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.
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.
Cite as: Nicole Huberfeld,
Finding a Positive Right to Healthcare, JOTWELL
(July 31, 2013) (reviewing Edward Rubin,
The Affordable Care Act, The Constitutional Meaning of Statutes, and the Emerging Doctrine of Positive Constitutional Rights, 53
Wm. & Mary L. Rev. 1639 (2012)),
https://health.jotwell.com/finding-a-positive-right-to-healthcare/.
Jul 1, 2013 Elizabeth Weeks Leonard
Jessica L. Roberts’s recently published article, “Healthism”: A Critique of the Antidiscrimination Approach to Health Insurance and Health-Care Reform, offers a provocative, thoughtful rebuttal to the antidiscrimination rhetoric surrounding the Patient Protection and Affordable Care Act (“ACA”). Some of the ACA’s most popular reforms, namely, the ban on preexisting condition exclusions, guaranteed issue and renewal, and community rating were touted as eliminating insidious health insurance industry practices that—in then-candidate Obama’s words—“discriminat[e] against those who are sick and need care the most.” Roberts cites another commentator who characterized the ACA as a “civil bill of rights for the sick.” But, as Roberts aptly notes, the practice of “discriminating” against the insured on the basis of health conditions and expected risk is endemic to commercial health insurance underwriting.
For her titular concept, Roberts refashions the term “healthism,” defining it “as discrimination on the basis of health status.” She argues that despite the political rhetoric surrounding federal health reform and ACA provisions intended to eliminate “healthism,” other provisions of the law in fact operate as proxies for health status discrimination. She notes that previous federal statutes intended to eradicate healthism similarly fell short of this goal. The ACA, on its face, surely does eliminate discrimination, first, by requiring “guaranteed issue” and, second, by requiring “community rating.” Guaranteed issue means that health insurers must sell a policy to any individual, regardless of preexisting conditions, and community rating means that the insurer cannot discriminate in the price of the policy based on preexisting conditions or other health status indicators.
But Roberts points to four notable exceptions to those requirements, which she concludes operate as subterfuge for “healthism”: the ACA expressly allows insurers to vary premium rates based on (1) age, (2) geographic area, (3) tobacco use, and (4) participation in approved workplace wellness programs. Each exception, she contends, implicitly represents health status. Older people tend to use more health care than younger people. People in congested urban areas (or medically underserved rural areas) tend to have worse health status. Similarly, allowing rate variation based on tobacco use and wellness program participation, she contends, are proxies for health status discrimination.
That sounds right, but the latter two exceptions seem not so much proxies as express congressional endorsement of “healthism.” Surely the reason that Congress allowed premium rate variation based on tobacco use and participation in wellness programs was precisely because those behaviors do, in fact, strongly correlate with worse (in the case of smoking) or better (in the case of wellness programs) health status. The ACA’s retention of at least those two forms of health status discrimination somewhat undermines Roberts’s starting premise that the goal of the ACA was to eliminate healthism. But setting aside my quibble with Roberts’s characterization, a more interesting question to me (and the focus of my new project on “individual responsibility rating”) is why Congress expressly allowed insurers to continue discriminating based on those particular health-related habits or activities, which seem largely in individuals’ voluntary control. One answer, as Roberts notes elsewhere in her illuminating discussion of discrimination, is that lawmakers tend to treat “mutable” and “immutable” conditions differently.
Roberts’s convincing bottom line is that the antidiscrimination frame is both descriptively inaccurate of the ACA and normatively unproductive for health reform. Instead, she offers a universal rights frame. More accurately, the goal of the ACA, she suggests, should be seen as “ensuring a minimum level of care for all Americans.” Under this frame, she views the ACA’s controversial individual mandate, along with the essential health benefits package, as embodying a sort of universal right. It is counterintuitive, yet intriguing, to recast the mandate as some type of affirmative right to health care, especially when it compels private purchase of health insurance, rather than guaranteeing that the government will provide health insurance to all. She acknowledges that this “right” falls well below a cognizable, affirmative claim to health care but at least expresses a moral norm that everyone is “entitled” to a certain basic level of health insurance coverage. While I am not entirely convinced that the ACA embodies this rights framework or that the belief in a right to health care is widely accepted, I do agree with Roberts that the antidiscrimination frame is flawed.
The article concludes by briefly suggesting future directions for health reform, consistent with Roberts’ universal rights frame. She points to insurance risk adjustment, nonprofit health insurance, and publicly financed health care as desirable next steps. With those proposals, Roberts just scratches the surface of deep veins of theory and policy, which she may tap in her later work, including fragmentation of the health care system, definition of a universal right to health, and comparative models of social insurance.
In addition to providing rich food-for-thought for other scholars (myself included) and a host of possible further research projects for herself, one of the article’s most welcome, useful contributions is Roberts’s clear, plain-language description of the health insurance market. She methodically and comprehensively explains the operation of commercial health insurance, defining key concepts, such as risk-pooling, adverse selection, the “death spiral,” information asymmetries, community versus experience rating, deductibles, coinsurance, and copayments, providing easy-to-understand examples of each term. This descriptive background portion of the paper, alone, would be a welcome mini-treatise on health insurance for my students, who often struggle to grasp these concepts. All in All, Healthism, is an exciting project from a terrific emerging scholar.
May 27, 2013 David Orentlicher
Empirical research often teaches us that our intuitions are misleading. In an important discussion of her recent studies, Sunita Sah provides good reason to believe that public policy has gone down the wrong track when addressing physicians’ conflicts of interest.
As conflicts of interest for physicians have come under greater scrutiny, regulators commonly turn to disclosure as a remedy for the problem. If patients know about their doctors’ conflicts, the patients can take the conflicts into account when making their health care decisions. Patients can discount a conflicted physician’s advice or seek a second opinion. In addition, disclosure may discourage physicians from accepting payments or making investments that put them in conflicted positions. As it is said, sunshine can be an effective disinfectant.
With these apparent benefits, disclosure has become the most common response to conflicts of interest in medicine. The American Medical Association and the Medicare Payment Advisory Committee emphasize disclosure as a strategy for dealing with conflicts of interest. And the Patient Protection and Affordable Care Act requires manufacturers of drugs, devices and other medical supplies to report consulting fees, honoraria, gifts, grants and other payments to physicians. The Centers for Medicare and Medicaid Services will publish the reported payments online for public access.
However, policies of disclosure have serious drawbacks. For some physicians, disclosure can result in a greater willingness to enter into a conflict of interest. Once physicians disclose their conflicts, they may feel they have met their ethical obligations and therefore are fee to remain conflicted.
In addition, disclosure policies rely on the recipients of the disclosures to police the conflicts, and it may not be realistic to have that reliance. In her research with colleagues George Loewenstein and Daylian Cain, Sah has found that patients may not respond appropriately to the existence of a financial relationship when deciding whether it should affect their willingness to agree to their physicians’ recommendations. For example, studies show that while patients worry when their physicians have conflicts, they also are reluctant to act on their concerns. Patients fear that if they reject their physician’s advice after being told of a conflict of interest, they will signal to their physicians that they do not fully trust the physicians. Ironically, disclosure may make patients less likely to decline their conflicted physicians’ recommendations.
As Sah concludes, the likelihood that disclosure will make things worse should lead regulators to rely less on disclosure and more on prohibition as a remedy for the problem of conflicts of interest in medicine.
In her article, Sah also illuminates other important questions about conflicts of interest. For example, she discusses studies that tell us why physicians engage in conduct that creates conflicts of interest and how second opinions affect the extent to which the first physician will give biased advice. Scholars interested in conflicts of interest will find this article of great value.
Apr 23, 2013 Mary Crossley
Abigail R. Moncrieff, When the Tenth Justice Doesn't Bark: The Unspoken Freedom of Health Holding in NFIB v. Sebelius, Boston Univ. School of Law, Law and Economics Research Paper No. 12-44, available at SSRN.
Given the intense popular, political, and academic interest in the challenge to the Affordable Care Act, it comes as no surprise that the Supreme Court’s decision in NFIB v. Sebelius would launch a flotilla of articles about that decision, particularly since the outcomes (with respect to both the individual mandate’s constitutionality and the expansion of Medicaid) were not what conventional academic wisdom had predicted. In the coming months and years, we will undoubtedly spend a good deal of time thinking through and reading about the possible implications of what the Court did, and didn’t do, in that case.
But the most intriguing and enjoyable article that I have read so far about NFIB focuses not on what the Supreme Court did or didn’t do, but on what Solicitor General Donald Verrilli chose not to do in defending the individual mandate against a commerce power challenge before the Court. In “When the Tenth Justice Doesn’t Bark: The Unspoken Freedom of Health Holding in NFIB v. Sebelius,” Abigail Moncrieff hypothesizes that the Solicitor General deliberately chose to forgo raising a more persuasive legal argument regarding the individual mandate’s constitutionality and that this politically strategic decision represents a previously unexplored terrain of popular constitutionalism.
According to Moncrieff, the argument that would have had a better shot at persuading a majority of the Justices goes something like this: By steering consumers’ savings and consumption in the market for health care, health insurance of the sort mandated by the ACA performs an “aggressive regulatory function” in overcoming market failures flowing from optimism bias, hyperbolic discounting, and the credence goods problem. So understood, the mandate functions to make the enormous, existing market in health care more efficient by eliminating the inefficiencies of self-insurance and shifting individuals into efficiency-enhancing insurance plans. From there, Moncrieff argues, the forgone argument is straightforward: “Obamacare wants to prohibit self-insurance because self-insured health care is systematically less efficient than fully-insured health care. This story is an easy fit for existing commerce clause doctrine.”
Moncrieff is an expert when it comes to this forgone argument, having co-authored an amicus brief presenting it to the Supreme Court. I can imagine that, if I had presented a novel and at least seemingly compelling argument like this, I might wonder why neither the Solicitor General nor the Court picked it up and ran with it. I might even feel a bit underappreciated by the Justices. But instead of privately grousing, Moncrieff wrote an article offering a thoughtful explanation that reaffirms the strength of the argument while suggesting an intriguing hypothesis as to why the Solicitor General ignored it.
The core of Moncrieff’s argument is that, by creating incentives and disincentives that steer health care consumers’ choices, the health insurance mandated by the ACA is in effect an instrument of soft rationing, and that a constitutional justification of Obamacare based on this rationing function was politically unacceptable, particularly in an election year. To Moncrieff, the only plausible explanation for Verrilli’s decision not to play this high card was that it would generate a strongly negative popular response. She characterizes this populist sentiment objecting to health care rationing as being aligned with a “freedom of health” principle protecting autonomy in medical decision making, a principle that lacks full doctrinal recognition but conforms to a “loose substantive due process norm.” She goes on to suggest that this popular political constraint effectively “muzzled” the Solicitor General (here acting clearly as an agent of the President rather than the Court) and thus functioned as a form of popular constitutionalism. As Moncrieff puts it: “The popular constitutional freedom of health is … a populist sentiment that has the fortitude of a constitutional principle, the effects of a substantive constitutional right, and the strength of a constitutional argument that can shape judicial opinions – albeit silently and politically rather than openly and doctrinally.”
Moncrieff is the first to admit that characterizing this hypothetical scenario as an instance of popular constitutionalism in many respects does not fit neatly within established academic conceptions of that phenomenon. But that is part of what I like so much about this article. Moncrieff’s attempt first to put herself in the position of the Solicitor General to hypothesize why he left a constitutionally powerful argument unmade and then to explore the broader significance of this puzzling decision is a wonderful example of legal scholarship that observes with a realist’s eyes how legal actors behave and seeks to make sense of that behavior against the background of legal rules and institutions. Her hypothesis as to why Solicitor General Verrilli chose not to present a compelling argument in one of the most important constitutional cases in recent decades is intriguing, and – while the article may not rival Sir Arthur Conan Doyle’s Sherlock Holmes (to which Moncrieff’s title refers) for plot twists and suspense – it has a narrative flow that held my attention to the end.
While I found “The Tenth Justice” a provocative and enlightening read, at the end I found myself wondering about a question that was admittedly beyond its scope. If Moncrieff’s hypothesis is right, President Obama (acting through the Solicitor General) decided to protect his re-election prospects at the price of forgoing his strongest argument for the constitutionality of the individual mandate – an integral part of his historic legislative accomplishment. Why? We know now that the gamble turned out well from the President’s perspective: The Supreme Court upheld the mandate (though as an exercise of Congress’s taxing power rather than its commerce power) and the President won re-election. But neither of those outcomes could be foreseen with any certainty when the Solicitor General briefed and argued the case. Perhaps some good detective work will someday uncover the story behind the President’s decision….
Mar 20, 2013 Kristin Madison
Joanna C. Schwartz, A Dose of Reality for Medical Malpractice Reform, N.Y.U. Law Rev. (forthcoming), available at SSRN.
Discussions of patient safety often begin with the depressing statistic that 98,000 Americans die every year due to hospital medical error. From there, they may veer toward a conversation about the culture of silence that hinders efforts to identify and address medical errors. The reasons for the culture of silence? There are many, but the law usually features prominently among them. Fearful that any discussion of errors may find its way into malpractice litigation, the providers best suited to preventing medical error are often reluctant to share the information necessary to do so. Thus, rather than deterring error, tort law ends up deterring its prevention.
But this gloomy story is often told alongside a more hopeful one. Thirty years ago, prompted at least in party by high malpractice insurance premiums, anesthesiologists made a concerted effort to improve anesthesia safety – and they succeeded. So tort law can sometimes fulfill its deterrence function. And it does not always chill communication about errors, either. In institutions such as the Veterans Administration Hospital in Lexington, Kentucky, and the University of Michigan Health System, errors are not just discussed internally, but also disclosed to patients.
One way to reconcile these two very different perspectives on patient safety and medical malpractice is to say that these more hopeful anecdotes are just that, anecdotes. In a fascinating article forthcoming in the N.Y.U. Law Review, however, UCLA law professor Joanna Schwartz shows that they are more than just anecdotes: medical malpractice claims regularly play an important part in patient safety improvement efforts, and not just at a few prominent institutions.
Schwartz documents the relationship between malpractice law and patient safety through semi-structured interviews with individuals performing risk and safety functions in hospital settings and through a survey sent to members of the American Society of Healthcare Risk Managers. Using the results of 35 interviews and more than 400 survey responses from hospitals across the country, she confirms that the patient safety culture in hospitals has been changing and illustrates the many functions that malpractice claims perform in patient safety improvement initiatives.
Schwartz’s results reveal that hospital risk managers traditionally responsible for limiting financial losses have become increasingly focused on patient safety issues. While they once might have sought to curtail discussion of medical errors, risk managers now often promote increased transparency, both internally and in communication with patients. In addition, they frequently work alongside patient safety officers in efforts to enhance hospital safety.
Schwartz also examines ways in which malpractice litigation supports patient safety. More than 85% of survey respondents reported often or sometimes using “notices of claim and legal complaints for performance and safety lessons.” Individual claims prompt internal investigations that can point toward safety problems, while claims trends highlight areas in need of further investigation. Respondents also frequently reviewed information generated during discovery; examples of this practice included gleaning information from depositions or from regular conversations with defense attorneys. And the majority of respondents reported using closed claims files. Files were used for education and training purposes, and, in some cases, to identify areas of safety concern.
While the survey results suggested that none of these malpractice-related sources of information were as useful as adverse incident reports or reports to risk management, many respondents still found them quite useful in responding to safety and quality concerns. More than 80% of survey respondents characterized claims trend information, for example, as “very useful” or “somewhat useful.” Most respondents also found complaints and legal notices of claim useful. These documents revealed new allegations of medical errors with surprising frequency, especially in larger hospitals, and especially with regard to diagnosis and treatment errors.
Schwartz also presents evidence suggesting that the malpractice system’s chilling effects linger. Some risk managers acknowledged a reluctance to discuss cases being litigated, for example, and some reported that limits on legal protections for peer review had shaped their patient safety efforts. These findings do not detract from the central conclusions of the article, however, which are that hospitals are increasingly open about medical errors and have been able to make systematic use of malpractice-related data in patient safety efforts.
This study’s central results might not come as a big surprise to scholars of health law and policy. But even so, the study makes a major contribution to the academic literature. The article’s reliance on systematically-collected data and a richly detailed, concrete discussion of how risk managers go about their work set it apart from much other work in this area. In addition to survey data, the article makes extensive use of interviewee quotes that vividly illustrate and support its conclusions. Readers more accustomed to bland and brief discussions of hospital risk managers’ tasks will likely find this approach both engaging and informative. Moreover, Schwartz’s thoughtful and careful discussion of the implications of the study’s results for medical liability reform is worthwhile reading.
Like any empirical study, this one has limitations. While the inclusion of hospitals with varying characteristics helps to establish that the trend toward openness extends beyond just a few hospitals, the survey response rate raises questions about the representativeness of the sample, an issue that Schwartz acknowledges. And Schwartz did not study malpractice claims’ implications for patient safety outcomes, just their usefulness in patient safety improvement processes, as perceived by a survey sample consisting mainly (but not exclusively) of risk managers.
Nevertheless, the article provides ample evidence for a phenomenon that Schwartz has labeled “introspection through litigation.” The article should prompt not only a fuller acknowledgement of the role malpractice claims can play in reducing medical error, but also more systematic use of the medical liability system in promoting patient safety.
Feb 20, 2013 Tim Jost
Colleen Flood, Charter Rights and Health Care Funding: A Typology of Canadian Health Rights Litigation, 19 Annals Health L. 479 (2010).
When lawyers (or, at least, U.S.-trained lawyers) think of legal rights, they think of rights enforceable in courts. While a “right to health” or “right to health care” is widely recognized in international legal conventions and national constitutions, judicial decisions effectuating these rights are quite uncommon. Moreover, it is not altogether clear that litigation is the most effective approach to realizing these rights.
Colleen Flood is one of Canada’s leading health law professors. In Charter Rights & Health Care Funding: A Typology of Canadian Health Rights Litigation, (which appears both at 19 Annals of Health Law 479 (2010) and as a chapter in Grand Challenges in Health Law and Policy (Catherine Regis and Robert Kouri, eds., 2010), Professor Flood and Y.Y. Brandon Chen analyze health care rights litigation in Canada. They identify several categories of cases in which health care rights have been asserted in Canadian courts, classifying the cases by whether the claim sought to establish a positive or negative right, was accepted or rejected by the court, and in fact succeeded or failed to establish the right the claimant asserted.
The claims they analyze were brought under the Canadian Charter of Rights and Freedoms, the Canadian equivalent of the U.S. Bill of Rights. The Canadian Charter does not recognize a right to health as such. Rather the litigation was brought under section 7, which guarantees a right to life, liberty, and security of the person, and section 15, which guarantees equal rights. Litigation has been brought in Canada both to establish positive rights—such as the right to sign language interpretation in medical facilities or access to in vitro fertilization—and negative rights—notably challenging laws limiting access to abortions or physician-assisted suicide or prohibiting the purchase of private health insurance to finance services covered by public insurance.
Few positive rights Charter claims have succeeded; the claim for sign language interpreter services being the notable exception. Negative rights claims have been more successful, including R. v. Mogentaler, the Canadian equivalent of Roe v. Wade, and Chaoulli v. Quebec, which held that Quebec’s ban on private insurance violated the Quebec Charter of Human Rights and Freedom. But even success in litigation does not guarantee that the right for which the litigants fight is in fact realized. Sign language interpretation is still woefully underfunded, abortions are arguably less accessible than they were before Morgentaler, and access to private insurance remains contested, (although the Chaoulli decision has gone far toward legitimating private health insurance and health care in Canada). Unless a health care right in fact is accepted politically—and resources are made available to make it a reality—mere judicial recognition counts for little. Indeed, Flood and Chen are unable to identify a single situation in which the recognition of a positive right has in fact resulted in universal availability of the claimed service.
More interesting perhaps are claims that have failed. Flood and Chen note that failed rights claims can have two results. In some instances, illustrated by Auton v. British Columbia—a claim for autism services—the court has rejected the Charter claim but the case has generated support for the claimants, resulting in wider availability of the service. In other cases, such as Cameron v. Nova Scotia—a claim for IVF services—the rejection of the legal claim has contributed to undermining political support for making the service available.
In sum, the establishment of health care rights has, in the end, less to do with judicial decisions than with political realities. Litigation, successful or unsuccessful, can help illuminate a problem hitherto unrecognized, generating political support for solving the problem. But failed litigation can render a claimed right less credible. And successful litigation does not guarantee the ultimate establishment of a right.
In the end, as Flood and Chen demonstrate, the narrow focus of legal scholars on litigated claims, successful or unsuccessful, misses the point. Rights come to exist when they are accepted politically, socially, and economically. Judicial decisions may help or hinder the process of acceptance, but they do not determine it.
Cite as: Tim Jost,
Litigating Health Rights, JOTWELL
(February 20, 2013) (reviewing Colleen Flood,
Charter Rights and Health Care Funding: A Typology of Canadian Health Rights Litigation, 19 Annals Health L. 479 (2010)),
https://health.jotwell.com/litigating-health-rights/.
Jan 14, 2013 Abigail Moncrieff
Kenneth Abraham, Four Conceptions of Insurance, ___ U. Pa. L. Rev. ___ (forthcoming 2013), available at SSRN.
In the highly contentious debates over the Patient Protection and Affordable Care Act (ACA or “Obamacare”), different conceptions of health insurance vied for supremacy. But the struggle occurred silently. The debaters never explicitly acknowledged—and may not have completely understood—that the foundation of their disagreement might be their underlying sense of what health insurance is and ought to be. Ken Abraham has ably shone a light on this silent struggle in his recent article, Four Conceptions of Insurance.
Abraham lays out and critiques four views of insurance: as contract, public utility, product, and regulator. In the end, his conclusion is simple. All four visions have some explanatory power for the content of modern insurance law, which necessarily means that none of the four visions is fully descriptive of modern practice. Modern law sometimes treats insurance as contract, sometimes as public utility, sometimes as product, and sometimes as regulator. But one’s preferred conception of insurance has much to do with one’s preferences as to what the law should be. When law treats insurance as a contract, those who see insurance as akin to a public utility are quite unhappy.
Although Abraham’s project is not to explain the health insurance debates at the center of Obamacare’s tortured history, his careful exploration of the four conceptions of insurance does just that. To a large extent, the Obama Administration and its supporters saw health insurance as a mixture of public utility and regulator—a service to which everyone should have access (like electricity and water) and a service that should be bound to basic public notions of nondiscrimination, due process, and communitarian equality (like a government). The ACA’s market reforms and individual mandate both seek to implement this very public vision of insurance.
The Tea Party and its supporters, by contrast, saw health insurance as a contract-based private product—and one that ought to be voluntary, transparent, and fairly priced. Their litigation strategy quite obviously reflected that vision, arguing that the federal government should not be allowed to force people to buy a private product or to enter a private contract. Understanding what’s at stake in this fundamental disagreement—the assumptions that underlie the competing conceptions and the conclusions that arise from them—will be crucial as we move forward in implementing the ACA. Indeed, given that Tea Party sympathizers retain significant power through state governments to implement their own visions of Obamacare, the conflict between the federal government’s utility-regulator conception of insurance and the Tea Party’s contract-product conception will undoubtedly continue to rage, whether we acknowledge it or not.
For scholars of health law and health care policy, I highly recommend Abraham’s article. Although it is not without its flaws, it usefully disaggregates a set of contradictory assumptions underlying modern health care debates, demonstrating how and why the conflicts matter to the evolution of the law. As Obamacare moves forward in history, these contradictory assumptions will continue to clash in important ways. And Abraham’s taxonomy will be useful.
Nov 30, 2012 Kathleen Boozang
Harvard Professor Daniel Carpenter’s Reputation and Power epitomizes the best of academic scholarship. While this review focuses on its substantive contributions to the health or life sciences professor, the theme of the book is actually much more significant – whether and how government bureaucracy can effectively contribute to the common good – which is the take reviewed by others. For those who are not intimately familiar with the Food and Drug Administration and pharmaceutical regulation, reading Carpenter’s book significantly resolves this knowledge gap. While I can’t disagree with David Zaring‘s observation that the book is “methodologically eclectic,” it is nonetheless an invaluable resource for students of drug regulation as well as the administrative state.
Carpenter’s opus provides a comprehensive history of each piece of legislation that contributed to the agency’s creation, describes how the responses to a few major drug safety crises, or what Carpenter calls “policy tragedies,” contributed both to the passage of key legislation and the FDA’s reputation, and posits that the agency’s reputation with its multiple constituencies is the key to its vast power. Ultimately, Carpenter is interested in how a government agency in a country that is anti-big government can be so trusted and hold such power over a multi-national industry. In concluding that the agency’s power derives from its reputation, Carpenter explores the relationship between the institution and those who populate it, paying tribute to the many FDA officials whose own ethical and scientific integrity created, maintained and were inextricably linked with the ethos for which the FDA is so respected. According to Carpenter, Dr. Frances Oldham Kelsey of thalidomide fame was not unique in her commitment to the public’s interest, scientific rigor and tenacity; those characteristics were embedded in the agency and, by virtue of its power, necessarily transformed the pharmaceutical industry from a not-always trustworthy and sometimes sloppy enterprise into one that adheres to generally accepted scientific methods.
Carpenter’s observation that the status of the FDA in the U.S. is unique in a country generally suspicious of the regulatory state resonates as we exit from an election season largely focused on the philosophical divide about the role of government in society. Carpenter reminds us of how extraordinary it is that an entire industry requires the imprimatur of a government agency before its products or advertisements may enter the marketplace, and that government may seize products already in the stream of commerce if deemed necessary to protect consumers. The FDA’s reputation lead to the solidification of its power by other branches of government, most notably in the 1943 Supreme Court decision of United States v. Dotterweich. Power and Reputation reinforces the notion of the tremendous scope of the FDA’s power by describing the numerous nations that emulate the FDA’s methodologies, structure, and assessments. In short, Carpenter asserts that “the FDA rules the entire global pharmaceutical market.” The key to the agency’s success, Carpenter believes, is its ability to inspire the trust that, despite being an agency of the government, the FDA ably protects the public.
As described by Carpenter, the history of how the FDA garnered its power, especially in the face of opposition from both the AMA and several of the power-house pharmaceutical companies, is fascinating, posing the obvious question of whether it would be possible to recur in the United States. The public’s ambivalence about environmental science, as well as Congress’s treatment of FDA jurisdiction over tobacco-related products, medical devices, food and dietary supplements suggests not. Also instructive is Carpenter’s description of how the FDA strategically aligned itself with academics to raise the bar on its own scientific standards, thereby necessitating that industry also expand its scientific capacity. That the agency’s focus on the scientific method and demands for extensive data ultimately contributed to its trustworthiness is somewhat ironic as we struggle with the consequences of the politicization of science in so many regulatory domains today. That the FDA obtained its reputation by close work with academic scientists, and stayed ahead of emerging developments, provides an interesting juxtaposition to former FDA Commissioner von Eschenbach’s recently expressed concerns in the Wall Street Journal that insufficient resources and fear of criticism from consumer groups have interfered with the FDA’s ability to work collaboratively with researchers developing new technologies so that they are able “to craft standards for evaluating new technologies while they are still being developed.”
Objections to the FDA’s attempts to eliminate proprietary medicines and quackery more generally remind one of current debates about complementary and alternative medicine and even libertarian views about the FDA’s role more generally, as evidenced by the Washington Legal Foundation’s position in the Abigail Alliance case. The FDA’s early twentieth century moves against patent medicines were met with charges that it was undermining the “right of self-medication” which encompassed the “absolute liberty of the consumer or patient to purchase any and all medications for the amelioration of his or her ailments.” These objectors did support labeling requirements that would allow the “intelligent layman” to make informed decisions about their pharmaceutical purchasing.
Also intriguing from an historical perspective is to encounter yet another example in which the AMA fights on the losing side of a major piece of social legislation. Perceiving that the powers sought by the FDA would interfere with physicians’ decision-making autonomy, the AMA objected both to FDA-enhancing legislation, and the expansion of non-MD pharmacology, despite “the average physicians’ incapacity to assess the quality and hazards of drug treatments.” We are likely once again entering an era where the sophistication of certain drugs and medical devices should limit their use to specific highly trained physicians – whether this evolves through the market, professional self-regulation, government regulation or the tort system will be interesting to watch.
The study of the power and influence of the FDA reminds us that we continue to struggle over the policy questions regarding the ideal scope of government authority over the pharmaceutical industry. Carpenter notes that, even though public disgruntlement about drug company profit margins and “spiraling medical inflation” persist from one century to the next, the FDA has historically and shrewdly side-stepped drug pricing issues, leaving the debate about “socialized medicine” to Congress. In comparing the FDA with its European counterparts, Carpenter also suggests that comparative effectiveness analysis is gradually occurring in the United States. The pressures for life-saving drugs created by the AIDS crisis created the template for disease politics and upped the pressure for the FDA to approve new drugs more quickly, and time will tell whether this is to the detriment of the agency’s mission.
Carpenter’s history recounts the frequently-heard criticisms of the FDA as being both too restrictive and insufficiently protective of consumer safety, and that certainly remains the case today. According to some contemporary critics, conflicts of interest by appointees to FDA review panels and the payment of user fees by companies whose products are under review also threaten another historic FDA strength identified by Carpenter: FDA freedom from industry capture. Unsurprisingly, these claims are controversial, with FDA critics such as Richard Epstein charging that consumer advocates have persuaded Congress to shackle the FDA with excessive regulations and made it cripplingly risk adverse.
This book is a must- and easy read, irrespective of whether you teach an FDA course. Its lessons about the administrative state when it is as its best and worst are instructive to any student of public policy, but especially to those of us dedicated to the public’s health.
Nov 30, 2012 Michael Froomkin
Health Law Section Editors
The Section Editors choose the Contributing Editors and exercise editorial control over their section. In addition, each Section Editor will write at least one contribution (“jot”) per year. Questions about contributing to a section ought usually to be addressed to the section editors.
Professor Kathleen Boozang
Seton Hall School of Law
Professor Elizabeth Weeks Leonard
University of Georgia School of Law
Contributing Editors
Contributing Editors agree to write at least one jot for Jotwell each year.
Professor Nathan Cortez
SMU Dedman School of Law
Professor Mary Crossley
University of Pittsburgh School of Law
Professor Thomas Greaney
Chester A. Myers Professor of Law
SLU School of Law
Professor Nicole Huberfeld
Gallion & Baker Professor of Law
University of Kentucky College of Law
Professor Timothy Stoltzfus Jost
Robert L. Willett Family Professor of Law
Washington and Lee University School of Law
Professor Kristin Madison
Professor of Law and Health Sciences
Northeastern University School of Law
Professor Amy Monahan
Solly Robbins Distinguished Research Fellow
University of Minnesota Law School
Professor Abigail Moncrieff
Peter Paul Career Development Professor
Boston University School of Law
Professor David Orentlicher
Samuel R. Rosen Professor of Law
Indiana University, Robert H. McKinney School of Law
Professor Christopher Robertson
University of Arizona, James E. Rogers College of Law
