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Originally published in Hospitals & Health Networks Daily on June 5, 2012
By Emily Friedman
Earlier this year, nine medical specialty societies issued a list of 45 tests and procedures that their members concluded are not indicated in all of the situations in which they are used. It was the latest salvo in a long battle over whether much of the care provided to patients is effective and advisable. But this is a complex picture, replete with issues of physician judgment, medical education, patient preference and the threat of malpractice litigation. Is there a way through these woods?
In 1967, John Wennberg, M.D., a newly minted physician with a deep interest in epidemiology and sociology, was named director of Vermont's Regional Medical Program and charged with determining the quality of care in the state. He received a federal grant and used what today would be considered archaic computers (which were all that were available) and innovative research techniques to learn about what care was being provided where.
"Our results were fascinating," Wennberg told Managed Healthcare Executive in 2003, "because they ran completely counter to what conventional wisdom said they would be. Everyone expected that we would clearly see underservice in the rural hospital service areas remote from academic medical centers. But when we looked at the data, we found tremendous variation in every aspect of health care delivery, even among communities served by academic medical centers.
"We found the same thing when we compared health care in the Boston and New Haven communities served by some of the finest academic medical centers in the world. The basic premise — that medicine was driven by science and by physicians capable of making clinical decisions based on well-established fact and theory — was simply incompatible with the data we saw."
Decades later, Wennberg's work culminated in, among other things, the Dartmouth Atlas. At the time, however, his research was either dismissed or was heavily criticized, often by providers who undoubtedly felt threatened. When he and his colleague Alan Gittelsohn sought to publish their findings in prestigious medical journals, they received, in his words, "form-letter rejections." Their groundbreaking paper was finally published in Science in 1973 (Wennberg and Gittelsohn. Small area variations in health care delivery. Science, vol. 82, Dec. 14, 1973, pp. 1102-1108).
To boil down a number of elegant studies, what Wennberg and his colleagues found over the years is that rates of common procedures vary geographically for reasons that do not appear to have much, if anything, to do with patient population characteristics, disease patterns or other objective factors. Sometimes the rates appear to be almost random in their variation. Some correlations have been found with provider supply and other measures, but no one satisfactory explanation has generally been accepted.
In 1986, Wennberg published another classic article whose title reflected a question we are still asking today: Which rate is right? (Wennberg. Which rate is right? New England Journal of Medicine, vol. 314, Jan. 30, 1986, pp. 310-311). He argued that there are diagnoses for which there is wide agreement as to the optimum treatment, and there are others for which opinion about the best treatment is all over the map. As he put it in the article, "When physicians agree on the value of an operation and make similar judgments about its appropriate use, the rate of surgeries between communities or regions tends to vary according to the incidence of the condition, at least among insured populations. There is little controversy concerning diagnosis, treatment, or the need for treatment for an inguinal hernia, and, not surprisingly, inguinal herniorrhaphy shows relatively little variation between hospital markets or between regions. The rates for most operations, however, are highly variable from one population to another, and the probability of having an operation is conditioned by the supply of surgeons and their opinions on the value of the operation." This was found to be true in many different parts of the United States.
Fast-forward 39 years since Wennberg and Gittelsohn's seminal article in Science. On April 5 of this year, nine medical specialty societies announced that their members had identified 45 treatments and tests that were often unnecessary. Each of the societies highlighted five procedures that its members thought were the most overused.
The effort was spearheaded by the American Board of Internal Medicine Foundation and Consumer Reports magazine, which is published by Consumers Union. (These outfits might be considered odd bedfellows, but not in this instance.) The goal is to educate clinicians and patients alike about the necessity and value of treatment, and to start conversations between them about what's best.
Christine Cassel, M.D., outgoing president and CEO of the ABIM Foundation, explains that the effort, in part, "grew out of a frustration I've had with all of the political talk about rationing and 'death panels' and even evidence-based medicine. Physicians and patients get sideways with the rhetoric. Patients think that something is going to be taken away from them that they need, and physicians think that someone is going to order them how to provide care. The foundation wanted to get away from that and move to stewardship of resources instead."
The result was an educational initiative, Choosing Wisely. It has a website, www.choosingwisely.org, which lists the participating organizations as well as consumer groups that are cooperating in the effort (they range from the American Association of Retired Persons to the Pacific Business Group on Health).The site also lists the 45 tests and therapies that have been identified as possibly overused. They include:
According to Cassel, 10 more medical societies have indicated their desire to join the campaign, and others are in the pipeline.
Meanwhile, Consumers Union highlighted its support of the effort in the June 2012 issue of Consumer Reports, with an article titled "When to Say 'Whoa!' to Your Doctor." It recommends caution in the use of at least five procedures:
Donald Berwick, M.D., former administrator of the Centers for Medicare & Medicaid Services and a lifelong campaigner for better quality of care, told The New York Times that the Choosing Wisely initiative is a game-changer that "could be a turning point if it is approached with energy. Here you have scientifically grounded guidance from a number of major specialty societies addressing a very important problem, which is the overuse of ineffective care."
Questionable use of therapies is not a new issue. Although estimates vary, most observers agree that a significant proportion (many say at least a third) of the tests and procedures used in this country and others have not been evaluated in terms of their efficacy. The most prevalent guess is that $700 to $800 billion is wasted every year through the overuse or inappropriate use of therapies and tests. Jack Lewin, M.D., former chief executive of the American College of Cardiology, which is a pioneer participant in Choosing Wisely, says, "At least one-third of what we produce in health care has no positive effect and sometimes has injurious effects."
Although most health care carries some risk, harm caused by unnecessary services is hardly defensible. A friend of mine who received a transfusion in the course of an unnecessary gall bladder surgery contracted hepatitis C as a result and ended up requiring a liver transplant. Other people I know, whose tonsils were irradiated in the 1950s and 1960s as treatment for tonsillitis, ended up with thyroid cancer; the glands had to be removed. (Radiation was widely, and often indiscriminately, used in the 1950s and 1960s as treatment for all kinds of things.) A study published in April of this year found that people who have been exposed to higher-dose dental X-rays have a much greater chance of developing meningioma — a type of brain tumor — later in life.
And occasionally — fortunately, not often — unnecessary treatment can kill, as has occurred with cardiac stent implantation and bypass surgery performed on patients who were not candidates for the procedures.
Also — obviously — overuse or inappropriate use of therapies wastes money and resources in a system that could certainly put them to better use.
But more rational treatment decisions are not the only potential consequence of a campaign like this. If misused or misinterpreted, these recommendations could do harm. There is little point in replacing one dubious approach to care with another, or swapping one set of questionable incentives with one that is just as iffy. As Lewin says, "The important thing is not to put out pronouncements as hard and fast rules that certain things should never be done. Rather, this should be seen as empowering and informing clinical judgment."
Certainly, insurers could seize the opportunity to deny payment for these treatments even if they are indicated. Lewin warns, "The insurance companies need to approach these announcements with some discretion. It would be frustrating if they decided to never reimburse for these services. I hope they will recognize the importance of it, but not jump too fast."
Cassel emphasizes that "our intention is not that this should become payment policy; we are not saying that these things should never be done. Care should be customized for the individual patient. But the insurers are interested and are watching this. I tell them that physicians should be paid in a way that encourages them to have conversations about this with patients."
It seems to me that this current iteration of a long-running issue should not be about payment policy, in any case. Money should not be the primary consideration, because in the end, this is really about quality of care.
In other words, this effort should encourage both patients and physicians to stop and think before acting. As a sign in the delivery suite of a hospital where obstetricians were trying to reduce the cesarean section rate read, "Don't just do something; stand there!"
Even if worries about money trumping clinical judgment and possibly perverse incentives prove to be unfounded, convincing physicians and patients to join this party will be fraught with difficulty.
For one thing, pharmaceutical manufacturers, medical device makers and some advocacy groups are likely to find these recommendations threatening. Suppliers that are pushing off-label use of approved drugs and devices and swift acceptance of those just coming to market are not likely to warm to the idea of more questions and deeper evaluation.
An example is the recent federal approval of Provenge, a medication that can extend life for an average of four months for men with late-stage prostate cancer. A course of treatment costs $96,000, and it doesn't always achieve the desired result. Nonetheless, Medicare officials were heavily pressured, not only by the manufacturer, but also by cancer advocacy groups, to approve it. There are many other examples of this kind of outside lobbying in favor of a treatment whose benefits are debatable.
Furthermore, although the U.S. health care system is in the throes of changing the very basis of payment from piecework to outcomes (or at least, payers hope so), the fact is that in most cases, as of now, providers make money by doing things, not by refraining from doing them (not that refraining would be any better if the treatment was, in fact, indicated).
We need look no further than Medscape's Physician Compensation Report 2012. It found that the highest-grossing specialties in 2011 were radiology, orthopedics, cardiology, anesthesiology, urology and gastroenterology — all heavily procedural. A radiologist's income averaged twice that of a pediatrician or family physician. Procedures pay, and radiologists do not earn money by not doing imaging.
Physicians themselves offer a host of reasons for resisting what many consider to be "cookbook medicine." One of Wennberg's findings was that physicians often defend their decisions with the argument, "That's how I was trained" — and there is evidence that the style of practice learned in medical school can influence a physician for an entire career. A parallel argument is, "That's how I've always done it." Physicians also have a legitimate fear of being sued if they do not check out every possible diagnosis, no matter how exotic; failure to diagnose a condition is one of the most common causes of litigation. It may look, walk and squawk like a duck, but that doesn't prevent fearful physicians from seeking to rule out emus, birds of paradise and California condors.
And it isn't just the plaintiff's bar; patients themselves can spur overuse. Cassel reports that research has shown that 30 percent of physicians admit that they have prescribed a drug or provided a therapy that they did not think was necessary "because the patient demanded it." Direct-to-consumer advertising of pharmaceuticals and, more recently, medical devices undoubtedly has increased patients' appetite for products and services.
But it must be kept in mind that some things work for some patients, and other things work for other patients. A friend of mine, a professional opera singer, is given to frequent sinus infections, and the only therapy that gets rid of them is an expensive antibiotic. He was, shall we say, not exactly thrilled to hear that use of antibiotics for sinus infections was identified by Choosing Wisely, and cited by Consumer Reports, as questionable.
As Kristy Larch, a breast cancer patient who has benefited from use of the drug Avastin, which is no longer approved for treatment of that condition, told The New York Times in April, "I did very well; I was what they call a 'super responder,' and now I have no evidence of disease. Doctors can't practice good medicine if we tie their hands."
The more serious the condition, and the more desperate the patient, the more likely it is that a conservative approach will be rejected. And it's all well and good for a policy wonk or payer or researcher to say that a drug is overused or useless; it's not so easy when it's you, your father or your brother who might gain a few precious months of life by trying it.
The only way this initiative is going to make a real difference is if all the stakeholders agree that these are recommendations designed to spark discussion and even debate, not commandments brought down from the mountain on stone tablets.
However, payment policy could well change the dynamics of patient demand. As Cassel observes, "More and more people [19.3 million, according to the Employee Benefit Research Institute] have high-deductible health plans, and when they end up paying $3,000 or more [out of pocket] for test after test, they begin to ask, "Do I really need this?'"
On the other hand, there is ample evidence that patients can become very suspicious about limits on the availability of care, and it doesn't take much. Anyone who remembers the battles of the early 1990s, when insurers sought to implement tight-network capitated managed care, also will remember the massive negative reaction of patients, providers and politicians alike. Even state legislatures got into the act, passing laws requiring hospitals to allow new moms to remain in the hospital overnight and that sort of thing.
One reason for patients' paranoia — and it's a very good reason — is that if they feel they are being asked to sacrifice something, they would like to know who will benefit from that sacrifice. If it is only to fatten an insurer's bottom line, there is likely to be a pronounced lack of enthusiasm for the venture. In a system such as that in the United States, there is no guarantee that the savings achieved will be applied to the greatest need — or to any need at all.
Despite all these uncertainties, advocates for Choosing Wisely and other efforts designed to put medical decision-making on a more rational basis argue that the ride would most definitely be worth the fare. As Lewin says, "We are getting to a place in our technological revolution at which we can use point-of-care data to really inform clinical judgment. This could revolutionize how payers pay and how hospitals, working with physicians, determine that they are providing value-based care. And, certainly, physicians in medical groups can better set standards of care. This will not only improve clinical judgment, but also will help get us out of the quagmire we are in with the ballooning federal deficit."
Cassel agrees: "We are moving toward global payments, bundled payments and other models in which providers, including hospitals, would benefit from considering these recommendations. But beyond that, this is what physicians should do."
And although it seems to some — perhaps many — physicians to be counterintuitive, these initiatives could actually protect provider autonomy. Lewin explains, "Left to their own devices, Congress, insurers and other payers will continue to resort to caps on spending and price controls, until and unless they understand that we now have data and point-of-care tools that can systematically produce greater efficiency."
But eliminating unnecessary treatments can empower clinicians beyond keeping meat-axe policymaking at bay. Cassel emphasizes that "physicians want to do the right thing, even with the payment incentives misaligned. Even if, under the current system, they may lose revenue by not doing some of these things, they want to have honest conversations with patients." And any system or policy that supports physicians who don't want to prescribe antibiotics for what are clearly viral infections, or who resist ordering expensive imaging for garden-variety backaches, would be a positive development.
In the end, although changing existing practice will benefit other stakeholders, patient protection should be the prime directive, the driving force. As Joseph M. Smith, M.D., chief medical and science officer for the West Wireless Health Institute, told a Medscape writer in April, "We do [clinical] things because we have always done them. That is going to be less tenable, and [physicians] will be put under more and more scrutiny about 'Why is that? Why is this happening to me?' or 'Why, Doctor, are you doing that as opposed to this?' You peel back the layer that says, 'Well, actually, there isn't any evidence to support that. That was merely my historical preference, as opposed to my data-driven wisdom and decision-making.'"
He goes on, "We do a lot of things that are population-based when we fully know that 30 to 40 percent of the people to whom we provide such therapies derive no benefit, but do experience all the costs and all the adverse consequences. [Yet] all it takes is understanding the genetic determinants, the historical determinants or the epigenetic [changed expression of genes] determinants that say, 'In you, this therapy won't work, so skip it.' The opportunity to take potentially lifesaving therapies and give them only to the 30 to 50 percent of a cohort that [can benefit from them], by virtue of having some positive impact, saves half of the expense."
Again, it is impossible, in a system such as ours (or anyone else's), to separate money from medicine entirely; but if we can improve care and save money at the same time, who can protest?
Even if these approaches are embraced by most of the major players, this will not be any overnight conversion. Culture change is usually incremental and takes a long time. Whereas younger physicians are more open to evidence-based medicine, there are still many older practitioners who consider electronic medical records to be some kind of communist plot; one shudders to imagine what they think of outside recommendations regarding what works. As Lewin says, "It's going to take a while for this to filter down to the rank and file."
And, as with all such things, adoption, if it occurs, will be on a bell curve. There will be a few early adopters who take on the most risk (and must do so with one foot in old payment systems and the other in new ones), a much larger group who will wait and see before signing on, and a smaller "tail group" who will want to have nothing to do with it unless they are virtually forced to accept it. And some of them never will.
Efforts to use scientific evidence as a basis for clinical decision-making go back, at least, to Florence Nightingale, who thought that the results of surgeries should be made public. John Wennberg has been a forceful voice — sometimes in the wilderness and sometimes in good company — for nearly 40 years. Donald Berwick has devoted his professional life to improving the quality of care. Many others have struggled to get the voodoo out of medicine. Some progress has been made, but it has been agonizingly slow.
I was talking about all this with a physician as we recited to each other the many therapies that have become popular over the years, but eventually were proven useless and, in time, were discarded. He smiled and said, "And 30 years from now, what I do today will be considered archaic."
So are things any different this time? Will these physicians and consumer advocates succeed in moving the mountain? I am reminded of the climatologist who, after a couple of years of goofy weather in the northern hemisphere, was asked if this was proof of global warming. "Ask me in a hundred years," he said.
Maybe this is a watershed moment in health care. And maybe it is just more water under the bridge of efforts to put treatment on a more scientific basis. Only time, and the responses of those who are truly committed to improving patient care, will tell.Copyright © 2012 by Emily Friedman. All rights reserved.
Emily Friedman is an independent writer, speaker and health policy and ethics analyst based in Chicago. She is also a regular contributor to H&HN Daily and a member of Speakers Express. The opinions expressed by authors do not necessarily reflect the policy of Health Forum Inc. or the American Hospital Association.
First published in Hospitals & Health Networks Daily on June 5, 2012
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