Emphasis on cost containment by third-party payors has intensified economic competition within the health care system, creating powerful market forces which retail pharmacists had not envisioned a few years ago. Hospitals and alternative delivery systems now sell prescription drugs in direct competition with retail pharmacists. These entities are able to purchase their pharmaceuticals from manufacturers at prices far below those of the retailers. Retail pharmacist plaintiffs allege that such activities violate the Robinson-Patman Act which prohibits price discrimination. Retail pharmacists have achieved landmark victories in decisions establishing that nonprofit, state and local governmental hospitals reselling pharmaceuticals in competition with retail pharmacies are not exempt from the Act. This Article demonstrates that despite these victories, plaintiffs will have difficulty proving an actual violation of the Act by manufacturers and hospitals. Plaintiffs must establish competitive injury as well as refute the meeting competition defense. Retail pharmacists might discover that the Robinson-Patman Act is not the ally they had hoped for; instead, they should concentrate on innovative alternatives which will allow them to compete in an evolving health care system.

I began teaching Health and the Law in January, 1985. Louise Brown, the world's first “test tube” baby, was six years old. Karen Ann Quinlan, whose ventilator had been disconnected years earlier, was still alive and being tube fed in a New Jersey nursing home. Acquired Immune Deficiency Syndrome (AIDS) was a still little understood disease. Although forward looking scholars had been writing important books about access to expensive health care, few legal challenges had been made to alleged treatment (whether ordinary or extraordinary) refusals. Oh, what a difference a decade makes! In keeping with the theme of this issue, this article focuses on law and bioethics in the year 2000, particularly the teaching of bioethics. In some ways the challenges of teaching bioethics in the year 2000, or anytime, are the challenges of teaching any course in the year 2000, or anytime. In other ways, the special topics covered in a bioethics (or any health law) course and the dramatic impact on the area of health law by science, medicine, and technology make the challenges far more difficult than in many other areas of the law.

In January of every odd-numbered year, a new Congress convenes, made up of new or re-elected Members of the House of Representatives and of the Senate, along with Senators who are entering the second or third Congress of their six-year term. In both its first year (“first session“) and its second year (“second session“) the new Congress stays at work until adjournment in late autumn or early winter.

Any Member of Congress may introduce a legislative proposal when Congress is in session. Ideas for bills and resolutions may emanate directly from a Member (or a group of Members) either in the House of Representatives or in the Senate. Often the proposals are a response to the appeals of constituents, such as trade or professional associations or consumer groups, who may participate in their preparation.

A hospital, while performing its major function of providing health care, is also viewed as a business. It needs capital from a wide variety of sources, many of which are government regulated. Over the past few years, federal expenditures for Medicare have increased dramatically, as has regulation of hospital revenue sources. Congress enacted the Medicare Prospective Payment System (PPS) to curb hospital cost inflation.

This Note examines historical trends in health care financing and analyzes the Medicare reimbursement system, with emphasis on PPS and its impact on hospital revenues. The Note suggests that hospitals, due to the effects of PPS, will be forced to reduce their levels of financial leverage and will have to look for corporate financial alternatives. PPS may signal a new era in hospital finance. Survival mandates an increased focus on efficient corporate, financial and managerial policies.

Society has long associated acquired immune deficiency syndrome (AIDS) and human immunodeficiency virus (HIV) with homosexual men. One reason for this association is the statistics that establish a close connection between the homosexual lifestyle and HIV infection and AIDS. While there are an abundance of statistics and widespread perceptions that indicate a strong correlation between AIDS and HIV and homosexual males, there are statistical justifications that oppose the assertion. According to projections, the majority of gay and bisexual men will not develop AIDS. Reports show that in many foreign countries, AIDS is largely a heterosexual phenomenon. In addition, the percentage of AIDS cases resulting from transmission through heterosexual contact is rising dramatically. Furthermore, groups such as racial minorities and intravenous drug users also constitute a large proportion of AIDS cases.

Statistics also demonstrate the high costs associated with treating AIDS patients and people infected with HIV. As the AIDS epidemic unfolded, the health insurance industry developed fears concerning the financial crisis that would result due to an increase in the number of AIDS cases and the emergence of expensive treatments.

This Article analyzes the initial efforts of the Federal Department of Health and Human Services (HHS) to implement the essential mental health and substance use disorder services benefit required by section 1302(b)(1)(E) of the Affordable Care Act (ACA) and proposes the adoption of a comprehensive and specific essential mental health and substance use disorder benefit set. At a minimum, the benefit set should cover medically necessary and evidence-based inpatient and outpatient mental healthcare services, inpatient substance abuse detoxification services, inpatient and outpatient substance abuse rehabilitation services, emergency mental healthcare services, prescription drugs for mental health conditions, participation in psychiatric disease management programs, and community-based mental healthcare services.

This Article builds on three previous articles that have proposed reforms of federal and state mental health parity laws and mandatory mental health and substance use disorder benefit laws.

National economies worldwide are in disarray, evidenced by escalating debts and growing deficits. As countries struggle with their faltering economies they are hard pressed to fulfill commitments of social programs made in more prosperous times, much less take on new government initiatives. The current experiences in health reform in the United States present an interesting example of the dilemmas governments now face when they embark on new ventures. While great political pressures have been launched and high expectations abound, the reality of American health reform quickly reveals that expanded access will come at a high price that won't be offset easily by conventional cost containment or market forces.

In the search for an acceptable model for health reform, it was popular for policy makers and academics to turn their attentions to the health systems of other nations. Recommendations were made that the US should adopt a German or Canadian solution for our health problems.

Over the last twenty years, state legislatures have enacted statutes incorporating medically and legally established criteria to be utilized in the determination of death. Similarly consistent criteria for determining the onset of life have yet to be established. As a result, unacceptably conflicting statutory language defining life and the state's interest in that life exists. This conflict can be resolved by a functional approach that consistently applies criteria used to define the end of life to the beginning of life.

City of Revere v. Massachusetts General Hospital presented the United States Supreme Court with its first opportunity to consider whether a state or municipality has a constitutional duty to pay for medical treatment received by an individual in police custody. The Supreme Judicial Court of Massachusetts had held that the city had an eighth amendment duty to pay for an arrestee's treatment. The U.S. Supreme Court reversed, observing that eighth amendment rights and duties are not implicated prior to conviction and that fourteenth amendment due process concerns were met once the arrestee received adequate medical care. No obligation to pay arises, the Court held, absent a specific state law provision requiring such payment. Because arrestees are subject to physical restraints similar to those imposed on convicted prisoners, this Case Comment argues that courts undertaking to determine the scope of a state's duty to provide treatment to arrestees should apply a due process standard which draws upon eighth amendment analysis. The Comment concludes that under such an eighth amendment equivalence approach, no duty to pay arises because the state's failure to pay the health care provider does not reflect "deliberate indifference" towards the recipient of the treatment.

The incidence of HIV infection and AIDS in children has grown at an alarming rate. Approximately one million children worldwide have HIV infection. By the year 2000, an estimated ten million children will suffer from the disease. Currently, the United States has a population of an estimated 10,000 to 20,000 HIV-infected children. As of June 30, 1993, the Centers for Disease Control and Prevention (CDC) reported 4,710 known AIDS cases in children twelve years-old and younger. At that point, New York City reported 1,124 pediatric AIDS cases which represented twenty-four percent of all cases in the United States.

With the rising number of HIV-infected children, the medical community in the United States has begun to search for HIV-and AIDS-related treatments particularized for children. In addition to establishing guidelines for HIV-infected children's frequent check-ups and timely immunizations, the medical community has initiated research studies involving HIV-infected children.

By signing the Balanced Budget Act of 1997 (BBA) on August 5, 1997, President Clinton made the most significant changes to Medicare, since its inception in 1965, by adopting market-driven reforms in an effort to balance the federal budget. One of the most significant Medicare reforms in the BBA was the creation of the Medicare+Choice program that provides Medicare beneficiaries access to a wide array of private health plan choices as well as traditional fee-for-service (FFS) Medicare. In addition, Medicare+Choice enables Medicare to further utilize delivery innovations, including preferred provider organizations (PPOs), openended health maintenance organizations (HMOs), point-of-service plans, provider sponsored organizations (PSOs), integrated delivery systems (IDSs) and primary care case management, that have helped the private sector contain costs and expand health care delivery options.

The freestanding emergency center, which combines the functions of a doctor's office and a hospital emergency room, has emerged as a new provider of health care. These centers have generated considerable controversy over their role in the health care market. Proponents argue that freestanding emergency centers reduce costs by providing care in a more efficient manner and cause other health care providers such as hospital emergency rooms to reduce costs and improve service. Opponents argue that the centers create an additional layer of health care which duplicates existing services and increases total health care costs. This Note examines the controversial issues of licensure, regulation and reimbursement. The Note concludes that freestanding emergency centers can help to reduce health care costs and discusses the steps that should be taken to aid centers in achieving this goal.

Criminal confessions made in response to custodial questioning are excluded from evidence unless a defendant voluntarily, knowingly and intelligently waived his Miranda rights. In Connelly, the Supreme Court erred by holding that, absent explicit police coercion, a mentally ill individual's waiver is valid. The Court failed to consider the defendant's subjective impairments that might invalidate his waiver. By contrast, the Patterson Court suggested that a defendant's right to counsel may attach at an early stage in a criminal proceeding if the defendant has a significant need for counsel.

This Note addresses the special needs of a mentally retarded person in the criminal justice system. The Note argues that mentally retarded suspects require careful explanation of Miranda rights in order to understand them. The intellectual and adaptive deficiencies which characterize mental retardation also necessitate an inquiry into a valid waiver that accounts for these disabilities. Furthermore, the special needs of the mentally retarded mandate that the right to counsel attach as early as the precustodial stage of an investigation. Early access to counsel most effectively assures that a mentally retarded person's waiver of constitutional rights is voluntary, knowing and intelligent.

Biologics include a wide range of products, such as vaccines, allergenics, gene therapies, and tissues, among others. Biologics are complex combinations of sugars, proteins, or nucleic acids that are produced by biotechnology methods or other advanced technology. Biologics often represent the only medical treatment for complex medical conditions such as: Hepatitis B; Measles, Mumps, Rubella and Varicella; and Tetravalent meningococcal conjugate among others. As a result, biologic sales are growing at twice the rate of chemical pharmaceuticals and are expected to exceed $158 billion by 2015. Various interest groups, including patients, insurers, and regulatory agencies, raised concerns about the financial impact that biologics may have on health care costs. Congress and the Food and Drug Administration (FDA) faced pressure to provide a solution to the soaring biologic costs, namely through a regulatory pathway for generic biologics (“follow-on biologics”) to manufacture cheaper products. Although a regulatory pathway for generic chemical pharmaceuticals (“generic”) exists under the Hatch-Waxman Act, a similar regulatory pathway for follow-on biologics did not exist prior to 2010.

The state is increasingly criminalizing reproduction. While prosecutions of pregnant people for prenatal drug use began occurring several decades ago,1 this type of prosecution remained relatively rare for many years.2 But such prosecutions have increased dramatically—thousands have now occurred across the United States.3 In addition, the criminalization of reproduction is not limited to instances of prenatal drug use,4 but extends to a wide array of prosecutions in the reproductive space—including the criminalization of stillbirth,5 miscarriage,6 breastfeeding,7 home births,8 and c-section refusals.9 And, of course, recent changes in the Supreme Court have resulted in an almost certain change in the criminal regulation of abortion, as well.10 The criminalization of reproduction often occurs at an initial point of access to the health care system – at the hospital, the doctor’s office, the lactation consultant appointment, or the addiction treatment clinic. In this way, health care settings become gateways into the criminal justice system, and it is the attempt to access reproductive health care that results in criminal prosecution.11

There was an argument that the Obama Administration's lawyers could have made—but didn't—in defending Obamacare's individual mandate against constitutional attack. That argument would have highlighted the role of comprehensive health insurance in steering individuals' healthcare savings and consumption decisions. Because consumer-directed healthcare, which reaches its apex when individuals self-insure, suffers from several known market failures and because comprehensive health insurance policies play an unusually aggressive regulatory role in attempting to correct those failures, the individual mandate could be seen as an attempt to eliminate inefficiencies in the healthcare market that arise from individual decisions to self-insure. This argument would done a better job than the Obama Administration's of aligning the individual mandate with existing Commerce Clause and Necessary and Proper Clause precedent, and it would have done a better job of addressing the conservative Justices' primary concerns with upholding the mandate. This Article lays out this forgone defense of the individual mandate.