Tort Reforms Don’t Pack a Punch

Of the oft-cited “frivolous lawsuits” supposedly decimating our nation, medical malpractice suits are probably public enemy number one—the bogeyman of our medical system that drives the nation’s health care price tag ever higher (or so we’re told).

In reality, medical malpractice settlements and awards account for less than one-half of a percent of our total health care bill—a relatively miniscule amount. Of course a half percent of 2 trillion is still a lot of money, which means that if tort reforms—changes to the legal code that make it more difficult and less rewarding for plaintiffs to sue doctors—were as vital as their proponents claim, we’d end up with some significant savings. But as it turns out, tort reform barely makes a dent on either the frequency of successful malpractice suits or the amount of money our system pays out to them.

A Health Affairs study from last year compared state laws to see if tort reforms have a strong effect on four “outcome variables”: the average amount of a paid malpractice claim, the total number of such claims, the average dollars per practicing physician of a paid claim, and the number of paid claims per practicing physician. Together, these variables comprise what we’re really thinking when we talk about personal injury law suits: how often people win their lawsuits, how much they get, and how these numbers compare to the number of doctors in a given region (in this case, a state).

The study’s authors, who hail from the University of Tennessee, the University of Oklahoma, and the Kaiser Foundation, found that “strong tort law provisions can explain at most only one-fourth of the variation among states in the average payment on a medical malpractice claim.” That means three-quarters of the differences in payment amounts across the states has nothing to do with tort reform!

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Nailing The Hand-Off

In the most recent issue of the New England Journal of Medicine, Dr. Thomas Bodenheimer defines the coordination of medical care as “the deliberate integration of patient care activities between two or more participants involved in a patient’s care to facilitate the appropriate delivery of health care services.” Or, to put it in layman’s terms: doctors working together to get things right.

The value of this sentiment should be self-evident, but the coordination of medical care is more complex than it initially seems—even when discussing admittedly uncomplicated concepts. Consider the “hand-off,” that transitional moment when a patient is passed from one provider  to another (e.g. from primary care physician to specialist, specialist to surgeon, surgeon to nurse, etc)– or is discharged  This transition is unavoidable—as Bodenheimer points out, modern health care necessitates a “pluralistic delivery system that features large numbers of small providers, [which] magnif[ies] the number of venues such patients need to visit.” 21st Century  medicine is too complex for one-stop shopping.

Inescapable though it may be, the hand-off is fraught with pitfalls. As Quality and Safety in Health Care (QSHC), a publication of the British Medical Journal, noted in January, the simple transition of a patient from one caretaker to another represents a gap that is “considered especially vulnerable to error.”

Even the most common hand-off—your standard referral from primary care physician to specialist—is not risk-free. As Dr. Bob Wachter recently noted in his blog, “in more than two-thirds of outpatient subspecialty referrals, the specialist received no information from the primary care physician to guide the consultation.” Sadly, the radio silence goes both ways: “in one-quarter of the specialty consultations,” Wachter says, “the primary care physician received no information back from the consultant within a month.”

These missteps are indicative of what can go wrong during the hand-off, such as, according to QSHC, “inaccurate medical documentation and unrecorded clinical data.” Such misinformation can lead to extra “work or re-work, such as ordering additional or repeat tests” or getting “information from other healthcare providers or the patient”—a sometimes arduous process that can “result in patient harm (e.g., delay in therapy, incorrect therapy, etc).”

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Guess Who Foots America’s Health Care Bill?

In the latest issue of the Journal of the American Medical Association (JAMA), the always-compelling duo of Ezekiel Emanuel and Victor Fuchs—associated with the National Institutes of Health and Stanford University respectively—dispel the myth of “shared responsibility” in health care financing.

What does this mean, exactly? Simple: “the common claim that employers, government, and households all pay for health care is false. Employers do not share fiscal responsibility and employers do not pay for health care.” In fact, the “money [for health care] comes from [our] own pockets.” 

As simple as this assertion may seem, it’s actually a ground-breaking statement. As Emanuel and Fuchs point out, most of the political rhetoric surrounding health care reform implies that everyone—individuals, employers, households, and governments—struggle with health care costs equally. Implicit in this formulation is a sad tale of businesses getting crunched: Because employers provide health coverage to most Americans who are insured, employers are often singled out as victims. It often seems like the health care crisis is their burden.

Indeed, “burden” is quite the buzzword here. Barack Obama says it’s a tragedy “when businesses have to lay off one employee because they can’t afford the health care for another.” Hillary Clinton notes that “large American companies compete in a global economy against companies in countries that impose far lower health care burdens on employers.” Congress celebrates reforms that supposedly “takes [the health care] burden off employers.” It certainly sounds like businesses have it bad. 

Not so fast, say Emanuel and Fuchs. We need to consider the “health care cost-wage tradeoff.” A large body of economic research shows that, when you crunch the numbers, employers don’t lose the money they spend on health care, but rather take the costs out of their employees’ paychecks. In fact, a 2004 study from the International Journal of Health Care Finance and Economics found that "the amount of earnings a worker must give up for gaining health insurance is roughly equal to the amount an employer must pay for such coverage."

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Healthy Kids, Less Crime? Part II of II

In Part I of this post,
I discussed the policy implications of recent research from Duke
University showing a clear link between mental disorders in children
and their criminal activity as adults. I particularly focused on the
impact quality child care and poverty reduction can have as a means of
improving mental health—and thus, potentially prevent crime. Part II,
which focuses on education, health care, and the juvenile justice
system, follows below.

But a high-quality continuum of mental health services can’t only
engage with preschoolers. The reality of life is that people develop at
different rates, and the kid who’s quiet at age 3 can become a
hell-raiser at age 9. As such, schools have become a particularly
important site of diagnosing and treating mental health problems among
children.

For all the problems public schools face today, there has been some
progress on the mental health front. The Substance Abuse and Mental
Health Services Administration (SAMHSA) reports that 70 to 80 percent
of children who receive mental health services get the aid from
school-based mental health service providers (e.g. guidance counselors,
school psychologists, etc). Many schools have coordinated programs of
education, observation, and counseling that partner up with community
health experts.

But there’s still a ways to go. The American School Board reports that
there are around 1,700 school-based health centers in the United
States, a tiny fraction of the nation’s nearly 90,000 public schools.
There are many reasons for the relatively small number of centers
including the basic difficulties that come with implementing what
experts call an "ecological" model of mental health. This is a fancy
way of saying that schools that are serious about mental health can’t
just have mental health resources; they must integrate those
resources—educational materials, counselors, information, activities,
etc—into the every day school environment (e.g. classes, discipline,
etc).

This is, as you might imagine, a costly undertaking, and research from
SAMHSA has found that low-income and minority schools are far less
likely to have mental health programs in place. Those that do often
have very limited programs.

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Healthy Kids, Less Crime? Part I of II

There’s one issue that hasn’t seen much airtime during the Presidential election, and you probably didn’t even realize its absence. That issue is crime, and it hasn’t come up because it’s just not as scary as it was in the past. In one of the great mysteries of criminology, crime began to fall in 1993 and continued to plummet throughout the 1990s and into the 21st century.

Experts have offered explanations ranging from higher incarceration rates to more cops on the streets to the legalization of abortion (this last theory, put forth by economist Steven Levitt in the best-selling Freakonomics, has since been disproved). But ultimately no one can pinpoint exactly what happened, mostly because no one really knows what causes crime as a broad, social phenomenon. If we can’t explain what causes it, we can’t understand what causes it to decline—and thus politicians can’t take credit for it or offer solutions.

But for all the head-scratching, there is one promising line of inquiry that’s only now beginning to see scholarly attention: the link between peoples’ health as children and their criminal activity as adults. Believe it or not, there’s been relatively little empirical work done to link childhood mental disorders and adult offenses. That’s changing. In November, The American Journal of Psychiatry published a study that asked whether “the national crisis in child community mental health services” contributes to “delinquency,” and whether more robust, timely responses to “youths with mental disorders” can reduce adult crime. The answers were “yes” on both points.

The study, carried out by researchers at Duke University, consisted of interviews with a cohort of 1,420 children aged 9 to 13 and a reassessment of these kids every year through the age of 16. During those years, the team identified those youths with mental health problems and diagnosed them. Everyone was tracked until 21 to identify arrests (criminal involvement is far more common between 16 and 20, and drops off sharply when people move into their twenties). The findings were telling.

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Update on FDA Stories: Business as Usual

In my last two posts, I touched on some pretty significant FDA-related developments—and even though they’re barely a week old, a lot has happened since my commentary. Here’s a look at where things stand now. It’s not pretty.

The FDA, Avastin, and Wall Street

In a post last week, I urged the FDA not to approve Avastin for use with breast cancer patients, because (1) the science shows it’s not effective enough to warrant approval and (2) giving it the okay would set a precedent for approving mediocre drugs..

Naturally, the FDA approved Avastin at the end of last week.

In a comment quoted by MarketWatch, analysts called the FDA’s decision “a welcome outcome” because "investors and companies have expressed growing concern that the FDA’s hurdle for approving drugs is a moving target and that a survival benefit is a necessity.”

But wait—just last week the Wall Street Journal noted that FDA “evaluation methods have remained largely unchanged over the last half-century.” In fact, the Journal cited this long-term consistency as emblematic of the agency’s “bureaucratic culture”—and yet here are the analysts, claiming that the problem is inconsistency.

Of course, the logic behind approval is a secondary concern to
investors—what really matters is the financial consequences of an FDA
decision. In this case the green light from the FDA sent Genentech
shares shooting up by almost 10 percent in a single day. Predictably,
financial analysts see big things in the company’s future: the
investment bank Cowen & Co. forecasets  a peak potential sales
estimate of $1.5 billion in 2012 and RBC Capital Markets analysts have
upped their 2008 and 2009 sales forecasts by $17 million and $30
million respectively (the drug’s 2007 sales already clocked in at a
whopping $2.7 billion).

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The Supreme Court’s Medical Device Decision Misses the Point

Last week the Supreme Court ruled that medical device-makers are protected from personal injury lawsuits so long as their products have passed the most stringent FDA approval process. The principle that the Justices cited in their decision was “preemption”—the idea that the FDA stamp of approval is final, binding, and supersedes any problems or malfunctions that may subsequently occur.  This means, more or less, that if your pacemaker blows up the device-maker can shrug and say “sorry buddy, the FDA gave it the okay; you’re on your own.”

As harsh as this may sound, there is an argument to be made for preemption. The principle was pretty clearly written into a 1976 medical device law and the pro-business contingent has a point when it says that without some degree of preemption, competition is nigh impossible (it’s tough to navigate 50 different state codes, and the companies that can are the big, established ones).

But regardless of the principles behind the Court’s decision, the practical dimensions of the ruling leave much to be desired. Preemption only has teeth if the FDA does—but the agency is all gums.

For years, the FDA has been in a state of steady decline. According to a former FDA chief counsel, the agency’s staff has shrunk 14 percent over the last 14 years. Experts say the FDA needs a 15 percent boost in funding per year for the next five years in order to be effective, and a November report revealed that the FDA barely has any computers or personnel infrastructure.

In short, the FDA is a mess, and the entropy hasn’t spared medical device regulation. To help fill its empty coffers, since 2002 the FDA has had a system in place that allows device-makers to pay fees in order to expedite product inspections. It is estimated that between 2007 and 2012, the FDA will collect $287 million in fees from medical device companies—just over a fifth of the total cost to the FDA to review new devices.

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The Wall Street Journal Is Wrong on Avastin

Today the Wall Street Journal ran an editorial urging the FDA to approve Avastin, a drug used to help treat colorectal cancer, for breast cancer. It’s an angry—and ultimately, wrong-headed—piece.

In December, an FDA advisory committee voted against allowing Avastin for breast cancer treatment; the FDA is expected to make a final decision this weekend that either affirms or rejects the committee’s recommendations. The Journal supports a rejection the committee (and approving the drug) because “in clinical trials, Avastin demonstrated the longest reported ‘progression-free survival’ for patients with advanced breast cancer.” In other words, patients “live longer before their disease spreads or worsens” when they take the drug. So, says the WSJ, the FDA has a moral obligation to approve Avastin, because it “translates into an improvement in quality of life by delaying the onset of symptoms.”

But in reality the situation isn’t nearly this simple—and for all its good intentions, the Wall Street Journal trips over its own logic.

Clinical trials show that Avastin plus paclitaxel (the scientific name for the brand drug Taxol) helped to keep cancer from growing for five months longer than in patients on paclitaxel alone—this much is true. But there’s more: as an American Cancer Society summary of the original December decision notes, “overall survival was not significantly better [for those who took Avastin] and women who received Avastin had more serious side effects compared to those who got paclitaxel alone.”

The Journal is quick to note that “not significantly better” refers to the fact that women on Avastin “lived slightly longer, a median of 26.5 months compared with 24.8 with Taxol alone.” That means that, even though cancer was slowed for five months, the average lifespan of an Avastin-taker was ultimately only lived two-months longer than it was for those who didn’t take the drug. The newspaper is angry that the FDA trivializes this time be deeming it a statistically insignificant extension. But there are other things to consider besides time—like side-effects.

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A Lesson in Health Care Innovation…from the Government?

Government gets a bad rap in American politics. Not all of it is undeserved, mind you, but one thing that isn’t deserved is the accusation that the public sector is unable to innovate. In fact, for some of the innovations that matter the most—like electronic medical records—the public sector might just be our best bet for progress.

Consider the example brought up by Jack E. Lohman, a Health Beat reader who comments on Wisconsin politics. Responding to one of my posts, Lohman offered information about VistA, the Veteran Administration’s electronic health records system. Lohman notes that VistA works by “instantaneously search[ing] for patients around the country with similar diseases and lists the physicians’ treatments and successes, grouped by the most common treatments.” In other words, it aggregates and cross-compares data to see which treatments have worked for which kinds of patients.

This information is then matched up with “a one-time, lengthy health questionnaire that would be turned over to the physician for evaluation.” Translation: patients are surveyed to see where they fit in the VistA database so that doctors can better assess their situation. (This might sound familiar: it’s similar to Germany’s system of “diagnosis-related grouping,” which I mentioned in a post last month).

VistA is a great tool—and, I would argue, one that exemplifies the benefits of getting the public sector involved in health care IT.

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In Defense of “The Downsides”

As some readers may have noted, a recent post of mine discussing some of my concerns about virtual medicine has been met with some hostility—mostly (but not in all cases) reasoned, intelligent hostility– but dislike nonetheless. That’s fine, but here’s the issue: what’s being framed as a litany of inaccuracies is really just a difference of opinion.

First thing’s first: there is one hard fact on which I misspoke. Companies that facilitate online doctor-patient conversations like Medem, Inc. and RelayHealth have been around for close to a decade. I erroneously referred to them as new. For that, I apologize.

But here’s the thing: my post wasn’t about these companies, and even less about their age. I was writing about some concerns I have over virtual consultation—primarily, how much of the hubbub over virtual medicine will really translate into addressing what I feel are our most pressing health priorities.

Some people took offense. A comment from Matthew Holt, editor of The Health Care Blog, suggested I was “slagging off technologies that have some slight promise”—a sentiment he repeated on the front page of his blog. This is an overstatement. In my post, I made perfectly clear that I understand the excitement about online consultation and would most even likely use it myself. My reservations come from the Internet-as-messiah mindset.

One concern is with access—web medicine seems like another innovation that will benefit the “haves “more than the “have-nots” in part because poor Americans have less access to the Internet. Matthew counters my worries about the digital divide by saying that Internet penetration might be uneven in homes, but it is very high in schools, libraries, and workplaces. This is true, and it’s this sort of broader definition of Internet access that informs statistics celebrating America’s near-universal web presence.

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