Addressing the Health Care/Public Health Dichotomy through Justice

Lindsay F. Wiley, Health Law as Social Justice, 24 Cornell J.L. & Pub. Pol’y 47 (2014), available at SSRN.

A longstanding and confounding divide exists between treatment of the individual and care for the collective. While the former is deemed health care, the latter is called public health, and American medicine has long maintained this dichotomy (a story that Paul Starr told decisively in The Social Transformation of American Medicine). This divide exists not only in the medical establishment but also in the law pertaining to it. While the field called health law tends toward being subject matter inclusive, it paradoxically has excluded public health law as a separate discipline. In part, this dichotomy may result from public health’s focus on the whole community rather than individual relationships, rights, and treatments. But also, this divide is strengthened by the historic primacy of private law rather than public law in health care, a hierarchy that has reinforced bias toward protecting medical stakeholders’ rights in their professional space. In addition, the law has sidestepped race, gender, economic, and other disparities in health care, allowing inequalities to fester. Though health care reform took on some of these issues, health disparities are a persistent problem. Fortunately, Professor Wiley is battling these old lines with her new work.

Health Law as Social Justice makes a convincing case that health law includes more than health care finance, bioethics, and regulation of related entities and markets. Instead, Wiley argues, health law and public health must be intertwined to effectively battle health disparities. The article contends that such a merger could be facilitated by drawing on the social justice movement and its understanding of the societal factors that affect certain industries and their corresponding fields in the law. Wiley argues that America’s deeply entrenched health disparities can only be uprooted by the communitarian considerations inherent in the booming study of social determinants of health, which she urges can translate to policy reform, effective advocacy, and legal change through broadened health care law inquiries.

Professor Wiley begins by exploring three variants of social justice: the environmental justice, reproductive justice, and food justice movements, each of which includes health disparities in its core objectives. These movements offer key takeaways for the “health justice” theory being developed here, which include focus on collective action and community in health; the role of government in securing social determinants of equality; and the democratizing instincts of these three movements that encourage participation, reject explicit and implicit biases, and encourage cross-pollination of societal priorities. The three sub-movements provide a foundation for importing social justice concepts into the field of health law.

The paper next considers existing legal mechanisms for addressing health disparities, beginning with a brief tour of major federal statutes that have addressed health disparities over time, including Medicare, Medicaid, EMTALA, HIPAA, COBRA, and the ACA. The article describes that the ACA does more to address disparities in health than create near-universal insurance coverage; the Obama Administration also has developed a variety of plans and committees to address enduring health disparities along the lines of race, ethnicity, income, and other factors. In contrast, Wiley highlights certain types of legal incentives and programs designed to encourage healthy behaviors, such as “wellness programs,” which some states have eagerly implemented for their Medicaid programs, and which were encouraged for employers by the ACA. These and other healthy behavior laws often disproportionately penalize the poor for failure to comply with measures that require a health literacy many do not possess. Similarly, Wiley argues, “healthy community” initiatives create tensions for the very communities they are meant to benefit, especially given the industry interests driving food accessibility in low-income neighborhoods. According to Wiley, the dissonant and confusing state of health law reflects the multifarious interests and general perplexity facing lawmakers at all levels who are attempting to address social and other determinants of health.

The idea of health justice then is considered through a three-part framework that facilitates tackling health disparities via mechanisms alternative to traditional market competition and patients’ rights paradigms. To that end, Wiley first recommends broadly defining health law to include all social determinants of health rather than just finance and delivery. Second, she suggests taking a hard look at individual responsibility approaches that may harm the communities they are meant to serve. And third, she proposes implementing interventions that engage communities in designing methods used to address their health disparities rather than simply imposing intermediations. Wiley’s use of social justice theory as a vector to further health care reform and to help reduce disparities is persuasive and important. The theory of “health justice” is such a significant idea that I wished for a cocktail party definition in addition to this complex three-pronged engagement.

Perhaps a future project could also incorporate work on vulnerability theory, which relates strongly to social justice themes and could further strengthen the argument that the old paradigms do not account for enough of the human condition to facilitate health justice. Vulnerability theory adds to the critiques of “market justice” and individual rights advanced in this article by further underlining the state’s responsibility for improving health based in the notion that all citizens are vulnerable, and in similar ways. Like health justice, vulnerability theory rejects the limited individual pursuit of rights-based equality, and it complements the normative themes in the paper.

Professor Wiley has made an important contribution just by, as she stated, “start[ing] a conversation” about health justice and how it can fit into the debate about health care policy in America. The constellation of factors that she names address both individual and communal health, and health disparities will only be defeated through such comprehensive catalysts for change. While moves such as expanding Medicaid and leveling insurance accessibility are key steps toward eliminating health disparities, they are only pieces in a larger puzzle. I look forward to Professor Wiley’s further development of the health justice principle to help complete that puzzle.

Cite as: Nicole Huberfeld, Addressing the Health Care/Public Health Dichotomy through Justice, JOTWELL (April 2, 2015) (reviewing Lindsay F. Wiley, Health Law as Social Justice, 24 Cornell J.L. & Pub. Pol’y 47 (2014), available at SSRN), http://health.jotwell.com/addressing-the-health-carepublic-health-dichotomy-through-justice/.
 
 

Making Cost Sharing Fairer and More Effective

Christopher T. Robertson, Scaling Cost-Sharing to Wages: How Employers Can Reduce Health Spending and Provide Greater Economic Security, 14 Yale J. Health Pol’y L. & Ethics 239 (2014), available at SSRN.

While many popular policies that require individuals to share the costs of their health care can be counter-productive, as when high deductible health insurance plans discourage people from seeking necessary care, Christopher Robertson’s “scaled cost-sharing” proposal offers considerable promise.

Robertson observes that employers typically use a one-size-fits-all approach to the cost-sharing features of their health insurance plans. Whether workers earn $40,000 or $400,000, they face the same deductibles, copayments, and other cost-sharing features that kick in when individuals seek care. In particular, these cost-sharing requirements come with an annual cap on out-of-pocket spending that is the same for all employees. Plans that cap out-of-pocket spending at $5,000 apply that cap to all workers, and plans with $10,000 caps also apply their cap to all workers. The Affordable Care Act (ACA) reinforces the practice of standard caps with its maximum amounts for in-network, out-of-pocket spending.

As Robertson notes, fixed annual caps come with a number of problems. For example, they are regressive in the way that flat tax rates are regressive, and highly so. If employers peg their annual cap for family plans at $8,000, the $40,000 wage-earner would have to pay as much as 20 percent of income on health care while the $400,000 wage-earner would have to pay only up to 2 percent of income. In addition, standard annual caps distort health care decision making. For the highly paid employee, a cap at only 2 percent of income may encourage overconsumption of health care. For the poorly paid employee, a cap at 20 percent of income may result in underconsumption of health care.

To address the problems with fixed caps, Robertson would switch from a dollar-based annual cap to an income-based annual cap. That is, instead of using a standard cap of $8,000, employers might peg their caps at 6 percent of income. A worker earning $40,000 would face an annual cap of $2,400, while a worker earning $400,000 would face an annual cap of $24,000. Such a switch would be desirable from a number of perspectives. It would be fairer to low-paid workers, it would reduce the distortions in health care decision making, and it would be financially advantageous to employers. Employers would benefit because their higher-paid employees would bear a larger share of the company’s insurance costs. Nevertheless, the health of those workers should not suffer—income-based annual caps address the incentive that fixed caps create for overconsumption of health care by highly-paid employees. Indeed, writes Robertson, empirical data indicate that cost-sharing leads higher-income persons to reduce their consumption of health care without compromising their health.

Robertson also considers the barriers to adopting income-based annual caps. For example, health insurance is a group-based benefit, making it difficult for employers to treat workers differently under their plans. In addition, changes in the law are needed to facilitate the adoption of income-based caps. In particular, Congress needs to revise—or the Department of Health and Human Services waive—the ACA’s maximums for annual caps. Currently, out-of-pocket annual caps may not exceed $6,600 for an individual plan or $13,200 for a family plan. An income-based cap of 6 percent would work up to incomes of $110,000 for individuals or $220,000 for families. Hence, while it is possible to fully implement income-based caps for low-income workers, ACA limits their use for high-income workers.

In the meantime, Robertson provides an intriguing argument for why current law might actually require some degree of income-based caps (i.e., income-based caps when fixed caps present a barrier to care for low-income workers). As Robertson observes, federal health insurance law includes anti-discrimination provisions to prevent employers from favoring their highly-compensated employees. But when low-income employees must pay a higher percentage of their income for their care, they are less able to afford care and therefore less able to draw on their health care benefits. Fixed annual caps very much favor highly-compensated employees.

And the disfavoring of low-income employees can come with harms to health. As Robertson points out, much of the problem with cost-sharing in health insurance comes from its impact on low-income individuals who are more likely to suffer an adverse impact on their health when increases in cost-sharing lead them to reduce their demand for medical care. By tying cost sharing to income, employers can better ensure that all of their employees realize the benefits to health from health care insurance.

Cite as: David Orentlicher, Making Cost Sharing Fairer and More Effective, JOTWELL (February 27, 2015) (reviewing Christopher T. Robertson, Scaling Cost-Sharing to Wages: How Employers Can Reduce Health Spending and Provide Greater Economic Security, 14 Yale J. Health Pol’y L. & Ethics 239 (2014), available at SSRN), http://health.jotwell.com/making-cost-sharing-fairer-and-more-effective/.
 
 

Law Learning from Medicine

Evan D. Anderson & Scott Burris, Educated Guessing: Getting Researchers and Research Knowledge into Policy Innovation, Temp. U. Legal Stud. Res. Paper No. 2014-10, available at SSRN.

The Society for Empirical Legal Studies (SELS) was created less than a decade ago to create a forum for scientific research on the law itself, and the Society has grown each year, with now hundreds of submissions from all over the world for its annual conference and flagship journal. Although there are many strands of such research, a primary research question is whether any particular law works to achieve its end, and if so how? Does the death penalty reduce crime? Does medical malpractice reform promote patient safety or lower costs? Do restrictions on the practice of medicine promote health?

Even before SELS was created, scholars in many fields were looking at the law as an independent variable, and looking at various dependent variables that could be used to access their success or failure. Health outcomes present an obvious dependent variable, given its importance for overall welfare and given the rich data available in this sector. Five years ago, the Robert Wood Johnson Foundation created the Public Health Law Research Program (PHLR), and appointed law professor Scott Burris as its director. PHLR is dedicated to “building the evidence base for laws that improve public health. PHLR funds research, improves research methods, and makes evidence more accessible to policy-makers, the media, and the public.” PHLR has helped to create a rich multidisciplinary field of scholars and practitioners engaged in this sort of research to understand the impact of law on health.

This empirical turn in legal scholarship—drawing other scholarly disciplines into the law and developing empirical capacities among legal experts—creates a wonderful opportunity to improve the law itself. As the methods become more rigorous and the breadth of the work grows, it will be possible for lawmakers to make more intelligent decisions about which laws to enact and which to repeal, based on the empirical evidence as to whether they in fact work. In this way, evidence can supplant ideology in the law, just as evidence has supplanted superstition in medicine. In the grand scheme of things, this approach begins to fulfill the aspirations of philosophers like Francis Bacon, Jeremy Bentham, John Dewey—who all sought to bring intelligent evidence into the domain of social policy.

With this background, I turn to the excellent new work of Evan Anderson and Scott Burris. In this paper, Anderson and Burris begin to explore the question of how empirical evidence can feed into the lawmaking process. Assuming that the science has been performed, and that it is good, how can policymakers incorporate those findings to actually improve the laws on the books and the laws as enforced? This inquiry is analogous to the question of “translation” in medicine, the movement of scientific findings from the bench to the bedside.

Anderson and Burris first note that there is a problem of synthesis: it does little good for there to be dozens of research studies performed on a given question, if they are not all published, not all found, and not all commensurable, given their divergent datasets, methods, and interpretations. Thus, the authors are correct to note that there is an urgent need for more synthesis. We have a model for doing so, again from medicine. As Anderson and Burris explain:

The Cochrane Collaborative grew out of Archibald Cochrane’s observations in the early 1970s about the fragmented and often misleading state of knowledge on the effectiveness of maternal health interventions (Cochrane 1972). The Collaborative quickly became an international force in the promotion of rigorous and methodologically consistent reviews. There are currently more than 5,000 systematic reviews covering a wide range of health interventions in the Cochrane collection, each following a standard protocol detailing how the research question was defined, the relevant studies were identified and the overall body of evidence was characterized (Cochrane Collaborative 2013).

In my view, there is an unmet opportunity for legal scholars to be trained in these methods and begin incorporating them systematically. We also need to get the right outlets and incentives for producing this sort of systematic synthesis. For law professors, just as much effort should be directed to systematizing scientific evidence about whether the law works, as is currently directed towards systematizing legal doctrine (and rhetoric) about what the law is. A systematic account of judicial superstitions provides little guidance as to whether the law works, and what the law should be.

That said, the movement towards bringing evidence into lawmaking is fraught with the danger of bias, and junk science, a problem that is exacerbated by the role of self-interested funders and investigators. Some of this biased research will skew the systematic reviews. In particular, much of the recent development in empirical legal methods has focused on adopting more and more sophisticated mathematical methods (drawing especially from the field of econometrics). In my view, this is often a zero-sum game. As the methods become more complex, it simply creates more opportunities for analysts and consumers to exercise discretion in how they model and interpret the data.

Anderson and Burris acknowledge another deep problem with this agenda of using evidence to shape policy. “For all the value of these efforts, a practical paradox confronts exponents of evidence-based public health law: if a legal intervention is truly innovative, there will not yet be direct evidence of its impact. There will be no studies for systematic reviews and syntheses to digest.” In my view, the answer is experimentation, first in the laboratory (using vignettes or other forms of simulation), and then in the field (with the cooperation of actual policymakers or their proxies exercising law-like power in private settings). Aside from its power to test truly novel interventions, experiments often allow robust causal inference, due to random assignment, without the need for complex and discretionary modeling choices. Instead the discretionary choices are more transparently made in the design of the experiment, and those choices are made behind a veil of ignorance, before the data is known.

We should much more often collaborate with policymakers to conduct randomized rollouts of policy interventions, and similar mechanisms, which allow gold-standard scientific inference about the impact of laws on their expressed goals. And today, we see this agenda gaining steam, as the United States Government, following Britain, is implementing randomized controlled trials to test the efficacy of federal policies. Unfortunately, however, experimentation is woefully under-represented in empirical legal scholarship, and policymakers sometimes seem to conceive the enactment of laws as the fulfillment of ideologies (ends-in-themselves), rather than as mere means for promoting welfare or liberty.

One of the greatest contributions of empirical legal research is to simply train analysts and policymakers to ask the right questions. Anderson and Burris demonstrate the importance of careful causal inquiry through “causal maps,” which are simply graphical depictions of pathways for causation, which help distinguish and clarify the potential relationships. Simply seeing these potential pathways can give rise to important research questions and hypotheses. In particular, using the example of traumatic brain injuries in sports and potential regulatory solutions, Anderson and Burris provide a compelling example of how causal mapping can make explicit the empirical questions and enhance our ability to conceive solutions. The causal map allows the analyst to reject the obvious reforms in favor of real solutions that get to the root causes. In this way, training analysts and policymakers to be careful about causal inference about data can also help us understand how policy reforms actually work.

This is an important paper, laying the groundwork for future empirical research and the translation of that research into smarter law and policy. Anderson and Burris help us understand how laws can work to improve the world and how evidence can enhance the chances that laws will actually do so.

A version of this paper appears as “Researchers and Research Knowledge in Evidence-Informed Policy Innovation” in Regulating Tobacco, Alcohol and Unhealthy Foods: The Legal Issues (Tania Voon, Andrew Mitchell & Jonathan Liberman, eds., 2014).

Cite as: Christopher Robertson, Law Learning from Medicine, JOTWELL (February 2, 2015) (reviewing Evan D. Anderson & Scott Burris, Educated Guessing: Getting Researchers and Research Knowledge into Policy Innovation, Temp. U. Legal Stud. Res. Paper No. 2014-10, available at SSRN), http://health.jotwell.com/law-learning-from-medicine/.
 
 

Beginning with the End (of End-of-Life Law) in Mind

Lois L. Shepherd, The End of End-of Life Law, 92 N.C.L. Rev. 1693 (2014).

No one is happy these days with how we die in America. In just the past few months, we’ve received reminders of that sad reality. In September 2014, the Institute of Medicine came out with its report Dying in America: Improving Quality and Honoring Individual Preferences Near the End of Life, and in October, Dr. Atul Gawande published Being Mortal: Medicine & What Matters in the End to much acclaim. Each of these works describes our society’s—and in particular the medical care system’s—failure to provide people with meaningful choices and support regarding the care they receive at the end of their lives.

While certainly not the only culprit in this woeful state of affairs, the law undeniably plays a significant role in shaping practices surrounding end-of-life choices. The latest article by Lois Shepherd, The End of End-of-Life Law, seeks to reorient how we think about the law’s approach to medical decisions made near the end of life. Shepherd has thought and written about dying and the law for years, and in this latest article she argues that the law should approach questions about end-of-life care in the same way it approaches other important medical choices, without “special laws, special burdens of proof, or unique requirements for documentation.” As she points out, decisions made at the end of life are not the only medical decisions that are important and permanent, with potentially irrevocable consequences. The touchstone for all these decisions, according to Shepherd, should be respect and care for patients and their families, and our legal framework should help rather than hinder that focus.

The article starts with a helpful summary of the existing legal approach to end-of-life decision-making (an approach synthesizing statutes and case law from fifty states and supplemented by federal laws and payment systems), and then it recommends that we jettison this elaborate structure. In the section titled “Even if you do everything right, the law is still a problem,” Shepherd recounts in some detail the stories of two cases that illustrate some of the many problems with the existing framework. To be clear, her point is not that the law is either too permissive or too stingy in permitting the termination of treatment; instead her point is that the law—with its obsession with documentation, formalities, and rigid priorities—too often proves uncaring and disrespectful of the true needs and interests of patients and their families.

To remedy the situation, Shepherd describes eight general principles that should guide the law relating to important medical decisions, whether or not they are usually described as end-of-life decisions. Several common themes emerge from this list of principles: The law should enhance, not obstruct, the ability of patients and their families to reach and implement choices consonant with the patient’s interests and values, even when the patient has failed to engage in any advance care planning. Communication about health care decisions should be encouraged. Decisions should not be rushed. It should be simple to appoint a health care agent with broad decision-making authority. Yet despite a general reluctance to see “more and better drafted laws” as the cure for existing problems, Shepherd is resolute that the law should include protections tailored to some patients’ particular vulnerabilities and provide a forum for resolving cases where irreconcilable disagreements among patients, families, and providers arise.

A critic might chide Shepherd for failing to present any kind of roadmap for turning her general principles into a legal reform proposal or to detail the challenges that any attempt at reform would encounter, but those are not her project. Shepherd’s goal, as I understand it, is to describe the key characteristics of a legal approach to important health care decisions that prioritizes care and respect for patients and their families. In short, she is prodding us think carefully and anew about what the ultimate goals for laws governing medical decision-making should be. To borrow the oft-quoted phrase from Stephen Covey’s The 7 Habits of Highly Effective People, she is reminding us to “begin with the end in mind.” That’s good advice, particularly since the “thick and sometimes impenetrable end-of-life legal apparatus” that exists today is the product of multiple, uncoordinated attempts over the past four decades to fix discrete problems that arose as technology advanced and ideologies advanced or receded. One could argue that we got where we are today by proceeding without a clear and overarching end in mind.

Of course, “beginning with the end in mind” has dual meanings here. In reviewing Being Mortal for The Guardian, Gavin Francis wrote: “The message resounding through [the book] is that our lives have narrative – we all want to be the authors of our own stories, and in stories endings matter. Doctors and other clinicians have to get better at helping people with their endings. …” The law needs to get better at helping people with their endings as well, and The End of End-of-Life Law provides a wonderful contribution to that project.

Cite as: Mary Crossley, Beginning with the End (of End-of-Life Law) in Mind, JOTWELL (December 9, 2014) (reviewing Lois L. Shepherd, The End of End-of Life Law, 92 N.C.L. Rev. 1693 (2014)), http://health.jotwell.com/beginning-with-the-end-of-end-of-life-law-in-mind/.
 
 

Super-Sizing Health Reform

William M. Sage, Putting Insurance Reform in the ACA’s Rear-View Mirror, 51 Hous. L. Rev. 1081 (2014).

For this Jot, I wanted to review recent or forthcoming scholarship on the bombshell D.C. Circuit Halbig v. Burwell decision, now awaiting en banc rehearing and buttressed by a similar decision from an Oklahoma District Court in Pruitt v. Burwell. But the only articles that I could find were Michael Cannon and Jonathan Adler’s piece that started the whole mess and a succinct rebuttal in State Tax Notes. My search, however, did turn up a terrific Commentary by Bill Sage, which I had somehow missed in my routine reading. Appropriate at the time that Sage wrote his Commentary, Sage gave Halbig a mere one-line, one-footnote reference in his insightful perspective on the aims and limits of recent U.S. health care reform efforts. Thankfully, it was Halbig that enabled me to discover Sage’s piece.

Necessarily, given the Affordable Care Act’s 2,400-page length and complexity, many of us have focused our writing on discrete aspects of the law. Sage instead offers a cogent flyover, bringing to bear his years of experience in this business, to explain what is and isn’t working in the ACA. Stepping back from the details, Sage identifies the ACA’s ambitious agenda not only to achieve near-universal health insurance coverage but also to reform the health care delivery system and improve population health. He commends this “triple aim,” emphasizing that insurance reform is, and must be, just the beginning of a successful health policy agenda.

Most commentaries have focused on the first aim—health insurance reform. But Sage urges that if we stop there we cannot hope for any real change. Sage aptly analogizes the second aim—health care delivery—to a ballpoint pen, representing health care providers’ largely unrestrained discretion to order more and more health care services and products. The third aim—population health—is colorfully analogized to a French fry, representing the public’s unchecked appetite for high-calorie, highly processed convenience foods and distaste for physical activity. Addressing the first aim “simply” (would that it were so simple!), by getting the remaining 15% of the U.S. population insured, will do little to address the pen and French fry problems. But combining all three aims in one large statute could potentially derail the entire effort. Sage (and we) hope not.

Sage identifies three underlying assumptions that stymie the United States’ health reform efforts. First, the ACA hews a managed competition approach, combining a patchwork of public and private structures to deliver health care, rather than making the leap to a single-payer approach. Second, the law operates from the premise that there is enough money in the system and that universal coverage with a minimum essential package of benefits will distribute those funds more efficiently. Third, the public accepts the necessity of a social safety net for certain segments of the population and assumes that those needs are valid, unmet, and properly delivered through existing program design. Sage offers those three explanations for the ACA’s shortsighted strategy of trying to address the underlying problems with aims two and three, health care delivery and population health, largely through aim one, health insurance reform.

As things have played out, of course, health insurance reform itself has faced multiple unanticipated challenges, including obstructionist, federalism-propounding states opting for federally, rather than state, run health insurance marketplaces; major technology glitches with rollout of the healthcare.gov website; President Obama’s promising what he couldn’t really promise—that health insurers would not drop subscribers; the Supreme Court’s NFIB v. Sebelius decision upholding the individual mandate as a tax while striking down Medicaid expansion as exceeding congressional spending power; and, most recently, in Halbig and Pruitt, the courts’ acceptance of a seemingly laughable argument that federal subsidies to make health insurance more affordable would be available to only a portion of the nation’s population, depending largely on the politics of their statehouses and capitols.

If we learned anything from the policy debates around the ACA, it is that everything old is new again; there are few new ideas in health reform. And Sage’s article does not purport to offer a wholesale, novel rethinking of approaches to the triple aim. But what I most enjoyed about his Commentary were the novel nuggets (including but not limited to the colorful ballpoint pen and French fry analogies) that connect apparently disparate dots in existing thinking about these problems.

For example, Sage notes that Medicaid now competes with education for the biggest share of state budgets, and that tension necessarily undermines demonstrated synergies between education and health. Instead of pitting those agendas against each other, policymakers need to recognize that healthy children learn better, and that better-educated people live healthier lives. He also offers a different way of framing the ACA’s much-touted health insurance reforms, including guaranteed issue, community rating, mandated benefits, and mandatory participation, as about not just expanding the risk pool (as the standard narrative goes) but also encouraging insurers and insureds to think about health insurance as prepaid health care, rather than insurance against risk. That rethinking, we are left to surmise, operates as a mental down-payment on more ambitious future reforms, such as a single-payer system. For now, although Congress declined to consider a Canadian or European-style national health insurance program, Sage observes that the ACA was enacted in similar historical climate as Social Security and Medicaid, namely, the country’s most severe economic downturn since the Great Depression. The ACA, he concludes, “conveyed solidarity, if not uniformity” with the view that health reform is a national problem requiring a national solution.

Sage concludes with cautionary optimism about the future of health reform. The ACA’s triple aim is the right idea. But health insurance reform will not succeed without serious commitment to changing payment systems, improving information flow, rationalizing pricing, and reducing barriers to innovation and efficiency. Moreover, we must take steps to improve our health, combining both communitarian public health and libertarian individual responsibility approaches, and in so doing, must avoid bogging down in the partisan politics that so far have derailed insurance reform.

Cite as: Elizabeth Weeks Leonard, Super-Sizing Health Reform, JOTWELL (November 7, 2014) (reviewing William M. Sage, Putting Insurance Reform in the ACA’s Rear-View Mirror, 51 Hous. L. Rev. 1081 (2014)), http://health.jotwell.com/super-sizing-health-reform/.
 
 

The Medicare Shared Savings Program: A Missed Opportunity to Address Providers’ Growing Market Power

Thomas L. Greaney, Regulators as Market-Makers: Accountable Care Organizations and Competition Policy, 46 Ariz. St. L. J. 1 (2014), available at SSRN.

Most discussions of the Affordable Care Act (ACA) focus on its primary goal—expanding health insurance coverage. Often overlooked, however, are various ACA initiatives targeting another important goal—reigning in health care costs. Included among these initiatives is the Medicare Shared Savings Program (MSSP). The MSSP ambitiously seeks to shift the health care delivery system away from independent providers who provide costly, uncoordinated care to organizations that focus on coordinated, evidence-based care. Specifically, the MSSP encourages the formation of accountable care organizations (ACOs), clinically integrated organizations of physicians and other providers that work together to provide patients better care while lowering overall costs.

Proponents of ACOs believe ACOs hold great promise for slowing the growth in health care costs. Professor Greaney’s article, however, offers a cautionary note. As he explains, the movement toward ACOs threatens to exacerbate the problem of health care providers’ increasing market power. Although federal regulators are cognizant of this risk, Greaney contends that the MSSP’s regulatory framework does too little to prevent provider market power.

Although implemented under the Medicare program, the MSSP also is intended to benefit private payors and their enrollees. ACOs participating in the MSSP share in a portion of any savings they generate for the Medicare program provided they meet certain quality performance standards. To succeed under the MSSP, then, an ACO must redesign its clinical care processes in ways that improve the quality of care provided to Medicare beneficiaries while also lowering Medicare’s costs. These changes also benefit the private sector, as privately insured patients treated by ACOs likewise receive higher quality, more efficient care. In addition, ACOs are attractive contracting partners for commercial insurers and employers seeking alternative payment arrangements, such as bundled payments and capitation.

Greaney, however, cautions that encouraging the development of ACOs brings risks. As providers come together to form ACOs, we are seeing an acceleration of a 15-year trend of greater provider concentration. This increased provider concentration strengthens providers’ leverage in their negotiations with commercial plans and employers, leverage they have used to both extract higher fees and resist alternatives to traditional fee-for-service. Of particular concern are ACOs that leverage their market power in one provider segment (e.g., hospitals) to negotiate higher prices in other provider segments (e.g., physician services). In addition, reduced provider competition weakens incentives for providers to alter their clinical practices so as to improve quality while economizing patient care. This lack of innovation also threatens the quality of care provided to Medicare beneficiaries. Finally, providers extracting higher prices from private payors may be less willing to treat Medicare beneficiaries for whom they receive lower payments.

Although the MSSP regulations and the FTC/DOJ Statement of Antitrust Enforcement Policy Regarding ACOS Participating in the MSSP (“FTC/DOJ Statement”) address these concerns, Greaney argues that federal regulators did too little. He sharply criticizes the government’s decision to abandon its earlier proposal to require mandatory review of certain ACOs by the FTC or DOJ as a prerequisite for their participation in the MSSP. He notes that a pre-screening process would have discouraged providers from forming ACOs that press the outer boundaries of acceptable arrangements under the antitrust laws. A pre-screening process also would have allowed the FTC or DOJ to condition their approval of an ACO on the organization agreeing to certain stipulations that protect competition (something the FTC and DOJ frequently do in merger cases).

Greaney also argues that the FTC/DOJ Statement focuses too narrowly on collaborations among otherwise independent providers, ignoring the potential competitive harms posed by ACOs formed by dominant providers or resulting from mergers. This omission encourages providers to consolidate into single entities, a trend we are seeing in the form of hospitals employing physicians and acquiring physician practices. Of particular concern is that consolidation may frustrate the emergence of a competitive ACO market, as individual providers integrated into a single organization are less likely to withdraw and form a competing integrated network. Greaney argues that CMS, the FTC, and DOJ missed an opportunity to facilitate closer monitoring of ACOs formed by dominant providers or through mergers. For example, federal regulators could have conditioned MSSP participation on ACOs providing data on their costs and negotiated rates with private payors. Regulators also could have required ACOs with dominant hospitals to unbundle their competitive and non-competitive services when negotiating with payors, a step that would have allowed private payors to bargain down fees for services for which there exist substitute providers.

Many people, myself included, believe the MSSP and similar programs have the potential to fundamentally re-shape the health care delivery system. Importantly, the shared savings model provides a bridge from fee-for-service to the risk-based payment models that hold great promise for slowing health care inflation. Greaney’s thoughtful analysis highlights that this transformation may prove harmful to the private sector if regulators fail to aggressively protect market competition from dominant ACOs.

Cite as: Jessica Lind Mantel, The Medicare Shared Savings Program: A Missed Opportunity to Address Providers’ Growing Market Power, JOTWELL (October 8, 2014) (reviewing Thomas L. Greaney, Regulators as Market-Makers: Accountable Care Organizations and Competition Policy, 46 Ariz. St. L. J. 1 (2014), available at SSRN), http://health.jotwell.com/the-medicare-shared-savings-program-a-missed-opportunity-to-address-providers-growing-market-power/.
 
 

New Governance as the New Weapon in the Fight Against Fraud

Joseph W. Yockey, Choosing Governance in the FCPA Reform Debate, 38 J. Corp. L. 325 (2013), available at SSRN.

Health law scholars sometimes pay inadequate attention to those who don’t write specifically in our area, which is the reason I have dedicated this and my previous jot to articles by non-health law professors that give us the big picture on issues related to the False Claims Act and the Foreign Corrupt Practices Act (FCPA), both of which are key enforcement mechanisms in the health sector. Bribery is unquestionably one of the most significant risks global life science companies face, given the SEC and DOJ’s recent increase in FCPA enforcement. Growing numbers of academic medical centers are engaging in joint ventures throughout the world, particularly in emerging economies where the risks of corruption are greatest. For these reasons, then, the FCPA is increasingly relevant to the health lawyer and compliance professional.

Professor Joseph W. Yockey’s recently published article, Choosing Governance in the FCPA Reform Debate, is a worthwhile read for three reasons. First, it summarizes the history and salient parts of the FCPA for those requiring a primer on the law. Second, it examines the two sides of the debate—between the business community (led by the Chamber of Commerce, which is also fighting vigorously for changes to the False Claims Act) and entities such as Human Rights Watch and Amnesty International —over whether Congress should revise the FCPA and whether DOJ and the SEC are over-enforcing the law. Third, the issues evoked by the concerns about FCPA enforcement are quite similar to the debate surrounding enforcement under the False Claims Act thereby giving the health professor, like myself, who is not a white collar specialist, a ten-thousand-foot view across the statutory spectrum of enforcement agency behavior.

Congress enacted the FCPA in 1977 to criminalize bribery of foreign officials by publicly traded entities, domestic concerns, and those operating in the United States, with the corrupt purpose of obtaining or retaining business. The law is key to those in the healthcare sector who do business abroad because hospitals are government instrumentalities in most foreign countries, with doctors assumed to be foreign officials for FCPA purposes. Formulary and pricing decisions are generally made by health ministries or hospital districts, thereby making the FCPA relevant to the entire procurement process.

Critics argue that DOJ is getting away with aggressive and unchallenged interpretation of the law—including its broad view of jurisdiction, who counts as a foreign official or government instrumentality, what it means to behave “corruptly,” and other undefined terms. The lack of interpretive guidance is exacerbated, critics assert, because so few cases are tried—most settle to reduce fines (by cooperating) and avoid debarment (by haggling over the ultimate disposition to avoid whatever the statutory trigger for debarment is). Such settlements leave unchallenged the government’s statutory interpretation.

As articulated by Yockey, the “crux of the reform argument [is] that the leverage that prosecutors hold through corporations’ fear of indictment means that there is nothing to stop prosecutors from applying the FCPA’s expansive scope beyond what is necessary for deterrence.” Yockey questions this assertion. He believes that traditional economic analysis of the relationship between harm and penalties is questionable because of the difficulty in quantifying the business that would be obtained as a result of the bribery, as well as the uncertainty over whether the consequences of indictment and trial would be as serious as the business community suggests. Would a patient decline to get a brand-name prescription filled upon learning that the manufacturer bribed the head of the patent office in China? Also difficult to quantify, argues Yockey, are the costs of structural reforms (changes to the company’s compliance program) required by the Deferred Prosecution Agreement. Yockey also points out the difficulty in detecting bribery, and he stresses that, while Western European countries are cooperating with DOJ in prosecuting corruption, many other countries, where corruption is arguably worse, have as yet shown little interest in such collaboration or enforcement more generally.

More to the point, Yockey detects some developments in the private sector as corruption is more widely discussed and analyzed, which suggests to me that maybe enforcement, albeit spotty, is changing norms:

Whether framed in terms of corporate social responsibility or not, these firms have come to realize that there is a business case to be made for avoiding bribery that goes beyond the risk of regulatory sanction. Bribery raises their marginal tax rate, increases the chance of continuous solicitation, raises the cost of capital due to the time lost during haggling, makes it harder to recruit and keep talent, and, for some companies, can have adverse branding and reputational effects. Contracts obtained through bribery may also be legally unenforceable, and can undermine employee trust and confidence in management. (P. 356.)

In the end, Yockey suggests a climate that is not unlike that of healthcare enforcement more generally: “Some firms likely remain undeterred by the present FCPA enforcement climate, whereas the risk and expense associated with even modest FCPA scrutiny can cause socially responsible firms to seek check-list solutions to compliance challenges that they (and regulators) often do not fully understand. This dynamic does not help firms that seek to remain law-abiding, nor does it help regulators operating with limited capacities find ways to reduce overall levels of bribery.”

Yockey suggests a solution to this state of affairs in new governance, whereby firms would work in a consultative manner with regulators to create compliance programs that are context-specific and therefore more likely to be effective in combating corruption. This conversation seems quite timely, as life science companies are discussing whether it is more effective in resisting corruption to adopt a single template compliance program or tailor made programs specific to each region. Some support for the context-specific approach can be found in the October 2013 European Union Study on Corruption in the Healthcare Sector, which suggests that, because the triggers for corruption vary by economy, a one-size-fits-all solution does not best address corruption, the form of which also varies by member state.

Yockey concludes that the ambiguity of the FCPA makes it well-suited to the task of eliminating corruption. The appeal of new governance is that it shows how a statute like the FCPA, which is more principle than rule-based, can make regulation more effective and less burdensome. Working collaboratively, industry and agencies can focus on the problems that require resolution simultaneous with norm building, thereby giving the law content. Yockey hopes that this process will achieve industry buy-in while fashioning on-the-ground solutions that actually work. Finally, responding to one of the biggest challenges to corporate compliance, he hopes that this approach “discourages efforts at cosmetic compliance or ‘the gaming of detailed rules’ and emphasizes the importance of internalization as the way to long-term compliance.”

Yockey’s exposition on how new governance would work in implementation displays a thoughtfulness and practicality that makes the article a strong prescription as well as an excellent read. Any health law professor looking for an introduction to the international fight against bribery will spend her time well reading Yockey’s article.

Cite as: Kathleen Boozang, New Governance as the New Weapon in the Fight Against Fraud, JOTWELL (September 8, 2014) (reviewing Joseph W. Yockey, Choosing Governance in the FCPA Reform Debate, 38 J. Corp. L. 325 (2013), available at SSRN), http://health.jotwell.com/new-governance-as-the-new-weapon-in-the-fight-against-fraud/.
 
 

Getting Specific About the Financial Security Aspects of Health Insurance

Allison K. Hoffman, Health Care Spending and Financial Security After the Affordable Care Act, N.C.L. Rev. (forthcoming), available at SSRN.

Too often, discussions about health insurance coverage are one-dimensional, and focus solely on whether someone has coverage (good) or not (bad). Having health insurance coverage is undeniably a good thing and an important policy goal. However, as Professor Hoffman’s article points out, simply focusing on health insurance coverage, without examining the type of protection it provides, gives us an incomplete picture of an individual’s protection against health-related financial risks.

One of the primary goals of health insurance, after all, is to protect individuals from the financial insecurity that can result from medical spending. What is perhaps less obvious to the casual observer is that health insurance can provide very different levels of protection against financial insecurity depending on the plan’s premiums, cost-sharing structure, and coverage terms. In her article, Professor Hoffman first provides a taxonomy of the types of financial risk health insurance could attempt to reduce. She then uses stylized examples of three health insurance consumers to examine how various forms of post-ACA coverage provide financial security. Her examination leads to some surprising results.

The types of financial security identified include: low baseline spending (where premiums for coverage are low); low variability in spending (where spending on covered benefits is not widely variable from year to year); no catastrophic risk (where variable spending is within an individual’s capacity to absorb while maintaining a decent income level and living standards); and transparency (where an individual is aware of the range of possible spending under her health insurance policy).

The article then examines how three different types of health care consumers will fare under the ACA’s regulatory structure, using currently available cost estimates and median income levels to flesh out the examples. The first consumer is one who purchases average silver-level coverage on the individual market. This consumer is well protected against catastrophic risk, but faces potentially high baseline costs and some variability in spending. The second consumer is one covered by an employer-sponsored plan. As Hoffman points out, individuals covered by employer plans have historically been well protected against nearly all types of financial risk. She also acknowledges that the ACA provides no guarantees that such protections will continue. It’s likely that employer-provided coverage will continue to provide low baseline spending, but going forward it may subject individuals to increasing amounts of variability and catastrophic risk. Finally, the article examines a retiree with Medicare and Medigap coverage. The retiree example is particularly interesting, as it illustrates that an individual with only Medicare coverage will benefit from low baseline spending but face significant variability and catastrophic risk. By electing Medigap coverage, however, the retiree can shift into a high baseline spending model that involves low variable spending and low catastrophic risk.

As I read through the analysis of various types of risk protection in each market segment, I couldn’t help but think that perhaps we need not be concerned about the variation present because of the ability post-ACA for many individuals to move between market segments. For example, if your employer offers you a lousy plan that doesn’t provide you with the financial protection you require, you can simply buy coverage on the individual market. Hoffman easily handles this concern, by explaining that moving between markets (1) is not always possible (an individual can’t simply opt in to employer-provided coverage if none is offered) and (2) requires the individual to be fully aware of the financial risk protection of various forms of health insurance and to make a rational decision on the basis thereof. Given what we know about how people make complex decisions, she is right to suggest that the type of high-level analysis and decisionmaking is not likely to be the norm.

The article concludes by attempting the difficult task of trying to make sense of this mixed-model of health insurance as financial security. My own sense is that the inconsistent approach to the financial security aspects of health insurance were likely driven by the varied political forces at play in the lead up to the ACA. But regardless of why we ended up with these divergent models of financial security, the article provides an important contribution to all who are interested in health policy. It is not enough to focus on whether an individual has or does not have health coverage. In order to evaluate whether health reform satisfies our policy goals, we must first have an understanding of what we want health insurance to do, and what risks we want it to protect against, and evaluate outcomes within that framework. Hoffman’s article not only draws attention to this important issue, it also gives policymakers important areas for monitoring and further study by identifying potential sources of financial insecurity among the insured.

Cite as: Amy Monahan, Getting Specific About the Financial Security Aspects of Health Insurance, JOTWELL (July 23, 2014) (reviewing Allison K. Hoffman, Health Care Spending and Financial Security After the Affordable Care Act, N.C.L. Rev. (forthcoming), available at SSRN), http://health.jotwell.com/getting-specific-about-the-financial-security-aspects-of-health-insurance/.
 
 

Can Information Technology Save Health Care?

Nicolas P. Terry, Information Technology’s Failure to Disrupt Health Care, 13 Nev. L.J. 722 (2013).

The massive stimulus bill of 2009 included the HITECH Act, by which Congress pledged roughly $30 billion to encourage providers to adopt electronic health records and other health information technologies (HIT). The bill cited a long list of familiar but elusive policy goals—improve health care quality, reduce medical errors, reduce health disparities, control costs, reduce inefficiencies, improve public health, promote competition, increase consumer choice. If the health policy literature had a fantasy genre, the HITECH Act solving our health system’s problems through a new nationwide HIT infrastructure would feature prominently.

But a few years later, as Nicolas Terry observes, and “HIT still appears to be a large rock that only a few dedicated converts are pushing up a steep and expensive hill.” Why is that? Why wouldn’t our lumbering, dysfunctional, and fantastically expensive health care system be transformed by information technology like so many other industries? Doesn’t our health care system practically beg for the efficiencies of information technology? Terry’s article, Information Technology’s Failure to Disrupt Health Care, tries to answer these questions.

The framework he uses is the idea of “disruptive innovation.” Coined by Harvard Business professor Clayton Christensen, a disruptive innovation is a novel product, technology, or business practice that undermines and ultimately displaces existing products, firms, or even entire industries—usually by being much less expensive and more accessible than incumbents. Terry cites familiar examples, like iPods undermining traditional music distribution, web sites undermining the traditional newspaper industry, and Wikipedia undermining Encyclopedia Britannica’s print editions.

Of course, it didn’t take long for the idea to hit health care. Out of the roughly 48 articles on Westlaw that cite one of Christensen’s publications on “disruptive innovation,” roughly half appear in health law articles. (See here at note 7.) Christensen himself applies disruption theory to health care in The Innovator’s Prescription: A Disruptive Solution for Health Care. Again, our GDP-devouring health system would seem ripe for “disruption.” This notion is not limited to business theorists. Leading medical thinkers like Eric Topol think that health care is primed for some creative destruction.

The disruption formula fits health care so well, it seems like a matter of when HIT will transform our health care system, not if. This makes Terry’s sober, rigorous review of HIT in health care so timely and valuable. For example, Terry tells the familiar story of Google Health—perhaps the poster child for Silicon Valley’s conceits—which aimed to transform health care (not modest) by creating web-based personal health records (pretty modest). Before that, Healtheon had tried something similar. Both failed. Were they simply ahead of their time?

Terry astutely observes that HIT innovation to date has not been radical enough—it has been largely “sustaining” innovations, made by incumbents to slightly improve incumbents, rather than truly “disruptive” innovation, per Christensen’s framework. The problem with outsiders like Healtheon and Google Health is that they didn’t offer much in the way of a new “value proposition.”

Another important contribution is identifying structural reasons why HIT has not transformed our health system for the better. First, Terry argues that HIT suffers from the same market failures that plague the health care system—too numerous here to cite. Second, he observes that the health system itself creates barriers for HIT with byzantine organizational and reimbursement schemes more tailored to episodic care, not process-oriented care. Third, he notes that HIT itself suffers from a lack of standardization, which inhibits data interoperability, exchange, and transparency.

So is all this HIT spending for naught? Terry argues that we would need to reform the things that make health care inhospitable to disruption. In Part V: The Value of Waiting, Terry explains that HIPAA’s privacy rules, the HITECH Act’s meaningful use requirements, and perhaps even the Affordable Care Act’s insurance and delivery reforms introduced even more fog to a health care system that was already menacingly complex.

But Terry also notes that a potentially disruptive category of HIT products already exists, though it may not be mature enough yet—mobile health technologies, including medical apps for smartphones and tablets. These products allow, for example, diabetics to track their blood glucose levels, or cardiac patients to perform mobile electrocardiograms. Mobile apps allow us to do other previously unimaginable things because we carry powerful computers around in our pockets or purses.

Per the disruption model, Terry argues that mobile health technologies might be “smaller, simpler, and more convenient,” introducing a new value proposition to the market by making health care available wherever you can carry a smartphone, unbundled from far more expensive health professionals and facilities. In fact, Terry notes, mobile phones are smaller and more accessible even than retail medical clinics, which Christensen singles out as a “disruptive innovation” in The Innovator’s Prescription.

The scope of the mobile device market also points toward genuine disruption. Today there are more than six billion mobile devices in the world, and by 2017 the number of mobile devices (nine billion) might exceed the world population. Downloads and users of medical apps are skyrocketing as Apple, Google, and Samsung rush to add even more sensors and hardware with potential medical uses to their devices. All the fervor makes one wonder whether HIT is a real solution to our health care problems, or mere technological solutionism.

Terry has always had a keen eye for the new and unusual in health care. And he has become one of the most well-respected voices on the legal and regulatory complications of HIT, particularly on patient privacy. At its base, Terry notes that HIT must go beyond simply storing, receiving, and sending health data to actually doing something with it. The promise might reside in innovative ways to use clinical decision support (CDS), algorithms, artificial intelligence (AI), and process-oriented improvements, perhaps using “big data.”

So many want so badly for HIT to transform health care. But Terry’s appraisal shows that all this disruption talk does not fit reality—yet.

Cite as: Nathan Cortez, Can Information Technology Save Health Care?, JOTWELL (June 25, 2014) (reviewing Nicolas P. Terry, Information Technology’s Failure to Disrupt Health Care, 13 Nev. L.J. 722 (2013)), http://health.jotwell.com/can-information-technology-save-health-care/.
 
 

The Public-Private Enforcement Regime: Does the False Claims Act Work?

Pharmaceutical companies represent the poster-child defendant for whether public-private enforcement works. While subject to FDA prosecution for violation of the Food Drug Cosmetic Act, they more often face qui tam suits by private relators, usually but not exclusively for off-label promotion. DOJ may or may not choose to intervene, but if it does jump in, the Department operates with the advantage of a 90% success rate (frequently as a result of settlement because the companies can’t risk debarment). Before the case is concluded, it may have been joined by some combination of the Veterans Administration, state Medicaid Fraud Units or relators under mirror state-law False Claims Acts for recovery of Medicaid dollars, as well as by private insurance companies under RICO, and states’ attorneys general under consumer protection laws. The Department of Health and Human Services Office of Inspector General (HHS OIG) will likely be at any settlement negotiations to hammer out a 100-page Corporate Integrity Agreement (CIA). If the company’s activities are really offensive, DOJ may throw in a mail or wire fraud charge. When the fines are announced, and the CIA is signed, shareholders will file a derivative suit against the directors seeking reimbursement, claiming that if they weren’t asleep on the job the company would have avoided what often exceed billion dollar fines. And that’s just for off-label activity. The enforcement regime currently policing the life sciences industry is mind-bogglingly complex, representing a new and clearly unimagined era in “public-private enforcement.”

A must-read for health academics is David Freeman Engstrom’s trilogy of articles about public-private enforcement, focusing specifically on the False Claims Act (FCA), the “gold standard” of hybrid enforcement: Harnessing the Private Attorney General: Evidence from Qui Tam Litigation, found in Columbia Law Review, Public Regulation of Private Enforcement: Empirical Analysis of DOJ Oversight of Qui Tam Litigation Under the False Claims Act, appearing in Northwestern Law Review, and Agencies as Gatekeepers, published in Yale Law Journal. Unsurprisingly, healthcare cases comprise a disproportionate share of FCA cases, thereby making Engstrom’s work extremely important to the health law academy. These articles represent a breath-taking amount of work, providing a theoretical framework from which to analyze the balance and effectiveness of a public-private enforcement regime as well as empirical data to assess both fans’ and critics’ perspectives of FCA prosecution as well as relators’ and DOJ’s roles.

Readers lacking familiarity with the False Claims Act would do well to start with Harnessing the Private Attorney General, which provides an accessible summary of how the FCA is structured, and how the cases proceed. Engstrom’s ultimate question is whether the Act’s combination of reward and procedural barriers achieves the right balance in incentivizing efficient deployment of DOJ’s resources in prosecuting fraud cases reflecting the right priorities, while avoiding socially undesirable enforcement efforts. More specifically, he seeks to test the most common claims of FCA critics and proponents in order to determine which if any of the on-going calls for further amendments to the FCA are empirically supportable. Engstrom’s findings upend most of the claims of FCA critics, including those directed at repeat relators and law firms that specialize in FCA cases. He finds that “former DOJ prosecutors turned private sector relator counsel…are far more likely to persuade the DOJ to exercise its powerful authority under the FCA to intervene in qui tam cases and push them to resolution.” “And yet,” he writes, “when they win, former DOJ insiders achieve impositions that are $10.6 million and $3.4 million smaller on a per-win and per-filing bases, respectively, than those achieved by their non-insider counterparts.” These findings, says Engstrom, “strengthen concern about ‘revolving door’ dynamics.”

Public Regulation of Private Enforcement is a bigger article essentially comprising two parts. Part one presents a theoretical framework for thinking about whether agencies are effective gatekeepers of private litigation, factoring an agency’s ability to avoid inefficient enforcement activity, police collusive settlements, and leverage deficient but socially desirable enforcement. Engstrom creates a taxonomy by which to consider agency behavior: welfare maximizer (optimize deterrence), rent-seeker (maximize recoveries), politicker (maximize public recoveries), and belt-notcher (win-loss ratio). Part two offers Engstrom’s empirical analysis of FCA cases, from which he 1) concludes that DOJ too rarely uses its termination authority (4% of qui tam cases); 2) rejects claims that the DOJ’s intervention decisions are politically motivated; 3) decides that DOJ’s interventions (in about one-quarter of cases) do not appear arbitrary but evidence an ability to screen cases on the merits, although DOJ also appears to factor in its resource constraints and the power of the defendant. Engstrom’s research confirms that DOJ intervention results in recoveries 90% of the time while declined cases more frequently result in no recovery. However, he rejects what he identifies as a too-frequent assumption by judges that declined cases are meritless. This latter conclusion rebuts calls for amending the FCA to preclude relators from going forward with cases declined by DOJ. On the other hand, Engstrom concludes that DOJ should affirmatively act to terminate relator cases more frequently.

The Yale article, Agencies as Litigation Gatekeepers, drives home the point that the public-private enforcement balance is not about choosing between the two models, but determining how optimally “to coordinate multiple, overlapping, and interdependent enforcement mechanisms”. Engstrom analyzes whether the rise of private enforcement is good or bad, as well as whether administrative agencies are effective litigation gatekeepers, using zealousness, coordination, and legislative fidelity as his criteria. Engstrom uses this taxonomy to assess the effectiveness of the tools embedded in, inter alia, the FCA to reach the optimal balance between public and private enforcement, ultimately suggesting that the FCA is a comparatively well-constructed statute to achieve this end.

Professor Engstrom has made a significant contribution to our understanding of the FCA enforcement regime, suggesting that it mostly works. However, his analysis focuses on all FCA cases, and it is not clear whether it would yield the same results had it looked exclusively at FCA cases in the healthcare sector. In this arena, a public-private enforcement regime is even more complicated, not the least because of the ever-present threat of debarment.

It is impossible to do justice to Engstrom’s work in a jot. Hopefully, this review has convinced you of the importance of his work, and its contribution to our understanding of the FCA landscape, so that you will be enticed to read his work yourself.

Cite as: Kathleen Boozang, The Public-Private Enforcement Regime: Does the False Claims Act Work?, JOTWELL (May 27, 2014) (reviewing David Freeman Engstrom, Harnessing the Private Attorney General: Evidence from Qui Tam Litigation, 112 Colum. L. Rev. 1244 (2012). David Freeman Engstrom, Public Regulation of Private Enforcement: Empirical Analysis of DOJ Oversight of Qui Tam Litigation Under the False Claims Act, 107 Nw. U.L. Rev. 1689 (2013). David Freeman Engstrom, Agencies as Litigation Gatekeepers, 123 Yale L.J. 616 (2013). ), http://health.jotwell.com/the-public-private-enforcement-regime-does-the-false-claims-act-work/.