Category: Health Law

Jumping the Queue

queue.jpgThe D.C. Circuit recently heard, en banc, the panel decision in Abigail Alliance, which tried to establish a constitutional right of terminally ill patients to access drugs that had passed Phase I clinical trials. Glenn Cohen gives a nice summary of the case and the issues it raises here. Both Eugene Volokh and John Robertson have examined how the decision could push regulations governing organ transplantation, stem cell research, and even medical marijuana in a far more libertarian direction. Even though many commentators doubt the controversial decision will stand, its resonance with a recent Supreme Court of Canada case makes me think its principles may influence American law in future cases.

In Chaouilli, the Canadian Supreme Court articulated a substantive right to pay for private health care, despite Quebec’s insistence that certain forms of private payment would divert resources from and thereby undermine its one-tier Medicare system. As Colleen Flood has documented, it is a deeply flawed decision, relying on questionable generalizations about the Canadian health care system and health policy generally. But the opinion rests on a visceral reaction that is hard to refute: when one’s life is at stake, taking virtually any measure that does not harm others seems appropriate.

So what’s the “harm to others” at stake in Abigail Alliance? Perhaps an “outsourcing of risk” from the wealthy to the poor. What will likely happen if anyone able to afford the “real thing” opts out of Phase II clinical trials? We already know that “Low-income individuals are more likely to sign up for [toxicity-detecting] Phase I medical trials and enroll in trials multiple times.” If Abigail Alliance stands, then anyone with enough money could opt out of Phase II trials (and the possible risk of being assigned to the control or comparator group). It presents one more way of tiering the medical system, and while that concern may not be enough to trump terminally ill patients’ right to treatments of choice, it certainly recommends some taxing of that tiering to redirect resources to groups hurt by it.

Is a similar harm at stake if Chaoulli is applied to all Canada? Tough question. To the extent that there is a relatively fixed amount of health services in Canada, the diversionary effect will be strong. If private health insurance manages not merely to fund more demand, but to induce more supply, we won’t have to worry so much. It is a difficult empirical question…but certainly the tiering of the U.S. health care system provides a cautionary tale.

PS: Apropos the last post, kudos to the Washington Legal Foundation for challenging Medicare’s refusal to reimburse some “off-label” cancer drugs.

Photo Credit: Flickr/PJS.

Self-Defeating Savings Strategies

cost balloon.jpgYesterday I did a CLE presentation for lawyers in pharmaceutical firms, focusing on the interaction between the new Medicare Part D and companies’ patient assistance programs (PAPs). The PAPs try to provide very-low-cost drugs to low-income individuals who fall through the cracks of existing insurance programs. Astonishingly, a complex web of Medicare “fraud and abuse” law could actually lead to criminal (and civil) sanctions for such programs if they offer financial assistance designed to get someone through the “donut hole” gap in coverage; as the Office of the Inspector General (OIG) of the U.S. Dep’t of Health and Human Services put it, “Pharmaceutical manufacturer PAPs that subsidize Part D cost-sharing amounts present heightened risks under the anti-kickback statute.”

After extraordinary controversy, the Centers for Medicare and Medicaid Services backed down a bit, claiming merely to insist that PAPs exist outside Part D coverage. This helped a bit, but when one reads the advisory opinions the OIG issues, they are not exactly perfect safe harbors. They contain pretty contradictory language, only purport to assess risk probabilistically, and raise the possibility that conduct that does not present a high risk of liability under the Anti-Kickback statute may well implicate other state and federal laws. (Ahh, the joys of guidance documents in admin law.)

According to the agency, it wants to put pharma under fraud & abuse scrutiny in because they might “increase the number of beneficiaries using the manufacturer’s product who reach the catastrophic benefit in any given coverage year,” steering people away from cheaper drugs. But one has to wonder if this particular obsession with cost-saving is really all that helpful to the program. Consider the following research on “meat-ax” rationing in the New Hampshire Medicaid program:

Jerry Avorn and his colleague at Harvard, Steve Soumerai, were responsible for showing that, when New Hampshire put a cap on the monthly number of prescriptions that welfare recipients would get for free, the result was an increase in nursing home admissions that probably cost the state government as much as it saved on drug costs.

In other words: one part of the bureaucracy may avoid paying for $200 of diuretics, but other parts may well end up having to cover a hospital admission due to congestive heart failure that runs to tens of thousands of dollars. Squeeze one part of the medical cost balloon, and it may just start bulging in some other area.

This is one reason why I’m happy Jason Furman’s recent report on cost-consciousness in health care reform does acknowledge this “big picture,” and proposes little to no cost-sharing for especially helpful interventions, especially preventive care. The OIG might want to focus less on new applications of fraud and abuse laws to Part D, and more on the type of economic analysis that allows us to see the true costs of denying drugs to the elderly.

Photo Credit: PingNews/Flickr.

Costs of Inequality

As tax day approaches, Sheryl Sandberg of the Google Foundation has some sobering insights on the “charity gap”–how small a percentage of donations actually help the disadvantaged. “[O]nly 8% of donations provide food, shelter or other basic necessities. At most, an additional 23% is directed to the poor.” International deprivation is not a major concern of most donors; “The most generous estimate shows that only 8% of U.S. individual donations supports international causes of any kind.”

Another article, on the prevalence of organ markets, shows how this persistent inequality affects the global supply of and demand for body parts. It pleads for another type of giving:

Fewer than 40 percent of Americans have signed organ-donor cards, and only about half of their families consent to the donation of a loved one’s organs. . . . Many assume that if they don’t supply the organs, somebody else will. But [even if that is the case,] that somebody won’t be a corpse. It’ll be a fisherman or an out-of-work laborer who needs cash and can’t find another way to get it. The surest way to stop him from selling his kidney is to make it worthless, by flooding the market with free organs. If you haven’t filled out a donor card, do it now.

Both quotes bring to mind a recent quote I’d read, reportedly from an upcoming book by Pope Benedict XVI:

Confronted with the abuse of economic power, with the cruelty of capitalism that degrades man into merchandise, we have begun to see more clearly the dangers of wealth and we understand in a new way what Jesus intended in warning us about wealth.

As Thomas Berg has blogged, “great disparity seems likely to make it harder for people to practice the value of solidarity, that is, ‘see[ing] the “other”. . . not just as some kind of instrument, . . . but as our “neighbor,” . . . to be made a sharer on a par with ourselves in the banquet of life to which all are equally invited by God.'” (citing Solicitudo Rei Socialis, para. 39).

I look forward to seeing what the distinguished legal scholars attending the upcoming Class Crits Workshop (hat tip: Feminist Law Profs) at the SUNY Buffalo Law School have to say on these and related topics. (Note–they are still accepting proposals until April 23).

“Rationally” Choosing to Be Uninsured

hospital.jpgNYM has a good piece on low-paid, young New Yorkers who are increasingly taking chances with their health by choosing to be uninsured. Here’s one painter’s off-the-cuff calculations:

“Now I find myself making all these stupid calculations. Like, it would cost me around $3,000 a year to have insurance, right? Okay, isn’t that about what it would cost out of pocket if I broke my wrist? Chances are I’m not going to break my wrist once a year, so why not save the money for that onetime emergency?” Like many I spoke with, [the painter] said he’d happily pay for insurance, if only the cost-benefit analysis tilted more in its favor. “What’s ironic is that I would never live without my cell phone, but I won’t consider buying health insurance. It sounds ridiculous to say that out loud, but the fact is insurance is just too expensive. If it was the same price as my phone”—$150 a month sounded reasonable to him—“I’d buy it in a second.”

This internal struggle reminded me of a recent debate among Republicans on RomneyCare in Massachusetts–namely, the wisdom of an individual mandate to force everyone to have medical insurance, just as everyone who drives has to have car insurance. To the Heritage Foundation, the individual mandate makes free-riders pay for the care they are almost inevitably going to demand (and probably not be able to pay for) at an ER sometime. The libertarians at Cato think that it’s the thin end of a wedge designed to speed us to socialized medicine.

My own take: it’s pretty hard to see the rationality of the painter’s decision. Perhaps, ala a really generous view of heuristics, that hypothesized wrist injury is really a cognitive shortcut that averages out the range of illnesses the painter could have in a given year, and weighs the costs and benefits of insuring against them. But I doubt there’s any data available to back up that characterization. And he doesn’t appear to take into account the range of chronic illnesses that can greatly reduce life expectancy before they ever become emergent.

The only thing that makes the “calculation” at all reasonable is the idea that, as a backstop, the Emergency Medical Treatment and Active Labor Act (EMTALA) forces (many) hospitals to treat critical illnesses. A widespread culture of counting on it may well make individual mandates as porous in health insurance as they are in car insurance (where about 14% of drivers persistently fail to get insurance). In which case, how much should people who fail to sign up for health insurance, and need expensive ER care, be punished? Should they be denied care? Saddled with never-dischargeable debt (i.e., become hospital serfs)? How about their children?

The saddest thing about “forcing the poor to pay something” (via, say, an individual mandate) is the number of children who are still uninsured because of it. Oftentimes the programs demand really trivial premiums or copays…which nevertheless seem too steep (or are too bureaucratically demanding) for parents to make. It’s too bad they can’t just be automatically enrolled.

Consumer-Driven Health Disasters

One of the buzzwords of “market-oriented” health reformers is the importance of “consumer-directed health care (CDHC):” assuring that patients get more choice in exchange for taking on more financial responsibility. As Regina Jefferson noted in a prescient article, some aspects of CDHC have a lot to offer the “healthy, wealthy, and wise.” But there are some darker trends.

Consider, for instance, the rise of specialty hospitals–those that only focus on a particular type of medical problem (usually the most lucrative ones to treat, like cardiac or orthopedic surgery). Such hospitals are often physician-owned, and offer enormous financial rewards: all the profit from high-margin operations, and none of the common general hospital obligations to subsidize emergency rooms, physician training, or care for the uninsured. Specialization also allows the hospital to build up an expertise on particular problems, which is great for patients…until complications ensue.

Then, as this NYT article reports, the specialty hospital may well have to call 911 to save its patients. The physician-owned hospital, long “assailed for cherry-picking the most profitable procedures from the nation’s . . . full-service hospitals,” is thrown on their mercy in cases like that.

Federal regulation of specialty hospitals has been all over the map, as a moratorium on Medicare funding for them expired in 2005. But as Republican Senator Charles Grassley notes, “The problem with physician-owned specialty hospitals is that decision-making is more likely to be driven by financial interest rather than patient interest.” Now it appears that at least their ER responsibilities are getting renewed scrutiny:

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Minding the Obesity Epidemic

supersize.jpgJeanne Whalen at the WSJ has a fascinating piece on a slew of new obesity drugs now in clinical trials. There’s a lot to comment on, but I was struck by a chart on the front page, giving the following rates of obesity (BMI > 30) in different countries in 2005:

US: 39%

UK: 23%

France: 7%

China: 2%

Japan: 2%

These are pretty shocking figures. The chart mentions that the obesity rate in the US was 35% in 2002….so the percentage by which obesity increased in the US in three years is double the overall percentage in the Asian countries mentioned. How is it that twenty times as many Americans are obese than Chinese or Japanese nationals?

I plan to look for answers in Avner Offer’s The Challenge of Affluence: Self-Control and Well-Being in the United States and Britain Since 1950. The book is a masterpiece of meta-analysis, reportage, and Jon Elster-style explication of the microfoundations of social action. Offer’s thesis is (inadequately) summarized below:

Resources and cravings do not map precisely on to well-being. . . .Over the last two decades, a new understanding began to emerge, especially from psychology and economics, that what we want and choose can often fail to deliver, and can even be counter-productive. . . . This understanding is the work of many inquiries and disciplines. My effort here is to extrapolate it to the personal dynamics of affluence during the last six decades. . . .

Offer has a whole chapter explaining the ways in which high levels of competition, stress, and inequality in American and British society contribute to compulsive, mindless, or otherwise unhealthy eating.

Kudos also to Cass Sunstein for exploring the issue in his review of Brian Wansink’s diet book Mindless Eating . Bottom line:

Wansink has concluded that much eating is mindless. Americans are fat not because they have made a rational calculation that French fries are so yummy that they are worth the costs in health and svelte. Nor are French fries essentially irresistible. Often Americans eat because of contextual cues, or “hidden persuaders,” to which they are blind, but which greatly affect their behavior. . . . Wansink’s real subject is choosing, not eating, so even thin people should read it.

Philosophers ranging from Aristotle to Dewey recognized the ultimate importance of habit, and Wansink brings their insights into a world of diet fads sorely in need of philosophical perspectives.

So what’s the bottom line for law? Well, given the insights of Offer and Wansink, the agenda for regulation currently pushed at The Situationist makes a lot more sense.

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Your money or your life

A flurry of scholarship on Lochner v. New York surrounded its 100-year anniversary in 2005. It’s clear why Lochner gets so much attention. But as a matter of constitutional doctrine, I wonder if we pay insufficient attention to the stealth anti-Lochner, Jacobson v. Massachusetts. The two U.S. Supreme Court opinions were announced just a few months apart, Jacobson in February 1905 and Lochner in April. Both involved claims of individual liberty pitted against public health laws—a mandatory vaccination law in Jacobson, a limitation on work hours (as well as regulations of working conditions) in Lochner. But the outcomes could hardly be more different. Jacobson embraced a broad police power to use coercion to ensure public health; Lochner infamously struck down restrictions on bakers’ working hours as a violation of economic liberty. (Justice Peckham dissented in Jacobson and wrote the Lochner majority opinion; Justice Harlan dissented in Lochner and wrote the Jacobson majority opinion.) Lochner didn’t last, of course, but for a while it seemed that the state could use coercion to protect your life (or health) only if it didn’t mess with your money along the way.

I’ve been thinking about Jacobson and Lochner as I work on an article about the state’s interest in the preservation of life. Jacobson (and maybe, to some degree, the renunciation of Lochner) reflects a widespread assumption that the state has such an interest and may use coercion against citizens’ bodies to further that interest. So we see Jacobson cited in abortion cases to support the state’s interest in the preservation of fetal life, in refusal of medical care or “right to die” cases, and to support indefinite civil commitment (Kansas v. Hendricks) or indefinite detention (Justice Thomas’s dissent in Hamdi v. Rumsfeld) in the name of public safety. In fact, Jacobson has been cited by the Supreme Court more often than Lochner, and the Jacobson references are almost universally favorable while the Lochner references are usually not. A pedagogical question: Should Jacobson get more attention in constitutional law casebooks? And a political / philosophical question: Is it so obvious that the state has an interest in preserving individual lives—especially those of individuals who do not themselves wish to continue living?

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The Death Spiral

Uninsured.jpgAccording to a new Gallup Poll, 69 percent of Americans believe that “it is the responsibility of the federal government to make sure that all Americans have health care coverage,” 10 percentage points higher than in 2000. Law conferences at Hamline, Cumberland, and Kansas have focused on innovations in state health care this academic year. What has happened in the past 7 years to make comprehensive health care reform more of a “when” than an “if”?

I think Sered and Fernandopoulle’s book Uninsured in America provides some excellent answers. They tell the stories of ordinary Americans devastated by lack of health coverage. Consider the story of Kim, whose uncontrolled diabetes may be a prelude for critical illness:

Untreated diabetes not only makes her feel worse day to day but also hastens the onset of the serious complications the disease can cause. Because she is unable to monitor and manage her blood sugars and get recommended preventive care, she is at high risk for premature blindness, heart disease, limb amputations, and kidney failure. Standard medical treatment aims to prevent or at least significantly forestall such outcomes, but Kim does not see a way to access standard treatment.

Apropos of Dan’s post below, Kim’s story also show how the market drives dominant employers to slash benefits: Walmart, for instance, “has cut health costs per worker to $3,500 per year, fully 40 percent less than the US average . . . and 30% less than the average paid by other retailers” (34). Here’s how Kim’s employer, Walgreens, fattens up the bottom line:

Kim works part-time at a Walgreens drugstore. Though she isn’t thrilled with the work (which doesn’t utilize her college training), she would agree to work full-time, except that Walgreens isn’t hiring full-time employees either. Kim explained that she tried working more hours there after her boss told her that she would need to work full-time for twelve weeks in order to be eligible for insurance. But when she approached the twelve-week mark, her hours were cut, making her ineligible for insurance.

On a personal note–my father was an assistant manager at Walgreens, and saw that sad story played out more than a few times by managers driven to “beat last year’s numbers.” Moreover, after he was recovering from a broken leg, his boss there repeatedly forced him to do work that would be painful and exhausting for him (and easily assigned to others at the store)–almost certainly in an effort to get rid of him, since his seniority made him one of the higher paid workers there. It’s “just business” for the companies–they really can only expect to be undercut by competitors if they try to be more humane.

These market realities have led more and more Americans into (or to be aware of) a “death spiral” of lost employment, lost insurance due to that lost employment, and future inability to find work due to poor health. As Sered and Fernandopoulle explain:

Because employment and health insurance are tightly linked, job disruptions such as layoffs or firings, starting one’s own business, or taking time off to care for small children or elderly parents can lead to the loss of health coverage. That loss can easily lead to health concerns going untreated, a situation that can exacerbate employment problems by making the individual less able to work. Alternatively, the downward spiral can begin with health problems that lead to employment problems, making it less likely that one will have health insurance and thus reducing the chances of solving the original health issues.

If we see universal health insurance after 2008, I think it will be largely because of fear of such a death spiral. Americans are, by and large, willing to accept the vagaries of a globalization that destabilizes incomes and reduces job security. But they are not willing to die for it.

Pharmaceutical Law Symposium

I just wanted to invite readers in the greater NYC region to the Seton Hall Law Review’s symposium on pharmaceutical law tomorrow (Friday, Feb. 16). We’ve got some interesting panels lined up, and the general counsel of HHS (Daniel Meron) will be giving the keynote.

The Symposium will focus on how the FDA’s drug approval process affects public health, intellectual property protections, and the economy. Panels will explore the FDA’s role in determining whether a drug is safe and effective for its intended uses and how its approach addresses public health needs, affects research and development, and influences insurance coverage decisions.

We’ll also have a panel on global public health, including Terry Fisher, Shamnad Basheer, and me. My presentation, inspired in part by this Laurie Garrett article, will focus on the public health infrastructure necessary to assure the proper distribution of drugs in LDCs.

Competing Ourselves to Death

In the run up to the Superbowl, the NYT has a disturbing story on the fate of Ted Johnson of the New England Patriots. Johnson suffered several concussions while playing and now suspects that they have permanently diminished his mental capacity. Johnson’s case is not isolated, and is leading to worries about “the N.F.L.’s record of allowing half of players who sustain concussions to return to the same game.” What’s next, the return of the flying wedge?

From a brute lawyerly perspective, the controversy raises some interesting issues. Are coaches and trainers negligently encouraging the injured to play? Could the players sign away any right to sue their teams (or the league) in cases like these? Might some political pressure need to be brought to bear here, like that which finally got baseball to face up to its steroid mess?

From a broader social perspective, other concerns arise. I’m presenting tomorrow at the Int’l Association of Science and Technology Studies on biotechnological enhancement that raises cognate issues. I’ll address a potential inversion of the traditional relationship between technology and values. Usually we think of values as guideposts that allow us to judge the worth of certain technological advances. But what happens when technology itself alters our cognitive capacities? Can it undermine our values? Certain drugs, trainings, or even game strategies might blunt or otherwise obscure our understanding of the world and ourselves. If we share Martha Nussbaums’s account of emotions as judgments of value, might these so-called performance-enhancements diminish the possibility of our rightly discerning our ends?

Any sporting pursuit that requires its participants to systematically risk their health in competition is troubling. But concussions like Johnson’s are doubly so, since they appear not merely to diminish or distort cognition, but to compromise one’s ability to even recognize the diminution taking place. The difficult question for regulators of various performance-enhancing neuropharmacological interventions is whether they have the potential to blunt users’ perceptions of the deep changes they wreak in users themselves. Substance addiction has been modeled as a case of “increasing marginal utility,” where the more one uses, the more one wants. New neural performance enhancement addiction might work in a far subtler way–by blunting the appeal of alternate sources of value and satisfaction.