The ultimate aim of health care policy is good care at good prices. Managed care failed to achieve this goal through influencing providers, so health policy has turned to the only market-based option left: treating patients like consumers. Health insurance and tax policy now pressure patients to spend their own money when they select health plans, providers, and treatments. Expecting patients to choose what they need at the price they want, consumerists believe that market competition will constrain costs while optimizing quality. This classic form of consumerism is today's health policy watchword.

This article evaluates consumerism and the regulatory mechanism of which it is essentially an example — legally mandated disclosure of information. We do so by assessing the crucial assumptions about human nature on which consumerism and mandated disclosure depend. Consumerism operates in a variety of contexts in a variety of ways with a variety of aims. To assess so protean a thing, we ask what a patient's life would really be like in a consumerist world The literature abounds in theories about how medical consumers should behave. We look for empirical evidence about how real people actually buy health plans, choose providers, and select treatments.

We conclude that consumerism, and thus mandated disclosure generally, are unlikely to accomplish the goals imagined for them. Consumerism's prerequisites are too many and too demanding. First, consumers must have choices that include the coverage, care-takers, and care they want. Second, reliable information about those choices must be available. Third, information must be put before consumers, especially by doctors. Fourth, consumers must receive the information. Fifth, the information must be complete and comprehensible enough for consumers to use it. Sixth, consumers must understand what they are told. Seventh, consumers must be willing to analyze the information. Eighth, consumers must actually analyze the information and do so well enough to make good choices.

Our review of the empirical evidence concludes that these prerequisites cannot be met reliably most of the time. At every stage people encounter daunting hurdles. Like so many other dreams of controlling costs and giving patients control, consumerism is doomed to disappoint. This does not mean that consumerist tools should never be used. It means they should not be used unadvisedly or lightly, but discreetly, advisedly, soberly, and in the fear of error.

The U.S. healthcare system continually confronts the challenge of controlling costs, improving quality and patient safety, and increasing or maintaining patient access to care. Payors and purchasers of healthcare (both public and private) strive to develop mechanisms to guarantee that they are purchasing the highest-value care – seeking to ensure that amounts paid take into account and provide incentives encouraging the delivery of high-quality, cost-efficient care. Through “value-based purchasing” (“VBP”) strategies, healthcare payors and purchasers are transforming from passive payors of claims (as in a traditional fee for service system) to active purchasers of quality care. To date, employers, health plans, and the Centers for Medicare and Medicaid Services (“CMS”) have implemented well over 100 VBP programs. However, progress is slower than anticipated. As the Institute of Medicine (“IOM”) and others have noted, adoption of VBP reforms may be hampered by legal barriers arising from a number of state and federal laws. The goal of this paper is to identify potential state and federal legal impediments to implementing VBP in healthcare.

In 1894, John Drinkwater, the befuddled, searching architect in John Crowley’s compelling fantasy, Little, Big, built his own home, Edgewood, “as a kind of compound illustration” of Victorian architectural styles.1 Rounding each corner, the visitor sees a different façade and interior – Italianate villa, Tudor manor house, neo-classical, country cottage – complete in itself, its attachment to the others invisible from a single perspective.

Reading a small flurry of articles from the past few years attempting to describe the field of health law, one feels like a visitor to Edgewood. The different perspectives are pleasing in themselves, without necessarily revealing the whole. This essay examines what I call the “architecture” of the health law field. By this I mean, without pressing the metaphor too far, the framework of beams and studs in which interior spaces can be designed, furnished and accessorized in different ways.

The current medical malpractice system is broken. Many patients injured by malpractice are not compensated, whereas some patients who recover in tort have not suffered medical negligence; furthermore, the system's failures demoralize patients and physicians. But most importantly, the system perpetuates medical error because the adversarial nature of litigation induces a so-called “Culture of Silence” in physicians eager to shield themselves from liability. This silence leads to the pointless repetition of error, as the open discussion and analysis of the root causes of medical mistakes does not take place as fully as it should. In 1993, President Clinton's Task Force on National Health Care Reform considered a solution characterized by Enterprise Medical Liability (EML), Alternative Dispute Resolution (ADR), some limits on recovery for non-pecuniary damages (Caps), and offsets for collateral source recovery. Yet this list of ingredients did not include a strategy to surmount the difficulties associated with each element. Specifically, EML might be efficient, but none of the enterprises contemplated to assume responsibility, i.e., hospitals and payers, control physician behavior enough so that it would be fair to foist liability on them. Likewise, although ADR might be efficient, it will be resisted by individual litigants who perceive themselves as harmed by it. Finally, while limitations on collateral source recovery and damages might effectively reduce costs, patients and trial lawyers likely would not accept them without recompense. The task force also did not place error reduction at the center of malpractice tort reform—a logical and strategic error, in our view.

In response, we propose a new system that employs the ingredients suggested by the task force but also addresses the problems with each. We also explicitly consider steps to rebuff the Culture of Silence and promote error reduction. We assert that patients would be better off with a system where physicians cede their implicit “right to remain silent,” even if some injured patients will receive less than they do today. Likewise, physicians will be happier with a system that avoids blame—even if this system placed strict requirements for high quality care and disclosure of error. We therefore conceive of de facto trade between patients and physicians, a Pareto improvement, taking form via the establishment of “Societies of Quality Medicine.” Physicians working within these societies would consent to onerous processes for disclosing, rectifying and preventing medical error. Patients would in turn contractually agree to assert their claims in arbitration and with limits on recovery. The role of plaintiffs' lawyers would be unchanged, but due to increased disclosure, discovery costs would diminish and the likelihood of prevailing will more than triple.

This article examines the legal and policy issues surrounding the establishment of Societies of Quality Medicine, particularly the issues of contracting over liability, and outlines a means of overcoming the theoretical and practical difficulties with enterprise liability, alternative dispute resolution and the imposition of limits on recovery for non-pecuniary damages. We aim to build a welfare enhancing system that rebuffs the culture of silence and promotes error reduction, a system that is at the same time legally sound, fiscally prudent and politically possible.

Human Papillomavirus (HPV) is a major cause of morbidity and mortality worldwide, with most of the disease burden concentrated in developing countries. Over 90 percent of cervical cancer deaths, almost all of which are caused by HPV, occur in low- and middle-income countries where access to goods and services for prevention and treatment pose major barriers to intervention. In resource-poor settings lacking the capacity for routine screening for cervical cancer, the HPV vaccines developed by Merck and GlaxoSmithKline are desperately needed to help prevent these unnecessary deaths. The initial development of currently available HPV vaccines took place at a number of universities and other publicly funded institutions, yet there is little low-cost access to the vaccine in developing countries where access would be most critical. This is the rule rather than the exception with most university-discovered medicines. Universities and other publicly-funded institutions can adopt a number of licensing methods to ensure that vaccines discovered on their campuses are available at low-cost in developing countries. Universities Allied for Essential Medicines has proposed that universities adopt Global Access Licensing policies to implement these changes by enabling generic or low-cost production of the end product in developing countries. Generic competition is a critical market force that has, for instance, driven down the price of HIV/AIDS treatments from more than $10,000 to less than $99 per patient per year today. While the central barrier to creation of small molecule generics is patent-protection, there are multiple additional barriers that need to be addressed in order to ensure the efficient production of cost-effective generic vaccines and other biologics. While certain biologics may require generic producers to perform additional clinical trials, vaccines are in a somewhat unique situation with respect to both safety and efficacy. With access to appropriate patents, materials and knowledge, vaccines have the potential to be evaluated efficiently and cost-effectively via a pathway parallel to establishing bioequivalence for generic small molecule drugs. A new paradigm is needed that addresses the additional barriers that exist, outside of simply patent protection, to the generic production of vaccines and other biologics. One possible framework, which builds upon previous work on prize funds and patent pools, is discussed here: a Patents, Materials, and Know-how Pool (PMK Pool), based on the patent pool model such as those outlined in the Essential Medical Inventions Licensing Agency and proposals recently put forth by the governments of Barbados and Bolivia. University approaches to licensing vaccines and other biologics need to ensure access not only to patents, knowledge, and materials covered by intellectual property, but must also address the problem of access to materials and know-how that are often proprietary trade secrets. Universities should actively participate in the creation of this and other novel mechanisms, and in the meantime use currently available technology transfer mechanisms to ensure low-cost access to medicines in developing countries.

Imagine that you are lying in a hospital: conscious, partially paralyzed, and terminally ill. Physicians predict that you will die in a couple of weeks. You have heard about the shortage of viable organs in the United States and consider consenting to transplantation of your organs after you die. Trying not to think about your imminent death, you open the New York Times brought by your family and skim the table of contents. You notice an article and slowly start to read. The headline reads “Surgeon Accused of Hurrying Death of Patient to Get Organs.” After you finish reading, you are not willing to donate your organs for transplantation. It does not matter that you are altruistic or that you want your life-sustaining treatment to be removed when your condition worsens. You do not want your death to be hastened. You do not want the physician to play God. You want to die with dignity in a peaceful and friendly environment.

Disparities in health outcomes and access to the essential medicines that affect health outcomes are two of the most pressing issues facing the world today. The lack of adequate health care in developing countries is rooted in a number of systemic problems, including insufficient health infrastructure, lack of medical personnel, government corruption and incompetence, and the high price of pharmaceuticals. These problems are not mutually exclusive. Instead, they are mutually reinforcing, particularly in least developed and developing countries.

The high cost of drugs and vaccines is undoubtedly one of the driving forces in disparate health outcomes, and partial solutions to poor health in the developing world rightly focus on lowering the cost of health products, while preserving the financial incentive for innovation. The high cost of many medicines is largely due to the international patent system, codified by the Trade Related Intellectual Property Rights (TRIPS) Agreement, which grants a monopoly to the innovator and allows it to completely control pricing for a period of years. The result is an access gap, whereby patients in low- and middle-income countries (LMI) cannot afford expensive patented drugs, while patients in wealthy countries can afford and do have access to such treatments.

It has become a truism to cite Enron as the new millennium’s watershed impetus for government assertion of power to improve corporate governance. While indictment of corrupt corporations and their executive leadership seems an obvious corrective to corporate norms that have gone astray, the unsuccessful prosecution and demise of Arthur Andersen proved a stunning backfire of such a blunt weapon. The public accounting industry shrunk even further, to the detriment of clients, and thousands lost their jobs. Arthur Andersen taught that an indictment itself may be sufficiently damaging to close the doors of a public corporation.

Online sales of pharmaceuticals are a rapidly growing phenomenon. Yet despite the dangers of purchasing drugs over the Internet, sales continue to escalate. These dangers include patient harm from fake or tainted drugs, lack of clinical oversight, and financial loss. Patients, and in particular vulnerable groups such as seniors and minorities, purchase drugs online either naïvely or because they lack the ability to access medications from other sources due to price considerations. Unfortunately, high risk online drug sources dominate the Internet, and virtually no accountability exists to ensure safety of purchased products. Importantly, search engines such as Google, Yahoo, and MSN, although purportedly requiring “verification” of Internet drug sellers using PharmacyChecker.com requirements, actually allow and profit from illicit drug sales from unverified websites. These search engines are not held accountable for facilitating clearly illegal activities. Both website drug seller anonymity and unethical physicians approving or writing prescriptions without seeing the patient contribute to rampant illegal online drug sales. Efforts in this country and around the world to stem the tide of these sales have had extremely limited effectiveness. Unfortunately, current congressional proposals are fractionated and do not address the key issues of demand by vulnerable patient populations, search engine accountability, and the ease with which financial transactions can be consummated to promote illegal online sales. To deal with the social scourge of illicit online drug sales, this article proposes a comprehensive statutory solution that creates a no-cost/low-cost national Drug Access Program to break the chain of demand from vulnerable patient populations and illicit online sellers, makes all Internet drug sales illegal unless the Internet pharmacy is licensed through a national Internet pharmacy licensing program, prohibits financial transactions for illegal online drug sales, and establishes criminal penalties for all parties—including websites, search engines, and health care providers—who engage in and facilitate this harmful activity.

The Revolving Fund of the Pan American Health Organization (PAHO) has an almost 30 year track record of providing access to essential vaccines for the entire population of Latin America and the Caribbean region. The activities of the PAHO Revolving Fund, coupled with the provision of high-quality technical assistance, were crucial to the successful control, elimination, or eradication of most of the region's great childhood killers, including measles and polio. Today, however, the Revolving Fund faces new challenges in the form of procuring a new generation of vaccines for human papillomavirus infection, rotavirus, and pneumococcal disease, which are priced orders of magnitude higher than the traditional childhood vaccines. The high cost of these essential new vaccines may require the PAHO Revolving Fund to establish innovative financial mechanisms for procuring these products at prices affordable for national immunization programs in Latin America and the Caribbean. The alternative, namely to bypass the Revolving Fund, could severely threaten the health of the region, especially Latin America's poorest people.

Primary care is crucial to the United States health care system. It is essential to the provision of high quality care; including the ability to reach health outcomes, ensure patient satisfaction, and facilitate efficient resource use. Primary care also places strong “emphasis on health promotion, disease prevention, and care of the chronically ill.”

Physicians have introduced two business models in their attempts to improve the delivery of primary care: Concierge Medicine (“CM”) and the Patient Centered Medical Home (“PCMH”). Both models provide personalized, comprehensive preventive care services.

CM is a private medical practice in which the physician charges patients an annual fee to be a patient in the practice. In exchange, the physician limits the number of patients in order to offer more personalized services and amenities such as: direct access through email or cell phone, same day or next day appointments, longer, more personalized appointments, house calls, and physician accompaniment to a specialist.

Cervical cancer disproportionately affects women in lower- and middle-income countries. But the new vaccines developed to prevent infection with some strains of the human papillomavirus (HPV) that cause cervical cancer are priced beyond the reach of most women and health agencies in these regions, due in part to the monopoly pricing power of brand-name companies that hold the patents on the vaccines. Compulsory licenses, which authorize generic competition with patented products, could expand access to HPV vaccines under certain circumstances. If high-quality biogeneric HPV vaccines can be produced at low cost and be broadly and efficiently registered, and if Merck and GSK are unwilling to grant licenses on a voluntary basis, compulsory licensing could play a pivotal role in ensuring vaccinations against HPV are available to all, around the world, regardless of ability to pay.

The day before the inauguration of his Democratic successor, President George W. Bush oversaw the promulgation of an administrative rule that extended “sweeping” new conscience protections to healthcare providers, one which would allow them to refuse to participate in or refuse to refer for medical services to which they morally or religiously object. Enacted in a funding regulation through the Department of Health and Human Services (“HHS”), the rule – commonly called the Provider Conscience Regulation (“Regulation”) – purported to clarify and implement existing federal law; by its own terms; however, the Regulation pushed the boundaries of those laws, granting protections to a broader class of individuals and across a wider range of services. In so doing, the Regulation sought to resolve an ongoing tension between patient access and provider autonomy, yet it served to reignite a long-standing debate over the proper role of morals in medicine.

President Obama’s ambitious universal health care plan aims to provide affordable and accessible health care for all. The plan to cover the estimated 46.5 million uninsured, however, ignores the over thirty million non-citizens living in the United States. If the United States passes universal health care coverage, Congress should repeal the prohibitions of the Welfare Reform Act, extend Medicaid coverage to non-citizens, and allow non-citizens to purchase employer-based insurance coverage.

President Obama’s plan follows the lead of state universal health care legislation by retaining private, employer-sponsored insurance coverage and expanding the eligibility requirements of the Medicaid program. This strategy will not aid uninsured immigrants or overburdened states and hospitals, though, because current law excludes most non-citizens from nonemergency health care services.

The emergence of in-store retail health clinics (RHCs) has sparked a debate that pits quality of care concerns against the advantages of consumer choice in the marketplace for health care. RHCs appear in pharmacies, grocery stores, and big-box retailers like Wal-Mart, offering basic health care services on a walk-in basis that are administered primarily by nurse practitioners (NPs). Proponents of these clinics hail their pro-market effects: convenience and cost-savings associated with consumer-driven health care; lower prices from increased competition between providers; and increased access to basic health care. Critics of RHCs raise concerns that quality of care is hindered by the lack of physician oversight, disruption of the “medical home,” and the conflicts of interest arising from prescribing drugs at pharmacy-housed clinics.

When Lind Weaver starting receiving collections demands for a foot amputation she never had, she assumed it was a clerical error. Unfortunately, the operation had been performed on someone pretending to be Weaver, causing Weaver's medical history to become entangled in the thief’s. Media reports about identity theft show Weaver's experience is far from unique. For example, a Chicago man was arrested after using his friend's identity to obtain $350,000 worth of cardiovascular surgery at a local hospital. Hackers broke into the medical records of thousands of University of California students. A staff member left a laptop containing records of patients of a local AIDS clinic on Boston public transportation.

Over the past several years, new vaccines have become available to prevent serious illnesses and conditions in the adolescent population. Several have already been approved by the FDA for use in this age group; others are still in development. Recently, significant public attention has been focused on the availability of vaccines for several strains of HPV, to prevent both cervical cancer and genital warts. Prior to that, the vaccine for Hepatitis B was approved and recommended for the adolescent age group. Others currently available and recommended include vaccines for pertussis, meningitis, and influenza. In the future, additional vaccines are expected to become available for sexually transmitted and communicable diseases such as herpes simplex virus and HIV. Unfortunately, financial limitations and consent requirements can impede adolescents’ access to the vaccines that are recommended for their age group. However, a variety of policy options exist for overcoming the barriers and expanding access. These policy options are grounded both in international principles of human rights and in the existing framework of laws in the United States, and can be enhanced by attending to variations in age and developmental status among adolescents.