Clinical Care & Research Recommendations

>> Like the other committee chairs I want to thank my group, welcome, Julie, who participated
in our call and our work up to this meeting. A little bit of learning curve, jumping right
in with two feet. For those of you listening or on the webcast,
just a reminder there is a lot of overlap between long term services support committee
and the critical care committee so I'll try to emphasize less on the thingious heard already
and more on some differences. Not disagreements at all but just augmented
things. So under work force, by the way I didn't -- we
didn't get a specific into how recommendations will look in January.
Not written out but just in areas we want to have recommendations some were ones we
already had, some are new things, this is more a framework.
We need to really acknowledge I think as a committee that while research is incredibly
important, preventive strategies and therapies and potentially curable one, they are not
imminent. We have five and a half million people, many
more families affected by this. Our clinical care work force -- we need to
pay attention to that now because these people are not going to go away and not somehow magically
not have this condition. Under work force we need stronger more robust
incentives to work in geriatric. Not everyone that has Alzheimer's disease
is in the geriatric population but there is a huge overlap.
To be more specific about incentive, loan forgiveness exists when you choose to practice
geriatrician in an underserved area but you can say all the United States is underserved
with really full confidence we say that in terms of geriatric specialties or geriatric
or dementia capabilities. So we might need to expand loan forgiveness
for people working in geriatrics anywhere. I'm not about expert on this, I apologize
for the typo but title 7 in the public health services act I know it funds interprofessional
geriatrician education but fully funded and possibly expanded as we need the develop not
just content but sheer numbers capable of dealing with aging and -- yeah.
My fault. I didn't advance the slide.
I apologize. Population.
So that's what highlighting that first bullet, the second one enhancing current work force
to be more dementia capable. We are working with HRSA and other partners
to collaborate on curricula and disseminate broadly. In our initial plan $2 million was
allocateed to HRSA on a quick time line to augment their ongoing projects education and
while that's great I think we need to think about new money and next plan to broaden further.
We have ideas that national program built by a broad constituency of public private
partners needs to be targeted throughout the different health professions when disseminated
broadly. Emergency ROM if physicians, who are on the
front line of caring for people coming to emergency rooms.
Look at transition, quality and appropriate diagnosis of evaluation and management, they
need to be targeted with some specific education about care for people with dementia.
If they don't factor that in, if they don't know how to detect it, remember half of all
people with Alzheimer's disease do not have Alzheimer's disease in their medical record
so even if you have medical records half don't reflect that. Then you really get the treatment
wrong, you get the plan wrong for them. So we're working with our committee is committed
to working with our HRSA partners as a conveneor, as part of the solution for enhancing dementia
capable work force. I don't think we should lean on HRSA to do
all of it. They other not the whole solution.
We're actively talking how to do that better. One thing that's not yet come up is when you
want to leverage change in the quality of care delivered or the dementia capable work
force one that hasn't come up is to think about certificationnd licensure.
So whether you're certified nursing assistant or a nurse at a nursing home or assisted living
environment, you may live in a state where there are opportunities for education to be
more dementia capable in your clinical care. You may live in a state were there are requirements
to work in a dementia facility or program, but every state has different requirements.
There maybe an opportunity here to leverage developing national standards for certification
and licensing for direct care work force that maybe develop consistency and quality and
we think about it not just happening on a state by state basis, there can be some uniqueness
but maybe we can agree on that or at least explore the possibilities there.
Under detection and diagnosis, we have the detection work group recommendation on the
array of work toolings offered. And thank sherry and others and Richard for
leadership in this but I think our earlier discussion illustrated there is a lot to do
from this point forward. So we need to really work on education and
dissemination in a very meaningful way so primary care providers who are the front lines
for the field that they understand the tool, know where to access them, they have options
for different tools and different languages and educational abilities.
Then what to do with the result there is. So you will see that in recommendations coming
forward. I think we still favor the Medicare considering
a comprehensive coverage for diagnosesis and care planning. This is not a detection, this
is a diagnostic visit. Just as a little aside, reimbursement I think
can drive behavior, it does drive behavior. There's many, many examples of that in our
healthcare system and some are bad examples, some are quite good examples of being able
to deliver a more comprehensive product when reimbursement matches the time and effort
spent. We do not have a code for doing a comprehensive
multi-disciplinary evaluation and diagnosis for dementia that includes -- dementia.
That includes care planning we know to be incredibly valuable and will affect costs
down the road an caregiver satisfaction and time to nursing home placement and these things.
So we need to think about this. There's a barrier if the patient is not present
a provider cannot bill for the service and that is also a barrier to good care planning
with families. It would be a reimbursement if CMS would consider
it, that certainly would have a high bar. There would be enhanced requirements for documentation
and for involving paraprofessionals in this care planning or other professionals, intraprofessionals.
And finally, we still need more clarification on HIPAA and dementia care an communicating
with families. This is a vague area, yet incredibly important
area. So for those of you that haven't heard it,
if I'm working with the patient and family and I want to talk to the family about safety
issues in the home and will you check on her an will you -- is she using a stove, things
like that, if the patient says no, you can't speak to my daughter, that's a really tough
spot to put me in. That I have a person ma lacks maybe insight
and judgment about how important those things are to their safety.
That's not a problem, et cetera. Yet I'm blocked.
Effectively I think providers get around it a little bit but it's to their risk legally
I think and we really need more guidance on this.
I don't think our first plan effectively got that.
Not just for this committee, then we would disseminate out to primary care -- front line
providers where they are unable to talk about this with people other than the patient.
Their care team. My next slide talks about the accountable
care act and the medical home. Our current plan suggests subgroup analysis
of existing programs but not any new programs. In other words, looking at medical homes and
looking at outcomes that they might find important among the subgroup of people that have dementia.
But I think think we should consider a specific grant for a medical home just for people with
dementia. That that whole medical home is for people
and their caregivers with dementia. We compare that with some of the other models
where they are integrated into another type of medical hope, that probably wouldn't work
everywhere, especially not in rural areas but it is really worth looking at.
And we should consider asking CMMI to fund one of those as a study.
On multiple chronic conditions we hear, we have heard in David's report and most understand
Alzheimer's disease is a multiplier and makes management of chronic disease more difficult
and costly. But frankly, sitting as I do in a care environment,
there's very little available currently for front line providers to support this incredible
challenge of multiple chronic conditions and when you add dementia in how difficult it
adds exponentially becomes more difficult to manage those conditions with the resources
we have. There have been demonstration projects that
include people with Alzheimer's and other dementias in chronic care management strategies
but none of those are really adopted or incorporated in how we reimburse providers or how we incentivize
providers. There are two CMMIs funned projects in the
first plan, our committee is aware of and applauds looking at community-based dementia
care which involve these chronic conditions as well.
We look forward to hearing their experience but we also want to be sure to point out there
are learnings and best practices already in this area that could be adopted by CMS and
other funders to help now. More research chronic care management for
people with dementia, though there's compelling extended hospitalizations and increased costs
for people with dementia in the healthcare system, there's very little specific in terms
of applying concern to research projects or changing our healthcare system currently.
Lot of room there. In terms of care throughout the stages which
is part of my subcomittee as well a specific charge chronic conditions is in there too,
I'm no policy expert obviously but there are many accordances that could make significant
differences. There's a lot of opportunity for CMS to lead
here and we look forward to ideas that we can work with them on.
Acknowledging that reimbursement is a strong motivator or influencer on behavior of providers.
Eric hall outlined these couple of ones I list as bullets here, as possible policy changes
and David acknowledged that as well with the tax credit.
We spent time on our call speaking about advanced dementia.
So briefly we talk detection, diagnosis an work force issues, transition and hospitalization
areas, now moving to more advanced dementia, we see this as a very hypoyourty on our committee.
-- high priority on our committee, coordinated care is costly and there's evidence now that
the care we do provide for dementia is not just costly but it's not quality care, it's
burdensome to patients sometimes promotes worse outcomes.
So we think that improvement in this care arena, can make differences quickly in our
system. We maybe waiting for some years for a meaningful
treatment but we could really change care quickly in this area.
Many areas that have been identified in advanced dementia dove tail with current CMS initiatives.
I outlined those so those are quality initiatives within CMS but we can Augustment the power
of those initiatives by including people with advanced dementia and leveraging that.
I had -- we had a few researchers and leaders in the field speak to us on our conference
call about where research can identify quality innovation, what policy incentives promote
best practices and beginning to address the disconnect between Medicare and medicaid for
this growing population and vulnerable group. We are going to strongly push recommendations
sorry it was this way. That we -- that CMS and other appropriate
agencies and sherry in her division is going to look at who should be at that.
Bringing together a blue rib Bob panel of experts -- ribbon panel of experts an researchers
to guide policy suggestions and research suggestions for the future.
So that will be a strong recommendation. Finally in terms of awareness, appreciate
the website obviously and other opportunities around raising awareness about this.
But feel we have thought to parallel campaign for health professionals an emphasizing important
of of early detection and managing the Medicare wellness visit, hey this is a problem, look
for it but these are the tools you have to look for it.
And offering resources as well for providers as well.
That hits our topic areas on our subcomittee. But we'll be looking more at details recommendations
in to the next meeting as we formalize that for the January meeting.
Questions.
>> Thank you, Laurel. Questions, comments for her or her group?
>> >> When you use the term geriatrician, we
talk a broader definition, not justify sessions, right?
Or are we?
>>Ieria trick nurse practitioners.
>> When I spoke about people capable of caring for an aging population I was talking more
than doctors, yes.
>> In the first category? Back to the first slide.
>> In terms of work force?
>> Yeah, definitely. Joan can speak to that what their target audiences
are at HRSA too.
>> My other question is terms delivery and coordination.
Those are terms we use. It sounds like coordination is easy thing
somehow, we deliver care and have to get people talking to each other.
But we undersell it with those terms and that what we're talking about is team work clinical
getting information to the right people to make clinical decisions at the right time.
Just because you have a nurse practitioner working with a geriatric doesn't mean communication
works or any of that. So I worry about using those terms kind of
undersells. We use those terms all the time but I think
of it as, we have a lot of different models of organizational care a lot is how people
communicate and who leads and what are the roles an it gets down to the microlevel, if
we don't understand that, we don't know if the delivery is really going to happen and
coordination is going to happen.
>> I don't disagree with you at all. I don't know that the complicated fragmented
healthcare system is not all our purview here. There's a lot of moving parts but where it
touches the care of people with dementia is where we're trying to focus our attention
so some work force development is training new people coming to the feel about geriatric
principles and dementia principles. And making them dementia capable so new people
coming in might be better advocates to communicate about what their --
>> Some of the training should be about working together as a team and developing roles that
are not just specific to if physicians specific --
>> That's one of the standard operating manual things about geriatrician, it's a team approach
all time taught, emphasize, Joan can -- and our trainings are legislatively mandated to
be interprofessional. So the geriatric education centers train four
or more disciplines which must be met as being and Charlie know we explore the use of our
team steps as additional training for this group.
They're familiar with the concepts required to deliver interprofessional education an
interprofessional care. This team takes that to another level and
includes not only health professions work force within a practice but also includes
non-professional staff which are key component, your receptionist some days could make our
break your life. So we're looking to that but rest assured
these trainings are interprofessional.
>> I would also point out we can train people effectively.
Say we can do that. Retrain the ones effectively to be dementia
capable. When we have a system that silos people and
treats them differently from what's expected from them, example skilled care in the nursing
home and what their outcomes -- what they paid for, what they're incentivized to do
could be very different and almost at odds in some cases, to the best care for that person
over time. To the extent the system needs to get aligned
and out of the way we can also consider system design issues not just work force issues because
we can hinder their great training by the system.
>> Also I would like to address Laurel's earlier point about licensure and certification.
And from a health profession's perspective, the best way to integrate whatever principles
you're trying to foster, this case in this case dementia care, so one way to get that
integrated to health professions curriculum is require it on a licensure exam.
From there everything Cascades -- questions, you don't have to have a lot of questions,
2 or 3 questions but if it's on the licensure exam, the accreditation bodies for education
will include it as one of their standards the health profession schools will integrate
into their curriculum and then will be institutionalized into the formal education of health profession
students. So that's something we can definitely work
with, we workedded with accrediting bodies in the past to get geriatrics content on licensure
exam and into accreditation standards as well as concept of interprofessional education.
AAAMC now has standards, WACN have standards of interprofessional education.
Pharmacy, physical therapy, there's several disciplines that require that.
So this is another area we can work with the accrediting licensing bodies.
>> Just to add to that, this is sherry. Changing behavior is as Laurel has articulated
is no simple matter. There's behavior -- in order for what we achieve
to be sustaining, it has to happen in parallel both people who are already in practice and
out there as well as the pipeline. So part of the effort that we work on is with
training new professionals but there's also as you mention, incentivizing changing behavior
than those already in practice. As such we too at CMS engage in conversations
with professional societies to make this about professionalism.
About doing the right thing. The patient at the center focus.
One question back will be how important will it be and what would it look like if it were
dementia specific or dementia centric as opposed to just general patient centered goals of
care. Along that line one other area Laurel mentioned
worth emphasizing is when all is said and done, the challenge of care planning is really
front and center and central to all that we do.
Operationally, what that actually looks like is really important.
How might we operationallize the measurement of care planning.
I'm not saying it is ours to do but if we can actually articulate the driving principles
would be, that one would meet in order to say a care plan has been done and is good
and goal directed and really has the patient and family at the forefront, that operational
clarity and granularity would be helpful. Final point as far as best practices, here
is another opportunity for public private partnerships in a global way, as part of our
efforts to improve behavioral health and quality of life of nursing home residents we started
conversations about best practices. Are there examples of best practices.
We have been identified nursing facilities an homes minute million change in staffing,
consistent staff assignments with top tier in all quality metrics.
What's their secret sauce? We engage in conversations what that looks
like trying to apply it towards a method of sharing that information so that it too becomes
can be adopted operationally where that is challenging is still this is one site of care.
So it's one care setting. It's nursing home.
So where the public partnership opportunity might be, there are systems of care out there
who are able to do this better. Than others so can we get stories -- figure
out what their special sauce is, operationallize what the critical components of that are in
a way that can be tested and implemented. So almost like an intermediate step because
I think there maybe more successful systems out there as opposed to less, that question
will go back to y'all, what that looks like where might we look to obtain that guidance.
>> I'm going to follow-up with that, related very much to sherry's comments but coming
from a different direction, drill down a little bit into the concept of the medical home one
challenges of using the medical home as a construct here is that it tends to require
cross platform changes. Cross system changes that are specific.
Efforts that are condition specific focused around medical homes are challenge in primary
care because you can't change your system for a certain number of patients, you end
up needing to change your system for a whole. -- whole cohort, that's a big investment.
Reimbursement tied to a specific condition won't necessarily fund transformation across
primary care. If we think about what are the components
of dementia capable primary care, what does it look like what the specific components
we think primary care should do to improve quality outcomes.
They will be part of the medical home but it may not require the broad cross system
changes medical homes do so getting to a discrete set of practice functions we think drive improved
outcomes in primary care allow a test of those practice changes.
In primary care without asking the whole system change as is usually done in medical home.
>> Laurel, back to your comment about potential certification licensesure of direct care work
force, I got an email from David hyde pierce during lunch who asked me to use this example,
this I think directly applies. If we go down the road of state lead entities
that road goes in both directions. So if we're thinking certification and licensure
of direct care work force we can look at what states are now doing, look at states as a
laboratory and say what's working where, how well is it working and then come together
and establish some federal minimum criteria or standards for licensure and certification
that then become part of package of measures that a state lead entity has to meet in order
to receive federal funding so the road goes in both directions and leads to improved quality.
This is an example where I think the recommendations from our group and the recommendations from
your group are so complimentary it's just very encouraging to hear this.
>> Bruce's point really quick. I think there have been demonstration projects
and a lot of studies about this, about what is quality dementia care an primary care.
Because your point about what are the components, can it be done, can it really only be done
in a dementia specific medical -- the answer is no but we see very poor adoption to what
we know to be effective. Usually it's cost, social workers and care
planning. Education, time with if physician and staff.
Those are hard to support. In the current model but a challenge to pull
that together for the group for our subgroup what are benchmarks of quality and barriers
in our current model end in an evolving medical home implementing those things we already
know. They aren't being implemented.
>> One thing that struck me when you were talking also during your -- the conference
call is emphasis on advanced stages of the disease because discussions are toward prevention,
early identification, as vital as that is we have to cover the spectrum of the disease.
We have to care for people who have disease at advanced stage.
There are cost saving measures to be done there through improvement of for individuals
advance stages. Also the research aspect we thought about
early identification and trying to prevent predict an prevent but there can be research
consequences too and we should emphasize the importance of that in our subgroup.
>> Hopefully since you heard discussion on the call sin you're on the research subgroup
can advocate for research in that area. That's one of the things we hope for with
this blue ribbon panel for lack of better word, for them to say as a group these are
research investments to leverage those changes quickly, to improve quality to lower costs,
and this is what we need in order to do that. That is one of the important reasons for getting
them together. I think they gave examples for where they
thought that would be.
>> You my know the answer to this question but CMMI funned two projects related to dementia
care, one is UCLA, the other one in Indiana. Do either of those use or incorporate the
home health model or not? My recollection was the UC areLA one did but
I wouldn't -- >> At least many components of one, it will
be important to realize they have a lot more resources for that than a typical practice
would have.
>> The reason I'm raising it is just that if we're going to look at -- if bun recommendation
is looking at how the -- one recommendation is how the health home can be used, we should
figure out the extent to which we have got that program, there's an evaluation component
that goes along with all of the CMMI funded project.
So we might think about piggy backing on the one that does or both of them -- than on both
of them.
>> One thing I forgot to mention in my presentation, it's just become -- I have become aware that
both from the researchers speaking to us on our call realizing where gaps in research
and funding say for advanced, severe dementia, especially in someone's home, most of the
care for someone with advanced dementia, a large proportion will occur in long term care
because of the nature of the disease and physical care giving that happens.
30%, 25% depends on course of disease. Some occurs at home.
Looking at quality dementia care and home environment because you can't randomize this
kind of research. By nature there is a block right there.
To do funding research that's a requirement of NIA funding.
We need to get past that barrier to answer some of these questions that are really important
for the millions of people moving to this stage of illness.
That's not the research part is not my area of expertise but that's a barrier to getting
those good answers.
>> Laurel have you given thought to implementation part of this plan in terms of next steps,
what can be done, existing resource, what we need to do in terms of bringing in other
groups professions or schools into the process so we think through execution steps by here
or over period of years to get to certain outcomes?
>> We're starting on that, I don't agree the granularity we were ready to write recommendations
yet. That's why I presented the way we have but
we work on the public private partnership aspect in terms of dissemination of information
and education and Joan and I and others are speaking about that.
-- starting that. As far as the granularity we're looking for,
it's hard around system changes that we don't have control over, we can recommend but CMS,
we don't have a lot in this game for care of people with this illness.
Put them on the time line.
>> Well, if you're going to get to a goal you need at least some notion of what steps
can be taken now, what's steps are taken an built upon.
Surely with the wellness visit in terms of what she's done so far and what she will do
in January coming back with a time line. I'm suggesting that coming back in January
what a time line might look like and barriers to getting one, whether resources or the right
players in the room or whatever, would be useful to this particular member, a very useful
next step.
>> Try to get more granularity on that, there are things within our control for sure.
Blue ribbon panel could -- should definitely be done before June.
that doable. We have broad consensus it would be helpful.
It's a matter of getting the right partners to convene and sherry, we're working on that
too.
>> So a comment about time lines recognizing their value.
One of the operational challenges that we have is that almost have to back into et at
times so if there were resources already committed, if these were lined items already in the budget
that was proposed is floating out there somewhere, if there were not, it becomes challenging
to implement something in June that we haven't committed funds to.
I think how to do -- have this conversation recognizing the importance of it with all
the right type of people to guide that is not in question.
The question more is how do we actually do this in a way that is feasible and maybe a
series of conversations rather than one particular event.
From the CMS standpoint certainly technical expert panels we can participate and host
technical expert panels for specific questions but questions that usually pertain to coverage
payment, quality measurement, what is under the authority of CMS, will have to work with
our other agency partners to actually know what the authorities and what the mechanisms
might be. But I think the conversation is what's important.
The prize at the end would be helping gain direction.
How to back into it in a way that's feasible.
>> You make an excellent point. One rhythm we have been talking about when
recommendations occur, when the next plan occurs we ought to keep in mind the sequence
on the congressional budget cycle, because if we go up to the hill as Harry and I and
others here in this room will do and say support the national plan they say what does that
mean? If you had a list of ten items, supporting
the national plan is putting a line item in the CMS budget that does X.
According to the national plan means doing this on the research funding.
We need some granularity there that is very, very precise to the extent we have it potentially
greater shot at getting something, whereas if we haven't aligned the priorities what
you're talking about the time you're talking about with our ask on the hill, it's harder
to articulate with granularity what we really need.
And what year. Some things are feasible in one year,some
things are not feasible in one year, so we need -- that's why time lines are useful to
us as advocates as well as obviously to the administration and being able to execute on
this.
>> We maybe able to host that. I don't know what the rules are, there would
be public or private funding to support the cost of that meeting.
No strings attached. And everybody participate bus we dope have
to -- it doesn't have? sherry's budget which obviously is constrained.
Q. Private yes public, no. Certainly if members of the FACA want to reach
out (off mic)
>> It might accelerate -- >>
(off mic)
>> There's a charge for the realm, there will be a hat, as you leave you can contribute.
>> To clarify there is no charge.
[LAUGHTER]
>> You have to contribute to this panel.
>> The Coleman track.
>> Funny jokes are not funny -- >> Completely inaudible, those on the phone
and the web part here.
>> Inaudible.
>> All right. Any other comments for Laurel?
>> Thank you, Laurel. Okay.
Let's turn then to Jim and the research subcomittee.
>> I want to tell you about the work the research subcomittee has been doing.
As you recall, the recommendations were although certainly developed with the partnership of
the federal members of the research subcomittee who were Don Moulds and Richard Hodes and
rusty Katz, the federal members of the committee did not vote on the recommendation.
So just as that was developed originally, we as a group have had some good discussion
around this work but we suspect and we're still discussing this, but there certainly
are some parts of our recommendations that federal members cannot vote on such as budget
recommendations. So I want to point that out straight out.
But there was a good lively discussion and lot of participation from every -- for every
member. Our process for this meeting was to look for
overlap between the recommendations we made last time and the national plan to determine
in our recommendation what is still important in group of recommendations not reflected
in the plan, what if anything in our recommendations could be dropped or reconfigured for the new
version and also come up with any brand new recommendations that we didn't have last time.
But these four seem still that are projected now still drive the work we do in our subcomittee
and drive the recommendations that we made. So I'm going to go through each of the recommendations
that we made briefly and then spend time how we saw this in terms of overlap and any kind
of revisions we might want to make. Our first recommendation, I'll spend quite
a lot of time on this, we heard discussion about interim milestones at this meeting.
It certainly has been a point of discussion in the research subcomittee as well.
We applauded the 2025 goal for effectively treating preventing slowing progression delaying
onset of Alzheimer's disease, but we fell strongly that interim milestones including
ones that involve identification of behavioral pharmacologic intervention business 2020, are going to be
important. The underlying thing is that any interim milestones
need to take into account this balance between basic and -- basic research and treatment
discovery. We saw in the plan in appendix 4 provides
implementation of each goal and action including those in goal one.
Research goal. This implementation plan didn't provide in
our committee to sit comfortably. You'll see this throughout all of our recommendations
and it's certainly hard for us to know whether 2020 goals we recommended would be met.
Let me just say we talked earlier about the question, is this plan working?
If somebody steps back and says is this plan working?
One advantage of setting interim milestones will be that we could say yes even though
the 2025 goal is not yet here for example. So I think there's some practical advantages
to in the plan identifying at this smaller level interim milestones.
I think our whole committee agrees one or two people or even our subcomittee can't come
up with these interim milestones ourselves, it really deserves broad input.
That's where I think the tricky part will be between now and January, figuring out what
exactly the milestones would be. Let me give some examples of that have come
up in our discussion. If you want to slow the progression of the
disease by 2025 and you have a potential behavioral entersection, that you want to test out in
research, you need to think about what the effect size of that intervention will be and
how many people to recruit into your study in order the see that effect and how long
it will take you to recruit that number of people needs to be built into the time line.
If you're doinging a primary prevention taking people without the disease and looking at
outcomes like mild cognitive impairment or Alzheimer's disease, how long it takes people
to develop the disease, it could be a very long time to get enough outcomes for you to
see the result. We also discussed this as it relates to drug
development so we know now existing length of time in that pipeline for drug discover
arery. How much time on basic genetics which would
then lead to molecules developed as targets and then move to clinical trials and so on,
all the things that need to go in between in that pipeline that has a certain length.
is the certain goal we can start moving backward on research again, I want emphasize this needs
to happen in concert with the national research strategy.
I'll talk about that more in a built but we are having a discussion about how much we
can as a research subcomittee and then bringing to the FA ccA how much detail we would like
to get into, regarding explicit time lines an interim milestones.
All the rest then will go faster but I thought since we had a lot of discussion about that,
we should really spend some time on that. This is a big recommendation about the ramp
up to level of 2 billion per year for annual federal research funding.
What we found in the plan was that there was certainly mention of what could be the initial
stages of a ramp up, we heard from Richard earlier today how the 2013 money will be used
in a series of RFAs that will be hopefully released today or tomorrow.
But we still feel the urgency of getting to the 2 billion level is unchanged.
We're not near that yet. So that's still a critical part of our recommendation.
In our third recommendation originally we wanted -- we're hoping that the HHS would
develop a strategic research plan that would outline priorities for research to accelerate
break throughs in Alzheimer's disease in achieving that 2025 goal.
As a critical part of this we want to expand that research people not just with the disease
but study of caregivers. And people with Alzheimer's disease and the
impact of care giving on caregivers. Acts 1A 1 and 1A 5 in the plan, there's overlap
between recommendation and those actions. We heard productive meetings that occurred
in the may summit, there's been a number of other meetings that have come up with recommendations
and processes that come up with research recommendations. We heard about the RFAs, but what we think
is still not in the plan and what is not here is a comprehensive strategy of applying public
and private funding sources. That plan, there's no discussion of the synchronization
of that strategic research plan, the coordination of that strategic research plan with the entire
national plan. We felt that was important.
The other piece, that I have been thinking about as we have had the other discussions
the reserge subcomittee members can chime in, in goal 1 there's mention of caregivers.
In the language of goal one. Language is important, I think it leads to
Ohio led to the implementation of the plan and care research needs to be in the research
goal within the plan in order to reflect the importance of that work on society.
In addition to people with the disease. Our fourth recommendation was about addressing
disparities and Alzheimer's disease and we recommended not only translation of research
findings would be applied to populations at high risk for developing the disease and we
mentioned racial and ethnic groups, social economic status as well as other populations
at high risk like people with down's syndrome. And we also wanted clinical research studies
to focus on those groups as well, not just translation of research to those groups.
There's wonderful overlap there in the plan strategy 1B had a nice discussion about interchange
about this earlier today. I think where Richard brought up some of the
existing resources within federal funding within NIA that are already doing this work
and that we maybe able to leverage some of that like the resource center for minority
aging research, satellite, RO-1s that have individually done a great job of recruiting,
ethnic minor at this and doing science relevant to those groups and the other thing again,
language is important, down's syndrome an intellectual disability populations were not
specifically mentioned within goal 1 which is the research goal.
So we know that work is being doesn't. If it can be integrated into the plan we thought
that would be important. Number 5 of the research recommendations is
about accelerating public access to new therapeutic interventions.
Compressing the average time line in the process of starting with identification with therapeutic
targets all the way through regulatory review. Here I'm going to make a general comment,
the next several recommendations have to do with compressing this time line.
5, 6, 7, 8. So our subcomittee hasn't decided this but
we are considering perhaps consolidating not losing aspects of what we say in these recommendations
but consolidating 5, 6, 7, 8 to make a more holistic recommendation about come pressing
the the time line. So you see that reflected here.
There's action 1A 1 specifically about compressing the time line if you read through the recommendations
in the hand out there's so much detail what we were talking about.
That is not reflectd if the implementation again.
Interim milestones about specific steps that need to happen in order for this to occur.
So that's where I think most of our discussion has been, is about how would this happen.
We recommended number 6 that identify and prioritize action steps needed to reduce time
for moving therapies ed becomes available to the public.
Again we have overlap, general overlap with some of the language in the plan.
Also action 1E 2 focuses on public private partnerships for dissemination translation
and implementation of research results. We felt in the plan, the role of public private
partnerships in enhancing basic discovery and innovation was really there.
So that's the piece. We had the discussion before launch but we
feel it needs to be integrated to the plan moving forward is that if we have the strategic
research plan, we know that some of the efforts will be taken by private companies, Pharma
or whatever. We need to -- it would be helpful in the plan
to begin to specify what those roles are and who is accountable.
For each. Then I talk about the possibility that we
maybe consolidating shortening recommendations along with one that specifies the broad role
of public private partnerships. Here are more details about recommended -- in
recommendation number 7 we recommended that the secretary do in order to shorten the time
line. And potentially address barriers to treatment
development. Again we had this issue where we went into
more detail than the man and we felt the detail and recommendation was critical in order to
move forward. We hope that we can find a way of suggesting
and hope we can find a way of making it happen, the level of detail increases in the plan.
Number 8 specific about roles of FDA working things out.
Identifies the implementation plan we found identifies FDA as partner but it also says
by September 2012 which is last month there's feedback offered by this group about ways
to compress the time line. Between target identification and release
of pharmacologic treatment. I haven't heard anything about that.
Yet.
(off mic) September is the convening point recommendations
are I think January.
>> Okay.
>> So I can -- I'm happy to -- >> We look forward to seeing that.
This is one example how -- if we get detailed how important time lines are.
So in our ninth recommendation, we specifically suggested a joint NIH and industry working
group. That can inform research priorities.
We talked about ha earlier today. That's well on its way.
In the plan though the specific example was to release an RFI to invite public and private
input and there wasn't much discussion in the plan how this would be an ongoing interactive
process. So as public private partnerships initiatives
are begin, we hoe integrated into the plan some of the mechanics of how that's going
to happen and how that's going to happen on ongoing basis can be integrated.
Metrics. Specifically for assessing the impact of Alzheimer's
disease and related disorders on the U.S. economy.
We made specific recommendation that we hoped that those metrics would be developed.
It's easier said than done obviously. But goal 5 discusses metrics in the plan.
I think that we're hoping in the next version there can be a specific referral to economic
impact. That was not part of the outcomes mentioned
in goal 5. Or anywhere else in the plan that we could
find so far. To goal -- this recommendation 11 has to do
with ways that we can emphasize encourage private investment in the development of treatments.
We have goal 1 which mentions private partners but the acts underneath that goal has to do
with global partner only. In number 11 we had tons of specific recommendations
how that might occur and it's that detail wasn't carried through to the man much less
specific referral to how HHS may want to encourage private investment.
Subcomittee how to structure these recommendations so that they have maximum impact.
We have a lot that talk about public private partnerships.
This is one piece of that and we may want to consolidate or not.
Our recommendations were spread out. We also got placed at number 34.
It doesn't make it less important but it's about global -- it has -- the reason why is
it reflects things important to not just research but all of the subcomittees, work of each
subcomittee. We suggestion ad global Alzheimer's action
plan. We heard about from Richard the ontology being
established on an international basis. And that meets a lot of aspects that are mentioned
in the plan. Global partners did participate in the may
2012 meeting. And there was a meeting at the Alzheimer's
meeting in Vancouver as well, a number of bilateral efforts is that have already begun.
Quite a lot of action in this area in terms of international partnership we know early
spring of next year is the target date for international meeting of U.S. and also other
regions and countries that have national Alzheimer's plans.
But in the plan there's no mention we thought this was important, for global Alzheimer's
disease plan. There was also -- there's not necessarily
language, high level official or high level office that is responsible for this international
cooperation. We know it's you, Don, but in the plan if
we know who is responsible, we can see you about it.
Another aspect of our recommendations were about regulatory hurdles and discussion on
an international basis. We didn't see it reflected on the plan.
our last one. We recommended that there be a specific office
and official within the white house and the office of secretary of HHS responsible for
effective implementation and reporting of the national Alzheimer's's plan.
Certainly within the the implementation strategy, there are offices that are named that are
responsible for those actions, obviously there's no -- I don't think anyone saw this, there's
no separate office in the white house mentioned in the plan.
What's addressed here in the plan, goes back to what I was saying was number one, details
about metrics who set those metrics milestones, implementation steps and most importantly
central accountability and central to what is in the plan.
That's what I have. Let me invite other members of the subcomittee
to make comments about what I presented.
>> Let me jump in. To comment --
>> You're member.
>> I am in fact a member. Proud member of the research committee.
Let me comment a couple of things you alluded to.
Two items in particular, and the second is the collaboration item.
I think the wording and plan is that we're supposed to start convening the conversation
about the pipeline issues by September which is last month.
And then have a series of recommendations together back to the FACA in January.
To date what we have done is convene a series of -- and this started actually several months
ago of internal to HHS meetings to talk about a handful of medical products development
issues and including these issues, this is the conversation included NIH and FDA.
And AHRQ and CMS among other entities. We have had more informally some conversations
specific specific to AD pipeline. Our hope and expectation I should say has
been that these would be one of the areas we would have public private dialogue.
I think there has been -- there have been a number of different places conversations
on the private side. What hasn't happened yet, is the conversation
involving everybody at the same time. So they are going it's fair to say anyone
on the private sides wants to join in, welcome that certainly.
The conversations within gong independently -- going on independently.
One reason I'm anxious to identify the structure for the public private collaboration is that
it is beyond time now to pull those together. Particularly ongoing to be making preliminary
recommendations in January. So that's where that sets.
On the international collaboration action items, so there are really a couple of tracks
that has taken, one is Richard's, research conversation that Richard has been leading
over at NIH. And as they have done planning those really
are and Richard you can jump in or at or correct. But those have been truly international conversations.
So certainly the purpose primary purpose research agenda, within the US Government, as we looked
at research priorities within, we looked at what's going on across the globe.
The other piece of course is collaboration across governments both who have planned are
doing planning more generally around AD and related dementia, there's considerable instance
in -- so there have been a number of conversations that I would characterize as bilateral there
have been multi-lateral conversations but they have been for the large part more focused
on the research and they haven't involved government as much as I think on the government
planning or actively planning in this area would hope.
So we had hoped that the conversation in Vancouver would shape up to be the first of those conversations
touched on some of those aspects but not as comprehensive as we're hoping, Alzheimer's
disease international has been working with British government with the hope they would
be hosting a meeting hosting a meeting in early spring countries that are interested
in this area or actively doing planning in this area so there is a good amount of promise
there. I think the time line and goals here would
be to queue something up so there are a number of countries in this space interested in having
that be a track we reteenly convene interested countries to discuss how we do this collaborative
work going forward. In addition to that, we have a handful of
we continue to have conversations more informal nature one or two more formal nature with
nations that are active in this area.
>> I could add to what Don said about the international at least research side, here
in Washington next month from the JP and the joint program neurodegenerative diseases about
to participate in the meeting as well to see if we can bring aspects of our plan into theirs
and theirs into ours. I think it is moving forward.
>> Richard did you want to add anything?
>> Very well, on the international side you mentioned in addition to many of the ongoing
multi-lateral individual efforts there's increasing effort to coordinate.
You mentioned meetings in Vancouver, credit the partnership there, NIH very prominent
in that. We have commitment now towards a winter meeting
which we will in a work group format update progress so that the next international Congress
in Boston in the summer we will carry this forward.
Want to be careful not to lose the momentum that began in Vancouver.
Couldn't agree more there. Comment on a couple of things very well, she
talked the difficulty in laying out time lines especially if we have a long range initiative
that comes from basic science to translation. She herself clarified very well when we said
it's difficult when we know this research can take X years, we're not passively accepting
the fact that -- doesn't manage the difficulty but our efforts and thoughts towards way to
accelerate this at each step as well. The caregiver research, the point is very
well taken, it needs to reside in one of our domains within the plan.
The question is where and in some ways having one group called research is -- was one way
of cutting the pie but it maybe sort of no, ma'amer in a sense that the other groups require
research in order to inform what they do in evidence as well.
So we're happy to be part of the discussion somewhere caregiver research incorporated
in the domain of the whole FACA. , trying to best understand where it should
lie.
>> Several observations PCAST has identified about six major priorities in terms of improving
the clinical trial infrastructure and making them more efficient and shortening the pipeline.
They call explicitly for Alzheimer's, for disease specific execution underneath that.
So they have moved the conversation significantly forward and given us a sense an agenda what
are to focus on as we open up the private -- public private partnership discussions
that you describe. So there's move in the a sense in identifying
the priorities needed here. On the NIH industry collaborative on identifying
a systematic scientific research plan, that's beginning to come together, we obviously industry
was present at the may summit last year. The New York academy of science is having
a convening that follows up on that in June 10 and 11 of next year where explicitly they
are bringing academic and industry researchers together, Ron and JEN serving on the work
group for that and clearly we need to connect NIH to make sure they're involved in all suspects
of that planning so that can actually become a conversation that is a joint in character
and can move that needle. I would also say that there is a good deal
of discussion about regulatory pathways in PCAST analysis.
The number of ways Alzheimer's specifically called out in this about the several avenues
by at least which the white house is recommending the FDA expand anding is sell rate the review
processes for evaluation of the safety efficacy of drugs.
I have got one question, it raised this question, the implementation plan at the moment you
referred to earlier is essentially what the Federal Government is doing.
And there are obviously going to be implementation steps that are working with the Federal Government
in terms of implementing this plan. The question is whether in that role the implementation
plan as you conceive is intended a stewardship of the joint activities.
Including what is going on as relates to execution of this plan or is it intended simply to be
a chronic and following of what it is that the federal agencies do.
It does seem to me useful to have a place at least we can chronicle the joint activities
or the partnering activities that occur between HHS on the one hand any on the second hand
and NGOs and non-profits and advocacy organizes and others on third hand.
To the extent that we have -- third hands. To the extent there are similar implementation
steps in long term service area, it's useful to chronicle this in a common place so we
can make it a national implementation plan rather than federal.
You raise a good point and good question. I think certainly you're right that success
in a number of areas that we have identified in the plan is going to depend on progress
that is achievable by the government and then progress that necessarily takes place outside
of the government. The challenge with -- the challenge with including
the non-governmental pieces and implementation plan of course is that this is the secretary's
plan. And the secretary certainly can and should
be responsible for the action steps she's identified for the department but she can't
in a similar way command that kind of authority outside the government.
She can encourage, she can convene but she can't tell the private sector they have to
do something. My hope is that as we convene these public
private partnerships, and even just that the private groups getting together complimentary
way to the plan, that they will identify the same types of goals and milestones and include
them and self-regulate how we coordinate that I think is with the federal plan is the open
question, the only thing that give mess pause is putting deliverables in the national strategy
that ultimately the secretary can't -- isn't ultimately responsible for.
>> That's the give and take, I think we can certainly include language that would say
-- that would identify what success would look like outside of the government, there
are all sorts of other things but when it comes down to an actual implementation strategy,
that becomes more challenging. I would say I think this will be -- I think
this will be a center point when we have this public private dialogue and that we'll need
to work through how we do this. Having these conversations in and outside
the government about increasing collaborative space and sharing failure information and
all these other things and certainly there are places in that where conceivably the government
could have a role but some of that is outside. And how -- I think figuring out which action
steps belong to who and how we put them in various implementation plans is going to be
key where we're getting to be.
>> At the very at least we need to make them very transparent, whether it's a separate
private report or whether it's sort of a working plan partnership umbrella making it visible
to this group and then to the public is going to be important to make sure we're held accountable
to the interim milestones that will hopefully start setting the next January meeting.
>> I think that makes sense in terms of you talk about, what I'm imagining at least is
if we get the groups together to talk about the way it might work, Ron was talking about
earlier sort of the derisking thick. Pharma -- thing.
ma can't go way back to pipeline. Some things like sharing of data, government
could have a role in that. If we can identify the things that collectively
we agreed to need to be done, then if nothing else, if the roles for government could be
identified, those could be in the plan at a minimum.
If we could get there, that alone would be huge as advanceed to the overall process.
Further discussion? Jim, marching orders for January?
>> What Harry was saying we have a lot of work and discussion to do with respect to
interim milestones and metrics. I think that we can make both broad recommendations
and we also are going to have a discussion about specifics.
So we'll see what happens. Any other comments from folks?
>> Very good.
>> I'm curious to see how you want -- what you're thinking about squaring the circle
around whether the research agenda for clinical services, long term services and supports
ends up in goal 1 or should end up somewhere in the other goals.
What are your thoughts about that?
>> I don't know what the whole committee feels. I don't think it would be a bad thing to include
some of those research goals within goal 1. We have made the decision to split it out
research and critical care an long term services. I think that we have heard meeting after meeting
the importance of those aspects of research and I think that while it definitely should
be somewhere in the plan, it is entirely appropriate to put it in research.
I don't know as the plan develops there can be more detail attached to those, as national
research strategy develops there's more detail attached to those goals.
We have -- we have a lot of people who are affected by Alzheimer's disease who are not
patients of Alzheimer's disease or people with Alzheimer's disease and we really -- there's
a tremendous amount of top notch research going on about that interaction and about
the effects. The more that can get out there, and developed
and broadened, I think refined, the better off we'll be as a community.
So this should be explicated within the research goals.
That's my personal take on it.
>> This is an intracommittee conversation but I tend to agree with you that we have
to be more explicit about what research is needed to support the other elements of these
goals so that we are clear we're not just focusing on therapeutic development but supporting
on the social science and other behavioral research needed to support the other goals.
I can go either way but explicitly call it out.
Changes in behavior can be -- >> What we're talking about here is research
on people who coo D&O not have Alzheimer's disease but are there caregivers.
>> I would agree with you, I'm not speaking from my subcomittee pause we haven't talked
about this, I think we need to talk about this but it makes sense to me.
Under the -- research report out this morning and yours we hear a lot about shortening the
pipeline for the FDA and really where does that end up?
That ends up in Laurel's group because the end product is going to be carried out by
clinical care. Not by researchers.
Researchers get us there. I think following that logic it only makes
sense that research about caregivers which may get a lot of discussion in our subgroup
on long term services and support and in clinical care belongs in recommendation number 1.
>> It's interesting, some of the private conversations that we're putting together around the subject
of the pipeline. Company regard this as through line that goes
through to the patient and to the family. They think what they're thinking about, they're
thinking about in the end how is an easy to use affordable method of therapy or behavioral
intervention get adopted in the marketplace. So when they're thinking about this, they're
also thinking about awareness and stigma reduction and they're thinking about a wide variety
of whole -- their view of the pipeline is a lot longer than the view of the pipeline
that is outlined even in the PCAST report which base basically talks up through FDA
evaluation of drugs. They're thinking how does it get reimbursed?
How do families afford whatever it is we're going to do here.
Part is going to be reimbursement by Medicare or other mechanisms, but not all of it and
how do we think through family savings plans that are lifetime saving plans for the healthcare
cost of aging. How we think through market adoption practices
which the resistance to people detecting their own impairment in brain help as they market
barrier to getting their therapies to to market. So the way in industry is much more a continuum
all the way from basic discovery through market adoption and that means how do you make sure
the patient and the family is ready to receive thinking about how to manage care planning
as well as interventions of potentially behavioral as well as pharmacologic actually get adopted
in the marketplace. So I do think that this is -- comes back to
I agree should be on the research but we need to call out those elements of research which
relate to the other goals.
>> A little less certain about where on the spectrum of activities where more evidence
is needed, therefore research is needed, the assignments ought to be.
I think specifically the case we have about caregiver research, NIH support, it falls
within a domain of that research. On the other hand we have to be careful if
we have the research group responsible for evidence gathering across the spectrum of
what we have, we better not do it unless we have the expertise an orientation to do it
and we currently don't have it. Those are focused in the other two groups.
That's where I hesitate and have concerns. The other groups are better preparedded to
identify where the need for evidence and research is.
I want to be careful, we match the needs and domains of need ratherther than convenience
research if lease not enough evidence and we need more we'll put anytime the research
group. I want to be careful we have the right groups
thinking about the evidence in the right way we needed and then talk how to best gather
that.
>> I tend to side with Richard on this one. I think as we're thinking about research agenda
on clinical care for example, it makes a lot more sense to have Laurel and sherry leading
that. Than it does the research subcomittee because
they're the one whose have the expertise, they know where the knowledge gaps are.
I think you identified an essential component for all three areas.
That is exactly right but you want to keep it where you have got the policy expertise
and that is in the three groups rather than the one.
>> I think we can all share.
>> Yes.
>> And as a part of the strategic research plan, one o our recommendations originally
of our group was to include research on caregivers. I think that therefore our recommendation
is that appear in goal one of the plan and that that be integrated into the strategic
research plan, which is what is part of goal 1.
So I do not -- I'm not saying the other subcomittees shouldn't mention it or they don't have the
expertise, I think that's absolutely correct. There maybe different aspects of this different
takes, different approaches within goal we may feel is important to mention and to in
practice, integrate. Into the research plan.
>> Remembering that the subcomittees are configured in arbitrary fashion.
It's not that there were hard lines among the three.
So absolutely. And the recommendations come from the -- sound
like it's from this subcomittee and that subcomittee. They come from all of us, we have to integrate
and have calls and meetings and bring the subcomittees together.
(off mic)
>> Okay. I just wanted to say first of all as a representative
of caregivers, that I can't tell you how much it meant to me what you said, suggested that
they're getting research be included, the first goal.
I think it's important for caregivers, I also thought it was incredible because it was a
real example of silos coming down. And even the convenient important to be created
subcomittees recognize caregivers in that way,.
It's hugely talked about research about the economic effect of the the disease (indiscernible)
look what it does to the caregivers that piece of pie that it is.
So I'm talking my vote in for agreeing with the -- including us in that first goal.
>> Thanks, David. Bill.
>> At this point I would like to say aagree with Richard.
My fear is that -- we have had discussions about research in our group.
It was kind of felt like -- we spent a lot of time about was it part of our goal or not.
So if we're not careful we're creating -- making it much harder the caregiver research to be
part of this and get the same interest and work.
If we put it all over the place. We're now asking for another level of coordination
between three committees for this one area, caregiver research.
It doesn't sound good to me. It sounds like we're trying to? You make something
harder it doesn't work. One alternative would be to make sure we had
somebody with interest and expert's in the research committee in care giving research
which we don't have now. And then that person's role and responsibility
will be for that. Then we have somebody to feed in ideas from
the different committees as it comes up when we decided to not really relevant to the committee
because research and care givers is not part of care giving, not part of clinical care
and or not it's part of the research groups. We don't have that person, this is consistent
with David's approach, state person, any state, we need a caregiver research person research
committee or it's not going to work.
>> I'm going to encourage folks that we don't overdo this.
My attitude toward this would be I think general is right, -- Jim is right, having this in
research construct is great. Richard is right, I'm ahead where you are
Lale bit Bill not as much structure. Personally overlap is good.
That is, if research ideas are getting generated out of long term services and supports or
getting generated out of Laurel's group, great. We come to this group and say we've got the
same ones you have got. I'm not worried about that.
If we don't have the people collectively, we may not get it right the first time around
as we acknowledge and things discussed here today.
We'll catch it on the next round most likely with all the good inputs we have got, not
only from here, from the folks in this room and folks listening and watching and providing
input. The idea of getting to the research plan is
great. I think the idea of not trying to set it up
so that there's only one path is also great. I believe we follow the course we're on but
make sure each subcomittee knows that can be generating what needs to be done on research
that will be applicable to what their needs are.
We will will bring them here, figure it out and shake down to what is set of recommendations
and hopefully see it wind up in the plan. That would be my attitude, to not overbuild
this.
>> Expand upon what Harry said, we chose caregiver as one area but only one of many in domains
of two groups, clinical care long term services that come up.
All those examples come to research group and build in expertise, I -- does not seem
optimal, whether it has to do with housing or transportation or there's so many issues
where research is needed, it doesn't -- to me I would be concerned because evidence is
needed for all those that went to one committee or we even try to build all -- recreating
the whole FACA.
>> Okay. Other comments I issues regarding -- Jim is
smiling. Gotten comfortable.
Okay.
>> Uncomfortable with stopping the discussion.
[LAUGHTER]
>> That's what I interpreted. I inferred you were done wit.
All right. We're ahead of the game.
Thank you very much. So why don't we take a break for about 15,
20 minutes and reconvene wrap up and have public input session.