Yearly Archives: 2013

Don’t Get No Respect: Defining the Field of Public Health Law

Dec 17, 2013 Elizabeth Weeks LeonardAdd a Comment

In a methodical, comprehensive exposition, Micah Berman’s forthcoming article considers why public health law remains the Rodney Dangerfield of the legal academy. As a member of a working group of scholars and practitioners who share the mission of advancing the prominence of public health law, I am well versed on the issue but was enlightened by Berman’s insights. I especially appreciated that he began by begging his own question: What difference does it make to recognize public health law (or any other area of law, for that matter) as a “field”? Why it matters, he answers, is respect: For an area of law to be recognized as “field” is to be in the mix of law school hiring priorities, to headline symposia and conferences, and generally to be taken seriously within the academy and practicing bench and bar.

Berman’s article is exceptionally well organized, stepping through difficult foundational questions, clearly explaining the paradigms, testing those paradigms with other examples, and engaging the leading scholarship on the problem presented. His roadmap proceeds by: (1) Defining a field of law; (2) defining public health law; and (3) evaluating whether public health law is a field of law.

To frame his first question, “What is a field of law?,” Berman carefully sets out two alternative rubrics. The first is Todd Aagaard’s two characteristics: (1) commonality and (2) distinctiveness. The second is Ted Ruger’s more traditional test: (1) a reductionist focus on internal logic; (2) a focus on essential legal form; (3) an emphasis on linear historical development, and (4) a high level of institutional specification and centralization. Underlying both schema are prescriptive and descriptive approaches; members of the field might share a normative perspective or might simply write and teach the same subject matter.

Before applying the definitional rubrics to public health law, Berman applies them to two other relatively recently recognized legal fields: environmental law and health law. Descriptively, each of those fields involves common subject matter but neither offers a distinct analytical perspective on the law. Prescriptively, environmental lawyers may seem to share the goal of protecting natural resources and future generations. But Berman finds that suggestion under-inclusive of existing environmental law scholarship. For health law, it is even harder to identify a shared normative perspective, with scholarship presenting a range of social justice, patient autonomy, economic, and other analyses of the law. Both environmental law and health law lack universal organizing principles or unique methodological approaches.

Tellingly, Berman finds health law even harder than environmental law to defend as a field under either Aagard’s or Ruger’s characteristics. That admission should give pause. If health law does not meet the definition of a field of law, how can an arguable sub-topic, public health law, possibly receive that recognition? Yet Berman ultimately concludes that the volume of scholarship and active debate regarding the definition of health law is sufficient to establish it as a field. So concluding, Berman unfortunately sidesteps his otherwise careful analysis, effectively suggesting that if enough people are doing it, or wanting it to be a field, then it is a field.

Berman hits his most comfortable stride in answering his second question, “What is public health law?” He begins where many of us do, with Larry Gostin’s definition, ultimately tweaking and simplifying it to a more manageable mouthful. Gostin is widely credited with giving academic gravitas to the public health law renaissance at the beginning of the millennium and continuing the mission of bringing coherence and distinctiveness to the “field” in the post-9/11, post-Katrina, post-Bloomberg era. As Berman notes, Gostin’s recent revisions to his seminal texts, strike a notably more prescriptive cord, defining as public health law’s “prime objective,” the pursuit of “the highest possible level of physical and mental health in the population, consistent with the values of social justice.” Berman acknowledges that this more strident tone is likely to turn off those who do not share Gostin’s objectives and who resist more invasive government action, or “nanny state-ism.”

Ultimately, Berman concludes that the key to defining public health is its population-based perspective. This view exposes the hyperindividualism that characterizes much American legal discourse and instead focuses on populations, rather than individuals, as the primary objects of law and policy. Berman aptly notes that Wendy Parmet has done extensive work infusing traditional areas of law, especially constitutional law, with public health’s population-based perspective and scientific methodologies. He would go further and include the population-based perspective as a defining element of a separate field, not merely an analytical approach applicable to already recognized fields. Berman’s streamlined, “workable” definition of public health law starts with Gostin, including the reference to social justice, but not as the field’s “prime objective.” He adds Burris’s notion of “incidental” public health laws (e.g., land use) and Parmet’s focus on population health and public health science.

Finally, Berman turns to his third question, “Is public health law a field of law?” He readily concedes Ruger’s “traditional” test unmet but finds Aagaard’s two characteristics more easily satisfied. The population-based perspective is critical, establishing public health law as not merely a field addressing common subject matter – Aagaard’s “commonality” prong. That approach also offers, if not unique legal rules or doctrine, a distinct value and concern of the law – the “distinctiveness” prong. Moreover, public health law’s reliance on epidemiological and social science methodologies distinguishes it from traditional legal analysis. The population-based perspective also answers the question whether public health law is a field separate from, or merely a subfield of, health law. The two are “direct opposites” in many ways, urges Berman. Public health law focuses on disease prevention and population-level interventions, while health law perpetuates an individualistic focus on medical care and the patient-provider treatment relationship.

Although Berman ultimately concludes that public health law does not entirely satisfy any formal definition of a legal field, he finds promise in the proliferation of public health scholarship, centers and programs, and course offerings across the country. As with health law, he suggests that more people doing public health law brings it closer to the respect and legitimacy that fields of law enjoy.  But it is not clear how a deeper public health law infrastructure would establish it as a “field” under the tests that Berman sets out at the beginning of the article. A more satisfying conclusion, after finding Aagaard’s and Ruger’s tests inadequate to the task, might have been for Berman to define an alternate approach applicable to emerging, interdisciplinary areas like public health law.

A Big Picture View of What Could Be Done About the Institutional Corruption of Medicine

Nov 15, 2013 Christopher RobertsonAdd a Comment

Since long before his 2011 Oxford University Press book that takes a comparative approach to the problem, Marc Rodwin has been a leading voice in the debate around the pharmaceutical-healthcare industrial complex, and the conflicts of interest that it perpetuates. In his latest contribution in the Journal of Law, Medicine, and Ethics (JLME), Rodwin wisely moves from the language of ethics—which finger-waggingly suggests an individualism of bad guys and good guys—to the language of “institutional corruption.” Rodwin writes that, “in the past, physicians and scholars typically conceived of conflicts of interest as an ethical issue to be resolved according to individual judgment or professional and organizational norms. However, society can mitigate or eliminate conflicts of interest by changing financial and organizational arrangements in medicine.” Larry Lessig has encouraged this sort of move from individuals to institutions in his own work, and in his leadership of the Institutional Corruption Lab at the Edmond J. Safra Center for Ethics at Harvard, where Rodwin is a lab fellow. (Disclosure: I receive support from the Lab too).

Institutional corruption is useful as a lens to understand these problems because it directs us to examine the two-way economy of dependence. To the extent that incentives matter in our world of rational actors, an economy of dependence is an economy of influence. Rodwin notes that the pharmaceutical industry depends on public support in the form of tax subsidies, patent law rules, and other incentives. It is a strange exchange relationship, one where our government gives tax breaks for research and marketing, and even enforce a monopoly, for any new chemical compound invented by a drug company. It does so to the same extent, regardless of whether the new chemical is a cure for cancer or a “me too” drug, which makes no real improvement to clinical care. On the other hand, Rodwin identifies several ways in which the public, physicians, and patients now rely on drug companies. Pharma—not the Food and Drug Administration—sets its own priorities for drug development; designs and conducts the clinical trials that demonstrate safety and efficacy; monitors adverse drug reactions; and finances continuing medical education (CME), medical societies, and journals.

Rodwin gives us a big-picture agenda for reform, in a punchy article that takes full advantage of the short and lightly-footnoted format of JLME, to stay out of the weeds. His self-titled “agenda for reform,” includes everything from changes in patent length (to calibrate with degree of innovation) to new funding for National Institutes of Health research grants to explore drug safety and efficacy, funded by a small tax on drug company sales. Rodwin also revives a proposal from the 1970s, which would have required that drug companies pay for clinical trials that are actually conducted by the FDA, thus minimizing bias (assuming regulatory capture does not just replicate the problem). He argues for expansion of the mandate for disclosure of clinical trial data, to combat the publication bias that currently infects biomedical journals, and repeal of the tax deduction for marketing of pharmaceuticals, given the evidence that it is often inaccurate. He also seeks to tax the healthcare industry to support CME, medical societies, and journals, rather than making them subservient to commercial interests.

What I like about Rodwin’s article is that it is a concentrated indictment of the status quo, paired with an equally efficient proposal for comprehensive reform. In these 10,000 words, Rodwin has delivered the critical yet constructive agenda for reform, which has until now been scattered across hundreds of disparate scholarly reviews, academic books, Congressional hearings, and Office of Inspector General reports. As Rodwin acknowledges, “the details of the reforms suggested in this article need to be worked out, the proposals have limitations, and there are certainly alternative ways to reduce improper dependency on pharmaceutical firms.” Indeed. And, there is much to be said about the political economy of such reforms: I would be the last to suggest that we could levy new taxes on a humongous industry, and tinker with patent law, with a mere stroke of the pen.

But every now and then, it’s nice to have the broad outlines of a comprehensive package of reforms articulated in a single compelling statement. If nothing else, Rodwin has provided us with the regulatory ideal of what a coherent policy might aspire towards.

Harnessing the Power of Comparative Effectiveness Research for More Rational Health Care Financing

Oct 16, 2013 Amy Monahan

Nearly all health insurance contracts currently sold in the U.S. cover all medically necessary, non-experimental services, subject to only specifically listed exclusions. As a result, the coverage provided is what those in the benefits industry would refer to as “rich” coverage. If the treatment is non-experimental and is expected to have a positive clinical benefit, no matter how small, it is covered regardless of cost. This rich coverage leads to some predictable problems. Because individuals typically have little incentive to decline treatment that might benefit them, utilization is high and costs rise accordingly. This, in turn, makes health insurance more expensive for all purchasers. Our health system has tried to remedy this issue by adopting managed care structures to create incentives for providers to limit utilization of a treatment where it has only marginal benefits. And, more recently, consumer-driven health care has been developed to create incentives for patients themselves to reduce utilization of marginally beneficial treatment.

Russell Korobkin’s new article seeks to address this well-known problem through a novel use of comparative effectiveness data to create health insurance contracts that only cover services that provide a given level of cost effectiveness.  He refers to this type of insurance as “relative value health insurance.” The basic idea is to start with an index of treatments based on cost-effectiveness, with a proposed scale of 1 for highly cost-effective treatments to 10 for treatments with low cost-effectiveness. Health insurance contracts could then be sold based on the level of cost-effectiveness they will cover. For example, insurers might offer a policy that covered all treatments with a rating of 3 or above for $X, while charging significantly more for a policy that covers all treatments with a rating of 7 or above. Korobkin’s basic argument is that relative value health insurance would greatly simplify an individual’s tradeoffs between medical care and competing goods and services.

The idea of offering a health insurance contract that provides a lower level of coverage for less money is not new.  But while there has been theoretical interest in these “pay less to get less” contracts, no one has yet come up with a practical way for insurance companies to structure such contracts, particularly to structure them in such a way that consumers could meaningfully shop for and compare policies. Professor Korobkin’s proposal seeks not only to create a reasonable way to buy “less” health insurance, it also relies on behavioral insights to create a choice architecture that will allow consumers to make meaningful choices, or at least better informed choices, than are possible under current contract structures.

I admit to being skeptical initially of this basic proposal. In particular, I wondered whether any insurance purchaser would actually want to buy insurance that provided perhaps less-than-complete coverage based on cost-effectiveness. What if you develop a life-threatening illness and the treatment your physician tells you is necessary to give you the greatest chance of survival happens to score low on the cost-effectiveness scale? Korobkin’s reply to this concern, which I found helpful, was to make an analogy to car purchasing decisions:

“Few people purchase the safest possible car, completely ignoring the tradeoffs this would entail, as they would do if they were truly to adopt a non-compensatory decision strategy that refused to trade off health and safety against other product attributes. In this sense, the relative value health insurance purchase decision would probably look much the same to most consumers. The promise of infinite and unlimited medical care would be nice to have, just as the safest care that technology can produce would be nice to have. The reality, however, that resources are scarce and dollars spent on medical care cannot be spent on other things likely would encourage boundedly-rational decisionmakers to employ a consciously compensatory decision making approach, leading to more efficient resource allocation decisions.”

There are clearly big hurdles to implementing a system of relative value health insurance, most of which Korobkin acknowledges. First and foremost, we would need to have the data necessary to construct a meaningful index of cost-effectiveness.  While the Affordable Care Act funds the Patient-Centered Outcomes Research Institute (PCORI) in order to generate better data to support evidence-based medicine, we may be decades away from having sufficient data to make a relative value index possible.¹ And once we have the necessary data on outcomes, we’d need to agree on the methodology for converting the data into an easy to understand cost-effectiveness index. Assuming we could get the index up and running, there are also significant adverse selection problems with relative value health insurance that would need to be thought through and addressed.

To be clear, the article does not present a ready-made perfect solution to growing health care costs that can be implemented tomorrow. Indeed, there are many details that would need to be thought through and ironed out.  But the reason this article is important is that it gets the ball rolling on needed discussions of how we can allow consumers meaningful choice in health insurance without simply suggesting that costs and burdens should be shifted to consumers. And it does so using thoughtful insights from behavioral law and economics, and by proposing a system that will take advantage of the clinical outcomes data to which we should (relatively soon) have access.

Medicare’s Design Flaw

Sep 16, 2013 Nathan Cortez

Medicare is a behemoth. But the legal literature on it is almost negligible by comparison. Only a few scholars tackle Medicare broadly, like Ted Marmor, Tim Jost, and David Hyman. Most articles (like Jacqueline Fox’s two must-read articles on coverage decisions), tackle discrete problems with Medicare. And there is no shortage of those.

It takes a fair bit of pluck to confront Medicare’s design flaws, as Nicholas Bagley does in Bedside Bureaucrats. Bagley applies administrative law sensibilities to argue that Medicare can’t implement its programmatic goals in large part because it relies on decentralized administration by private insurance contractors and, more importantly, by hundreds of thousands of private physicians as “street-level bureaucrats.”

One of the article’s major contributions is observing that private physicians run Medicare on the ground: they judge whether treatments are eligible for reimbursement; they certify whether Medicare will pay for hospital stays; and they diagnose conditions that determine how much Medicare pays for treatment. In administrative law terms, each participating physician is an “adjudicator”—making judgments about which Medicare beneficiaries need which care under which circumstances. But the Medicare statute, according to Bagley, “deprived federal administrators of the conventional roster of legal and management tools typically used to control frontline bureaucrats.”

Deference to private physicians highlights a persistent tension in Medicare. The very first words in the 925-page Medicare statute declare that “Nothing … shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine….” As Bagley notes perceptively, these words from the original 1965 statute describe the root of Medicare’s biggest problems: cost and quality controls. Bagley argues—and many agree—that fixing Medicare requires us to “adjust physician practice patterns.” But Medicare’s design creates a conflict between competing public values: Medicare was designed to preserve physician autonomy and patient choice; but those two values now hamstring our efforts to rein in costs and impose quality controls.

Not surprisingly, Bagley observes, four decades of reforms have not changed Medicare’s basic administrative design. Instead, they skate the periphery. For example, in 1972, Congress tried to influence physician practice patterns and combat Medicare fraud by creating peer review organizations. But these were controlled by private physicians. Then, to battle overbilling under fee-for-service payments, Congress adopted a physician fee schedule. But instead of allowing Centers for Medicare and Medicaid Services (CMS) to make hard choices, Congress outsourced the duty to a committee run by the American Medical Association. When Congress experimented with Medicare managed care, it turned to private insurers. But Medicare Advantage and its precursors are considered to be colossally expensive failures. Finally, when Medicare decides whether to cover new technologies, it largely defers to local coverage determinations (LCDs) made by private contractors who do not have the capacity or incentives to enforce them.

Instead of equipping CMS to manage Medicare more effectively, Congress has preferred outsourcing administration to private organizations. If CMS is Medicare’s centrifuge, it is a weak one. Again, this is by design. Bagley emphasizes that outsourcing administration “absolves the federal government of direct responsibility for controlling physicians and, in bypassing agency officials, mutes public concerns with government interference.” What makes Medicare palatable also makes it unsustainable.

Another important contribution here is emphasizing the administrative importance of scale. Medicare spends more on private sector services ($502 billion) than all other federal contracts for goods and services combined ($450 billion). It pays for services provided by hundreds of thousands of physicians to almost 50 million beneficiaries, processing 4.8 million claims per day, and 1.2 billion per year. The task of managing anything of this scope is hard to imagine.

CMS is a small, virtually unknown agency, “with a staff about the same size as that of the Smithsonian Institution,” managing “a Medicare budget that exceeds the size of Argentina’s economy.” In turn, Medicare is good at doing one thing: providing prompt payment. It is not good at meaningful oversight, or, more importantly, influencing physician practice patterns. Instead, physicians define and legitimate Medicare, not the other way around, as it is with most agencies (here, Bagley invokes Jerry Mashaw).

Congress designed Medicare to protect private prerogatives, and now genuine reform efforts are hamstrung because of it. Bagley appreciates that Congress cannot simply turn CMS into a massive bureaucracy that suddenly micromanages hundreds of thousands of physicians. Nor can Congress simply morph Medicare into the National Health Service without sacrificing Medicare’s political legitimacy.

Bagley’s answer is politically pragmatic and not entirely obvious: leverage private providers even more. Medicare reforms, Bagley argues, should encourage physicians to join integrated delivery systems, which are better positioned than CMS or private contractors to “adjust physician practice patterns” through things like treatment protocols, disease-specific checklists, and bundled payment systems. Bagley mentions the much-hailed integrated delivery systems of Intermountain, Geisinger, and the Mayo Clinic.

But didn’t these integrated delivery systems inspire several reforms in the Affordable Care Act? And doesn’t the Act contemplate most of these things? Bagley says these reforms will fall short, again because of Medicare’s core design. For example, the Independent Payment Advisory Board (IPAB) is more likely to prefer temporary, short-term spending cuts rather than structural, longer-term ones. Similarly, the new Center for Medicare and Medicaid Innovation will encourage experiments with new payment and delivery models, but CMS still lacks the resources to scale them up as the ACA envisions. The Patient-Centered Outcomes Research Institute (PCORI) is tasked with comparing the clinical effectiveness of alternative treatments, but its recommendations (“Gee, that new treatment costs a lot and adds zero benefits over existing therapies!”) are non-binding. And “Accountable Care Organizations” (ACOs), designed to generate “shared savings,” are not true bundled payment systems.

Bagley argues that Medicare needs bold change, but even the bold changes contemplated by the ACA probably need even further authorization by Congress. Eventually, we will have to reform Medicare again. And when Congress does, it should consider Medicare’s design flaws.

Finding a Positive Right to Healthcare

Jul 31, 2013 Nicole Huberfeld

A wealth of formidable scholarship has weighed in on the constitutionality of the two aspects of the Patient Protection and Affordable Care Act that were at issue in NFIB v. Sebelius (which recently celebrated the anniversary of the historic decision), and so it can be hard to find a new perspective on either the statutory and constitutional aspects of the ACA. Nevertheless, Professor Rubin has furnished a fresh take by proposing that the ACA expresses a legislative interpretation of positive constitutional rights that articulates a right to healthcare in the United States.

The article begins by positing that the ACA faced an impassioned resistance movement because the law represents a sea change in the way we “think about American citizenship and the nature of our political community.” To prove this point, Rubin offers a consideration of the nature of the Constitution by working through its historical and philosophical origins. The first part may test the endurance of those not in the business of constitutional theory, but stick with it, because the payoff is a theory worth understanding—that the government serves the people, that a constitution is designed to be an instrument that implements the goals of the people, and that the goals of the people reveal themselves to be the “strengthening of the national government, liberty, and equality.” Importantly, this means that the Constitution must serve not only the people who drafted the text but also the subsequent generations bound by the original document’s terms. For this to be true, the meaning of the document cannot be fully understood at its drafting, because every generation will have a hand in its interpretation by acting pursuant to the principles of the document as they become meaningful in a given era. Rubin argues that this purposive view of the Constitution alters the constitutional significance of legislation, because legislation reveals the meaning of the constitution to the people living by the document in their time.

Rubin suggests that newer constitutions in other countries have benefited from the groundwork of the United States’ experiment in representative democracy. Thus, rather than fighting for first-wave struggles such as establishing the form of government and articulating its constraints (as the framers did), newer constitutions present second wave concerns by articulating positive rights that should be protected by modern democracies. In other words, the work has moved from structure to substance. Professor Rubin advocates for moving to a positive rights view of the Constitution and asserts that this evolution is underlined by the core purposes of liberty and equality. Thus, “strong national government, liberty, and equality” should be recognized by the Court as central to a functioning democracy, but these purposes are also reinforced by legislative efforts that serve to declare the importance of positive rights to the citizenry. The Social Security Act, Food Stamp Program, and housing support programs are examined as examples of federal legislation articulating a constitutional baseline for basic human needs such as food, shelter, and protection against the vagaries of aging and disability.

To bring his early observations full circle, Rubin examines the ACA as a “declaration of positive rights” that adds healthcare to the list of basic needs protected by federal legislation. To explain the dogged pushback against the ACA, the article describes three key features of the law. First, the ACA applies to all Americans, rather than certain segments of the population, rendering it more like a right and less like a targeted program for suitable populations. Second, the law is “uniform,” unlike Medicaid, or public housing, or food stamps, and perhaps threatening to those who challenge it because it diminishes the distinctions that have allowed Americans to be parsimonious with social welfare programs. And third, the law was presented as a moral choice, establishing a normative minimum of healthcare access that belongs to all Americans. These three key features, according to Rubin, track constitutional rights, and therefore the ACA legislatively establishes a positive right to healthcare that should challenge courts to reconsider such unfortunate decisions as DeShaney v. Winnebago County Department of Social Services (or even Harris v. McRae).

I found the arguments in this article to be persuasive, though I may be less sanguine than its author. Nevertheless, the strong background section provides a solid foundation for arguing that a right to healthcare can be found in the Constitution and that the ACA is a legislative step in that direction. One minor critique stems from disappointment with the analysis of the ACA itself. The statute played a surprisingly small role in the article, especially given that these arguments could have been even more powerful through deeper engagement with the legislative details of the ACA. For example, Medicaid is addressed only in passing, but the Medicaid expansion provides a strong example of the federal government’s choice to abandon outdated ideas regarding which populations are deserving of government assistance. The federal government deemed expanding Medicaid to all impoverished citizens so important that it will fund the expansion of the program 100% for several years. The expansion of Medicaid may say more about the commitment to the basic human need for healthcare than the article acknowledges.

It is easy to underestimate the role the ACA may play in American lives by minimizing the law to its small patches on the concatenated whole of the healthcare system. Professor Rubin provides a greater sense of coherent, important change by articulating the law as establishing a right within the larger project of discovering positive rights in the Constitution. Though the Court found no “emerging doctrine” in NFIB that shares this view, perhaps in time it will.