PTAC Meeting, Day 2, The COPD and Asthma Monitoring Project (CAMP) Part 1

PTAC Meeting, Day 2, The COPD and Asthma Monitoring Project (CAMP) Part 1


CHAIR BAILET: Good morning, everyone, and
welcome to this April meeting of the Physician-Focused Payment Model Technical Advisory Committee,
or PTAC. We’re delighted to have you all here. As you know, this is our first series of meetings
that will include deliberations and voting on Medicare physician-focused payment models
submitted by members of the public. We would like to thank all of you for your
interest in today’s meeting; in particular, thank you to the stakeholders that have submitted
models, especially those that are here today. Your hard work and dedication to payment reform
is truly appreciated. We spent the past year establishing our processes
and procedures for receiving and reviewing physician-focused payment models. We want to stress that our process is shaped
by input from stakeholders. Although we begin deliberating and voting
on proposals today, we are committed to listening to your feedback and evaluating our processes
accordingly. We value your comments at every level, especially
as they relate to our receipt and review of proposals. We also wanted to remind all of you that PTAC
is a committee of 11 members, not a committee of one. To the extent that questions may arise in
the process as we consider your proposal, please reach out to staff through the PTAC.gov
mailbox. The staff will work with me as Chair and with
Elizabeth Mitchell, the Vice Chair, to answer your questions. In the interest of consistency and responding
to submitters and members of the public, please reach out to us through this process that
we have in place. Today, we will be deliberating on two models. Discussions of each proposal will begin with
presentations from our Preliminary Review Teams, or PRTs. The PRT reports are from three PTAC members
to the full PTAC and do not represent the consensus or positions of the PTAC. PRT reports are not binding. PTAC may reach different conclusions and a
different recommendation from the one that was contained in the PTAC report. And, finally, the PRT report is not a report
to the Secretary of Health and Human Services. PTAC will write a new report that reflects
the deliberations and decisions of the full PTAC, which will then be sent to the Secretary. Following the PRTs’ presentations, some initial
questions from PTAC members, the Committee looks forward to hearing comments from the
proposal submitter and the public. The Committee will then deliberate and vote
on a recommendation to the Secretary of Health and Human Services. It is our job to provide the best possible
recommendations to the Secretary, and we are excited to begin this process. I will turn to Elizabeth for any additional
comments and then any from our Committee. VICE CHAIR MITCHELL: Thank you, Dr. Bailet,
and I wanted to just thank everybody. As you�ve heard, we are very committed to
an open and transparent and fair process. We are eager to hear from you, and our Committee
has been very, very committed to making sure that we are inclusive and really looking to
make this as successful as possible, understanding that these are ideas from the field, and we
are hoping to expand the portfolio of models that are available. CHAIR BAILET: Do we have any other opening
remarks from our Committee members? Tim. DR. FERRIS: Jeff, I just wanted to add that it
occurred to me during yesterday’s discussion that not everyone in the audience knows that
we abide by the FACA rules and do not deliberate on any of the proposals, except in this public
setting, and so have not discussed any of these proposals, except within — the PRT
has. And I just wanted to clarify that because
I think that might not have been clear yesterday that we are truly talking about this as a
group for the first time, here, now, in front of the public. CHAIR BAILET: Thank you. Seeing no other comments from the Committee
members, I think it would be nice to start with introductions and also disclosures of
conflicts, and I’ll start with myself — or just disclosures that we are required to make
to address any conflicts or impartiality issues. My name is Dr. Jeff Bailet. I’m an otolaryngologist. I am the executive vice president of Blue
Shield of California. I am privileged to be here and leading this
esteemed, impressive group. Elizabeth. VICE CHAIR MITCHELL: Thank you. Elizabeth Mitchell. I am the president and CEO of the Network
for Regional Healthcare Improvement, and I have no disclosures on this proposal. DR. FERRIS: Tim Ferris, internist and primary
care physician at Mass General Hospital, senior vice president of Partners HealthCare in Boston,
and no disclosures. DR. PATEL: Hi. Kavita Patel. I’m an internist here in DC, and I have no
disclosures. DR. BERENSON: I am Bob Berenson. I am a fellow with the Urban Institute and
no disclosures. DR. CASALE: Paul Casale, cardiologist at New York-Presbyterian,
Weill Cornell, Columbia, and I have no disclosures. MR. MILLER: Harold Miller, Center for Healthcare
Quality and Payment Reform. I have helped over the past year, the American
College of Allergy, Asthma, and Immunology on a payment model for asthma, but I have
no financial interest in that model, and I do not see any conflict between that work
and the proposal that’s here before us today. And I think also it’s probably important for
people to know that there is no limit on the number of proposals that the PTAC can approve,
so it’s not like as if this is a competition amongst a proposal. DR. NICHOLS: I’m Len Nichols. I’m a health economist from George Mason University. I direct the Center for Health Policy Research
and Ethics, and I have no conflicts. DR. TERRELL: I’m Grace Terrell. I’m a practicing general internist at Cornerstone
Health Care, a multispecialty medical practice in North Carolina. I’m on the board of a population health management
company called CHESS, and I am the chief executive officer of a biotechnology company called
Envision Genomics in Huntsville, Alabama. No disclosures. MR. STEINWALD: I’m Bruce Steinwald. I have an independent consulting practice
in health care financing and Medicare issues. I’m a former government official in numerous
positions, and I have no conflicts. MS. PAGE: I’m Ann Page. I’m staff in the Office of the Assistant Secretary
for Planning and Evaluation, PTAC staff, and also the Designated Federal Office for this
FACA Committee. MS. STAHLMAN: And I’m Mary Ellen Stahlman, also
with the Assistant Secretary for Planning and Evaluation. I’m the staff director for the PTAC staff
supporting the Committee. CHAIR BAILET: Thank you. We are now going to turn the meeting over
to Len Nichols, who is the lead for the PRT for the COPD and Asthma Monitoring Project. DR. NICHOLS: Thanks, Jeff. I would like to call attention to the lead
slide there and remind everybody I stand on the shoulders of giants with Dr. Tim Ferris
and Dr. Grace Terrell. I don’t know how a non-economist got in charge
of this, but, hey, it’s America. It’s an interesting country. We’ll do the best we can. And maybe even this will work. I’m supposed to click to the right. Do I point this to the sky? See, I told you we should have had a doc in
charge of this, so it would work better. We could probably find a human to do it by
hand, if we had to, I would guess. CHAIR BAILET: We could. That’s why they have “technical” in our name. Right? DR. NICHOLS: Oh, looky here. Progress is being made. Thank you so much. So I’m going to briefly review the PRT’s role. I’m going to talk about the proposal in general,
the summary of our review and some of the key issues, and we’ll talk through then the
evaluation. Basically, the way the process works is a
proposal comes in after a letter of intent has indicated a proposal is coming. The Chair and Vice Chair of PTAC will assign
three members to serve as a preliminary review team, and one of those members is tapped to
serve as lead reviewer. Basically, the first thing we do is read the
proposal and make sure that we have the information we think we need, and that includes both questions
to the submitter. And I would like to commend the submitter
for the response to our questions, which were quite voluminous, and your answers were very
good. And we also turned to ASPE staff and some
of their contractors to get more information. After we review the proposal, we get all the
information and so forth, and as you probably know, public comments are available at all
these stages. They see the LOI. They see the proposal. They see the comments. We prepare a report of our findings to the
full PTAC. That report is posted on the website two weeks
prior to this Committee meeting, and it’s important to reemphasize, as Jeff did at the
outset, that PRT report is not binding. PTAC may reach different conclusions. In fact, members of the PRT may reach different
conclusion. We’re free to do that as we deliberate and
discuss things with our colleagues going forward. I will also say since the PTAC report became
public, the submitters filed a statement in response to that, which I found insightful,
but I think not everybody had a chance to read it before today. But I’m pretty sure my PRT members are reading
it as I talk, so we’ll keep going here. Okay. The intervention in general is to look for
COPD and asthma beneficiaries, and they would receive a Bluetooth peak flow meter and some
software tools to permit data to go to a central server, which through monitoring and management
could trigger clinical interventions to reduce early exacerbation and respond quickly to
infection detection so that we could accomplish improvements in quality of life as well as
lower cost. The payment model calls for CMS to pay for
the flow meters, to pay an inflation-adjusted per-beneficiary, per-month remote monitoring
and management fee, to waive copays for beneficiary access to the services, allow collaborating
pharmaceutical and device companies to provide beneficiaries with discount pricing and coupons
for drugs or equipment that may be prescribed to control their particular pulmonary conditions. The proposal aims to improve the health of
patients, reduce avoidable ED visits and inpatient hospitalizations. Reductions in emergency department and inpatient
utilization are expected to offset the costs of the intervention and thereby lower the
total cost of care, and the submitter expects to reduce mortality as well. We briefly review our preliminary judgments
of each of the 10 criteria as specified by the Secretary in the final rule, and you can
see pretty quickly, if you just scan through there, they meet criterion on 8 of the 10. On scope, we definitely think they did. We’ll go through these in general. You see there are two where we didn’t think
it met the criterion. The first, a high-priority item, is the payment
methodology specifics, and then integration and care coordination, we didn’t think it
met criterion. We were unanimous on all decisions, except
for one on flexibility. We had two vote one way and one another, but
in general, the conclusion was it met the criterion by a majority vote. The key issues that we identified, basically
there’s no question this is a very high-priority issue for CMS. There are a lot of patients with COPD and
asthma, and the framework the submitter has proposed, we think has great merit. And I think it’s fair to say we would like
this to be a successful payment methodology going forward. We do think, however, there are elements of
this proposal that require further development, and that’s why we raised the concerns that
we did. Our first concern, which was clear from the
way the documents were presented, there were no quality performance requirements to earn
shared savings. In the letter that I talked about that was
submitted after the PRT report became public, the submitter has indicated there are some
quality metrics, which I’d be happy to connect, and we’ll talk about that today as we go forward. Do all of the PTAC members have that response? I think it was handed out in paper before. Yeah, it was electronically sent, but there
were a lot of things sent, so not everybody caught it. The model does not count some real cost, such
as Part D spending and waiving of copays, and we can talk about that as well. The risk adjustment was the thing that probably
concerned me as an economist the most. The proposal was based upon a number of chronic
conditions the patient has. This method has not been tested, and frankly,
I think it would be too risky to put a risk adjustment regime in place like this, but
we do think we can talk about how to modify that over time. And then the clinical concern was mostly that
the model didn’t seem to have enough detail about how integration would be achieved. Primary care providers would not share in
the financial risk or the incentives of the program, and other providers behind the pulmonary
subspecialists were not clearly integrated with the care delivery model as well. So now I’ll go through each specific criteria
and what our assessment of it was, and where I think it’s important, I’ll bring in what
the response of the submitter was. And then we’ll go from there. So the proposal, as I said, aims to care for
patients with COPD and asthma to well-defined and clinically important conditions, roughly
5.4 million Medicare beneficiaries with either COPD or asthma or both. The proposal would cover the daily monitoring. It would utilize new technology, have two-sided
risk, a lot of good features we want. It would certainly broaden CMS’s alternative
payment model portfolio by including pulmonary physicians who are not participants in existing
APMs, and of course, it would be a large scope because of the size of the Medicare population. The initial proposal is for a 2,000-beneficiary
pilot, but it could be scaled up over time. So, in our view, there was no question, this
met the scope criterion. The second criterion is quality and high priority,
and here, I think it’s important to pay attention to specific words. We do believe it meets the criterion, but
I think it’s fair to say we think it mentally met the criterion. There is considerable literature that investment
in programs that enroll well-selected patients with chronic conditions, characterized by
frequent exacerbations, resulting in hospitalization can effectively improve quality and cost. However, for this particular kind of intervention,
there is really only one study with sufficient end to give us confidence. That study was conducted in Germany, where
a few things are different. They have better beer. They also have different prices of devices,
and we didn’t think that there was enough details specified. And we can go through the details of that,
but many of the clinical details remain to be worked out. However, we thought the promise of the intervention
and the plan of the submitter was sufficient to say it met the criteria, assuming the other
criteria were met. We didn’t want this to be the stumbling block
to success. The payment methodology is the place where
we felt like there were questions that needed to be answered before we would recommend going
forward. Just remember the basic approach. There will be a PMPM payment and a shared
two-sided risk arrangement, and that certainly seems appropriate for this kind of clinical
intervention, but there are too many unspecified or questionable features. I said in the proposal, there were no quality
performance requirements linked to earned shared savings. In the response to the PRT report, the submitter
identifies a number of quality metrics, which I will leave to my physician colleagues to
discuss when we get to that. The model does not count some real cost such
as Part D spending, which was a concern. I think we can talk about that. When the submitter gets to talking, we will
have a back-and-forth. But one issue that was clear to us at least
in the way we interpreted the proposal was that the model would waive the copays for
the beneficiaries in the project, and that we were afraid those costs did not count in
the way they described the model. In the response to us, they said, “Oh, yes,
we meant those costs to count.” So I think there was confusion about whether
those costs should count against Medicare savings. So, fundamentally, they would have to be made
up in order for the submitter to win a bonus, and that’s important to understand. Risk adjustment was the bigger issue, at least,
again, in my mind and I think in our collective minds because — and I think it’s fair to
say, Mr. Chairman, that this group suffers from the same problem everybody else suffers
from. They don’t have access to the great data that
would enable them to develop a more fleshed-out risk adjustment model. So they proposed using number of chronic conditions,
which given the data they had was a reasonable first step. Our concern is that that has not been tested. Our concern is there may be much better ways
to do it if they had access to good Medicare data, and that’s precisely the kind of technical
assistance we would like to make sure this submitter and others have access to at some
point. The per-beneficiary, per-month amount was
not based on the cost to provide these services. It was based upon sort of an adjustment, given
a number that had been worked out for, I think, cancer care or something. So that clearly needs a little bit more work. And then the cost structure that would guarantee
the savings assumed device prices that were based on European pricing, which is where
this thing has been done full speed before, and obviously, in the United States, those
prices are likely to be somewhat different than they are over there. And so, for those reasons, we reached unanimous
conclusion, this payment methodology does not meet the criterion as laid out by the
Secretary. On value over volume, we thought it certainly
did. There’s no question that it would enable clinicians
to efficiently monitor and manage a patient population with great need, and the early
detection is precisely the kind of innovation that we want physicians to bring to fruition. Flexibility, here is where we had our one
non-unanimous decision. We agree about all the facts. We differ on the judgment about what to do
with those facts. The proposal is simultaneously rigid and somewhat
vague. There did appear to be a reliance on one specific
device and data transmission method. The exact clinical protocols have not been
completely worked out, and that was a concern. But I think the larger concern is that the
proposal lacks sufficient detail on how the coordination with other providers would occur
given the lack of specificity of the clinical protocols. So two of us were willing to give the benefit
of the doubt; one of us was not; and that’s why the majority as opposed to a unanimous
decision was reached here. There’s no question this thing is eminently
evaluatable, and here integration and care coordination, which is somewhat related to
the flexibility one, we felt unanimously that it did meet the care coordination criteria,
but did not meet integration. It does not describe in sufficient detail
how primary care physicians will be made part of this and does not describe really that
much about ensuring that the financial benefit will flow to anybody other than the pulmonologist. So we thought there was too much unspecified
about integration, and this decision was unanimous. Patient choice, the patient enrollment is
optional, so it’s kind of hard to argue with that. Patient safety, again, there’s a lot of focus
on preventing early exacerbations and infections, so we think patient safety is strongly supported. HIT, I think it’s fair to say there’s a lot
of work to do here because the specific software and device interfaces would need to be developed,
and for those of us who have banged around these systems, that’s not a simple thing. But, again, we thought this is certainly all
doable and, therefore, we felt like the judgment was correct that it did meet the criteria
of the Secretary. So there you have it. CHAIR BAILET: I want to thank you, Len, and
also thank the members, Tim and Grace, for their efforts on this PRT and all the heavy
lifting that they did in your analysis and summary. Thank you very much. I’d now like to ask the Committee members
if they have any questions for the proposal review team. Seeing — oh, Bob? DR. BERENSON: Yeah, I was hoping somebody else
would go first. In their proposal, they say the following:
“Based upon the review with the peak flow meter findings,” et cetera, “any recommendations
for medication change will be sent through the primary care provider. Alternatively, if the PCP allows the pulmonary
specialist, the CAMP will make these changes, and they will be recorded in the patient’s
EMR.” Did the PRT pursue this at all to determine
accountability for the patient’s well-being? That’s a concern I have. In the questions, I didn’t sort of see anything
additional to sort of ask — find out how this would work. I could imagine responsibility falling through
the cracks in this kind of a situation. DR. FERRIS: We agree, and that was precisely why
we — DR. BERENSON: The integration [off microphone]–
DR. FERRIS: The integration. We did not — there was not an explicit plan
for the integration of care between multiple providers. Those patients with COPD don’t just have COPD,
so it’s not only the primary care provider for whom this specific question you ask, Bob,
but also other specialists. Very frequently have cardiac disease, it’s
very frequent for COPD patients to have a cardiologist. So the proposal, I think it’s fair to characterize
the proposal as being fairly robust in the specific area of care for patients with COPD
and asthma, but much more limited in its description of how you provide in this model patient-centered
care that involves the integration of all the other physicians who are taking care of
the patient. DR. BERENSON: I mean, this, I guess I could reserve
it for later, but in the clarifying letter, which is a helpful letter, in the current
model we envision using medical assistants supported by pulmonary nurses, IT software
engineer, two nurse case managers, a behavioral psychologist, a respiratory therapist, a statistician,
and a medical director, but no pulmonologists are mentioned. And it seems like it’s not a physician-focused
payment model. It seems to me it’s disease management support. And that’s one of my concerns about it. I will mention some others when we get to
the later discussion. DR. FERRIS: Can I respond [off microphone]? CHAIR BAILET: Please, go ahead. DR. FERRIS: So because of where the proposal is
coming from, I think we gave the proposer the benefit of the doubt that this was pulmonology-focused
since that was the ostensible platform on which this is working. And I would say that the team of people identified
in that list is precisely the kind of practicing at the top of your license, have the real
work done by physicians, and have the constant contact associated with other monitoring systems
through IT or outreach to patients that helps stave off remediable exacerbations. That’s precisely the kind of team that one
might put together to enable that kind of performance. So I think we — while I agree with you it’s
not explicit, I think we read it as part of a whole in this setting. CHAIR BAILET: Harold? MR. MILLER: This I guess is somewhat related to
the question Bob raised, but the issue that — this is also related to the proposal yesterday. So we have an applicant who is, in fact, a
physician practice who has a particular approach to changing care, in this particular case
using or wanting to use Bluetooth monitors and, you know, respiratory techs, et cetera,
et cetera, et cetera. But the payment model, if I understand it
correctly, is to pay a per-beneficiary, per-month payment. It is not specifically to pay for Bluetooth
monitors or to pay for respiratory techs. And if this particular practice would choose
to use the PBPM in that way, that would be their choice. But if the payment model is a PBPM, then some
other practice could choose differently to be able to do that and would then be accountable
for the outcomes. So I just wanted — and I’ll ask the applicant
this, too, but was your understanding of the model that it was to give the practice a per-beneficiary,
per-month payment, and then they could decide, whoever got it could decide what to do with
it? Or was the payment model to pay them specifically
for this particular defined technology and intervention? DR. NICHOLS: So part of the payment model was
to provide the Bluetooth meter to the patient, so that’s a given. The technology is a given. And the PMPM was to provide the resources
for the team that Bob just articulated in addition to the pulmonologist to manage those
patients. MR. MILLER: Right. There were two pieces —
DR. NICHOLS: Certainly — and there’s also a third. There’s a shared savings component against
the target — MR. MILLER: But the PBPM would not be tied —
DR. NICHOLS: No. MR. MILLER: — to a specific structure of —
DR. NICHOLS: That was not my understanding. It would be flexible from the clinician’s
point. DR. TERRELL: Although there was some — in the
questions, some discussion of particular algorithms that they had developed or would develop with
respect to how the management of these patients would proceed with the team that they were
involved with. So whether it was a specific algorithm or
care pathway or another or some other way, whether there was flexibility in the model,
I think your questions, both of you, are getting at how much of this is proscribed is a good
one. There was work that was alluded to with respect
to the fact that they have some of this fleshed out and have developed algorithms in place
that were particularly tied to a care pathway. This gets back to what we talked about a little
bit, I think, yesterday with respect to care models versus payment models and the concern
that I expressed then that this is going to continue to be the thing that we’ve got to
understand the relationship between the two. So I think your question is a good one. MR. MILLER: Well, and particularly when we have
a practice with a particular approach coming in and saying the payment model would allow
this, but the payment model then would also potentially allow other things, which is a
— and that’s one of the issues on the flexibility is, is there the flexibility to do it differently
or does the payment require use of that algorithm and does the payment require this particular
staffing structure? DR. TERRELL: And the other side of that from my
point of view is you really have to have very robust quality and outcomes measures as part
of a payment model if there’s flexibility in what it pays for. And the supplementary information that we
receive that you all have in front of you on paper today, we’re seeing some of those
outcomes measures laid out, hospitalization, ED visits and all of that. But the real need in the situation where there
is flexibility and some people could potentially use it for other ways of doing care management
has to be around very, very vigorous outcomes measures, in my opinion. CHAIR BAILET: Elizabeth, your question links
to Harold’s? VICE CHAIR MITCHELL: Yes, thank you. I think it’s actually very similar, but I
just wanted to get a little bit more precise, because we’re talking about a specific product. And as we talked about yesterday, that might
not always work in some practices. So you say that this same model could work
if another product offered the same functionality, so you could endorse the model without endorsing
the specific product? DR. NICHOLS: Yeah, that was a concern we had when
the proposal came, and, in fact, when the proposal came at that time, the device had
not yet received FDA approval, which even made me nervous. But we asked CMS about this notion of having
one particular supplier of a given commodity, whether or not it had FDA approval, and they
said, “Well, you know, in certain circumstances we could work it out.” And they sort of implied it really depends
a lot on what kind of price they’re going to charge and other things. Since then, in the communication we got after
our PRT report was posted on the website, it’s clear that the submitter understands
and would like us to understand you could use different technologies to do — you don’t
have to have that one machine. And, by the way, it has now gotten FDA approval. VICE CHAIR MITCHELL: Thank you. DR. NICHOLS: But yes, you could use different… DR. FERRIS: I’d also respond just to add on to
that. I think maybe building on Grace’s comments
about the care model and the payment model dynamic that I think we saw yesterday and
we’re going to see more of, you know, it’s fairly easy for someone to propose, a physician
to propose or a group to propose, just give me a fee and I’ll figure it out, put me at
risk and I’ll figure it out. And that’s the payment model, right? Having the submitter specifically explain
what they’re going to do lends credibility to the proposal, or not, if what they propose
to do doesn’t seem credible. But having the care model — so the application
appears to present us with very specific — like we will use this Bluetooth thing. I think when you think about the payment model,
I’m reading the application as this is a credible, or not credible, clinical intervention that
is going to provide greater outreach for a group of unstable patients, and that’s going
to reduce their rate of hospitalizations. But once you propose that, I don’t feel when
I’m evaluating the payment model like I’m tied to the very specific care model that
they propose, because that care model works in that practice and in that situation. And so specifics on the care model are important,
but not determinative of whether or not the payment model is a viable payment model. That’s just sort of the way I’m thinking about
it. CHAIR BAILET: Thank you, Tim. Kavita? DR. PATEL: So I’m going to ask questions to the
PRT, but I found also that it might be helpful to hear what Jeff and Elizabeth think. I’m struggling a bit what to do because it
does seem like the responses clarify some of the issues specifically around the quality
metrics, cost metrics, and that may or may not — I mean, for me at least changes a little
bit on kind of how I think about that section on quality, cost, and potentially the value
of volume question. So I’m not sure — kind of I’m out loud kind
of questioning, you know, do we kind of take this information and how would you kind of
process responding to what I think is clarified? So that’s a little bit of a process and substance
question. The second question I — oh, go ahead. DR. NICHOLS: Well, let’s just get one at a time. How about that? DR. PATEL: All right. Go ahead. DR. NICHOLS: Because I think that’s a very important
place to start, because let me just say this is why I’m glad I’m not a doc. I think that Tim and Grace should respond
first, but all of you should talk about the proposed quality — because we saw the absence
of that — in the response letter you just saw, they said, “Oops, we meant to include
it,” you know, whatever. So here we are. So I think you should look at it specifically
and draw your own conclusions, and I’d be glad to learn from your thoughts. CHAIR BAILET: Tim. DR. FERRIS: I guess, Kavita, I, too, found their
responses very helpful, and they now put us in the realm of plausibility. But they actually don’t tie — there’s no
formula to tie them, and as we know, tying them to the model is actually a nontrivial
exercise. So what I would say is it’s very helpful and
directionally appropriate. But I’m still not sure that the response constitutes
a payment model, at least in a payment model insofar as it is specifically evaluable. Like I still can’t say would this work or
not because there’s no math there to — there’s no formula. CHAIR BAILET: Kavita, also embedded in your
question was a process issue. DR. PATEL: Right [off microphone]. CHAIR BAILET: We have spent considerable effort
lining up the evaluation, communicating with the submitter, working with the proposal review
team, drafting the recommendations. A lot of distillation of information has occurred. And, again, we operate transparently, and
we want to have the back-and-forth with our submitters and our stakeholders. Everything is put out for public comment. That’s the other thing that is digested by
the proposal review team. Our challenge — and this is really not specific
to this proposal — is that as a Committee, when you get a six- or seven-page letter with
exactly the kinds of information that will help us sharpen our thinking on this proposal,
the timing makes it very challenging for us as a Committee to digest this information
thoughtfully and then be able to have a rich deliberation, as you see playing out before
you this morning. That’s a challenge, that’s a process challenge,
and I don’t profess to be able to solve that today. But that is something that we’re going to
have to address going forward, because we’ve had — you know, it’s not just this proposal,
but we have a similar circumstance with some of the other proposals as well. Harold, and then Grace. MR. MILLER: I think it would be good just to spend
a minute on this, just to build on Jeff’s invitation to people who are listening to
send us suggestions about how we might improve our process, because it seems to me that there’s
at least three options one might do to address this. One is that the PRT report, the draft PRT
report, needs to come out farther in advance of the meeting, which would then give people
an opportunity to respond to it and then to have it potentially revised, but that would
delay the process. The second option would be to have a process
for tabling something at a meeting and saying we can’t make a decision today because the
new information that we’ve gotten is more significant, or to have some kind of a rapid
revision, resubmission, and re-review process afterwards so people don’t sort of get a no
and then have to completely start all over again. And I’m not sure at all which of those is
the right approach to use, and it would be, to me, useful to hear from, you know, people
who are thinking about this and watching the process kind of what their reactions are so
as we consider the options, we could take that into account. CHAIR BAILET: Grace, and then Len. DR. TERRELL: One of the issues, therefore, is,
is the process we have of our review adequate or not to where these things could have been
put forth earlier? So, I mean, you can question this for any
of the reviews — the one later this afternoon, this one, or the one yesterday — well, why
are we getting information at the last minute or later than sort of the process that may
be changing our mind or allowing us to have a richer set of things? We set the process up with 20 pages only so
that we wouldn’t get hundreds of pages of stuff that wouldn’t necessarily get us to
where we needed to go. And then we have a review of that information,
research that we do. And then we have a series of questions back-and-forth. And I’ve participated in two of these now,
and they have been based on some free-form conversation between the members of the PRT
saying, well, I’ve been thinking about this, and you’ve been thinking about this, and developing
a series of questions, some of which were, you know, 39, 40 questions, of which we got
very good answers back. But maybe that’s not — maybe that’s really
a problem in the process right there. That needs to happen, and then there needs
to be something much more specified that would get there. I don’t know. But it would seem to me that as we’re evaluating
this one in front of us now, we based our initial assessment and reports on the information
that we had after going through that process, and then we’ve got other information here
just like we did yesterday that elaborates on that. I’m not sure that’s a bad thing. It could potentially always happen but — simply
because you learn as you go along. But whether this changes the outcome today
or not really is going to depend on as we go through the rest of this process. It doesn’t, I believe, eliminate the essential
problem we saw with this particular proposal, and that is, they needed help that we weren’t
able to give them because of the constraints we’re under. And that is, had they had some ability to
under — had some technical help that would have allowed them to maybe flush through some
of the issues with respect to the payment model particulars that we then critiqued them
for, it could have made it stronger. That’s what we’ve got to get better at. This is a good example of a proposal that
has some very, very, very good things. We desperately need in this country ways of
providing better care to COPD patients, that is, probably several types of innovative care
models linked to payment methodology that will allow physicians to do that. But the actual details that they needed to
get there, as we’ve talked about earlier this morning, were not part of our process, and
we weren’t able to help them do that, as you know. CHAIR BAILET: Len. DR. NICHOLS: So I would just pick up on Grace. I think, in fact, this is working. I sort of don’t think that we need to necessarily
change it. I’m not sure I’m convinced it’s broken. What I think has happened is that we got the
proposal. We asked a bunch of questions. They answered the questions. We asked questions of professionals who know
more about data than we do. We thought about it. We wrote the PRT report. I think the PRT report, if you will, sharpened
the mind of the applicant in a way, “Okay. That’s what they’re worried about.” Boom, boom, boom. This thing right here is a good piece of information. I don’t think it came too late for us to be
able to think about it. It did come in email. It’s just that I don’t think everybody on
the Committee got that email. I think that’s where we are. And so, to me, this is the way it should work. I totally agree with Harold. If the information was sufficiently game-changing,
I might want to table, but I don’t feel like that’s required today, given everything else
that we’ve got. So, in some ways, the only thing I would suggest
we’d change in the process — and I think this might have been proposed at one point. I’m looking at Mary Ellen, because you probably
thought of it, and we probably nixed it. Maybe we should send the PRT report to the
submitter before we go public and have a little more time, one more round of back-and-forth. I think my concern was, oh, my God, that will
delay it, but if these guys respond as fast as this man did, I don’t think we’ve got a
real problem with delay. So I think maybe we should reconsider that. CHAIR BAILET: I want to make sure, Kavita,
you have another section to your question, but I think, Paul, if you’re going to respond
to the original — DR. CASALE: Yeah, this will be quick. I’m sort of with Len. I mean, I don’t think that it’s really very
broken. I mean, at some point, you put out the report;
you’re going to get a response. We’ve seen it. All three, we’ve gotten responses organically
from all three, and I think whether we send it to them earlier, et cetera, but I think
we need to receive it earlier as a full Committee, to be honest with you. And I don’t think — you know, if I had it
a week ahead would be fine. And I just want to emphasize —
DR. NICHOLS: Well, to be fair, it did come in
an email. DR. CASALE: Right. DR. NICHOLS: — and I saw it, and Mary Ellen called
my attention to it. And I said, “That’s interesting. I’ll read that next week when we get there.” DR. CASALE: Yeah. Right. And I guess the other point that I’d want
is this is the preliminary report, and I think preliminary is okay. Again, it doesn’t have to be perfect and have
everything when we get here. Just two points. CHAIR BAILET: Thank you, Paul. And Elizabeth. VICE CHAIR MITCHELL: Yeah, just a quick additional
comment. I’m associating myself with Len. The entire intent of this public forum is
to get additional information, and I think we are genuinely committed to incorporating
that to the extent possible. I am relying on my colleagues to help sort
of evaluate do these new metrics make a difference in your initial assessment, but — it might
be hard to watch, but we really are deliberating in real time, and I think additional information
is really the name of that. CHAIR BAILET: Thank you. Kavita. DR. PATEL: Oh. So the second — I have kind of a second set
of questions around kind of the PRT’s reaction, and I know there’s some kind of mention to
it around the risk adjustment. If I look at your PRT recommendations and
even aside from your recommendations kind of go through each of the criteria, thinking
through that — and we’ll vote on that — I still find myself kind of hung up on — I
found myself kind of troubled by the risk adjustment kind of — or the — it’s, on one
hand, very novel because we certainly — they made a very interesting argument about kind
of using the number of conditions. We know that using HCC — we know that there
are a lot of flaws in current risk adjustment methodology to explain kind of the clinical
variance. But my question to you all is how much of
that was a discussion around specifically that section. You reference it in your summary of the PRT
kind of section, Len, but I’m just — and especially now seeing the response from the
submitter. And then I will say I agree with — I just
— and then the — kind of a related question is how much of this tension of — you know,
this is a very highly — you know, unlike the conversation we had yesterday, this is
an incredibly prevalent disease, an incredible opportunity to reduce hospitalizations, ED
visits. We now see that they are actually thinking
about those quality metrics as part of the response. So tell me a little bit about the struggle
to think about — or did the kind of sense of prevalence or impact that this could have
on a very kind of burdensome condition kind of come up? So — and then I’m done. Those are the two questions. CHAIR BAILET: Go ahead, Grace. DR. TERRELL: I just have a quick technical point. Because of work that my organization has done
in this same area, including developing care models in COPD, I did not feel compelled to
have a lot of discussions about that because one of our criteria were Charleson scores
or basically identifying people who had five or more chronic diseases as being in and of
itself a risk model. So getting the details from them of the stuff
that I guess I already assumed was knowledge I had from my own experience, there was not
a lot of dialogue back-and-forth. That may well have been an error on my part
or our part, but it was the risk adjustment, that there is data out there that you can
use number of chronic conditions with an n of 5 being the number that seems to be a cutoff
for levels of stronger development of care models. So you can have five stable chronic diseases
and one bad one, COPD or whatever, and that in and of itself can be a — for those that
don’t have fancy data, EMRs, any other types of things, including registries that many
sophisticated groups have, you can do that with a relatively simple practice criteria. To the Secretary’s point earlier about smaller
practices or rural practices, that’s one thing that’s a very simple way of sometimes doing
some of this. DR. PATEL: So you saw that as a plus? I just want to make sure. DR. TERRELL: I saw it as a plus. DR. PATEL: Because I know that in your submitter’s,
I couldn’t — DR. TERRELL: We didn’t have that dialogue. DR. PATEL: — infer —
DR. TERRELL: I had that dialogue in my own head
so — DR. PATEL: Okay. Because I couldn’t tell from the questioning
back-and-forth if you thought those — DR. TERRELL: Yeah. There was not the questioning back-and-forth
— DR. PATEL: — if you felt that was a detractor
or a — okay. All right. DR. TERRELL: — because I was making so many a
priori assumptions. DR. PATEL: So that would actually indicate that
this has a novel aspect to it that’s not incorporated in any other current payment methodology,
just to clarify. Okay. DR. NICHOLS: Oh, I think it’s very creative. I think unambiguously in favor of giving them
the technical assistance we think they need to get to the Promised Land. I will point out that the letter that came
around in email said they agreed with our assessment of the number of chronic conditions. A letter that came more recently did not. DR. PATEL: Right. DR. NICHOLS: Well, I’m confused, too, because
I thought this was a printed version of what came in the email, but this is a different
letter. Okay. CHAIR BAILET: Yes. DR. NICHOLS: So there are some differences of
opinion, and we probably should just table that. I would just say, in my mind, I’m still not
in favor of chronic conditions, but go ahead. CHAIR BAILET: Tim. DR. FERRIS: Well, I did want to say that, harkening
back to our discussion yesterday about what might work for one group and what one group
is willing to do, our job is actually to think about the implications of a model generalized. And, again, it’s novel. It’s really interesting. There are risk adjustment methods where you
can simply count conditions, but in this particular setting and in this particular model, this
has not been tested. And I would say to base the financial future
of a group of physicians on a risk-adjusted model that there is no empirical experience
with is a risky thing to do, and that is where it sort of fell down for me. CHAIR BAILET: Kavita, are you —
DR. PATEL: Yeah, I’m done. CHAIR BAILET: Okay. Very good. Any other questions from the Committee? [No response.] CHAIR BAILET: Well, then at this time, I’d
like to invite Dr. Ikeda up to the microphone, and please introduce yourself for your remarks,
which will be in the 10 minutes. Thank you. DR. IKEDA: Thank you very much. CHAIR BAILET: There you go. You’re good. DR. IKEDA: Thank you very much. My name is Daniel Ikeda, and I am a physician
from Sacramento, California, in private practice. I am boarded in pulmonary medicine, infectious
diseases, and critical care medicine. I belong to a multi-pulmonary and infectious
disease group in Sacramento in private practice. We have about 25 of us, and we operate both
in an office-based practice as well as act as intensivists in multiple hospitals in the
Sacramento area. And so when we looked at the changes in MACRA,
one of the things that we were anxious to look at is a way to use telemedicine in order
to achieve the six goals that Dr. Price had talked about. We have had — been very experienced in telemedicine
in the intensive care unit, where one of the — probably the beta site for the VISIQ EICU
back in 2003, and through that experience really got a feeling as to what telemedicine
has to offer medicine in general. Not only are we able to use a single physician
to multiple, multiple hospitals for acute interventions, but the data repository developed
through this system allowed us to actually look at outcomes to create pilots on various
papers or ideas and to see whether or not we can validate these very different things. Early work in sepsis allowed us to reduce
mortality from 40 percent to 28 percent in a matter of months, and we’re able to use
that experience to then apply protocols throughout the city to achieve similar results. And as we come to look at COPD, the problem
with COPD in the clinical practice is that it’s a difficult disease to manage, and the
problem with the expertise in the area is that much of us as pulmonary physicians are
really drawn more toward a hospital-based practice. Currently, I spent a week a month in the office
because all the priorities for my expertise is in the hospital, and clearly, there is
a need out there for better monitoring and management of these sick patient populations. Now, in looking at this project, I mean, I
figure when you create a proposal, you ask for everything you want, with the expectation
you’re going to get pushback, and that’s why I’m here. [Laughter.] DR. IKEDA: But I didn’t know how else to write
the proposal. But, clearly, the one thing I do want to talk
about is the risk adjustment methodology. Part of doing risk adjustments, especially
when we’re willing to take risk, is looking at what are current models of risk-based treatments. As you look at history of capitation, it’s
all generally based upon a benchmark base, typically on a mean, and the goal is to improve
financial outcomes based upon that mean. Now, the problem with that is that in the
past, these types of plans are subject to cherry picking. In other words, if you can get a population
of low-risk patients and skew your distribution curve to that side, your numbers are going
to look great, but you don’t necessarily provide the care that you really want to do. So, for instance, in COPD — and having access
to the chronic condition database, which appear to be very robust and stable based upon just
looking at averages over years, it provided us at least a thought of an opportunity to
see if we can actually develop a capitation model that doesn’t reward cherry picking,
because if you think about how this would work under a classic condition, as part of
the evaluation, somebody created brand-new tables that were great. I wish I had them when I wrote the proposal. And among the comments was a fact that based
upon their evaluation of a universe of COPD patients with existing COPD, which had the
biggest n, the average cost of care was about $24,000. Now, when we did our proposal, we specifically
removed the low-risk patients, patients with Conditions 1 and 2, and by doing so, our average
cost of care was $32,000. Now, it’s the same population because we did
the calculations both ways, and so that suggests that if this [unintelligible] were to go forward
on a classic capitation model, then there is a risk that the whole process would fall
apart because of game-sharing, and that’s not what our purpose was. As a critical care physician, I am very comfortable
taking care of very sick patients, and it’s really this population of patients in the
outpatient that needs the case. In a classic capitation model where I’m at
risk for losses and wins, for every sick patient I get, I want two or three healthy patients,
if that’s the model of capitation. But using a model that actually forms separate
buckets of risk — and, in this case, using chronic conditions as that — informing a
mean, a median, knowing what the 99 percent distribution on the high side is for the fat
tail, it provides us now a much better ability to skew my distribution curve toward the sickest
of the population, which is the population that really needs the service, without the
fear that I’m going to screw myself over because I’ve chosen a [unintelligible] distribution
of patients. And so, as we look at the risk to me and to
our group, I am far more concerned about a risk-based model that is based upon the universe
of COPD patients because, first of all, the annual cost of care is much lower. Therefore, I would have to actually improve
care by a much more dramatic amount in order to achieve savings for Medicare. On the other hand, if I had a capitation model
that actually looked to capitate the high-risk group at their true cost, then reductions
in cost related to reductions in ED visits and hospitalizations will dramatically improve
the overall cost in the high-risk group, which will be reflected in the overall cost of care
based upon a comparison, an apples-to-apples comparison of distribution of, say, patients
with, say, nine chronic conditions or seven to nine chronic conditions. You can probably lump them at that base, because
in those tables, Table 1 shows that the distribution of patients from 1 to 20 actually formed a
pretty good normal distribution, but obviously, the costs associated with the zero percent
versus the 99 percent are vastly different. And that’s why we developed this proposal,
specifically looking for a model that we would be willing to take risk in, and the only model
that really works is not taking care of the healthy portion of that population, because
that would actually cost money to Medicare as opposed to save money to Medicare. And so that’s why we developed this methodology,
to really address that question, and based upon that, obviously we have concerns about
tail risk in this high-risk population. I don’t have an answer to that, except to
say that as we did our per-member, per-month fee, we started first with an assumption that,
well, what is a reasonable number to start working with as a benchmark, and so we went
to the oncology model. And they suggested about a six percent cost
increase. Now, whether that is valid or not, at least
it gave us a benchmark that we can put aside and say, well, okay, for 2,000 patients, that’s
a revenue stream of $4.2 million for our proposal. Then the question is, is this something we
can financially do, make it valuable, but more importantly, can we create a model that
is then scalable? So setting that aside, we have been working
on budgeting as to what we would actually need for this process, and part of that is
really in the paper that I sent today, where basically outlining what are beneficiary-to-health
care ratios that would be appropriate and safe, what are the supervisions, what type
of ancillary help I need, setting up a new office, needing health care consultants to
help through this process of the data, which is really critical to this type of project. And our annual budget to maintain the program
right now is running about $3 million, proposed. Plus, there is infrastructure cost that started
that we probably will estimate at about 5- to $800,000. And then that leaves the remainder, which
we felt in order for us to have a go at this, we would need at least a 20 percent revenue
withhold in order to protect ourself if the project fell apart. So we’re talking $800,000 to $1 million that
we would basically put in a withhold account in order to cover our downside risk. And with that, we felt we can actually do
this project and accept the risks, which are still unknown to us to a great extent, but
create a model by which population monitoring can now be financially viable. And that’s the key. That’s a problem with telemedicine. There is no good financial model to make it
a viable product, but if this project works, then all of a sudden, it opens the door for
other things. Now, regarding coordination of care, when
I did the proposal, I realized that if we are talking about receiving revenue for multiple
chronic conditions, at some point we would have to address the other chronic conditions. And the dilemma I had in the proposal was
not talking about that because I didn’t want to deviate focus from the primary project. So now we’re talking about, well, we can do
telemonitoring for multiple chronic conditions. And in reality, that’s not really what I want
to do right now. I need to validate our assumptions first with
what I think is the easiest of the chronic conditions to actually save Medicare money. You know, as a 30-year expert in infectious
disease in pulmonary, this type of system will recognize infections at early stage. It doesn’t have to be pulmonary. It could be something else. It will recognize early exacerbations of COPD. And if we can capture that and, more importantly,
train patients on a continuing interaction to recognize these things and know what to
do ahead of time, we will go a long way in preventing ED visits and hospitalizations. And so, you know, I find the discussion between
the care model and the reimbursement model very interesting because we struggled with
that, too. We want the care model, but we have to develop
a reimbursement structure that would make it viable, but more importantly, if successful
on a limited basis, is it economically feasible to scale up? And that’s the input I can give you right
now. And I’m open for any other questions. CHAIR BAILET: Thank you, Dr. Ikeda. Tim you had a question, and then Bob. DR. FERRIS: Well, first just a comment. If more physicians in the United States were
so focused on the integration of a care model that is proactive and attempting to minimize
the utilization of services, at the same time so thoughtful about the payment models that
are necessary to undergird and support that kind of care model, then we wouldn’t have
a reason for existing. [Laughter.] DR. FERRIS: So having said that, I did just want
to get your take on a specific concern around — I’m sorry, this is going to be a little
technical, but you seem to be up to it. If you simply count conditions, I’m going
to read you five conditions for two different patients, chronic conditions. So the first patient, Patient A, has hypertension,
arthritis, gout, psoriasis, and chronic sinusitis. The second patient has heart failure, amyloidosis,
stroke, coronary disease, and diabetes. Those two patients are not even remotely similar
from either a cost or a care delivery perspective. And so while I am really excited about the
novelty of the method you’re proposing, I’m not sure, given those two different scenarios,
that there is not still an opportunity for a risk adjustment system to either be abused
— which all of them do; we’re not letting the perfect be the enemy of the good — or
that through some random chance, the risk adjustment system actually might leave a physician’s
practice in the lurch due to just the variability in the selection of patients that it was unanticipated
and uncontrollable. And so I just wonder if you’d comment on that. DR. IKEDA: So what I will tell you is that, obviously,
the two patient examples you gave me, first of all, none of them had COPD, all right? And I think that’s critical at least to this
proposal. DR. FERRIS: The comorbidities. DR. IKEDA: Right. DR. FERRIS: There was an assumption that they
both had — DR. IKEDA: So everybody in my cohort of patients
will have COPD or asthma as a defining condition to enter the program, because that’s the area
where I have the expertise to intervene. You know, and just looking at the new data
tables that came out — and the one I’ll reference is Table 2B. So if you look at that particular table, and
you look at ED visits, ED visits related to COPD, hospitalizations, hospitalizations related
to COPD, there’s a validation that in patients with COPD much of their high utilization costs
are due to their lung disease and not to their other comorbid diseases. And that’s the disease state that I’m targeting
to control, and that’s why I am proposing I take all this risk to prove it. Does that answer your question? DR. FERRIS: It answers the question in the sense
that you, because of who you are and what you’re committed to, are willing to take on
the risk. But it does not answer the question of whether
or not either the system is gameable or that it could result in adverse financial consequences
to any specific practice given an uncontrollable risk selection. DR. IKEDA: So I presume we’ll be a guinea pig. DR. FERRIS: I’m sorry? DR. IKEDA: I presume we’ll be a guinea pig. CHAIR BAILET: Yeah, yeah. Thank you. Bob? DR. BERENSON: So let me start by saying that I’m
very sympathetic to what you’re trying to accomplish here. I have a family member who wound up on a ventilator
two consecutive winters for weeks at a time because early symptoms were ignored, and that’s
what happens. So I’m all for it. But I have some concerns. Let me ask you this: You’re in Sacramento. It is the heart of Medicare Advantage country. Are there Medicare Advantage plans who have
been interested, or capitated medical groups — there’s over 200 of them in California
— that would be at risk and presumably would be quite interested in a technology that could
reduce hospitalization and morbidity and mortality. So what’s been the experience there? DR. IKEDA: Well, the answer is there is a great
deal of interest. But the question is: At what cost and what
reimbursement? That’s unestablished since we really don’t
have — this is not a viable program as we sit here today. So, you know, part of this proposal from our
minds is to establish what is a pricing model that we can use as a benchmark as we go to
a Medicare Advantage plan. And I don’t know what the answers are related
to that, because I know what our costs are going to be, and it’s not inexpensive. And so from that perspective, you know, I
have two medical directors that want to talk to me, you know, after we get this process
done, and we are anxious to look at that. Down the road, we want to treat asthma in
MediCal, or in Medicaid since we’re in Washington, DC. And, originally, this project was developed
for, I think, the Innovation 2 grants, but I couldn’t finish it in time to submit for
that. I really wanted to treat a Medicaid population
using this model. Obviously, since it was a grant, I didn’t
know what the payment model would be afterwards and whether it would be sustainable. But that’s water under the bridge now. But I think that this type of care is easily
replicable for Medicare Advantage plans and capitated plans. Now, whether it’s designed to improve care
or reduce costs is a different matter because you can — because in each individual Medicare
Advantage plan, they may not have the sufficient volume of patients in, say, COPD to make it,
you know, worthwhile for us to do and for them to entertain, although it may be very
viable for them to choose high-risk patients in general and monitor them that way. But then the goals and outcomes would be different
necessarily. It’s not necessarily to save money — it is,
in one sense it is, but really to provide better overall care and hopefully through
that process reduce the costs to Medicare, which are not as predictable as with patients
with COPD. DR. BERENSON: Let me just follow up. My concern basically is that — well, if I
were — let me just say this: If I were a Medicare Advantage chief medical officer,
I would be looking for more than a German study to demonstrate the proof of the concept. This strikes me as quite relevant for clinical
research to prove the effectiveness. We do know that disease management has potential
negative impacts when one organization is doing the disease management and they are
not integrated with the practice that’s actually responsible for the patient. Those would be the kinds of questions — so
I guess my question is: Have you attempted or thought about the need for doing clinical
research to prove that the intervention actually works to improve quality and decrease cost
before trying to get a national payment model in place? DR. IKEDA: The answer is I’m a clinician; not
a researcher. And through, you know, our experience with
telemedicine as well as in the practice of pulmonary medicine, we strongly believe as
a group we will save money. We will prevent people like your relative
from hopefully getting sick enough where he ends up intubated. I mean, I see this all the time in the intensive
care unit. And when I talk to them after we’ve hopefully
saved their life, I ask them, “Well, how many days of symptoms did you have before you came
to the hospital?” And typically there’s this window of time,
whether it’s two to five days, where patients ignore their deteriorating symptoms and come
in where it’s too late to intervene at a point where they don’t need to go to the ICU. If I can capture these patients early, I will
prevent their hospitalization. I know that. And so based on the studies that we have read,
we’ve seen enough information so that we are willing to take risks on this because we firmly
believe we will achieve the outcomes that will provide the six points that all of you
are looking for in all your projects. We have that type of conviction. CHAIR BAILET: Thank you. Harold? MR. MILLER: Thanks. And thank you for doing all this work. I agree with Tim that this is the kind of
thing that we hopefully will be encouraging. I had, I guess, three questions. The first one in some ways is related to the
question that Bob was raising, which is that, if I understand the proposal correctly, the
physicians in your group would not actually ever see the patients in person — you can
clarify if I’m wrong about any of this — and that there would be basically a remote monitoring
to support other physicians, primary care physicians or otherwise, who are the primary
care managers for the patient. And as Bob was referencing, most of the experiences
with care management programs have shown that unless there is some, a direct patient contact,
at least for a portion of the time, not totally, and that there is some real involvement of
the patient’s primary care physician who’s managing the condition, that the results are
less successful. I have my own personal experience, having
run a project like this, which is getting the primary care physician or whoever is managing
the patient to be engaged with the patient, to have them accept that this thing that they’re
participating in is helpful is important. So I wasn’t quite sure that I understood exactly
in reading the proposal how you envisioned that connection sort of from the patient’s
perspective working. So someone is helping them manage their COPD
or asthma. You’re helping them manage that. And how would this appear from the patients’
perspective? And how would the patient feel like there
was really a team working together to support them? DR. IKEDA: Those are all very good questions. MR. MILLER: Thank you. DR. IKEDA: What I will tell you is that everything
we envision looks at these issues. The reality of what we actually are going
to do still is in flux, you know, because I don’t have a specific answer for you. What we envision, though, is that as patients
become linked to us through this daily interaction, what we hope to happen is that they will call
us first if they think they’re in trouble. And based upon that call, we can intervene,
initially remotely, with maybe hourly or daily follow-up to ensure that they’re not getting
worse. And if they are not getting worse, you know,
we will plan to see the patients if they are local. Now, as we go to a more scaled issue, that’s
going to be much more difficult, but that’s why I believe in scaling. It will require a consortium of physicians
to really take over that portion, that role. You know, I think that what this continuous
interactive monitoring will do behaviorally is really try to reset behavior, to make patients,
you know, adherent to a certain time of day doing certain functions, becoming more educated
and empowered to recognize their symptoms, to take presumptive action given a specific
set of rules, and to call us and let us know what’s going on so that we can make sure they’ve
made good decisions; and if they’re not doing better, to get them to an appropriate health
care provider immediately so that they don’t end up in the emergency room. And if that health care provider is us, then
that’s what we’re committed to do. MR. MILLER: That all makes perfect sense to me,
and I have seen that in action. The challenge I’m talking about is how to
actually get the patient started in that process, to actually be — because I’ve seen the problem
that patients have had enough of yet another person being involved. So I guess I would just suggest that I think
that sort of how you get the patient engaged and how do you have the PCP engage the patient
is important. The second question I wanted to ask is: If
I understand it correctly, again, you’re proposing a flat per-beneficiary, per-month payment,
and the risk adjustment would apply to the spending target, even though it would seem
to me that the patients who have more needs and more diseases are, in fact, going to take
more time. So I wonder if you think there is still a
potential for a cherry picking problem with a flat PBPM. DR. IKEDA: I don’t know the answer to that. You know, I presume that as patients have
many more chronic conditions, that bucket mean cost will be much higher than somebody
with three less chronic conditions. Obviously, that sicker patient will have a
higher likelihood of going to the ED and being hospitalized. And, yes, they will require more time, but
really that’s the patient that needs the time. You know, that’s why when we look at ratios
of providers to patients, we’ll get a sense as to who the patient populations are at highest
risk of having problems. And, you know, I can’t tell you we have processes
for that right now, because we don’t. But, clearly, you know, if we can identify
a cohort, a subset of that patient, that we can say they’re going to be in the hospital
in the next three months unless we change things, then it’s imperative on our part,
even if only from a financial point of view, to create a treatment plan designed to attack
this in conjunction with the primary care provider, because many of the problems that
we may face and I expect to face will be non-pulmonary. And we have to acknowledge that we will play
a role in that intervention to get the patient to the right provider. MR. MILLER: But I’m accurate that you’re proposing
a flat per-beneficiary, per-month payment —
DR. IKEDA: That is correct. MR. MILLER: — and not a risk-adjusted payment. And the third question, which I was convinced
that Bob was going to ask but he didn’t — and probably will if I don’t — is COPD and asthma
are both underdiagnosed and misdiagnosed conditions. And I wonder what you have thought — so,
again, when a model like this all of a sudden the payment is based on the patient having
the condition rather than a particular service being performed. And I wonder if you’ve thought about particularly,
again, given your, in a sense, distance from the patient, that you won’t actually, if I
understand again correctly, have seen the patient yourselves and diagnosed the patient,
whether you’ve thought about what problems that might create and whether there are ways
to address that. DR. IKEDA: Well, I think part of it is patient
selection, correct? And that’s particularly what you’re pointing
to. You know, we foresee, starting the project,
initially looking at our own patient population to see how many chronic conditions they have
and whether or not they would fit a program like this. We envision that many of the patients that
we try to enroll into this program will be patients who actually are captured through
their ED visit and hospitalization. And so meeting that gold standard of having
a disease sick enough to be treated in an ED and hospital kind of skews the population
more toward the more at-risk side than to the healthy side. MR. MILLER: Well, potentially, I guess it does
get still to the issue of how good the risk adjustment is, but I just want to make sure
I am understanding this correctly. I thought when I read your proposal, you were
talking about providing this support for a broad regional range of practices. This is not essentially we are a pulmonary
medicine practice and we want to have this service for the patients that we manage completely
ourselves, sort of a specialty medical home concept. This is the concept where you would be providing
a supplemental special service for others who are managing it. So the point is you would not necessarily
have been seeing these patients. You would only see them after something bad
happened eventually. DR. IKEDA: Correct. MR. MILLER: And even — I’m not even clear on
whether then you would see them, because they might end up at a hospital that you don’t
staff. DR. IKEDA: That is correct. MR. MILLER: Okay. DR. IKEDA: So I don’t know what happens when it
scales, when we go beyond areas that we physically can service, and to that extent, I am kind
of trusting the database because I figure the database is going to be the same, either
way, as patients become more remote to us physically, that people all of a sudden aren’t
going to come up with new diagnosis of COPD in order to get into the program if they lived
90 miles away, at least that’s my assumption. MR. MILLER: Thank you. CHAIR BAILET: Kavita and then Bruce. DR. PATEL: Dr. Ikeda, I first wanted to commend
you because I can only imagine — it seems like your imprint is all over this proposal. I can’t imagine how in private practice and
what sounds like a very typical busy practice, you actually had the time to pull this together. So I wanted to just tell you that I could
never have done that, and I’m impressed. I wanted to ask kind of two — you’ve seen
now the communication kind of back-and-forth, and it seems like there is some kind of questions
about how — even with your thoughtful response about the quality metrics, kind of how you’re
thinking about maybe tying that to the payment model. I respect that your day job is to actually
take care of patients, so you don’t study payment models on a daily basis. But do you mind — just having heard that
critique, can you articulate how you may have thought about the linkage in quality with
what you’re proposing? And then my second question — that was just
the first one. DR. IKEDA: Okay. DR. PATEL: The second question ties to what Harold
mentioned about the diagnosis issue — DR. IKEDA: Right. DR. PATEL: — because, as an internist, we know
that so many people are misdiagnosed probably by my own hands, and so there’s reliance on
your ability to do kind of thoughtful pulmonary function testing, et cetera. In whether it’s the German study or other
studies, have you seen some kind of requirement or criteria that has like a documented basis
for the diagnosis? DR. IKEDA: Well, most of the studies don’t talk
about chronic conditions, number one. DR. PATEL: Right. DR. IKEDA: They talk about COPD. DR. PATEL: Right. DR. IKEDA: And most of their entry criteria are
based upon spirometry data. Now, as it turns out, these new peak flow
meters actually have spirometry capabilities, and so looking — and that’s why we chose
that, because, number one, it would meet PQRS standards daily, and we’d be able to evaluate
that to determine if, in fact, we thought patients were misdiagnosed based upon that
data. That’s not great, but at least it gives us
more information to deal with. That’s that question. Regarding the first question, as providers
of care in our telemedicine unit in the ICU, we have been dealing with quality standards
and metrics for the past 13 years, and typically, our reimbursement for our services are tied
to meeting certain benchmarks in those quality standards. So we don’t have a problem being benchmarked
to quality standards and attempting to meet those goals. I guess the question is, What are the important
quality standards of the person paying me, and what do they want? Because I can propose a list of different
quality standards, and they may not have an interest in those, maybe because I can achieve
them so readily. And I’m more than happy to ask the payer,
“What are your quality standards, and what benchmarks do you want to hold us to?” And I’m perfectly happy doing that. We’re very comfortable with that process. DR. PATEL: In one of your letters of support — I
want to make sure; I was trying to flip through to find it — it looked like it was the State
of California or DHS, perhaps. DR. IKEDA: Yeah. DR. PATEL: So you mentioned Medicaid. DR. IKEDA: We mentioned Medicaid. DR. PATEL: We have a letter of support from the
state. California enjoys one of the broadest delivery
system reform waivers. Was there ever a question or potential for
like a State of California Medicaid-level pilot or kind of building a — Bob talked
about MA. I’m just curious —
DR. IKEDA: Right. DR. PATEL: — if that came up in —
DR. IKEDA: Well, they were really interested in
us getting the grant. DR. PATEL: You mean getting this to work? DR. IKEDA: Getting the grant in order to do the
pilot. DR. PATEL: You mean the original CMMI grant that
you had applied for? DR. IKEDA: No. For the Innovation II grant. DR. PATEL: Innovation II, okay. CHAIR BAILET: Yes. Right. DR. IKEDA: And so when that fell through, they
were not necessarily interested in creating a funding model for it. DR. PATEL: Okay. Thank you. CHAIR BAILET: Bruce. MR. STEINWALD: I would like to follow up on one
of your responses to the question raised by Dr. Ferris on risk adjustment. Clearly, that was an important issue for the
Preliminary Review Team. I want to make sure I got this right. When Dr. Ferris identified these two very
disparate patients with five chronic comorbidities and you agreed that they were very different
— but I think you said because they all have COPD and COPD tends to dominate the costliness
of the patient, you weren’t so concerned that those comorbidities were very different from
each other. Do I have that right, and if I do, could you
remind us on why — on what basis do you make that assertion that it’s the lung disease
that really dominates the patient’s costliness? DR. IKEDA: Well, I have to look at the data. I mean, the data with COPD as a primary or
secondary condition dominates ED and hospital admissions, at least looking at the data that
was provided to the team. That was our initial assumption, quite honestly,
is that in patients with multiple comorbid diseases, inability to breathe is probably
the single most frequent symptom forcing people to go to the emergency room. Now, inability to breathe may not be due to
COPD. It may be due to heart failure, but clearly
that plus infection. So, based upon that, I don’t really know how
to control a lot of these other chronic conditions like arthritis. Clearly, I know that control of hypertension
is good, but it won’t necessarily be reflected in any immediate outcome benefit. So based upon lack of information that control
of other chronic diseases adversely impacts the overall cost and utilization, as long
as they have COPD, that’s the one variable that I propose to control. Does that make sense? Does that answer your question, I guess? MR. STEINWALD: Let me follow up just for a moment. Yes, it’s the one intervention that you hope
to control, but it also — as I understood your response to Dr. Ferris, it also makes
you more comfortable that the differences in comorbidities of different patients with
COPD don’t concern you that much because the COPD lung disease dominates, in your view,
the costliness of the patient. DR. IKEDA: I guess the real answer is I don’t
know. MR. STEINWALD: Okay. DR. IKEDA: But I am willing to find out. MR. STEINWALD: Thanks. CHAIR BAILET: Grace. DR. TERRELL: Just a series of questions, some
of which are just very quick answers. First one is there’s chronic care management
codes that are part of the fee-for-service system now. Did you all look at those? Have you used them? If not, why not? Has there been an opportunity to think about
that with respect to the processes that you’re doing? DR. IKEDA: Well, I don’t see that code as necessarily
being applicable to telemedicine — DR. TERRELL: Okay. DR. IKEDA: — because the proposal, as written,
is not really designed to be a chronic disease management skill, although that’s incorporated
into the process. If we’re being paid a per-member, per-month
benefit and taking risk, I don’t see why I should be charging an additional charge for
chronic care management. I mean, that seems to be double dipping. DR. TERRELL: I was just looking at in lieu of
that. In other words, right now, without this payment
model, there were some other things that are out there. Are you utilizing them, and if not, why not? DR. IKEDA: Obviously, the whole impetus for us
wanting to do this project is to look at MACRA and how as specialists we can participate
in some form of advance payment methodology that would basically allow us to get a five
percent increase in our Medicare payment. DR. TERRELL: Okay. DR. IKEDA: And that’s a very big incentive for
us, as it would be for any other provider that enters this program. I don’t see how using the chronic care management
codes achieves that goal, unless you can tell me. DR. TERRELL: Okay. My next question is, if you were wildly successful
with this — you’ve sort of alluded to this with some of your answers to some others,
and we just were able to really work this out for your group and your region. What steps would you see that we would take
to make this a national payment model, given the specificity of your particular situation
with your practice resources, versus sort of the Wild Wild West of the entire U.S. health
system? And the reason I’m getting to this, you alluded
to it earlier. You wrote, I think, initially a grant proposal
that you didn’t get in on time — DR. IKEDA: Right. DR. TERRELL: — and used that thought process
to actually write a proposal for a payment model, and one of the tensions, I believe,
that’s going to continue to happen at the level of PTAC are folks who are thinking about
their own circumstances and saying, “You know, if I had this particular thing, I could really
practice better medicine and achieve things that I can’t in the current system,” versus
if we looked at that, how could we roll that out above and beyond just an individual practice? As we are thinking about that at the level
of PTAC, that’s one of the things that we are really working on. So any wisdom you have or any thoughts you
have as to how we could go from your specific circumstance to a wider policy approach, I
would be interested in hearing your thoughts. DR. IKEDA: Well, what we assumed is that if we
were wildly successful, people would find out and re-create the model —
DR. PATEL: Okay. DR. IKEDA: — because the payment methodology
would be there, and that’s part of the intent. Do I think I could provide services nationwide? No, I don’t think so. DR. PATEL: Okay. DR. IKEDA: I mean, if I can just provide a region-wide,
that would be a start, and maybe we’d have some expertise at the end of this to scale
up and down California and maybe some of the local states. But my expectation is the economic benefit
related to this and the ability to be designated as an advanced payment methodology will attract
other people once they figure out that the real risks in doing this right are small. Right now, people think I’m crazy to propose
a capitation model that’s based upon treating the sickest of the sick, but I do believe
— and as a group, we believe — that we can accomplish this goal. So I hope from that standpoint, we’re successful
because, if we’re successful, the proposed payment model is economically robust enough
so that it should withstand, hopefully, the bad fat tail risk that is always going to
be out there or ultimately will come to agreement with CMS assuming — that’s one of my questions,
actually, is if the proposal gets approved to pass on to the Secretary, it’s really my
assumption that CMS will look at the proposal and at that point start making changes to
the actual implementation of the concept to an entirely different plan, and I was kind
of preparing for that discussion at some point in time to see how that works. Once those particulars are worked out, then
the model is then out there for other people to duplicate. DR. TERRELL: Okay. DR. IKEDA: And I think that’s the answer I will
give you. DR. TERRELL: All right. DR. IKEDA: But I think if I am wildly successful,
this will scale rapidly because it has all the advantages that we all seek in terms of
patient care outcomes, and it’s financially viable for whether it’s a system-wide health
care plan to incorporate and then start using those revenues to treat their Medicaid patients
in addition, because if I am correct and we are wildly successful, that’s the population
I really want to treat, because there is no good payment model for that. And providing the service individually is
very expensive. DR. TERRELL: A couple more questions. One of the things that’s interesting about
a model that’s taking care of the sickest of the sick and doing it in a capitated risk
point of view is related to end-of-life issues, and there’s a point where integration with
palliative care and not doing everything, it sometimes prevents the patients on a ventilator. How much of the model that you have here —
DR. IKEDA: Envisions —
DR. TERRELL: — can address that? DR. IKEDA: Envisions that possibility? DR. TERRELL: Yeah. DR. IKEDA: Well, it’s interesting that you mention
that. One of the Innovation I projects that was
completed was a project called AIM, which deals with the last life of care, and that
project was performed by Sutter Health, which I’m affiliated with. So I’m well aware of that process. One of my partners is certified in palliative
care, and so we’ve talked about, to some extent, how to incorporate these concepts. Obviously, in doing so, it will increase our
mortality — DR. TERRELL: Right. DR. IKEDA: — since in planning for end of life,
we have to assume that we’re actually increasing mortality over the short term, as documented
by the successful study by Sutter, where they did save Medicare in that program a large
sum of money. So, obviously, we’re not going to reinvent
the wheel there but intend to work with Sutter in this process. DR. TERRELL: Okay. The final question I have is respect to the
quality stuff that initially we felt that your application didn’t address adequately. What you’ve brought back to us today are quality
measures that are related to utilization of services. It’s hospitalization and ER and all that. But one thing that’s true about the pulmonary
and the chest specialist is they’ve got very specific, more traditional guidelines with
respect to quality that have to do with utilization of certain types of pharmacotherapy, long-acting
beta-agonist vaccine, many, many other things, when to use pulmonary rehab. Is there a reason why you did not think about
those as being something that should be part of this measure with respect to quality and
outcomes? Is that something that you’re just already
doing? Is that something that the care model itself
would or would not be part of? I’m just curious about that because those,
I presume, are the things that, at least as far as we know right now, have some impact
on long-term management of COPD exacerbations. DR. IKEDA: Well, you are absolutely correct, and
in fact, in the proposal, I listed that we would be using guidelines from these models. Now, whether or not Medicare would want to
benchmark on compliance with these, we’re perfectly open for that, because really benchmarking
to quality goals is, in our minds, primarily the desire of the person paying us, because
we want to be benchmarked to the goals they want to measure versus the goals necessarily
that we want to measure. DR. TERRELL: Thank you. CHAIR BAILET: Dr. Ikeda, I share Dr. Patel’s
earlier comments and applaud your efforts, given that you’re a busy critical care physician. I have a couple of questions. I don’t want to get, necessarily, into the
weeds, but you made an earlier comment about your experience with the eICU. You were one of the early adopters or worked
in a system that had adopted that. Having placed that system within a 2,000 employed-physician
group and 15 hospitals, I want to understand that. These initial 2,000 patients, are these your
patients specifically, or is this a population of patients that you are going to be monitoring,
much like the eICU methodology? DR. IKEDA: Well, I think for this initial recruitment,
it would have to be locally. For the pilot we would have to look into Sacramento
County residents. Now, in Sacramento County, based upon the
latest data, there are 18,000 people, Medicare, with a diagnosis of COPD. CHAIR BAILET: Okay. DR. IKEDA: So the population is there. And so, you know, we, in our office, see just
the tip of the iceberg, which are typically the sicker of the sick, and obviously a number
of my patients, in my practice, would benefit from something like this. But we also see many patients that are not
as well monitored or cared for, through the emergency rooms at various hospitals, that
get admitted, and we envision trying to create a program to recruit and enroll those individuals
into the program, and we’ll find out how successful that is once the program is running, assuming
it’s approved. CHAIR BAILET: Right. DR. IKEDA: But that’s what we envision first,
is really, it’s that high-risk population where the capture point typically is going
to be in the hospital-based setting. The other component will be an outreach to
the varying groups in town, as well as to competing organizations, such as, in Sacramento
there is Kaiser and UC Davis. CHAIR BAILET: Right. DR. IKEDA: And we want to be open with them as
well, to offer the services and allow them to participate in this as well. But I think before I can go that next step,
I need an actual payment model that I can say, you know, we’re going to pilot this. Dr. Louie, you know, at UC Davis, you know,
can you — are you interested in, you know, in doing the research and seeing how this
works as an independent provider? And so I think, you know, we’ll be able to
achieve that 2,000 through a variety of means, although I clearly don’t have an actual number
of distribution as to how that’s going to happen. CHAIR BAILET: So, thank you for that clarification,
and here is directly what I have a question about. This is new, and I was on the ground when
eICU concept came to the fore, and the challenge that we had, which was not necessarily just
the challenge within my own practice, was that these patients, if they’re not your patients,
have very strong relationships, because of their comorbidities and just their sort of
genetic makeup, if you will, they are very sticky to other physicians. DR. IKEDA: Exactly. CHAIR BAILET: And the other physicians have
a very significant influence over what happens with these patients, and what happened in
the eICU environment were that you had this cohort of physicians who were not their physicians
but they, by chance — by just the nature of the program, were monitoring these patients. And there was a lot of tension between the
monitoring physician and the physician cohort that actually had a very strong bond, and
patients were — there was a lot of tension. There was a lot of opt-out. There was a lot of challenges in the early
adoption. And so I guess I’m curious, have you thought
through — have you had that experience? You’ve thought through those challenges, having
been in the trenches? DR. IKEDA: Well, I was the medical director during
the time. CHAIR BAILET: And you’re still here to talk
to us. DR. IKEDA: And so I had to talk about the fact
that we weren’t big brother, and we’re not trying to take over the care of their patients. And it took a long time, in some instances. You know, obviously, you know, whenever we
did write an order on such a patient we certainly contacted the physician, indicating the reason
why we intervened. But over time it worked out. You know, they lost fear. But regarding this project, you know, clearly,
you know, if we get the green light, one of the first projects is really a physician outreach,
town hall if you wish, to find out how do they feel about entering their high-risk patients. What do they get in return? Obviously we want to make sure that any patient
that�s entered into the program meets their MIPS PQRS standards, so that they can report
that. Clearly, we want to be a lifeguard and a safety
net for their high-risk patient population, similar to what we do in the eICU. And, clearly, we want to figure out how coordination
of care should occur without the physician on the other end feeling we’re usurping their
responsibility and their patient population. So those are all issues that, you know, we
look at, and that’s why, in part, with the coordination of care I kind of didn’t know
what to do with that question. CHAIR BAILET: Yeah, well, and that’s something
that we’ll discuss when that metric comes up a little later. Elizabeth? VICE CHAIR MITCHELL: Thank you, and thank
you very much for the proposal. I have two questions and a comment. My comment, first, was just to sort of recognize
and applaud your statement that said you were ready to be held accountable for the priorities
for whoever is paying you. Having worked with public and private employers,
that is not always something that people are so bold about, so I just wanted to recognize
that. My question, one is on sort of the HIT aspect
of this. I think the PRT — and you said that there
is clearly a technology component that people are comfortable with. I’m more interested in the information-sharing
aspect of that criteria. And you’ve acknowledged some potential barriers
created by the, perhaps, lack of interoperability across the HRs. So can you comment on how much of a barrier
you think that will be, and some of your thoughts on how that will be addressed? DR. IKEDA: Locally, it shouldn’t be that big a
problem. You know, right now, you know, in our private
practice we use an EMR called Athena, which has no connectivity at all with any of the
EHRs from the groups, so currently we end up faxing and scanning a lot of stuff. But at least within our region we are now
— it is starting to coalesce around Epic. You know, the Sutter system has it. It looks like the Mercy outpatient system
is going to — or Dignity now — outpatient system is going to evolve to it. Kaiser has it. UC Davis has it. And so for the purpose of this project, we
would probably use Epic as our platform, which allows connectivity to the varying providers
city-wide. So locally, that’s easy. You know, as we think about scaling it, it
does become an issue, and I don’t have good answers to how we’re going to — how we would
approach and overcome those issues. That’s what I think I need an IT, you know,
person to talk to, other IT people, about how we can make that happen. VICE CHAIR MITCHELL: Well, thank you. That actually segues to my other question,
which is very similar to, I think, Grace’s question about scale, because, obviously,
scalability is a key — well, key part of our thinking. But my question was more focused on readiness. You have been, I think, extremely candid and
open about the unknowns of this model, which is entirely appropriate. That’s why you’re here. But do you have a sense — and this may not
even be fair — sort of the readiness of others in the field to test this, or how much needs
to be learned before it is scalable? DR. IKEDA: I think a lot depends upon whether
or not we’re as successful as we hope we can be. You know, success breeds a lot of interest
and taking people off the inertia step. You know, clearly, if we see signs that this
is working very well, you know, we can start contacting other major groups in different
cities to see if they have an interest. I mean, you know, as pulmonary specialists
we do have a network, and we can utilize that network, potentially, to scale people into
their own communities if they have the interest. But everybody is going to be scared in the
beginning, because the risk-sharing model I’m proposing is obviously unique. You have concerns about them. They are going to have even more concerns,
since it would be their money on the line. And so the answer is, if we are wildly successful
then scaling becomes a slam-dunk. If we’re not successful, it goes nowhere. VICE CHAIR MITCHELL: Fair enough. Thank you. CHAIR BAILET: Paul. DR. CASALE: Yeah. I will just add my gratitude for bringing
this forward. Thank you. Clearly a lot of work has been put into this. Just a quick question. You know, in the BPCI model, one of the clinical
conditions is COPD, asthma. Did you ever have a conversation or think
about, again, within the physician community that you work in, to participate in that,
and maybe leverage this as part of that? DR. IKEDA: No, we did not. I mean, we’re not that familiar with that
model, to be honest. I mean, most times I’m in the intensive care
unit, and so, you know, I used to have a big outpatient practice but I don’t now, and from
time to time my interests, you know, aren’t necessarily, you know, over there, because
I can’t — don’t have the time to spend on it. But since this particular project is one I
created previously, it was easy to dust off the shelf, honestly, and certainly I could
commit to this to the point where I already told my senior partner — actually, I’m pretty
senior myself — [Laughter.] DR. IKEDA: — my boss, that I’m willing to give
the ICU back to the youngsters and devote time to this to make it successful. CHAIR BAILET: That’s very noble of you. We have no more questions within the committee. DR. IKEDA: Okay. CHAIR BAILET: Seeing none, I want to thank
you again for your attention and the detail and the effort that you put in interacting
with us and being extremely specific and helpful in answering our questions, as we consider
your proposal. So that is very kind. DR. IKEDA: Well, honestly, I found this to be
a very fascinating project. It kind of enlivened my intellectual side,
after just seeing patients day-in and day-out. And so I appreciate the opportunity to have
a chance to bring this proposal forward and sit before you. And if Blue Shield is interested, I’m willing
to talk. [Laughter.] CHAIR BAILET: So, yeah, we’ll talk a little
later about that, but again, thank you very much. DR. IKEDA: Okay. Thank you. CHAIR BAILET: All right. So our next section of the meeting is, as
we said, being transparent and working with the stakeholder community, we have opened
up the floor for public comment. We had some folks on the phone who have been
listening in to the entire session, but I’d like to have James Gajewski step up forward,
if he is here, to present. I think I got that right. You’ll thank me for that. DR. GAJEWSKI: I do thank you, but you’re only
close. It’s Gayeski [phonetic.] CHAIR BAILET: Oh, my goodness. Okay. Well, maybe another couple sessions we’ll
get it worked out. DR. NICHOLS: It worked out yesterday. CHAIR BAILET: Yes. Absolutely. Yes. DR. GAJEWSKI: Yes. Anyway, I again want to thank the panel for
the opportunity to speak. As I stated yesterday, I represent the American
Society for Blood and Marrow Transplant. I actually deal with a lot of pulmonary disease,
primarily bronchiolitis obliterans, but I take care of my COPD and my asthma patients
because, as I noted yesterday, I, for six months to one year, to two years, sometimes,
am the primary care physician for this. Yesterday I made lots of comments about the
issues of cherry picking and patient access, and I just want to remind the panel, bone
marrow transplant has lived under case rates since 1991. We have some outlier clauses but we live under
case rates. We also, since 2005, have had our one-year
survivals published by center, and we now are having physicians and groups having to
say no to patients, either because we can’t get proper compensation or we have to worry
about our acuity adjustments issues and our survival. I have been on the front line to say no to
the patients for therapy when the therapy is their only chance for living. I have also been on the front line for stopping
ventilators, many times in my life, in career as a physician. So these issues are very personal to me, because
of the type of practice I have, because I take care of transplants in acute leukemia
patients. So acuity adjustors — and I appreciate all
the comments about risk adjustment and I agree, perfection will be the enemy of the good,
and yet we have to preserve access for these patients. So one of the issues with acuity adjustment
is data collection, and everybody here has talked about the robustness of Medicare data
and yet many of us, in other settings and venues, will say that the claims data for
ICD-10 and ICD-9 is very specious. One of the issues for these complex patients
is that all of us who are cognitive care providers with these complex patients are billing Level
3 inpatient, we’re billing Level 5 outpatient. Sometimes we get to bill critical care with
these patients, but if I do team-based care I can’t bill critical care because those codes
were never designed by CPT and RUC for those. The answer for some of Grace’s questions,
which is not the chronic care management codes but maybe something that was approved this
year, is prolonged service, non-face-to-face time that may capture some of this work effort. But it is also very hard for us, as cognitive
care providers, to get that problem list into any sort of claims software to be as robust
as it should. And so as I think about COPD and asthma, and
many of the people at this table, I know, have treated COPD and asthma, but how many
of you have put in chronic hypoxia? How many of you have put in CO2 retention
or mixed acid-base disorder with primary hypercapnia, because these are the patients with COPD who
are the most brittle, the worst, the highest complication rate. Also, as we deal with these COPD-ers, they
are also, like my patients, they have ischemic heart disease, and there is an interrelationship. Many of them have diabetes. They also have peripheral vascular disease,
cerebrovascular disease, all of these things. One of the sad lessons, having negotiated
transplant contracts, both with my honorable colleagues from Blue Cross but with every
major payer in the country — I have lived under case rates for commercial payers since
1991. When I was a young man doing those sort of
negotiations, without all these gray highlights in my hair, I tried to write a contract where
we would just deal with the disease and any comorbidity we would get a supplemental payment
for. The problem is, when you’re looking at a three-
or six-month payment time period to say that the creatinine is due to the hypertension
or the diabetes versus the immunosuppressant drugs I prescribe, you can’t do that, and
that’s why we’ve had to live with outlier clauses. But the issue of these comorbidities — and
I applaud the presenters for coming up with an idea, but there is going to be risk stratification
with it and it’s not just going to be those five comorbidities. The patient with ischemic heart disease who
also has an ejection fraction of 30 percent and has COPD is a very different patient than
some of the others with five comorbidities, and we are going to have to think about this
or there will be this cherry picking, and the patients most in need of care will be
denied access of care. The other issue with a lot of these patients
is going to be cognitive decline, and all these new, wonderful systems we’re talking
about require in-home sort of monitoring with electronic sophistication and usually a home
caregiver. Well, not everybody has that. Not all these patients, when you hit 65, 70,
75, have a lot of sophistication, and these are patients on 20 meds a day. We can’t get a visiting home nurse there every
day to help them with medication management. We all try very hard to do that. I also would say that some of the other issues
that I, who takes care of these critically ill patients, struggle with is some of the
other requirements under MACRA and some of the things for electronic health care, having
patients have immediate access to my notes. My friends who are mental health providers
get some protected space of access for their notes, where they can make comments, but anything
that affects a patient outcome should be documented in my note. So as I deal with patients going through divorce,
that hurts. As I deal with cognitive decline, patients
with what I feel are personality disorders that is affecting their compliance, where
they’re actually sabotaging their care, I put those into my notes. They have immediate access to them. I get comments back. It is a huge issue. And so if we are going to do any of these
complex patients correctly, how we do this documentation of the complexity is going to
be important. How we pay the providers to do this complexity
of documentation is important, because the claims data is not as robust as we would like
it to be, and to do this well, to preserve access, it will have to be. The final issue, as I think about this model,
you really do have a dimorphic patient population between COPD, and if you think about the Medicaid
patients with asthma, which will primarily be children and adolescents and you have to
deal with things of dysfunctional home situations, you have to deal with the inability to get
homes cleaned because parents are working or there’s family dysfunction and disaccord. All these things, and the emotional health
of the environment, will drive a lot of the issues. That’s data that’s never been coded in claims
data, number one. Number two, how are we actually going to have
some control or do acuity adjustment for that, and yet we must. And so, you know, I commend the presenter
for all they have done, but I also need to have this panel to think and deliberate about
all these complexities, because these are not easy. But this is what it’s like taking care of
patients in real-life situations. CHAIR BAILET: Thank you, doctor. Any other folks in the audience who may want
to come forward and provide public comment? [No response.] CHAIR BAILET: We are now going to ask the
operator to open the lines. I believe there’s potentially some folks who
may have registered to comment. OPERATOR: At this time, if you would like
to ask a question, please press star and the number 1 on your telephone keypad. We will pause for just a moment to compiles
the Q&A roster. Please press star and the number 1 if you
would like to ask a question. And there are no questions on this end. CHAIR BAILET: Thank you very much. Before we start deliberating we are going
to take a 10-minute recess. Thank you. [Recess.]

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