolitan areas
this was 22.1 per 100000. In non-metropolitan areas
it was 19.8 per 100000. Additionally they also had
the largest percent increase in the number of deaths
from 1995 to 2015 amongst all racial and ethnic
groups in the United States. In non-metropolitan areas
this was a 519% increase. So today’s discussion
focuses really on HHS strategy number one. In the collaborative
approaches Indian Healthcare is using to improve access
to prevention, treatment, and recovery services. So the Indian Health
Service developed the National Committee
on Heroin, Opioids,
and Pain Efforts committee in 2017
and this evolved from the prescription
drug abuse work group which was started in 2012. Its a multidisciplinary
team made up a physicians, pharmacists, behavior
health providers, nurses, epidemiologists, and injury
prevention specialists to promote appropriate and
effective pain management, reduce overdose
deaths from heroin and prescription opioid misuse, and improve access to culturally
appropriate treatment. So as part of the
HOPE committee’s goal to improve access to culturally
appropriate treatment access to medication
is a vital component. The first is to increase access
to FDA approved medications in support of recovery. IHS has added buprenorphine,
naloxone, and naltrexone. Both the oral and extended
release formulations to the national core formulary. This now requires federal
Indian Health Service pharmacies to have
these available and dispense these
medications pursuant to a valid prescription from
an authorized prescriber. The second is to
expand and share best and promising practices
surrounding MAT. Collecting and publishing these
promising practice examples from the field fosters
and promotes collaboration and support for service
units and providers. Thirdly, as to
encourage development
of local action plans to coordinate
access to services. These local action
plans should evaluate the current MAT capacity and
identify local strategies to facilitate and
coordinate access to MAT. This will be required through
a special general memo. Currently IHS lacks
the infrastructure to create inpatient and
residential treatments and we partner with
tribes to increase access to these services. Additional resources are
necessary to help facilitate especially in our rural areas. Next we need to
encourage the development of integrated programs that
include behavior health, traditional healing,
and cultural practices. An integrated care model for
opioid use disorder provides a holistic approach with
the full continuum of care. IHS is evaluating the impact
of integrated behavior health and collaborative
care models currently. And lastly, to provide
guidance for American Indian and Alaska Native
pregnant women and women of childbearing age with
opioid use disorder. IHS has collaborated with
the American College of OBGYN to create a guideline
surrounding care, specifically for
American Indians and Alaska Native pregnant women and women of childbearing
age with opioid use disorder as well as partner with
the American Academy of Pediatrics to create
a best practice guideline surrounding the management of neonatal opioid
withdrawal syndrome. So as mentioned in the previous
slide, integrated programs should include traditional
healing and cultural practices for American Indian
and Alaska Natives. American Indian and Alaska
Natives combine traditional healing practices with
allopathic medicine to promote health and well
being through psycho-social and spiritual wellness models. These practices vary
by tribal community. Remember 573 federally
recognized tribes. And the access to these
services can vary as well. However these integrated
practices have
qualitative evidence that demonstrate improved
addiction outcomes. Some examples include
healing ceremonies that integrate prayer. Sweat lodges, songs, music,
and dance into wellness, talking circles to share
resilience and empowerment, story telling and
prevention activities that blend a
connectedness to the earth and environment and overall
healing and wellness. Next is workforce development which as we’ve
talked about today but it does play a key
role in improving access. So expanding staff
capacity within IHS to support MAT services
is currently being done through a required
essential training and pain addiction
online module. IHS provides a weekly tele
ECHO video conference allowing frontline clinicians
to consult with experts in pain management, addiction,
and behavior health. And additionally IHS
is partnered with
the American Society of Addiction medicine to
provide provider booklets on MAT and offer half
and half training on pain and addiction for our providers. Next we need to create a culture
of trauma responsive care and this is vital
to our workforce and the patients we serve. IHS is partnered with the
University of New Mexico to develop and implement a
training curriculum related to trauma informed care. Providers working
with American Indian and Alaska Native
populations should have a basic understanding of
the impacts of colonization, Indian relocation,
and boarding schools. And the impact that
they’ve had on patients. Our workforces needs
to still be trained on early identification
and screening with such tools as
DAST-10, NIDA, 4P’s for substance use
disorders along with brief intervention
and referral to treatment. We’re developing
software enhancements to the electronic record
to capture substance use screening results and track
referrals to treatment for pregnant women and
those of childbearing age to really continue
that follow up so that we’re tracking them
throughout their entire care. And lastly, increasing
both patient and community
education and awareness about opioid use disorder and
medication assisted treatment. Is necessary to connect
to services, reduce stigma surrounding opioid use disorder. We partnered again
with ASAM to develop a culturally appropriate
patient booklet discussing opioid use disorder and
medication assisted treatment and are working on developing
brief educational videos to continue that decreasing
the stigma surrounding this. In conclusion there’s
still a lot of challenges to accessing treatment. For American Indian
and Alaska Natives one of our biggest
challenges is that we’re in very remote locations. Many of our healthcare
facilities are in
rural locations that are considered
hardship sites. As we talked about earlier with the internet eligible
controlled substance or the Ryan Haight Act,
we’re working additionally on drafting legislation
to address some of those barriers
contained within that to expand access
to tele MAT models for our rural, remote
American Indian and Alaska Native communities. And lastly is data extraction. We still have barriers
to extract real time data on our opioid metrics. This still continues to
remain a challenge for us. So despite the barriers and sometimes lack of
access, our American Indian and Alaska Native population has a long history of
resiliency and strength. And we know that when we
partner with our tribal partners we facilitate a model
of collaboration that extends that
access and expands that to our populations. So thank you for the
opportunity to share with you today some of the
things Indian Health Service is doing to increase access. (applause) – Alright, thank you
very much for having me. And for bringing
in the Rhode Island Department of Corrections. I think people often
forget about prisons and jails, mostly we
wanna forget about it. I think especially
in the United States. Oops, backwards sorry. ‘Cause we do such a great
job incarcerating people. I have no financial disclosures. I work for the state of
Rhode Island, state employee. So while the United
States, so I’m gonna take the conversation in a
slightly different direction, while we only have 5% of
the world’s population we have 25% of the world’s
incarcerated population. And its not even. We have incredible racial
and ethnic disparities in how we incarcerate people. So you can see from
this slide while one in nine men will
have a lifetime risk of incarceration, its
one in 17 for white men and one in three for black men. One in six for latino men. So these differences cannot
be explained just by behavior. There’s really what
we have in our system is institutionalized racism. We have laws that affect
African Americans who tend to use crack cocaine more
than regular powdered cocaine. We have laws that have
different sentencing rules for different drugs
which make no sense when you think about
how these drugs work. You know, there was
always the crack cocaine makes people crazy and makes
them want to rape and steal. So we really have to
get away from that. Fortunately we have
changed a lot of the laws. But another thing we
need to reflect upon is we really
criminalized addiction which is so much of
what the stigma is. And we’ve talked a
lot about stigma, so to really address
the stigma we have to address our laws. So I will sort of step
off my soap box now. Its really hard to get off. So we’ve seen huge
increases in the number of people who are incarcerated. Fortunately its sort of
plateauing and decreasing. Mostly because we found out
that its really expensive and really a terrible
way to treat addiction. And who is behind bars? You can see this first bar here is mostly drug related offenses. And why is it so
important, particularly with opiates to treat
people while in corrections? This is an article from,
oh I think it was 2005, looking at the death rate
from an overdose post release. And what we find is people
in the first two weeks of release are 129
times more likely to die of an overdose than
the general community. So really when we see
people in corrections its so important, especially
as they transition to the community, that
we make MAT available. Another more recent
study also looked at the time from release
to an overdose death and this just sort of
shows risk in prison years. Its highest right after
people get released. It continues to be higher
than the general population but decreases over time. A lot of people have told me,
so people are incarcerated they’re in for a
year, they’re cured. I know this audience
doesn’t have that belief but really we have data to show that people who come
in and start treatment while they’re inside do much
better in the community. This study looked at
methadone continuation versus forced
withdrawal, that’s what the vast majority of prisons and jails do across the country. So if we have people coming in
on an FDA approved medication we take them off because
they’re incarcerated, they’re not as likely
to go back on treatment in the community. And so the red versus
the blue bars there shows the difference in
followup as randomized. This is from Rhode
Island where we have sort of a slow withdrawal
protocol or we had at that time. So that has randomized. The second graph looks as
for people who actually came off versus people
who were still on. There you can see the
difference is even greater. So if people come
off less than 50% are gonna followup
after release. So these are people
who were in treatment. They might not have
been doing fantastic but they were in
treatment, engaged. We take them off, they’re
not going back to treatment. This shows a similar result
looking at buprenorphine. So I work at the Rhode Island
Department of Corrections. I’ve been there
for about 20 years. Became the medical program
director three years ago. So I went from
doing primary care to taking care of
the whole facility. We’re a little unusual
in Rhode Island, mostly ’cause we’re so small. We’re a unified system,
there are no county jails. Everybody comes to
the same campus. I can walk to each
one of the facilities. Which really helps in
providing continuity of care in that we’ll see
people throughout their whole incarcerations. In other states the jail
system and prison system are completely
separate so that one has to be careful
what you’re doing in the jail because
they might not continue it in a prison system. We have about 3000
people at any one time with over, excuse me,
12000 people going through the system every year. So historically we
took everybody off of MAT when they came in. We had a protocol, oh
except for pregnant women, which I always find
amazing that this is the one medication where
you’ll say, hey its effective. We have to keep pregnant women
on it, but we’re not gonna make it available
for anyone else. Generally with pregnancy
we’re saying, lets get the women off of any medication. You know, we won’t
let you take a Motrin but here we’re saying
this population is so, and this medication
is so beneficial that we’re gonna have to
give it to pregnant women but everybody else
we’re gonna take ya off. So we were taking people off
up until about two years ago when the governor put
together a task force to address the epidemic
and from the task force we decided that we need
to make MAT available in the prison,
its just one prong of the overall state
plan but its the part of the plan that I’m in charge
of and that I’m gonna share. So we basically, we
have three populations that we look at. The first step we took
was people who come in on MAT the first thing
we did was we stopped taking them off of MAT. So that was pretty
much a no brainer. Very easy to do. I shouldn’t say very easy to do. There was a little resistance. We worked together as a
team and we made it happen. Second population
is people coming in and withdrawing,
feeling sick. We offered them MAT. Final population that
had the most resistance from people was people who’d
been in for a long period of time, were vulnerable
when being released. We would offer MAT before people
got released in community. And here you can just see how
our numbers have increased since we changed our practice. The green is people
on methadone. The blue is buprenorphine
and the red is naltrexone which is a very small line. Not appropriate for most people. Most people don’t want it. Everybody asks me,
how do you decide what the right treatment is,
basically the right treatment is the treatment
somebody’s gonna stick with so its a totally like
in the community. We work with the
patient, provide the most appropriate medication. And so we’re discharging
over 100 people a month on treatment. A vast majority
would not have been on treatment in the past. So we’re getting
people, trying to use the unfortunate event
of incarceration as an opportunity to
engage in treatment. So what have we found so far? A majority of people
are on methadone and the majority of
people are continued from the community. While its the majority
we’re also getting in this less than a year period
we started over 600 people on treatment that
wouldn’t be on treatment had we not had this program. So what did we find? Findings, oh wait
that’s the followup. Followup was great for
people who we now continued on treatment over 93%
followup in the community. For people, and
this was early data when we’re just starting
them off on treatment. Lowest followup rate, 35%. So we know that’s the
population we have to work with more to try
and keep them engaged in treatment in the community. And you have to remember
they’re not coming to us saying, I want
to get on treatment. They’re brought to us,
they don’t wanna be there, we’re using that
as an opportunity to say, you’ve never tried
buprenorphine before. Maybe they’re only
there for two days. They try it and they’re
like, actually I feel alright for the first time. And that might be what
gets them into treatment in the community. So we looked at the
results of the study. Looking at overdose
deaths, we looked at the six months, we
looked at a six month period before we had the
expanded MAT program and six months during
the MAT program and what we found was a
65% decrease in mortality from an overdose for those
who’d had a prior incarceration versus a 3% decrease
for the rest. Clearly showing we need
to make MAT available for this population. And with that I have to stop. Thank you very much. (applause) – Thanks so much to
each of our panelists and you know you all
could go on individually for an hour and we
would all learn so much. So now I’m supposed to read what the polling question is perhaps? There it is. Could someone tell me
what the third thing says, because I can’t read it. I know someone else can. Improving, so what the, it was
improving care coordination. Or transitions to care
is the first answer. So do our panelists wanna
discuss, address that issue? Agree, disagree? Its basically whether or
not improving coordination of care really would
address the issues that your populations
are facing. – Yes, yes so really the
most critical component for my patients in my
clinic has not been which medication to use
or those type of things. Its been how do I
continue treatment for a person who’s
treatment episode began with the temporary
condition of pregnancy and continue her
treatment postpartum. And including all the
people who become involved in her life and her child’s life during pregnancy and beyond. And so that has really
been incredibly important for my clinic to work closely with our county social
service departments. So every county is a
little different, right. And when we talk about
correctional care, for us in Colorado every
county jail is different and different than
the prison system and so same with
social services. And so really making
key connections not just within the
medical community but the other people
who will be involved in our patients lives has
been incredibly important. – [Regina] Right, any other? – You know I think you’re right. I think it has broad
applicability across all of these special populations
and across all patients. We are so much oriented
towards acute crisis driven episodes of care,
whether med based or not. Its very easy, all to easy for
patients to run outta steam and providers and delivery
systems to run outta steam and our retention
across the board, as good as our tools
are, our retention is alarmingly crummy. That’s a technical term. – I don’t think any of
us are gonna disagree that care coordination
is a key point. Treating patients with
opioid use disorder is not a silo, we
all are a team. So the more points of
contact that patient has for that care
coordination are going to be continued
opportunities to check in, to follow up with that patient. Utilizing integrated care models to help facilitate
that in a team model to give that care coordination
is extremely important. – One of the things
that I think has made the Rhode Island program
successful is there is a community OTP provider
or set of seven clinics that actually has a licensed
site within the prison. So everybody who is
enrolled in the MAT program is already enrolled in their
clinic so they are still a CODAC patient both
inside and outside. So there’s no need
for a new appointment. There’s new need
for a new intake. They just go the next day,
show up with a picture ID at any one of the seven sites and they can continue
on treatment. – I’d add one other thing. I might have voted for the one
that says patient reluctance also, so just to put
in a plug for that. As good as our tools
are, if people don’t come or we don’t go to
them it doesn’t matter and I would say we’ve gotta look at our marketing or
our engagement, or
our welcoming-ness because if people aren’t
buying what we’re selling it doesn’t do them
a lot of good. And I think we have to
do some very serious self reflection about
this issue of uptake. Given that this is a
motivational illness at its core, in large part. – So we’ll take some questions
now from the audience. Sir, if you wanna say your name and what your question is. – [Captain] Yes, thank you. Captain Webb with
Malacar Pharmaceuticals. This question’s for Miss
Clarke, you answered the first part as far
as whether the OTP was actually within
the prison system. But in line with the
coordination of care concept, how much coordination
needs to take place within all the other institutions
that are involved within the prison systems? Judges, other, the
legal system itself. Or are there other
elements that you needed to coordinate with
to bring in that type of services within
the prison system? Or was that a decision
that prison system within Rhode Island was
able to make on their own? – The prison system was
able to make that decision on their own. We make it very clear that
MAT is a medical decision and not a legal decision. So the judges can’t say
somebody has to be on MAT. Its a decision between a
patient and their provider. There were many security
issues within the prison. Many challenges that
we had to address. You know, whether or
not somebody could be bullied into or
manipulated into cheeking their buprenorphine and
sharing it with somebody else. So we had to make sure
the patient is safe and that the whole,
everybody within the prison system is safe. So we had to do a lot
of medical security work but we didn’t need to get
approval of any judges. – Go ahead. – [Cathy] Hi, my name
is Cathy Longerbeam and I have a question, for
one thing I was not aware at all about the
pregnant women having these addiction problems. I hadn’t heard of
that really at all. Its a terrible surprise. And my question kind of
follows up with the pregnancy and also preventative measures. Like what preventive
measures could be approached, I know you’re
talking a lot about the mar, is that
what its called? A MAT, I’m sorry. About to treat all
this, and I understand the gentlemen there
said that its such an acute problem that
you’re so caught up, the provider’s so
caught up in trying to help people or treat
people the best they can, but what preventive
measures, like especially the pregnancy
could be allocated? What I’m bringing up
is because yesterday in the paper I read where
Senate, President Trump’s Senate had not just proposed
but apparently passed a big allocation of money
to fight opioid epidemic. I think that’s
correct what I read, and those funds, do you
think those funds could be utilized to kind of
address some of the problems and the issues you
all brought up today? Not just your panel
but the panel before? And to include paying providers
more, making it more known. Like social media, I don’t
know much about social media. Honestly, I don’t use it
myself, but to, I don’t. I don’t even know
what Twitter is. And I don’t really
care about it. But the pregnancy
women, no this is not a joking matter to me,
honestly its not folks. That the pregnant women,
you mentioned before that social media might
help reduce stigma. I can’t imagine when a
pregnant if she’s addicted and never was
before just happens or whatever happens and
she has to face that alone or with her husband
or however it works. What she’s going through and
you know, what she could lose. What she faces to
lose within the system that apparently is
constructed now. What–
– Thanks, so we’ll– So your question– – [Cathy] That’s the question,
what preventative measures? – Great, okay. – [Cathy] Are there
any that you can think of that could be placed
that brings this out to the forefront, but I had
never heard of a lot of this– – Great, thank you
for your question. – Oh absolutely, I’m like
salivating when you’re like, what should we do
with all this money? I’m like– I’m like here’s my list. So yes, are there preventive
measures I think yes. And specifically for
pregnant women I know it becomes very dramatic
to talk about substance use in pregnancy but I
can’t emphasize enough that pregnancy is often the
event that is highlighting a person who already has
a substance use disorder. And so any of the
preventative measures that we would think
about for anyone else, non-pregnant people would
be absolutely worthwhile with respect to women of
reproduction potential. I can’t emphasize
enough that my, I hope that my spirit is coming
through correctly. That I’m not advocating
for past atrocities that have occurred
such as coercing women into sterilization who have
a substance use disorder. Absolutely not. But helping women who may
become pregnant make decisions about their desired or
intendedness for pregnancy and putting those types of
reproductive health resources in a co-located or integrated
way that’s accessible. When we talk about trauma and truly healthcare
associated trauma. Asking my patients who
experienced severe sexual abuse to go get an IUD is
a really large ask. And so making sure that we
have not only a wide variety of reproductive
healthcare available but that we have reproductive
healthcare available in a way that’s accessible
and is not going to be re-traumatizing for
our patient could not be more important for me. – [Regina] Thanks, anything
else about prevention? – Just real quickly, prevention
in youth since most people who progress to an
opioid use disorder have initiated with other
non-opioid substances. Most typically in young
people, cannabis and alcohol. I think its important to
talk about intervention in cannabis and
alcohol use disorders as an OUD prevention strategy and we don’t spend
enough time doing that. – [Cathy] I’m sorry,
I’ve got a follow up. ‘Cause it seems like
the sustainability of the economy is not going
to keep these programs going so many lives are going
to be destroyed permanently ’cause the state of the
economy is not going to be able to
sustain this forever. So I’m just wondering
if the allocation needs to be smart, and
fair, and equitable. If that makes sense. – So Yngvild and then
we’ll move over to Sharon. – [Yngvild] I have a
question for Dr. Clarke, so you mentioned that in
Rhode Island and the DOC there are now all three options the
medications are being offered. Do you have any
protocols or do you, is there discussion
around protocols of switching from medications
from one to another? So for example from
methadone to buprenorphine to naltrexone or methadone
to buprenorphine? That came up earlier
and just kind of curious as to
what you all did. – So in corrections
there’s a lot of moralizing around
MAT where naltrexone, long acting naltrexone is
the morally superior option. We aren’t here to moralize,
although we are corrections. Although we are a
prison, I know its weird. So that is not our goal. Our goal is to have
people get on a treatment that they will stick
with, thank you. – [Yngvild] Thanks. – [Regina] Sharon. – [Sharon] A question
for Dr. Klie, Clay? – Klie, you’re right. – [Sharon] If you could
say a little bit more about the universal screening
for pregnancy. I mean right now the US task
force does not recommend universal screening of
anybody and I’m wondering if you would say
for all substances or if you could flesh that
out a little bit more? – Sure yeah, and that
screening recommendation, so universal screening
for, although many people probably should be
screening for pregnancy in your patients
that you’re treating for a substance use
disorder, what I meant to say was screening
for substance use
among pregnant women. And that’s come out of
ACOG in collaboration with ACM and the triple
AP and AAP as far a recommendation
to use pregnancy as an opportunity
to find out more than just about what your
blood type is and you know, are you up to date on your pap. But finding out more about
people’s overall health including potential
substance use. And so the screening
recommendation really is to find a tool that
works for that clinic. They haven’t said this is
the tool you have to use to screen but I
just wanna make sure that we have very
carefully separated in our mind screening
for substance use as a verbal tool
or a written tool with lets say the audit
or the NIDA quick screen or something like that
compared to either consent or non-consented
biological testing for a presence of substance. And so that recommendation
is most commonly comes from ACOG but also
collaborating societies. – [Marc] Imagine that,
talking to the patients. – Yes, face to face. – Do you have a
question, Dr. Walley? – [Alex] Hi, my
name’s Alex Walley from Boston Medical Center. I have a question for Dr.
Clarke about Rhode Island. In corrections, so its
specifically about diversion within the facility after the
medication was implemented. One of the, we’re in
the neighboring state in Massachusetts I’ve been
to other panels with you and heard our colleagues
in corrections speak and I’ve heard that Rhode
Island administrator say, yes there’s contraband
that’s our job. That’s what we
deal with everyday. You know buprenorphine isn’t
any different than cigarettes. Whereas in Massachusetts
the corrections officials put up this evil specter of
buprenorphine as contraband. I will say that my own
patients have told me, a few of them, have told
me that they’ve purposely been incarcerated in order
to bring buprenorphine in because the value
of buprenorphine, the so called street
value of buprenorphine inside a Massachusetts
incarcerated setting is 10 times what it
is on the street. And so there’s a big business, a big gray market or
black market business that exists in
smuggling buprenorphine in and out of incarceration
that I think not only prisoners but also corrections officers
have a vested interest in. And its really a perverse
reason for why there’s barriers to the expansion of medication. So now you’re on the
other side of that and I wanna hear
what your comments and thoughts are
on my impressions from the other side
of the state border. – So there’s a great
thing about making a service available, or
a medication available. The demand goes way down. So we are in the process
of looking at urine screens to see if we can quantify
it, but right now I just have one of the wardens who’s
told me that she believes that the amount of
contraband buprenorphine has gone way down since people
now have it if they need it. So people aren’t trying to get
it if they’re coming in sick. We are providing it. That’s the short
and simple answer. – That’s good, that’s good. Because I know they’re doing a
pilot in Massachusetts, right so that’s what the
legislature passed. So that will be helpful
information for them to have. So I apologize because
we are running up against the break and I’ve already
gone a few minutes over. And I’m getting the high sign. So really, really fast but
we could let your colleagues see if you wanna take
away their break. But go ahead, really fast. (laughing) – [Questioner] This is
really quick for Kaylin. Would you characterize the
screening of pregnant women as screening for the
risk of use rather than actually screening
for the use of substance? Because you, would
that be a good way to characterize what
you’re trying to say? – Let me make sure I understand. So screening to find
out about potential risk for use in the pregnancy? – [Questioner] Right, as
opposed to a biological thing which detects the actual use. – Yes, yes, yes. So when we use a screening
tool, right, where you’re using a series of
questions to assess for like, an example for a
marijuana screen you can use the one question screener. Have you used a marijuana
product in the last year? Right, like you can
ask these questions to get the information
you want rather than relying on an irreliable,
often non-reliable test– – [Marc] But it still screens
for use, not possible use? – Yeah, yeah and then if
you detect use, right, then you can ask questions
to determine does this person have a use disorder, right? The vast majority of
women who use substances and get pregnant stop, right. But then there are some women
who cannot without help. – Okay thank you very
much to our panelists. This is a great discussion. (applause) And we have a break until
2:55, so nine minutes. Thank you very much. Thank you, that was great. (crowd murmuring) – Okay we’re gonna go
ahead and get started in the next session
if could ask you all to start taking your seats. And I’ll ask the panelists
for this next session to join me up here on stage. (crowd murmuring) Okay welcome back. This session we’ll be
examining the future directions for treatment for OUD
through defining success and meaningful
outcomes for patients. We’ve had a great
discussion throughout this morning and
this afternoon around the various
treatment modalities, the barriers to access,
and a lot of very thought provoking ideas that have come. In this session we’re
gonna talk about okay, so what are the outcomes
that we’re hoping to achieve. And we heard this
morning by Sara Eggers from the FDA that although
treatment efficacy has traditionally been
measured by reductions in drug use, more
meaningful outcomes for patients and caregivers
and patients suffering from OUD might also
include reduced symptoms. Like cravings, but
the drug sick symptoms that Sara talked
about, skin crawling and other issues, potentially
reduced mortality, reduced need for
medical intervention, improved social functioning and other potential measures
that we’ll hear more about from our panelists
in this session on what some of those
outcome measures might be. As the healthcare system
also increasingly moves away from fee for
service methods for paying for our services
to more value based methods that try to link payment
for healthcare services to outcomes of quality,
patient reported outcomes. Other measures of
potential value. So much emphasis is
becoming on, well how do we measure those outcomes? And what are the most
important outcomes given the condition that a
patient might have? So as we look at
OUD the question is as we move to
those better measures of quality and outcomes
what could those be? And then also what
is practical in terms of measuring and collecting
from data perspective? Presentations in this session will address current
challenges to these kinds of measurements, new approaches
for measuring quality in OUD treatment, and how
improved outcome measurement can facilitate
quality improvement, innovative payment approaches like alternative payment models and access to effective care. With our earlier sessions
we’re gonna go ahead and do one of those
online polling. I’d like to invite the audience
to go back onto your phone or computer and
to those watching on the video to do the
same through the chat box. The question is, based
on your own experience what patient treatment
outcome might be considered the most meaningful
for OUD treatment. Clearly you might actually
answer a couple of these, but pick the one that
you think is the best. And as with the previous
sessions we’ll keep this running
throughout the session and we’ll come back to results at the end of the session. Again with all of
these there might be important outcomes
related to OUD treatment and there are many more
that we could include. So this clearly isn’t
an exhaustive list. As you’re thinking about
that and logging on I’d like to introduce our panel who
all have valuable insights on how we might
think about success in OUD treatment and
how understanding these outcomes are crucial
to understanding some of the payment barriers
that we discussed in earlier sessions. So joining me here
are Alexander Walley, associate professor of
medicine, Boston Medical Center and Boston University
School of Medicine. Sarah Hudson Scholle,
vice president research and analysis at the
National Committee for Quality Assurance, NCQA. Mady Chalk, principal
and managing director the Chalk Group. And Shawn Ryan, president and chief medical
officer at BrightView. So I’ll go ahead and turn to
Alex for some opening comments. – Great, thanks so much. I’m really excited to be here. And I, oh– So I’m at Boston Medical Center, Boston University
School of Medicine. I see patients there as
a primary care doctor doing addiction treatment
and primary care. I learned a lot of
what I know from Coleen LaBelle
who spoke earlier. I’m also director of
an addiction medicine fellowship program, one of
the things we didn’t talk about today was
training the workforce which is a major, major issue. If no one’s there to
deliver the treatment then we’re not gonna
deliver much treatment. And I also work with
the health department in Massachusetts on
overdose prevention through the naloxone
distribution program and one of my mentors
also was on one of the other panels,
Sharon Stancliff and so I’m excited
to be here with them. I also, this is supposed
to be about outcomes. I’m gonna talk about two
or three, or four outcomes that wasn’t on the question
that you just asked and also I’m glad you
mentioned Dr. Eggers and I didn’t participate
in the FDA session but I think it
really is important that the FDA conducted
that and I thought that was a really nice
way to start out the day. And so I hope folks
will keep that in mind through this session. So first thing, I’m actually
not gonna talk about is an outcome its
actually the pool. The pool of people at
risk for a bad outcome. The people with
opioid use disorder. So what this is an
analysis that we did in Massachusetts
using a new database that is individually
linked actually across 13 or 16 statewide data sets. Its the first time
its really been done in the US at the state level. Some administrative
health insurance databases can do this, but this is really a Scandinavian style
linked data set. And we looked
through the data set to find who had
opioid use disorder. And we came up with a quite
strikingly high number of over 4% in 2015. Now Massachusetts is
a big opioid state. We have a long history
of opioid use disorder and we’re in the top as
far as overdose deaths and so forth. But 4% is, that’s a high
percentage of adults. That’s like, I think its
more than the prevalence of diabetes and asthma. And so that compares
with the National Survey on Drug Use and Health
which is only .6%, okay. So and that’s a survey. We’re using a data set
that’s individually linked where we’re looking at
people’s, we’re looking at their insurance claims. We’re looking at their
access to treatment. We’re looking at whether
an emergency department, they went to the
emergency department. So knowing how many
people actually have
opioid use disorder is one of the biggest
issues, right? Because its highly
stigmatized condition. Most people who have a
highly stigmatized condition are not gonna raise their
hand and declare themselves and go into healthcare and
seek treatment right away. Its gonna take awhile. So that I think is one of
the just biggest conundrums that we have to deal
with is that, you know I think we’re
underestimating the number of people who actually
have the condition. And perhaps studies
like this we’ll see more of in the future. Okay so, if you look
in another database which is national, its a
commercially available database that has over 200
million people in it. The Truven Marketscan Database. We looked at in
succeeding years and saw that there was a
four fold increase. And now here the
prevalence is quite low. Actually lower than it
is in National Survey in Drug Use and Health. So maybe not as accurate
but we’re seeing it grow by four fold from 2010 to 2014. That’s a four fold
increase, okay. And so that actually
kind of, it fits that as the awareness of the
opioid use disorder crisis is coming to light
that more diagnosis are gonna be made and
commercially insure people. That makes sense. What we would also hope
is that you’re gonna see an increase in treatment, the
proportion that were treated. But in 2010 only a
quarter were treated whereas in 2014 only
16% were treated. So we actually saw a
decrease in the proportion of people who were
treated as we saw more and more people diagnosed. So that’s quite concerning. We really wanna move in the
opposite direction of that. We want to have
more and more people be treated as more and
more people are diagnosed. And then there’s a
third piece of bad news that we see in this
commercially available database which is that discontinuation
is common, okay. So you’ve heard a lot,
I’m a huge proponent of medication for
opioid use disorder and I thought well
you know, we’ve heard from a lot of the speakers
how effective it is and how its life saving
but one of the big problems with is people that are
started on it don’t stay on it. And so we see that here. So this is days after
initiating a treatment. The best treatment was
buprenorphine where at about a year you had
a little bit, let’s see, in this commercially available– If you go out to 360 days
right here we got about a quarter of people
still on buprenorphine. So that’s not fantastic, right. For that quarter of
people who are still on buprenorphine that’s
actually is really good news but you know, that’s
a quarter full, three quarter empty glass. If you look at other
treatments like this dark gray line here
is injectable naltrexone. You see really rapid
decay and oral naltrexone which we didn’t really
talk about, is even worse. Okay so these are, what
I’m getting at here is I think the
discontinuation actually, or retention in care
is an important outcome that we need to look at when we’re thinking
about medication. So I also think that when
we think about outcomes we need to think about
special populations. The way in that original
database where we found that high prevalence of
opioid use disorder we were looking at places
where people hit the healthcare system or
the criminal justice system and they had obvious signs
of opioid use disorder. Those are touch points. Those are places where
we can identify them and ideally treat people. Or if they’re not ready
for treatment we can offer them some safety advice,
some harm reduction. Some overdose education. Okay so this is looking at one
of those special populations. The number one risk factor
for an opioid overdose that’s fatal is a
nonfatal opioid overdose. And those, while we hear a
lot about fatal overdoses nonfatal overdoses are
actually quite common. So in that, going
back to that link to database I was telling
you about, we identified 17000 people who had a nonfatal
overdose in Massachusetts. And then we looked
at what happened a year before they
went into, sorry, a year before they had
the nonfatal overdose and a year after they had
the nonfatal overdose. And the first thing that
was clear was that very few of them were receiving
buprenorphine, methadone, or naltrexone either
before or after. So in the 10% range. Now we’re gonna zoom
in on this Y-axis. Okay, 10% here, same
graph just different scale and you see what happens. There’s 6% of people
on buprenorphine and then it rises
up to about 8% after the nonfatal overdose, so
some people are increasing. Methadone dips right
before the overdose. That kind of makes
sense, that people are getting discharged
from treatment and then maybe they overdose. And then naltrexone is
low before and after. Okay if you look at the
time, this 12 months after, if you add up all the
time that people were on, 17% received buprenorphine,
12% received methadone, and only 6% received naltrexone. So these are the highest
risk people in Massachusetts a state that has universal
healthcare coverage that’s probably far out
ahead of other states in delivering
treatment to people and we’re still not getting
treatment to people. Okay so just getting
treatment to people, that’s an important thing. And then when people get on
treatment they don’t stay on it. Especially naltrexone. This is the months that
you receive the treatment if you got it. You only get it for one month
if you’re on naltrexone. Okay, methadone’s
better, five outta the 12 months you
get on methadone and buprenorphine
not quite as good. Okay so this looks at
what happens when you’re on the treatment. If you’re on the treatment
like many, many other studies before, guess what? You survive, right. So here’s the death rate if
you’re not on any medication. It actually is quite high. It goes up to 5% at 12 months. That’s one out of 20 people
who has a nonfatal overdose is dead at 12 months if
they don’t get a medication. If they do get a
medication while they’re on it that death rate goes
down by way more than 50% with all three
medications, okay. So that shows what
we already know, that these medications
save lives. I’m arguing for mortality
as a very important outcome in a condition
that is very fatal. Now this changes things. What we know is that in
the month after people stop their medication, their
overdose death rate actually goes up higher
than it was while they were on the medication
and even goes up higher than it was before they
started the medication. Discontinuation is deadly. That’s what this
graph is showing you. So that benefit which
was down here has now been pushed up
because we’ve taken that month of discontinuation,
we put that risk into the medication. I would argue that it is
attributable to the medication. They wouldn’t have had that
risk if they hadn’t have gone on the medication
in the first place. And because people
are on naltrexone for such a short period
the death benefit, or the survival benefit
is completely erased if you include the
discontinuation time in the risk for the medication. So there’s still a benefit
with discontinuation even from buprenorphine and
methadone, its still there. Okay but its attenuated. Okay so I’m arguing for,
first of all lets figure out how many people there are,
that’s really important. Think about the fact that
discontinuation is deadly. And who are the people
who discontinuing? Its these people that are in
these high risk population. Okay thanks very much. I look forward to
the discussion. (applause) – Thanks, Sarah? – Good afternoon,
thanks so much. So I think my slides which
are just as hard to read actually tell a similar
story to Alex’s. We’ve been measuring
at NCQA, we measure the quality of care. We have about 800 health
plans that report data to us every year. And you can see
we’ve been measuring the initiation and engagement in substance use disorder
treatment for over, for actually close
to two decades. But I’m just showing you
a time trend from 2005. And typically what we’ve
seen with quality measures is that when we
measure things improve because there’s a
focus and attention. And that has just
not been the story for drug treatment
and actually not even for mental health, its
a problem in both areas. But this is a measure where
we’re actually seeing declines and the only difference
is we see just a little bit of an uptick
in 2016 data for medicaid. Which might give us
a little bit of hope that there’s some more
attention being paid to the first step of
initiating treatment. And this also
includes the 2016 data for the first time includes
the use of medication treatment as well as the use of
other kinds of visits. So overall terrible story. Maybe its gonna get better,
but what’s contributing to this and you’ve
been here all day so you’ve heard about
all the barriers that we could imagine that
have to do with the lack of data sharing, the
lack of integration, the lack of payment
and incentives. So where we’ve seen the
diabetes quality measures go up and up and up, we see that for
controlling blood pressure. We see, that’s
even harder right? That’s another patient
adherence measure and we see it go
up and up and up. And we see that its improving
for all across the board. We haven’t seen that
in drug treatment. And part of the concern
is about accountability. Who is accountable? The health plans say, well you
know is it the primary care is it specialty? How do we put them together? How do we get our
networks to focus? A lot of attention on,
what is the outcome? What are we really
driving to outcomes? So as we’ve been
thinking about this issue at NCQA and thinking
about where do we need to go to try to improve
outcomes for addiction and in particular for
opioid use disorder. We go back to the
Donabedian model about how do you measure quality? You think structure,
process, and outcome. And part of the structure
is to have organizations, healthcare clinics, primary
care, specialty care, emergency departments
that are prepared. That have the capabilities to actually provide
high quality care. And so what does that
mean in addiction? That means people that
are waivered and prepared to deliver medication
treatment but also all the other systems you
have to have in place to find people who get
that first medication and engage them so that
somebody’s reaching out and helping them to
get back into care and to come back for
the next treatment. So you need registry systems. You need electronic
systems that allow you to go out and do that. You need somebody who’s
job it is to do that. You may need peer navigators
to go out and work and do some help with
all the other factors that contribute to
ongoing addiction. We think process measures
like this initiation measure, its based on claims
data, it helps us to understand access
to care and access to evidence based treatment. And its easily available
from claims data. That’s what we’ve been
using almost exclusively. For mental health and substance
use quality measurement. We use those claims data. They’re easily available
and from that we can dig in and look at some
other measures. And we’re actually working
on adding more measures to our armamentarium
that look at specifically at the use and
continuation on medications that look at followup
after, whether people have followup after
emergency department or hospitalization, or detox,
so that we can have more measures that help us to focus in on the opioid
use disorder group but also to understand where
are the patterns of care. But we can’t stop there. What we really need to do
is look at the outcomes. And as we’ve been
talking with stakeholders what we’ve been hearing is
that the outcomes that matter are overdose death, but
also as we think about the young population
we’re looking, are
they back in school? Employers are telling us,
are they back to work? Are families back to work? But where do we get
that information that would allow us to
understand are we moving the dime on outcomes? Well its not in claims data. And it really means
that we have to make an investment in thinking
about where the data come from. So currently when we can
look at structural measures, you know we have
that at NCQA we have about 20% of primary
care clinicians are in an NCQA recognized
primary care practice and so we understand what kinds of structural
capabilities they have to help with screening
and identification. And now we have a distinction for integrating
behavioral health including medication treatment. Coordinating with
specialty treatment. So we know how to measure that. We have tools for doing it. We know how to do
the process measures. Using claims data is an
efficient way to do it and we think that we can
actually use those claims data from states or from plans to get at the addiction treatment
provider settings and to understand where
there are providers that are keeping patients
on medication treatment and what are the
patterns of followup. But the get to the outcomes
we’re really gonna have to think about the
future and create and link together
new data sources. The kinds of, being able to
know something about overdose and near overdose. Massachusetts can do that,
I know in Arizona they have a way that if you use NARCAN
you have to, a registry to say you’ve used it. But that’s not a
nationwide tool for us. We think that registries like the American Psychiatric
Association has a clinical registry that will get information
directly from patients. For this population
does it also need to be a registry that
would get information from families or caregivers
so that we have multiple ways to get information about,
are there overdoses? Are there symptoms? What are the symptoms? What’s happening with school? And also to try to use that
information to help engage and motivate patients. We’ve got work going
on where we’re working with people with functional
disabilities, people with serious illness and we’re
saying, what matters to you? What matters most? And using goal setting and
work to capture symptoms, functioning, and to
help motivate and guide the treatment care plan. And we think maybe
that’s an option here but its gonna require that
we develop new data systems. We link the data that we have so that we understand
who’s on the streets. We understand who’s involved
in the justice system and we begin to look
at those outcomes as well as information
that clinicians and care teams can
use as they’re doing
their care planning to say, hey you’re doing
better how does that feel? I look at this information
I can see that your symptoms are going down, what can
we do to improve that? How’s school going? Are you back in school? We need that information
integrated in care so that it becomes
something that is useful for care planning. Its useful for the patient,
for patient engagement. Its something we can
use to improve care. So we need this to
be aligned across all the different settings and
part of what we think about is we measure the
health plan today. We wanna measure at
the provider level and then all the networks. Pulling together these data
across all these settings its a challenge. And at NCQA as we think about
where the future’s going we really want to focus
on beginning to pull data from all the electronic
sources where it sits so that we can come up
with a clear understanding where we apply the same
measures and specifications and where we can begin to
create some joint accountability on patient centered measures that can really help us achieve the outcomes we’re
looking for, thank you. (applause) – Mady? – So I’m gonna jump
this up a level. And try not to be repetitive. Keeping in mind that what
we’re really all here about is the person at the
end of all of this which is an individual
human being with a problem. And I may differ with some
of the previous speakers. We really have a
paucity of measures. We’ve got a lot of
home grown measures that lots of providers are using and lots of states are using
but at a national level there are currently
3000 measures for all kinds of
conditions of which seven are process measures related
to substance use disorders and opioid use disorders
and one outcome measure. The one outcome measure
which was approved and endorsed by NQF last
month, or two months ago, has to do with
retention on medications for opioid use disorder
for six months. And where I think I
differ a bit with Sarah is that the current
framework that we’re using that has to do with structure
process and outcomes has not yielded us at a
detailed level what we need to know to track individual
patients and groups of patients through
treatment and recovery. Reporting by providers,
whether they’re commercial or in the public sector is
at extremely low levels. No less use of measures
at the provider level to help people design quality
improvement strategies. It is apparent now
that simply requiring that plans and providers
implement measures and report them doesn’t
seem to be producing the results that we
would like to expect. We need to begin to think about new accountability structures. And I think I’ll move on. So I wanna talk to you about a new framework for measurement. Some of you may have heard
of the term the cascade of care which was
implemented by HRSA, the Health Resources and
Services Administration for HIV AIDS some years ago. What the cascade of
care is, is a framework that gives us the
opportunity to set goals at every stage of
treatment over time to trend outcomes, identify
critical gaps in care, and develop systems
improvement strategies. This is the cascade
but let me make it easier for you to read. What the cascade does
is begin with what Alex was talking about, about
identifying populations at risk and at risk populations. Diagnose of those
who are identified. So you have to go through
each stage successively. Of those who are identified
what percent were diagnosed? Of those who were diagnosed,
what percent for example, were engaged in treatment? Including tracking
patients throughout care for however long they are there. Of those who are in treatment, what percent
initiated medication? Of those who
initiated medication, how many were retained and
continued on medication? Including the clinical
services they needed to support that for
at least six months. And then of those,
how many entered either remission or recovery? That’s what the
cascade of care is. For substance use
disorders, for HIV AIDS they have established a baseline. And they established goals. And the goals were that
90% of the population that has HIV AIDS
should be identified. Of the ones identified 90%
should initiate treatment and of those 90% should
be able to be maintained in the community. Clearly, for opioid use
disorders we are very far from anything close to that. It’ll be a long time
before we can get there. But we don’t even
have the baseline. We don’t have goals
that are set that way for opioid use disorders
and what I am proposing is that we need to think
about outcomes in this way. That an outcome of
initiating treatment should be that you get evidenced
based practices. An outcome of getting
evidence based practices, including medication,
ought to be that you move on to the next set of goals. So we know that there are
a number of challenges in implementing a
cascade of care. Not the least of which is
that you can’t find all of that data, as Sarah
mentioned, in claims data. But we need to begin
to work on that and there are places
that are working on it. The state of Washington
for instance, has an ability to identify,
they have patient identifiers that can connect
with all the services a patient receives
in that state. From, and identify
where people are. Whether they have jobs. Whether they’re back in
school and that sort of thing. Now I’m gonna shift topics. Assuming that we’ve
thought about those kind of outcomes, what can
we do to encourage people to plan to implement
this kind of reporting? Alternative payment
systems have begun. Experiments with
alternative payment systems are now operating in
a number of states and I wanna talk about
a couple of those. I’ll move quickly. So lets begin talking for a
moment about bundle services for medication
assisted treatment. Increasing access to
medications for treatment of addiction rests
heavily on our ability to support physicians and
patients throughout care. And what I mean by that
is that there has been a notion around that all we need is more waivered physicians. I recently took a hard
look at the percent of waivered physicians that
are prescribing medications in particular states. And without naming the state,
in one particular state there were 117 waivered
physicians and of those seven were prescribing medications. So you know what the
percentages are there. Okay I’ll move more quickly. Administrative, in the states
that I have been involved in looking at its clear
that administrative and clinical supports
need to be provided to physicians if we’re
going to expect them to prescribe medications and thereby increase
access to medications. Bundled arrangements
that, and bundled services that include the clinical
and administrative services to support physicians
as well as patients is being experimented
in a number of states and we should be able to have
those results fairly soon. In other places health
homes for individuals, health homes for individuals with substance use and
opioid use disorders are being experimented
with by OTPs, opioid treatment programs,
using incentivized payments. So opiate treatment programs
and other treatment programs that are able to provide
intensive services and intensive clinical and
administrative supports are provided
incentivized payments to increase the
level of services that they are providing
severely ill patients in those health homes and
as appropriate move them into community settings
with primary care physicians and waivered physicians that
can continue to treat them. A third experiment
that is going on now is pay for reporting
and pay for performance. Tied to quality services. It is as I said when
I started, reporting is very low and performance
measurement is even lower. With that in mind several states and plans, health plans
in the commercial sector are beginning to pay
providers to report. As sad as that may seem to some, that should be
necessary it seems to be and its clear, it
should be clear to all of us that
unless we get providers to report and to
measure we’re not going to be able to get to the
point of improving outcomes. – [Greg] Thank you, thank you. (applause) Shawn? – Afternoon, actually gonna
move straight from Mady’s point on through and transition
all the way back to the patient at the very end. Which Dr. Walley started
off so nicely with. I’m gonna talk just
briefly about the issue. I’m gonna primarily
present a fair bit of information about the
alternative payment model that ASAM and AMA worked
collaboratively on. And then I’m gonna go
back to again focusing on patient access. Oops, sorry. I do wanna go ahead
and say that most of these slides, at
least the content of them was produced by the American
Site of Addiction Medicine and I did not spend
all of my time making these fancy graphics. So this is a very pretty
graph saying basically only one in five individuals, and we all know we see
measures all the time. I’m not sure if this
is just jumping around. We all know that
we see measures all the time related to how few
patients are getting access. I don’t think I need
to belabor that point. Dr. Walley presented some
fairly concerning evidence. Especially in the
high risk population of how few people actually
get evidence based treatment including medication
assisted treatment. I will go back to
Miss Chalk’s point and say that although it may
sound potentially ridiculous to some that we have
to pay providers to report measures,
I will tell you that the American physician
is over worked. We have a record
high burnout rate. Some primary care physicians
have approximately six minutes to see, I just don’t
know what’s going on today. I’m not touching
it at this point. You have approximately six
minutes to see patients. On a day I have colleagues who– I’m a board certified addiction
and emergency physician but I have primary care
folks who see 20, 30, 40, 50 patients a day with an
advanced practitioner. To perceive that we’re
going to convince them to see a very
challenging patient they were never trained on using
a controlled substance that they could
potentially get in trouble for mis-prescribing
and then report on that without increasing
reimbursement is ridiculous. I cannot name a
single physician, in fact I will tell you
that in northern Kentucky across the river from
our Cincinnati practices I had a friend who
years ago said well I’m just gonna get retired
physicians to come on out of retirement and provide medication
assisted treatment and they’ll come
because they feel like its the right thing to do. How many people do you think
showed up for that program? Okay so it is not
at all ridiculous that given this
current environment of physician overworking
and burnout etc, that we should
expect to, we need to improve the reimbursement. And you can see
here some measures or some comments on a
unnecessarily complex billing and paper work etc. And so alternative
payments are one version of doing everything kind
of at the same time. I’ll tell you we did
spend, Miss Sandy Marks in the back from the
AMA and we appreciate the AMA’s collaboration
on this model. We spent and inordinate
amount of time. A couple years and
thousands of hours of work between ACM and the
AMA getting this thing done. So one of the reasons that
I was so intensely focused on producing the model
was really the fact that we have the
broadest bell curve, and I would describe as
a lack of standardization of treatment in the
United States period. So you literally
might see me and one of our board certified triple
addiction psychiatrists in Cincinnati or if you
call the wrong number you’re gonna end up riding
horses on the beach in Florida. These are not even
on the same planet. And so why another
reason is to do an alternative payment
model is to jump the quality in care and
standards that we’re seeing in the United States
forward by saying, does anybody else
know what’s going on? Is it just me? – [Greg] It might be on like a– – [Shawn] Timer?
– [Greg] Presentation timer. – [Shawn] I talk really fast,
I’m not really sure why. – [Greg] The people
in the back are trying to get ya to– – [Shawn] Yup. So anyways, the
medical psychological and social model is
what we have to apply. So not every patient
needs exactly the same medication, not
every patient needs exactly the same psycho-social
intervention. But not conceptualizing
the psycho-social model is incorrect and we
need to standardize that so you don’t end up
riding a horse in Florida. Although if you can pay
for that and you happen to get medical psychological
and social care and ride a horse at the
same time, that’s okay. Can I go on now, do
I have permission? You can see down here
that the key areas of focus, guys paperwork. At one point there was
a four page diatribe of a prior authorization
in Kentucky for medication
assisted treatment. It was the most ridiculous
thing I’ve ever seen in my entire life. I probably
could have gotten the patient a kidney transplant
faster than buprenorphine. And it was unreasonable,
they’ve changed it since because I’ve said
that probably 50 times in the past three years but
it was most asinine barrier to getting a patient
something that’s life saving and not even that
expensive and very safe. And so reducing this
administrative burden of paper work etc. is
really going to increase and improve the access to care. And we have to think about
copays for patients, by the way. So if a patient is in
a high level of care as dictated by the ASAM criteria and they are placed in
the IOP plus medication assisted treatment, and
they have a $50 copay for their approximately
15 visits they’re gonna have to get that month,
what do you think happens? They don’t show up. Right, they don’t do it. So we focused on
outpatient treatment. We did this for a
multitude of reasons. I know there’s other models
out there talking about the full spectrum from
inpatient residential on down to their continuing care but the problem with
that was actually that it is unbelievably
complicated to try to drive a bundle towards, especially
to do it efficiently, effectively and
actually make it happen. So for those in the
audience who might know me, I’m all about execution. And as we’ve looked at
this and we mulled it over with all the professionals
on team that I ran, that evaluated this program,
we just could not possibly think that we were
gonna get it done in a reasonable
timeframe with any pair no matter how hard we tried. And not only that
but outpatient folk, and so I say this clearly
as others have said it, residential and inpatient
care is necessary for some patients but
they all need outpatient continuing care period. And so we really
should be focusing on what I would describe
as limited dollars despite the Senate’s,
and I do appreciate the Congressional passing
of all these things or close to passing
of all these things and the money associated
with it but we really, that’s not that much money. And so we hope to get more
money through multiple resources and spend it wisely
but in order to spend it wisely we have to focus on
the most cost efficient levels of care and that
is outpatient care. So we focused on that. We talked about initiation
and maintenance. So IMAT and MMAT, I did
not make these terms up. I don’t remember
actually who did. But they are, they
were meant to be saying its a little harder
to see a patient and get them initiated
and get them engaged and kinda get them
hooked into treatment so that they’re going to stay. And then hopefully
after that initiation of treatment they’re
going to stay and do maintenance therapy
for whatever duration of time is necessary. And approximately 90% of
the time patients will need to stay on medications
for quite some time. We talked about the
ASAM levels of care. Both IOP and outpatient, that’s
two and one respectively. And just focused on that
part of the spectrum. And then we also wanted to
make sure that we evaluated for places like where I work which is a completely
integrated care delivery model. Or coordinated
care delivery model because you might have
a counseling center or a social support
network that works with a primary care
physician who’s willing to provide medication
assisted treatment. So we built the model
to allow for flexibility because far be it for
me to dictate what was gonna happen
you know all over the place in the United States. That wasn’t reasonable. These are the
measurements of quality that we put forth in this model. It is things that you
might think are reasonable and have already been
talked about at this point. Starting with, what
were the percentage of patients who filled and
used their medications? Medication is saving lives,
they need to fill it. They need to use it and
they need to stay on it. We talked about the
treatment compliance, so who stayed on their
medications is number two. And then the two utilization
of service measurements were around using drug
testing appropriately. We all know there’s been
too much waste, fraud, and abuse in that space. We’ve lost millions if
not billions of dollars in inappropriate utilization for toxicology testing by urine. And so we were measuring
the appropriate use of those things. And then finally things that
people really care about at the end of the day,
which is reduction in average number of
emergency department visits per patient. These are the
measures we put forth. I know that everybody
is looking at somethings but I would also say
as I stated before, we have to think fairly
simply about this so we can execute some
time in the near future because we are losing time. We did include
performance based measures so that patients
will, excuse me, so that the providers
will be focused on doing a good job and
there will be some incentives or disincentives
depending on how they do. And I’m gonna go back
to patient access. I really wanted to bring
this home by saying this is why we’re here,
this is why I’m here. As an emergency physician
I was extraordinarily frustrated with what
was going on in the ED. Basically just drowning in
overdoses in Cincinnati. I had colleague and a
friend both fall victim to opioid use disorder. At the end of the day
when I’m thinking about these things that make up all
these fancy slides, its them. That’s what I’m worried about. They needed access to
treatment years ago, they did not have it. One of them is dead. And when we in
Cincinnati decided that we were going
to make a difference by making access to care
24/7, you call you get an appointment
same day, next day. The people thought I
was out of my mind. Well we did it and I’d
like to see it done again. And I think this
alternative payment model and all these other efforts
we’ve talked about today are key and critical in
making that difference and I hope, I don’t
wanna be back here in a few years talking
about how we still haven’t improved access. I hope Alex and I can have
a different conversation next year or the year
after, so thank you. – [Greg] Okay, great thank you. (applause) Okay, so thanks
to the panelists. I’ve got a couple questions and I know that,
I’ve been watching this group all day and
you’re sort of very attentive and you tend to have
a lot of questions. So I see people
usually lining up at the end of these sessions. As opposed to other
topics that we engage on where you might get
like one or two questions maybe if you’re
lucky, for a panel. But you all have been very great and I’ll leave time for
questions from the audience. But I’d like to see
some of the results of the original poll that
we, I can’t see that. So I think– Yeah okay. So patient well
being, some of these, I guess what I would classify
as some of the more difficult to measure outcomes and
I do wanna ask the panel. I got one question around
the outcome measures itself. What I expected to
hear from the panel was overwhelmingly we need
to get to measures like what we see the audience
responding with. Functionality, decrease in
symptoms, things like that. And I heard Sarah, Sarah
did mention a couple of those like getting back to
work, getting back to school. Really important measures
from a patient’s perspective. It seems like. But, and usually in other
therapeutic areas we hear things like we do too
much of measuring process and we never get to the outcome. However, I think what
I heard from this panel is that some of the
process measures, we’re not even doing that yet. And especially Alexander
your presentation where you actually linked process
measures to mortality and showing that
these process measures are meaningful especially
in the cascade. And Shawn your measures
in the AMA model kind of mirrored the cascade
where its like, lets get a handle of who’s
getting treated, who’s staying untreated, who’s
getting to the next stage. Those are all kind
of process measures but it seemed overwhelmingly
from this panel that those are not
usually recorded and those would be a good
place to actually start. So can you guys
comment on this sort of process versus the more
patient derived functioning and symptom measures and
where we should be with that? – Absolutely. We need them both and you
know the process measures, actually we’ve got data on now. So, that show that
we’re doing a lousy job and the reason we’re
doing a lousy job is because we don’t
have the payment systems and the accountability
and our thumb on the places where there
are opportunities to improve. So we have to, I think
we have to measure those and then I hear you
Mady, saying we need to set some goals for where
those numbers should go and I was impressed this
morning about, you know we’re decreasing mortality
and because we’re doing a lot of work to try
to rescue people. But if we want to do,
if want to improve we really need structured
efforts at every level of the healthcare
system and working with individuals to do that. Its not gonna be easy. As we’ve talked
about trying to move to outcome measures or
to try to raise the bar for providers what we’ve heard
is until I get more service, until I can improve
access I’m reluctant to require additional efforts because you know, one kind
of, any kind of treatment’s better than no treatment. – That’s not true though. – And that’s a question really that I think we
have to get over. – Yeah. I don’t agree that any care
is better than no care. Any care is not
better than no care. Evidenced care is
better than no care. And I have heard as
recently as yesterday, a group of treatment
providers get up at a meeting and say, well you
can’t expect me to deliver evidence
based practices to everyone in this program. Oh well yes I do expect that. So while I think there are
two, I agree that there are two levels of measures
that we’re talking about. You’re talking about
individual clinical outcomes that have to do
with functionality. I used to have my four, I had
four crummy outcome measures. You have a friend,
you either are back in school or you’re
back at work. You’ve reduced your use. And I can’t even, oh
and you haven’t beat up on anybody recently. I mean, those were
my four measures. And I figure if somebody
is coming out of treatment that way its not so bad. On the other hand then
you have the measures of how the system is functioning and if the system
isn’t functioning to get you to those
points we need to identify how to change that. – So I would say, this is
a very smart group here. Well that side of
the table anyway. So we’re in, like we know this. So where I work we do
measure the KORTOS, if you’ve never seen
the K-O-R-T-O-S, the Kentucky
criteria for outcomes which are basically
what Mady just described is what we really
care about at the end of the day for
patients, no question. But what you heard
us describe I think is born out of frustration
and lack of standardization. So why the four of us
primarily described, we were like, we would just
like to see people initiate on medications is ’cause we
know the mortality is piss poor. And we know how to fix it but
we can’t seem to get there. So I think that the
focus, what would seem a little bit bizarre focus
on the process measures is bore out of
frustration more than lack of understanding
that we need to get to those meaningful outcomes. I know that we, I think
we could all identify four to six that we
would drive towards but we don’t know
that we’re, you know we’re still riding
horses in Florida, so. – Yeah it seems like
the system itself isn’t functioning
for the patients so if we don’t measure
where the system is failing, like
through the cascade and those then any
lack of responses or challenges in collecting
the patient outcomes we won’t know where to go back and try on that system side. So I understand the sort
of need for both, I guess. – The legacy or the culture
of addiction treatment, I think going back
quite some time and also just sort of the
culture around addiction was this concept that
the patient needs to work for their treatment. – [Mady] Yeah right. – That the way to really
succeed in getting to recovery is to work
for your treatment. And so I think that has really
allowed treatment providers to put it on the patient rather
than put it on themselves. Patients fail
treatments, well no. Treatments fail patients
and ideally rather than making the patient work
for the treatment we need to figure out how to
make the treatment work for the patient. So these medications
are great, they work, if people take ’em. But they’re not working for
patients who don’t them. And we shouldn’t blame
the patient we need to figure out how to deliver
evidence based treatment in a better way. And yeah, ideally
you know, using the patient centered
outcomes that the FDA was trying to illicit
during their meeting but I do think we’re
not even there yet. Like its, you know. – It also seems to me,
taking off from your point that if we don’t
figure out ways to pay for the additional work
that needs to be done so that we don’t say
well, the patient needs to be motivated, which I
got so tired of hearing from providers, that
we do want Marc Fishman who was talking about earlier, which is build in
a sort of outreach to find what will
motivate that patient. Not ask them to be
motivated but what, there’s no patient
that is not motivated, no person that is not
motivated in some way. We just don’t know what it is. And we don’t wanna
pay to find out. – And so one question and
we’ll go to Larry next after. We do have one more question about alternative
payment models. Sarah you focused on sort of the organizational
competencies and the infrastructure for
collecting, not just collecting the data but sharing the
data with a coordinated team or integrated team. And Mady you talked about,
you know like bundling or medical home or
paying for performance. Just on like bundling,
and I’m not sure how this works, Shawn
with that AMA model but one of the things
that was in the back of my mind is like, what
triggers the bundle? If its an OUD sort of
conditioned bundling then there’s a, you know
once there’s a diagnosis then that sort of
triggers the care and services but that
doesn’t really incentivize going out and finding
those patients necessarily. Whereas if you had symptoms
or utilization patterns that actually triggered
the bundling of services then the provider system
might be more incentivized to get those patients
in, get ’em diagnosed and then get ’em sort
of on that cascade. Any thoughts as you’re
thinking through the alternative
payment model designs, does that factor in,
does that come into play? – I’m not actually entire sure that I know the exact
answer to your question. I think Nina and I were
talking earlier about how the RT and VESPR is broken. And so there’s primarily
an issue of identification. So we’re doing a
better job of that. We’ve done millions
more expert screenings than we’ve ever done
in the past few years but little to no actual
execution on the treatment side and so the trigger could
be either, basically. Again, the patient
has to be referred. They have to be screened
and then referred. The treatment has to be
provided so that I’m not sure that I understand
exactly which part of that would be the
trigger to initiate. – [Mady] I mean they
can get, the trigger can be okay you were
screened in primary care. Your physician asked you the
two questions that they asked. – [Greg] Yeah so that’s
exactly what I’m getting at. A payment reform
that incentivizes the primary care to
identify these patients and screen them
versus the more sort of specialized care
that might kick in once there’s a diagnosis. – But then it seems
that you’ve got a payment model that
is actually focused on a network rather than
on an individual clinician. Right, because if
its the clinician and I’m the treatment provider, when does my
accountability begin? Does it begin when
the person calls me or does it begin when
the person comes in? And at what point
am I responsible and for how long
am I responsible? Am I responsible for, you know, ’til the person says
I’m not coming back? Or am I responsible say
for the next six months? You’ve gotta try to
work to bring to an end. So the way that you create that
and whether you’re creating these you know, virtuous cycles
of referral and connection. Because that specialty
provider needs the primary care to
help out with everything and if you create
a payment model that’s too narrow and too
short then you’re not creating that incentive for
joint accountability that is so critical when you’ve
got people who’s problems aren’t single dimensional. They’re multidimensional
and they often require a lot of outreach
and ongoing work. So I think that’s part of
it, is we need to think about a broader payment model
that’s looking over time, across settings and that is
encouraging joint collaboration, coordination of data,
and coordination and collaboration and
joint accountability. – Yeah great, thank you. Larry? – [Larry] Larry
Greenblatt from Duke. I’m a primary care
physician but also waivered. I have a brief
comment that’s quick and then kind of a complicated
or a difficult question. So my brief comment is,
I think its important for us to keep in mind as we
think about identifying people that need treatment
for opioid use disorder with the epidemic
really shifting heavily to overdose deaths
from illicit drugs. Many of these people
have minimal interactions with the health system. So its not like we’re
necessarily aware that these people
are in our community. They’re purchasing from
somebody who’s delivering who they text, its
a cash business. They’re not coming in and trying to get prescriptions anymore. And so I think that makes
it much, much harder to identify the truly
at risk individuals. That’s my comment. My question is–
– Can I just respond to that? – [Larry] You can. – So I agree with you
but, but nonfatal overdose is an interaction
with the health system and absolutely nothing
happens at that touch point. And hospitalization for
endocarditis no addiction treatment is offered
for that person. They’re extremely expensive and they get a
ton of healthcare. And likewise we know
that people who, we’ve criminalized drugs to the point where
we filled jails with people use drugs
and like so there is a big fraction of that
population is identifiable and we’re not offering
them anything. So I think I would just argue
that’s a place to start. – [Larry] So speaking on behalf of Duke Health System I’ll
say guilty as charged. That’s exactly
what we need to do. My question, so a few
people talked about a couple things that are
kind of near and dear to my heart, one was decreasing the bureaucracy and the
administrative burden of initiating treatment. Another was making
sure that people are paid more fairly because
now its often perceived as being under resourced
for the amount of work. And I think that
those things are true. But other things that I
hear from, particularly in primary care is, I’m so busy. My practice is
busting at the seams. I can’t see the people that
I’m already committed to in terms of who’s in my panel. And then another thing
I hear is people raising a concern that if I had a
patient with another condition or their condition
got more complicated and I needed help I have
lots of consultants. You know, my cardiac
patient decompensates I have a cardiologist who can see
that patient very quickly. You know, help me
straighten things out. Get the patient back to me, etc. But with, for OUD I think a
lot of clinicians feel like, I don’t have that
kind of backup. I feel like if these people get to be very challenging to
manage what am I gonna do? I feel kind of stuck. And that’s particularly
for office based, you know buprenorphine
treatments. Comments on those things. – I’ll tell you two
things that we’ve done. We’ve done a project
ECHO which many people are familiar with. Who provide the ongoing
kind of case review. But that’s not the immediate and so at our organization
we’ve actually started an addiction consult line
so we’ve been very blessed to kind of amalgamate so
many addiction specialists. We have extra capacity at
least to get on the phone for 10 minutes. And so we’ve initiated
with multiple kind of local health systems,
primary care networks, etc. They can call this hotline. Its only 8:00 to 6:00 Monday
through Friday right now but we’re looking
at a 24/7 hotline. But its a heck of a lot
more than was available a year ago before we did it. And so I’ve taken innumerable
calls from the hospital. I got a post TBI which
actually a result of an overdose, etc. And that has made so many
more physicians more confident in their practice. And like you know actually
you’re right, Shawn. This is not that hard
I’ll get ’em started and you can see ’em in
three days, perfect. And so I would advocate
for in any situation that’s actually possible to
people start looking at that. Again its different than
the ECHO but can be part of it if there’s
any sort large group of addiction specialists
that can make that available. Its a wonderful service. – And there are other places where physician mentoring
programs have been established. That are doing quite well. Where there is a group of
addiction specialty physicians who make themselves
available throughout a state in different parts of a
state for people to contact. For physicians to
contact to mention them. – Question over here. – [Peter] Yeah hello,
hi I’m Peter Strumph from Amygdala Neurosciences. Its been a great conversation
on increasing utilization of evidence based
care for treatment of opioid use disorder. I’m a little bit surprised
that we didn’t even hear about the concept of the cascade of care until the very
last panel of speakers. So its a question to the group, is the cascade of
care which was really a very productive way to
think about utilization, opportunities and
progress for HIV is that construct being
applied to opioid use disorder? Is there something unique
about opioid use disorder that explains why we
don’t hear more about the cascade of
care in the context of opioid use disorder? – Yeah, yeah Mady wanna? – We did talk about the cascade,
actually I talked about it. – [Peter] I didn’t hear
it ’til the very end. I was happy that
you did mention it. So thank you. – Yeah well, we
don’t, I think there are a whole lot of reasons
why we don’t hear about it. I think about a year
and a half ago I held a meeting with health
plans and providers and payers about the cascade. And why it was not being applied to substance use disorders
or opioid use disorders. And the issue was
that then, they felt that HIV had set
such a high standard they couldn’t reach it. And my response
to that was, okay but can we start
somewhere please? If we start, no we
can’t do 90, 90, 90 but how about since
we know that only 20% are getting identified
even or 3% I guess are getting identified
in NCQA data. Maybe we could say
the goal could be 10%. We could start with
that as the baseline and then start moving. There are some of us
who are continuing to work on the cascade. And there will be, I published
in the Health Affairs blog a couple of months ago and
there’s another one to come. And we are gonna just
continue pushing it. – [Greg] Okay quick
comment, Alex. – Yeah sure, so I’m an
HIV primary care doctor. The concept of the cascade,
I don’t know where he went but the concept of the
cascade is familiar and it fits really well, along with a lot of other parallels
to the HIV epidemic. Like stigma, like the fact
that we had development of medications
which were effective but didn’t work because
they couldn’t get to people until
there was Ryan White, which was a massive investment. There’s HDAP that every
state in the nation if you have universal
healthcare coverage if you have HIV for medications, or you should anyway. There’s actual extra
funding for that. So I think cascade
is just one concept that we can take
from HIV and apply it to the opioid crisis. The opioid crisis is
killing just as many people as the HIV epidemic
did at its peak. It deserves the same sort
of approach and investment as we put into that. And 90, 90, 90 is the goal now, but that wasn’t where
we started in 1993 or in ’94 and ’95 when
they initially thought of the cascade. Like when effective
medications came out. They were dismal, dismal. And there still are now,
there’s huge disparities in HIV success rates in
the United States still. So while overall its
a good picture we still have major issues, so. – [Greg] Okay,
question over here. – [Yngvild] So Yngvild
Olsen from Baltimore. I just wanted to also
make a comment about the PCSS, the mentorship and
really using not only PCSS but there are absolutely states,
Maryland has what’s called the Maryland Addiction
Consultation Service which is actually run through
the University of Maryland. Which is a warm line
for physicians to call and get kind of real time
advice about buprenorphine and patients,
challenging patients. So yes absolutely there are some of those resources out there. My question, I guess actually
has to do with the data and the data measure. So in Maryland we are held to the National Outcome
Measurement System and the NOMS measure
things like admission to treatment, discharge from
treatment, discharge planning, and for a chronic
disease those are words that don’t fit in
kind of my lexicon. And so I love the
cascade of care. I love kind of all the
various different measures but if those are the
National Outcome Measurements and measures how
does that kind of fit with where we’re really going? – I agree with Mady, she just
said it doesn’t and I agree. I think you know,
what we’re trying to do both in mental health
and behavioral health and across as we think
about difficult populations where we can measure
some evidence based treatments where
we can but we also need to have the outcome
measures be part of what we monitor and track. In depression we’re
using the concept of measurement based
care and we have measures that say did you track
symptoms over time and if they didn’t get better
what are you doing about it? And that’s the same way
that I think we need to be thinking about
these measures like, do you have a friend? Did you hurt
anybody or yourself? School, work symptoms. I think that piece
of really trying to incorporate that patient
reported information and maybe we need some
caregiver reported information as well to help us
understand what’s going on. That information and our
processes we think about capturing the
information once, using it for multiple purposes. We wanna use it to
engage the patient. What really matters to you? You know, what would
help you get better? Where do you wanna be? And then for the
clinician it becomes part of the care planning. It becomes part of
what’s reported out. But it requires a whole
new way of thinking about where we get data and how
we use it for measurement. – And we do know that
there are tools out there, there are automated tools now. There weren’t five years
ago, that can track that a clinician can use
to track during treatment with a patient,
how are you doing? And what can we do to
help you in a better way? – Okay I’ve got
three minutes left to do wrap up, closing. Three minutes left to do wrap
up, closing, thank everyone and all of that. It means I have
two more questions. You’ve been standing,
really quickly and we’ll get to a
very fast answer. – [Matthew] Okay great,
thank you very much. Yup I’ll be as quick as I can. My name is Matthew
Iorio, I’m the president of Eighty Eight Pharma. I’m also working with
the research project out of MCPHS University out
of Boston on withdrawal. I’ve got two comments
and one question. The first comment
I just wanna plug, if you’re looking
for a nice novel that sort of encompasses
the opioid epidemic, Junkie by William Burroughs. Its actually written
in 1953 but I think its got amazing perspective if
you like books and what not. The other thing, I haven’t
heard anybody comment on PDT, prescription
digital therapeutics in this entire discussion. Which is something that is
part of that clinical package of treatment options that
hasn’t been discussed. My question for the panel. MAT, its a lifelong
commitment and so that’s, I can understand why a
primary physician would be hesitant to make
that leap with somebody who might be sort
of on the fence. Is there a way to
salami slice OUD into a way that’s not
a lifelong commitment? Is there any sort of
hope in that direction or is it one or the other? – I got it, no. I’ll catch you afterwards. – You’re gonna say no too? Okay well I was gonna adjourn. Apologies, there was
a question online. We’re gonna go ahead
and skip to the end. I’d like to thank the
panelists very much for all of your comments
and presentations. Really helpful panel. I’m gonna ask you to
leave so that Mitra can come up and give
closing remarks. So thank you very much. (applause) Okay now let me
welcome Mitra Ahadpour from the FDA to give
some closing remarks for today’s
conference, thank you. (applause) – No need to. So thank you, I had put two
pages of closing remarks. I’m not gonna look at it at all because I know its
at the end of the day and everyone wants to go home. So forget about
that presentation. Just really on behalf
of FDA I wanted to thank all of you. The wonderful speakers and
the Duke-Margolis team. A special thank you to Dr.
Woodcock, Admiral Giroir, Katie Greene, Isha
Sharma, Dr. Emily Deng, and Nancy, Dr. Nancy Chang. We’ve been working on
this for a few months so I really appreciate
all of your help. It has been an amazing day. For me personally it
has been very valuable, very informative, so I really
appreciate all the comments all the topics
that we discussed. I heard a lot of challenges
that we are facing but a lot of opportunities. So I am personally very
hopeful that together we will be the generation
that will end the opioid epidemic. So thank you so
much for everything and I give the mic to him. – Thanks to everybody,
exactly who I was gonna thank. So thanks FDA Mitra,
the Duke-Margolis staff. Especially Katie Greene
and Isha Sharma who have planned this event
from the ground up. Excellent execution, we
can’t thank you enough for your help on this project. To the FDA and all of the
panelists and speakers that we’ve had and
everyone in the room. You stayed, most of you
stayed throughout the day. That’s hard to do and I
appreciate all of you staying and we’ve had great
viewership online as well. So thank you. Look for next steps
on our website. We’re looking forward to
following up with FDA. The video will be
archived on our website and we’ll be also producing the power point
presentations as well. Thank you very much
and have a great day. (applause)

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