What is the ethical role for physicians in the "business" of health care?

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Health care is a complex business. “Business” in the sense of “a human endeavor”, but also as “an organization seeking to make a profit.” Over the last several decades we have seen increases in the portion of health care delivery services that are formally organized as “for profit”. Hospitals, especially, have undergone such changes, joining the ranks of long-term care facilities, pharmaceutical companies, device makers, home health agencies, and insurance companies that have always been primarily “for profit”. Indeed, most physician practices, whether solo, small-group, or large group, are for-profit, organized into “professional” or “limited liability” corporations.

“For profit”, however, means that these organizations pay taxes, but because an organization is “not-for-profit” does not mean it behaves significantly differently. Not-for-profits are granted this status because a significant part of their activity is providing a public good, and their income-over-expenses (profit, which we can call “margin” to be less confusing) is not owned by shareholders but is rather intended to be re-invested to further enhance that public good. But not-for-profit hospitals generally follow very similar business practices to for-profit. They have to “compete for market share”. While they may have a mission, they often cite the mantra “no margin, no mission” as they invest in high-margin product lines (heart disease, cancer, neurosurgery) to attract more paying customers. Rather than, say, spending that money providing their wonderful care for free or at great discounts to the poor and uninsured. Or expanding their provision of high-need but low-margin services (primary care, obstetrics, pediatrics, psychiatry). The salaries paid to management of not-for-profit hospitals and professional personnel are often as high as those paid by for-profits (who, after all, have to maximize profit to please their shareholders, so want to keep costs, largely salaries, down).

So what is reasonable profit in health care, for companies that are for-profit? Should there be any? Does competition with for-profits distort the behavior of non-profits or would they act in the same ways if they had to compete only with other non-profits? Is competition good or bad? And what about doctors? Do they behave differently in their practice if they are salaried or have an incentive to make profit? Is this a good thing or a bad thing? So many questions!

In their commentary “Physician stewardship of health care in an era of finite resources” (JAMA 27Jul2011; 306(4):430-1), David B. Reuben and Christine K. Cassel address some of these issues. They start by noting that “Although there are varying opinions about the quality of health care in the United States, there is consensus that it costs too much.” I would guess that this is probably true, but may be as far as it goes. I suspect that each individual player or industry dependent upon health care dollars is unlikely to think it is their part that costs too much. It’s those other guys!

Reuben and Cassel focus on physicians. Not on how much physicians earn (salary or profit), but how they choose to spend health care dollars, because “Health care costs are directly related to decisions made in clinical practice”.  They go on to say that “These decisions are difficult to influence because they are made in the context of individuals who are often sick and vulnerable, with little understanding of the potential benefits and risks of diagnostic and therapeutic options. Patients seek help from physicians and physicians chose careers to provide this help, or at least the hope of it. Because of this relationship, it is futile to expect that changing physicians' behavior through evidence and shared decision making alone will solve the problem of high health care costs. Alternative approaches will be necessary.”

Cassel, the President and CEO of the American Board of Internal Medicine (ABIM, the organization that certifies internists; not to be confused with the American College of Physicians, ACP, the internal medicine professional organization), is both a geriatrician and a medical ethicist. I have heard her discuss physician stewardship in individual cases, arguing that the use of resources ordered by an individual physician for an individual patient should not be based on issues other than the benefit and risk for that patient, since the physician and patient have no control over what money “saved” might be used for. (My patient and I cannot decide to not do expensive interventions and instead use the money for housing the homeless or feeding the hungry – unless s/he is that rare person paying all the costs out of pocket --  all we can decide is whether to do those interventions or not.) Savings have to be looked at on a more global level, with a shared understanding of what those “saved” dollars will be used for.

The contribution that Reuben and Cassel make in this piece is to provide something of a taxonomy of physician stewardship, examining the various levels at which it can occur beyond that of individual patient decisions. These include the “highest” level, of national and state policy where spending decisions (initially, one presumes, via Medicare and Medicaid) should be based on evidence of benefit and consistency with national policy objectives (such as, I imagine, Healthy People 2020). The second level is that of payers (insurers) who would choose to pay for interventions that are shown to be beneficial (and presumably cost effective) rather than those that are ineffective or marginal. They suggest that rather than charging high deductibles and co-pays for services that are known to be beneficial and cost-effective, they simply do not pay for those that are not. This makes sense; why should insurers pay even a significant portion of procedures that are of little or no benefit while excluding such things as hearing aids that are of great benefit and (relatively) inexpensive?

The third level that they address is the practice level, where groups of physicians can use evidence to guide their group decision making and decrease inappropriate variation in physician practice. An example of this would be the use of a limited drug formulary emphasizing generic medications (this could also occur at the insurer level). Finally, there is the individual patient level; while making cost-effective decisions at this level can be more complex, it can certainly be done. While it is certainly unfair to ask a sick person to decide upon the choice of having, or not having, a medical intervention that they can scarcely understand so that saved dollars may possibly benefit some unnamed person more, it is quite a different thing to educate people about the impact of their health decisions, especially before they become critically ill. Advance directives, such as living wills, are one method, but there are many others.

What is clearly unethical and unacceptable is for physicians to encourage patients, sick or well, to undergo a diagnostic or therapeutic intervention because the physician stands to gain financially from doing it. Unfortunately, this happens. Sometimes it is done consciously, but often it is because the physician who does the procedure (and will happen, coincidentally, to benefit financially from doing it) truly believes it is of benefit. To not believe it would, in fact, be cognitive dissonance. Although there are increasing numbers of procedures being called into question for everyone, there are far more that are of benefit to some people but not to others. It is the ability of physicians to distinguish between these people and present recommendations honestly and free of financial bias that will make the biggest difference. The fact that there are still many physician-owned for-profit hospital and “surgi-centers” in which the doctors benefit financially not only as the providers but as owners of the facility from more procedures being done argues that we have a long way to go. (See also my commentary in an earlier post,  Greed, corruption and medical procedures: ignoring or suppressing the evidence?, August 12, 2011.)

The greed of human beings is not going to be wished away, whether they are physicians or lay corporate executives; whether of for-profit or not-for-profit companies. The taxonomy of Reuben and Cassel is useful for thinking about these issues, but it is only comprehensive – and thoughtful and balanced – regulation that can be sufficient impetus to make these changes happen.

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Greed, corruption and medical procedures: ignoring or suppressing the evidence?

One of the challenges for physicians who seek to advocate for patients by championing cost-effective, evidence-based medicine is opposition from the medical community itself. Physicians and other health care providers, as individuals, may practice evidence-free medicine, continuing to do things that have been shown not to work, to cost more than treatments that are equally effective, and sometimes to do harm. Sometimes this comes from ignorance of the evidence, because it may seem to be too hard to keep up. Sometimes it is because practitioners have “always” done it this way”, taught years or decades ago by their teachers. Or they may think that “their” patients are different from the ones who were studied; that “their” practice has shown them what works; that there is an “art” of medicine separate from the science. Maybe they are sometimes right, but usually they are wrong.

Yes, many important studies from which evidence-based guidelines are derived do not include all types of patients. For years poor and minority people were the main substrate for research (see “Tuskeegee”). More recently, perhaps in overcompensation, poor and minority people have been left out of research trials, which funders interested in health disparities (including the National Institutes of Health, NIH) are trying to change. But the fact that the patients you take care of were not included in these studies is not sufficient evidence for the results not applying to them. And, importantly, providers caring for exactly the population of patients who were studied are no less likely to ignore the results.

It is good to learn from your teachers. Hey, I’m a teacher. But new evidence emerges, and your patients count on you to be aware of it, to use it, to be on top of the knowledge that they cannot be. Does it take time? Sure. But that is the job. And for doctors that is one of the reasons that they are well-paid. To keep up. But what about one’s own personal experience? Experience is a good guide, in the absence of other evidence, but rarely does one provider have sufficient experience to have stronger evidence than large clinical trials. Moreover, “anecdotal” experience (“I once had a patient who X treatment didn’t work for”, or more likely “I once had a patient where Y treatment worked great”) has its own pitfalls. Mainly, it is usually wrong, even in the context of that individual provider’s practice. We have a tendency to remember the unusual, and to remember that for use in our future practice rather than the usual. I remember, while working in an urgent care center before the advent of “rapid step tests”, I had to  review yesterday’s throat culture results. I would see a positive result and say “Ha! I knew that patient had strep!”, but not consider all the negative tests on patients for whom I may have thought the same thing.  This is why we do large clinical trials. The “art” of medicine is important, especially in areas where there is no, or insufficient, evidence, and in translating that evidence into what the patient should do. The art of medicine is not, however, in ignoring the evidence.

Much more serious, however, is when greed causes physicians refuse to abide by the evidence because it shows that something that they are doing, which makes them money, is not indicated. This too can be subconscious, because if you have been doing a procedure for a long time believing it works, it is hard to suddenly change your mind because of new evidence. It is easy for your subconscious to deny that this resistance has anything to do with your own economic benefit, and is rather the result of your knowing it works. But when large groups of physicians, professional societies, get involved, it is no longer subconscious. It is financial protectionism pure and simple.

A good example of this is the recent opposition to recommendations by the Institute of Medicine (IOM) suggesting how the Food and Drug Administration should make rules governing the use of medical devices. Some manufacturers and physician groups  began to criticize them before they were even published (“Study of medical device rules is attacked, unseen”, Barry Meier, NY Times, July 28, 2011). The failure of many medical devices currently on the market, including artificial joints and defibrillators, was the impetus for this report. The IOM, a group of independent physicians and scholars convened by the National Academy of Sciences, are tasked with making recommendations on a wide variety of medical issues. Many of their most well-known reports focus on quality and patient safety, such as “To Err is Human: building a safer health system”. As Meier reports, a business group representing many of the device manufacturers went for the old “the best defense is a good offense” strategy and attacked the rules before they were promulgated. It is self-serving, but not surprising: “With millions of dollars of product sales at stake, the experts said, it is not surprising that the device industry and others would want to avert what they see as potentially restrictive new rules. Still, the lobbying has taken on a tone akin to Washington infighting over an issue like bank regulation, rather than patient health, they said.” Guess what? With millions of dollars at stake, it is exactly like attacking new bank regulations rather than focusing on patient health!  (For those who are interested, the actual IOM recommendations on medical devices, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years  is available on line.)

Of greater concern than these actions by the Washington Legal Foundation (additional information available in Wikipedia), a “pro-business group”, representing the self-interest of manufacturers, is the involvement of physicians. WLF’s attorney, Richard Samp, “… said his organization took action after the issue was brought to its attention by a lawyer who works at a firm that represents device makers. Shortly after filing its petition, the legal foundation was contacted by an official of the American Academy of Orthopaedic Surgeons, which represents doctors who perform joint replacements, who congratulated it for ‘taking the bull by the horns,’ Mr. Samp said.”

This is not the first time that orthopedics organizations (which for some reason choose to use the British-style diphthong “orthopaedics” despite being Americans who do not make a practice of using other medical diphthongs such as haemorrhage, oesophagus, anaemia or oedema) have chosen to attack evidence-based rules by political means. When, back in 1995, the Agency for Healthcare Policy and Research (now the Agency for Health Quality and Research, AHRQ) issued evidence based guidelines that recommended that certain popular (and remunerative) surgeries for back pain were not very effective, the orthopedic groups were able to convince Rep. Henry Bonilla (San Antonio) to introduce legislation to de-fund the agency! (“Agency’s report provokes a revolt”, by Neil A. Lewis, NY Times September 14, 1995).That’s playing hardball! However, the procedure, vertebroplasty, was overused, usually didn’t work and often caused harm. Interestingly, mounting evidence of its inutility continues to this day, recently for vertebral fracture in the British Medical Journal[1] [2], the results of which summarized by the editors of Journal Watch General Medicine.[3]

I don’t want to pick especially upon orthopedists (or orthopaedists), although as high-income procedural specialists, they have been involved in more than their share of these issues. Many of the IOM’s recommendations involve procedures done by other specialists, including cardiologists. Indeed, we need to applaud the work of the academic cardiologists who have done the studies that show that many of these procedures that constitute a major source of income for their practicing colleagues (the pâté and vichyssoise if not the bread and butter) are not indicated.

The researchers doing this work are some of the true heroes of medicine. Those who hold on to evidence-free procedures because they make a lot of money from them need to be careful that they do not join the villains.

 

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[1] Staples MP et al. Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials: Meta-analysis. BMJ 2011 Jul 12; 343:d3952. Medline abstract (Free)

[2] Wilson DJ. Vertebroplasty for vertebral fracture: On the basis of current evidence, cannot be recommended as the first line treatment. BMJ 2011 Jul 12; 343:d3470

[3] “The results do not support routine use of vertebroplasty in patients with vertebral compression fractures, including those with recent-onset pain or severe pain at baseline. Strengths of this meta-analysis include its use of individual patient data and the blinding of patients to vertebroplasty or sham procedures. As noted by the authors, lack of blinding overestimates treatment benefit, which casts doubt on the results of a recent nonblinded randomized trial that suggested vertebroplasty is superior to conservative treatment (JW Gen Med Sep 2 2010).”

Insurance company greed: To know them is to not trust them

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Anthem Blue Cross, a subsidiary of WellPoint of Indianapolis, has taken a lot of criticism for its proposed rate increases on its 800,000 individual policies in California (“Anthem Blue Cross dramatically raising rates for Californians with individual health policies”, Duke Helfand in the Los Angeles Times February 4, 2010, http://www.latimes.com/business/la-fi-insure-anthem5-2010feb05,0,3002094.story), to the extent that a follow-up article by Helfand on February 12 (“Anthem's parent company defends health insurance rate hike”, http://www.latimes.com/business/la-fi-anthem12-2010feb12,0,3807841.story) calls them “beleaguered”. They deserve to be. Their action is not only outrageous, it points out the absolute absurdity of thinking that a solution to the nation’s health care access problems can involve for-profit insurance companies.

Anthem announced increases of up to 39% on individual policies, but the WellPoint announcement adds insult to injury when it says “…that less than a quarter of affected Anthem customers in California will see rate increases of 35% to 39%. The average will be about 25%, while some customers will see rates fall…” Whew! Only 25% on average! Only a quarter of those affected will see increases in the 35-39% range. I guess those folks – and the rest of us because, as I will keep saying, we are all in this together! – can now rest easy.

In addition to investigations by the California Insurance Commissioner and possibly the Attorney General of the state, this one outrageous act has been the target of increasing criticism from the administration and from Congress. Rep. Henry Waxman, Chair of the Energy and Commerce Committee, announced hearings into the rate increase (http://www.speaker.gov/blog/?p=2149), and HHS Secretary Kathleen Sebelius is quoted by Helfand as saying “It remains difficult to understand how a company that made $2.7 billion in the last quarter of 2009 alone can justify massive increases that will leave consumers with nothing but bad options.” Sebelius, who is absolutely correct, has a history with Anthem. In 2002, as Kansas’ Insurance Commissioner, she blocked sale of Blue Cross/Blue Shield of Kansas to Anthem because it was ”not in the interest of Kansans”, an extremely popular position with both the medical and hospital societies and with the public, and played a significant role in her election as Governor later that year.

It would be a mistake, however, to see the WellPoint/Anthem action as an isolated case of stupendous greed by one insurance company. It is an example of the widespread stupendous greed of all of the health insurance companies. The New York Times’ Katharine Q. Seeley (“Administration Rejects Health Insurer’s Defense of Huge Rate Increases”, http://www.nytimes.com/2010/02/12/health/policy/12insure.html) also quotes Sebelius, but also notes that the top 5 health insurance companies, WellPoint, Cigna, UnitedHealth Group Inc., Aetna Inc. and Humana Inc., “…had an average profit last year of 5.2 percent — for a combined total of $12.2 billion. This was an increase of $4.4 billion, or 56 percent, compared with 2008…” The data comes from Security and Exchange Commission filings, and is contained in a report by “Health Care for American Now” (http://www.healthcareforamericanow.org/). The report, at http://hcfan.3cdn.net/a9ce29d3038ef8a1e1_dhm6b9q0l.pdf, also notes that the “medical loss ratio” for these companies is incredibly low. As a reminder for regular people, the ones who pay the bills, the “medical loss ratio” is the percent of the premiums insurance companies collect that they actually have to spend on providing health care, that is, that they do not get to keep!

The medical loss ratios for these companies for 2009, notes Don McCanne in his wonderful “Quote of the Day” for February 12, were:

· WellPoint - 82.6%
· UnitedHealth - 82.3%
· Humana - 82.8%
· Cigna - 81.2%
· Aetna - 85.2%

Or, “…of the estimated $809 billion spent on private health insurance in 2009, the five biggest for-profit companies... captured $232 billion.”

In case you had any illusions that these insurance companies might have made a mistake, or be embarrassed, or in any way could be thought to be serving the public, the statements of WellPoint’s spokesman, Bart Sassi, should change your minds.
"We welcome the scrutiny and are confident that our rates reflect anticipated medical costs and are established consistent with actuarial principles and state law.". That means he thinks it is legal, not that folks can afford it. He adds that Anthem's insurance policies "remain very competitively priced when compared with the dozens of other plans competing in the California individual market." Competitive with the other huge rapacious insurance companies, that is. Oligopolies don’t compete.

Helfand (Feb 11) also reports that “Anthem is not the only health insurer imposing double-digit rate increases. Competitors such as Blue Shield of California and Aetna also have raised premiums significantly in recent years, insurance brokers said. But they said the impending Anthem increases are the largest they have seen.” But at least we know that they have a human side, and are empathic. "We care deeply about our California customers and community,"Sassi said, "Clearly, we understand that these increases create a challenge for many of our members." Not that they are going to do anything about it except raise rates. Words are cheap.

The real message here is that health care reform must happen, and that to include for-profit insurance companies as the centerpiece, or as any meaningful component, is absurd and will guarantee failure in both of its goals: meeting the health access needs of the American people and controlling costs so that medical care does not bankrupt us and prevent the society from implementing the other necessary programs essential to health. If not a government-run single payer plan (the best choice), any health reform plan that does involve insurance companies must require them to be non-profit, or at least closely regulated by the government regarding the services that they must provide and the prices that they can charge. One of these methods is used by every other developed country, all of which have better outcomes for lower cost than we do.

The physician and ethicist Howard Brody has written an important article, “Medicine’s ethical responsibility for health care reform – the top 5 list”, New England Journal of Medicine, Jan 10 2010;362(4):283-5 http://content.nejm.org.proxy.kumc.edu:2048/cgi/content/full/362/4/283, in which he calls on physicians to take a strong and concrete role in cost control by limiting the tests and procedures that they order to those which are evidence based. He suggests that each specialty, through its specialty societies, identify the “Top 5” procedures that are commonly done their field that are both costly and not evidence-based, and exert pressure on their members to refrain from doing them. Indeed, to keep. Brody’s ethical justification for calling on doctors to do this is that “Physicians have, in effect, sworn an oath to place the interests of the patient ahead of their own interests — including their financial interests.” He adds that, while insurance companies, along with pharmaceutical companies, have promised the President to cut their costs as a “contribution” to health reform, “None of the for-profit health care industries that have promised cost savings have taken such an oath.”

You can say that again. This latest round of premium increases to bolster their obscene profits also shows how false their promises were. From the Obama administration and its Congressional allies who have been trying to steer an impossible “middle course”, to the Republican who have united in obstructionism and whose only offering is more give-aways to the insurance industry, to the “teabagger” populists who fear big government but should fear the private insurers rapacity more, it should be clear: To know this is to not trust them.
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