PMTF Day 1 pt 6 Subcommittee

VANILA SINGH: All right, folks. I hope that is a long enough break, probably
not. But we have been going at it. We’ve touched on so many great topics. I really appreciate everybody taking part
and bringing up crucial questions, ensuring that our speakers are appreciated. And I know they are, and I think that it’s
been clear from everybody, from our Assistant Secretary for Health, our congressmen, our
invited speakers, that they all value you. And we made sure that they knew that the quality
and caliber of our task force is excellent. And so I want to congratulate you on that
for behaving. And I’m kidding about that. Everyone’s been great. So our final subcommittee presentation is
the one that actually involves the complementary, alternative, and integrative therapies. So we’ve had the modalities of treatment,
including medications, physical therapy, and movement modalities, as well as interventional
procedures. That was all covered in subcommittee one. And then we also did some coverage of the
sub-population or special populations. In terms of other modalities, we talked about
the behavioral health or psychological. And the final one was complementary, alternative,
and integrative. Along with that modality covered in subcommittee
three, we added two more sections. And the purpose of this was, again, feeling
that if we identify gaps and inconsistencies and update the best practices, it’s all for
naught if we don’t do all that’s needed around it to actually make it happen. So the categories of education and access
to care were added to ensure that if this actually gets done, that the education that’s
needed for patients, for physician, providers, and for societies as a whole is there so people
can start to appreciate, what do we mean when we say the generic term pain? Is it a symptom? Yes. And can it be a categorization of disease? Yes. And it’s a multitude of different diseases
and co-morbidities, as we saw in the earlier slides. So that’s education. And with access to care, we’ve already touched
on this. But it’s the recognition of all that’s required
in terms of managing these very complex patients. Even if it’s just looking at one medication
class, such as opioids, with all the risk assessment that’s needed, the time, the resource,
the history, the tools, recognizing that as a complex management, but also in general,
the multi-disciplinary approach, the coordination of care with the primary care team, the pain
specialists, and/or the other specialists involved– a hematologist, a rheumatologist,
a neurologist– And so to bring all of them together, to have team conferences, to give
the best care that we can, we know that access to that here has to be important. And that looks at reimbursement policies. It looks it what are the barriers, what are
the limitations. So subcommittee three, which was led by Dr.
Sherif Zaafran, who’s the chair, along with Dr. Chung, Dr. Clauw, Dr. Fellers, Dr. Hagemeier,
Dr. Lynch, Dr. Rosenberg, and Ms Cindy Steinberg, they all worked hard on this aspect of all
that was done. And of course, we all knew already what the
other subcommittees were doing. So taking that into account, we were trying
to anticipate and integrate what would be the most supportive in having success. So next slide. Just as an overview before Dr. Zaafran gets
into it, the complementary and alternative, and integrative approaches included a wide
variety and sometimes overlapping sense of modalities with the movement modalities. And that included acupuncture– which we know
that there is a subset, an indication of patients– spiritual therapy or help– which was something
that was brought up multiple times– massage therapy, art therapy– which right now I think
the Second Lady has been pushing in. And when I had a tour of Walter Reed, I saw
in their pain area they had an unbelievable art therapy where they had their patients
make really incredible efforts that help them in ways that I had never known– and manipulation. Of course, we know all of this plays a great
role, but more evidence is needed and a better understanding of the mechanisms and perhaps
more that’s involved in it. Then the access to care portion was about
reimbursement for complex and time consuming care and reimbursement for the various different
modalities that sometimes with PT, for example, often initiated once but then not covered
again, even though it was the singular item, perhaps, along with the procedure that would
keep the patient from losing their jobs, so things like that. And then education, the patient, the providers,
society. Having the education or not having it really
played a role in stigma and continues to do that. And understanding the therapeutic options
goals and risks, benefits the work force a big deal, of course, in that as we have an
aging population and a growing population, having the specialists there to support our
primary front line providers, clinicians, physicians, in both the pain specialty area
but also pediatric pain, behavioral health, psychology, pain psychology, psychiatry. And then looking into the smarter ways of
accessing health to the rural areas or perhaps even some urban areas where Telehealth, tele-mentoring,
and, of course, the ECHO project, but also mobile apps, validation of that and all that
that’s been suggested, they have some role of course in terms of either therapeutic benefits,
access to the providers, or even access to social support groups. And with that, Dr. Zaafran’s going to come
up and get into the rest of it, which will be the next phase. And then after we’re done with that we’ll
do deliberation and discussion. And then we’ll end with a final review. And then we will hear from Senator Cassidy,
who should be coming soon. Thank you. SHERIF ZAAFRAN: Great. Thank you, Vanila. I really appreciate that. I just wanted to thank the members of our
subcommittee that spent a lot of time talking and deliberating through this. I just wanted to give a quick shoutout, though,
to Cindy. I’ve got to tell you that having a patient
advocate and a patient herself on our subcommittee really grounds you to making sure that what’s
important at the end of the day, which is the patient– and the patient’s perspective,
is something that we always really have to pay a lot of attention to. We can come up with a tremendous amount of
recommendations. But if it’s not centered around what’s important
for patients and their perspective, then it doesn’t really mean much. So having her on the committee really taught
a lot of us quite a bit. And thank you for that, Cindy. So I really appreciate it. Again, thank you to Mac and to Molly. We spend a lot of countless hours together
in the past couple of weeks finalizing this. And I think we’ve come up with an excellent
product. So from the standpoint of the highlight of
our recommendations, the first one was complementary, alternative, and integrative therapies. Not a lot of data on there, not a lot is quite
understood. Although, anecdotally, there’s a lot of evidence
that it works, not by itself, but in conjunction with a lot of other modalities. So from the standpoint of our gap, we looked
at the fact that there’s a large amount of complementary and alternative and integrative
therapies that remains unknown in the management of pain, as well as a gap in the understanding
of mechanism of action and how it applies to special populations. What works with who was one of the things
that we really couldn’t help identify. So from the standpoint of key recommendations,
the highlights that we pulled out– considering complementary alternative and integrative
therapies, including but not limited to– and we know that we’re not all inclusive here–
acupuncture, mindfulness, meditation, art therapy, massage therapy, manipulative therapy,
spirituality, yoga, and tai chi in the treatment of acute and chronic pain when indicated. Again, I know that this list is not all inclusive. But we tried to at least highlight the ones
that are very evident. Sound therapy for example, we know that works
a lot of times when in the perioperative setting, or even in labor and delivery, as well as
many of the other modalities that we have listed out there. The other recommendation really centers back
on trying to gather more evidence as to what works and why does it work. So conducting further research to determine
therapeutic value, risks, and benefits, mechanism of action, and economic contribution to the
treatment of various pain settings, including the perioperative surgical pain period, along
with various chronic pain conditions and syndromes. And finally, what’s really important here
is that none of this works unless you have a proper payment mechanism in place, which
we’ve identified as a large gap. If you try to tell if payers today to pay
for sound therapy, they would just kind of stare at you. So from the standpoint of understanding that
is important as a component of multimodal multi-disciplinary therapy, our recommendation
says that CMS and private payers should investigate and implement innovative payment models that
recognize and reimburse holistic, integrated, multimodal pain management, including but
not limited to complementary, alternative, and integrative therapies. Next slide please. Education, so public, patient, and physician
and provider education is tremendously important in the management and treatment of acute and
chronic pain. We’ve identified a lot of gaps from the standpoint
of there being consistency, from the standpoint of there being continuing education, and from
the standpoint of there being coordination and making sure that if we’re asking folks
to be educated on this, that it’s done in a coordinated fashion. So again, these are the highlights of our
recommendations. One is developing a national evidence-based
pain awareness campaign that emphasizes the public’s understanding of acute and chronic
pain syndromes. And one of the important things about this
is we talked a little bit earlier about stigma and de-stigmatizing the concept of acute and
chronic pain. And the first way to start de-stigmatizing
all of this is to make sure that the public is well educated as to what really is acute
and chronic pain. Unless we do that, we’re not going to really
get anywhere. Convening a chronic pain expert panel that
consists consisting of experienced patients, patient advocates, clinicians to develop a
set of core competencies and other essential information specific to patient pain education. Again, this goes back to what I said earlier–
unless you have the patient involved in this process, it really doesn’t mean anything. We can say a lot as to what we think is right. But unless you have that patient advocate,
patient input into that process, it really doesn’t make a lot of sense. Exploring intensive continuing pain education
for primary care providers, I think we talked a little about that earlier, making sure that
they are also up to date since they’re typically the first line of defense. This includes but is not limited to Telehealth
tele-mentoring and the project ECHO model, which we’ve seen works very well as a means
to provide pain education for primary care providers by pain specialists, especially
in areas where there may not be adequate access– making sure that in those areas of inadequate
access that there is a mechanism that folks who are out there in the front lines again
treating patients have access to that kind of information and education. And most importantly, at the end is recognizing
chronic pain as a category of diseases, that it’s not something that is out there in isolation,
that it has to be dealt with as a disease process. It has to be educated as the disease process. It has to be compensated for as a disease
process. But looking at it as a category of diseases
when the pain persists for more than the expected recovery time– approximately three to six
months despite appropriate treatment of the original inciting injury or disease. And the last one was probably one of the most
difficult to try to put together, because it encompasses quite a bit, which is the access
to pain care. We essentially broke this down into several
categories as far as what areas of access to care are important. We looked at medication shortages, insurance
coverage, shortages in the workforce, and gaps in research as it impacts pain conditions. The first recommendation, which centers around
medication shortages. One of the things that we’ve run into all
the time is what do you do when you have a shortage of medications, especially one of
the opioids. We ran into several years ago when hydromorphone
had to be used even more often, because morphine was in short supply or vise versa. And that creates a lot of difficulty. So what we ask is that the FDA should monitor,
report, and prioritize the availability of key opioid and non-opioid medications, including
injectables such as local anesthetics that can adversely affect patient pain care. We’re running into this problem right now
because of a lot of local anesthetics are simply in short supply or non-existent or
in backwater. From the second standpoint, insurance coverage
payers should reimburse pain management using a chronic disease management model. CMS and private payers should reimburse integrative
multidisciplinary pain care using a chronic disease management model in the manner that
they currently reimburse things such as cardiac rehabilitation and diabetes chronic care management
programs. It’s got to be done in a horizontal fashion,
not in a vertical fashion. It’s got to be all of the above, not just
one here and one there. Enhance the physician and other health care
provider pain management specialty workforce training and treating chronic pain with psychological
co-morbidities. This should include improved curriculum training
in residency, fellowship, CME courses, and other continuing education modules that help
improve patients’ understanding and engagement and psychological treatment. And last but not least, increase federal and
state funding through the NIH, DoD, and other agencies to support and accelerate basic science,
translational and clinical research of pain. Allocate funding to develop innovative therapies
and to build research capabilities for better clinical outcomes tracking and evidence gathering. And that is our report. VANILA SINGH: Sorry. So with that, actually, I was just going to
say it over there. We have one other part after this. But let’s go ahead and open that up for discussion. And does Dr. Schoneboom have something to
say first and then Dr. Trescot? OK. BRUCE SHONEBOOM: Well, thank you for the work
for subcommittee three. And a couple of comments that I would like
to make related to first of all complementary and alternative therapies. We have not talked about medical marijuana
at all and how it might be used in the treatment of chronic pain patients. States are experimenting with medical marijuana. VANILA SINGH: You had go there. BRUCE SHONEBOOM: There is some evidence that
states who are experimenting with it are reducing opioid use. And so just for the task force to consider
recommending the decriminalization at the federal level and that there should be an
investment in research in how medical marijuana may be a useful alternative therapy to treat
patients with chronic pain. My second comment relates to education. I would encourage the entire task force to
incorporate language that includes interprofessional education. We’re going there. Health professions is going to IPE. And we should consider if we’re going to treat
in teams, we should educate in teams. And that way, we know what our roles are and
how we can work together in treating these very complex patients. Finally, I said it nice this morning. I’m not going to say it’s nice this afternoon. We need to get rid of some of the language
that other non-physician providers, and I’ll use that word. And when you get labeled that, you don’t like
it. It doesn’t feel good. I would encourage that we remove language
like non-physician provider from the report. Because as you use those terms, it marginalizes
you. You feel like you’re not valued in the work
that you do. Nurses are the largest health care provider
in this country. There are over three million nurses in this
country providing care to patients, these patients every day. Nurse is not said once in this report. We need to recognize everybody that is coming
to the table to work on this important issue that is trying to address it. And nurses are on the front lines of this. And we need to recognize them– all types
of nurses, the advanced practice nurses, but the nurse at the bedside, the nurse in the
clinic. That word is absent from this report. And we need to make sure that the largest
health care provider group in this country and the work that they do every day is recognized
in this report. Thank you very much. VANILA SINGH: I guess it’s working now. Cece, go ahead. Or actually, I’m sorry. It was Andrea next. ANDREA TRESCOT: First of all, again the committee
subcommittee should be complimented on how they’ve tried to take a very amorphous group
of ideas and tried to put them into a more organized and thoughtful approach. However, none of these therapies has any evidence
for their effectiveness. Granted, they are for the most part don’t
have bad side effects from them. But my tremendous concern is that we have
a limited pot of money. And when you force something like medications
and interventional pain management to show the evidence or not be covered and then you
have a group of therapies that have no evidence and say, oh, but they can be covered, I think
that puts us in a very difficult position where we have seen that the AOCME had said
that the interventions didn’t work. But because things like Tens unit also had
no evidence but they had no bad effects that they would recommend that for occupational
medicine and for rehab, but not recommend any of the interventions. And so I just think we have to be really,
really, really careful, because if this is a zero sum game, we have to look at those
things that do have evidence of their effectiveness and at least preface with, there is no evidence
other than anecdotal that these are effective. And while it’s wonderful to encourage patients
to experiment with these, to then turn around and say that the government should be responsible
for paying for them is a concern. VANILA SINGH: Thank you. Dr. Spitznas? CECELIA SPITZNAS: I just want to offer that
we have been making an investment as a federal government in studying the components of cannabinoids,
the cannabis plant. And I can get information for the Committee
on the extent of that investment and research: also I wanted to mention that– and now I’m
losing it. What was it that you had also said. You had another comment. BRUCE SHONEBOOM: Nurses? CECELIA SPITZNAS: What was IPE? BRUCE SHONEBOOM: Interprofessional education. CECELIA SPITZNAS: No, it was before that. BRUCE SHONEBOOM: Decriminalization. CECELIA SPITZNAS: Yeah, oh that. BRUCE SHONEBOOM: Just a little one. CECELIA SPITZNAS: That one. Just say that a lot has gone on and I want
to reiterate that if we are going to be adding recommendations at this point, I think it
would be really important to understand before tomorrow what we are voting on And what the
process is moving forward. So if we could get information about that,
that would be extremely helpful, because adding something like that is a lot and it is illegal
currently under federal law. VANILA SINGH: Thank you for that. Who was next? Maybe Dr. Rosenberg, Prunskis, Tu, then Porter
or Porter then Tu. MARK ROSENBERG: Just a comment regarding medical
marijuana. I am one who prescribes medical marijuana
to end of life patients and had great success. But it’s not always for pain. It tends to be for a lot of other issues of
suffering. And I’ve had some great success with it. However, I do believe that more work has to
be done with marijuana to make it a Schedule II drug, whatever that takes so that true
science research can be done. However, with all that said, I think the decriminalization
and the rescheduling of medical marijuana is really outside of the scope of our charge
as a committee. I think it is a valid discussion. But I really did not feel that it was appropriate
to discuss the charge of the committee. Just my comments, thanks. VANILA SINGH: John? JOHN PRUNSKIS: Thank you. Thanks for your report. And the public education part we’ve mentioned
before how important it is for health care practitioners to make the proper diagnosis
perhaps in the awareness that we’re recommending for public that we perhaps consider you know
to the public, ask your doctor to give you as precise diagnosis possible of what’s causing
your pain. There was a recommendation in your report
to make information available on mobile phones. Maybe I missed the intent of that. I thought perhaps it would be better to just
say online so that– make it mobile phones, I don’t know if you meant texting or whatever. But I think online might reach a broader audience. And my final comment is in the three to six
month time frame that was alluded to when recognizing that something else might need
to be done. The way the way we approach it Illinois Pain
Institute is we make a diagnosis specific. So if someone sometimes has had a pain for
two weeks, we are alerted that this is not a normal length of time for recovery based
on their diagnosis and their other diagnoses that we will wait six weeks on before we alert
ourselves or alert our team or are alerted by referral sources that there is a problem. So that might be a suggestion or at least,
in my opinion, something that perhaps could be fine tuned. And there was a comment too also. Maybe I missed it too, but someone else brought
it up, maybe it was Dr. Spitznas. I’m actually also not sure what we’re voting
on tomorrow. But I don’t know if that means we brought
up now or at another time. VANILA SINGH: Did you guys not get the email
sent yesterday on gaps and recommendations. JOHN PRUNSKIS: Well, I received an email,
and I think it’s enclosed in this handout on gaps and recommendations. But there are multiple phrases and words et
cetera that in its current form, I think some of us would have trouble voting on. So that’s all I’m saying. But I remember you said also, Dr. Singh– And my recollection now that I’m 62 is fuzzy. But you said that it’s a breathing, living
document. And I don’t think anybody wants to run out
of time. So maybe even after this meeting, there will
be opportunities for discussions. So thank you. VANILA SINGH: So in case it wasn’t clear today
this is an initial recommendations set. We will be voting on it tomorrow as it is. And it will be posted for a 90 day public
comment period to follow. [INAUDIBLE] If need be. And that’s it. JOHN PRUNSKIS: OK so what do we do if we have
specific issues with specific sections and phrases in this draft recommendation? I thought that, again, maybe I was wrong. I thought we were going to have a chance to
discuss those as a committee and vote them up or down. VANILA SINGH: That’s what we’re doing tomorrow. JOHN PRUNSKIS: But I are we just say we’re
accepting them? Are you going through each section? VANILA SINGH: No. We’re voting up or down as was explained in
the subcommittees the last couple weeks and in multiple e-mails. JOHN PRUNSKIS: Right. So that might be problematic. VANILA SINGH: That’s OK. JOHN PRUNSKIS: It’s something that has to
be looked at because there are certain things in here that some people have what changed. How are you left with voting something up
or down when it’s not the entirety that you’re having a problem with, but certain sections
of it? VANILA SINGH: Linda? LINDA PORTER: So I wanted to actually talk
about the evidence base for some of these complementary modalities. And so recently the AHRQ did have a systematic
review on a number of these different modalities, not in specific pain conditions, some of the
more common pain conditions. And also in recent conversations that we’ve
had with CMS, we’ve been sort of taking a deeper dive into some modalities that weren’t
covered there and really looking at what’s out there for the evidence base. And I think for many of these modalities there
actually is a lot of evidence. It’s not necessarily systematically done across
pain conditions, and it’s not done for a long term. But if you look at the evidence phase for
what some interventions are being paid for, it’s probably not a lot of difference between
the strength of the evidence base or the strength of the evidence for the duration, because
these studies are often done on a shorter term. And we call for studies over a year for testing
the innervation in patients. And literally, those studies don’t exist for
much of any interventions, whether they’re complementary or the more what we think of
as interventions that some of the recommendations are regarding. So I would argue there actually is a fair
bit of evidence for some of these modalities. And I think when Dr. Ling comes tomorrow and
talks about how reimbursement determinations are made, they’re not based on a we will pay
so much money for all the interventions that could possibly be given. They don’t really actually look at the cost. They consider that the benefit to the patient
and the outcomes of the modalities. VANILA SINGH: Thank you for that. Dr. Ling who is deputy CMO and who had made
generous time for our subcommittee to learn about how CMS works did make a point that
might answer some of your question about coverage. And that’s something that when Dr. Koroshetz
was here just now, we were talking about they have something where they provide coverage
with evidence development, meaning it’s promising. And so in this arena with what Linda just
referred to, there is enough of a suggestion with these various modalities that there’s
more promise. And zero sum game, I think we just have to
look at it was a return on investment, because many people do end up going to the emergency
rooms often don’t have many options. And we’re trying to step back. And it’s actually not that new. Before managed care got involved. Multi-disciplinary clinics existed. And so it’s part and parcel of that. And I think we’ve called for some better understanding
mechanisms for some of these complementary, alternative, or nontraditional means. And so that’s the way we’re looking at it. LINDA PORTER: I just make a quick clarification
on the comment that Dr. Koroshetz made when he said evidence based on promise that it
would work. So that is what CMS is looking for promise
that it will work in their patient population based on evidence across the full population. VANILA SINGH: That’s right. LINDA PORTER: So it’s not to suggest that
there is no evidence, but we just think if there’s promise. There actually is evidence, but they are looking
specifically at those over 65. And it may not have been tried specifically
in trials for those groups yet. VANILA SINGH: Great point. That’s very important clarification, because
they have their demographic who they cover for. And then let’s see, I just want to make sure
I’m in order here. So Lin is done. And then let’s go to Dr. Sandbrink Dr. Tu,
Dr. Zaafran, and then Mary. And then over on this side– oh OK. Finally, very good. I feel like am always– I’m sorry. Or actually you know what? We could hold. But let’s start with Dr. Cheng. We’ll go down this way just to be fair, because
I have no idea when you come up. JIANGUO CHENG: Well, many of the interventional
approaches, the patient population will be very different from the ones we use in alternative
or complementary medicine. For example, fibromyalgia, very few people
want to do any intervention in this population of patients because the efficacy is usually
very dismal. But for tai chi, for instance, there’s several
publications, including one in the New England Journal of Medicine has acquired pretty high
quality evidence supporting the efficacy in that patient population. It’s very difficult to treat population. It still can be beneficial. So therefore, I think the all the different
modalities of treatment have different all depend on the patient’s need. I think this is something we need to emphasize. MICHAEL LYNCH: Just because I’ve had the opportunity
to talk to a lot of peers in the last couple of months about this issue. And they all are pretty adamant about this
at this point that we shouldn’t look at this as a zero sum game. For those of us, for, example, in the pain
field that are more that are less enamored with interventions and surgery than others,
it would be a mistake for us to say, well you don’t have very much evidence to do those
things. And thus, let’s stop doing those things and
pay for some of the things that we think are more effective therapies. And they all, to a person, say that’s a terrible
way to look at it, because that is not how they make coverage decisions. They make coverage decisions on the merit
of the therapy like Linda said. And so all we’re going to do by thinking of
this as a zero sum game is shoot our aggregate feet we will because we’ll get powerful groups,
very powerful lobbies that want to be able to continue to do those things that will start
fighting the work of the task force. And so to a person, they said don’t look at
it that way as a zero sum game. That’s not how we look at it as payers. And it really shouldn’t be the way that any
group like this really looks at it, because they may end up then harming themselves by
pitting these therapies that we think need to be newly reimbursed against things that
have been historically reimbursed. VANILA SINGH: Basically, it will come back
to bite us all. MICHAEL LYNCH: Exactly, right. VANILA SINGH: Dr. Gallagher? Oh you were– OK. Anybody there you go, doctor. NICHOLAS HAGEMEIER: I’m usually quick to think
and slow to talk. But I appreciate serving on this committee. And I appreciate bringing attempting to bring
a non-physician perspective to a group that’s a majority physicians. And I’ve been reflecting on a couple of comments
one was a patient comment that was shown that I’ve been warned that pain clinics are not
a good solution. And I’ve been thinking about that and applying
that. Trying to think about that where I hang out
in South Central Appalachia, that’s a very prominent perception among primary care physicians. I know I’ve worked with them, and I’ve interviewed
them. We’ve done statewide surveys. Just to give you some feedback, here are the
stats. So among primary care physicians, they were
asked what percentage of medication assisted treatment providers in your state are engaging
in evidence based care. So among physicians, they estimated 32% of
their colleagues. When asked the same question about their pain
management clinic colleagues, 44% are engaging in evidence-based care. So I say that because access to treatment
doesn’t necessarily mean that folks will refer to treatment, because there’s a lack of trust
that underlies a lot of it. And I can’t speak to that nationally. But I can tell you in Tennessee, that is the
case. And it’s the case with pharmacists as well. So we need to think about that. And I think part of that has to do with stigma
within the professions, which comes to Bruce’s comment, and I want to echo that. And sub-committee three is probably tired
of hearing me say this. But I think we need to set the report up to
allow every health profession to bring their best to the table. And when the language is physician and other,
that’s going to be a tough sell. and I certainly value the physician perspective. And we’ve discussed, and Sherif, you’ve mentioned
the ship, the captain of the ship. I would like that there’d be other people
on there with the captain. So I think that that’s what we’re trying to
do when you allow everybody else to bring their best to the table and do that in an
evidence-based way. But allow the other professions to the table. I think that was the. I felt like there was one other thing. That’s it. Thank you. VANILA SINGH: Thank you, Nick. I appreciate that. Mary? MARY MEAGHER: Yeah. First, I’d like to echo the concerns about
the language for providers, that we just use the term provider. If we truly are adopting a biopsychosocial
social model, the psychosocial matters. And the different disciplines really need
to be empowered to be effective. And there needs to be mutual respect across
disciplines. So I just wanted to reiterate that because
I think it is an important point. Then the second issue is I wanted to also
echo the issue of alternative medicine being characterized as based on anecdotal evidence
is, I think, a misrepresentation of literature. I don’t know this literature as well as I
know the psychological literature. I do know, however, the studies on mindfulness-based
stress reduction and mindfulness approaches to pain management. And there’s a pretty strong evidence base
for that. And the effect sizes are comparable to the
effect sizes that you get for cognitive behavioral therapy or acceptance and commitment therapy. So we have to be really careful not to minimize
those approaches. That’s all I had to say. Thank you. VANILA SINGH: Molly, go ahead. MOLLY RUTHERFORD: I just want to speak to
what Nick was saying about pain clinics and the stigma around that. I’m not sure why, but it seems that, especially
currently in Kentucky, a lot of pain clinics are being targeted for fraud. And I want to say as someone who has worked
within the system for both the hospital system and then for a patient centered medical home
that fraud is not unique to the pain management space. It is a problem with our health care system
due to the complexities of billing and coding and people just trying to keep their doors
open. We’re seeing it with toxicology. I personally was involved in a case around
complicated lipid testing with a company that went bankrupt. And I was named in the bankruptcy litigation,
even though I wasn’t involved in what was going on. So I think maybe because of the opioid epidemic,
pain management clinics and maybe addiction clinics are being targeted more highly for
fraud. So I think that’s part of the stigma around
people not wanting to– when you see on the news that a pain clinic is getting closed,
it just sends a bad message. So that was my one point. And then the other, we talk about reimbursement. We talk about payers. And again, I know this is not a committee
to reform health care. But if we could somehow empower patients with
their money or even if the money came from the government, if they had some kind of card
similar to like an HSA account that they can use for modalities that may not be covered
or maybe kind of new so they’re not completely approved or covered by Medicare. But with people with their HSAs, they can
use them to buy an Apple Watch. They can use them to get massages. They can join gyms. So if something similar were available, we
don’t have to call it an HSA because I know the politics around HSA are not favorable. But if we could somehow empower people to
have some of that benefit in their control and they can spend it how they want. Just a thought. MARK ROSENBERG: Within guidelines. MOLLY RUTHERFORD: Right. The government or we could still have oversight
in that. Certain places would be on the list of where
the card would work. VANILA SINGH: Do we know that currently if
FSAs or HSAs cover any of our modalities on the CAI? Does anyone know that? MOLLY RUTHERFORD: They do. Acupuncture for sure. I’m pretty sure I’ve had some patients use
Flexible Spending accounts for acupuncture. Absolutely. VANILA SINGH: I’m just wondering if that might
not be something that we could say to put these modalities on those lists, because someone’s
determining what gets on that list and what doesn’t. There was a time when Tylenol and NSAIDs were
on it, and they’re off of it. But whatever that body is– I’m forgetting
the name. There is the name. Is it MedPack? Oh yeah. There is someone that we can perhaps while
CMS is determining which ones make the cut and third party payers are– I mean this wouldn’t
be for this time, something that in that 90 day public comment period if there’s other
folks who want to comment on it, we’re putting it out there. Perhaps that might be something that we can
ask would be added to that list that they can then utilize. It’s a bad idea. Oh, go ahead, Friedhelm. FRIEDHELM SANDBRINK: Yeah. So that actually was one of my two requests
that I have that we maybe flesh out what we understand are these contributary integrative
health modalities, really I think to going away from bundling them all, but look at the
ones that are actually evidence-based. Some of them have very strong evidence. Dr. Cheng already mentioned fibromyalgia has
tai chi in group settings, which was not just in the New England Journal, but also in the
British Medical Journal just earlier this year, phenomenal results that clearly medications
don’t reach yet, at least as far as we know. But it really brings us to the point also
that we have to truly study the evidence of these modalities often in comparison or maybe
in conjunction, because they’re used as an integrated modality. That aren’t used separately and in isolation. And that brings me to the point that we should
probably, at least in my opinion, avoid the language that there are alternatives. And I would probably try to strike that completely. It gives both patients somehow the sense that
this isn’t something that’s embraced whole-heartedly by everybody, that it’s as an alternative
to maybe interventions or medications. When, really, it’s probably best used in combination. So I would really maybe go away from that
language completely and just call them integrative health modalities. Truly, understand that they are somewhat complimentary
and maybe use that CIH model. I know the NIH certainly struck the alternative
out of that. Yeah. So in any case, that’s one of my suggestions. The other one is because language is so important
also when we talk about physician versus non-physician providers, that was already mentioned. I would like to include in the education–
we talked about public awareness, patient awareness, physician education. I want to make sure that everybody on the
team, the whole entire interprofessional team is educated. That starts with a staff who is a receptionist,
as well as a nurse who does the vital signs, that they always speak the same language and
understand the importance of an integrated approach, because inconsistent language is
a detriment. VANILA SINGH: But we’re saying we need pain
receptionists, just think about. FRIEDHELM SANDBRINK: No. I think but if the receptionist speaks in
a language that supports an integrative model, obviously we need to validate the patient’s
pain at every level where we are but. We also need to have a positive expectation
in regard to the different modalities that are available used in conjunction. And an inattentive you know poorly placed
sentence by somebody who is maybe not the medical provider prescriber can truly provide
significant harm and undo lots of good of what other people are trying to do, whereas
a supportive comment from the nurse, from somebody who checks in the patient can truly,
I think, enhance the success of our treatments. So I would like to have the education of the
whole team included, not just as a physician provider and the patients and maybe the public
awareness. VANILA SINGH: So how would you say that? FRIEDHELM SANDBRINK: No. I think if you in our recommendations truly
educate everybody who is involved with the patient about a biopsychosocial pain care,
creating awareness that it is not limited to biomedical approaches, but it’s a whole
person approach. I think we do that not just for pain. We’re certainly trying to do it also in regard
to diabetes or cardiac conditions where we emphasize nutritional aspects, exercise stress
management, sleep– the whole gamut of whole health approaches. I think that is something that everybody who’s
in the medical field should support. VANILA SINGH: So society. FRIEDHELM SANDBRINK: Yes. But I think if you are interacting with a
patient in a professional capacity, I think you have an even greater responsibility to
make sure that your health care that you deliver in that system is consistent. VANILA SINGH: And I get the ideal look of
that. I think it’s just a matter of whether we’re
creating barriers to people who take it and then find that someone’s not qualified to
help when, in fact, getting staffing and clinics and things are already challenging. I mean, I understand completely what you’re
saying. Let’s see, we did get everyone? Oh Dr. Zaafran, Dr. Tu, and then Scott there. SHERIF ZAAFRAN: Thanks. I just wanted to kind of address a couple
of things that were mentioned. When we talk about physicians, as well as
all other providers, I just want to make sure that we emphasize that everything starts with
the diagnosis. And after a diagnosis, you have a prescription
of a treatment plan that involves everybody that’s involved in that fashion from a multi-disciplinary
standpoint. So when we talk about the idea of a captain
of the ship as well as navigators and so forth, the idea is that it’s got to start somewhere
with actually coming up with a formal diagnosis. And everybody who’s involved in the treatment
plan from the physical therapist to the pharmacist to the nurses to everybody else– and the
treatment plan or the diagnosis, if it’s a dental issue, could be the dentist who’s actually
forming the diagnosis to begin with. But the point is that it has to start somewhere. And when you talk about a captain of the ship,
there can only be one captain– just like there can only be one chef– coordinating
care. Does that minimize the importance of everybody
else? Absolutely not. And the whole point of what we’re talking
about from the pain navigator standpoint or from everybody else’s standpoint is that there
has to be an open line of communication to make sure that the coordination, the implementation
of a treatment plan for a pain patient, whether it’s acute or chronic, has to be absolutely
done in a proper fashion. But nothing starts unless you have a proper
diagnosis, somebody saying, you have pain because or you have pain, and this is what
we need to do, whether it be acute or chronic. As far as the pain management clinics, I have
a little bit of experience in this because my other hat is a regulator. And in Texas, we have what’s classified as
pain management clinics. Some are licensed. And after our last legislative session, we
have non-licensed pain clinics. All that means is that any physician that
prescribes opioids, or what we call dangerous drugs, which includes benzos and soma and
barbiturates, to more than 50% of their patients would be considered a pain management clinic. All that means– and we had to have a lot
of education of our providers to make sure that that was clearly understood– is that
all that meant is that you have to follow certain guidelines to make sure that you’re
taking care of those patients properly. What does that mean? Having a proper medical record, having a proper
treatment plan, the stuff that we already know has to happen. The concern that is absolutely valid is that
the perception out there is that we’re coming after you. And we put out multiple newsletters out there,
making sure that providers were completely aware that, no, that’s not the case. In fact, we don’t want you to stop prescribing
opioids because that is going to just drive patients into a dark area. It has to continue here’s the construct of
how that would work. So from the standpoint of education and how
we structured it here is to deconstruct that whole stigma that’s out there, to make sure
that patients feel safe that they can go to a pain clinic. It’s stigmatized right now because we’ve allowed
society to stigmatize it, for whatever reason it might be. And our job as a task force over here is to
de-stigmatize it to, put out what we think it should be– that it is a safe place, that
if you aren’t able to get it from that place, that there’s a mechanism to be able to be
steered toward that so that you can continue getting your care, so that you can continue
getting the medications that you need, that if you do not have that if you’re not able
to get it from a pain clinic, that you can go to the emergency room, and you’re going
to be able to get it properly. Or you’re going to be able to steer it in
a proper way as we have in our specific recommendations. So from the standpoint of making sure that
we take what we have that may not be working and put guidelines and recommendations out
there to make it work so that patients can get the care that they need, whatever it might
be– whether it is continuing to get opioids or whether it’s a multi-disciplinary plan. Whatever it might be, they’re able to do so
in a safe manner. Again at the end of the day– and I’ve said
this many times– we don’t want perfect to be the enemy of good. We’re trying to make it work for everyone
as best as we can. And the last comment that I’ll make– the
subcommittees, I know, did a lot of work in making sure that we came up with gaps and
recommendations. And as the subcommittee chairs talked about
this, I don’t think we really changed any of that. I think we simplified a lot of it. We may have consolidated a lot of it. We wanted to make sure that we were mindful
of what other subcommittees’ opinions about certain things that might have crossed over
to other subcommittees were. And we came up with what we thought would
be a consensus in making sure that those who had issues at least got that information so
that we could come up with a consensus set of recommendations along with the gaps that
are out there. I don’t think there’s anything here that we
change from what came from the original subcommittees that I know was deliberated and discussed
on a constant basis week after week after week. So this is not something that came out of
nowhere. VANILA SINGH: It came from the members. Scott? Yeah, no. Oh, Dr. Tu, sorry. HAROLD TU: With due respect to Dr. Zaafran,
I can tell you the culture in the operating room has changed. I as a surgeon no longer refer to myself as
captain the ship. In fact, it’s a teamwork oriented approach. But one thing I think is as a full time dental
educator, I believe that report is remiss in not acknowledging dentistry and dental
education as an integral part and especially relevant in the fact that dentists are– VANILA SINGH: –I’m sorry. Say that part again. That does not acknowledge– HAROLD TU: The report says physicians and
other health care provider educators. So this is especially relevant since dentists
are one of the largest prescribers of immediate release opiates and by far the largest prescribers
to young people between the ages of 10 and 19. And so our impact is significant. And in fact, dental education is taking a
leading role in just that, dental education. In fact, the Continuing Dental Education standards
were changed this year, and the following was added to a must, “including considerations
of the impact of prescribing practices in substance abuse disorder.” In the University of Minnesota school, we’ve
carved out six hours of education for pain management, and in fact, much larger than
our medical school colleagues. So I would add that– VANILA SINGH: Six hours in dental school? HAROLD TU: Right. VANILA SINGH: I mean, I don’t know if that’s
less than medical schools. I think it’s much more. ANDREA TRESCOT: No. The University of Washington currently has
30 hours of pain education for– VANILA SINGH: –Pathophysiology and what not. HAROLD TU: OK. So I think it’s how you count those curriculum. VANILA SINGH: But you’re the one who brought
it up. HAROLD TU: So OK. So I think the thing is that I would request
that be edited and added to the final report. VANILA SINGH: So yep. The 90 day public comment period is for this,
all this. We’ve got our product right now, and we’ve
worked hard on it. And people have had plenty of time– well,
actually, I would have loved more time. But we’re on a deadline to try to accomplish
something very important. And I understand completely that everybody
has important perspective and role. And not once in any subcommittee did I ever
feel or hear any one of you who I consider my colleagues say anything negative or demeaning
to anyone else. And so I think that was the spirit that we
were trying to keep. And I think that we’ve managed to keep it. So if there is there’s a nomenclature issue,
that can be brought up in the 90 day public comment period. And we can work that out and make everybody
feel valued as they are, because anyone who knows in the operating room or the clinic
setting that it takes a whole team of folks with different degrees and different backgrounds
to take care of patients. So I hope that that comes out loud and clear. And insofar as other issues, I think that
there are interesting thoughts about what we could get included in some manners that
may not immediately get coverage but we do know has value. And that may be another thing that we can
hear in the 90 day public comment period. So are we almost ready? Our last part act before the senator comes
is really our review, kind of a highlight review of the CDC guidelines, because that
was specifically mentioned in our charge, if you will, in the care of legislation. And so one thing I want to make clear before
we go over those is that the word gap in your document was used because it’s a three letter
word and was shorter than the word inconsistency and update and emphasis. And so throughout, we’ve really tried to look
at what were the items that had to be identified as lacking or inconsistent– so in some places,
identified and valued, in other places not so at the federal, state, local, and private
sector. And so we found those things to be something’s
inconsistent. We also found that some things were better
known today in 2018 and the data that we understand now that weren’t present before, so are considered
updates. We also found things that were emphasized
and stated before but were either missed or misapplied or misinterpreted it and are being
re-emphasize now. So in the overview of the CDC guidelines,
we want to emphasize that, because some things that are criticized about the CDC guidelines,
in fact, are present but were lost perhaps in who knows the various agendas or endeavors. And some things we felt honestly needed to
be expanded on and were recognized as gaps. And so what we’ve done is highlighted those. But in your packets in the quote “G-A-P”,
which represents all of that and the recommendations, it goes a little bit more into detail. And one thing that I want to make clear is
that from the beginning, there was a philosophy that I wanted to keep, which is that the blame
game doesn’t have any place here in our task force. What does have a role is what’s the best we
can do where we are now and what we understand now for our patients in a patient-centered
manner that will improve their ability given the millions of people who are affected, and
what can we do to ensure that that happens? And so we’re trying to be very productive. We looked at all the guidelines in the same
view and took them all together. CDC is being highlighted because it was mentioned
in the legislation specifically. So in that light, I’ve asked Dr. Zaafran–
because he is on the regulators side of things, but he also understands from an anesthesiologist
perspective the importance of acute and chronic pain– to present those, though he was not
on the subcommittee one deliberating it so that it is neutral. And we really just want to send a message
of what we think needs to be improved and updated here in 2018 from the lessons learned
from the last few years, taking into account those that are most important, which is the
public and our public comments and our patients and remaining in a patient centered fashion. So with that, I’m going to ask him to– you
could either get up and stay there, or you can just state it from right here. SHERIF ZAAFRAN: I have it in front of me also. OK so I just wanted to emphasize that number
one, this was in many instances a reinforcement of a lot of the guidelines that were there,
maybe a clarification of some of the gaps that were perceived that were there, and the
importance of making sure that the message that was given to providers and to patients
out there was consistent with all the recommendations that we had. So as such, the key recommendations that we
put out there– and it’s not inclusive of everything that we have, but these are the
main ones– was number one to conduct clinical studies or complete systematic reviews to
identify which subpopulation of patients with different chronic pain conditions may be appropriate
for long term opioid treatment in conjunction with the various non-opioid modalities. Again, we’re trying to state it in a very
clear fashion. It may not necessarily conflict with the original
guidelines. But I think it’s an attempt to make sure that
it’s very clear what the intent is. The second part is to develop guidelines for
tapering and dose escalation for subpopulations of patients with chronic pain conditions that
includes consideration of their co-morbidities, again, with the understanding that tapering
or escalation is not a one size fits all. It depends on the patient, it depends on their
treatment plan, and it’s got to be thought of as such. The third is that once a stable dose is established
for at least two months, avoid increases in dose until the patient is re-evaluated for
the underlying causes of the elevated pain. And in many other places we talked about making
sure that there is compensation for the patient to be seen by a physician for an adequate
amount of time to be re-evaluated and reassessed and to make sure that if there needs to be
a change that thta’s properly established. The fourth one is to discourage the use of
arbitrarily defined and MMEs on daily dosing limits and chronic pain management, and utilize
established and measurable goals such as functionality, Activities of Daily Living, and quality of
life measures. Again, we understand that there are patients
who are opioid naive that a small amount of enemies may not necessarily make sense to
them. We also know that there chronic pain patients
who, again, may have been on magnitudes of MMEs that is appropriate for them. And we want to make sure that that is looked
at from a functionality standpoint, from an Activities of Daily Living standpoint, from
a quality of life standpoint in assessing it and not having some arbitrary number that’s
out there that may confuse a lot of providers and clinicians. And the final one is to undertake opioid tapering
or escalation with a thorough assessment of the risk benefit ratio. This should be done in collaboration with
the patient whenever possible. Again, we want to make sure that the patient
is involved in the decision making process here, especially when it comes to escalation
and to tapering. If the patient’s is not involved in that decision
making process, chances are it’s not going to succeed. So we wanted to make sure that that was part
of the recommendation that was there VANILA SINGH: More details, they’ve been passed
around for the last couple of weeks. So I think all of you have them. But this is for the public to see what the
key recommendations are. And once again, it’s to understand the individual
differences that exist with underlying medical issues, differences that exist in metabolism–
rapid and slow metabolizers– differences that exist in terms of what goals are there,
and ultimately clinical decision making at the end of the day with the person who is
taking care of the patient and the patient themselves. So with that, I think we’re very close to
having Senator Cassidy here. ALICIA RICHMOND: We have [INAUDIBLE] here. VANILA SINGH: Oh yes. OK, good. I get to do my reflections. That’s where you just get to hear me talk. So we’re just going to review basically. OK, thank you. I was just looking through my notes actually
from the whole day. And so we’ve had a lot today. And I just want to first start off by telling
you that when I was reviewing what we’ve done this last summer– it was May 30th and 31st
that we all just got to know each other. And I know the application process was long
and prolonged, and there were many regulations and rules. And sometimes it’s not obvious. And it was clearly not obvious to me, because
it wasn’t that long ago that I was outside the federal capacity, and then I was here. But we suddenly came here. And there’s been a lot of rules. There’s emails that go around. Our intent at all times was to protect the
integrity of this very important task force and that people on this task force bring amazing
perspectives. People in private have shared with me their
great concerns about taking care of this patient– a very vulnerable community at large. As we can see, it’s millions of people, 20
million alone at chronic high impact pain and then 50 million or more, depending on
the source, who have pain otherwise that affects their lives tremendously. And I think that we’re an advanced society
when I think it was John [? Banneker ?] who began to describe the various different types
of pain syndromes and mechanisms and really showcased the complexity and amazing capacity
of our neurologic system and the neuroscience that goes with it. And there is much in the way that I hope is
coming forth with the pharmacology and the physiotherapy and the procedures and the understanding
of a chronic disease being looked at from a biopsychosocial model and that we are advancing. And so when we looked back and saw that it
was just May 30th and 31st, and then everybody took a little bit of a break. And then we had a sequence of weekly 90 minute
meetings where at first it was getting to know each other, putting out thoughts, so
sometimes us discussing, but pontificating as well, because like there’s frustration. And then we had to get those thoughts on paper,
get content, and then begin to formulate that. That was a process that was done with everybody
here present, that everybody contributed in some form or fashion with all their history–
whether it’s from the federal side of things, whether it’s from the emergency room or the
operating room or in the clinic. So it was a long time in the meetings, but
it was a very short quick summer. And from that to this where I think we’ve
responsibly tried to be balanced and fair and take agendas out and just put the patient
first with science and compassion, it amazed me. And I especially want to thank our subcommittee
chairs, Sherif, Molly, and Mac, who literally we would get on a phone call at 7:00 PM and
end the night at 4:00 AM after we were going through and trying to wordsmith and really
protect what people’s thoughts and ideas were. And then of course, Alicia who’s been present
with me. And so we’re not done yet but, it’s really
more a motivational factor that it’s not lost on us, what everybody has done and certainly
our team our administrative Booz team over there. So we have tomorrow to vote. But really in reflection right now, I was
just thinking, wow, this is a lot. But to add to that, of course, we have more
things that we were thinking of. And some of those things that I think were
emphasized today was the no one size fits all, which Sherif just said. But this is something that has come from many
different people on this panel in various times– the patient-centered individualized
care. Today specifically, we also got a chance to
re-review the Poison Center, the risk and benefits, what it does. The issue of access meds that exist out there,
I think that’s a real issue where oftentimes perhaps the person who’s prescribed the meds
is the one that’s held culpable. But in fact, we know that there’s excess meds. And people who maybe suffer from addiction
as a disease will figure out ways to get those meds. And we are the Acute and Chronic Pain Task
Force, but we’re still trying to help solve some of that. By calling for acute pain guidelines for common
surgical seizures, we can perhaps cut back on some of that. We can also mitigate opioid exposure through
multimodal approaches in the operating room, with pre-medication and infusions and nerve
blocks and smart non-opioid medications or in the larger scheme of things, with greater
understanding of the importance of behavioral health and coping skills and catastrophizing
skills. But at the end of the day, we also know that
as it sounds right now, opioids have a value in acute and chronic pain and how to get our
colleagues to have the tools to do the risk assessment, the periodic revaluations to keep
our patients safe, but also provide them the pain relief that’s necessary to often rehabilitate
and keep their lives keep going with their ADLs that have their quality of life and keep
their jobs often. There’s a great economic burden that goes
along with this disease. And I think Mack and I were talking about
this the other day, but it really supersedes a lot of different disease processes that
affects the endocrinologist when they have patients have diabetic neuropathy. we know that in the cardiac, world we’ve been
doing paravertebral roadblocks for those patients who have the– it’s just escaping me right
now– those cardiac surgeries with the small vessels and hip fractures where we do the
femoral nerve blocks and our other colleagues who do kyphoplasty for spinal fractures. And there’s a lot of different means. So we’re trying to combine all of that so
that patients can basically not only not suffer, but retain their life. And that has come up through and through today. We also had physical therapy and occupational
therapy and other modalities come up, which we can definitely expand on to ensure that
it’s inclusive. I know that the American Physical Therapy
Association was one of the organizations that was very interested to insure those modalities
were there. We’ve talked about the VA and the DoD and
the collaboration there, the need to share information but not just there. But also, outside of there as the VA allows
for more of our veterans to not have to wait but get to be seen on the outside, it’s going
to be that much more imperative. Also, that the tools such as the PDMP are
important, but they’re not error proof and that know they’re shared, but that’s just
one tool. And also to utilize any aberrancy or red flags
as a means to help give treatment and not abandon our patients or rapidly taper them,
which can lead to even worse consequences than that which we’re concerned about in the
opiate crisis. We also emphasized the pain navigator, given
the complexity of our health care system. We also know that NIH may help us with the
portal. That is what Linda said. And so we’re going to hold her to that, possibly. And then we talked about some changes in terms
of how we refer to all our health care providers, as well as how we consider getting the modalities
under HSAs and FSAs and just make treatment access easier. And I don’t know if I– know the other thing
is we heard today from two congressmen, one being a physician and very involved with the
opioid bills who came here made mention of the avoidance of the rapid tapering, and the
other one who has been very involved with the disability-Downs community and also with
other medical interests and has been part and parcel of supporting NIH and innovative
treatments. So that was very good. We heard from DoD for the first time. They were not at our first meeting. And they are partners in our interagency task
force. So it was really great to have Dr. [? Quartz. ?] Here we heard from IHS again, Indian Health
Services. They have their own set of challenges that
oftentimes are probably harder than what we may see, some of you may see. I think Andrea sees some of that population. And then and NINDS, Dr. Koroshetz sees they’re
on the cutting edge. They have the money now to start to really
look at those biomarkers and other potential innovative means to help treat pain, which
is something that’s largely overdue. So that there was a lot today. And tomorrow, we have some very exciting people
who are going to come speak to us. And that we’ll start with first, we’re going
to do the welcome roll call and call to order. We’ll also hear remarks from the VA representative. And this time it’s Dr. Lucille Beck. She’s the deputy undersecretary for Help for
Policy and Services at the VA. And we’ll also hear from our very own Surgeon
General, Dr. Jerome Adams who’s looking forward to being here and also Dr. Sherri Ling, who
some of you may have already heard from. She’s the Deputy Chief Medical Officer. And she’s giving a talk, and she’s been very
keen. We also heard from the Assistant Secretary
for Health today, who I think in no uncertain terms made it very clear about the value of
the members on the task force. So be nice. No, I’m just kidding. No, it’s important. What I’ve said all along is that we have a
very important opportunity where I think that it’s being seen and valued that what we recommend
may actually in fact translate to care that impacts millions of patients. And I think those are only speakers and then
we will give a brief review of the recommendations more for the public’s sake. And then we will be voting on them tomorrow. The report will be posted in a matter of weeks. That’s the context that surrounds the GAP
recommendations. And then once that gets posted, that triggers
the 90 day public comment period. We will then take those modifications. We will use, hopefully, some more machine
learning– Am I getting a nod from back there– to help us even better understand what the
public are saying, which is really real time data. So that will be very important. And then we will meet again, likely once by
webinars and maybe once more in a one day public meeting. That’s where what we’re anticipating, excluding
any unusual circumstances. And then we’ll sunset at the end of May, a
year from our first meeting. As far as things go, I think that would be
a pretty– what is the word for it– ambitious? Alicia is saying ambitious. I don’t think we have a choice in that. I would say very constructive, highly accomplished
year as things go. And we’re on track for it. So we’re just waiting on the senator. ALICIA RICHMOND: Yes. It is my understanding he should be here,
hopefully in about five minutes. VANILA SINGH: So we could do a five minute
break. But as soon as he comes, you guys have to
come right back to your seats. Excuse me? But as a group, we didn’t discuss the CDC
guideline recommendations. And there was time on the schedule for that. So I have a comment. And that is I just would really appreciate
more clarification. I know there’s a 90 day comment period. But we are here at the end of September. And the materials that we got beforehand when
we did our initial training said that there was going to be HHS and government review
from about mid-October to about mid-December, and then there would be 90 days of public
comment. So I’m just trying to get clarification on
if we’re just recommending that these recommendations go to public comment or if we’re voting on
something else, and there’s going to be another time where we vote on a report. If we could just have clarification on that,
I think that that would be really helpful. ALICIA RICHMOND: So this is Alicia. And I would say in terms of these are the
draft recommendations. And in terms of the initial what you’re citing
in terms of during the administrative meeting, in terms of the timeline, the purpose of this
meeting today and tomorrow is to cover the draft recommendations. And what Dr. Singh was also sharing in terms
of there being a webinar, that would be to have for the final recommendations once we
receive feedback from the public comment period, as well as receiving feedback from our other
stakeholders. So I wanted them to be able to identify for
the group in terms for the purposes we were able to consolidate the draft recommendations,
which is what you had before you. And in order for us to move forward with having
the 90 day public comment period, we wanted to be able to put these draft recommendations
based on the subcommittees and the content from those to be able to have this meeting. JOHN PRUNSKIS: Can I ask a follow-up question? Thanks for asking that question. So I’m just asking for a little bit of clarity. And we’ve had great meetings so far. We’ve provided input into our subcommittees. And then decisions have been made by the leadership
of what words or phrases to include. To my recollection– and maybe I’m looking
at this wrong– we’ve never gone through certain things and had a vote all in favor, aye, all
opposed, nay, on different sections. So is our role to make recommendations to
the leadership of the task force so the the final report will be the report of the leadership
with input from members of the task force? Or will it be the final recommendations of
the task force? Because without a vote all in favor aye or
nay on each one of these points– and maybe that’s going to occur down the road. That’s where I’m looking for the same clarity
where right now there has been input. It goes into the leadership. Decisions are made. A draft is produced. But there are certain things that I know some
people would like to see improved. Will we ever have an opportunity to go through
section by section, does anyone have any recommendations, and if they are, what are they? A short period for brief debate and then all
in favor, aye, opposed, nay, and then move on to the next section. That’s my question. VANILA SINGH: So John, we looked at the rules
and regulations on this. So we’re going to be voting on them as a group. And if anyone has any particular item that
they don’t want, they can just let us know, and we figure out a way to make note of it. JOHN PRUNSKIS: I guess what I’m saying is
that– maybe it’s just me. VANILA SINGH: It could be. JOHN PRUNSKIS: I feel that there’s such a
talent at this table that if one of us has something to say, I’d like to hear perhaps
a brief live debate from the members at this unbelievably talented group. And if anyone else if no one else shares that
sentiment, I’m done. But right now I feel that we’ve done a lot
of great work. And it might be a better way to rephrase it
is unless there’ll be time to do something like that, these are the findings of the leadership
of the task force that was given input by its members. But again, maybe I’m looking at it that way
differently than some of the others. VANILA SINGH: So this was the input given
by the membership to the leadership. JOHN PRUNSKIS: So then this– I’ll stop talking. I don’t know. I don’t want to make a big deal. So this is the leadership’s consolidation
of the members input, correct? VANILA SINGH: That’s correct. Leadership also are members too. So it’s not that no one else had any input. Every member had input to the extent that
they wanted to. Some people did a lot more work. There’s a timeline. I mean, there’s nothing we can do but BRUCE SHONEBOOM: Can I make a quick comment? VANILA SINGH: Please. BRUCE SCHONEBOOM: On the agenda tomorrow,
it says presentation, deliberation, and vote. Are there opportunities to deliberate any
further on the report, or is it strictly presentation info? Is there no more discussion? VANILA SINGH: It’s presentation and vote. BRUCE SCHONEBOOM: Finally, I’m just going
to highlight in section 1.14 the interventional piece. I was not aware of some of the language in
that until today. And I plan on voting no just because it restricts
the accreditation and the recognition of providers who do interventional pain management to physicians
and those that are go to a ACGME fellowship trained fellowship program. There are other accredited fellowship programs
out there for other providers. And there are other regulators that are regulating
other providers that are doing interventional pain management. And so without modification of that section
and particularly recommendation 3b, I plan on voting no on the report tomorrow. VANILA SINGH: Thank you, Bruce. Dr. Losby, go ahead. JAN LOSBY: Thank you. So I also share concerns that have been mentioned
by other force members, specifically around if there is an opportunity for federal members
to review, because that was in the earlier timeline. And so will it now be after the 90 day public
comment period? VANILA SINGH: It’s going to be at the same
time. JAN LOSBY: At the same time. VANILA SINGH: If they’re treated the same
way. JAN LOSBY: And then my other comments are
related to CDC’s guideline. And so I certainly appreciate the sort of
nuanced approach and how the word GAP is intended to be interpreted around both an emphasis,
an update, and an inconsistency. My concern is that the recommendations as
they appear in the document perpetuate some of the misunderstandings of the guideline
itself. And so I would encourage the task force to
consider an opportunity to articulate perhaps in the recommendations organized around emphasizing,
updating, and inconsistencies. Because as they’re currently set forth, it’s
hard to really tease out what exactly is being proposed– if it is an emphasis or if it is
an inconsistency. The guideline itself is voluntary. It’s based on the best available evidence
at the time in 2016. So the point is well taken that the evidence
and research has evolved in the last several years. And so it’s completely logical that new research
would inform the guideline. But also in terms of who guideline is intended
for, it’s primary care physicians. It’s also intended for patients over 18 years
of age. And it’s not intended for patients who are
in active cancer treatment, palliative care, or end of life care. The guideline is very thoughtful in that the
patient and the clinician having conversations around pain management, understanding the
risks and benefits of various treatment approaches, there is specific language connected to tapering,
and that there’s not involuntary tapering or that patients would be abandoned from care. And so I would just urge the task force to
consider how the recommendations are organized and if in fact they’re emphasizing the content
and the science that’s already in the guideline or if it’s perhaps introducing greater confusion. VANILA SINGH: Cindy, did you want to say anything
about that? CINDY STEINBERG: Yeah, sure. In terms of the way these were written, it
seems to me that they’re making updated suggestions of what needs to be done to them and recommendations. And they seem to make perfect sense to me. So if you could point out what parts of them
you’re dissatisfied with that, that would be great. I think we’ve heard from thousands of patients
about what has happened with these guidelines. And regardless of the way CDC has defended
or interpreted them, they’ve been taken as the rule, the legislation that’s been written
around it, the confusion of doctors has led to people seizing on individual MMEs and using
that as a hard stop. And I think the CDC knows that. We all know that. And I think these have done a great job in
terms of what aspects of need to be updated. JAN LOSBY: I appreciate that feedback. I do believe that there is a recommendation
statement specifically around tapering, the tapering guideline. There’s not tapering information in the guideline. And that’s actually factually inaccurate. There is tapering information included in
the guidelines. There have been challenges around implementation. So I think the task force will then potentially
have an opportunity around identifying what are those implementation fixes, if in fact
they’re being interpreted as rules or regulations. So I think there is a way that the force could
identify opportunities for additional research, and at the same time identifying ways in which
perhaps groups that are interpreting the guideline as rules or regulations could be urged to
look at education or looking at training information or also materials that would help better inform
what’s actually contained in the guideline. RENE CAMPOS: If we can better clarify, because
I did have a team member that helped with some of the guidelines. And the DoD/VA guidelines are very similar
in terms of having specific doses mentioned. The idea behind mentioning those doses was
with the amount of risk that was associated with those doses. The unintended effects were being interpreted
as [? ceiling. ?] So that information, I feel, is still useful
to them. Thank you. ALICIA RICHMOND: Excuse me. We’re going to table the discussion for now
so that we can have the honorable Bill Cassidy to speak. VANILA SINGH: All right, great. So we have one more guest of honor today. We saved the best for last. I want to welcome introduce the honorable
Senator Bill Cassidy Dr. Bill Cassidy is a United States senator for Louisiana. And he’s married to Dr. Laura Cassidy, and
they have three children. They are from the Baton Rouge area where Senator
Cassidy attended Louisiana State, LSU, for both undergraduate and medical school. Excuse me, we’ve been talking all day. So for nearly three decades, Senator Cassidy
has provided care for uninsured and under-insured patients in Louisiana’s Charity Hospital System. And during this time, he co-founded the Greater
Baton Rouge Community Clinic, which is a clinic providing free dental and health care to the
working uninsured. Senator Cassidy also created a private-public
partnership to vaccinate 36,000 greater Baton Rouge area children against hepatitis B at
no cost to the schools or parents. Now in the wake of Hurricane Katrina, the
great senator let a group of health care volunteers to convert an abandoned K-Mart building into
an emergency health facility, providing basic health care to Hurricane evacuees. And we know with all the hurricanes of late,
of course, those efforts mean so much to folks. In 1990, Senator Cassidy joined the LSU Medical
Center, following his tenure at Earl K Long Hospital where he taught medical students
and residents while treating the uninsured. Senator Cassidy was elected to the Louisiana
State Senate in 2006. In 2008, he was elected to the US House of
Representatives to represent Louisiana’s sixth congressional district. In the US House, he served on the Energy and
Commerce Committee and supported a conservative agenda. Senator Casey was elected to the US Senate
in December 2014. He serves on the Energy and Natural Resources
Committee, as well as the very important HELP committee, which is health, education, labor,
and Pensions, Finance, Veterans Affairs, and Joint Economic Committee. So he’s still an overachiever. So basically, we are thrilled Senator and
Dr. Cassidy that you’re here to address us, because we’re addressing one of the most vulnerable
populations, both with the acute and chronic pain community and are thrilled that you’re
here to give us some of your thoughts and wisdom. With that, welcome. BILL CASSIDY: My staff gave me a script. I’m going to do what President Trump would
do at this moment and throw it to the side. Because although it’s a great script, I try
to think of that which I thought was most meaningful. Now I wear a couple hats. Obviously, I’m a physician. My wife’s a physician. We used to talk about the chronic pain patients,
you go, oh my gosh, thank goodness for the pain doctor, because I would treat patients
with chronic pancreatitis, for example. And so as you know, they have that chronic
pain. But every physician who’s actually treating
patients deals with those with pain. And we know how difficult it is. And so thank goodness for those who treat
pain. On the other hand, as I was listening to Vanila
go through my bio, I thought, you know, my bio in some sense is a metaphor for what these
folks are doing. I worked in a public hospital for the uninsured–
desperate patients who oftentimes had no recourse or so they felt. And we can say that both of the pain patient
and also of the addict. They are often desperate and they really don’t
know which direction to go. They would love to be free of addiction, but
they fear that pain. They would love to be free of pain, but they
fear that addiction. And they sometimes feel like they’re just
getting crunched in this box. My patients are– actually I’m a gastroenterologist. During the campaign, my laugh line was “gastroenterology
prepared me very well for politics. Sometimes the views seem the same.” But that said, it did. In one way, as a liver doctor, I treated a
lot of patients who came out of addiction. So the wonderful thing about it is I know
that you can come out of addiction. And I know that you can come out of addiction
and have a life which is very positive going forward. The second thing is that I did a lot of public
health. Vanila mentioned the vaccine program. And really, what I imagine is what I imagine
you’re doing is, if you will, public health when it comes to pain. How do we, one, help those who are currently
addicted? But how do we help a whole generation of folks
to avoid addiction? And then how do we actually help the public
health problem of chronic pain? And so it is an application of public health
otherwise. Now let me take off my doc hat and put on
my Senate hat. We are so interested in doing something positive
for the opioid epidemic and for the other issues that are before us. I say if we had as many people dying from
a terrorist attack as die daily from drug overdose, what would be the attitude on Capitol
Hill? But I’m one of three physicians in the US
Senate. My wife doesn’t include ophthalmologist as
physicians, no offense to anybody. So she should say there’s only two. Rand Paul is an ophthalmologist. But in all seriousness– and it takes an education
of my Senate colleagues who are passionate about the issues, who speak openly about a
grandchild dying of an overdose as an example, who each gets calls from constituents regarding
chronic pain. It takes education of us to know that which
is the most, the best, the informed public policy. And that is you. That is totally you. Now I met with a group of great folks last
night who do finance. And I mentioned at the close of it our task
as Americans is to take all the knowledge that you would have that would be for the
greater good and to somehow channel it through my office as a senator into that public policy
which does the greatest good. That is similarly your task before you. And I know you need it. But I guess I’m here only to emphasize almost–
I cannot emphasize enough how important it is, how we will not have wise public policy
that does the greatest good for the greatest number without your input. And our highest, best calling is to take your
wisdom– you’re actually seeing patients, you understanding the issues of addiction,
and that tension that you manage as best as possible to resolve– and to channel in two
ways public policy. So I come to you with humility, because although
I still technically are practicing physician and come from many years seen patients, I
do not even approach your level of knowledge. And I might be one of the most knowledgeable. So again, thank you for what you’re doing. I cannot overstate its importance. I look forward to your final deliberations. If any of you think that you should reach
out to me directly– knowing some of you may be restricted for whatever reason from doing
so– please do so. Because for me, this is about our country
and those patients who are desperate, desperate because of their pain, desperate because of
their addiction, but somehow feel as if they are in a box. You hopefully will give us the key to unlock
that box. Thank you all very much for what you do. Thank you. [APPLAUSE] VANILA SINGH: Let me see what your actual
speech was. It takes a lot of support. Thank you so much for coming. We appreciate it. We know how busy you are. [APPLAUSE] ALICIA RICHMOND: So good evening– good afternoon,
rather. I am closing the meeting for the day. And we will resume tomorrow at 9:00 AM. Thank you. NARRATOR: Produced by the US Department of
Health and Human Services at taxpayer expense.

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