Implementing Genomic Medicine Programs: Financial Impact - Reed Tuckson


Uploaded by GenomeTV on 11.05.2012

Transcript:
Reed Tuckson: So, I’ve got to rush because I’m at the
end here and we’re late, but those two presentations from my colleagues were just terrific, and
they really have laid down, I think, the groundwork. So I’ve got -- let me just try to pick up
and emphasize a few points here and there as I piece through it. The one thing that
they, through their demeanor did that I like -- and it was somewhat in response to the
questions, is that we have to work together. And so what I like about this meeting is that
we create the template for conversation. There is nothing that we are talking about that
is easy; this is all hard stuff, and it can get emotional and it can get very ugly quick.
So at the end of the day, if we can’t have the conversation in rooms like this, we’re
going to be in big trouble, because at the end of the day we really all are in it together.
I don’t know whether I understood the EGAPP slide, but as far what I’m seeing is we’re
getting past the point of genetic exceptionalism. Genetics is medicine, it’s in the game,
and so I’ll learn from you later why I need to be careful about saying it; by way of thinking
we are at the point now where, you know, we’re talking about medicine, and I think that becomes
sort of to me very important. Implementing it, then, provides opportunities as well as
it does challenges. So, both of my colleagues talked a little bit about cost, and I want
to just make sure you really get cost. Really get it. If you don’t get it in the way,
I mean, in your DNA get it, you’re going to be off in outer space and you are going
to miss it.
These curves on the lefts and the top two represent physician and hospital directed
care delivery. The slope of those curves is breathtaking. This is where the money is:
physician and hospital directed care. The other one’s doable medical equipment, pharmacy,
and all that kind of stuff, but the action is here, and that’s how you get the $2.5
trillion of expenditure. What’s scary is the right side, and that is looking from today
out. And look at the top two curves again, and it doesn’t take but a heartbeat before
you get to 4.3 trillion. That cannot happen. It will not happen, and so if you look at
it only from the point of view of Medicare and Medicaid. This was the “bend the cost
curve” slide when President Bush the second was in office, and he says we got to a problem
[unintelligible] with Social Security in America. And the Congressional Budget Office said,
“Look here, dude, you ain’t got a Social Security problem, you got a Medicare and Medicaid
problem.”
That quirk is going to get hammered, hammered down like you cannot believe, and it will
not be surgical. And there’s no state, by the way, in this country, not one state that’s
got any budget relief, and it’s not going to be in deep doo-doo because of Medicaid.
So they’re in deep doo-doo. The only place you can off-shift costs left is to the consumer,
and the consumer out of pocket costs looks like that, and wages look like that, and there
is nobody in this room that believes that wages are going to go up. So it’s over.
Now the highest component of escalation and costs is not utilization; it’s unit costs;
the price of things. So all of you who that are involved with companies that make stuff,
pay attention: unit costs are the highest escalation in health care.
Number two. Health care is complicated as hell already without you. And as my colleagues
said, half the time inconsistent with the best science. And so these folks are in deep
doo-do. 2001, there was the Crossing the Quality Cares and Report; if you have not read the
theology of the redesign of health care in America, you need to go back look at least
the executive summary, because it is very clear about what had to happen, and what has
to happen is -- everybody knows the mantra of safe, effective, timely, efficient, equitable
patient-centered. But the rules were redesigned; continue evidence-based decision-making, continuous
decrease of waste, anticipation of needs, patient a source of control, all of that integrated
by a shared knowledge and free flow of information.
So there’s all this stuff pouring into the delivery system every day, busting the bank
and making everyone crazy, and the assets being pissed away half the time. And then
we get you, and this is what we see as the scope of that curve; so yes, everybody’s
talking about how many tests, and you know the sense of it.
Our estimates are, probably between three and four billion in spending from 2006- to
'9, but then by doing some calculations that we’re pretty confident about and that we
have published and put into the public domain, we sort of see that national spending will
reach $5 billion in 2010, 8 percent of national spending on clinical lab, and we believe that
today, while it accounts for a fairly small amount of a $20 billion in vitro diagnostic
market that we believe that spending has grown substantially over the last 10 years with
the annual growth rate of an estimated 12 to 15 percent, rates much higher than for
clinical laboratory services as a whole, and with the scenarios we project that molecular
diagnostics will reach between 15 and 25 billion by -- we talking now real money, real dollars,
real stuff, no playing’ around.
For our company alone, $500 million in 2010, because we got to remember now, the size and
scale of a company the size of United Healthcare and United Health Group, and spending per
member increased by about 14 percent a year on average between 2008 and 2010. And this
is what really worries us; the volume of all of that and the pace of discovery increasing
the complexity of medical decision-making. So human -- if you think about the fact for
decision in the growing complexity of the [unintelligible] movement, and the red is
flat: human cognitive capability.
So can you imagine what is about to happen to the expenditures in health care for your
stuff tomorrow, and what it means to this country overall? Now, having said that, let
me address the question that just came up. We love innovation; the problem that we have,
if you look at it from an entrenched, narrow, managed care world is every new -- and you
heard it two presentations, every new thing in health care costs more than the old thing;
the only industry where that weirdness occurs. You can’t buy a thumb drive anymore; they
just give it to you when you go into the story. You know, memory -- I mean I can buy a 100
megabytes of memory, and it’s like $3.22. What goes on in the rest of industry, but
in medicine, every time we see something new, the price is higher. And it gets -- we don’t
know who it’s appropriate for, so you don’t have -- you have a real hard time figuring
out how you apply it to, and then when we do have guidance, we piss it away half the
time inconsistent with the guidance.
So when we see new stuff, we usually go running down the hallways screaming, which is not
the place to be, because what you really want is to find things that are going to take costs
out of the system and improve overall quality; in fact, I stated wrong. Bad me. I’ve violated
the theology. What we are looking for is innovation that improves quality and that takes cost
out of the system, because it’s quality first always, and costs decrease second.
So, that’s what we are looking for, and we do need to be on a "seek and find" mission
to find those things that are going to different, and so we look for innovation. So how do we
think about innovation? First of all, know this: innovation for innovation’s sake is
meaningless; I could care less that you got three more bells and two more whistles than
the other guy. It means nothing to me; just because it’s new is worth nothing. Does
it disruptively place more expensive and less effective traditional interventions? Is it
new value propositions? Improved performance based on new performance criteria? My cellphone,
my smartphone, it beats the hell out of phones because I don’t even care that it’s a
phone. Whole new value proposition; does it optimize health outcomes? Does it make preventive
and clinical care simpler and less complex to the deliver and more convenient? Does it,
most important, move hospital care to the outpatient, outpatient, to the home and to
the community? Now we’re talking; we can do some stuff like that, we got a chance to
do it.
So we want to support new breakthroughs in health care; true breakthroughs in health
care are rare. Usually they’re incremental additive, and so the new imaging procedure
comes and you add it to the old one, and then you get a discrepancy between the new one
and the old one, then you do a third one and then a fourth one, and then next thing you
know we’re all in deep trouble. So what you want is things that -- you don’t want
halfway technologies, you want to get straight through to the source of the problem, to the
root causes. So we like the idea that genetics is going to offer that possibility. Cut through
the crap, get to the source, eliminate the halfway stuff, and you’ve got an opportunity
to go forward, so to us it does make sense. The issue though is left to its own devices
the world will not give us the information that we need to be able to know when we have
it. So all that conversation about comparative effectiveness research and all that my colleagues
have laid the groundwork, and my friend ,Sean, who thinks that clearly about it; and by the
way Sean’s work is supported by the health plans in addition to other stakeholders. So
I write a check; so does Aetna. We write checks to Sean because those things that Sean is
doing is important, so don’t leave thinking we don’t put our money where our mouth is,
that we’re not invested in this stuff. We absolutely are invested in it.
We have to know whether the new thing works, does it work better than the old thing, and
if it is better, is the better justified the price escalation? That’s the question, and
there’s nothing wrong with asking it; and I’m not going to ever let somebody make
me feel nervous about asking that question because I sit every day with small business
owners, who have mortgaged their house two and three and four times to make a go of it,
employing five people tenuously, watching their health care costs go through the roof
because of all the nonsense that’s out here. Why should they pay for stuff that doesn’t
work, or doesn’t work well in the total cost of care? So we have to know it; it’s
a responsible thing, and yes, there’s rationing, and the rationing is on the backs of pregnant
women in inner cities who don’t get first trimester prenatal care and their babies die
worse than 50 other countries in the world. We ration all kinds of stuff, and nobody gets
pissed off about it.
So we’ve got some issues to do as a community. The reason why I’m being so forceful about
it is this: if your business model, if your purpose for doing what you are doing is to
keep trying to game the system, then yeah, health companies like ours are going to be
some mean sons of guns, and we’re going to hold you accountable and we’re going
to watch you and we’re going to be really cautious, and is that a good reason to go
to work every morning? It absolutely is not. What we want are people that start out with,
“Let’s do it right, let’s do it better, let’s find the answers to these things,
and then you will find willing partners.” Now, the reason why Sean is so important is
after I give a talk like this, they’ll maybe like 35 -- I go to these meetings with all
the innovators and the start of the people that are gambling their money with venture
capital. We get 30 of those people going, “Okay, I want to do a comparative effectiveness
research with you. I want to answer these kinds of questions, I really want to get there.”
Now what is the exam questions you’re going to ask us?
And we could spend every day of our lives, all day, answering questions about what is
the gold standard for what we need, and we don’t have that kind of time because we’re
trying to run our businesses. So Sean, I think, and his company is going to be very, very
important as a place for people to go, so what I want -- and I’ll say it in front
of my colleagues from the Blues, from Aetna: what I really hope, and we have to be careful
about the lawyers and the thing -- I’m not talking about what we’re going to pay for
anything, for the record. I don’t care about what we’re going to pay for, how much money
are we going to -- I’m not trying to price fix, I’m not going off to jail. But what
I am saying is why don’t we -- and that’s what I think Sean’s organization should
become in my opinion, the place where the plans increasingly say, “FDA criteria necessary
but not sufficient, not interested, thank you, glad you’re not killing anybody, but
the extra hurdle of comparative effectiveness research, here’s what we want in terms of
the questions that have to be answered.” Just because your new hip articulation moves
three degrees more than the old one, does anybody care? Because if it’s functioning
significant or not.
So that extra ingredient, whatever it is that we’re looking for, we all say to the researchers,
the manufacturers, here’s what we want, now go program to that, so you don’t have
to do it but one time. And I think that’s the way we sort of get at, some of what you’re
trying to get to.
But we have real problems in trying to develop that evidence to tell our customer. Now, our
customers are paying the bill; they are expecting somebody to watch out for their interests,
and we don’t have the information that we need, as we said a hundred times to do it.
So, random-ass controlled trials versus coverers of the development; these are really tough
issues, and I don’t have time to go through those any more. But the bottom line here is
that the key to any effort is broader use of analytics that can identify where the diagnostics
can reduce downstream medical costs and improve health outcome. So I’m talking about the
total costs of care, and then the big picture.
And then finally, the people who use these tools are going to also be changing. Fee for
service is going to die. Understand it. Nobody can keep paying piecemeal for crap. It isn’t
going to survive; it can’t. And it damn sure can’t happen for the people you care
the most about is you’re referral network, and that’s the primary care doctors. The
primary care doctors are done; there’s no money for them. They’re not making any money;
nobody goes into primary care. The only way primary care is going to survive is if they
are able to take responsibility for a population of people, provide better quality, more cost
effective care, take the savings, have the savings reprogrammed, and pour it back into
their salary, because nobody can write a check to primary care doctors because the unit costs
and the costs escalation, there ain’t no more money, the party’s over.
Well, guess what? The primary care doctor is going to look for the specialist and say,
“Look here, it becomes patently clear that this laboratory costs twice as much as the
other laboratory, and my criteria -- I’m being judged -- my scorecard says I’m out
of whack, and my cost reimbursement is going to affect, so why would I go to the highest
cost lab when I need to go to a lower cost lab?” This still can keep quality whole;
why would I go to a specialist that screws around and orders 15 more imaging procedures
that didn’t need to be done, why can’t I go to a [unintelligible] who can’t schedule
my appointment for my patient the same day, why can’t I get 24-hour coverage, there’s
going to be a whole other realignment of specialty care downstream to solve and serve the primary
care people, who are going to be back in the driver’s seat with a lot more control.
So you are starting to think, what is my relationship as genetic providers to the primary care delivery
system, and also in terms of how I’m going to be reimbursed for managing a population
of people who have a predominance of genetic base disease? This reimbursement model will
increasingly be moving from fee-for-service to accountable and will move people from solo
and three and five practitioners to groups, either real or virtual. But there will be
changes and modifications across the board.
And then finally, after you’ve pleaded, begged, given people information, done everything
you can do, got the [unintelligible], at the end of the day you still got do, as my colleague
just mentioned, you got to do medical management, because left to its own devices, people will
piss away half the time. So unfortunately, we still have to go to work and go, “Why
did you order the 18th MRI on that lady? Did you really need to do that?” I mean, and
that’s just something I wish we didn’t have to do, but we have to do. We have to
align all the incentives.
So I know I’ve irritated, like, everybody in the room, so I will just sort of end with
this sort of sense, and then I’ll be part of the group to take the questions if there
is time.
We need you to be successful. It is exceedingly important that you succeed, but you’re not
special in many ways. You are part of an engine that is completely churning and moving and
growing at rates that just cannot be sustained. It has to be new models. Where you are special
is at your highest, you have the potential to solve problems that most disciplines cannot,
because you’re not halfway technologists; you’re cutting through the crap getting
to the source of problems and can eliminate it. Your job is to figure out how to bring
those to the delivery system in responsible ways so that you can save money and enjoy
the savings, and make money that way. But if you have business models that are based
on Marcus Welby era thinking, you will not make it, you will have enemies, you will have
people that will be holding you down and watching you, and at the end of the day, you will screw
up your access to venture capital, which is the one thing you do not want to do. Health
plans like us, Aetna, Blues, we want venture capital to love you, because it is important
that innovation succeed, so do it the right way, do it for the right reasons, and you
will have partners. Don’t make enemies out of us, because we love you.
Dan Roden: Is that [unintelligible] of the lesson? Is
that the word? That’s [unintelligible] of the lesson.
[laughter]
Yeah, so Michael -- you know, and I know, you know; I’m the last person in this room
that should say that, but that’s -- go on. Michael.
Michael Murray: Well, one thing that hasn’t come up is that
the cost of the test, might in some part even to a great part be completely outside of health
care, and people will be coming with the results, two doctors and the health care system and
the downstream costs might make those testing costs look tiny. So I would propose that we
have a work group that collaborates with industry and others to really look at downstream cost
as well as cost of testing.
Reed Tuckson I think it needs to be a work group that -- I
think there should be a work group anyway that gets it, because, as I said, it’s so
important that we be aligned -- we have to be friends. We just have to be; but in terms
of that, I really like your point, because what you are saying is, in reality, there
are going to be a bunch of people that still want to know whether their baby is going to
have blue eyes or not, and they’re going to go off lying and do whatever the heck they
want to do, and there are going to be people that are going to, you know, have -- and so
you’re right, how you then -- what do you wind up with when you get your neutrogenics
for the new millennium test, and then you walk into the doc’s office, and what is
the responsibility the physician has to work that up with 18 MRI scans? And how does that
get paid for? I think your question is just spot on.
Dan Roden: Mark.
Male Speaker: We can make the case that a whole genome for
$2,000, you know, instead of doing a blockbuster test, would be a way to go and start doing
that right now, because then you could start the model Dave’s question of how does that
bring down overall costs, knowing about the whole genome?
Reed Tuckson: Yep. So I think that’s sort of again the
notion of that kind of sort of big picture thinking, so if I understand your question
is, “Does it make sense overall to” -- and of course, I don’t know how you figure it
out, but if I understand your question, do we basically make a national investment in
doing the entire genome sequencing for every person one time, store it, make multiple access
to it under rules and provisions of privacy and confidentiality, I don’t know, and then
basically it’s there, and then people can sort of fool with it or not, and what’s
the cost-effectiveness of that, and what are the costs of storing it, what’s cost of
accessing in health information exchanges, and blah de blah de blah de blah. But it’s
a question that needs to be asked, it needs to be a question that needs to be answered.
Dan Roden: Mark, then Geoff.
Mark Ratain: I’m Mark Ratain, Chicago. I mean, I think
that genomics is different in many ways, and -- well, it keeps getting lumped under diagnostics,
and is -- and I’m a practicing oncologist, I’m very familiar with the waste and abuse
and the patients I see referred in from the outside to see us at the University of Chicago
after they’ve been treated in the community with 3 trillion drugs that don’t work, and
7,000 MRIs, and every diagnostic you can think of, and CLIA proved -- CLIA Laboratories,
and even some FDA-approved diagnostics, and I cringe every Wednesday afternoon when I
go to clinic.
So -- but I think the point is we don’t need to be spending the kind of money that
is currently being charged per polymorphism in laboratories. I mean, to go and order a
single SNP, a one off SNP is I don’t know what the list prices are these, but you know,
I usually say it’s somewhere between 500 and 1000 dollars, list price, for most CLIA
Laboratories. I don’t know if Debra can comment on what goes on at her place, but
you look at the Mayo website.
And that’s crazy, and if you use those kinds of estimates, of course you come with figures
that are just completely unmanageable when you start looking at genomics, but we don’t
need to be doing that, and we absolutely should be thinking of ways to implement genomics
in a cost-effective manner, and whether it’s whole genome sequencing or its platforms to
identify that utilize polymorphisms of clinical relevance to really do it unmasked where you
drive the cost to pennies per variant, I think really allows this field to move forward in
a way that is truly different, and I keep coming back to the EMR, because that served
an investment for the future that people have accepted, and I don’t understand why we’re
not thinking about how genomics can be a whole new system.
Dan Roden: So, Geoff? John? Gwen?
Geoff Ginsburg: Okay, I guess I have a question, which is
-- I want to pick up on the themes of alignment of incentives and partnerships, and one of
the reasons we’re having those meetings is so that we can develop the right research
agenda that will enable us to really realize the vision of NHGRI's, you know, strategic
plan. So, we’re looking for people like you, the payers to help us find our way and
I’m wondering whether there’s a real possibility of partnering and helping us design our studies
with the appropriate metrics and funding them so that they’ll actually get done in a timely
fashion so that it will actually benefit the whole ecosystem that you spoke of.
Male Speaker: And make available data that you have that
we don’t.
Reed Tuckson: I would see what my colleagues think, but
that’s what I was sort of getting at, I’ll just re-emphasize; even though it is not a
fully-formed proposal yet but one that we have been talking about. And I think that
-- I don’t like recreating the wheel with creating new institutions and new organizations.
I came here today, along with my colleagues, because we believe that this is an important
forum that deserves our energy. I think the word Sean’s group is trying to do is a wonderful
place, because it’s where both the manufacturers, the innovators are sitting and the plans are
sitting together. And so I would say that in interest of time that your suggestion to
me sounds terrific. I think that we ought to at least use Sean’s house as a place
to get together and fool around with this a little bit, and do it in a hurry. That’s
my proposal with it, and I’m going to be talking more to my colleagues to see whether
or not that dog will hunt.
Male Speaker: Sorry, I forgot your name, it’s -- Mark,
right. So, you know, I was just going to try to re-emphasize; I think you’re asking a
critically important question, which, you know, around this issue of, you know, the
ways in which genetics is different and you’ve described it, but you know, that the possibility
that you’re going to get, you know, thousands of SNPs or hundreds of thousands or whatever
at ridiculously low costs compared to these, you know 21 sequence tests or whatever, and
so -- I mean, I think that offers the possibility that, you know, there would be extraordinary
ways to accomplish what Reed said, which is, you know, better outcomes for patients at
dramatically lower costs. Like, huge, and I think that’s the exciting, you know, opportunity.
What I think the way in which this technology is kind of the same in terms of what I heard
at Medicare -- and what I think all the other payers here is just pay for us now, and we
guarantee you, we’re going to save billions, you know, down the road. And I would say that,
you know, if we actually saved one-tenth of what was ever promised to me in a day of Medicare,
we wouldn’t -- the Medicare/Medicaid thing would not be an issue. So the real question
is at what point do we sort of cross the threshold between wanting to believe that this will
happen, that this can happen, and sort of, you know, being confident enough that we we’re,
you know, sort of willing to make that investment, because -- you know what I’m saying? And
so, it’s sort of defining how do we make that happen, where it isn’t, you know, a
tempting offer but we just, you know, it’s like every other offer that says, you know,
pay us now and you can’t believe how great the world will be, in the very near future.
Joanne Armstrong: And I would just add that every technology
company that comes in front of us comes with an economic model with assumptions of grandeur,
and it never happens. It just doesn’t happen. Yeah, but that wasn’t my question. My question
actually was to the laboratory folks; we talk about, you know, disruptive technologies,
and one of those may be multiple appropriate SNPs on chip that can drop dramatically the
price of the diagnostic. How does the laboratory business model fit into that? I mean, are
you excited about a new technology that decreases your reimbursements dramatically?
Hawazin Faruki: Okay. I think that we recognize the same thing
that everybody else recognizes that the curve on health care expenditures is unsustainable
to us, to you, to everybody else. And so to the extent that we can participate in developing
tools that would lead the industry in cost saving or more efficient delivery of care,
we are absolutely on board, and we are actually working on a number of initiatives to do some
of exactly of what you were saying, in other words, where we can combine things together
and actually offer them at a lower cost, where we can provide decision-support tools that
help the doctor order the right tests at the right time. There’s a number of initiatives
ongoing at LabCorps to support that.
Male Speaker: [inaudible]
Female Speaker: Sorry, I’ll tell you later, but I guess
I was just going to bring up the concept when we were talking about people coming in with
tests from the outside. I mean, we don’t even have standards for that. I mean, people
do it now for genome-wide raise [spelled phonetically] that they can buy on the street, and they
get these reports -- maybe not anymore, but some of them probably still have some old
ones, and they come walking in with these things and want to know what this means, and
I think more importantly, in cancer, there are many providers outside of the arena that’s
sitting in this room that are going provide people, and they’re going to buy it off
the street; a cancer test. And because they believe that this is their -- this is what
they need, and I think that we are going to have to think about those downstream costs
when they come in those with those tests that we don’t have access to necessarily all
the primary data.
Female Speaker: So to speak to Joanne's question about the
diagnostic tests, if I look at one of our disease panel tests, hypertrophic cardiomyopathy,
the cost for that test has not dropped at all in the eight years we’ve been doing
it, but the content has increased, so we -- increasing the multiplex from two genes to now 46 genes
but not raise the price of the tests. So even though the test cause hasn’t been dropping,
we’ve been able to add content over the years, and that’s where we save, and from
a business argument as a laboratory, we often compete on content between labs, and so we’re
constantly trying to add content to outcompete our competitors in terms of a better test.
But if we look it to the question of scaling to the genome because there’s a lot of efficiency
to be saved by getting multiple markers in the same tests, you know, I love the email
Mike sent us a few minutes ago -- the whole genome should actually be hole genome without
the W, H-O-L-E, because there’s still so many holes in it, and I would argue if we
implement hole with the H genome sequencing today, there’s so many holes that we will
have to reflex onto the targeted test after the genomic test is either uninterruptable
or negative. And so you haven’t yet saved that cost. We eventually will get there when
the W gets added to the, you know, the picture.
Dan Roden: So, Mary. I don’t want to stop this discussion.
Mary, David, Debra?
Mary Relling: I guess I just wanted to be sure. You know,
there’s something in between single gene tests and whole exome or whole genome tests,
and so there are several arrays like that, so just to clarify from the payers, is the
concern about running an array for 225 genes that cost less than a single gene test that
medical care costs will go up in general, because clinicians will work up additional
findings from those 225 genes that they wouldn’t have otherwise had you only given them one
test result? I mean, what -- you say that you think we’re, you know, you’ve been
hoodwinked before being sold that things will save money in the long run, but it’s very
hard for us to understand: why should we only test for one gene at a time when we definitely
have some array-based technology that can test for at least hundreds of genes, at least
as well for a fraction of the cots?
Joanne Armstrong: Yeah, I think it’s an area under development,
number one. I would think my first reaction is, we cover things where the medical evidence
is strong and the societies say you should do this, so I think I know -- you know, my
area’s reproductive genetics.
So you would say, you know, we had this discussion last night. You know, if for Ashkenazi Jewish
screening, ACOG said four mutations, ACMG says 11 or 13 or something, Genzyme does,
you know, whatever. What’s the right answer? So the first question is, you know, we’re
out there saying that we’re trying to support –
Female Speaker: But what about evidence?
Mary Relling: -- but what would be the downside that covers
all of those, plus more?
Joanne Armstrong: Okay, so maybe an Ashkenazi Jewish population’s
no downside. I’m thinking of, you know, the 100 genes on a chip that started as a
direct-to-consumer re-counsel technology specifically, that now that is put in reproductive endocrinology
IBF offices. These physicians are interpreting this, they’re getting results on maybe one
thing they wanted, a CF test, 99 things they’ve never heard of before, and then it’s churning
through this -- it’s either ignoring things that are potentially important, churning services
through the system, and I think we just don’t know what to do with that.
When we were talking about the radiology example, what I was actually reminded of is, you know,
medical school 101 lesson, which is if you are interested in pathology in the chest,
you aim the x-ray technologies at the chest. You get your hand slapped if you actually
looked at the appendix or the gall bladder, something I have -- but sometimes you’ll
find disease there, and you’ll say, god, wasn’t I lucky? But often, you’re finding
things that you didn’t anticipate, you don’t know what they mean, you know, you got this
variance of unknown significant, et cetera, and those things churn through the system.
So I think that this what we’re –
Female Speaker: Maybe they take money to work up.
Joanne Armstrong: They do take money to work up. For sure, they
take money to work up.
Dan Roden: So, let’s let -- quick comments and let’s
keep this discussion going. Debra? David? I’m watching him. I’m sorry, I’m sorry.
Debra Leonard: So I think it’s interesting that John, you
pointed out the testing cost that are only less than .5 percent of overall health care
costs, so I think when we look at testing -- the testing costs are actually a very small
portion of the health care costs, they drive a lot of the medical decisions, but I think
what we have to be talking about -- what you guys have to be talking about, I’m not part
of this -- but is how you do genomic medicine, and so it’s how this testing fits into the
entire pathway of patient care, and what makes sense and is useful to test for because there
is something actionable but can be done versus the discovery part that should be research
and not part of genomic medicine. It’s genomic medicine research, but not part of the health
system and health care process. And in my small project, private project that I’ve
been approved to do with hospital funding is looking at an entire care pathway from
how we identify the patients and enroll them and consent them and all the way through to
how, you know, we do the testing, but how that information is communicated backward;
decisions we would make having genomic case conferences. I mean the whole entire pathway,
and only testing for the things that that would be clinically actionable potentially,
and I think that’s where we have to get to.
Reed Tuckson: But just think though, just remember –
Female Speaker: Microphone.
Male Speaker: Please, yeah.
Reed Tuckson: Yeah. So I think it’s a very great question
and point. And then to the question before; please don’t misinterpret anything that
Naomi, Joanne or I are saying is drawing lines in the sand. Just because something is expensive,
first of all, does not make us nervous. It’s the total cost of care as I tried to say in
my presentation that we are interested in. Naomi, I thought, did a very good job of showing
for example the number of time a diagnostic test is decouple in terms of its behavior
with the therapeutics that’s based upon the presence of what the diagnostic test would
show. We love a test -- even if it’s expensive diagnostically that will allow us to titrate
the appropriate subpopulation for whom a therapeutic involved, but we give away Darnair [spelled
phonetically] expensive chemotherapy drugs for leukemia. We subsidize them because the
total cost of care means that patient is not going to be in the ER, is not going to have
hospitalizations, will decrease readmissions, and all in, it’s less.
So there’s nothing that scares us about costliness. It’s if it’s justified, so
I just want to make sure that we don’t argue that kind of thing out; and then what you
get to is, I think, is both of these questions is being clear about the particular clinical
paradigm that is under discussion, and making sure that we understand that. So we do -- we're
agnostic to, you know, we’re not trying any of these major lines in saying, “Oh
my God, no, no, no.” Case by case, specific by specific, now that’s where the problem
lies, is the capacity of the American comparative effectiveness research engine, not to mention
our clinical research engine, to answer the plethora of questions that are on board, and
that’s why Naomi, if I understand her presentation, why she decides to include the thing she did,
included what was on the list that came out of the IOM, and what’s on the list for Precori
to get looked at. And she’s sort of saying, “Listen folks; is there a relationship between
the priorities and the research enterprise?” And the fundamental clinical questions that
are the most determinate from the quality and cost-effective’s point of view. Because
those are the challenges that you’re going to be active in, so we hope that you will
be attentive to that, because you can’t answer everything all the time.
Dan Roden: David, and then --
Male Speaker: I’m going to pass.
Male Speaker: Okay. So you’re going to take a chip for
later?
Erwin Bottinger: Yeah, I wanted to --
Male Speaker: Was somebody behind me?
Erwin Bottinger: No, this is Erwin again. Wanted to second
Debra’s statement about -- I think the discussion has been focused very much of SNPs and tests
and all that, but I think what we really need is helping determining the value, not so much
the cost. I think, you know, and thinking of an in terms of there needs to be research
first that ties this into care pathways and has the whole game for this pathway, the picture
for a pathway, you know, as an outcome at the end, and that the question is value, not
so much that the SNPs are cheap and the genome is $1,000, but what value do we get out of
it, and then we can make a case for our community to be accepted.
Dan Roden: Howard? [inaudible], John’s way down there.
Howard, John, Paul -- Sean, did you want to say something? [inaudible]
Sean Tunis: I’m fine.
Male Speaker: So then [inaudible]. So the wheels are [inaudible],
we will have then finished our break. We’ll move the break back, but -- go ahead.
Male Speaker: I want to come back to a point that Geoff
Ginsburg was making about engagement with the payers, and we talked a little bit about
that back in December, for those of you who were at the meeting, but there -- [unintelligible]
in our low experience with Blue Cross Blue Shield North Carolina, when we talked about
endpoints that they care about, there was a little bit over overlap with academic endpoints,
but not a lot. And we’ve done a study with them where we have an MOU in place where if
we meet the endpoints that they chose, they will implement it across the state. If we
don’t we’ll shut up and not ask them to do it again, and I really do more of that,
where we partner, where the in point is decisive, at least for the moment, decisive information
where we can either be quiet or have it implemented, and we are -- right now we play around that,
but I think we need your partnership for that; we need some of your money, but we need more
your choice of endpoints, because I never thought adherence at the end of one year for
statins was an endpoint that I would ever care about. But Blue Cross Blue Shield not
only cared about it, but they were willing to pay for it, so, you know, there’s things
there that we just don’t really recognize.
Male Speaker: [inaudible]
Female Speaker: [inaudible]
Male Speaker: Okay, well you know.
Female Speaker: Okay. As usual, my opinions represent just
my opinion and not the Air Force or the Department of Defense. So I just wanted to issue the
same two challenges that are my usual personal crusade, and that is using international standards
to measure value in this country, which would be quality adjusted life years, not American
dollars. And then the second one has to do with the fact that what we’re talking about,
why I ask myself why on god’s green earth am I in this job, and that’s because what
we’re talking about is culture change. This is a paradigm shift; if we can continue to
talk about why this doesn’t make sense when we are western-trained physicians and we label
disease and treat it without looking at the underlying cause, we’re going to continue
to have the same debates over and over again, because looking at the genetic basis of disease
is something that is in theory looking at the underlying cause, not what we’re necessarily
trained to do as MDs or DOs, so thank you.
Dan Roden: Sean.
Sean Tunis: While we all beat up on the health care system
and the practicality of it not being able to continue the way it is, it is -- and just
picking up on the last speaker’s comment, something between 1960 and the present has
changed life expectancy from just about 60 to something about 80, and the health care
system and everybody involved in it is partially responsible for that. As a follow up question,
I’d be interested in the perspective of the third party payers on the new data that
suggest that the de novo mutation in the conditions of autism, schizophrenia and mental retardation
looks like it’s compellingly clinically useful. There’s no FDA approval, there’s
no clinical test that you can actually get for that, but it looks like the data that’s
recently published is overwhelmingly compelling that these conditions --
Reed Tuckson: I don’t want to get drawn into or have impression
left of artificial tussles. We are, in no way, are we arguing about -- well, first of
all, I [unintelligible] why we’re arguing, but again, but what we are definitely not
arguing about is how terrific the American medical care delivery system is. I serve on
the head of NIH’s advisory committee, I am very proud of the American biomedical and
research community, I am the former doc for the AMA, I am very proud of American medicine.
There isn’t anybody up here talking about not being happy about the fantabulously wonderful
benefits of our clinical care delivery system. However, let’s make no mistake; our life
expectance is 42nd in the world, and we pay orders of magnitude more in health care than
any of the other countries that are better than us 41 times. So there is an American
conversation that has to occur about how and where we use our precious health care assets;
that is unavoidable for a mature, civilized democracy.
So we do have some tough issues to deal with, but at the end of the day, let’s just be
all, “Amen” on the fact that yes, nobody’s here trying to say we’re not doing a good
job in terms of the things we do. Now, in terms of what I really like, is your last
comment, which gets to this point that we would at least -- we’ve been all three of
us trying to make around cut through halfway stuff and get to the root cause. So if your
autism example is true, you know, and it’s there, and we get at that and understand that
better, because the last thing that I want to do as a person who has to make decisions
about using dollars that are hard earned by American workers, the last thing I want to
do is give them an inadequate treatment for a disease that we don’t understand and can
be better proven, because anything anybody has had to deal with the development of the
disabled world, and I’ve run major systems of care for the development disabled. I understand
that world real well. So at the end of the day, if we can get some stuff that cuts through
and helps us, you’d be out of your mind not to want it.
Now, the issue then you raise is, “Okay, how do we, among the 50 priorities that we
have in this country, to get to root cause stuff that [unintelligible], where does autism
fit in it, what is the role of health plans who have to spend hard-earned employer’s
dollars to be able to say that we’re going to, you know, put that dollars to this one
and not this one and this one and not that one. How does that fit into the Precori with
the national” -- these are the kind of issues that a forum like this has to think about.
In your profession, and then be prepared to discuss it with those who are outside of your
field, so that we can come to priority decisions around the research enterprise. Because guess
what, by the way? There ain’t diddly squat in clinical researchers around anymore, and
when you finally get those, then you got to worry about the people who are going to do
the cost-effectiveness stuff. By the way, then you got to do the health services research.
By the way, somebody’s got to turn it into clinical guidance. By the way, somebody’s
got to do performance measurement. So, what did we just do to the work force for research
and all of that? So, priority, priority, priority. And I’m not saying your priority is wrong,
I’m just saying how do you have that conversation?
Dan Roden: So, Paul Ridker has been waiting patiently.
Last comment. Quick comment, Paul.
Paul Ridker: Sorry, I’m going to choose my words extremely
carefully for a second here, and partly because I have a conflict of interest, but more because
of a bigger issue, I think. So, Naomi, Joanne, and Reed have argued, among of things, that
they would favor potentially expensive diagnostic tests if it might actually limit therapy or
get to the right people. I think that’s probably correct. My experience in the diagnostic
industry and the payers is that you also fear diagnostic tests if it expand therapy, and
this has to do with my own technology and issues about how hard it was to get certain
companies to pay for CRP testing, even though we had randomized trials showing it could
save lives and lower vent [spelled phonetically] rates, that includes United Healthcare, which
is a hug battle. So I think there’s another side of this, which is we have to ask questions
about even when overwhelming evidence exists, there’s tremendous resistance to wanting
change, and I think that’s also a part of what Sean has to struggle with, but I think
we can talk about that.
Dan Roden: We can have an hour-long discussion -- I think
we’ll –
Reed Tuckson: No, I’ll just end it with -- because there’s
no need for us to be -- at least, I’ll speak for me, I don’t see my colleagues disagree,
for us to be defensive. Is it possible that we make mistakes? Is it possible we are wrong
sometimes? Is it possible that, you know, we make the wrong choice? Absolutely. And
do we need to change? That’s why I said, and I was very transparent, so I will agree
with you, because it’s important that we find common ground here as opposed to leaving
-- because the only point of all of this could be, it has to be we keep working together.
So at the end of the day, I said, we do go running down the hallway screaming when somebody
tells me we got three more bells and two whistles; we do that. That is our behavior. And I also
am saying deliberately to you, we’re trying to stop doing that dumb stuff, so we’re
trying to be different. So I accept your premise and if we were wrong I apologize.
Joanne Armstrong: Yeah, the other thing that I would add to
it is that we cover thousands and thousands of things, and those things require hundreds
and hundreds and hundreds of technology assessment conversations, deliberations, interactions
with the technology people. It is sometimes hard to get eight -- and I don’t know the
example that you’re talking about, but it’s sometimes hard to get the attention of a large
organization. It is very helpful to get technology assessments done through the medical professional
colleges, CMPT, others that can help synthesize it; EGAPP. That sort of gets to a higher level
of attention in an organization and quicker decision-making; I don’t know the example
that you’re speaking of, but --
Dan Roden: So, I will -- I’m the chairman, I’m going
to stop. I’m going to stop, I’m going say one thing; if the autism example is true,
then it’s just one illustration of the real promise of this kind of new technology, which
has been around for years, not decades. And so, this is the beginning of a long conversation,
and we will resume in 11 minutes. My computer says it’s 3:39, so we’ll start again at
ten to 4:00.
[end of transcript]