At the end of last year, President George Bush implemented a smallpox vaccination plan covering military operatives, health care workers, and “first-responders” (such as firefighters and police). The program is administered by the federal Department of Health and Human Services in conjunction with the states and follows the smallpox vaccination guidelines established by the Centers for Disease Control and Prevention (CDC) in September 2002. While inoculation is mandatory for military personnel, health care workers and first-responders are vaccinated on a voluntary basis. The Administration had hoped that 450,000 health care workers would be inoculated within the first month of the program. Toward the end of February, however, only about 1 percent of the anticipated recipients had been inoculated. In Connecticut, which was the first state to begin the nonmilitary component of the program, only three people received vaccinations on the first day.

This is a volatile time for health insurance policy. Medicare and Medicaid are in turmoil, as is the private health insurance market. Public and private health insurance costs constitute eighty percent of healthcare spending in the United States. Public health professionals depend on the insurance system to behave in ways that are responsive to public health in prevention and crisis management.

Seventy-five percent of the American population, excluding the elderly, has coverage through the private health insurance system. Ninety percent of this group receives their insurance through employer-sponsored programs, and the remaining ten percent buy their own coverage. Approximately ten percent of the non-elderly population has insurance through a government program, and fifteen percent of the non-elderly population, almost forty-one million Americans, is uninsured.

As therapeutic advances in the treatment of AIDS began to emerge in the late 1980s and public health began to have more to offer than just the threat, or the perceived threat, of quarantine or partner notification, fissures began to appear in the alliance against named HIV reporting that had emerged a few years earlier. In 1989, New York City’s Health Commissioner stated that the prospects of early clinical intervention warranted “a shift toward a disease-control approach to HIV infection along the lines of classic tuberculosis practices,” including the “reporting of seropositives.”

Although his proposal met with fierce and effective resistance, it is now clear that his call represented part of a national trend. The CDC continued to press for cases of HIV to he reported by name to health departments, an effort that assumed the dimensions of a campaign. It was supported by a growing number of public health officials.

U.S. Department of Health and Human Services (HHS) federal regulations pertaining to the protection of human subjects at Title 45 of the Code of Federal Regulations, Part 46, Subpart A (“the Common Rule”), refer to the need for special precautions when persons characterized as vulnerable are used as human research subjects. Under the Common Rule, persons considered “vulnerablae” are those who are likely to be susceptible to coercive or undue influence; the term “vulnerable” includes “children, prisoners, pregnant women, mentally disabled persons,” or those who are “economically or educationally disadvantaged.” The need for special precautions with some of these vulnerable persons in the context of research has long been addressed by both mandatory additional protections found in Subparts B through D of 45 C.F.R. pt. 46 (that are not, coincidentally, part of the Common Rule) and additional detailed guidance documents provided by HHS or its components to investigators and their respective institutions.

In Saks v. Franklin Covey Co., the Court of Appeals for the Second Circuit held that the American with Disabilities Act (ADA), Title VII of Civil Rights Act of 1964, the Pregnancy Discrimination Act (PDA), and New York state law do not proscribe an employer's self-insured employee health plan from excluding surgical impregnation procedures from its coverage. Although the court found that infertility qualifies as a disability under the ADA, it restricted required coverage of certain infedty treatments.

Title I of the ADA prohibits an employer from discriminating on the basis of disability “in regard to … fringe benefits available by virtue of employment, whether or not administered by the covered entity.” The ADA defines “disability” as “a physical or mental impairment that substantially limits one or more major life activities.” In Bragdon v. Abbott, the U.S. Supreme Court found that reproduction was a major life activity under the ADA.

SARS and monkeypox have given the public health community a unique opportunity to examine the use of quarantine measures. Until recently, the word “quarantine”was not used in polite conversation, and evoked unsavory images. The recent SARS epidemic illustrated the important role of quarantine and isolation as a public health response to communicable disease.

As public health officials in Toronto began to take control of the SARS epidemic, a second wave of the disease (SARS II) emerged. In the first SARS epidemic, approximately 8,200 individuals were isolated. There were approximately 82 probable cases, 66 suspect cases, and 24 deaths. On May 22, 2003, SARS II emerged. In total, approximately 13,000 people were quarantined. SARS II saw the onset of difficult questions being asked about the control and spread of SARS.

The province of Ontario establishes the public health policies and legislative framework for the entire province.

Dr. James Graves was convicted of manslaughter, racketeering, and drug charges in association with overdose deaths of four of his patients from the painkiller OxyContin. A Florida court then sentenced the physician to 62.9 years in prison. This is the first criminal conviction of a doctor in the United States related to OxyContin deaths.

Dr. Graves, who ran a pain management office, was charged with recklessly writing prescriptions to those that could afford an office visit and failed to ask appropriate questions beforehand. Prosecutors in the case said that the physician prescribed drugs like OxyContin to as many as ninety patients a day, after only a short office visit. The prosecution claimed that Graves was “‘selling prescriptions for cash without any real examination, diagnostic testing, or follow-up, no consultation, no real assessment of their medical needs.’”

No one questions the importance of protecting human subjects of research, but over the past few years dissatisfaction has surfaced with the manner in which the protection is conferred by the federal regulatory system referred to as “The Common Rule. ” Some of the criticism surfaces in print. Some bubbles out anecdotally in conversations among researchers, with complaints about the review process being virtually inevitable whenever the topic arises. Like those in other disciplines that differ more or less dramatically from the world of clinical medical research around which the Common Rule was conceptualized, public health researchers, particularly those working in official public health agencies, have experienced some tension and difficulty in adapting to the rules. The Centers For Disease Control and Prevention (CDC) has adopted guidelines that require Common Rule review for “research” but not “practice” activities.

Compared to evidence-based public health, evidence-based medicine is a more familiar phrase. Evidence-based medicine has become increasingly popular in the past decade, due in large part to the emergence of computerized database search technology and advanced statistical tools which allow researchers to quickly identify and summarize vast amounts of scientific information.

Today, the concept of evidence-based public health is gaining momentum and has grown in popularity. However, the term “evidence-based” lacks clarification and is subject to a variety of interpretations. The evidence that supports evidence-based medicine or public health may include individual experience, anecdotal information, the content of a single scientific article, or the results of a sophisticated systematic review of scientific literature. The imprecise language used to describe evidence leads to confusion over what types of evidence are most appropriate in answering different types of questions.

In In re Christopher I., the California Court of Appeal upheld a juvenile court's decision to withdraw life-sustaining medical treatment for a then-1-year-old dependent of the court. Christopher I. had come under juvenile court custody after his biological father, Moises I., physically abused him and rendered him comatose. Christopher's biological mother, Tamara S., was either unwilling or unable to protect him. After the disposition hearing, Tamara petitioned for a “Do Not Resuscitate” (DNR) order for Christopher and/or removal of his life-sustaining medical treatment. Moises opposed, asserting that the juvenile court did not have authority to make medical decisions for a dependent child, for whom counsel had been assigned, without appointing a guardian. The juvenile court rejected Moises's argument and proceeded with an evidentiary hearing. All six physicians who testified supported the withdrawal of treatment or at least a DNR order.

Effective November 1, 2002, the federal Department of Health and Human Services (DHHS) reclassified developing fetuses as “unborn children,” thereby providing health insurance benefits for prenatal care under the State Children's Health Insurance Program (SCHIP). By broadening the current definition of “child” —and thus expanding SCHIP insurance coverage — DHHS hopes to increase the number of low-income pregnant women who receive prenatal services. As noted by one commentator, the new rule represents the first time “any federal policy has defined childhood as beginning at conception.”

In an attempt to improve access to publicly funded health insurance for poor children not covered by Medicaid, Congress established SCHIP a 10-year, $40 billion program jointly funded by federal and state governments. Through a series of block grants, SCHIP allows states to either expand income-eligibility for their existing Medicaid program or to create a separate child health program to decrease the number of uninsured poor and near-poor children.

“Public health practice” consists of activities and Programs managed by public health agencies to promote health and prevent disease, injury, and disability. Some of these activities might be deemed to fit within the broad definition of “research” under federal regulations, known as the Common Rule, designed to protect human research subjects. The Common Rule defines research as “a systeniatic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Public health activities that might under some circumstances be considered research include disease reporting, review of medical records, surveys, interviews, focus groups, specimen collection (blood, urine, etc.), and laboratory testing (both identifiable and anonymous).

There are questions about the extent to which the Common Rule applies or was intended to apply to public health practice: and it has been suggested in any case that Common Rule regulation of public health practice may not be socially optimal for both practical and principled reasons.

The advent of sales over the Internet has led to interesting developments in sales tax policy as states attempt to monitor, control, and collect revenue from illusive Internet tobacco vendors. Tobacco sales have been successfully monitored and regulated, to some extent, in convenience stores, grocery stores, and smoke shops, and in most cases sales taxes are collected. The Internet, however, is extremely difficult to regulate. States could use their regulatory powers to ban the sale of products such as tobacco and alcohol over the Internet, but enforcement would be nearly impossible.

The issue of enforcement of Internet sales is extremely difficult. Keeping the products out of the wrong hands, under aged children for example, is difficult. Also, it is difficult in terms of tax policy.

Protecting the privacy of individually-identifiable health data and promoting the public’s health often seem at odds. Privacy advocates consistently seek to limit the acquisition, use, and disclosure of identifiable health information in governmental and private sector settings. Their concerns relate to misuses or wrongful disclosures of sensitive health data that can lead to discrimination and stigmatization against individuals. Public health practitioners, on the other hand, seek regular, ongoing access to and use of identifiable health information to accomplish important public health objectives. The collection and use of identifiable health data by federal, tribal, state, and local health authorities support nearly all public health functions and goals.

Identifiable health data are the lifeblood of public health practice. When aggregated, these data help authorities monitor the incidence, patterns, and trends of injury and disease in populations. Health data are acquired by public health authorities through testing, screening, and treatment programs.

On September 25, 2002, California Governor Gray Davis approved the Health Care Providers’ Bill of Rights (A.B. 2907). The legislation, which went into effect January 1, 2003, outlaws several practices by insurers that physicians complained represented an imbalance of power. Insurers are now unable to compel doctors to take more patients than they feel they can handle, and managed care companies cannot unilaterally change the terms of their contracts with doctors without notice. Governor Davis praised the legislation, stating, “in order to provide patients with world-class care, we must ensure that our doctors have world-class rights.”

California has one of the highest levels of health maintenance organization (HMO) penetration in the nation, at 52 percent. Seventy-eight percent of HMO patients are enrolled in five HMOs. As a result of these practice conditions, doctors reportedly often felt pressured to comply when HMOs “ordered [them] to take on additional patients,” “changed contracts without warning,” and were “lax in payments.”

“Public health legal preparedness” is a term born in the ferment, beginning in the late 1990s, that has led to unprecedented recognition of the essential role law plays in public health and, even more recently, in protecting the public from terrorism and other potentially catastrophic health threats.

The initial articulation of public health has not kept pace with rapid evolution in the concept and in practical development of public health preparedness itself. This poses the risk that legal preparedness may fall behind construction of general readiness in the public health system—and may, in fact, undercut achievement of comprehensive public health preparedness for massive threats to health in both the United States and world-wide. Inadvertent results might include both negative health impacts and infringement on individual rights.

Current economic conditions have coincided with the implementation of the Health Insurance Portability and Accountability Act (HIPAA) and forced public health officials to consider how to ethically incorporate compliance into their already strained budgets, while maintaining the integrity and intent of the legislation.

As of April 14, 2003, the HIPAA Privacy Rule provides a new federal floor of protections for personal health information. The Privacy Rule establishes standards for the protection of health information held by many physicians’ offices, health plans, and health care clearinghouses. The Rule protects personal health information by establishing conditions regulating the use and disclosure of individually identifiable health information by these entities, also referred to as covered entities. The Rule does not prevent the daily operations of health care establishments (i.e., the treatment of patients and the collection of payment).

In Vencor, Inc. v. National States Insurance Co., the U.S. Court of Appeals for the Ninth Circuit held that a Medigap insurance provider was only obligated to pay the rates that Medicare would have paid for the same care.

Clarence Rollins purchased a Medigap insurance policy from National States Insurance Company (NSIC) to supplement his Medicare coverage. When Rollins became ill and required care beyond that which Medicare would cover, he received his medical treatment from Vencor Hospital-Phoenix (Vencor). Upon Rollins's death, NSIC paid Vencor $38,760. Vencor claimed that NSIC owed an additional $132,438 because NSIC was not entitled to the lower care rates established by Medicare. NSIC refused to pay Vencor's higher rates. As a result, Vencor sued NSIC for breach of contract.

The U.S. District Court for the District of Arizona held, on a motion for summary judgment, that no breach occurred, and that NSIC was obligated to pay only the lower rates established by Mediare. The Ninth Circuit affirmed this decision.