Discovery rule in medical malpractice under the Federal Tort Claims Act: the Supreme Court's decision in United States v. Kubrick was not meant to be secondary authority.
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This is the fourth review on the maternal mortality and obstetrics in the federal state of Hamburg comprising, this time, the years 1968 to 1972. 70 cases of maternal mortality are described classified, and discussed. All cases of maternal death with a temporal relationship to pregnancy, labour and delivery and puerperium were analyzed individually. There were 70 maternal deaths in 113, 564 deliveries. 10 or 8.8/100,000 cases were due to embolism. 1 or 0.9/100,000 cases were due to amniotic fluid embolism. 10 or 8.8/100,000 cases were due to infection. 9 or 7.9/100,000 cases were due to hemorrhage. 8 or 7.0/100,000 cases were due to toxemia of pregnancy. 5 or 4.4/100,000 cases were due to criminal abortions. 1 or 0.9/100,000 cases were due to chorio-carcinoma and 26 or 23/100,000 cases were due to non-obstetric causes. Our experience over many years shows that maternal mortality, stillbirth and death during the first year of life should be considered an epidemiologic entity.
CONTEXT: Health care fraud and abuse enforcement actions have significantly expanded in number and scope during the past several years. The Department of Health and Human Services Office of Inspector General named review of in-office pathology services a critical priority in its 2005 Work Plan. As providers of pathology and laboratory medicine services, pathologists need to be aware of the potential impact of these laws on their practices. OBJECTIVES: To review the major statutes and regulations underlying most federal investigations and prosecutions of health care fraud, with a special emphasis on their relationships to pathology practice. DESIGN: The authors reviewed pertinent federal statutes, regulations, and other documents, along with relevant legal literature. RESULTS: The health care fraud and abuse laws are complicated and potentially impact pathology practice in unforeseen ways. CONCLUSIONS: The health care fraud and abuse laws are complex and often counterintuitive. The penalties for violation of these laws are severe. Because they may impact many areas of pathology and laboratory medicine practice, pathologists are advised to consult experienced legal counsel prior to embarking on potentially suspect health care arrangements.
The author outlines the regulation of animal experimentation in the United States of America (USA). Regulation in this field is at the developmental stage; issues are still being defined as public interest in animal welfare focuses on various aspects of animal science. Society continues to initiate regulations for animal experimentation in response to technological advances which were unknown when the first USA Federal legislation in this field (the Laboratory Animal Welfare Act) was signed in 1966. Under the sponsorship of animal welfare activists and, more recently, animal rights advocates, amendments to the 1966 law have increased the scope of Federal authority by extending both the number of species covered and the areas of care which are regulated. A greater awareness has evolved of the issues raised by animal experimentation, both among the general public and within the scientific communities. The importance of the Institutional Animal and Care Use Committees in research facilities is described, together with other factors which affect Federal legislation. Government regulatory philosophy is also changing towards a participatory relationship between regulators and public interest groups. Various affiliations to global and regional organisations have heightened national awareness with regard to the perceived exploitation of animal species. The author demonstrates clearly that the prevailing trend in the USA is towards expanded agreements which are jointly derived and implemented, and which will be instrumental in the search for resolutions. The author concludes that these resolutions will continue to revolve around the ethical need to respect the nature of animal species and the need for knowledge concerning both humans and animals which can help to extend and enhance the quality of life.
Allogenic bone grafting is an established method in revision surgery of artificial joint replacement and spinal surgery in case of bone defects. In Germany, femoral heads from living donors undergoing total hip replacement are frequently used. These grafts are processed according to the "Guidelines for the management of bone banking" issued by the Federal Medical Board. Bone grafts are drugs according to German law. Local bone banks are excluded from the regulations of the federal law on drugs [Arzneimittelgesetz (AMG) section sign 4a (4)] if certain requirements are fulfilled. The Directive 2004/23/EC of the European Parliament and of The Council on Setting Standards of Quality and Safety for the Donation, Procurement, Testing, Processing, Preservation, Storage and Distribution of Human Tissues and Cells has to be implemented into national law within 2 years. The exception of section sign 4a (4) will no longer be possible. Thus a legal construction has to be found which allows running local bone banks in compliance with the new legal settings. Three conditions will be possible: (1) a single physician procures a graft for another patient of his, (2) grafts are procured in one hospital and are used exclusively in this hospital: a license from the local authorities and a strict quality assessment according to GMP-rules is required, (3) if the grafts are distributed to other hospitals, a license from the local authorities and registration as a drug by the federal authorities are necessary.
This paper describes the universal health insurance program in Canada and identifies the historical events and social values leading to its adoption. Universal hospital insurance was adopted in 1958, ten years before medical insurance, as a result hospital-based patterns of practice were solidified. Through cost sharing, the federal government influenced the provinces to enact relatively uniform universal plans. From 1951 to 1971 health care expenditures rose rapidly to 7.3% of the gross national product (GNP), but have since decreased and stabilized at about 6.9%. In contrast, health care in the United States represents 8.6% of GNP. Hospital use also increased rapidly in Canada to 1970 but appears to have stabilized and decreased slightly in this decade. Physician incomes rose rapidly before 1971, but since then the increases have slowed and relative incomes of physicians have fallen. Althouth the percent of GNP spent for health care has leveled, there are still substantial annual increases in expenditures that are paid for by government. Two federal initiatives, Bill C-37 and the Lalonde Report, have their roots in cost containment; Bill C-37 transfers greater taxing authority from the federal government to the provinces. To meet the goal of containing costs, provincial governments are moving in the direction of regionalization, decentralization, and greater coordination. In the short term, the provinces have limited hospital budgetary increases to percentages less than the rate of inflation. Cost constraints may be long overdue. Imposing fiscal limits encourages rational planning. It does not appear that the health of Canadians will be adversely affected or essential benefits curtailed by present budgetary restrictions or reorganization.
11 per cent more men and 23 per cent more women died of lung cancer in the German Federal Republic during 1960-1971 than would have been the case if the age structure had remained unchanged. This increase involves exclusively (men) or predominantly (women) the over-65 years age group. It is still showing an upward trend in men and is most pronounced in the 45-74 age group. Mortality from lung cancer differs significantly between the Länder of the Federal Republic. It is highest for both men and women in the City States and is lowest in the less industrialized areas, particularly South Germany. This difference is presumably not entirely population: the particularly marked increase (especially in men) in the Saarland and North-Rhine-Westphalia-Länder with a predominance of heavy industry-suggests that occupational noxae may play a part.
The paper shows the authors' opinion as to the use of digital X-ray fluorography (DXF) to detect pathology of the lung, primarily its tuberculosis and cancer from organizational-and-methodological and purely diagnostic standpoints. Based on a great body of data pooling 21,295 studies of patients, which comprised two (screening and routine clinical) groups, they authors state their views on the place and role of lung DXF in the work of public health facilities in the Russian Federation (RF). The objectivity of the authors' opinion is confirmed by the different nature of a lung abnormality detected by DXF at both the municipal and regional levels of the RF public health system and by a comparative analysis of the findings with those of film fluorography, routine X-ray study, linear tomography, X-ray computed tomography (XCT), and surgical evidence. The study has allowed the authors to express their opinion by recommending DXF as a method for primary diagnosis of lung diseases instead of film fluorography and routine X-ray study and to appreciate it in screenings. The authors' data indicate that XCT in its simplest variant rather than linear tomography should become the optimum method that specifies the diagnosis of lung diseases detected by DXT.
The response of the U.S. government to the AIDS epidemic is reviewed within the context of health policy making in the U.S.A. in general and the reduced role of the federal government in domestic social programs in particular. This review involves multiple levels of government, the relationship of government to the private sector, the diffusion of authority within a federal system, the long delays in policy implementation because of the absence of mechanisms to deal with emergency situations, the tendency to fund the response to AIDS from reallocation of appropriated funds, thereby creating financial distress for existing programs. The federal response to AIDS is considered uncoordinated, insufficient and inadequate in particular with respect to the support of public health education and the financing of health care for AIDS patients. These are needed while a vaccine may still be years away.
The author notes that "for calculating income distribution and expenditure by groups of households, annual averages are required concerning the number of private households by household groups and...the structure of the household members in a socio-economic classification." Problems of adjusting such household data so that they are compatible with data from other sources such as employment statistics are discussed, and a procedure for adjusting annual micro-census data on households in the Federal Republic of Germany is described. "Results for the year 1982 are presented, showing the main development trends as compared with the year 1972. Finally, the quality of forecasting with the adjustment procedure is studied." (summary in ENG)
Federal waiver programs enable states to bypass the requirements of federal programs such as Medicare and Medicaid to experiment with different ways of financing, organizing, and delivering health care. In tracking waiver activity from 1980 to 1990, the authors found that federal involvement with waivers lost momentum during the latter part of the 1980s, while state involvement increased. Three key issues dominate the discussion of waivers: administrative control, the role of the states, and the ability to evaluate demonstration waivers. Examination of the chronology of waiver activity suggests the emergence of a new era, wherein federal control reemerges as a way to counter the increased fragmentation of health policies among states. If this is the case, four areas need to be addressed: (1) balance of political and research objectives; (2) administrative flexibility for states; (3) careful scrutiny of rules; and (4) increased accountability. These recommendations can guide the federal government, with the states as partners, in its attempt to regain momentum in the use of waivers to expand the knowledge base.
The problem of HIV transmission in prisons in Québec and elsewhere is increasingly urgent and requires the attention of federal and provincial authorities. Prison officers are among the key players who should be kept in mind when preventive measures are being developed. We reprint the executive summary of a study conducted in federal and provincial prisons in Québec. The goal of the study was to identify the factors influencing prison officers, with respect to whether they would agree or refuse to make accessible the tools needed for the prevention of HIV transmission among inmates (i.e., condoms, bleach, tattooing equipment, and needles). Among the factors studied are officers' perceptions and beliefs as well as their attitudes, perceived social norms, emotions, and perceived barriers with respect to making preventive tools accessible.
Native Hawaiians are highly underrepresented in the field of medicine, both nationally and in Hawaii. Since 1991, the Native Hawaiian Center of Excellence (funded by the Bureau of Health Professions) at the John A. Burns School of Medicine in Honolulu has developed programs to encourage Native Hawaiians to enter and complete medical school. In this article, the authors focus on a revised version of a six-week summer enrichment program for high school students developed by the Center in 1995 and funded by the Hawaii State Department of Education and the federal government. The authors trace the difficulties in attracting Native Hawaiian students and how these difficulties were overcome. They show that once Native Hawaiians have entered the academically rigorous, culturally rich program, their academic and career ambitions have been kindled, and some are planning careers in medicine. The history of the program illustrates that a committed medical school and dedicated individuals in the community, with the support of the federal and state governments, can increase interest among underrepresented students in medical and other health professions careers. Eventually, when such students graduate, there is a likelihood that some of them will go back to serve the health needs of their communities.
In a typical third-party payer situation--representative of most U.S. health care delivery--the payer is likely to have interests that are at odds with the patient and provider. The separation and overlap between Medicare and Medicaid for individuals eligible for both programs introduces an additional level of complexity: multiple masters over plans, providers, and patients. This creates opportunities for shifting costs and administrative burdens between states and the federal government, providers and governments, and patients and everyone else. Program designers who wish to minimize unwanted consequences must find ways to structure their programs to produce financial incentives that encourage the pursuit of societal goals, including appropriately shared intergovernmental responsibilities and appropriate plan, provider, and patient behavior. Here the authors review nine federal and state initiatives that use varying strategies to integrate Medicare and Medicaid services for vulnerable populations. For each initiative, the authors examine and critique program design features in three areas: (1) eligibility determination, (2) finance and administration, and (3) service delivery. They find a few strengths and many weaknesses in design. Future efforts would be well served by carefully considering the incentive structures designed into these initiatives and working to improve them in the next generation of Medicare-Medicaid integration efforts.
Native American health care programs face complex and unprecedented challenges resulting from the increased assumption of clinical operations by tribal authorities, shortfalls in Federal funding, modifications in state and Federal health and welfare programs, and intensifying involvement with managed care organizations. These challenges are further complicated by service populations that are increasing at a faster rate than the growth in funding. The authors conducted onsite surveys of 39 Native American health programs in 10 states in order to assess the organizational and management problems they faced. The trend toward transfer of health programs from the Indian Health Service to tribal operation seems likely to continue and accelerate. The survey results indicate that in order for programs to be effective in the long run, they will need to be guided by skilled managers able to adapt to these powerful changes in the health care environment.
Mary Story, Karen Kaphingst, and Simone French argue that researchers and policymakers focused on childhood obesity have paid insufficient attention to child care. Although child care settings can be a major force in shaping children's dietary intake, physical activity, and energy balance-and thus in combating the childhood obesity epidemic-researchers know relatively little about either the nutrition or the physical activity environment in the nation's child care facilities. What research exists suggests that the nutritional quality of meals and snacks may be poor and activity levels may be inadequate. Few uniform standards apply to nutrition or physical activity offerings in the nation's child care centers. With the exception of the federal Head Start program, child care facilities are regulated by states, and state rules vary widely. The authors argue that weak state standards governing physical activity and nutrition represent a missed opportunity to combat obesity. A relatively simple measure, such as specifying how much time children in day care should spend being physically active, could help promote healthful habits among young children. The authors note that several federal programs provide for the needs of low-income children in child care. The Child and Adult Care Food Program, administered by the Department of Agriculture, provides funds for meals and snacks for almost 3 million children in child care each day. Providers who receive funds must serve meals and snacks that meet certain minimal standards, but the authors argue for toughening those regulations so that meals and snacks meet specific nutrient-based standards. The authors cite Head Start, a federal preschool program serving some 900,000 low-income infants and children up to age five, as a model for other child care programs as it has federal performance standards for nutrition. Although many child care settings fall short in their nutritional and physical activity offerings, they offer untapped opportunities for developing and evaluating effective obesity-prevention strategies to reach both children and their parents.
Waterborne diseases, such as cryptosporidiosis, cause many cases of serious illness in the United States annually. Water quality is regulated by a complex system of federal and state legal provisions and agencies, which has been poorly studied. The authors surveyed state and territorial agencies responsible for water quality about their laws, regulations, policies, and practices related to water quality and surveillance of cryptosporidiosis related to drinking water. In this commentary they review the development and current status of federal drinking water regulations, identify conflicts or gaps in legal authority between federal agencies and state and territorial agencies, and describe court-imposed limitations on federal authority with regard to regulation of water quality. Recommendations are made for government actions that would increase the efficiency of efforts to ensure water quality; protect watersheds; strengthen waterborne disease surveillance; and protect the health of vulnerable populations.
The impact of adjusting 1980 U.S. population census figures for the undercount on federal grant allocations to cities is examined. In contrast to claims by local officials that their cities have lost up to 200 dollars per uncounted person in federal grants, the authors suggest that an undercount adjustment "could be expected to add little more than [20 dollars] per uncounted person in a few large cities--with most large cities experiencing much smaller gains or even federal aid losses after an adjustment." Several reasons for this finding are discussed. "They relate to the significant limitations of available techniques for estimating the census undercount; the fact that population data are not used in all formula allocation systems; the varied ways in which population data can affect formula allocation systems when they are used; and [the] assumption that federal aid funds would not increase in proportion to the population added as part of an undercount adjustment procedure for federal grants."