Comparative Effectiveness

QUALITY: "Lucky 13" Policy Wonks Map Out Path to Health Quality

Julie Barnes — Tue, 13 May 2008 14:23:00 -0400

A lucky 13 top-notch health policy wonks outlined concrete and achievable stops to improve quality, reduce cost, and repair our health care system in the May/June issue of Health Affairs. For instance, beyond the common refrain for increased use of "evidence-based" medicine, the "Quality Crossroads Group" called on Congress to immediately create a national center to support effectiveness research so we can at least get started on examining what treatments work best and when to administer them.

We also liked the call by the authors, including New America's Len Nichols, to replace the fee-for-service payment model with systems that reward clinically effective and efficient population health management--like bundled chronic care episode payments and paying for population health performance.

As we continually say in this space and elsewhere, successful reform must address coverage, costs and quality at the same time. This Quality Crossroads Group outlines better and more succinctly than most how quality improvement, cost containment, and coverage expansion are inextricably linked. Ultimately, the group offered five ways to achieve a high-performance health system:

Create a national center for effectiveness research.
Develop models of accountable health care entities capable of providing integrated and coordinated care.
Develop payment models to reward high-value care.
Develop a national strategy for performance measurement.
Pursue a multistakeholder approach to improving population health.

To be succinct, we agree.

QUALITY: Domo Arigato Dr. Roboto?

Paul Testa — Fri, 02 May 2008 14:37:00 -0400

We love robots as much as the next guy, as long the next guy is our colleague Tom Emswiler. No offense to Shia Laboeuf, but Tom knows how to talk about transformative technological change and its place in health reform. His post on minimally invasive, or laparoscopic, surgery perfectly explained the link between innovation and value in medicine--a complex relation on full display in Wednesday's USA Today article on the da Vinci robot—a four-armed surgical system that is the $1.5 million Bentley of laparoscopic surgery.

As Tom writes: "Technology is valuable, even if it costs more, if it improves outcomes." But, "If a hospital spends a million dollars on a new piece of equipment that doesn't do a better job, there is no value added." This dynamic is essential to understanding that: "Comparative effectiveness is not a way to keep new innovations from patients; rather, it is a way to determine what works best, for whom, when. In this case, new technology results in better outcomes."

For the da Vinci robot, Tom's insights made us think about the good, the bad, and the crucial questions of value and cost for patient and provider. Starting with:

The Good: The doctors quoted in the USA Today article believe the da Vinci robot has the potential to greatly improve the outcomes and costs of coronary bypasses by performing the procedure without having to split open the patient's chest and stop the patient's heart. Two 100-patient studies have produced positive results, with the latest coming from the University of Maryland this week, where researchers found the da Vinci improved mortality rates, reduced complications, decreased in-patient stays and produced savings that made up for its added $8,000 in costs. Encouraging results but with such small sample sizes, they're far from definitive. An editorial last year in the Journal of Thoracic and Cardiac Surgery (subscription) was less convinced by what it called the "emperor's new clothes." Which brings us to:

The Bad: Prostatectomies accounted for 55,000 of the 85,000 da Vinci procedures last year, despite the lack of clear evidence that laparoscopic surgery produces better results for a patient than open surgery, or that prostatectomies are a better treatment for prostate cancer than other remedies. Forcing us to ask:

The Crucial Questions of Value and Cost for Patient and Provider: We all know that robots can be great dancers, maids, and even police officers. For health care, robots and medical innovation in general, must be justified in terms of value and improved outcomes. Four robotic arms may be a better option for some procedures (provided the clinical evidence is there), but they should not be just another tool to win market share in a medical arms race. Neither hospitals, nor patients can afford it.

QUALITY: Sometimes, Technology IS Better

Tom Emswiler — Mon, 28 Apr 2008 19:47:00 -0400

You know you're a health wonk when you get excited at the sight of the word "laparoscopic" in your inbox on a Friday evening. But after four years of thinking about health policy all the time, here I am.

Researchers at Emory have found that "laparoscopic surgery to remove pancreatic tumors or cysts leads to fewer complications and shorter hospital stays."

Compared to standard surgery, laparoscopy resulted in fewer complications (57 percent vs. 40 percent). Patients who had the laparoscopic procedure also had less blood loss and spent three fewer days in hospital (six vs. nine).

Last year I published a column that discussed laparoscopic (minimally invasive) prostate surgery. Blogger/hospital CEO Paul Levy had written about having to buy a new, million-dollar robot that was surrounded by questions of whether it improved quality over "regular" open prostate surgery. Results were mixed.

A skim of my column might leave you to believe that I hate technology, don't have a computer (maybe I'm dictating!) etc. That's not accurate. I just bought a fancy new laptop. I have an iPod.

What I don't like is technology that doesn't improve value (value means quality that's worth the money). If a hospital spends a million dollars on a new piece of equipment that doesn't do a better job, there is no value added. Instead, the cost of insurance rises for all insured, because the premiums of the healthy go towards paying for the prostate surgery of others. And the last thing a country with 47 million uninsured people needs is more reasons for insurance costs to rise.

Technology is valuable, even if it costs more, if it improves outcomes. While the jury is still out on prostate surgery, the new Emory study states that the quality of pancreatic surgery is better when performed with a minimally-invasive procedure.

Comparative effectiveness is not a way to keep new innovations from patients; rather, it is a way to determine what works best, for whom, when. In this case, new technology results in better outcomes.

COST: Even with insurance, seriously ill patients face high costs for expensive drugs

Joanne Kenen — Mon, 14 Apr 2008 16:52:00 -0400

You may have seen this story in The New York Times today: even people with health insurance end up paying hundreds or thousands of dollars each month for life-saving medicines if they have the misfortune to need a really expensive drug.

Many health plans already "tier" their drugs, making patients pay more if they opt for brand names instead of generics, or if they use a drug that's not on a "formulary" or list of preferred drugs. Now they are asked to pay up to a third of the cost of these new, very expensive drugs for diseases like multiple sclerosis, hepatitis C, hemophilia, rheumatoid arthritis, and some cancers. New treatments can cost $100,000 or more a year. "The system means that the burden of expensive health care can now affect insured people, too," Times reporter Gina Kolata writes, adding that the patient's share of these drug bills can be more than they pay for housing in a month, or even more than their entire monthly income. And for chronic diseases, the drug bill isn't a one-time occurrence. Patients have to take them month after month, year after year.

"It is very unfortunate social policy," Dr. James Robinson, a health economist at the University of California, Berkeley told the Times. "The more the sick person pays, the less the healthy person pays."

Some oncologists have told us that within a few years we may have genetic information about specific patients' cancers, which could in turn help predict which of these new expensive new drugs will or will not work well for an individual patient. If we have knowledge, not guesswork, it would help decide when to go ahead and prescribe a $100,000 drug and when it would offer no hope.

One vital component of any solution is a health care system that covers everyone—we can spread the risk better if the healthy as well as the sick are covered. We also need more comparative effectiveness research to find out if these drugs really work better than older, cheaper alternatives and for which patients.

Other bloggers are weighing in. Gooznews writes about what we do and don't know about the benefits of MS drug Copaxone, and the role of taxpayer dollars in gleaning that knowledge. Ezra Klein suggests that having a patient pay more for the unproven or experimental drug might be sensible policy, but dumping the cost on insured people who have the misfortune to have an expensive disease rather than a cheap one is not.

COST: Disease Management or Smart Spending?

Joanne Kenen — Tue, 08 Apr 2008 16:59:00 -0400

Earlier today we put up a guest post by Robert Berenson of the Urban Institute on the troubles with a Medicare pilot program on disease management. Here's another interesting take by Gooznews' Merrill Goozner. Merrill doesn't rule out the value of (good) chronic disease management, perhaps through medical homes, but he also shares our belief that we need a lot more comparative effectiveness research so we know how to spend our health care dollars more wisely:

To squeeze out short-run savings to cover the uninsured, government programs need to develop a strategy to eliminate some of the wasteful use of drugs, procedures and tests that now permeate the system. There's a growing consensus to set up a comparative effectiveness agency in the U.S. to combat that waste. But even this long overdue reform can run off the tracks if it isn't done the right way, an issue I'll address later this week.

Our colleague Tom Emswiler has also posted on the emerging consensus around comparative effectiveness, and he'll address it again too.

QUALITY: Consensus Developing Around Comparative Effectiveness

Tom Emswiler — Mon, 07 Apr 2008 17:52:00 -0400

I was expecting a battle royale at last Friday's Alliance for Health Reform event on comparative effectiveness. After all, two of the guests of honor, David Nexon from AdvaMed and Karen Ignagni from America's Health Insurance Plans (AHIP), were from opposing sides of the debate. I was struck though by the amount of agreement among the panelists at Comparative Effectiveness: Can We Get Better Health Value for the Dollars We Spend?

A point of contention in the ongoing debate about comparative effectiveness -- how we figure out how well and at what cost drugs or devices or treatments or procedures work vis-a-vis alternative options -- has been what kind of agency or entity should oversee the research. The device industry has been portrayed as being quite skeptical; I saw that for myself last year when I attended InHealth's 2007 Symposium. But I was pleased at how supportive Nexon sounded, and it makes me think the medical device industry's opposition is overstated. This shouldn't have been too surprising, as Ann-Marie Lynch, commenting for AdvaMed at MedPAC's April 2007 meeting, sounded cautiously supportive as well (p. 101).

Nexon addresssed what the shape and scope of the agency should be. His chief concern was about using cost to determine medical decisions. Ignagni took the other view, saying that ignoring cost in the face of high projected medical inflation would be "putting our heads in the sand." She also made a very reasonable point when she said most of health plans in her organization will not look at this as a stark coverage/no coverage decision. More likely, they would give patients some options, but if they went for the ones that scored lower on the comparative effectiveness ladder, they might have to pay a bigger share of the cost. (Hat-tip to Alan Garber of Stanford and reference pricing).

The important thing is to get the long-overdue research started; as we find out what works, we will inevitably learn about what various treatments cost. If two procedures/devices/drugs have exactly the same effectiveness for a certain population (me-too drugs are a great example; hat-tip GoozNews), then the more expensive drug should be reference-priced higher by insurers. That way other people in the insurance pool don't have to bear the cost of one person's champagne taste for what could be achieved with a cheaper drug. But if a slightly more expensive procedure/device/drug is more effective for certain populations, then it should be only marginally higher in price, if at all. Insurers already make these decisions; in the future these decisions will simply be better informed.

Occasionally, comparative effectiveness research will uncover procedures/devices/drugs that are harmful to large populations; Vioxx and Lung Volume Reduction Surgery come to mind.

With such consensus, we think it's highly likely that Congress will pass legislation this year establishing a comparative effectiveness institute (or at least taking a big step toward it). Senators Max Baucus (D-MT) and Kent Conrad (D-ND) are crafting a bill to create a public-private entity and Representatives Tom Allen (D-ME) and Jo Ann Emerson (R-MO) introduced a similar bill last year. Representative Pete Stark (D-CA) also had language in the House-passed version of the children's health insurance bill. Gail Wilensky published an important piece in 2006 about what such a center should look like.

VOICES FOR REFORM: Let a Thousand Health Care Flowers Bloom

Joanne Kenen — Mon, 31 Mar 2008 18:38:00 -0400

Dr. John Kitzhaber, physician, former Oregon governor, health researcher and prophet of comparative effectiveness, ended a provocative speech about health care not with graphs and charts and reams of numbers but with a photograph of flowers and the words of a poet, tending his garden for the last time. He wanted the flowers to bloom, he said, for the next generation.

The flowers represent the health care system in America, and Kitzhaber, now the president of the Estes Park Institute and director of Center for Evidence-Based Policy at the Oregon Health and Sciences University in Portland, has been a prominent voice in reminding us that the problem in health care isn't just about how we pay for it. It's about how we deliver that care, how good that care is, and how we make sure people get what they need when they need it. Ordinary people don't care about "health care" per se, he reminded his listeners. They care about health.

In his keynote speech at the Institute for Healthcare Improvement conference on redesigning clinical practice and in a conversation with me afterwards, Kitzhaber was blunt. "This is a dysfunctional system and we don't have much time to fix it."

Kitzhaber wants to create a "safe space" free from the usual political stalemates and economic self-interest that have historically blocked health reform. And he wants people to just think differently about our health, to use a different mindset and vocabulary.

He likes to compare how we think about health care versus how we think about public education. We finance schools, because it is in the public interest, for our democracy and our economy. We give universal access (all kids) to a defined benefit (K-12 education). When we have a financial shortfall, we argue about benefits. We cut electives, or enlarge class size or maybe shorten the school year. But we don't argue about eligibility. We don't say, "We don't have enough money so this year we won'teach 11th and 12th grade. He'd like us to begin thinking in parallel ways about our health.

Kitzhaber doesn't see a quick fix for anything as complicated as health care. He hopes the next president will act decisively to start the country on a road to change, like John Kennedy got us on the path to the moon. But he says a true transformation into an equitable, high-quality, cost-efficient system will take a decade or more, just like it took us years to reach the moon. Step-by-step progress is OK, he said, "as long as you know your end point" and you keep taking one step and then another, working together for a common purpose.

Right now, he said, our system is locked into a 50-year old model that centers on acute crises. That doesn't work well for treating chronic disease, which eats up more than 70 percent of the health care spending. A chronically-ill person has "seven or eight physicians who don't talk to each other." They keep records on seven or eight sets of paper records, locked up in their separate offices. Patients end up not getting the care they need (or getting care that they don't need).

His message set the stage for this IHI conference which focuses on clinical practice and outpatient care. IHI usually gets attention in the lay press for its work on antibiotic resistant infections and hospital quality but there are hundreds of doctors here in Grapevine, Texas (some from as far away as Yemen and Yugloslavia) who want to learn how to run better practices, giving them more time with patients than paperwork, and giving patients the care they want, need and deserve. We'll be posting more about what folks here are saying soon.

COST: Getting the Prescription Right for Medical Imaging

Guy Clifton M.D. — Fri, 28 Mar 2008 16:44:00 -0400

Medical imaging, such as CT scans and MRIs, has become synonymous with medical cost growth, and both private insurance and Medicare looking for ways to rein in costs, according to a recent AP article by Linda Johnson.

Citing work done by the Center for Studying Health System Change, the article noted that from 2000 to 2005 the use CT scans in the U.S. rose from 12 scans per 100 people to 22-with each test generating between $500-$1000 in revenue. During that same period, Medicare's spending on imaging services nearly doubled from $6.4 billion to $12.0 billion, accounting for 23 percent of total outpatient hospital payments in 2005, according to MedPAC-Congress's advisory committee on Medicare.

Concerns are not just about the costs, but also the quality and value of the imaging services. Growth in CT scans—which expose the body to much more radiation than X-rays—has led some doctors to conclude that the amount of radiation exposure may actually increase the rates of cancer in future years (subscription required). Insurers have responded to the growth in imaging by requiring precertification before ordering new studies, much to the chagrin of some doctors and radiologists,

The problem is that no one can distinguish necessary from unnecessary imaging and all the financial incentives in medicine are for over-performance of imaging. One-third of medical malpractice suits are for failure to diagnose, so if a doctor has the slightest question about whether a symptom heralds something serious, an imaging study is ordered. The care of an individual patient is highly disorganized because patients are cared for by multiple doctors who rarely know what the other has done. Unless a single doctor is coordinating or managing the care of a patient—which is rare—duplicate studies are commonplace. Another factor is that no one measures the quality of a doctor's practice and without standards of performance who is to know necessary from gratuitous imaging? Even when there are standards for performance, such as in coronary angiography, the evidence is overwhelming that those standards are not followed with any regularity. Furthermore, in an effort to increase income, doctors have increasingly installed imaging units in their office rather than referring patients to radiology facilities for studies, further escalating the problem of unneeded studies.

The only way out of this box is to gather more information on what does and does not work, establish clear standards for the use of imaging, to hold doctors accountable to those standards—such as paying only for a standard workup unless the doctor certifies the need for additional studies in unusual cases—and to hold doctors harmless from medical malpractice suits for failure to diagnose if they follow those standards.

QUALITY: Comparative Effectiveness in the Federal Budget

Tom Emswiler — Thu, 13 Mar 2008 20:00:00 -0400

Today in Washington, the House and Senate consider their respective versions of the budget before they close up shop for two weeks of spring recess. By reading the budget you can usually get a sense of the big-ticket items, but smaller-ticket items are usually left out of the text in the House, and only added in the Senate by floor amendment.

That's why I'm so surprised that the budgets of both Rep. Spratt and Sen. Conrad included specific text to create a reserve fund for a public-private entity for comparative effectiveness research -- i.e a way to find out what really works for patients and at what cost.

As the Senate Budget Committee's supplementary materials state:

"The purpose of such research would be to evaluate and compare the clinical effectiveness of two or more health care interventions, treatment protocols, procedures, medical devices, diagnostic tools, pharmaceuticals, and other processes or items used in the treatment or diagnosis of patients. This information could lead to savings over the long-term by allowing providers to avoid treatments that may be clinically ineffective, while at the same time improving health care outcomes."

Hey, that sounds good, right? Even if you don't agree, there's an out taught to me by physician-economist Alan Garber last year at the Federal Reserve Bank of San Francisco. It's called reference pricing. For example, a private insurance company can cover two treatments for a specific medical problem, but if one is cheaper and/or more effective, the patient's share of the cost is lower. If the patient wants what has proved to be a more expensive and/or less effective option, they can have it -- if they're willing to pick up more of the tab (note: Medicare is a passive claims payer and is unlikely to adopt reference pricing).

The House Ways and Means Health Subcommittee held a huge, three-panel hearing on this issue last year, and it's been in the news more recently because of CBO Director Peter Orszag (Health Populi's Jane Sarasohn-Kahn recently covered this well both last fall and more recently). Heck, I even wove it into my winding WaPo.com piece last year.

Oprah's favorite health economist Uwe Reinhardt says we should treat the federal budget like a memo to God regarding our nation's priorities. I'd say making health care more effective and affordable fits the bill.