Priority Setting in the Age of Genomics

Priority Setting in the Age of Genomics

Jacobs University Bremen
Priority Setting in the Age of
Genomics
Hartmut Kliemt
Priorisierung in der Medizin
FOR 655 Nr. 01 / 2007
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28759 Bremen
Germany
www.jacobs-university.de
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Priority Setting in the Age of Genomics
Hartmut Kliemt*
Frankfurt School of Finance and Management
Since resources are scarce priorities in medical care must be set. This
cannot be done in terms of science. It has to be based on non-medical
values of a rather broad kind even though medical information does
play a role for priority rankings. The question to what extent
genomics – as broadly understood – may play a role in this context is
explored with the result that transparent urgency based priority
setting and withholding of care will become less easy in the age of
genomics but not impossible.
As a thought experiment, though not in practice, it is conceivable that the GNP of an
advanced economy be spent on health care services. All these services would still have
some – though rather low – net benefit for the patients on which the money is spend.
Therefore eliminating pure waste will not impose limits on spending. It is necessary to
deliberately set some limits on the guarantees of health services financed from the public
purse. It is within this context that the ascent of genomics must be seen, too. It puts
another threat on our ability to do set limits. Moral and political pressures to expand
health care provision beyond reasonable boundaries might be fuelled by increasing
genomic knowledge.
__________________________________
Prof. Dr. Hartmut Kliemt
Frankfurt School of Finance and Management
Sonnemannstr. 9 - 11
D-60314 Frankfurt
phone: 069/154008-0
e-mail: h.kliemt@frankfurt-school.de
FOR655 – Nr. 01 / 2007
Priority Setting in the Age of Genomics
This paper inquires how genomics may possibly affect what I believe is the best way to
solve the containment problem: urgency based priority setting among standardized
diagnosis treatment pairs in a publicly financed rationing system. In the next section I
will sketch what I mean by that (2.). Then I will scrutinize how this special form of
priority setting might conceivably be affected by the ascent of genomics (3.). The paper
ends with brief concluding remarks on the future of public health care in a liberal
Western political order (4.).
But before going on to the potentially problematic aspects of genomics it deserves to be
emphasized that we all may potentially profit from the ascent of genomics. As patients
we may live longer and more healthy lives for what is in store. It would be foolish not to
look at potential problems, though. As in the old wisdom that in securing the peace you
have to prepare for war you should always prepare for the bad to secure the good (see on
this already Hume, D. (1777/1985)).
2. Public health provision as rationing
2.1 Rationing
Public health care is based on rationing or the assignment of limited quantities of an
important medical good or service of fixed quality for personal use below market
clearing prices. This understanding of rationing identifies public health care provision
with rationing. It is different from the conventional one which has it that rationing
amounts to the withholding of care. But the latter is obviously mistaken. Nobody would
queue up for a good or service in order that this good or service be withheld if he or she
would reach the head of the queue. The whole point of queuing is that you are willing to
pay the non-monetary price of waiting time or other inconveniences to get access to a
good or service.
The latter must be granted below market clearing price because otherwise you would not
pay the additional prize of queuing.
To get something below market clearing prices is always advantageous for the
beneficiary. As opposed to a present personally assigned to her a beneficiary of rationing
will not have a monopoly on the receiving end. In rationing those granting the rations
will in general want to treat all potential beneficiaries according to general (impersonal)
rules. This is particularly true if the rations are publicly funded (at least in part). Because
we are willing to give away the rations of the good or service only in some limited
quantities competition among the potential beneficiaries emerges. The very fact that
assignment takes place below market clearing prices – in the moment of assignment –
induces excess demand. Without the countervailing force of full opportunity costs and
the monetary price representing them that form of assignment will make the scarcity
subjectively more strongly felt. To put it very bluntly: if you can buy a Picasso painting
or a Rolls Royce car at the same price and opt against the Picasso and for the Rolls
Royce then the frustration of not getting the Picasso is counterbalanced by the
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Hartmut Kliemt
satisfaction of driving the car. But if you were unlucky and did not get the single
discount Picasso offered by Wal Mart in its latest advertisement campaign for a
thousand dollars and thus far below the market clearing price you will be frustrated more
strongly. The countervailing satisfaction is not a Rolls Royce but only what ever it is the
$ 1000 can buy.
Now, there are not many offerings of Discount-Picasso paintings in our societies. But
health care rations are offered in civilized Western societies by the state or state
sponsored authorities as guarantees of minimum care. Here scarcity is felt quite strongly
by those whose demand is not satisfied at the prices charged (which may be nil anyhow).
Subsidies induce special forms of frustration. And that frustration will even increase if
we fulfil other requirements of a Western legal order under rule of law in particular
those concerning the definiteness and transparency of rules regulating resource access.
Scarcity will, as a rule, be felt more if the rationing is transparent.
Rationing should, as I suggest, be called “transparent” if the assigned services and goods
are provided in a standardized way according to rules open to judicial review. In a public
health system where redistribution is financed by coercive taxes it seems clearly
obligatory that the system be transparent. But also within the sphere of private health
maintenance organizations and other healthcare providers the two parties of the contract
will insist on transparency. The one-party would like to know exactly what its
obligations the other one what its rights are. There is a demand for transparency in the
public sphere as well. Though it cannot express itself in free contracting it should be
expected to be present as well.
It is also worth noting that quite contrary to the conventional wisdom which identifies
rationing in medicine with withholding care there is a private demand for rationing. If
somebody buys an insurance contract this amounts to buying into a rationing scheme.
This is s because in the moment of need she will not have to pay the “quid pro quo” of
the service she will receive as a person (very instructive on quid pro quo reasoning,
Weizsäcker, C. C. v. (1985) and rather extreme but very interesting on this Quante, M.
and S. Wiedebusch (2006)). In the moment of need not her willingness to pay but the
need will command the goods and services she is in need of. This is the whole point of
insurance: In the moment of need you want to get access to resources due to a contingent
contract defining a claim to a ration that is assigned to you without requiring direct
payment.
That we have the power to set priorities at all in a public health care system clearly
depends on rationing. As opposed to a purely contractual assignment of resources for
personal use the supplier of rations can decide whom to give what in which order.
Priority setting is possible only if we are willing to assign rations below market clearing
prices. One cannot reasonably intend to discriminate by other than market forces and
nevertheless let the market work “it” out. Under free contracting and market clearing
prices society or rather its agents would not have discriminatory power (or only at the
margin if two are willing to bid the same). Asking the market clearing price implies to
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Priority Setting in the Age of Genomics
go with the highest or lowest bidder depending on which side of the market one is
(which incidentally forms one of the reasons why the Freiburg school of political
economy always insisted that the main achievement of market competition is the control
of power; see Eucken, W. (1982)).
2.2 Priority setting
The kind of priority setting I am interested in henceforth is that of a (diagnosis,
treatment)-pair priority ordering within the public sphere. By such a priority ordering I
understand a complete, total-reflexive, and transitive relation among (diagnosis,
treatment)-pairs. I will also refer to this as a medical priority ordering.
Let us say that a medical priority ordering is preference based if it is determined by
pairwise comparisons of (diagnosis, treatment)-pairs according to the views of several
stakeholders, in particular, physicians, patients and observing citizens. The orderings of
different groups of stakeholders need not coincide. The stakeholders typically are asked
which of two (diagnosis, treatment)-pairs is to be provided to a patient “at the
opportunity cost” of not providing it to another patient. This way of questioning is rather
specific in disregarding monetary costs and numbers of affected individuals and in that
sense quite alien to some of the views on rational priority setting in a cost benefit
framework presently favored by many experts and politicians. The determination of a
preference based priority ordering in this way will be called urgency based.
Within the legal order of the Western type rule of law principles are central. This brings
into play requirements of definiteness of resource assignments. It makes what I call
transparent rationing and priority setting in medicine a necessity for public health
provision. On the one hand, this is so because the subsidies are financed by coercive
taxation. On the other hand, the discriminatory assignment is also using the fundamental
coercive power of the state and therefore needs to be open to judicial review.
As far as I can see, the necessary transparency cannot be brought about in ways other
than by standardization of (diagnosis, treatment)-pairs with respect to quantity and
quality of diagnostic effort and treatment (see on standardization Dietrich, F., M. Imhoff
and H. Kliemt (2004), Kliemt, H. (2006)). Within the approach favored here the priority
among those standardized pairs will follow from an urgency based medical priority
order. Finally, because not all medical care expected to be of net benefit for the patient
can be paid for defining a cut off point in the priority order is required. This is not a
medical but a political issue. Below the cut off point no service will be financed from the
public purse while all (diagnosis, treatment)-pairs above the cut off point will be
provided below market clearing – and typically at zero monetary prices – and paid for
from taxes (or tax like schemes as in German mandatory “insurance”).
Priority setting should basically be political not medical and the basic ethical concern
should be political stability rather than health (see Kliemt, H. (2006)). However,
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Hartmut Kliemt
political stability does not require to guarantee every medical service that would be of
medical utility for the recipient. Quite in line with urgency based priority setting we can
and should rely on the principle of acuteness in priority setting here: the more likely, the
closer in time, and the more serious a risk for life or limb is, the more intense is the
political obligation to guarantee the assignment of rations of health care; the less acute
the more easily can additional care that goes beyond the assigned rations be „withheld“.
Setting limits in health care provision becomes but is also possible only within the
constraints of observing the principle of acuteness. Observing the principle of acuteness
has implications for the more or less expert-driven priority setting that is envisioned by
public health officials and medical doctors almost across the board. It imposes a
feasibility constraint on any form of priority setting.
In political practice maximization of summed up qualys and other standard criteria tend
to be overruled by acuteness considerations. This is clearly shown by the fate of the
famous Oregon health plan. Once a person afflicted by a life threatening acute disease
had a face and a name (the little boy patient to whom a very expensive last chance
treatment with rather low success probability was “reasonably” withheld) the rational
plan was not feasible anymore. We should not blame that on the irrationality of the
public at large but rather on a deficiency in the priority setting mechanism itself. The
principle of acuteness was not taken into account at all or not sufficiently. The advantage
of an urgency based priority setting is that it more or less automatically will come to a
priority ordering that can be transparent and at the same time be sustainable once the veil
of ignorance about who is afflicted in which ways is taken away. For, if we would ask
the right questions on alternatives in such a setting and describe them as choices also
between concrete lives the principle of acuteness will automatically be factored in
(numbers will count less, see Lübbe, W. (2004); Lübbe, W. (2005)).
2.3 Public health as an input into the production function for rule of
law
How does this all relate to genomics and its ascent? It is important to note here that in
general preventive medicine can be limited according to the principle of acuteness. The
illness to be prevented is not yet manifest and no treatment of acute symptoms
necessary. In particular in cases of severe illness the person concerned is not yet in dire
straits and therefore the rescue impulse that makes it publicly unavoidable to assist a
concrete person in preventing severe and imminent danger does not kick in yet. This
holds good for diagnostic effort in particular. Diagnostic effort can in general much
more easily be withheld than treatment effort.
Both aspects are already crucial in limiting public health care resource use today. But
they will become much more crucial for that task if medical technology develops on as
in the past. Though this development is on the personal level for each of us entirely
desirable it is also absolutely desirable that it will not become a threat to the legal order
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Priority Setting in the Age of Genomics
of a free Western society. At least if we take seriously the Rawlsian principle of the
priority of liberty and if we also understand that liberty has to be protected in the
presence of the state and its fundamental coercive power by that state itself, we have
very good reasons to contain the size of the state (including the health care providing
state). The development of medicine will, however, put some very serious strains on the
ability to contain that size while maintaining transparent schemes of urgency based
priority setting and the assignment of rations (see early on this point Buchanan, J. M.
(1990)).
Because transparency is itself important for rule of law and judicial review it can not
easily be given up and should not be given up in liberal legal order of the Western type.
Neither is it feasible to let concrete lives perish if they can be rescued at bearable costs.
The belief in the legitimacy of the system would perish as well. However, if the costs of
public health care expenditures expand beyond certain limits the political system based
on inter-individual respect as expressed in the notion of the priority of liberty may go
under, too. The preceding sketch of a system of transparent urgency based priority
setting indicates how in principle setting limits would be possible without undermining
the belief in the legitimacy of the legal order as a whole and without eroding its guiding
principles from within. Guarantees that protect concrete individuals against imminent
risks to life and limb could be universally provided and thereby a central input in the
production function for maintaining the system of rights that form the core of a Western
liberal political order.
The issue I want to address next is whether the belief in the legitimacy of a Western
legal system can be upheld at reasonable costs if genomic knowledge will considerably
increase in scope and predictive validity. For instance, what will happen if additional
information on risks is or can be provided to specific patients or groups thereof? Will
they become organized and drive away any restrictions on spending that we might
otherwise intend to impose? Let us for the sake of the argument assume that some of the
wilder hopes about genetic knowledge and its accumulation will be fulfilled and reflect
on the scenario then emerging. It will become apparent that the consequences will be
less severe than might be feared.
3. Piercing the „veil of genomic
ignorance“
Once sufficient genetic knowledge exists those afflicted by a disease may know that they
incur a special risk beyond the general statistical risk affecting the population at large. In
that sense genetic knowledge can single out those who will with higher likelihood than
others be afflicted by the manifestation of a disease in the future. General statistical risks
become concrete probabilistic (e.g. risk of breast cancer) or deterministic risks (e.g.
Huntington’s Chorea) of specific groups who know of their specific condition. This
knowledge sets them apart from the population at large. Though a disease may be nonacute the knowledge of its increased likelihood may become “acute” due to genomic
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Hartmut Kliemt
information. The concrete awareness of a specific likelihood in the present will affect
individuals in ways differently than the awareness of a general likelihood to become a
victim of a disease.
More specifically speaking, due to genomic information (possibly large) groups of
subjects can know in advance of a severe illness afflicting them with higher likelihood
than others. These groups may have the ability to organize themselves as pressure
groups. This as well as other effects raise the question of what the consequences for a
priority setting scheme as envisioned above may be.
Our ability to set limits to collective health care expenditures in ways compatible with
rule of law and the priority of liberty in a Western type legal order may be negatively
affected by the growth of genomic information along four dimensions: 1. A modified
meaning of urgency and the relationship between statistical to concrete risks may
emerge and become an obstacle to the implementation of transparent urgency based
priority setting. 2. Creating private insurance markets may become problematic. 3.
Admittance to the community may become dependent on the submission of genetic
information. 4. Research funding and resource allocation to research projects may be
influenced by external pressures.
ad 1. As far as “acute awareness” that a specific severe disease is pending amounts
almost to the same thing as the disease being acute, urgency based transparent priority
setting may become difficult. At least in a way, the disease becomes “chronic” before
symptoms show and the potential patient actually falls ill. Preventive measures – if
prevention is possible – will receive higher priority than otherwise if specific groups of
people know to be differentially afflicted by the likelihood of the disease actually
becoming manifest in them.
It is hard to say apriori what the empirical effects of genomics will be. But it seems quite
plausible that the effects will depend on how much the probability of developing
manifest symptoms rises by genetic knowledge. Before symptoms develop a disease will
be treated more or less as if already manifest only if the conditional probability after
genetic diagnosis is high. Moreover it seems necessary that the probability of preventing
it some intervention or other must also be quite high if the knowledge of the increased
probability of the disease to become manifest is to provide a strong motive for action. If
both conditions are fulfilled the acute knowledge that the disease is pending may be
quite similar to the knowledge that the disease is manifest. In short, the product of the
probability of the preventive measure being effective and of the probability of the
disease in the group differentially affected is presumably crucial.
It is unclear, though, to what extent remoteness in time may act as a countervailing force
here. My personal hunch is that remoteness in time will have a rather strong influence on
the potentially ill as well as on observers. It will considerably decrease the urgency even
of a preventive intervention.
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Priority Setting in the Age of Genomics
If the conditional probability of the manifestation of the disease after genomic diagnosis
becomes rather high and the “scare factor of the disease” (as in cancer cases) is high as
well then this may possibly outweigh the effects of the remoteness of the manifestation.
This may be so at least if there are preventive measures that can be applied with
reasonable effort. But as can be seen from so many cases of diabetes where all it takes is
loosing weight and having exercise to prevent its manifestation (and often even after
manifestation) to eliminate or to reduce manifest symptoms the behavioural effects of
knowledge may not be strong. Closeness in time will have a rather pronounced influence
on how strongly the urgency of the claim for public assistance in prevention will be felt.
Since there will be individuals around who are already manifestly ill public opinion may
be mobilized to a much stronger extent also in favour of prevention than the inidivual
patient for whom the manifestation of symptoms may still be quite uncertain, in all
likelihood remote in time and cost him more effort than the bystanders who express their
willingness to help often at practically zero costs to themselves.
In general it seems that the ascent of genomics will not make an application of the
principle of acuteness impossible. But it may make it more difficult to act accordingly in
specific cases. As far as our ability to set limits to public health care expenditure is
concerned there will be some cases of cost saving prevention but in general the effects of
the growth of genomic knowledge will be cost increasing. How strongly these effects
will be depends on the reliability of predictions, the probability that the disease will
become symptomatically manifest, as well as the probability that preventive measures
will work and can be administered without requiring too much activity on the side of the
patients concerned. Moreover, the size of the concerned groups will be of great
importance. In general we may assume, however, that most of the diagnoses based on
genomics will concern diseases whose symptomatic manifestation is sufficiently remote
in time and sufficiently stochastic for making the withholding of expensive preventive
care viable. Transparent urgency based priority setting should remain possible and
therefore setting limits on public health care expenditure within a liberal Western legal
order, too.
I think there should be much more empirical research on the political effects of genomic
knowledge. This research, of course, is not medical research but research in the
psychology of risk perception or, for that matter, political psychology.
ad. 2 The very meaning of health insurance could conceivably become precarious with
greater genomic knowledge (though in a very distant future). But this is very unlikely.
There will not be many monogenetic and hardly many polygenetic diseases with a
certain or almost certain manifestation of symptoms in the future. Therefore there will
be still quite some scope for spreading risks among those differentially affected and
insurance contracts. This would speak in favour of a health system that would provide
basic guarantees to each citizen and finance the guarantees by taxes. Because the public
good involved is the maintenance of the legal order itself rather than individual health
this is more or less how it should be. For, if there is a public good involved whose
production is a legitimate public concern and may legitimately be financed by
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Hartmut Kliemt
compulsory taxes then everybody should contribute as a taxpayer. If there is no such
legitimate concern and consequently the application of fundamental coercive power to
raise taxes rendered illegitimate then nobody should pay. Making contributions
mandatory for some citizens while others may voluntarily contribute or not as presently
in Germany is verging on the absurd (in that regard, of course, not very different from
much of the rest of the tax system).
The idea to provide a standard basic care package and to pay for its guarantee from the
public purse seems reasonable in the age of genomics. It should be possible to use the
principle of acuteness to define the basic package and to leave the rest to private
responsibility. However, with increased genomic knowledge public health care provision
might become increasingly outright re-distribution between the more and less healthy as
opposed to the more and the less well to do. There will be much less uncertainty about
the redistributional effects rendering “social solidarity” possibly more precarious than it
would be otherwise.
Again there will be a countervailing effect which is exerted by the presence of
expressive voting behind the veil of insignificance in the voting booth (see on this
Brennan, H. G. and J. M. Buchanan (1984), Brennan, H. G. and L. E. Lomasky (1989),
Kliemt, H. (1986)). Since voters know that their vote will not tip the balance they can as
well express “unselfishness”. By casting their vote for the good health care causes they
can feel the warm glow of doing something good at the polls. This, of course, may also
put the political ability of society to impose a cap on health care expenditures at risk. As
far as this is concerned we can only hope that over the long haul a transparent rationing
system that implements an urgency based medical priority ordering will be accepted.
Whether this will lead to hard rationing, prohibiting in fact private additional health care
provision and insurance in the name of equality or soft rationing that allows for
differences remains to be seen. As adherents of the principles governing a Western
liberal order we should hope that limiting public care will go along with the entitlement
of citizens to use their own resources for improving their individual health care beyond
the publicly guaranteed level. But whether that in fact will happen remains to be seen.
ad 3. Admittance to the community may become increasingly health dependent in the
future. This is, of course, not an entirely new development. For instance immigrants to
the US have for a very long time been scrutinized concerning their state of health. There
is some reason to assume that this kind of inquiry will be intensified in the future in the
US and everywhere else around the world. The more expensive guarantees for medical
care will be the more reluctant a society may become to grant access to outsiders.
Therefore it seems rather safe to predict that immigration and granting full citizens’
rights will increasingly be made dependent on genomic testing. This is a side effect also
of implementing universal coverage.
Eugenics are lurking around the corner, too. Though the culprit is not genomics per se
but rather our inability to set explicit limits to medical rations concerning newborn
members of our societies it will presumably lead to problems in the more remote future.
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PID (pre implantation diagnosis) and selective choice will become if not mandatory in
certain cases clearly something that will be supported by increasingly many who observe
that they themselves cannot anymore finance state of the art non-acute health care. The
effects of our inability to set limits to collective state sponsored action and to privatize
responsibilities will be exacerbated by genomics.
ad 4. The knowledge of genomics may lead to a stronger democratic involvement into
what kinds of research are to be sponsored from the public purse and which not. It
seems, however, that this will not pose serious problems as long as private medical
research and funding of that research will not be hampered by state regulations.
4. Concluding remarks
Though it seems that limiting the guarantees of public health assistance will become
politically infeasible to the extent the advance knowledge of a pending disease is treated
equivalent to acuteness of the condition itself we may assume that such advance
knowledge will in most relevant cases not be treated that way. Though in the age of
genomics it becomes clearly more problematic to stick to the principle of acuteness it
will not be impossible in particular if we factor in the effects of remoteness in time.
There will be a tendency to identify acute knowledge of the differential probability to be
subject to a disease in the future with acuteness of that disease itself. However, it seems
likely that this will not prevail over the effects of remoteness in time – at least in those
cases in which the product of the probabilities of the effectiveness of preventive
measures and the conditional manifestation probability after genomic diagnosis is not
too high.
We cannot rule out that people may start to confuse acuteness of a threat to life or limb
with acute knowledge that such a threat is pending. It seems, however, rather unlikely
that this will in fact happen because the human weakness to give undue weight to what
is close in time as opposed to the more remote will work in our favour here. Individuals
who know that they will with differentially higher probability be afflicted by the
manifestation of symptoms of a disease in the more distant future will emotionally
distance themselves from that knowledge sufficiently as not to treat it in the same way as
imminent dangers. So there is some chance that we will be able to implement a
transparent system of public guarantees of health care provision according to an urgency
passed priority order. Genomics will make it more difficult to go that route but it does
not close of the possibility of a reasonable system of setting limits to public health care
guarantees without putting the basic principles of a Western liberal legal order at risk.
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*Author note
First draft, July, 03, 2007. I am indebted to Norbert Paul and participants of the
conference remaking the future of health care, June, 30 to July, 2007, Academy of
science and literature, Mainz.
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Working Paper Series FOR 655
1. Hartmut Kliemt: Priority setting in the age of genomics, December 2007 (1)
2. Marlies Ahlert: If not only numbers count – allocation of equal chances,
December 2007 (2)
3. Stefan Felder: The variance of length of stay and the optimal DRG outlier
payments, December 2007 (3)
4. Jeannette Winkelhage, Adele Diederich, Simone Heil, Petra Lietz,
Felix Schmitz-Justen, Margrit Schreier: Qualitative Stakeholder-Interviews:
Entwicklung eines Interviewleitfadens zur Erfassung von Prioritäten in der
medizinischen Versorgung, December 2007 (4)