Meaningful Use and Justice

As part of the 2009 economic stimulus bill, Congress passed the Health Information Technology for Economic and Clinical Health (HITECH) Act. Among other things, this act sought to increase the adoption of Electronic Health Records (EHRs) by providing financial incentives to adopters of certified EHRs who met certain benchmarks by a certain timeline. These benchmarks are known as “Meaningful Use.” To receive the financial incentives — up to $63,750 over six years beginning in 2011 — “providers” must attest to compliance with Meaningful Use. That this is a much larger task than originally assumed was demonstrated by the decision last month of the Center for Medicare & Medicaid Services to push back the timeline for reaching compliance with Stage 2 of Meaningful Use, acknowledging problems with the implementation of the required technology.

Last week a report on the progress of Meaningful Use showed that practices which serve primarily minority populations, and practices in areas with the highest levels of poverty, were least likely to have attested to Meaningful Use — and thus least likely to receive any financial incentives.

The cost for startup of an EHR is substantial– estimated to be at least $40,000 to $100,000 per provider. The cost for training, upkeep, upgrades, etc., are never-ending. The time involved in learning and maintaining such systems is also significant.

Areas with higher minority populations and higher rates of poverty are some of the most medically underserved areas as well. There is less money flowing than in more affluent areas, and there is less flexible time in the schedule, as there are fewer physicians seeing greater numbers of patients.

Therefore it appears that one of the unintended consequences of the Meaningful Use program is that those practices that have the least resources to spend on an EHR are the least likely to receive any financial stimulus, while those practices that have the resources to pour into purchasing and upgrading EHRs and training people to use them are more likely to receive financial aid. Those that need it the most don’t get it.

The Federal Government is pushing hard for EHRs (next year, Medicare will start penalizing physicians who don’t use them). It has set up a benchmark program that financially rewards those who are most financially well off, thus increasing existing disparities. It should restructure this program in such a way that it at least does not tend to increase disparities.

 

Toward Reasserting the Ends of Medicine: A tentative beginning, with some historical considerations

Recent posts (Here and here) on this blog referred to the “ends” of medicine, and last week Dr. Holmlund challenged us to explore more systematically just what those ends are. As I have considered that challenge, I have been stymied by the herculean magnitude and complexity of the task, especially given my limited knowledge of, and reading in, the relevant philosophical, theological, sociological, and historical disciplines. However, having been a practicing physician for about twenty years, I will tentatively start on the project, based more on my experience than on any great learning or reading; I hope that those who have the advantage of the learning and reading will make up for and (gently) correct my deficiencies.

One of the hurdles to overcome in defining the ends of medicine is that there are many views held by different groups of people, and they have changed over time. So the question becomes more focussed: What are the proper or correct ends of medicine? Is this something we can discover, or must we merely define it? If so, on what basis? Also, what do we mean by medicine? Are we talking just about the actions of physicians? Or does it include the actions of, say, hospital boards? Biomedical researchers? Public health departments? Medicare utilization reviewers?

My impression of the history of this subject is that the ends of medicine were originally narrowly defined in regard to physicians, and their goal was to help the sick. The Oath of Hippocrates, from around the 5th century BC, speaks of dealing with “the sick” and “sufferers.” There seems to be no reference to preventive medicine or promoting health. This view of medicine’s ends was taken up by the Christian medical tradition: “Care of the sick, grounded in the compassionate sharing of the sufferer’s pain and seeking ways of alleviating and perhaps curing it, is a witness to God’s work of redemption in Jesus Christ.”*

As modern science developed, its founding fathers such as Francis Bacon and René Descartes thought that by gaining power over nature, people could go beyond treating disease to preventing disease and preserving health. Measures to prevent disease were of course known from antiquity, as the health regulations in the Pentateuch demonstrate; and magic charms to ward off disease have probably always been widespread. But somewhere along the way, this idea of not just treating disease but preventing it, and in so doing promoting health, was taken from the priest’s job description and inserted into the physician’s. Thus, the physician’s ends expand to become, “Caring for the sick, preventing disease, and promoting health.” A Tall Order indeed. And one that adds umpteen layers of ethical considerations, such as, What does it mean to “Do no harm”? What is “health”? And many others that I can’t begin to mention in a 500-word post. But in future posts I will attempt to chart a course through this maze , and with Jon Holmlund I invite fellow bloggers and commenters to help us along the way.

 

*Robert Song, Human Genetics, 13.

On rationing health care

The dollars, whether public or private, that can be spent on health care  are finite.

The demand for health care, however, especially given multiplying technologies and escalating costs, is seemingly infinite. There is no way that any insurance company, country, or system can provide for all of its patients all that medicine has to offer. Thus, by definition, some type of rationing of health care must occur. (There, I said it; burn me at the stake as a heretic.)

Thus, by definition, some type of rationing of health care is occurring. Right now. Right here in our country.

The specter of rationed care has stopped many reform schemes in their tracks. Some even defend our current system against would-be reformers by pointing out that, “At least we do not ration care.” However, rationing does not have to be planned and rational to be rationing. (Irrational rationing? How’s that for an oxymoron?) As one Brit who lives under a system of rationed care asks, “How can a system which excludes [millions of] Americans from any guaranteed health provisions, be described as anything but a rationed system?” Our current model rations care using the blunt instrument of who can afford to see the doctor. In other words, in a typical system of rationing, all people are included but certain services are excluded. In our case, all services are included but certain people are excluded.

Most agree that this state of affairs is not a good thing and have proposed various ways to address it. Unfortunately, it has become a political power issue. Too often in the acrimonious debates of the last several years, lawmakers from both parties seem more intent on seeking what’s best for their party rather than what’s best for the people of the nation. And since nobody wins votes by promising to ration care, both sides deny that their reform plans ration care, and come up with schemes that studiously avoid even the appearance of rationing.

One scheme of reform, “Obamacare,” seems to have become the law of the land. Whatever strengths and weaknesses it has, it still avoids confronting this necessity of rationing care. Obamacare  will certainly go through many revisions as it is implemented; some hope that it will be repealed. Whichever happens, whichever reform plan is ultimately realized, it will be a much better plan if it explicitly addresses the exigency of rationing. That way, rationing can be dealt with in a rational way, rather than as the elephant in the room that we all try to pretend isn’t there, but that will squash us if we continue to ignore it.

 

(The Brit quote is by Stuart Horner, from his chapter in The Changing Face of Health Care entitled “Conclusion: Change Health Care–A British Point of View,” p. 280)

Professionalism vs. commercialism in medicine (or, Yet another Black Friday special!!!)

Some thoughts on medicine and commercialism on this, the high holy day of the gods of commercialism:

The understanding of medicine as the satisfaction of consumer wants is corrosive to the practice of medicine as a profession.

“The practice of medicine is not a business and can never be one . . . Our fellow creatures cannot be dealt with as a man deals in corn and coal; the human heart by which we live must control our professional relations.” (Sir William Osler, 1903)

A profession involves the freedom if its practitioners from the simple market reduction of the work to that of the tradesman. It is fundamentally an ethical and moral endeavor. It entails independence of judgment, a degree of self-regulation, a covenantal commitment to patients, the bearing of a characteristic set of responsibilities, and adherence to a distinctive ethical code.

*  *  *

From a hypothetical ad in today’s paper:

“Yes, you heard right, it’s our Black Friday special!! Have we in medical practice got a deal for you! Come over to St. Exorbitant’s where today, we’re offering one MRI for the price of two! (Actually, we’ll charge as high a rate as we can and take whatever your insurance company will allow!) Plus, we’ve got all the most-requested procedures of dubious benefit and unnecessary tests for your enjoyment!! (Unnecessary for your care, that is, but they might help finance that new atrium we’re building on to the hospital, which has really helped us attract patients away from our competition!)

“And if you don’t like our Hippocratic™ – brand selection, come on over to our other showroom, where you can peruse some of our less-traditional items! So, you’re not interested in our time-honored offerings of compassion, presence, and comfort? Well, we have a special discount today on Physican-Assisted Suicide (at such a bargain, too — at least, for our medical system which can finally stop paying for all those pharmaceuticals you’re taking!)! Looking for the perfect child? Sorry, we don’t have that yet, but we can test the one you’re carrying to see if she meets your specifications and tolerances! Now how much would you pay? But wait, there’s more! Our technicians can abort, ah, that is, terminate the child you’re carrying if we find something wrong, or for any other reason, or for no reason at all! We’re eager to serve — YOU! Here, the patient is King and Queen! We will do anything — anything — within our power (and your ability to pay) that you want, and if it isn’t within our power yet, don’t worry, we’re experimenting on your embryos to find ways to serve you better!  (We accept many insurances, cash, and all major credit cards!)”

 

Oh, wait — you say you can’t pay? No insurance? Well, well, funny how those market forces work, isn’t it? I’m sorry, we won’t be able to help you today. Why don’t you try the internet? I hear there’s very good care to be had there!

 

Rationing end-of-life care

The NPR program Intelligence Squared recently held a debate on the proposition to “ration end-of-life care.” Arthur Kellermann and Peter Singer argued for the proposition and
Ken Connor and Sally Pipes argued against the proposition. What became clear very early in the debate was that “should we ration end-of-life care?” was not the right question. All the debaters agreed that in one way or another all health care including end-of-life care is rationed. In the present system on the US care is rationed by some not being uninsured and not able to afford care. There is rationing done by HMOs and other insurance companies as well as governmental agencies. It is sometimes rationed by hospital and ICU beds being full and those already being treated taking precedence over those coming in needing care.

Since a certain degree of rationing of care is inevitable the participants in the debate were actually addressing something different than the original question. What was interesting was that the questions they were addressing were not the same. Those who took the position that we should ration end-of-life care were addressing the question “should a person at the end of life be entitled to any medical treatment that the person requests no matter how very expensive or how little expected benefit there is from the treatment?” They said the answer was no. That seems relatively obvious. There are some treatments that are very expensive and which are likely to be of only marginal benefit which the patient is unable to pay and it does not seem reasonable for society to be required to provide them. If that is what is meant by rationing end-of life care, then the answer is that it should be rationed.

Those who took the position that end-of –life care should not be rationed were actually addressing the question “should the federal government ration end-of-life care in the way that it is anticipated might be done under the provisions of President Obama’s Affordable Care Act?” Their answer to that was no with reasons ranging from an emphasis on the importance of individual decision making about medical treatment, to the wrongness of being denied reasonably effective care by the government due to age or incapacity, and faith in a free market to be able to manage health care costs better than centralized government. They were clearly talking about different things.

It seems clear to me that rationing of end-of-life care and other health care is happening now and is inevitable. We cannot as a society afford to do everything that is possible. The question is “who should make the decisions and how?” Much of high cost ineffective care can be avoided if patients, their families and physicians are well informed and directly address the issues of effectiveness and cost as well as limitations on the extent of desired treatment before situations get out of hand. We need to address our culture’s values and encourage people to think about and discuss end-of-life care before it happens. Physicians play a significant role in this, but the church can play an import role as well by encouraging a Christian understanding of dying well and preparation for death rather than denial of it. When that is not effective we need societal policy that there are some very expensive and ineffective treatments that we as a society will not pay for.

Reflections on the Olympic opening ceremonies

Of all the quirky elements that went into the opening ceremony of the London Olympics (think Shakespeare, James Bond, Voldemort, and — Mr. Bean?), the quirkiest to me was the tribute to the National Health Service (NHS). Wondering whether the acclamation was the idiosyncratic view of the ceremony’s director or reflected the attitude of the British public, I went online to do a (thoroughly unsystematic) search regarding Brits’ perspectives the NHS. I found a wide range of opinions, from complaints and disgust (Google “I hate the NHS” for a sample), to praise, to prophecies of doom. But overall, even when the British have bad things to say about the NHS, most express some degree of pride in it: and the thing that they are most proud of is that their health system provides access to everybody in the country, for no cost at the point of care.

In my (totally unscientific) research, I came across many websites debating the relative merits of the NHS and US healthcare. Those who favor US healthcare, while acknowledging that it has its problems, also express pride in it: and the thing that they are most often proud of is its unparalleled technology, its shorter wait times for many tests and procedures, and its vigorous R&D.

Now I am not here arguing for an NHS-like system in the US. But change of one kind or another is coming to how we fund and deliver health care. Wouldn’t it be grand — wouldn’t it be right — if we end up with a system in which we can be proud of the fact that we provide access to health care even for “the least of these,” and not just our technological prowess?

Human Dignity on the Cancer Cost Curve

I apologize for the grandiose title…
If medical care simply must cost less than it does now, and if one is concerned that the goals and values of sick patients will be steamrollered by opinions of small groups of experts, where might things be headed? One view that the experts—i.e., doctors—may do some things to keep outstanding care affordable and in the best interest of the patient was proffered in May 2011 by Drs. Thomas Smith and Bruce Hillner, in their article, “Bending the Cost Curve in Cancer Care,” in the New England Journal of Medicine.
Drs. Smith and Hillner proposed that oncologists change their attitudes and practices in 10 ways. I condense and summarize them here; while all seem eminently reasonable to me on their face, some may raise tensions for human dignity, if that is understood from the perspective of patient choice. The condensed list:
1) Test cancer patients who are in remission less frequently for recurrence.
2) For most advanced cancers, use less chemotherapy—fewer cocktails of several drugs, at lower doses (rather than toxic doses with expensive other drugs to mitigate the toxic effects), stop giving chemotherapy after 3 rounds of failure, and don’t give chemotherapy to bedridden patients.
3) Integrate supportive care, of the sort usually identified with hospice in the last days of life, earlier on, with active treatment.
4) Pay doctors more for end-of-life conversations and other treatment planning, and reduce their financial incentives to overtreat. (Many cancer doctors make half of their incomes giving chemotherapy.)
5) Accept that cost-effective analysis and limits on availability/allocation of some treatments are here to stay.
6) Both doctors and patients should adopt more realistic expectations (we tend to be over-optimistic about how well active treatments will work).
7) Patients with [advanced] cancer should have end-of-life discussions with their doctors fairly early on in treatment.
Of this list, the first three are supported by a growing corpus of medical evidence. The next two are policy matters that raise ethical issues (doctors’ values, rationing). I think all 5 are coming, regardless of whether our government’s policies are more “Democrat” or “Republican” going forward. Policy questions in particular demand the broadest public discussion, as Dr. Dan Sulmasy and others have argued elsewhere.
The last two are the most poignant, because they sound sort of defeatist but they go to how we think about, and how much we cling to, our earthly lives. They demand intimate conversations in relationships characterized by trust and the covenantal role of the physician. Our medicines can often do much, but they can’t do everything. Of course, the Christian’s eternal hope provides critical context for these concerns.
Any affront to the dignity of “do everything” autonomy can be more than offset by the dignity of physicians wisely providing the best care they can to their patients, and guiding their patients through the necessary decisions. But those decisions must remain as individualized as possible. A list of broad principles does not distill into an easy formula or blanket rule. And setting appropriate expectations need not collapse into “rationing at the bedside.” Still, it may be critical to remember—to turn around Dr. Robert Orr’s statement—that “we never withhold care, but we may withhold treatment.”

Can the Church have a distinctive take on health care insurance reform?

The Supreme Court has finished hearing the case for and against various provisions of the Obama health care plan. All that remains now is to wait for the decision, which will be handed down sometime in June.

There is much to be opposed to in any scheme of health care insurance reform. If we are waiting for a perfect plan before we will declare our support, then we will never support any reform plan. However, I believe the problem of how to justly provide health care to all is an opportunity for the Church to counter the perception of alignment with partisan political agendas and show instead its alignment with an agenda that transcends political or personal preferences.

The doctrine of God’s love, of the self-giving agape which God demonstrates toward us and enables us to show to others, should surely influence our attitude towards health care reform. One expression in Scripture of what our attitude should be is found in Philippians, where Paul writes, “Each of you should look not only to your own interests, but also to the interests of others. Your attitude should be the same as that of Christ Jesus . . .” (Philippians 2:4-5) Much of our resistance to reform comes from considering only our own interests, to the neglect of the interests of others: placing our own desire for limitless choice over the interests of those who have virtually no choices; putting our desire to keep more of our income out of the hands of the tax collector over the interests of those with much more meager incomes who would benefit from the care increased taxes might provide; placing our general principled distrust of government higher in importance than the real good limited government intervention might be able to accomplish in this particular situation. As Christians, we can be concerned not first of all with our own rights and interests, but with those of others, and can willingly insist not on a right to maximum health care but only to a level that is socially equitable and affordable.

As Christians, we have a unique opportunity at this time in history to be a singular witness to Christ by approaching health care and its reform from a theological standpoint rather than the standpoint of a political party agenda or our own rights and interests. By overcoming the tendencies that naturally make us resistant to health care reform, we will show that we are conformed to something other than our culture or our own private interests. By making clear that the followers of Christ are advocates for those unable to afford care, even when it may be disadvantageous to ourselves, we will take our place among the ranks of our Christian forebears who, as they started the first hospitals and hospices in Europe, were at the forefront of health care reform in their day.

Expertocracy, Paternalism, and “socializing” health care costs

If you haven’t already surmised, I confess it—the Wall Street Journal is my newspaper of record. (Apologies to the half of the country that prefers the New York Times.) Last Saturday’s WSJ review section carried a piece by Drs. Pamela Hartzband and Jerome Groopman of Harvard, decrying the “Rise of the Medical Expertocracy.” These two—particularly Dr. Groopman—have been writing thoughtfully about medicine for a while.
Their point: policy makers and citizens, regardless of whether they say they favor government or private-sector approaches, agree that all our health questions can and should be answered by the right panel of experts. It’s just a matter of whose experts we choose. Democrats have the Independent Payment Advisory Board, Republicans have insurance companies and their experts. Either way, the experts will “Figure out what works, and what doesn’t…pay for value and empower consumers…[and] no one will come between us and our doctors.”
Touche.́ I certainly have argued for so-called “best practices” in this blog. But these two doctors point out that expert opinions often conflict, outcomes cannot be guaranteed, rational patients do not make decisions primarily based on data, and “much of medicine still exists in a gray zone where there is not one right answer.” Moreover, “beyond safety protocols, there is scant evidence that [‘best practices’] improve our health.” What we are left with, they argue, is an objectionable new form of paternalism, when we should be emphasizing clinical decisions that are “based on a patient’s goals and values.”
These points are all well-taken and mostly correct. Where I would push back:
1) It seems to me that there IS a place for some clinical trial-driven “best practice” research, particularly regarding high-cost technologies of unproven or dubious value, where physicians have an (inappropriate) incentive to use them, either because entrepreneurship gets in the way or reimbursement rules are misplaced (see also the posts by Joe Gibes on Feb 17 and Steve Phillips on Feb 22);
2) It also seems to me that there is broad agreement that we should “socialize,” or share, at least the most egregious medical costs across large groups of people—whether through “public” or “private” options. We Americans are haggling over the most prudent and just way to do that. But what if the patient’s goals and values differ from others sharing the costs, not just regarding matters that most readers of this blog would consider moral concerns (e.g., paying for abortions), but also regarding questionable treatments? For example, I’m not so sure I’m willing to pay for someone else to receive Avastin for breast cancer, outside of a clinical trial. I don’t think it works. At some point, “We’re not paying for that” seems inevitable.
I suspect this new paternalism is here to stay. It may be soft, or not so soft. How much of it should we accept?

A bit more about drug shortages

Critical shortages of essential drugs continue to plague American medicine. My email inbox includes a daily update from the FDA with, among other things, the latest status reports on drugs in short supply. There were 24 on today’s list. The cancer drugs Doxil and methotrexate were not described; you may have seen that the FDA recently announced some stopgap measures to permit importation of substitutes for those drugs.
For people with cancer, that was a bit of welcome news, but sometimes a substitute won’t do. Pinch-hitting for Doxil, for example, is a drug called LipoDox, which is similar but not the same thing. The differences could be important for patient outcomes—especially for patients in clinical trials using Doxil. Those trials are on hold; the possibly different results with a substitute could make a whole trial uninterpretable.
Most of the drugs in short supply are, in fact, generic, and they generally are not pills but drugs that have to be provided and administered under sterile conditions, by vein. That makes them challenging to produce, and one hiccup in a pharmaceutical plant can ruin their whole day—or a few weeks or months while they shut down and fix things. That has happened to big producers like BenVenue and Teva.
The clearest ethical issue is the appearance of gray markets, consisting of some distributors who exploit shortages to charge larcenous prices. Investigations into these gray markets are ongoing. For example, an outfit called the Premier healthcare alliance has published reports in the last few months. (They don’t publish the names of the reportedly price-gouging vendors.) Drug manufacturers on one end, and hospitals on the other, are on the lookout for these gray market operators, and they say they are aggressively trying to avoid them. Price is not the only issue—drug counterfeits may be involved, as well.
Some weeks ago, a post on this blog raised the ethical issues of allocating scarce resources with regard to these drug shortages. That is, of course, salient, yet less interesting to me. Why? Because, as M.D. Anderson Cancer Center’s Dr. Hagop Kantarjian has put it, drug shortages are “a preventable human disaster.” We should be able to fix this problem.
How? Condemning the gray marketeers is generally agreed upon. But some would go further and say that enforcing price controls is the principal answer. In fact, relaxing those controls may be a better choice. Medicare and Medicaid pay “average wholesale price” plus 6% for these drugs, which are generally cheap. Professor Awi Federgruen of Columbia Business School recently argued in the Wall Street Journal that allowing producers to charge a bit more for these effective drugs would increase the incentive for more suppliers to make them and make the investments needed to be sure their plants avoid shutdowns.
Also, while there’s no lack of finger pointing toward manufacturers (who need to get their act together) or the FDA (for, supposedly, over-regulating), and while some regulatory adjustments may help, Prof. Federgruen has another suggestion: hire (or contract) more reviewers to reduce a 12-month backlog of applications for new generic drug manufacturing plants and processes. Does anyone else want to join me in saying “Duh?”
Maybe the best approach is less one of moral reflection or enforcement than practical problem-solving, in this case.