Tag Archives: ethics

Being right when you’re wrong: on NICE and the Cancer Drugs Fund

Conceptual work by Yves Klein at Rue Gentil-Be...

When rules don’t work [Conceptual work by Yves Klein at Rue Gentil-Bernard, Fontenay-aux-Roses, October 1960, photo by Harry Shunk. Le Saut dans le Vide (Leap into the Void) (Photo credit: Wikipedia)]

 

 

 

 

 

 

Sir Andrew Dillon, the erstwhile leader of NICE as said that it is irrational for the Cancer Drug Fund to pay for drugs that NICE has turned down.

 

He’s right of course, it is irrational. But only if NICE’s logic is compelling.

 

The problem for Sir Andrew, and likemined people, is that there is another logic that trumps NICE’s rational world. Don’t get me wrong. NICE performs a useful, but technocratic, function with analytical assessments that any rational person would indeed want to know. Where we part company is believing that NICE’s logic is the final word on the matter. Which it isn’t.

 

Tasked, perhaps unenviably, with parsing the performance of medicines and clinical practice, cannot also mean that they are above challenge. Many of NICE’s rulings fly in the face, not of logic, but of our beliefs as humans. It is why we do things when the odds are against us, because not to do so would be wrong. If we think of the challenges NICE faces as wicked problems, that is complex problems with a multiplicity of solutions, it becomes self-evident that their logic is just one way of deciding and choosing. We could use other rules, other criteria. The Cancer Drug Fund is just such an approach. It is another matter whether we should have in place alternative funding approaches that individuals can avail themselves of (such as co-payments or co-insurance); for extraordinarily costly therapies, co-funding would not apply, so we’ll back to the problem anyway.

 

NICE has a troublesome relationship with the notion of ‘rule of rescue’ and so has decided to ignore it. There replacement, the “end-of-life premium” is really just a reweighting of the logic they use.

 

You see, the rule of rescue is what we might call a meta-rule — it is a rule that tells us if other rules are working properly, and importantly, as a moral imperative which tells us what to do. The rule is often invoked in a particular form: that people facing death should be treated regardless of cost. The rule as originally formulated is really about assisting identifiable individuals facing avoidable death (Jonson, 1986); the bioethicists and economists have shifted this to a cost-effectiveness approach, making it one about trade-offs instead.

 

The problem for healthcare systems is that all patients are becoming identifiable as medicines become personalised (medicines may become orphan drugs). The problem for the NHS is that it does not allow such people to rescue themselves because it prohibits any sort of co-funding or other arrangements. The only option is an opt-out (and private medical insurance has rules about pre-existing conditions). Given the funding priorities of the NHS, we should be reflecting not so much on how to make the pot bigger, but on using the money that is available better (there will never be enough money), and ways to introduce practical co-funding.

 

Since individuals have no other options in the NHS, the rule of rescue as a moral imperative will be violated and we will act, not out of analytical error (i.e. make a technical mistake), but unethically. You see, the NHS must be the healthcare system of last resort and therefore of rescue, otherwise, identified individuals are destined to a death sanctioned by public policy and is that a policy or healthcare system worth having?

 

We have seen a similar challenge to NHS/NICE logic recently with the King family and proton beam therapy, and the NHS will also use NICE logic to determine access. Whether beams or drugs, it is the same argument.

 

But why cancer? The main public policy question is why should cancer patients be given preferential treatment as against any other deserving group? This may in part be driven by the often astronomical costs of new cancer therapies themselves, which demarcate cancer patients decisively from equally deserving patients with less cost-contentious therapies. I have just finished some work on motor neuron disease, for which there is one specific medicine and life expectancy from diagnosis is 3 to 5 years, with median survival rates that are measured in months. NICE reportedly is developing guidelines for this disease. Costs are considerable, and at least in the UK, highlight the bureaucratic illogic of separate healthcare and social care, but that is another story.

 

The moral dilemma that the economists at NICE are trying to reduce to an equation is whether a new therapy is extending life, or delaying death. The Oregon approach collapsed when the hard choices emerged and people were unable to resolve this dilemma, which is not a quantitative issue, but one of how we value our humanity. Kierkegaard’s Concluding Unscientific Postscript speaks of the leap to faith as involving self-reflection and the emergence of scepticism. It is worrisome that NICE is so confident.

Further reading

 

Cookson R, McCabe C, Tsuchiya A. Public healthcare resource allocation and the Rule of Rescue. J Med Ethics. 2008 Jan 7 [cited 2014 Sep 4];34(7):540–4.
Jonsen, AR 1986, Bentham in a box: technology assessment and health care allocation, Law, Medicine and Health Care, Vol 14, pp172–4.
Richardson J, McKie J. The rule of rescue, working paper 112, Centre for Health Program Evaluation, Monash University

Is health technology assessment morally defensible?

Capturing race

Is HTA like GO? (Photo credit: Wikipedia)

Increasingly widespread amongst the world’s healthcare systems is the assessment of medicines and devices using various types of cost-benefit or cost-utility analysis; this is called health technology assessment or HTA. HTA seeks to determine, using evidence of one sort or another, whether something is broadly speaking affordable, taking account of the cost of the medicine/device taken against the benefit to a particular constellation of diagnostic attributes in patients. This is usually quantified in a measure called a QALY: a quality-adjusted life year, which is a way to assess the value for money of a particular health technology. In short, it is a way of valuing lives.

HTA is a utilitarian approach to assessment. To some extent, this is not surprising as HTA is in the main a method developed by health economists, who, like economists in general, hypothesise that we make daily decisions based on the utilty of this or that, in terms of trade-offs (Pareto optimisation, for instance) and rational decision making (that people seek to maximise value, or utility in what they do). This approach is increasingly in dispute in light of the findings from neurosciences and behaviour economics: by posting that people do not always make decisions that are in their own best interests, a key assumption of traditional economics, that of the rational actor, always calculating trade-offs and maximising benefits, and so on, is questioned.

The problem with utilitarianism, though, is it doesn’t pay attention to the freedom of the individual; it positions the justification of its results on the net benefit to society, regardless of the impact on rights of individuals. Obviously, health economists don’t watch Star Trek or they would know that the needs of the one outweigh the needs of the many. But then, that, too, is a moral position.

Indeed, it is perhaps the sense that utilitarian conclusions don’t seem to correlate with many people’s moral sentiments that may explain why decisions of HTA agencies, for instance NICE in the UK (England) lead to moral outrage and a sense of, if not injustice, at least unfairness. While the results of an HTA process may lead to a quantitatively defensible conclusion, people sense that this conclusion is not morally defensible.

How are we to judge? Few would use utilitarian arguments in this way in other spheres: would we calculate who needs welfare in terms of the net benefit to society in terms of quality of life years, though perhaps we do allocate welfare on moral assumptions that some people deserve welfare while others don’t.

Do we allocate support to communities ravaged by floods based on their overall contribution, or utility, to society.  If you could donate £10 million to a university, would you pick Oxford University or Thames Valley University; which one is more worthy? But would you want to treat people this way?

HTA doesn’t even let us value lives in quite this way, since it neatly avoids deciding about the worth of any particular type of person, who just happens through misfortune to find themselves needing some medicine that fails the HTA tests. HTA keeps us from confronting the fact that HTA is a way of drawing a conclusion, without actually having to decide any allocations for any one person in particular. Bentham would approve.

There is, though, a technical problem with HTA and it has to do with whether at one level of assessment outcome, a utilitarian models can be used when the decision to be made does not have life threatening consequences for some people.

If the QALY threshold is, say £35,000, as it apparently is in the case of NICE, are the decisions below that threshold, which tend toward ‘yes’ or ‘approval’ morally different from decisions above that threshold?  I suggest that different moral criteria come into play above the threshold and this is where I think out moral outrage should be directed and where HTA fails.  Regretfully, HTA models see the results as broadly continuous, that is, decisions above and below this threshold are seen as essentially of the same type.  But I have argued elsewhere that above the threshold, HTA models fail but for reasons other their analytical soundness, because above this threshold, the conclusions may lead to a lessened quality of life, in other words, they actually crystallise the health outcome rather than avoid it.

Therefore, in valuing lives, those above the threshold experience greater injustice than those below; they are treated differently, unfairly, unjustly, perhaps less worthy, but certainly differently.  Indeed, above the threshold, we feel we are more in the realm of our moral sentiments about the value of human life, and less our moral sentiments about the allocation of scarce resources.

If this were not so, then we would be living in a society that believes that the determinant of all important moral and political decisions is affordability, and if that were so, they we could not even afford the costs of inefficiency brought on by democracy, the inconvenience of not being able to exploit people, the costs of equal rights.

Perhaps, though, on our financially contaminated world, all we can think about today is money and that is further contaminating our perception of what sort of society we are actually trying to foster.  Certainly, protests on Wall Street and elsewhere point to the view that there seems to be some unjust allocation of the benefits of government bail-outs that just doesn’t benefit those ‘at the bottom’.

John Rawls wrote that the we should distribute opportunity in a society in such a way as to ensure that the least well off benefit the most. In the context of HTA, medicines and technologies that benefit only a few, but at great cost, represent a cost worth having as the least well off, namely those who would need it most ( have the condition it treats, and in some societies can afford it least), would benefit, even if a little, as that is the price we pay for justice.

This, I suggest, is the root of our moral outrage at HTA, that is unjustly fails to serve those who need it most.

I am left with wondering about the underlying morality of HTA as a government scheme. Governments, as we know, are the last resort, when things are tough and one would hope, ensure that the least well-off in society are not penalised simply in virtue of being least well-off.  In healthcare, someone has to be the carer of last resort; using HTA as a way of avoiding this responsibility is not morally defensible.

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Of Free-riders, and a shake-down

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rationing

Item in the new: “The manufacturer of a drug which could extend the lives of thousands of people suffering from a rare form of cancer has agreed to pay for further patient treatment as part of a cost-cutting scheme.”  This arises from a decision of the English agency NICE to recommend limited use of this medicine.

We have a situation where the pharma company is going to provide the medicine for free to a certain group of patients (the details aren’t important for this commentary) at a certain point in their treatment — in this case toward the end of that person’s life.

How are we to make sense of this?

Who benefits?: the patients get the medicine which they would otherwise not get it toward the end of their life; indeed, unless they were able to pay for it themselves, they would be deprived of the medicine. NHS gets a medicine, which it would otherwise not pay for, for free, for a group of patients, one might argue they were abandoning.

Who pays?: the pharma company absorbs the cost of doing this for one final application of the medicine if needed; the public sector does not pay anything.

When some derive benefit for free from the actions of others, we call the former free riders; that makes the NHS a free-rider. Indeed, one might view NICE and other HTA agencies as acting to achieve free-ridership for the public system, by rationing public funding according to the HTA assessments. The pharma companies, wanting their medicines to be used (they might actually also want them to be paid for), give them away for this group of patients for their own reasons.

This small group of patients would undoubtedly suffer, a price NICE deems worth the cost, and the NHS in this case, is willing to be bound by a decision which may actually increase suffering. The pharma company has come to the rescue of these few patients and is now doing what one would think the public system should do, alleviate suffering. Had the pharma company put profits before use (which they appear not to be doing otherwise they would have sought payment) no doubt they would have been criticised for their prices, which of course underpins NICE’s cost-benefit analysis in part.

Did NICE shake down the pharma company?

I have argued elsewhere, that public health systems must be the payer of last resort (the so-called Rule of Rescue), which should challenge NICE’s models that would increase suffering, as that cost is something no state should ignore. The unethical conduct of public bodies here is breathtaking.

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When is the last 6 month’s of life?

As Death in The Seventh Seal (1957)
Death doesn’t make an appointment (from The Seventh Seal)

Informed research leads us to the conclusion that ageing is expensive for healthcare systems.  Indeed, it is widely tossed around that the bulk of healthcare costs incurred by individuals throughout their entire life time, are incurred in the last 6 months of life.  This is in part why policy makers and ministers of finance worry about the costs of healthcare.

But the problem we have is determining when we are in the last 6 months of life.

The somewhat awkward yet timely debate in the US about how to deal with health costs at the ‘end of life’ stage of our existence  has illustrated the fear we all have of the final moment, and what we will do to push it off.  It has been said that in the US, death is an option on the insurance application form.  From the debates characterising health reform today, one could think that was the case.

  • Is end-of-life an issue for policy?  If so, does that mean we revisit not just German National Socialism of the 1930s but similar euthanasia movements in other ‘civilised’ countries at that time?  Does it lead to death squads?).
  • Is it an issue just for doctors? No, we are now well past the time when doctors make these final choices for their patient.
  • Is some other option of voluntary euthanasia lurking on the fringes of our moral sensibilities?  This has been explored by Harry Harrison in his “Make Room, Make Room”, for instance, and the rather less satisfying movie, “Soylent Green”.
  • Will we live forever?  The transhumanists think so, and read through Kurzweil’s “The Singularity is Near” is road that takes us in part to Singularity University, happily located on some un-used NASA property in California.

However we try to square this circle, as I’ve said before, it is important to distinguish between prolonging life and delaying death.  Most of what medicine does prolongs life.  But some healthcare is really only buying time and thus delaying death.  How are we to tell the difference?

Moral argument will take us toward social values. The healthcare space will take us to a discussion between an individual and their family.  A policy debate will ask what interest does society have in the answer, what are the social costs (not necessarily meaning money here) and are these ones associated with a society we want to live in.

The answer to the question is dependent on who is asking the question, and that is different from those who are trying to answer the question.  We need to be clear about the difference.

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NICE, the Rule of Rescue and Supererogation: or what’s the State for anyway?

Lifeboat (rescue)
Someone will come, we all hope.

NICE’s position on the rule of rescue is incompatible with the purpose of the NHS as a state mandated healthcare system which must at least be the option of last resort for people where social values and preference would provide healthcare — despite NICE’s analysis.  Government cannot let HTA bodies such as NICE ignore the rule of rescue.  NICE argues that it adequately takes account of this — but there is a discontinuity in the applicable decision logic below and above NICE’s QALY threshold.  NICE in effect is applying below the line logic to above the line issues.  The issue of compliance and indeed civil disobedience may be applicable as doctors are prohibited from violating their professional codes of conduct, or acquiescing in acts or procedures that would cause them to violate their ethical code.  A doctor strictly speaking cannot not aid a person caught by the NICE threshold cutoff, where they are able.  The state is obligated to interevene and pay for expensive care as it is not an act of supererogation, but it is the State’s duty. Therefore, the State must act in cases above the line out of duty —  aiding people who might cost a lot by HTA QALY benchmarks but if the state doesn’t act, and who will?  This is especially troublesome in the UK where the NHS is presented as the health provider of last resort — not something NICE has clearly thought through.  Will the politicians allow NICE to wag, so to speak, the objectives of universal healthcare?

As other countries adopt NICE-like thinking, how will they come to understand the role of the state?

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More on Courts and Health Reform

European Court of Justice
Health Reformers?

The Canadian Supreme Court ruling on private health insurance has alerted us that individual rights do matter and now they matter in health care, more than people had thought. Perhaps the greater impact of this ruling may be the emergence of legal or rights-based challenges to health policy, something the European Court of Justice has shown global leadership on.

Traditionally, health care decisions revolve around money, how much who gets and how; Canadian health politics is littered with the wrangles between the federal government and the provinces, and where has it got us?  Years of polemic perhaps about fiscal priorities, but perhaps little mileage on how to ensure Canadians get the health service they are paying for.  Other countries have been rudely awakened from this complacent slumber and found themselves faced with a steep challenge; in the UK, government spending on their National Health Service is being virtually doubled, to bring average UK spending in line with average spending in the other European countries.  Indeed, it used to be a hallmark of the venerable NHS that is was parsimonious in delivering health care, but the social costs in waiting times and waiting lists became politically unacceptable when compared with the rest of Europe.  Canadians of course compare Medicare to that the US system, and thank heaven that we don’t do that here!  But reality is of course much different, and we are learning daily now that there are things our mother never told us about Canadian Medicare, and finally perhaps the public is asking, “so, remind me again, what is we have been paying for all along?”

How do we know if we are getting a decent health system for our money?  The answer is not easy, but there are some clues.  Unfortunately, waiting lists and waiting times are indicators of resource shortages, not necessarily whether the health system is working well.  It’s a bit like heading into Home Depot to buy some paint, they may have lots of paint, great variety in the catalogues, but you need to line up to discuss the colour with one person, line up to get the cans from someone else, and third person to mix them for you, and you still haven’t paid for the paint!  Canadian health care is fascinated with hospitals, the most expensive, inefficient and labour intensive institutions known to modern society.  Not noted for being particularly safe, people get sick there while they’re recuperating from being sick.

One way to make sense of how well as health system works is to look at how well it treats new entrants, i.e. babies.  Infant mortality is a measure of the deaths of newborns, up to 1 year of age, and measured as a death rate per 1000 live births, so a number of 5 means 5 infants died in year for every 1000 babies born alive (i.e. not still births). High death rates pick up on problems associated with access to health care facilities, medicines, as well as maternal knowledge of child-rearing, diet and hygiene.  Low rates suggest the opposite.

In 1996, Newfoundland had a rate of 6.6, compared to the Canadian average of 5.8.  Nova Scotia had a rate of 4.9, while Nunavik Region in Quebec had a rate of 22.9.  In Ontario, Quinte area, rated by some as one of the best places in Ontario to live, had a rate of 6.8, Northwestern Ontario at 8.6 with the lowest being Halton/Brant at 3.9.  As we head west, Manitoba sits at 7.3, Saskatchewan, the birth place of socialized medicine at 8.7, Alberta, the new driver of health system reform at 6.1 and BC at 5.3.  Nunavuk is 17.9 and the Yukon 8.7.  Quite a spread.  To put it into a different perspective, the infant mortality rate in 2003 in Austria is 4, Finland 3, Romania and Argentina 17 and Colombia at 21.

So, once we survive that first year, how long will we live?  In Canada it is about 78.3 years of disability free life (1996 data).  But the best place to live if you’re a woman is BC with 81.8 years, and the worst place is Nunavut for men at 69.8.  Does the health system have any impact on how long we live?  Probably not, as most people’s encounters with the health system are around accidents and child birth, and the regrettable tenure we endure in our final days when the system’s heroic efforts to keep us alive gradually fail.  Most health system expenditure is incurred within the last 6 months of life, we just know when those last 6 months are.

Does money matter?  Well, you’d think it did, but there isn’t really any accepted correlation with how much a country spends on health care and the results it gets for its spending.  Canada spends a lot of money percapita (per person).  Newfoundland is the biggest spender, at $2151 per person along with BC at $2157, and PEI the smallest at $1718 and Quebec at $1760.  This money is being used to buy the same sorts of things in all these provinces, with varying degrees of success in meeting public expectations and service standards.  But it is how we organize those resources, well or badly, that determines whether we get good value for our spending.  The case may be building that the problems with Medicare are problems with design, the choices we’re made on how to organize it.  The main problem in my view being this fascination with hospitals and the bottlenecks created through them in accessing diagnostic tests for example.  Most countries trying to reform their health system, believing it will improve the statistics mentioned above, are trying to reduce expenditure and use of hospitals, and move resources into the community where the focus is on greater real-time engagement with people to help them maintain their health, rather than respond with a ‘sickness service’.

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Health Reform and the Courts

Quebec City
Quebec City, Quebec: is this where a revolution in Canadian healthcare began?

The ‘perfect storm’ as the Canadian Medical Association (CMA) so wisely observed, gathers strength, most recently with the endorsement of private health insurance. Health system leadership and politicians have let the system fail on their watch; we face disrepair, and the risk of catastrophic failure.Canada’s relatively unique position, with a front window view of the US health system, has dulled our creative thinking and we have fallen into a false complacency, deaf to the cacophony of reform happening in other parts of the world.  Perhaps, they were paralyzed by the fear of creating a US-style health system.  But times change.

There are two lessons from the Supreme Court’s ruling on Chaoulli v Quebec.  The first is the failure of expert testimony to the Court to provide any evidence from any other health system in the world (!) that private health insurance should be avoided at all costs.  World renowned expertise failed to provide the evidence that health systems with private health insurance were to be avoided: just tell that to the Dutch, the French, the Germans, just about anyone else for that matter.  But perhaps not the Norwegians, who have a 100% publicly funded health system, and the longest waiting lists in Europe, so long in fact that they have a so-called ‘patient bridge’ programme to fly patients to Germany for treatment.

The second is that government policy can be tested against the Charter.  To paraphrase Richard Titmus, the sociologist and political theorist, a health system is a poor one when it fails to meet the needs of all.  The collectivist rhetoric that has characterized much health debate in Canada, and is a broad theme running through the Romanov work for example, conceals an important shift in contemporary values which has not been fully grasped in Canada.  Perhaps until now, that is.

Other countries have had to come to grips with changing public thinking and are making the movement, albeit slowly, and not always happily, to a new interpretation of the social contract: namely, that governments have no pre-emptive right to deprive individuals of their constitutional rights just to achieve collective social objectives, such as Medicare, and, perhaps more subtly, governments have no right to create monopoly suppliers of public services that manifestly fail to meet the needs of the public.  So services that are underfunded, underbuilt, but publicly funded or delivered are no longer defensible simply because they are public!  Therefore, governments have a new problem, concealed within this Supreme Court decision, that of learning how to provide services that the public will value and use.  It is no longer sufficient to argue that the proper role of the state is to provide public services, if they cannot do it well.

I’d like to think that this new world would be liberating for governments, but perhaps they like to meddle and tinker rather than provide strong leadership and direction, and importantly social purpose to public service institutions, like health care for example.  As was said it seems so long ago, by Osborne and Gaebler in their book Reinventing Government, governments should steer and not row. Put more elegantly by Mario Cuomo, former governor of New York: “it is not government’s obligation to provide services, but to see that they’re provided”.

The debate over private health insurance must not conceal the real problem, that the public purse is financing at federal and provincial levels, health systems in the various provinces that are manifestly failing to deliver value for money, or indeed a service Canadians will value and use.

Where can we look for some ideas?  Often a source of inspiration in welfare state reform, the United Kingdom has embarked on changes that will virtually reinvent the public service ethos there.  Under the banner of ‘consumer choice’, they are reinventing their National Health Service by giving consumers choices in how, when and from whom they receive public services, largely putting to rest the many tired arguments about whether patients cannot exercise informed choice in health care.  One consequence of this is greater private and voluntary sector involvement in service provision. In health care, the shift is virtually seismic, with the dismantling of the NHS as a ‘provider driven service’, characterized by services dictated by what the hospitals and other care providers can or want to do when and how they want to do.  The new ‘patient-led” NHS is focused on buying (what the British call ‘commissioning’) those services, responsible for doing what Cuomo says: ensuring that the health services that are provided are timely, convenient, and to high standards.  We in Canada have a lot to learn from this, as we try to avoid consumer demand, or protect acute care hospitals from the primary care revolution.

Governments can only tax with the will of the people, and when taxes produce substandard levels of service, inconvenience and delay, the public is right to call the government of the day to account.  Increases in taxes cannot be justified unless there is demonstrable improvement in service, and increased value for money. The UK is exploring this new territory, and rethinking in particular how its health service will work.  Funnily enough, much of the impetus for this also came from rulings of the European Court of Justice.  What they have learned, though, is that the government has no moral right to be a monopoly supplier of public services.  Choice is the hallmark of public sector reform there, and offers Canada lessons for its own restructuring.

Will an emphasis on private health insurance be the solution?  To adopt the position that private health insurance is the solution to a failing public system is to abandon the principles that are the logic of an effective system of health care. But countries which have wide-spread use of private insurance, such as Netherlands, Germany or France, also have integrated principles of private insurance into their national health system.  Interestingly enough, these countries also show the value in putting money into the hands of patients and consumers to reinforce the value of their health care decision-making  The private insurance market in the UK is an opt-out from the national system, not a complement to it, and as the reform of the NHS has quickened, the private health market has shrunk.  Other countries have had more success with mixed insurance models and do not appear to have fallen apart or suffered from widespread social inequality, indeed, the WHO rankings would suggest the opposite, with Canada ranked well down after France, Spain, and Italy.

The best direction for new thinking, therefore, is to look for reforming ideas which endorse greater consumer choice, greater consumer purchasing power whether through private insurance or through commissioning reform.  But purchasing choices require greater flexibility in how health services are delivered and this debate is, as Senator Rigby as observed, full of mythology.In the end we need a fully integrated public/private health system.

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