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Sage and Hammer use the analogy of Copernican astronomy to suggest that understanding the dramatic change wrought by managed care requires a conceptual reorientation regarding the meaning of competition in health care and its appropriate legal and regulatory oversight. Both share the belief that misperceiving the world limits potential for technical and social progress.

Misinformation about risks, prevention, and treatment of COVID-19 has cost lives. Misinformation comes from many sources, with many motives for spreading and believing it. In caring capably and compassionately for patients, a substantial majority of health professionals and health care organizations have vigorously defended the standards of medical science and public health practice. However, a vocal minority and their sponsors or allies have exploited their medical credentials to the detriment of the public. They have understated known risks of severe illness, challenged the safety and effectiveness of vaccines without evidence, touted unproved and risky treatments, and amplified conspiracy theories about science and scientists. These activities have compounded the ethical stress and moral injury the health care workforce has experienced during repeated pandemic surges.

The United States spends nearly twice as much per capita on medical care as any other country. The United States has the world’s most advanced biomedical technologies, sophisticated hospitals, and skilled health professionals. The United States has a national public health body, the Centers for Disease Control and Prevention (CDC), that is generally considered the world’s leader in infectious disease detection and response. Nonetheless, the United States suffered among the world’s worst COVID-19 disease burdens and outcomes, inflicting largely avoidable harm on patients, health professionals, and the broader community.Why this happened is clearly important. But that it happened is itself significant. Criticisms of the U.S. health care system abound, but often have a Lake Wobegon character: The “health care system” may be bad, but my personal doctor is good. A silver lining of the pandemic experience is the possibility that Americans will finally recognize that, whether or not one’s own doctor is in fact good, American health care is unreliable, wasteful, and unjust. Should this occur, the path forward should combine several issues of law and policy to which I have devoted much of my scholarly career. These include improving corporate governance, rethinking professional ethics and selfregulation, remaking health care delivery, and broadening competition policy— with the common objective of enhancing collective goals and obligations in U.S. health policy.

“Medicare-for-All” should be more than a badge of political identity or opposition. This Article examines the concept’s potential to catalyze policy innovation in the U.S. health care system. After suggesting that the half century of existing Medicare has been as much “Gilded Age” as “Golden Age,” the Article arrays the operational possibilities for a Medicare-for-All initiative. It revisits America’s recent history of pragmatic rather than principled health policy, and identifies professional and political barriers to more sweeping reform. It focuses on four aspects of health policy that have become apparent: simultaneous inefficiency and injustice in medical care, neglect of the social determinants of health, inertia resulting from the legal architecture of health care, and the latent power of generational change. It concludes by explaining how a Medicare-for-All frame might prompt ethical re-engagement by the medical profession and help the health care system take specific steps on a path to improvement.

This supplemental statement focuses on missed opportunities—potential conclusions and recommendations within the project’s Statement of Task, illuminated by the COVID-19 experience, that were not included in the report. I regard these as critical omissions because I do not think the goal of a National Academies report should be to publish a tome, or to compile a long list of approved areas for possible funding and future policy development. In my view, its goal should be to make a compelling case for action and advocacy through clear, unmistakable statements combining data, insight, and purpose.

It is no exaggeration to say that American health policy is frequently subordinated to budgetary policies and procedures. The Affordable Care Act (ACA) was undeniably ambitious, reaching health care services and underlying health as well as health insurance. Yet fiscal politics determined the ACA’s design and guided its implementation, as well as sometimes assisting and sometimes constraining efforts to repeal or replace it. In particular, the ACA’s vulnerability to litigation has been the price its drafters paid in exchange for fiscal-political acceptability. Future health care reformers should consider whether the nation is well served by perpetuating such an artificial relationship between financial commitments and health returns.

With hospitalizations related to coronavirus disease 2019 (COVID-19) soaring, revenue from elective procedures plummeting, and health professionals experiencing unprecedented stress, the pandemic is challenging the US health care system in unimaginable ways. Will there be further consequences? Another medical malpractice crisis is a growing possibility.

Law and ethics are both essential attributes of a high-functioning health care system and powerful explainers of why the existing system is so difficult to improve. U.S. health law is not seamless; rather, it derives from multiple sources and is based on various theories that may be in tension with one another. There are state laws and federal laws, laws setting standards and laws providing funding, laws reinforcing professional prerogatives, laws furthering social goals, and laws promoting market competition. Complying with law is important, but health professionals also should understand that the legal and ethical constraints under which health systems operate must themselves adapt if health systems science is to advance.

In this issue of JAMA, Mello and colleagues report findings from a review of 37 studies and conclude that increased liability exposure (such as numbers of malpractice claims, dollar amounts of liability insurance premiums, or changes to state malpractice laws) was not associated with improvement in the quality of patient care. Their review draws effectively from databases of peer-reviewed medical literature, economics scholarship, and legal publications, and presents a thorough, necessary, and rigorous analysis of recent research. The review also highlights limitations of prior work. Apart from obstetrical care, studies relating malpractice liability to the quality of medical care have provided few insights about specific practice areas, and there is scant research involving outpatient settings or no-liability control groups. Exposure types, controls, and outcomes were variable, which limited the inferences that could be drawn. Given heterogeneity among the studies, the authors appropriately refrained from conducting a meta-analysis.

The United States is often described as the only developed nation without a public commitment to universal health care. Instead, its health care system is widely considered a product of bio-scientific free enterprise – technologically sophisticated, extremely expensive, but inaccessible to the poor. This chapter offers a contrasting account, refuting the conventional narrative of U.S. health policy as private, competitive, and entrepreneurial. Beginning over 20 years ago, the poor performance of the American health care system has been slowly revealed. For nearly as long, steps that might improve that performance have been identified. But little has changed. Why? The answer, in large part, lies in an accumulation of laws, regulations, self-regulatory practices, and financial subsidies which locks US health care into inefficient, unfair patterns and practices. While most of these provisions were well-intentioned when put into place, this “deep legal architecture” now serves mainly to prevent meaningful competition in medical markets and to distort or limit collective investment in the nation’s health.

American society tends to medicalize or criminalize social problems. Criminal justice reformers have made arguments for a positive role in the relief of poverty that are similar to those aired in healthcare today. The consequences of criminalizing poverty caution against its continued medicalization.

On February 25, 2015, the United States Supreme Court ruled in North Carolina State Board of Dental Examiners v. FTC that state licensing boards controlled by market participants are subject to federal antitrust law unless they are “actively supervised” by the state itself. The ruling may sound narrow and technical, but the significance of the case can be inferred from the number and prominence of the amici curiae who lined up to support the North Carolina State Board of Dental Examiners (“North Carolina Board”)—first when the Federal Trade Commission’s (“FTC”) internal enforcement action was appealed to the United States Court of Appeals for the Fourth Circuit, and again when that court’s decision in favor of the FTC was reviewed by the Supreme Court. This Article evaluates the potential of North Carolina State Board to serve as a “disruptive innovation” that will make health care markets more efficient. Over time, the Supreme Court’s holding might induce states to reassess waste and inefficiency in professional services, rein in self-regulatory privilege, and modify political settlements built atop the scaffolding of professional self-governance that unduly constrain markets, even when they do not explicitly violate federal antitrust law. But, that will only happen if states embrace the opening that North Carolina State Board offers to disrupt the status quo.

Good patient care includes not only avoiding error and injury but also acting honestly and constructively should it occur. Communication and Resolution Programs (CRPs) commit the sponsoring institution to vigilant detection of error, full disclosure to patients and families, and timely redress. CRPs also seek to incorporate the perspectives of patients and family members into safety improvement activities. This chapter explains the principles underlying CRPs, traces their history, and describes current best practices for physicians, provider organizations, and the legal and regulatory environment. Transparency about error and proactive response to injury lagged other professional commitments to patient self-determination because of the emotion and politics surrounding medical malpractice. However, recent generations of physicians, patients, and policymakers have engineered a “quiet” revolution. Silence and secrecy are no longer ethically acceptable responses to medical error. Although additional research is needed on how CRPs affect safety, patient and provider satisfaction, and cost, the American College of Surgeons in 2014 declared CRPs to be, on balance, the most promising approach to medical liability reform.

The wealth trapped within American health care is simultaneously a tragedy and a miracle. It is a tragedy because stagnating wages, widening disparities in income, ballooning deficits, and stunted investments in education and social services make such medical profligacy shameful. It is a miracle because it still exists, whereas other U.S. economic resources of similar magnitude have already been dissipated by global market forces without addressing any of the aforementioned failings – indeed, sometimes having contributed to them. It therefore can be released and used. It is time to “frack the health care system” and innovate the de-medicalization of America. The catchphrase for this effort is assuredly not “Repeal and Replace,” the Republican party’s oversimplified solution to the overblown criticism it continues to level against the Affordable Care Act. A better mantra is “Recover and Repurpose” – releasing the value trapped in our underperforming health care system and directing it toward more individually and socially productive ends. With careful planning and responsible execution, recovering and repurposing the trillions of dollars being spent on low-value medicine can set an example for an economic transition that offers broad distributive and communal benefits as well as efficiency gains. The current condition of American politics compels such an approach. Cast in its best light, the cleavage revealed by the 2016 election cycle was not between the individual and the collective, or even between choice and coercion, but between re-invention and restoration. Moreover, the restorative forces made it clear that becoming “great again” meant recapturing many of the qualities that health care aberrantly if expensively has retained: jobs, nativism, regional fairness, paternalism, and trust.

Tracing the evolution of political conversations about health care spending and their relationship to the formation of policy is a valuable exercise. Health care spending is about science and ethics, markets and government, freedom and community. By the late 1980s the unique upward trajectory of post-Medicare U.S. health care spending had been established, recessions and tax cuts were eroding federal and state budgets, and efforts to harness market forces to serve policy goals were accelerating. From the initial writings on “managed competition,” through the failed Clinton health reform effort in the early 1990s, to the passage of the Affordable Care Act in 2010, the policy narrative of health spending acquired a superficial consistency. On closer examination, however, it becomes apparent that the cost problem has been repeatedly reframed in political discourse even during this relatively brief period. The clearest transition has been from a narrative centered on rationing necessary care to one committed to reducing wasteful care – although the role of accumulated law and regulation in perpetuating waste remains largely unrecognized and the recently articulated commitment to population health seems an imperfect proxy for explicitly developing social solidarity with respect to health and health care in the United States.

Objective To describe the litigation experience in a state with strict tort reform of a large public university health system that has committed to transparency with patients and families in resolving medical errors. Data Sources/Study Setting Secondary data collected from The University of Texas System, which self-insures approximately 6,000 physicians at six health campuses across the state. We obtained internal case management data for all medical malpractice claims closed during 1 year before and 6 recent years following the enactment of state tort reform legislation. Study Design We retrospectively reviewed information about malpractice claimants, malpractice claims, and the process and outcome of dispute resolution. Data Collection/Extraction Methods We accessed an internal case management database, supplemented by both electronic and paper records compiled by the university's Office of General Counsel. Principal Findings Closed claims dropped from 244 in 2001–2002 to an annual mean of 96 in 2009–2015, closures following lawsuits from 136 in 2001–2002 to an annual mean of 28 in 2009–2015, and paid claims from 60 in 2001 to an annual mean of 20 in 2009–2015. Patterns of resolution suggest efforts by the university to provide some compensation to injured patients in cases that were no longer economically viable for plaintiffs’ lawyers to litigate. The percentage of payments relating to cases in which lawsuits had been filed decreased from 82 percent in 2001–2002 to 47 percent in 2009–2012 and again to 29 percent in 2012–2015, although most paid claimants were represented by attorneys. Unrepresented patients received payment in 13 cases closed in 2009–2012 (22 percent of payments; mean amount $60,566) and in 24 cases closed in 2012–2015 (41 percent of payments; mean amount $109,410). Even after tort reform, however, claims that resulted in payment remained slow to resolve, which was worsened for claimants subject to Medicare secondary payer rules. Strict confidentiality became a more common condition of settlement, although restrictions were subsequently relaxed in order to further transparency and improve patient safety. Conclusions Malpractice litigation risk diminished substantially for a public university health system in Texas following legal changes that reduced rights to sue and available damages. Health systems operating in a low-tort environment should work with policy makers, plaintiffs’ attorneys, and patient groups to assist unrepresented patients, facilitate early mediation, limit nondisclosure obligations following settlement, and expedite the resolution of Medicare liens.

This chapter examines the role of antitrust law in the governance of healthcare competition in the United States as the Patient Protection and Affordable Care Act of 2010 (ACA) takes full effect. It provides an overview of U.S. antitrust law before turning to recent and ongoing controversies involving antitrust law and healthcare, including those relating to hospital mergers, consolidation in the health insurance industry, accountable care organizations, and generic drugs. It then steps back to consider deeper questions of competition policy in the post-ACA era that may determine the economic sustainability and quality of the U.S. healthcare system.

To both its supporters and its opponents, the Patient Protection and Affordable Care Act (ACA) is a law that redesigns the U.S. health care system in pursuit of sweeping health policy goals. This chapter explores in greater detail the principles underlying contemporary health law and health policy and reveals significant tensions between them. The chapter begins with an overview of public policy and the regulatory state, both in general and as applied to healthcare. It then turns to health law, identifying characteristics that shortchange its health policy capabilities, notably the antiregulatory bias that results from empowering physicians as proxy guardians of patients’ liberty interests. Finally, it explains why health law remains a significant obstacle to improving the quality and efficiency of healthcare delivery notwithstanding the ACA.

This Article argues that recent calls for antitrust enforcement to protect health insurers from hospital and physician consolidation are incomplete. The principal obstacle to effective competition in health care is not that one or the other party has too much bargaining power, but that they have been buying and selling the wrong things. Vigorous antitrust enforcement will benefit health care consumers only if it accounts for the competitive distortions caused by the sector’s long history of government regulation. Because of regulation, what pass for products in health care are typically small process steps and isolated components that can be assigned a billing code, even if they do little to help patients. Instead of further entrenching weakly competitive parties engaged in artificial commerce, antitrust enforcers and regulators should work together to promote the sale of fully assembled products and services that can be warranted to consumers for performance and safety. As better products emerge through innovation and market entry, competition may finally succeed at lowering medical costs, increasing access to treatment, and improving quality of care.

Importance Honesty and transparency are essential aspects of health care, including in physicians’ and hospitals’ responses to medical error. Biases and habits associated with medical malpractice litigation, however, may work at cross-purposes with compassion in clinical care and with efforts to improve patient safety. Objective To determine the frequency of nondisclosure agreements in medical malpractice settlements and the extent to which the restrictions in these agreements seem incompatible with good patient care. Design, Setting, and Participants We performed a retrospective review of medical malpractice claim files, including settlement agreements, for claims closed before (fiscal year 2001-2002), during (fiscal year 2006-2007), and after (fiscal years 2009-2012) the implementation of tort reform in Texas. We studied The University of Texas System, which self-insures malpractice claims that involve 6000 physicians at 6 medical campuses in 5 cities. Main Outcomes and Measures Nondisclosure provisions in medical malpractice settlements. Results During the 5 study years, The University of Texas System closed 715 malpractice claims and made 150 settlement payments. For the 124 cases that met our selection criteria, the median compensation paid by the university was $100 000 (range, $500-$1.25 million), and the mean compensation was $185 372. A total of 110 settlement agreements (88.7%) included nondisclosure provisions. All the nondisclosure clauses prohibited disclosure of the settlement terms and amount, 61 (55.5%) prohibited disclosure that the settlement had been reached, 51 (46.4%) prohibited disclosure of the facts of the claim, 29 (26.4%) prohibited reporting to regulatory agencies, and 10 (9.1%) prohibited disclosure by the settling physicians and hospitals, not only by the claimant. Three agreements (2.7%) included specific language that prohibited the claimant from disparaging the physicians or hospitals. The 50 settlement agreements signed after tort reform took full effect in Texas (2009-2012) had stricter nondisclosure provisions than the 60 signed in earlier years: settlements after tort reform were more likely to prohibit disclosure of the event of settlement (36 [72.0%] vs 25 [41.7%]; P P = .003), and to prohibit reporting to regulatory bodies (25 [50.0%] vs 4 [6.7%]; P  Conclusions and Relevance An academic health system with a declared commitment to patient safety and transparency used nondisclosure clauses in most malpractice settlement agreements but with little standardization or consistency. The scope of nondisclosure was often broader than seemed needed to protect physicians and hospitals from disparagement by the plaintiff or to avoid publicizing settlement amounts that might attract other claimants. Some agreements prohibited reporting to regulatory agencies, a practice that the health system changed in response to our findings.

For the first time, entrepreneurs are aggressively developing new medical technologies and care models accessible to consumers outside of established professional channels. As this sector of the health care industry expands, it is likely to require new forms of legal governance, which we term "upstream health law." Whether or not there is a field with that name 10 years from now, the connections between conventional medical care and population health will have become both broader and deeper. Many of these connections will have been formed by private entrepreneurship and commercial activity, not government investment. Public health authority will remain important, especially with respect to social determinants of health. So too will traditional laws governing physicians, hospitals, insurers, and suppliers, particularly for life-saving therapies. But a substantial part of health law will change as health care migrates upstream, where people are still people and not yet “patients,” where aging may be graceful and death dignified, where individuals are part of communities and social networks, where health is only one aspect of well-being, and where we expect what we buy to be inexpensive, convenient, and reliable.

Crisis, it is said, means both danger and opportunity. In medical liability reform, however, greater opportunity may lie in noncrisis. In this issue of JAMA, Mello and colleagues offer data suggesting that no crisis of the conventional sort currently exists in the medical malpractice system.

This Foreword to a forthcoming symposium on the "patchwork" health care system to be published in the Houston Journal of Health Law & Policy considers whether current reactions to fragmentation in health care represent minor variations on a longstanding theme in US health policy or offer a more substantial counterpoint to that theme. The theme is this: that perfect physicians should be allowed to control health care even if safeguards are needed in practice because real physicians are not perfect. The Foreword previews four scholarly articles featured in the published symposium. It concludes that, while all the articles present original and valuable insights, the future health care system they describe is more variation than counterpoint on the theme of physician control.

As hospital, physician, and health insurance markets consolidate and change in response to health care reform, some commentators have called for vigorous enforcement of the federal antitrust laws to prevent the acquisition and exercise of market power. In health care, however, stricter antitrust enforcement will benefit consumers only if it accounts for the competitive distortions caused by the sector’s long history of government regulation. This article directs policy makers to a neglected dimension of health care competition that has been altered by regulation: the product. Competition may have failed to significantly lower costs, increase access, or improve quality in health care because we have been buying and selling the wrong things. Competition policy makers—meaning both antitrust enforcers and regulators—should force the health care industry to define and market products that can be assembled and warranted to consumers while keeping emerging sectors such as mHealth free from overregulation, wasteful subsidy, and appropriation by established insurer and provider interests.

This Commentary acknowledges and applauds efforts to understand the mechanisms of insurance reform contained in the ACA and to evaluate their success or failure. But the Commentary’s principal purpose is to examine the pros and cons of connecting insurance reform to health care and health—the pen and the french fry—and to convey the importance to the country of moving beyond insurance reform as quickly as possible. The Commentary begins by describing the potential synergies among the three health policy domains and offering reasons why the ACA sought to make simultaneous changes. It then identifies the vulnerabilities that are revealed in the Act’s combined approach. It concludes with a few observations about ways of improving both health care delivery and health, while expressing the hope that the ACA’s indisputably sweeping ambition will not be its downfall.

Physician leadership is required to improve the efficiency and reliability of the US health care system, but many physicians remain lukewarm about the changes needed to attain these goals. Malpractice liability—a sore spot for decades—may exacerbate physician resistance. The politics of malpractice have become so lawyer-centric that recognizing the availability of broader gains from trade in tort reform is an important insight for health policy makers. To obtain relief from malpractice liability, physicians may be willing to accept other policy changes that more directly improve access to care and reduce costs. For example, the American Medical Association might broker an agreement between health reform proponents and physicians to enact federal legislation that limits malpractice liability and simultaneously restructures fee-for-service payment, heightens transparency regarding the quality and cost of health care services, and expands practice privileges for other health professionals. There are also reasons to believe that tort reform can make ongoing health care delivery reforms work better, in addition to buttressing health reform efforts that might otherwise fail politically.

Communication-and-resolution programs (CRPs) in health care organizations seek to identify medical injuries promptly; ensure that they are disclosed to patients compassionately; pursue timely resolution through patient engagement, explanation, and, where appropriate, apology and compensation; and use lessons learned to improve patient safety. CRPs have existed for years, but they are being tested in new settings and primed for broad implementation through grants from the Agency for Healthcare Research and Quality. These projects do not require changing laws. However, grantees’ experiences suggest that the path to successful dissemination of CRPs would be smoother if the legal environment supported them. State and federal policy makers should try to allay potential defendants’ fears of litigation (for example, by protecting apologies from use in court), facilitate patient participation (for example, by ensuring access to legal representation), and address the reputational and economic concerns of health care providers (for example, by clarifying practices governing National Practitioner Data Bank reporting and payers’ financial recourse following medical error).

Tort reformers blame the high cost of American health care on defensive responses to rampant medical malpractice litigation. Defenders of the tort system counter that holding health care providers liable for negligence improves safety and ensures compensation for injury. The relationship between medical malpractice and health care expenditures is more complex than either of these positions reflects. The existing medical malpractice system increases medical spending mainly because it has evolved in tandem with other inflationary features of the health care system and may make those features even more difficult to change. In other words, medical malpractice is both a symptom of a costly health care system and a costly disease in its own right.

There were two ways for the solicitor general of the United States to litigate the constitutional challenge to the Patient Protection and Affordable Care Act of 2010 brought by twenty-six states and the National Federation of Independent Business. One path, which the solicitor general pursued, was to cautiously navigate judicial precedents, claim the barest increment of new congressional authority, and give the Supreme Court as many hooks as possible on which to hang a favorable decision. The road not traveled was to offer a full-throated defense of federal authority to comprehensively regulate the U.S. health care system, a multitrillion dollar commercial and social enterprise that represents the largest component of federal expenditure after national defense. The ACA has three cornerstones. First, make health insurance coverage as widespread as possible. Second, improve the quality and efficiency of health care delivery. Third, make individuals and communities healthier. The second and third pillars are sometimes overlooked because so much attention is paid to expanding coverage, but the hallmark of the ACA is that it combines major changes to health insurance, health care delivery, and health in a single piece of federal legislation. The Obama administration's timidity echoes what is strikingly absent from the new law. Although the ACA represents the successful culmination of a decades-long struggle to universalize coverage, its structure and text never convey the intent that all Americans have a common stake in the health care system. This lack of shared national identity is the missing fourth pillar of the ACA.

The most serious problem with the Patient Protection and Affordable Care Act (ACA) is not its contents but its packaging. Because it requires significant departures from business as usual in health insurance, health care delivery, and health behavior, the ACA is unlikely to succeed unless Americans feel a shared stake in its success. Unfortunately, the new law has been branded only by its opponents. Neither the Obama administration nor its congressional allies have effectively communicated the law’s key elements to the public. Most surprisingly, the groundbreaking program of near-universal health coverage the ACA creates does not even have a name. This essay explores the process of branding major American social legislation such as the ACA, and suggests a strategy for improving public understanding and building loyalty. Legal brand equity, like its commercial counterpart, implies a functional, emotional, and expressive relationship between the law and its intended beneficiaries. Accordingly, an effective marketing strategy for the ACA means creating consistent expectations regarding the law’s goals and performance, and ensuring that those expectations are met.

In 1596, Robert Bainbridge carved “The patient shall conquer” into the wall of his cell in the Tower of London. It is highly unlikely that Bainbridge was an early advocate for recipients of medical care, imprisoned perhaps by a cruel sheriff denied his payroll taxes or by a domineering barber refused his fee. But its unintended meaning would immediately provoke sympathy from many health care reformers. As we confront the critical challenges of implementing national health-care reform, however, whether the patient should conquer is a legitimate topic for debate. Does the patient’s conquest risk the collapse of the health-care system that he or she would dominate? There are several reasons why it might.

Highly Commended in the Basis of Medicine, 2011 BMA Medical Book Awards. British Medical Association News of financial entanglements among biomedical companies and researchers has increasingly called into question the worth and integrity of medical studies, nearly three-fifths of which are funded by industry. This volume assesses the ethical, quantitative, and qualitative questions posed by the current financing of biomedical research. The ten essays collected here reflect the wide range of opinions about perceived financial conflicts of interest in medical studies. The opening section provides an overview of the issue, describing the origins of, and concerns raised by, dubious financial arrangements; explaining how certain common situations intensify problematic funding structures; weighing the risks and benefits of commercialized research funding; and detailing the nature, extent, and consequences of the present relationship among academe, government, and industry in the health sciences. The second section compares how the idea of conflicts of interest differs in biomedical research, legal work, and journalism. It includes a challenging look at the term itself and an argument for managed financial incentives. The final section describes and analyzes the existing regulatory regime, poses questions and directions for future self and external regulation, and provides perspectives from a third-party research company. This considered, balanced discussion will interest scholars of bioethics, public health, and health policy.

The culmination of a century’s effort to enact universal coverage in the United States is a law with an uninspiring title, the Patient Protection and Affordable Care Act, and an even more awkward acronym, PPACA. The Obama administration has decided to call the legislation the Affordable Care Act, but the expansion of health coverage that the law sets in motion has no name, and therefore no identity. It badly needs one.

Essays on stem cell policy seem to fall into three categories. Some essays in this collection are about logic and principles. Others are about practices and beliefs. The former group draws lines and defends them, a normative project. The latter group attempts to explain the lines that already exist, a descriptive project that may have important normative goals. Still other essays, by scientists, are about growing stem cell lines instead of drawing them. The purpose of this essay is to situate the lines being drawn around stem cell science in the larger landscape of health policy. I am interested in the things that cause health policy to take particular directions and the consequences of those directions for cost, access, and quality — all of which are determined in part by biomedical innovations such as those potentially derived from stem cells.

Amnesia is a common, important, but rarely noted side effect of antibiotics. Apart from medical historians, few recall the severe morbidity and mortality once associated with acute bacterial infection. However, decades of antibiotic overuse and misuse have compromised the long-term availability and efficacy of these life-saving therapies. If designed and implemented appropriately, regulation can reduce the risk of bacterial infection, reserve antibiotics for circumstances where they are necessary, and rationalize the use of the most powerful agents. Regulation of antibiotic resistance can be justified, and should be guided, by both efficiency and fairness. A range of regulatory options are available--some information-based, some incentive-based, some command-and-control--each of which has indications, strengths, and weaknesses. A desired set of regulatory strategies must then be matched with the appropriate legal and regulatory institutions. A renewed focus on regulatory and institutional design has significant potential to reduce antibiotic-resistant bacterial infections and increase the effective life of existing and new antibiotics.

Geographic information system (GIS) mapping can help communities visualize the health of their neighborhoods and identify opportunities for improvement. In Austin, Texas, Children’s Optimal Health, a nonprofit association, used GIS to map the prevalence of obesity among middle school children and to identify contributory factors. The maps indicated that obesity is a problem in all Austin middle schools. Two neighborhoods outside downtown Austin have particularly high concentrations of overweight and obese students. Maps also showed that the neighborhoods have different proportions of fast-food outlets, grocery stores selling fresh produce, green recreation space, and students failing cardiovascular testing. The mapping exercise spurred community groups to propose obesity interventions tailored to each neighborhood.

My purpose in this commentary is twofold. First, I want to offer a few thoughts on why the American medical profession sometimes has a hard time accepting law on its own terms. Second, I want to suggest that even “good law” from the perspective of the medical profession—should it overcome its habits of resistance—may still be bad health policy for the United States.

Illness, we are often told, is a private matter. Accordingly, none must interfere in the medical decisions that emerge from the confidential relationship be- tween physician and patient. Yet evidence of interdependence is ubiquitous in health care. One person’s malady can harm families, workplaces, clubs, churches, and sometimes entire communities. Similarly, a suffering pa- tient must rely on many individuals, associational groups, corporate entities, and government agencies for support and assistance. It is, therefore, unsurprising that various social units claim an interest and a voice in maintaining health and treating disease. However, explicit solidarity has long been out of vogue in America’s value system, despite persistent lack of af- fordable medical care. Instead, the public has prized sci- entific innovation, consumer sovereignty, and personal autonomy, and has installed physicians as benevolent oli- garchs to oversee these functions. The resulting system delivers idiosyncratic care at enormous expense to most Americans, while a sizable minority often goes without.

The coverage, cost, and quality problems of the U.S. health care system are evident. Sustainable health care reform must go beyond financing expanded access to care to substantially changing the organization and delivery of care. The FRESH-Thinking Project (www.fresh-thinking.org) held a series of workshops during which physicians, health policy experts, health insurance executives, business leaders, hospital administrators, economists, and others who represent diverse perspectives came together. This group agreed that the following 8 recommendations are fundamental to successful reform: 1. Replace the current fee-for-service payment system with a payment system that encourages and rewards innovation in the efficient delivery of quality care. The new payment system should invest in the development of outcome measures to guide payment. 2. Establish a securely funded, independent agency to sponsor and evaluate research on the comparative effectiveness of drugs, devices, and other medical interventions. 3. Simplify and rationalize federal and state laws and regulations to facilitate organizational innovation, support care coordination, and streamline financial and administrative functions. 4. Develop a health information technology infrastructure with national standards of interoperability to promote data exchange. 5. Create a national health database with the participation of all payers, delivery systems, and others who own health care data. Agree on methods to make de-identified information from this database on clinical interventions, patient outcomes, and costs available to researchers. 6. Identify revenue sources, including a cap on the tax exclusion of employer-based health insurance, to subsidize health care coverage with the goal of insuring all Americans. 7. Create state or regional insurance exchanges to pool risk, so that Americans without access to employer-based or other group insurance could obtain a standard benefits package through these exchanges. Employers should also be allowed to participate in these exchanges for their employees' coverage. 8. Create a health coverage board with broad stakeholder representation to determine and periodically update the affordable standard benefit package available through state or regional insurance exchanges.

The 2000s was mostly a lost decade for reform of the health care delivery system. Among the few significant innovations was the retail medical clinic, where individuals could receive basic health care at posted prices without appointments, typically from nurse practitioners or physician assistants. Most retail clinics were associated with chain drugstores, supermarkets, or other "big box" retailers. This short article describes the implications of the retail clinic model for US health policy and health care reform. It is no longer available from the online journal in which it originally appeared.

In response to a prominent editorial by Dr. Jeffrey M. Drazen, Professor Sage explains how a relational approach has impeded health law's ability to effectively govern the American health care system, arguing that health law has traditionally focused on the physician-patient encounter rather than on achieving collective objectives (which he calls regulatory duties). Professor Sage traces health law's relational emphasis to private and public law, professional ethics and bioethics, budgetary and general politics, and health care consumerism. He concludes that four areas of health policy-conflicts of interest in biomedical research, managed care and pay-for-performance, health care transparency and education, and public health-require a more collective regulatory commitment.

I am delighted to discuss retail medical clinics here at the Southern Illinois University School of Medicine. Ted LeBlang is a legendary figure in law and medicine, and I am honored to be the inaugural LeBlang lecturer. It may not be obvious from my title, but I am here to talk about national health care reform. For several months, I have been having—as Yogi Berra might say—“feelings of déjà vu all over again.” I cut my teeth on health policy in the Clinton Administration in 1993, spending half a year in the thick of that health reform effort. We seem now to be back where we were in the early 1990s, for reasons I can understand but with fewer novel approaches to expanding health care access being discussed than I might like to see. For example, this morning's USA Today contained an article entitled “States Consider Tobacco Tax Hikes.”Footnote1Why are states considering tobacco tax hikes? To fund universal health coverage, much as they (and the Clinton Administration) proposed in the early 1990s. It strikes me as challenging to fund major health insurance expansions from tobacco revenue, even if smoking generates health care costs. I teach my regulation and public policy students that, in general, you can only get one of two things from a tax. You can either get money or you can get behavior change. If you tax tobacco, you can either get people to stop smoking or you can get them to pay you money for the privilege of continuing to smoke. And the higher the tax, the less revenue it generates. I have also noticed many articles in recent weeks about large employers supporting comprehensive approaches to national health coverage. That reminds me again of the early 1990s, when large employers championed a combination of HMO-based care and cooperative public purchasing called “managed competition.” Remembering the health reform debacle 15 years ago, the fact that current conditions seem oddly familiar does not bode particularly well. Are there things that are different? That might make health reform more achievable? To begin to answer this question, I chose retail medical clinics—what, for lack of a better term, one can call the “Wal-Martization of health care”—as my subject for a lecture on health law and public policy.

Between 1993 and today, health policy experts have reached consensus that quality assurance, cost discipline, and equitable access depend on delivering health care at times, in places, and in ways much different from those to which we are accustomed. The challenge for the next generation of health reformers is to improve coverage by improving care. This can happen only if reform legislation has a theory for success, collective social meaning, and political champions.

The subject of this Essay is the retail medical clinic movement. Retail medical clinics-a few hundred exist at the time of this publication-are typically located in national or regional chains of discount stores, pharmacies, and supermarkets. 1 News articles describing this new phenomenon in American health care tend to examine its viability as a business. The symposium for which this Essay was prepared is devoted to the "Massachusetts Health Plan," that state's pioneering effort (in the current political cycle) to achieve near-universal health insurance for its residents. Accordingly, this Essay situates the retail medical clinic movement in overall "health policy," with particular emphasis on its implications for access to medical care.

This Article seeks to bring greater discipline to the analysis of conflicts of interest in biomedical research, and by doing so to reveal trends and tensions in the research enterprise that require a more deliberate and longer term response. By comparing tensions in biomedical research to those affecting indisputably "relational" professionals such as lawyers, this Article concludes that "conflict of interest" is the wrong language to describe most of these situations, and leads to the wrong solutions. Conflict of interest analysis in law derives from an image of professional obligation running directly from expert agent to dependent principal. Because a dyadic researcher-subject relationship is no longer the essence of biomedical research, this Article asserts, attempting to insulate researchers from concerns other than the wellbeing of research participants using conflict of interest discourse will be ineffective or counterproductive.

We are currently coming to the end of what I have described as the first malpractice crisis of the 21st century. Malpractice crises, which are defined by shrinking liability coverage and/or rising premiums, occur periodically. The insurance crisis that now seems to be ebbing was different in certain ways from its 20th century predecessors, but will almost certainly not be the last such period to arise. As interest in "solving" this crisis wanes for various reasons, we have to ask what we have learned from the last five years. In my opinion, this crisis has produced strong arguments for testing comprehensive approaches to medical liability that connect to quality, that connect to health insurance benefits, that connect to provider payment, that connect to the big professional and social issues in health care. Only in this way can we break through the conventional doctors-versus-lawyers battle lines that have defined malpractice reform for generations of physicians and politicians. Why do we have trouble taking this next step? Alice Gosfield hit the nail on the head when she commented that the trick is to change the system for the people who want and deserve change rather than for everyone at once. As Alice observed, why should the worst performing doctors get the benefit of an improved system of resolving disputes and compensating injured patients? Why not start with the best performing doctors? Why not start with people who want to change the rules and who can prove that they are likely to perform well in terms of quality, safety, and honesty under different rules? Proposals to "demonstrate" comprehensive malpractice reform follow from this insight. Funded demonstration projects are familiar in connection with complex, publicly financed care under Medicare and Medicaid, where the entity paying the bill sponsors and monitors experimental changes to existing rules. In malpractice policy, however, demonstration projects are far more controversial than one would expect. To understand why, let us explore liability reform during the most recent crisis period.

The political battle over trial lawyers and "tort reform" centers on whether or not to reduce incentives to sue for medical malpractice by capping damages in malpractice suits and limiting legal fees. But the current struggle mis-states the case for innovation in medical malpractice policy. Rather than focus exclusively on the financial consequences of legal claims, malpractice reform should move closer to the bedside, emphasizing error prevention, open communication, rapid compensation, and efficient insurance of the costs of injury. Academic health centers are well positioned to lead this effort in each of their three recognized missions: patient care, teaching, and research. Academic health centers enjoy greater institutional cohesiveness and research capacity than most other medical practice settings. Perhaps most important, their high visibility ensures that patients who suffer avoidable harm within their walls become salient to the public as individuals, not merely as dollar entries in a litigation ledger.

There is increasing interest among policy makers in an integrated approach to patient safety and medical liability. This chapter proposes and develops a breakthrough medical malpractice reform: a system of medical error identification, patient notification, rapid compensation, and safety improvement within the Medicare program. The reform would provide Medicare beneficiaries with better safety, improved communication in event of error, preservation of therapeutic relationships, timely settlement, and fair compensation at lower administrative cost. Disputes in the reformed system would be adjudicated by Medicare's existing administrative appeals system, which would work together with Medicare's quality improvement regulation and payment policy to reduce errors and compensate injured patients. Testing reform within Medicare would also make it possible to extend future reforms to the Medicaid population, which is also less likely than younger, nonindigent patients to bring malpractice claims.

When experts discuss health policy, they typically mean the factors that affect access to medical care, its quality, and its cost. The first medical malpractice crisis of the twenty-first century began in 2001 and continues into 2006. Previous malpractice crises occurred in the 1970s and 1980s. Until the current crisis, few connections have been drawn between the medical malpractice reform movement and overall health policy. Malpractice crises are defined by rapidly rising liability insurance premiums for physicians, sometimes accompanied by difficulty obtaining insurance coverage at any price. Because lawsuits are upsetting as well as financially costly to physicians, and because armies of white-coated demonstrators make good political theater, hand-wringing over physicians leaving practice and hospitals closing their doors is standard fare for “tort reformers” in crisis years. During the longer intervals between crises, when insurance premiums are stable, malpractice reformers sustain momentum for their cause by suggesting that physicians' fear of litigation leads them to waste health care resources on “defensive medicine” and contributes significantly to overall medical inflation. For the most part, however, these issues have been voiced as political rhetoric and not incorporated seriously into policy making.

With the United States embroiled in its third major medical malpractice crisis in the past thirty years, this volume brings together an array of experts from law, medicine, social science, and business to explore the public policy of medical liability. As malpractice premiums continue to rise, doctors and lawyers engage in bitter debates across the country, and legislators struggle to comprehend and consider a myriad of proposed medical liability reforms, this volume provides an explanation of malpractice policy past and present – and a set of promising paths forward. The major failing of the current debate over malpractice reform is that it ignores the relationship between medical malpractice policy and core characteristics of American health care. For reasons both deliberate and circumstantial that this book describes, conventional approaches to medical liability barely pay lip service to the persistent inequities of access to health care and health insurance in the United States, to the recent revelation of serious safety and quality problems in medical “systems,” or to the decades-long battle being waged against rising public and private health care expenditures. Yet these forces are largely responsible for the severity of the current malpractice crisis and point the way to solutions far more promising than the measures – little changed since the 1970s – on which malpractice reformers and their opponents both fixate. The authors' collective purpose is to close the gap between malpractice policy and health policy.