HLS Library Book Talk | Transparency in Health and Health Care in the United States: Law and Ethics

afternoon, everyone. Good afternoon. I’d encourage you to please
continue to get your lunches. We’re going to get started
with our introductory remarks so that we can move forward
and hear from our panelists. So I’m going to get started. My name’s Jocelyn Kennedy. I’m the Executive Director
here at the Harvard Law School Library. Welcome to our first
book talk of 2019. We’re very excited to
have everybody here today. Before we begin, I’d like
to thank the Dean’s Office for sponsoring our
lunch for this event, and the Petrie-Flom
Center for Health Law Policy, Biotechnology,
and Bioethics at Harvard Law School
for cosponsoring. So please continue to enjoy
your lunch while we proceed. I also want to let you know that
today’s talk is being recorded. It will be on the law
school’s YouTube channel sometime next week. I tell you that for two reasons. One, so that you
can watch it again, but also so that you
know that our Q&A period is also being recorded. Today’s moderator
is Elena Fagotto, who is a co-investigator of
the Project on Transparency and Technology
for Better Health, and former Director of
Research, Transparency Policy Project, Ash Center for
Democratic Governance and Innovation, the Harvard
Kennedy School of Government. She’s been affiliated with the
project since its inception. And her research focuses
on information disclosure, regulatory policy, and
transnational regulatory regimes. She’s analyzed dozens of US
and international transparency policies and has
published extensively on the role of information
disclosure as a regulatory tool and on institutional
designs to make transparency more effectively. She will be our moderator today. She’ll be introducing the
remainder of our speakers. I also want to let you
know that today’s book is for sale outside of the room. And I’m going to turn
it over to Elena. Thank you. ELENA FAGOTTO: Thank you. Thanks for this introduction. So good afternoon, everybody. Thank you so much for
joining us for the launch of this important volume
titled Transparency in Health and Healthcare
in the United States. It’s an edited volume,
edited by Holly Fernandez Lynch, Glenn Cohen, Carmel
Shachar, and Barbara Lynch. First of all, let me tell you
that I was extremely happy when I received an invitation to
moderate this book launch, because I am a self-defined
transparency junkie. I’ve studied
transparency policies for many years, anything
from transparency to improve our diets,
to transparency to help us choose safer cars,
or to reduce workplace injuries. And I can tell you that
there is no area where transparency has exploded as
the health and healthcare field. So this is a great field
to look at the evolution and the use of transparency
as a regulatory tool. So it seems that transparency
in health and healthcare has become the new panacea. So it seems to be the
cure all to empower patients to make better
health choices, to let them– for example, when we’re
sick, the first thing we do is we go online, we turn to
Google, and enter our symptoms. And it shouldn’t be surprising
that Google receives about a billion health
related searches every day, that 7% of all daily searches
on Google are health related. We can also go online
to look for hospitals where we are less likely to get
hospital acquired infections. We can log on to
a patient portal to access our electronic
health record. In some cases, we can even
look up our clinical notes and we can communicate
with our doctor. So, in theory, there
should be no better time to be an empowered,
informed patient. Some even say that we are
experiencing a perfect storm, where transparency and
digital technologies are going to change
health and healthcare in unprecedented ways. But we have to be
cautious, of course, because there are
limitations in transparency. Even though the
volume of information we can access nowadays
has expanded significantly like never before, before the
digital age, when we go online, we’ll still struggle to
find clear and comparable information on our doctors. There are several rating
systems, public rating system, non-profit rating systems,
rating systems offered by medical associations. So it’s still hard to make
sense of the information that we find. The information is not curated
enough for us to use it. And then we have
also learned that, like in many other
public policy fields, the motto if you build
it, they will come does not always apply. So there are some interesting
transparency tools out there, but nobody uses them. So when I read the book, I
learned in one of the chapters that New Hampshire has a
price comparison website that has been used by
only 1% of residents over a period of three years. So the information is out there
but nobody’s really using it. And only about half
of patients set up their patient portal
accounts, which doesn’t even mean that
they will regularly use it. So only half even set it up. So one thing that really
emerges vividly from this book, and I’m citing what
Holly wrote in the book, is that transparency
has no on-off switch. So it’s not about injecting
transparency or not. It’s really much more
complex than that. It’s about what you disclose
to whom, how often, and how. And before even
choosing transparency to address a specific problem,
we ought to think, how– we ought to envision how
transparency is going to work, because there are some problems,
and that emerges clearly in the book, that cannot really
be solved by transparency, that might require more
command and control regulation. So transparency has limitations. And this book, I think,
asks all the right questions about transparency, and
advances our understanding of this field in several ways. Well, first of all,
this books does the incredible
work, Titanic work, to put order in an
immensely complex field. Because, as I said
earlier, there are so many ways in which
transparency has been used in health and health care. So this book presents a really
broad spectrum of initiatives, and should be really
applauded for that. So from the notion of
consumerization of healthcare, so is it good to treat
patients as consumers? Is transparency going to change
the fiduciary relationship between patients
and their doctors? And then there is also a
very interesting chapter on HIPAA rights, and how
transparency and privacy– this might seem
counterintuitive– but they are actually
extremely connected. Because after all, you are only
transparent with your doctor because you know that your
privacy will be protected. The book goes on to
discuss informed consent, sunshine laws to expose
potential conflicts of interest between doctors and
pharmaceutical companies or medical device
companies that make gifts and give contracts to doctors. There are several chapters
discussing transparency and economics, in other
terms how transparency could help curb healthcare costs. So Ameet has an
excellent chapter on how transparency– so
exposing the costs of research and development in drugs
could help reduce the cost of prescription medications. There are a couple of chapters
about transparency in the drug approval process in the US
and in the EU, transparency for patient safety,
transparency in IRB protocols, even transparency in
electronic health records and how vendors of
such records actually use gag clauses
in their contracts to actually limit transparency. So the list of transparency
initiatives is long. And what I cited does
not even do justice to this book, which has as
many as 23 different chapters on transparency. So it’s so rich,
it’s overwhelming. And another reason why
I really like this book is that it takes a really
pragmatic look at transparency and looks at it through
a critical lens. So the book discusses the
trade-offs of transparency, and discusses some of
the political economy of transparency,
and the choices that go between disclosing
some information and keeping other
information from the public. It also explores the
distributive effects of transparency. Because an important
question to ask is whether injecting
more information is going to help those who
have the tools to understand the information, to look
for the information, and to use it for
their health choices, or rather will exacerbate
health inequalities. And this is a very
legitimate questions with 80 million Americans
having limited health literacy. And then there is
also a vibrant debate that is captured in the book
about whether transparency just creates noise and
obfuscates rather than clarifying our choices
with too much information. And another reason I think
why this book is so important is, and I’m citing
from the book, because it does not offer
an unqualified embrace of transparency. So the experts who
wrote this book are actually skeptical
about transparency and lead us to ask ourselves
important questions. For example, with our
insurance coverage and hospitals and doctors
that are within our network or outside our
network, does it even make sense to talk about
choice in healthcare? So does transparency
without real choice mean anything to patients? And also, the book
exposes some complexities of the healthcare
system that may not be solved by more transparency. For example, there is a plethora
of intermediaries, middlemen. I learned about
pharmacy benefits managers reading a
chapter and the role that they play in pricing
the medications that we buy as patients. And there are also some
aggressive marketing practices. So is transparency the solution? Or should we opt for
stronger regulation? And the same goes for
surprise medical bills. Should we be thinking about
ways to force health insurance to absorb the costs
of these bills, rather than just
informing patients about this possibility? So I would like to conclude
by saying that this book is very important and timely for
those of us who want to become more informed healthcare users. And also, it’s important because
it tempers the enthusiasm for transparency. So thank you for putting
together this excellent volume. And I think I should stop here
to allow for time for Q&A. And I will introduce
briefly today’s panelists. So we have– I’ll start with Glenn Cohen. He doesn’t really
need an introduction. But I’ll do it anyhow. So Glenn is the James Atwood
and Leslie Williams Professor of Law at Harvard Law School
and current Faculty Director at Petrie-Flom Center for Health
Law Policy, Biotechnology, and Bioethics. Glenn is an extremely
prolific scholar, with over 100 articles
and book chapters, and a leading expert in health
law and bioethics in the US and internationally. Holly Fernandez Lynch is
the John Russell Dixon M.D. Presidential Assistant
Professor of Medical Ethics in the Department
of Medical Ethics and Health Policy at the
Pearlman School of Medicine, University of Pennsylvania. She is also assistant
faculty director of online education
in the department, helping to lead Penn’s
first online master’s degree in healthcare innovation. And she’s also a leading expert
on the ethics and regulation of research with human subjects
and patient centered research. Ameet Sarpatwari is
an assistant professor of medicine at Harvard
Medical School, an associate
epidemiologist at Brigham and Women’s Hospital,
and assistant director of the Program on Regulation,
Therapeutics, and Law, whose acronym is PORTAL,
within the division of Pharmacoepidemiology
and Pharmacoeconomics. Ameet is trained as an
epidemiologist and a lawyer. And his research focuses on the
effects of laws and regulations on therapeutic development. So after this
introduction, I would like to start the discussion
by asking Glenn and Holly, in their role as editors,
to reflect on this volume, and your choice of transparency
in health and healthcare, and what you hope to
contribute with this volume. And then I would like
Ameet and maybe Holly to reflect specifically,
just to give you a sense of the
diversity of topics that are covered in this volume,
to reflect on their chapters. So Holly has a chapter on IRB. And Ameet has a
chapter on transparency for drug development. So if you could reflect
briefly on those. GLENN COHEN: Great, I’ll start. So every year, we
try to figure out what our conference should be. We have this open
call for submissions. And it’s quite competitive. I think we typically get 150
submissions for 23 slots, or 20 slots, or
something like that. We try to pick what we
think the hot topic is. And so in subsequent
years, we’ve got a book coming out on
disability, a book coming out on consumer genetic testing. The new one will be on
devices and the management of medical devices. What inspired this one? Speaking for myself,
you’ll see, and I think we’ve seen this even
more so into the Trump years, a focus on
consumer-driven healthcare and this idea that, well, the
real problem with healthcare is lack of information, problems
of action, and stuff like that. And if we only were more like
consumers in our healthcare needs, we’d all be happy. Kind of ironic now, when
you look at the tenor of the Democratic debates. And one of the key
engines for this is transparency, because
the idea is, well, as long as people
are informed, we can hold them responsible for
the choices they’re making, dot, dot, dot, dot, dot. So I think it’s
quite interesting because the classical
work on health care shows that it’s just beset
with informational asymmetries. That is one of the key
differences of healthcare versus other kinds of goods. And, yes, it is true
that transparency can, in some instances,
cure those asymmetries. But I think we wanted to both
honor the places where that is true, but also document
the number of places where consumer driven healthcare
and transparency turn out to be used opportunistically. I think a lot of
opportunistic privacy, as well, that the idea is, well,
now that you know and can make good decisions, A, the fact that
you don’t make these decisions, you’re going to be
responsible for it. And, B, let’s ignore the
other constraints on choice that you face, like not
having x in your space. And also, I think
quite interestingly, and this is documented in
a number of the chapters, including Liz’s chapter
on, a separate chapter on conscientious objection
and hospital systems. The idea that we can avoid
other kinds of regulation by curing with transparency,
and that’s a very easy sell politically. Don’t go deep. Don’t limit or change people’s
compensation structures, or the like, or the
pharmaceutical payments. Just to have a Sunshine
Law that exposes it, because we’ve all
heard that sunshine is the best disinfectant, a
famous phrase by a jurist. So I think we both
wanted to document places where this is true, but
also the myriad of places where it isn’t as kind of a
little bit of a prophylactic against movements towards
consumer directed healthcare. Or at least that’s
what I was thinking. What were you thinking? HOLLY FERNANDEZ LYNCH:
So I should also say that I used to be
the Executive Director of the Petrie-Flom Center. So Glenn and I were
working closely together in developing the idea
for this book back in 2016 when we were deciding what
our annual conference would be in 2017. So I have a very
specific anecdote that stands out in my mind
for how transparency came up in our conversation, which
is that Petrie-Flom’s administrative director, Christy
Hutchison Jones, at the time we were trying to pick
this topic, had broken her wrist while chasing
after her toddler while she was visiting
family in Florida. So she’s from here. Her insurance is here. So it turned out that she
had to go to Urgent Care and get her wrist checked out. And she got this astronomical
bill in the mail, because she got
out-of-network care. And she somehow was supposed
to have in-network care while she was in Florida. Her bill, she showed it to
me, was just ridiculous. You couldn’t possibly
understand what she was being
charged for in order to begin arguing that you
shouldn’t have to pay for it. And so we were just
kind of kvetching about how frustrating it
was that this bill was not transparent. And then we started
to think, Glenn and I, more thematically about areas
in which transparency has been kind of pitched as this
superficial solution without really thinking deeply
about the kinds of trade-offs that might be associated with
transparency initiatives. So I shouldn’t speak
for Glenn, but at least speaking for myself,
I’m not advocating reduced transparency, but
rather transparency plus, other solutions that
will help people take advantage of transparency. So we see examples coming up
in the drug pricing debate or in reporting physician
conflicts of interest, for example. And I think Glenn is exactly
right to kind of point out that these can become
kind of buyer beware. Look, we’ve told you
everything you need to know, and now it’s up
to you to do what you will with that information. But if you don’t have access
to alternatives, for example, in emergency medical situations,
or you don’t necessarily have comparison points
or the wherewithal to understand the information
that’s been given to you, it doesn’t really help
make people’s decisions be better informed. And then we started
to think deeply about many of the trade-offs that are
associated with transparency. So Elena had mentioned
privacy being a major concern, the more transparent
you get about things. And then this idea of
information overload, if you just kind of send
people to a patient portal or send them off to Google
to find information, it’s very difficult for them
to kind of separate the wheat from the chaff in terms of
how they should be making their healthcare decisions. And then the last
thing I’ll note, before turning to the
chapters, I suppose, is that the inordinate amount
of sludge that’s kind of built into the system
of transparency. So you mentioned patient
portals as one example. So if I want to get
into my patient portal, I have my own patient
portal, my three children all have their own patient portals. My husband’s is
somewhere separate. I need to have my phone
with me every time I sign in because it has the
dual layer security so they need to text me a code. I’ve always forgotten
my password. Even when I write it down
in my password manager, they have to send
me the new password. It just is ridiculous
for me to get in there and send an email
to my provider. And once you get in, there’s
all sorts of resources. I can see my health
data and all of that. But it just is such
a tremendous pain in the neck to get in there. And I don’t know
if it’s intentional or what’s going on there. But I think there are lots of
ways that we can streamline transparency that would make
it more useful to patients and their providers. AMEET SARPATWARI:
Well, I guess thank you for Petrie-Flom for hosting,
and Harvard Law Library. And I’ll take a little
bit of a different twist on this in terms
of transparency. We’ve been talking about
consumer driven transparency. And I’m sure when it
comes to drug prices, everybody knows drug
prices are extraordinarily high and increasing. In 2013, the average annual list
price of a cancer medication was $87,000 in 2017 dollars. In 2017, it was over $160,000. We have a gene therapy now
for spinal muscular atrophy that’s $2.1 million. We’ve got a loaded pipeline
of new gene therapies that are soon to hit the market
with prices that will probably all be over $1 million. In addition, we
have price increases of drugs that have been around
for a long time, like insulin. If you take NovoLog,
the list price has increased 350%
between 2001 and 2016. So the consequences of this
are about 1/3 of patients have reported in the
past year that they have not taken a medication
as prescribed due to cost. And from a consumer
perspective, there have been transparency
pushes in terms of– how many, just
out of curiosity, have used a site
called GoodRx to take a look at prescription costs? I’m seeing a few hands. So there is a good deal
of price variation. But there’s a lot of complexity. What the list price
is doesn’t necessarily mean what you’re going to
pay if you have insurance. But on a more systemic level,
there’s a question of whether or not transparency can be
a benefit for regulators. And that’s really what
our chapter focuses on. And I wrote this with
my colleague [INAUDIBLE] and [INAUDIBLE]. And what we had is we
had a push in 2016, 2017. A lot of states were pushing
forward these drug price transparency laws to
make manufacturers of select high priced
drugs, or drugs that have increased a
certain amount in price, to provide some sort
of justification for what was going on. And that transparency included
really principally focused on what the research and
development costs for the drug were. So there is a huge debate
in our field right now. What does it actually
cost to produce a drug? There is some people who
say it costs $2.6 billion. There’s some people who
say it costs $300 million. The truth of the matter
is, we don’t really know. And this is part
of the black box that goes into drug pricing. How are drug prices arrived at? And so that was the nature
of these transparency laws, to obtain knowledge of how a
drug’s current price relates to such factors as its
development, manufacturing, and marketing costs, which
would assist policymakers in determining when a
price was reasonable and perhaps pushing
back when it’s not. Underlying all of
this is this notion that what a drug’s
price should be, should not be, or
should not only be, a factor of its
clinical benefit, but also what the
manufacturer actually did to bring this drug to market. We can debate whether
or not that’s what we want drug prices to be about. But that’s the major
impetus of these, what I would say, first
generation of state transparency laws. Let’s actually make
manufacturers show us what they did to bring
these drugs to market. And what are the
possible benefits here? Well, perhaps greater
investment in R&D, if they know that
they’re going to have to reveal their research
and development costs. Perhaps knowing
what they’re doing will help us tailor
and promote innovation. And maybe if we actually
knew what a fair price was, this could help us calculate
what a fair price was, if we ever went down
the path of something like government use of patents. But what are the
challenges here? What sunk costs matter? It’s fine to go ahead and
say that this drug costs $200 million to produce. But we know for every drug that
actually makes it to market, nine others fail. And that’s of the
drugs that actually enter phase 1 clinical testing. So which do we– are we supposed to
allow and account for all of drug manufacturer’s
research and development costs? Is a drug for Alzheimer’s– do
we count a failure for a drug that was developed,
perhaps, for heart disease? What will this
information actual yield? Is it going to give leverage
for payers to push back? Well, we already handcuff
our payers a great deal. Medicaid has to cover every
drug that the FDA approves. Medicare has to cover
every drug in six classes, including cancer drugs. So even with this
knowledge, is it going to make a
difference in terms of pushing back and saying
what a fair price should be? And then, perhaps
most importantly from a philosophical
perspective, does cost matter? We don’t pay for an
iPhone based on what its development costs are. We pay based on the
value it provides. So should we even care what the
cost of development of a drug is? And I’d argue that– we can get
into this hopefully in Q&A– there are valid reasons
for understanding why. And perhaps part of this is
it’s been a common justification to explain why drug
prices are so high. And if we could tackle that
with a bit of transparency, that might be helpful. But I would argue that
there’s other areas in the pharmaceutical market
where transparency would lead to more actionable change. And there, what we’re
really talking about is we have a convenient game
of finger pointing going on, and it’s been
longstanding, which is, well, list prices of
drugs are increasing. What is causing that? Well, the drug manufacturers
are saying, well, it’s true, list prices are increasing. But net prices,
after rebates that we give to pharmaceutical
benefits managers, aren’t increasing as much. And basically,
what’s happening is the middlemen in this system are
not passing along the savings. And the pharmacy benefits
managers are saying, no, that’s simply not true. We pass through the savings. And so, conveniently,
there is ambiguity as to what’s going on. And there’s little action. So that’s one area in
which, perhaps, transparency could help lead
to further reform, in terms of actually
knowing how much is extracted throughout the
pharmaceutical chain supply. We also have cases where we
know that drug coupons are frequently being used. What are drug coupons? Well, if you go to
the pharmacy and you use a coupon for
a brand name drug, you could pay zero for a copay. But the system as a
whole pays a great deal. And there could be
effective generics that would cost less, but you
out-of-pocket might pay more. So how frequently are drug
companies using these coupons? And what is that doing to
overall appropriateness of prescribing on a
population health level? These are other areas in
which transparency can, again, yield to actionable reform. And so a real question
we have to ask is, what is worth it
for this expenditure of political capital? Over 80% of Americans now
think that the government needs to do something
to intervene to control drug prices. Now, what that action
that will actually yield meaningful
benefits to patients is important to consider. But each time that a
state passes this law, it takes a huge uphill slog
to get that bill passed. And how we’re
using transparency, it is a question,
which goes back to the beginning of the
conversation, which is, is it being used as a delaying
tactic, in the sense that it’s a convenient vehicle to show
that you’re doing something without really doing something? ELENA FAGOTTO: Thank you, Ameet. Holly, would you like to reflect
briefly on your chapter on IRB? HOLLY FERNANDEZ LYNCH:
Yeah, I can be very brief. ELENA FAGOTTO: And then
we can open it up for Q&A. HOLLY FERNANDEZ LYNCH:
So most of my work focuses on human subjects
research regulation. And if you have done any
research with human subjects, you know that you need to submit
your protocol for pre-approval by your institutional
review board. If you’re at an academic
institution like Harvard, it doesn’t even matter who
is funding your research. You still have to
submit it for approval. And so the IRB stands as a
really critical gatekeeper, in terms of what type
of research gets done and who is doing it. But we know very little about
how they make their decisions. A woman named Laura
Stark wrote a book called Behind Closed Doors about
IRB decision making. And she kind of got
permission to go and sit through several board
meetings to get a sense, kind of sociologically,
how people are interacting with one another. And so in my
chapter, I point out how strange it is that these
really important decisions are kind of being made
behind closed doors. The only people who really
know what’s happening are the IRB members, and the
chair, and the staff people. The investigators who’ve
submitted their protocols sometimes are invited to the
meetings and sometimes are not. They’re told what the
ultimate decision is about their research,
whether it’s approved, or whether they need
to make changes to it. But some empirical evidence has
suggested that IRBs very rarely give reasons for the
changes that they’re asking investigators to make. They are often
overly conservative in their decisions,
potentially concerned with protecting their
institutions from liability, or really focused on regulatory
compliance, as opposed to thinking more deeply
about really important ethical challenges
that are not always kind of a one-to-one
correspondence with what the regulatory
requirements are. And so in my
chapter, I basically set out all of the ways in
which IRBs are non-transparent, and how the system
could be improved if they were more transparent. And so that’s– I don’t remember if the
quote came from that chapter or from one of
the introductions. But the idea here was not,
should IRBs be transparent, yes or no? It was, yes, they ought to be
more transparent, but to whom, and how, and about what? Recognizing that
transparency is not free, IRBs are often underfunded
within their institutions. And so requiring
transparency does require resources to
write out opinions and have somebody who is
able to respond to questions. So I drew some analogies
to legal decision making, where we expect,
in most instances, for judges to issue a written
opinion about how they reached their decision, which also helps
create a system of precedent. So there’s this
efficiency benefit to transparency that, ideally,
even with your own institution, you would have a
clear sense of how you had made decisions before. If you were transparent
about those decisions more broadly than
your own institution, other institutions could
start to be informed by those decisions,
investigators could have a sense about how
similar cases were decided so that they can decide before
they even submit whether this is something worth submitting,
or how can I kind of in advance about how to shape my protocol? And then most interesting
and important to my own work, was that IRBs, when they’re
non-transparent, it makes it very difficult to do kind
of meta research on them, to get a sense about, are
their decisions high quality? Are they making the
types of decisions that we, as potential research
participants or beneficiaries of research, would agree with? And so those are
some of the kind of roads that I
travel in the chapter, totally different
than Ameet’s chapter. ELENA FAGOTTO: So thank you,
Glenn, Ameet, and Holly. So I think it’s about time
to open it up for questions from the audience. If you could please
identify yourselves, and your affiliation. And keep your questions
brief because there is a large number of people here. And make sure they end
with a question mark, to cite a Harvard
Kennedy School dean who used to say that at all events. Thank you. Yeah, and you can line up
here if you have a question. AUDIENCE: So I
will start, in part because I guess that’s
the prerogative of being a co-editor on this volume,
which was a lot of fun. So I’m Carmel Schachar,
the Executive Director of the Petrie-Flom Center. And my question is, one of
the biggest stories in health policy right now is about
the University of Virginia hospital system that had
been very aggressively going after people who
owed them money, including employees,
including taking really all of their assets. And, in some ways,
this is a story kind of about the success
of information, because action was taken
after Kaiser Health News published a big study
compiling what UVA was doing. And in a way, it’s a story
about the lack of success around transparency,
because it’s very clear that the
entire community knew what was going on, knew
how aggressive UVA was, that UVA leadership
knew how aggressive they were, and didn’t particularly
feel too bad until it started to make front page news. And so I was wondering in
the lens of that story, if you could reflect on
when transparency has positive attributes and
really does motivate a change or correct an injustice, and
when it’s just kind of, OK, we all know this, drug
prices are expensive. That’s not a surprise for
us that our cancer drug costs a lot of money,
and doesn’t see real action coming out of it. GLENN COHEN: Maybe I’ll
start, which is to say, there’s one chapter
in the book directly on this topic, which is Mark
Hall’s chapter on solving surprise medical billing. And that’s some of this, right? What Mark says is that
transparency is useful when it’s a
non-emergency situation, it is understandable
to the patient what is being billed
for, and the patient has a meaningful opportunity
to locate substitute providers. So an interesting
question to ask would be, what percentage
of care delivered in America meets those three criteria? Emergency, non-emergency,
OK, considerable. Could you explain the billing
in a way that is not so complex? Well, turns out it
might depend on the kind of number of people
involved, if it was surgery or
something like that, but alternative
provider that would offer you a different price. That’s the place where I think
Mark is quite clear about this, that I think we’ll find
the least number of cases where the transparency
will help, because people have
such poor choices. Now, all that said, I am
sympathetic to the idea of why a hospital system
would want to go after people. Maybe there’s a better way
of doing this versus not. I think what’s
interesting here what this is identifying is kind of
the difficulties of the payment structure in the United States,
and our view that you get struck by lightning, and
then you pay with your house, as opposed to some idea of
deeper cross subsidization and spreading cost
across all people. And I think the trajectory
for the Democratic side of the debate has been to
increasing cross subsidization and broadening of the pool,
which is what’s done elsewhere. But part of it is also what you
think health insurance is for. If your view is it’s for
catastrophes, that’s one thing. If you view it’s for
the best possible health of the population, then
the ways in which you pay for it and the amount
you pay are quite different. So I think there’s some
deep, normative choices here. HOLLY FERNANDEZ
LYNCH: Yeah, I mean I think what your question also– I agree with what Glenn
said, although I’m less sympathetic about
hospital systems going to lawsuits to recover funds. I think what your
question points out though, Carmel, is that there
is a threshold of transparency at which it could plausibly
make a difference. So in this context,
local transparency towards people who
maybe didn’t have the power to do
anything about it wasn’t able to move the ball. But it was this kind of
public, national shaming that was able to
make a difference. And so that, again,
gets to this issue about how much transparency, to
whom, by whom, and how? AMEET SARPATWARI:
And I would just add, I think there are
different dimensions of that transparency. So as Glenn mentioned, that
sort of price transparency on hospital services
may not benefit the consumer because
of all of the reasons Mark Hall has mentioned. But we definitely have a
need for, on a broader level, transparency in
terms of journalism and investigative journalism. And I think right now we
are in an era, obviously, where that is
coming under attack. And the benefits
of that are clearly seen in healthcare, in terms
of surprise medical bills, in terms of pharmaceutical
gag orders by your pharmacist not to tell you that
you could pay a lower price based on paying
cash rather than going through your insurance. There’s plenty of
instances where the outrage that is
generated has actually led to meaningful reform. And so there is a need
for local journalism. There is a need for
investigative journalism to give voices to people
who don’t have them. And that’s a form
of transparency. But what we need to
be careful about doing is to rely on transparency
as our sole mean of achieving reform. And particularly in the
pharmaceutical market, it cuts both ways. The outrage over the pharma
bro led to a lot of distraction in terms of, what is overall
costing the system a great deal of money and really let
brand name manufacturers off the hook in terms of
their own price increases and what was going on, in terms
of what Americans are paying. GLENN COHEN: I’ll just
add one more point, which is that the First Amendment is
a fickle friend when it comes to healthcare, that for every
instance where a gag order or compelled speech by
an abortion provider is struck down as
unconstitutional, there is a case where pharma
reps argue that promoting off-label drugs or
restricting the promotion of off-label drugs is
also unconstitutional, or compelling speech
about various databases and the like is
unconstitutional. So I think that if you charted
all of the cases in the last 20 years involving healthcare
and the First Amendment, I’m not sure if you’d be happy
from a policy perspective. I think it would come
off as kind of a draw. I don’t know. AMEET SARPATWARI:
That’s a good point. AUDIENCE: Hi, first of all,
congratulations on the book. I’m connecting this to
the more global discourse. Next week, there
will be a big summit at the UN General Assembly
on universal health coverage. And in global health, one of
the issues in transparency, which has also been emphasized
by ethicists like Norman Daniels, is when you cannot
meet all health needs fairly, how can you– all health needs, how
can you meet them fairly? And he emphasizes
publicity and transparency in setting the priorities
for what will be financed through the healthcare system. And I’m wondering–
and the United States has been particularly
resistant to that systematic explicit approach. And I’m wondering
whether that book addresses that kind of
transparency or those issues? GLENN COHEN: I’ll start. So there is a chapter
by Govind Persad that I think speaks
the closest to this. And that’s about trade-offs with
scarcity and health fairness, and information about
the benefits and burdens of health-related products. I think what’s interesting
to, now taking a step back to the Norm Daniels, to our
great colleague, now retired from the public health school,
whose book Just Health is definitely worth reading, and
has probably his most sustained defense of this view. I think one of the
interesting questions to ask, and I don’t mean this to
slag on the United States, but what deliberative
democracy as to health care would look like in this country,
and whether we think we could achieve kind of his ideals? Or if, instead, publicity
about a number of aspects of the healthcare would actually
reduce solidarity rather than increase it? So I think about things like
disability adjusted life years, and the costs of rare
diseases, and stuff like that, where
I think, actually, in some ways the majoritarian
approach would be, perhaps, in some
of these, produce a much less ethically
desirable outcome than one that was truly by majority vote. Now, part of the
question is whether you believe that there are
right answers here, such that it’s possible to
say the majoritarian approach results in wrong answers,
or whether you think that, in fact, as I
think Norm might say, when you get to these
unsolved rationing problems, it’s very hard for there
to be a right answer. And, therefore,
deliberative democracy is a procedural justice solution
to a substantive justice question, the best
that we’ve got. But I do think that, in
general, I would not– when I look at the reaction to
the Oregon Medicaid experiment from so many years
ago, and people got so upset that
heart transplants weren’t covered because they
were not cost effective. I’m not sure whether
that was right or wrong. But I’m very sure the
public reaction to that, and discourse about that,
was not the kind of thing that I think Norm envisioned
in an ideal world. AMEET SARPATWARI: And I can– just to build off of
that, I think, I guess, the warning about
that is well taken. But I think there is
also progress that is being made along those fronts. So one group that I’ll
highlight is ICER, the Institute for Clinical– Research. There we go. Thank you. Sorry, I always just say ICER. There we go. But in terms of, how do you
create a transparent process that brings together various
stakeholders in the system, so manufacturers,
patients, payers, and determine whether
or not a drug actually is cost effective? And what values, what
metrics, will you use? So there has been
pushback to the quality. But as a response,
ICER has developed a simultaneous metric that will
be used alongside the quality. So I’m just saying,
in this discourse, there is a lot of
potential for discord. But there is also some
promise for finding some compromise as well. AUDIENCE: Hi. Is this working? I’m Andy Orem. I’m a writer in
the computer field. I also cover Health IT. And I’m interested
in the problem of what data is available. Because you can’t be transparent
unless you have the data. I’ll give you a
really quick example. A friend of mine is
trying to figure out the results of treating
children who want to transition their gender. And what happens if
you give them that, and how much it costs if
you don’t give them that? They can’t find the data. So I wonder if the book talks
about things like the privacy issues, the cost issues, and
when you just don’t collect it. GLENN COHEN: That’s great. I’ll also say there are things
like ERISA, for example, which act as barriers– five letters that only
lawyers could possibly love, but a benefits and retirement
statute that turns out to have all sorts of effects. I think the biggest
gap, and maybe someone from computer science
will appreciate this, is that the American
electronic health records system is a billing system
that has been retrofitted to actually be a
repository for big data work and analysis by people. If you cared about getting
accurate understanding and information– and Sharona Hoffman’s
work, including I think her chapter
in this book, does a good job of
kind of showing this– it’s really not great data. It’s the best we have. But it’s not great data. And then accessing
that data raises a number of legal
and ethical barriers to privacy that I
think my co-panelists might like to address. HOLLY FERNANDEZ
LYNCH: Well, let me take this opportunity to talk
about clinical trial data sharing, which is not
exactly what you asked about, but I think we ought to talk
about before this hour closes. And so in that context,
there is an increasing push for pharmaceutical
companies, and academics, to share the data
that they collect from research subjects,
the primary data, not just the summary data. And one of the reasons
that there is this push is to allow reproducibility
of these studies, and also to allow subsequent
product development to kind of start where
the precedent left off, instead of having to
reinvent the wheel each time. And so it makes sense, on the
face of it, that, why should we do all of these
studies over again? Why should we ask patients
or research participants to put themselves, undertake
burden, undertake risk in clinical trials? This should kind of
be a common good, even though one company paid
for it and did all of the work. And then the companies
come in and say, well, actually, this is
our proprietary commercial information. Yes, research participants
gave of themselves. But they wouldn’t
have done it if we hadn’t brought them all together
and analyzed all of that data. And so they then
say, well look if we have to share our information
with all of our competitors, we’re just not going
to do it anymore. Or we’re going to do less of it. And so you have this
really challenging conflict between research participants
who, in most cases, say, yes, share widely. I didn’t do this for nothing. I didn’t do it just for you. I did it to advance science. And companies saying,
no, we’re going to be a bit more kind
of siloed about this. And you even have this happening
within academic institutions, where the way faculty members
in science get promoted is to, frankly, closely
hoard their data, and not share it with their
colleagues and potentially even their collaborators. And so what we need
to do is find ways to incentivize sharing. And there are different
carrots and sticks. So NIH says, you must share your
data if you want our funding. I think publishers have
a role to play here. And FDA has a role to play. There are lots of ways that
FDA can incentivize companies to do things that might inhibit
their intellectual property. So instead of saying, you’ve
got patent protection, FDA can come in and say,
we’ll give you exclusivity after we approve
your product if you are a good citizen
and kind of share your data with one another. And Ameet may have other ideas
about things that FDA can do. But I just want to
acknowledge that that is a, I think, a legitimate
conflict, that patients have an appropriate argument,
companies and researchers have an appropriate argument. And there was a now kind
of infamous editorial in which people
who wanted to use the data after it
had been collected were called data parasites. This was [INAUDIBLE],,
[INAUDIBLE],, sorry. GLENN COHEN: No longer
the editor, right? AMEET SARPATWARI: No
longer the editor. HOLLY FERNANDEZ LYNCH: You
can scrub that part out of the recording. Who basically put his name
on this editorial, saying, look, we did the work
to collect this data. And how are you going
to kind of compensate the scientists from
these data parasites who want to come
in after the fact and use the data that
was already collected? And there were kind
of robust arguments on both sides about how we
ought to go about doing this. But I don’t think
anybody thinks we ought to let the data go to waste. It’s really a matter
of figuring out how to appropriately incentivize
its collection and sharing. AMEET SARPATWARI: Definitely. And I think, on the whole– there’s limited time. So there’s a lot of stuff
I would weigh in on really quickly. But I guess I could just
say, to piggyback on that, there are so
many stakeholders in each decision about this. And they have vested interests. And trying to just
promote transparency without taking into account
those vested interest is going to run
into a brick wall. And so we need to be
very careful about how we reformat the system
to promote transparency. And we also need to be
really careful to think about recording of
this information in a way that’s useful
has a significant cost. And so you already
talk to physicians who say they spend
more time interfacing with the computer
in a patient’s visit than they do with
the actual patient. So if you’re going to ask them
now to record systematically, weight, smoking, everything
else in an electronic format, now how are you going
to compensate them for an extended visit
that’s now no longer 15 minutes but 30 minutes? And so the real
question is, we have to have a frank discussion
of trade-offs here. And on the population level,
the trade-off is, really, this question of, if you come
here, with lawyers usually, it’s very a
risk-averse discussion. The myth of anonymity is
popular and the big data concept among legal scholars. Or if you go to data
scientists, they really want to share these data sets. They really want
to link together outpatient claims with
inpatient hospital records. But does that increase the
risk of re-identification? It does. So it’s not an all
or nothing, can we have more transparency
and less risk of privacy? It’s a question of,
what level of risk to privacy we are willing
to entertain as a society to have this increased
transparency, and what benefit that increased
transparency actually has. ELENA FAGOTTO: OK. We have about five
or four more minutes. Archon– full
disclosure, Archon is one of the directors of
the transparency policy projects at Harvard. AUDIENCE: As often
the case, I’ve had the pleasure of working
with Elena for many years. So I haven’t had the pleasure
of reading the book yet, but I look forward to doing so. One of the basic dynamics
of many transparency systems is naming, and
shaming, and ranking, and then really making people
at the bottom of the list feel really bad. And maybe they do a
better job afterwards. And you see this in schools,
and restaurants, and insurance companies, many, many things. And so I’m wondering whether
the volume comes down in one place or another
regarding naming and shaming as a dynamic in the health–
for hospital outcomes, or costs, or whether or not insurers
turn down too many claims. You could imagine
1,000 versions of it. And there are
pluses and minuses. Where do you guys [INAUDIBLE]? GLENN COHEN: Yeah. I don’t think the
volume takes a position. But I think that there
is some good reason to be skeptical in the
healthcare setting, in particular when it comes
to outcomes reporting. So the biggest experiments, like
in New York and Pennsylvania on cardiac and stuff like
that, what’s interesting is that the first
order results is that people end up taking fewer
harder cases, because they’re worried. And it’s not clear that
that’s the effect you want. And, in fact, it seems
as though to the extent these have had positive
effects, what’s interesting is that the relevant
community ends up being the physician community
and not the patient community. There’s other research showing
that patients, in general, even when they are presented
directly, forced to look at it, they still tend to
prefer word of mouth and the like over these. So I think that if your
hope is influencing the patient community,
naming and shaming is not that effective. But if it’s other communities,
there’s a little bit more hope. AMEET SARPATWARI: And I
think that’s exactly right. Building off, there
has been some success in terms of how
you define success, of using nudging
concepts to promote lower prescribing of
opioids, just based on peer to peer comparisons,
and having that transparency. But the real, I think,
problem with this transparency from the physician perspective
is a lack of belief that the overall
system of transparency will be run fairly. And as long as that
belief is there, I think Glenn’s
point that physicians will take steps to reduce
their overall exposure and risk will
continue to happen. And so you need buy in
from those stakeholders. ELENA FAGOTTO: Is there
one more question? AUDIENCE: Thanks. I’m Carly [INAUDIBLE]. I’m [INAUDIBLE] fellow
here at the law school. I’m wondering if there’s
any discussion in the book, or if you have particular
thoughts on times when there are sort of
professional norms that might counsel
against transparency that patients might want? For instance, clinician
notes that talk about how a patient
prevented, or other sort of professional dynamics
along those lines? AMEET SARPATWARI: I can weigh
in on [INAUDIBLE] quickly. So there’s one huge
debate going on right now in terms of how much
transparency you want for substance use disorders. And 42CFR Part 2 has very
robust patient protections. And there are plenty of
people who I very much respect who argue that, in fact,
those protections should be strengthened. There are other
people who really want to, at a population
level, better understand what’s going on with the
opioid crisis and be able to study interventions,
and who say that we just need better transparency, because we
can’t, at the population level, do this without
better clinical data. And so there is a
real tension there in how do you assure
that these people’s privacy is going to be protected
through greater transparency. HOLLY FERNANDEZ LYNCH: Let me
just add one other example. I know we’re at time. But after the book was kind
of well down its path, in 2018 the EPA came out with a proposed
regulation where they said, we are going to
advance transparency and we are going to make
it so that we will only consider scientific research
if its underlying data is made available for other
scientists and industry groups to evaluate. And so you look
on the face of It And you say, oh, transparency,
this seems great, right? But actually, it turns
out that in order to look at a lot of the data
that was being provided to EPA, it was patient-level
identifiable data. And it was going to
knock out of contention huge swaths of
scientific research that was going to
better protect patients from environmental
health concerns. And so it’s just an
example where, on its face, transparency can look
great, but in practice can be really problematic. And I looked,
actually two days ago, to see what was going
on with that rule. It has not been finalized. And the government has to
wade through 600,000 comments that they received. So yet to be seen
what will happen. But I think it’s a great example
of the kind of trade-offs and the way that
transparency can be used for good and for
more nefarious purposes. ELENA FAGOTTO: OK,
so it looks like we used our time efficiently. I would like to
thank the panelists for writing and editing
this excellent volume, and all the audience. And thank you so
much for coming. And if you have questions,
maybe you can come and ask them. But yeah, our meeting
is officially over. But we’re still here. Thank you. [APPLAUSE]


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