Social movements and human rights rhetoric in tobacco control.

After achieving breathtaking successes in securing state and local restrictions on smoking in public places and restricting youth access to tobacco products, the tobacco movement faces difficult decisions on its future strategic directions. The thesis of this article is that the tobacco control movement is at a point of needing to secure its recent successes and avoiding any public retrenchment. To do so requires rethinking the movement's strategic direction. We use the familiar trans-theoretical model of change to describe where the movement is currently and the threats it faces. The new tobacco control strategy should encompass a focus on voluntary non-smoking strategies, use human rights rhetoric to its advantage, and strengthen the public health voice to be more effective in political battles. In developing a new strategy, tobacco control advocates need to build a social movement based on a more forceful public health voice, along with the strategic use of human rights rhetoric, to focus on the power of voluntary non-smoking efforts. Using human rights rhetoric can help frame the movement in ways that have traditionally appealed to the American public. Perhaps more importantly, doing so can help infuse the tobacco control movement with a broader sense of purpose and mission.

Legal and policy considerations in using clinical practice guidelines.

The increased use of clinical practice guidelines has implications for both public policy and for litigation. Physicians are concerned that the introduction of practice guidelines will reduce their clinical decision-making authority and that the failure to follow clinical practice guidelines will lead to medical liability. Although practice guidelines are an increasing part of medical practice, there has been only limited litigation to determine the extent to which guidelines will be used to set the applicable standard of care. This article discusses the potential legal and public policy issues raised by the introduction and use of clinical practice guidelines. From a legal perspective, the primary issue is whether guidelines will be used to set the "standard of care" or will be one piece of evidence that a jury would use to determine the outcome of medical liability litigation. Based on an assessment of the applicable legal and policy considerations, the article concludes that courts should admit guidelines into evidence, but that they should not be used as the sole determinant of the standard of care. Instead, guidelines should be treated as one piece of evidence to be weighed by the jury. This approach will facilitate physician acceptance of guidelines by not imposing liability for the failure to follow guidelines without additional evidence to determine the standard of care.

Legal challenges to managed care cost containment programs: an initial assessment.

The success of managed care cost containment innovations depends on many factors, including how courts decide litigation challenging various cost containment initiatives. Although such litigation is just emerging, enough cases have been reported to enable an initial assessment of court rulings. To date there is no evidence that courts have systematically impeded cost containment initiatives. Few courts seem willing to usurp legislative choices in formulating health policy or to obstruct the market in organizing and delivering health care services. The anticipated role of the courts as policymakers in shaping health care delivery has yet to emerge.

Influencing physician response to prenatal substance exposure through state legislation and work-place policies.

Little research attention has focused on ways to encourage physician response to prenatal substance exposure. We report initial results from a study examining the impact of state laws and work-place policies on physician response by combining legal analyses and data from a national physician survey. Our findings indicate that the message that laws and policies exist usually does not reach physicians. However, when the message does come through, some physician behaviors are influenced. In particular, physicians in states with clearer policies and behavioral expectations are significantly more likely to know and understand the law than physicians in other states. Further, believing that a work-place protocol on prenatal substance exposure exists is associated with significantly increased likelihood of an active response in case vignettes portraying prenatal substance exposure. The findings suggest that state legislative behaviors may increase physician response to prenatal substance exposure, but that response depends on the nature of the policy and on efforts to disseminate it.

Managed care litigation: legal doctrine at the boundary of tort and contract.

This article summarizes the various approaches to how the law should assign responsibility in a system where health care financing and delivery are combined. Health law scholars have been debating whether conflicts in managed care between individual patient needs and preserving assets for the patient population should be resolved by tort or contract law. Until recently, the literature has been dominated by scholars arguing that managed care should be guided by contractual arrangements and concepts to stimulate the market changes occurring in health care delivery. We summarize the arguments for and against both contract and tort, along with recent attempts to bridge the gap between the two approaches. The case in favor of a contract regime fails to account for the hybrid nature of managed care delivery and the context in which managed care litigation arises. Thus, tort law retains a fundamental monitoring role in the managed care era.

Washington State Health Services Act: implementing comprehensive health care reform.

In 1993, Washington State enacted the Health Services Act of 1993 (HSA) to guarantee universal access to health care through an employer mandate, with caps on premiums as the primary cost-control mechanism. The HSA represents the Nation's first formal experiment with managed competition. This article reports the results of a case study of the HSA's implementation. The study concludes that the Washington State initiative can be replicated in other States, but that implementation is complex, requires sustained public education, and requires cooperation from the Federal Government through program waivers. A major implementation challenge is to facilitate competition and minimize regulation.

Medicaid home and community-based waivers for acquired immunodeficiency syndrome patients.

Acquired immunodeficiency syndrome (AIDS), an increasingly significant health problem, presents a special challenge to Medicaid programs. Analyzed in this article is one particular approach to providing services for Medicaid-eligible AIDS patients: the Medicaid home and community-based (section 2176) waiver program, authorized by the 1981 Omnibus Budget Reconciliation Act and amended in 1985 to include persons with AIDS. The authors conclude that the AIDS-specific waiver is an attractive program for the States, but that changes in program administration and in how cost effectiveness is determined would likely facilitate broader acceptance by the States.

Use of diagnosis-related groups by non-Medicare payers.

Medicare's prospective payment system (PPS) for hospital cases is based on diagnosis-related groups (DRGs). A wide variety of other third-party payers for hospital care have adapted elements of this system for their own use. The extent of DRG use varies considerably both by type of payer and by geographical area. Users include: 21 State Medicaid programs, 3 workers' compensation systems, the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS), more than one-half of the Blue Cross and Blue Shield Association (BCBSA) member plans, several self-insured employers, and a few employer coalitions. We describe how each of these payers use DRGs. No single approach is dominant. Some payers negotiate specific prices for so many combinations of DRG and hospital that the paradigm that payment equals rate times weight does not apply. What has emerged appears to be a very flexible payment system in which the only constant is the use of DRGs as a measure of output.

Medical malpractice in California: recent trends and future prospects.

For many years, California court decisions and legislation have often presaged national trends. The expected debate over medical malpractice should be no exception. Thus, the court decisions on third party liability and the outcome of the MICRA negotiations are important both for California and as a harbinger of future national trends.

Nurse practitioners and physician assistants as primary care providers in institutional settings.

This paper describes the scope of primary care practice and autonomy of nurse practitioners (NPs) and physician assistants (PAs) at nine health maintenance organizations (HMOs) and multispecialty clinics (MSCs). We found that the larger an institution's managed care population, the greater the NPs' and PAs' scope of practice and autonomy, although patients with complex illnesses or multisystem problems usually were referred directly to a physician. Alternative policies to increase the number of primary care physicians might slow the growth in hiring new NPs and PAs, but are unlikely to reduce their primary care role in managed care settings. Further research is needed to consider whether these results are applicable to a broader range of practice settings.

Defining and implementing medical necessity in Washington State and Oregon.

This paper reports on a qualitative study of how health care providers in the states of Washington and Oregon define and implement medical necessity. Based on a series of semi-structured interviews, we found that few insurers or health care plans in our sample attempted to resolve the ambiguities inherent in defining medical necessity. More importantly, our results suggest that physicians in managed care plans were not using general definitions of medical necessity to make clinical decisions, but instead relied on utilization management techniques to guide the use of medical resources. We conclude that medical necessity as an organizing principle for clinical practice decision making is likely to continue to erode in a managed care environment.

ERISA litigation and physician autonomy.

The Employee Retirement Income Security Act (ERISA), enacted in 1974 to regulate pension and health benefit plans, is a complex statute that dominates the managed care environment. Physicians must understand ERISA's role in the relationship between themselves and managed care organizations (MCOs), including how it can influence clinical decision making and physician autonomy. This article describes ERISA's central provisions and how ERISA influences health care delivery in MCOs. We analyze ERISA litigation trends in 4 areas: professional liability, utilization management, state legislative initiatives, and compensation arrangements. This analysis demonstrates how courts have interpreted ERISA to limit physician autonomy and subordinate clinical decision making to MCOs' cost containment decisions. Physicians should support efforts to amend ERISA, thus allowing greater state regulatory oversight of MCOs and permitting courts to hold MCOs accountable for their role in medical decision making.

The implementation and enforcement of tobacco control laws: policy implications for activists and the industry.

We examine the process by which antitobacco laws and ordinances were implemented and enforced in seven states and nineteen localities. Our findings indicate that state- and local-level clean indoor air laws were rarely enforced by governmental agencies. Instead, these laws were largely self-enforcing in that changed social norms regarding appropriate smoking behavior led to generally high compliance rates. In contrast, teen access laws were not self-enforcing, but were often enforced through periodic vendor compliance checks. We also found that antitobacco forces did not devote a significant amount of attention of implementation and enforcement issues. Their focus was primarily on enacting new legislation and fighting tobacco industry attempts to weaken existing laws. Our results do not augur well for public health measures that require state-level enforcement and that are opposed by powerful and politically well-connected interests. For tobacco control laws to be effective, public health advocates need to consider the locus of enforcement responsibility and the sanctions available to the enforcement agency, such as license removal by local authorities. These results suggest that failure to specify such mechanisms in the legislation will lead to delays in implementing and enforcing the laws as well as to a number of compliance problems. Antitobacco coalitions will also need to become more actively involved in the implementation and enforcement process.

Cost-effectiveness analysis in the courts: recent trends and future prospects.

This article provides an initial look at how managed care organizations (MCOs) might incorporate cost-effectiveness analysis (CEA) into their decision-making process and how the courts might respond. Because so few medical liability cases directly involve CEA, we must look at other areas of the law to assess potential MCO liability for applying CEA. In general negligence cases, courts rely on a risk-benefit test to determine customary practice. Likewise, in product liability cases, courts use a risk-utility calculus to determine liability for product design defects. And in challenges to government regulation, courts examine how agencies use CEA to set regulatory policy. The results have been mixed. In product liability cases, CEA has led to some punitive damage awards against automobile manufacturers. But courts have integrated it in negligence cases without generating juror antipathy, and generally defer to agency expertise in how to incorporate CEA. The article discusses the implications of these cases for MCO use of CEA and outlines various options for setting the standard of care in the managed care era.

Licensing telemedicine: the need for a national system.

The expansion of information technology has shattered geographic boundaries, allowing for extraordinarily increased access to health information and expanded opportunities for telemedicine practice across state boundaries. But despite its recent growth, telemedicine technology remains embedded in a state-based licensure system that places severe limits on its expansion. The current system of medical licensure is based primarily on statutes written at the turn of the 20th century. This system is inadequate to address the emerging medical practices and future uses of medical technology in the telecommunications age. To respond to the changes offered by the telecommunications revolution, we need to design a new regulatory structure for the 21st century. The purpose of this article is to propose a policy of national telemedicine licensure. The primary goal here is not to simply develop a policy proposal, but to discuss the rationale for national licensure and place it on the policy agenda. A national licensure system will expand the market for telemedicine, promote both the use and development of new technologies, and simultaneously eliminate many of the legal and regulatory ambiguities that plague and constrain the present system.