Category: Health Law

1

Regulating Assisted Reproduction

06fertilizadoAnxiety arises from technological advances in the life sciences, and there is often uncertainty about what societal response is appropriate. Are we more likely to condone euthanasia as technology for prolonging life improves? Should we support the cloning of human embryos for research purposes even if we reject reproductive cloning? It is a common sentiment that legal regulation is a useful tool for fashioning rules about scientific activities and medical interventions. But in legal circles, we are not shy about questioning the limits of our discipline. The bulk of the literature examining law’s limitations explains that these limitations are most salient in times of crisis or upheaval, e.g., war, terrorism, or epidemic disease. All of these are phenomena with a significant public dimension. Although less theorized, law’s limitations are also evident in the more quotidian realms of human experience that have a significant private dimension—sexuality, substance abuse, prejudice, just to name a few. Fantasies of thought control aside, some scholars have theorized that law is uniquely unsuited to channelling attitudinal and libidinal expression, e.g., prostitution, and invidious discrimination. We know from vast experience that attempts to regulate these activities out of existence only drive them further underground, often with troubling consequences.

In the context of biotechnology, assisted reproduction is perhaps the area that inspires the widest range of voices calling for regulation and thus provides the most suitable subject matter for an exploration of the limits of the law in the regulation of technological advancement in the life sciences. Unlike the clashing interests of doctors and their patients or scientists and their research subjects, the creation of children through technological means triggers a wider range of responses by social groups and the political actors who serve them than do other applications of biotechnology. This may explain the wide range of regulatory responses to assisted reproduction around the world, from the “hands-off” approach of the United States to the prohibitive approach of countries in Europe, Asia and South America. What makes regulating reproductive technology difficult is that it exists somewhere between the extremes of public and private. On the one hand, it is dramatic and transformative in a public way, demanding the expenditure of public health and judicial resources; on the other hand, it transforms within a realm considered deeply private—the creation of families. The resulting tension is one that counsels some form of response but that simultaneously shies from intruding in a realm deemed sacrosanct—the choice whether to have a child. Thus, the question is not whether to regulate reproductive technology, but how.

 

A Strange New Front in the Medicalization of Penality

The headline says it all: “Cops Subject Man To Rectal Searches, Enemas And A Colonoscopy In Futile Effort To Find Drugs They Swear He Was Hiding.” We can at least hope that Rochin has some applicability to colonoscopies.

But the Supreme Court has “upheld invasive strip searches even for those charged with the most minor crimes—–including unpaid traffic fines.” Perhaps the drug war will lead to new job opportunities for medical professionals willing to ensure that various police or military interventions don’t cross the line into Rochin territory.

A Very Smart Take on PPACA

The narrative of President Obama’s quest for universal health care reminds me of Hemingway’s Old Man and the Sea: the prize catch of March, 2010 has been nipped and nicked for over 3 years, as SCOTUS, House Republicans, neoliberal regulators, and various other opponents degrade parts of it. Some of Obama’s political opponents are celebrating the botched rollout of HealthCare.gov. But as Mike Konczal observes, they should be careful what they wish for:

[T]his failed rollout is a significant problem for conservatives. Because if all the problems are driven by means-testing, state-level decisions and privatization of social insurance, the fact that the core conservative plan for social insurance is focused like a laser beam on means-testing, block-granting and privatization is a rather large problem. As Ezra Klein notes, “Paul Ryan’s health-care plan — and his Medicare plan — would also require the government to run online insurance marketplaces.” Additionally, the Medicaid expansion is working well where it is being implemented, and the ACA is perhaps even bending the cost curve of Medicare, the two paths forward that conservatives don’t want to take.

On the other hand, some aren’t chicken about bolder visions of health reform.

Kludgeocracy in America

The PPACA rollout has been termed a disaster (at least on the federal level). What went wrong? Both firms and governments find big software projects hard to manage. The federal procurement process is a mess. But perhaps the biggest problem is the level of complexity that American politics & law imposed on the project.
As Garance Franke-Ruta observes:

Obamacare was damaged at the outset by the political tug-of-war over its very existence, and the conflicts at its creation have had serious downstream effects, placing the federal government in charge of far more than it was supposed to be doing. It also has also suffered from what Johns Hopkins University political scientist Steven Teles calls “kludgeocracy”—the tendency of interest groups, lobbyists, bureaucracy, and bad management to combine to create highly complex legislation and giant public-administration kludges, a term defined as “an ill-assorted collection of poorly-matching parts, forming a distressing whole.”

That is what Obamacare is proving to be, though it has its bright spots, too among the 14 state exchanges. The law passed in March 2010, but final rules governing how the exchanges were to work were not issued until March 2013. A bid from the main IT contractor, CGI Federal, was accepted in September 2011, but the company did not start critical work until this spring because it was waiting for specifications from the government, leaving too little time to troubleshoot the enormously complex systems CGI and others were setting up.

It’s hard to believe that the whiz kids behind NSA data gathering and analysis couldn’t have done some good here. HealthCare.Gov cost less than 1% of spy agencies’ budgets. But to suggest health IT should command even a fraction of the resources of the intelligence apparatus is a heresy in Schmayek‘s Town.

Wellness Controversies Continue

Professor Jill Horwitz has coauthored a very troubling critique of workplace wellness programs, characterizing them as a possible form of cost-shifting to unhealthy workers:

[H]ealth-contingent programs encouraged by the Affordable Care Act rely on the assumption that the returns to health improvement are generally highest for employees with modifiable risk factors, such as an unhealthy diet or a behavior like smoking.

To assess these three assumptions, we reviewed research on the relationships among financial incentives, behavior, health status, and medical spending. We focused on randomized controlled trials involving four conditions—smoking, hypertension, high cholesterol, and obesity—that are typically included in health-contingent programs.

In our review, we found mixed evidence that employees with these conditions have higher health costs than other employees, which undermines the argument that employees with the conditions are particularly effective targets for incentives. We also found little evidence that working-age people change their behavior as a result of financial incentives, particularly over the long term.

These findings suggest that program savings may not, in fact, derive from health improvements. Instead, they may come from making workers with health risks pay more for their health care than workers without health risks do. Read More

Wellness Programs: The Face of Corporate Paternalism?

Wellness programs are running into resistance at Penn State. As the Harvard Business Review blog notes,

Penn State University’s wellness program has become every human resources director’s worst nightmare: national news. . . . [E]ven the major academic proponents of conventional wellness programs don’t think they save money, that vendors make up savings numbers, that the screens they insisted upon can’t even theoretically save money and a whole body of research opposes them, and that all the extra preventive doctor visits they required were useless

The fusion of the nanny state and the nanny corporation is not a pretty sight.  Professor Wendy Mariner recognized problems with wellness programs years ago; too bad more employers aren’t heeding her work.

7

Delaying the Implementation of the Affordable Care Act

I have a question for health law folks or administrative law experts.  (I am neither.)  Exactly where is the Administration getting its legal authority to delay various provisions of the Affordable Care Act?  Does the statute have some catch-all provision that addresses this?  Do the particular provisions in question give HHS that power?  If it is not in the statute, then how can this be done?  Is impossibility a valid reason for delaying a statutory mandate with a deadline?

5

Diabetic Kids, All Kids, and School Nurses

Much to the relief of many parents whose children have diabetes, the California Supreme Court ruled recently in American Nurses Ass’n v. Torlakson that insulin shots can be administered by school personnel who volunteer and get trained for the job. School nurses, the court ruled, are not required under state law. That’s a good thing for the kids who attend the 95% of California public schools that have no fulltime school nurse. It’s good for their parents as well, since some schools were telling parents to come to school to give their kids their shots, something most employed parents had difficulty doing without upsetting their employers.

But to say, as the American Diabetes Association does, that the decision should make parents of diabetic kids feel confident that their child is in good hands at school is a bit of an overstatement. Whether they can get a routine shot of insulin isn’t the only health issue that kids with diabetes face during the school day. Some will face emergency health issues specific to diabetes, including hypoglycemia and hyperglycemia. Sometimes, it may take someone with medical training to know whether a shot should be administered at all or if it’s time to do something else, such as calling the ambulance. Diabetic kids also face health issues that other kids face. Like other kids, they fall off of climbing equipment and run into each other, and they may need to be assessed for concussions. Like other kids, they may get too hot when their team is practicing in hot weather, and someone with training will know best whether to get emergency medical care.  Like other kids, they may get sick at school and need to be assessed for whether they need an hour on a couch or a call to a parent. Just as important, someone needs to figure out if it’s time to sound the alert about a communicable disease at the school.

The California legislature apparently decided that school nurses aren’t necessary because of the expense. And indeed it may be difficult to justify spending money on nurses when paying for teachers sometimes seems like a luxury. But what the parents of those California kids with diabetes know, as does the American Diabetes Association, is that a nurse is a better and safer alternative for the kids than a volunteer staff member, even one who is trained. Looking carefully at the diabetic kids, further, helps us understand that school nurses are a very good idea for all of the kids, not just those with chronic conditions. This happens a lot when a person has a disability – solving that person’s problem can improve the lives of others. (Think about curb cuts for wheelchairs the next time you’re pushing a stroller or pulling a piece of luggage on wheels.) All parents, not only those with diabetic kids, need to have confidence that someone at the child’s school is capable of paying attention to serious medical issues. It’s a good issue for parents to join together to solve.

 

6

Injured Kids, Injured Parents and Tort Law

When a child suffers a long-term or permanent disability because of someone’s negligent or even intentional act, the child is not the only one whose life changes. The child’s special health care needs become part of the daily caregiving routines of the parents. Those needs might include, for example, taking the child to medical appointments, interacting with health care providers, delivering medical and other therapies, working with a school to develop an educational plan, advocating with social service agencies, etc. On average, a family caregiver for a special needs child spends nearly 30 hours a week caring for the child in ways that other parents don’t confront. Most of the caregiving parents are mothers, and most of them either leave work altogether or reduce their hours of work significantly. Other consequences that caregiving parents face include mental and physical health problems, social isolation, and the deterioration of family relationships.

Let’s say the child’s injuries result from a car accident or from medical malpractice. Does the law require the driver or the doctor to pay damages to the parents for the changes in their lives? Damages for direct costs, such as medical bills, are always allowed. When caregiving reduces the parent’s earning capacity, some states recognize claims for the parent’s lost wages. In others states, responsibility is limited to the cost of employing an unskilled medical aide. In the last group, the tortfeasor owes nothing to the parents.

I call the three approaches “20/20,” astigmatism, and blindness. “20/20” applies to situations where the child is viewed realistically, that is, as a person who, by reason of age and experience, is dependent on parents for direct care and for interacting with the outside world. Law and policy suffer from astigmatism when the child’s connection and dependency are acknowledged, but the consequences that parents face are blurred. (I’ve got astigmatism and can testify to the blurriness!) Blindness is what happens when, as one court argues, parents are responsible for their kids, no matter what – no sharing of costs is appropriate, regardless of the fact that the child would not need unusual caregiving but for the tortious injury.

In my current work, I’m trying to explain why many courts suffer from blindness or astigmatism. One reason is gender. Caregiving is considered women’s work, and women should do it with happiness and generosity, so their losses should not be monetized. If any loss is acknowledged, it should only be those losses that a man might also experience, that is, paying someone else to do the caregiving. Since, for reasons of both gender and race, we pay very little for caregiving jobs, it makes sense to compensate the caregiving parent (i.e., the mother) at the same small rate. Another reason is a lack of foreseeability – perhaps tortfeasors shouldn’t be expected to anticipate that injuring a child would affect a parent’s life, so it isn’t fair to make them pay damages for that harm. This perspective is consistent with a general lack of awareness about the lives of people with disabilities and the lives of their families. That degree of ignorance may have grown over the last half century in light of radical changes in social, legal, and cultural practices around health care generally and disabled kids in particular. Family caregivers now deliver much more medical care at home, for example, and the medical regimes of their special needs children are often more complex. Also, happily, more disabled children are living at home rather than in institutions, and many more are surviving into adulthood and beyond. At the same time, more mothers are now working outside the home. Many parents raising special needs children are doing it alone, so, if a mother has to meet the unusual demands of caring for a child with special needs, her chances of losing her job and falling into poverty increase. A third reason may be horizontal equity. The unusual caregiving demands of special needs children depend on the child’s characteristics, not on whether the source of the child’s special needs is a tort. Covering the lost wages of parents of tortiously-injured children puts those families at an economic advantage compared to families of other special needs children.

I look forward to hearing your thoughts on which of the three rules seems to make the most sense, and why.

 

When “Skin in the Game” is Literal

Back in the Bush years, health policy was all about making sure patients consumers had “skin in the game,” and faced real costs whenever they sought care. More cautious voices worried that patients often didn’t know when to avoid unnecessary care, and when failure to visit a doctor would hurt them. Now there is renewed evidence that the cautionary voices were right:

One-third of US workers now have high-deductible health plans, and those numbers are expected to grow in 2014 as implementation of the Affordable Care Act continues. There is concern that high-deductible health plans might cause enrollees of low socioeconomic status to forgo emergency care as a result of burdensome out-of-pocket costs. . . .Our findings suggest that plan members of low socioeconomic status at small firms responded inappropriately to high-deductible plans and that initial reductions in high-severity ED visits might have increased the need for subsequent hospitalizations. Policy makers and employers should consider proactive strategies to educate high-deductible plan members about their benefit structures or identify members at higher risk of avoiding needed care. They should also consider implementing means-based deductibles.

To put this in more concrete terms: “skin in the game” for many poor families may mean choosing whether to “tough out” a peritonsillar abscess or appendicitis, knowing that the temporary pain may allow them to pay rent, but also may lead to sepsis, necrosis, peritonitis, or death. As Corey Robin has observed, there is a philosophical vision affirming the imposition of such choices, but it’s not utilitarian:

By imposing this drama of choice, the economy becomes a theater of self-disclosure, the stage upon which we discover and reveal our ultimate ends. It is not in the casual chatter of a seminar or the cloistered pews of a church that we determine our values; it is in the duress—the ordeal—of our lived lives, those moments when we are not only free to choose but forced to choose. “Freedom to order our own conduct in the sphere where material circumstances force a choice upon us,” Hayek wrote, “is the air in which alone moral sense grows and in which moral values are daily re-created.”

For some, the choice is between investing in gold or cryptocurrencies; for others, between searing pain and eviction. But the market, in the “skin in the game” vision, is at least distributing these opportunities for self-disclosure through choice to all.