Restructuring nuclear regulations

Nuclear regulations are a subset of social regulations (laws to control activities that may negatively impact the environment, health, and safety) that concern control of ionizing radiation from radiation-producing equipment and from radioactive materials. The impressive safety record among nuclear technologies is due, in no small part, to the work of radiation safety professionals and to a protection system that has kept pace with the rapid technologic advancements in electric power generation, engineering, and medicine. The price of success, however, has led to a regulatory organization and philosophy characterized by complexity, confusion, public fear, and increasing economic costs. Over the past 20 years, regulatory costs in the nuclear sector have increased more than 250% in constant 1995 U.S. dollars. Costs of regulatory compliance can be reduced sharply, particularly when health and environmental benefits of risk reduction are questionable. Three key regulatory areas should be closely examined and modified to improve regulatory effectiveness and efficiency: a) radiation protection should be changed from a risk-based to dose-based system; b) the U.S. government should adopt the modern metric system (International System of Units), and radiation quantities and units should be simplified to facilitate international communication and public understanding; and c) a single, independent office is needed to coordinate nuclear regulations established by U.S. federal agencies and departments.     

Restructuring federalism: the effects of decentralized federal policy on states' responsiveness to family planning needs.

The Reagan Administration sought to decentralize many federal programs by (1) consolidating categorical grants into black grants; (2) reducing their funding; and (3) relying more upon state fiscal support. This study examines the effects of this decentralist policy upon the federal family planning program. Two periods are analyzed: (1) FY 1976-1981, the period immediately prior to the Reagan Administration and (2) FY 1982-1987, the period during the Reagan Administration. Findings show that a more decentralized program produced less responsiveness to individual state needs for family planning, and that these effects could have been predicted from the previous period.     

Obtaining greater value from health care: the roles of the U.S. government

The problems of quality and cost in the U.S. health care system are unlikely to be solved without strong leadership from the federal government, which can mobilize action to set national priorities for quality; develop and promulgate standards for care; and stimulate implementation of performance measures and standards for providers. All of these functions would best be carried out by a new federal agency. Furthermore, the federal government should design payment policies based on the performance standards, invest in needed information technology, and invest in research related to improving care and in training professionals to support nationwide quality improvement.     

The Canadian health care system: an overview

Although health care is a provincial responsibility in Canada, universal hospital insurance was fully adopted by 1961; universal medical insurance followed 10 years later. Each province enacted universal insurance after the federal government offered to pay 50% of provincial hospital and medical care costs. Hospital insurance had wide public and provider support but universal medical care insurance was opposed by organized medicine. The federal government soon realized that it had no control over total expenditures and no mechanisms for controlling costs. In 1977 it enacted Bill C-37 which limited total federal contributions and made those contributions independent of provincial health care expenditures so that increased costs had to be met by the provinces. Since private health care insurance for universal benefits is prohibited by the federal terms of reference for health insurance, the provinces must raise the money by taxes and (in some provinces) premiums. Although prohibited by the terms of reference of the universal program, some provinces have adopted hospital user fees and are allowing their physicians to bill patients in excess of provincial fee schedules. The 1980s have seen increased confrontations between the federal and provincial governments and between the provinces and their providers. The issues are cost containment and control of the system. The provinces have two broad options. The first is more private funding through private insurance and user fees. The proposed new Canada Health Act will probably prohibit such charges. A second option involves greater control and management of the system by the provinces; this has already occurred in Quebec. Greater control is vigorously opposed by physicians and hospitals. The Canadian solution to health insurance problems in the past has been moderation. Extreme moves in either direction would represent a break with tradition, but they may prove to be unavoidable.     

美国鼓励仿制药替代使用政策与措施研究

目的：分析美国鼓励仿制药替代使用的立法过程、政策措施以及关键要素，为我国仿制药经一致性评价后制定替代使用政策提供建议。方法：通过查阅美国联邦法律、各州法律、指南文件、国内外文献等，全面分析美国鼓励仿制药替代使用的基本原则、监管理念和实施挑战。结论：美国仿制药替代法律的制定经历探索、发展和调整三个阶段。医师、药师和患者是美国各州法律鼓励仿制药替代的关键要素，联邦政府和FDA通过橙皮书、分级医保支付和开展认知教育的途径指导和影响仿制药替代。建议我国以尊重患者为基本原则，将鼓励仿制药替代写入法律，明确界定仿制药替代使用范围；建立具有替代决策支持工具的电子处方系统；加强宣传教育提高仿制药认知度。     

Price elasticity of expenditure across health care services

Policymakers in countries around the world are faced with rising health care costs and are debating ways to reform health care to reduce expenditures. Estimates of price elasticity of expenditure are a key component for predicting expenditures under alternative policies. Using unique individual-level data compiled from administrative records from the Chilean private health insurance market, I estimate the price elasticity of expenditures across a variety of health care services. I find elasticities that range between zero for the most acute service (appendectomy) and -2.08 for the most elective (psychologist visit). Moreover, the results show that at least one third of the elasticity is explained by the number of visits; the rest is explained by the intensity of each visit. Finally, I find that high-income individuals are five times more price sensitive than low-income individuals and that older individuals are less price-sensitive than young individuals.     

Ten Years of Addressing Children’s Health through Regulatory Policy at the U.S. Environmental Protection Agency

Background

Executive Order (EO) 13045, Protection of Children From Environmental Health Risks and Safety Risks, directs each federal agency to ensure that its policies, programs, activities, and standards address disproportionate environmental health and safety risks to children.

Objectives

We reviewed regulatory actions published by U.S. Environmental Protection Agency (EPA) in the Federal Register from April 1998 through December 2006 to evaluate applicability of EO 13045 to U.S. EPA actions and consideration of children’s health issues in U.S. EPA rulemakings.

Discussion

Although virtually all actions discussed EO 13045, fewer than two regulations per year, on average, were subject to the EO requirement to evaluate children’s environmental health risks. Nonetheless, U.S. EPA considered children’s environmental health in all actions addressing health or safety risks that may disproportionately affect children.

Conclusion

The EO does not apply to a broad enough set of regulatory actions to ensure protection of children’s health and safety risks, largely because of the small number of rules that are economically significant. However, given the large number of regulations that consider children’s health issues despite not being subject to the EO, other statutory requirements and agency policies reach a larger set of regulations to ensure protection of children’s environmental health.     

The Current and Projected Taxpayer Shares of US Health Costs

Objectives. We estimated taxpayers’ current and projected share of US health expenditures, including government payments for public employees’ health benefits as well as tax subsidies to private health spending.Methods. We tabulated official Centers for Medicare and Medicaid Services figures on direct government spending for health programs and public employees’ health benefits for 2013, and projected figures through 2024. We calculated the value of tax subsidies for private spending from official federal budget documents and figures for state and local tax collections.Results. Tax-funded health expenditures totaled $1.877 trillion in 2013 and are projected to increase to $3.642 trillion in 2024. Government’s share of overall health spending was 64.3% of national health expenditures in 2013 and will rise to 67.1% in 2024. Government health expenditures in the United States account for a larger share of gross domestic product (11.2% in 2013) than do total health expenditures in any other nation.Conclusions. Contrary to public perceptions and official Centers for Medicare and Medicaid Services estimates, government funds most health care in the United States. Appreciation of government’s predominant role in health funding might encourage more appropriate and equitable targeting of health expenditures.The United States has the world’s highest per capita health care costs—about double those of other wealthy nations.1 According to both official figures and public perception, most health care funding in the United States comes from private payers. For instance, the Centers for Medicare and Medicaid Services (CMS) estimates that federal, state, and local governments accounted for 43% of health expenditures in 2013.2These official figures reflect an accounting framework based on who wrote the final check as money flowed from households or employers to health care providers, and exclude many indirect government health expenditures. Thus, when government pays for veterans’ care, CMS classifies it as a public expenditure because government writes the checks that fund the Veterans Health Administration. But CMS classifies government-paid health benefits for senators or Federal Bureau of Investigation agents as “private” expenditures because a private insurer pays the claims. Moreover, the tax subsidies that fund a significant share of private health expenditures (e.g., private-employer spending) are not counted by CMS as government health spending, although the Office of Management and Budget (OMB) tabulates these subsidies as “tax expenditures” in official budget documents.3In a previous study, we estimated that the public share of US health spending—after inclusion of these tax subsidies and government payments for public employees’ health benefits—amounted to 59.8% of the total in 1999, nearly double the 1965 figure.4 The current study provides detailed estimates of direct and indirect government health spending in 2013, as well as projected figures through 2024.     

Rising medical costs and the reform of Japan's health insurance system

From the early twentieth century until recently, the Japanese health insurance system consistently expanded its coverage and benefits. In 1961, Japan achieved universal coverage for health insurance. In the 1970s, however, the insurance system began to experience severe fiscal problems, as total medical expenditures rose faster than national income, as medical costs for the elderly increased rapidly, and as enormous budget deficits accumulated in several insurance schemes. Controlling the increase in medical care expenditures became the top priority of the 1980s for the Ministry of Health and Welfare. The paper presents recent government policies and efforts to contain medical expenditures and establish a firm financial basis for Japan's social security system. The government began with regulating the demand side of medical care but is also introducing planning measures for supply factors. Possible government interventions to contain medical expenditures are proposed for both demand and supply approaches. Measures for cost containment, however, need to be balanced with efforts to improve people's health and maintain equity in the health insurance system.     

Recombinant erythropoietin. Orphan product with a silver spoon.

The U.S. Food and Drug Administration's (FDA) approval to the orphan biological product recombinant erythropoietin (rEPO) in June 1989 resulted both in a breakthrough treatment for the chronic anemia of people who suffer from chronic renal failure and a powerful argument for change in the legislation that spawned its development: the Orphan Drug Act of 1983. At a cost of over $6,000 per patient per year, Congress could not understand how a product that no manufacturer wanted to produce was suddenly costing the federal government hundreds of millions of dollars each year. Congress attempted to change the act in 1990 to preclude a manufacturer from using its provisions to secure lucrative monopolies in certain drug markets. In early 1991, the FDA finally issued regulations to implement the act that addressed some of the very concerns that were caused by rEPO.     

Health of newly arrived immigrants in Canada and the United States: Differential selection on health

Canada and the U.S. are two major immigrant-receiving countries characterized by different immigration policies and health care systems. The present study examines whether immigrant health selection, or the "healthy immigrant effect", differs by destination and what factors may account for differences in immigrant health selection. We use 12 years of U.S. National Health Interview Survey and Canadian Community Health Survey data to compare the risks of overweight/obesity and chronic health conditions among new immigrants in the two countries. Results suggest a more positive health selection of immigrants to Canada than the U.S. Specifically, newly arrived U.S. immigrants are more likely to be overweight or obese and have serious chronic health conditions than their Canadian counterparts. The difference in overweight/obesity was explained by differences in source regions and educational levels of immigrants across the two countries. But this is not the case for serious chronic conditions. These results suggest that immigration-related policies can potentially shape immigrant health selection.     

Dot-gov: market failure and the creation of a national health information technology system

The U.S. health care marketplace's continuing failure to adopt information technology (IT) is the result of economic problems unique to health care, business strategy problems typical of fragmented industries, and technology standardization problems common to infrastructure development in free-market economies. Given the information intensity of medicine, the quality problems associated with inadequate IT, the magnitude of U.S. health spending, and the large federal share of that spending, this market failure requires aggressive governmental intervention. Federal policies to compel the creation of a national health IT system would reduce aggregate health care costs and improve quality, goals that cannot be attained in the health care marketplace.     

USA government and family planning

The U.S. government has given remarkable support to family planning in the U.S. and abroad within the last 10 years. Until the mid-1960s there were fairly restrictive laws and policies regarding family planning and no government funds were given for this activity. It was not until 1964 that the first federal grant of $8000 was provided for a family planning project. By 1965 it was estimated that health departments in 40 states authorized referral of those needing family planning services. The Family Planning Services and Population Research Act of 1970 was the first explicit family planning legislation passed by the U.S. Congress. About $93 million was budgeted by the federal government for family planning services by 1971, with a proposed budget for 1973 of $155 million. The research budget was $38 million in 1972. The U.S. also increased its commitment to the support of family planning abroad, most of it through USAID. $96 million was allocated to population and family planning assistance abroad by the U.S. government in 1971.     

Burdens on research imposed by institutional review boards: the state of the evidence and its implications for regulatory reform

Context: Federal regulations mandate independent review and approval by an “institutional review board” (IRB) before studies that involve human research subjects may begin. Although many researchers strongly support the need for IRB review, they also contend that it is burdensome when it imposes costs that do not add to the protections afforded to research participants and that this burden threatens the viability of research. The U.S. Department of Health and Human Services recently announced its intention to reform the regulations governing IRB review. Methods: We used a search of the PubMed database, supplemented by a bibliographic review, to identify all existing primary data on the costs of IRB review. “Costs” were broadly defined to include both expenditures of time or money and constraints imposed on the scope of the research. Burdensome costs were limited to those that did not contribute to greater protections for the participants. Findings: Evidence from a total of fifty‐two studies shows that IRBs operate at different levels of efficiency; that waiting to obtain IRB approval has, in some instances, delayed project initiation; that IRBs presented with identical protocols sometimes asked for different and even competing revisions; and that some decisions made (and positions held) by IRBs are not in accord with federal policy guidance. Conclusions: While the evidence is sufficient to conclude that there is burden associated with IRB review, it is too limited to allow for valid estimates of its magnitude or to serve as the basis for formulating policies on IRB reform. The single exception is multicenter research, for which we found that review by several local IRBs is likely to be burdensome. No mechanism currently exists at the national level to gather systematic evidence on the intersection between research and IRB review. This gap is of concern in light of the changing nature of research and the increasingly important role that research is envisioned to play in improving the overall quality of health care.     

Paying for national health insurance--and not getting it

The threat of steep tax hikes has torpedoed the debate over national health insurance. Yet according to our calculations, the current tax-financed share of health spending is far higher than most people think: 59.8 percent. This figure (which is about fifteen percentage points higher than the official Centers for Medicare and Medicaid Services [CMS] estimate) includes health care-related tax subsidies and public employees' health benefits, neither of which are classified as public expenditures in the CMS accounting framework. U.S. tax-financed health spending is now the highest in the world. Indeed, our tax-financed costs exceed total costs in every nation except Switzerland. But the sub rosa character of much tax-financed health spending in the United States obscures its regressivity. Public spending for care of the poor, elderly, and disabled is hotly debated and intensely scrutinized. But tax subsidies that accrue mostly to the affluent and health benefits for middle-class government workers are mostly below the radar screen. National health insurance would require smaller tax increases than most people imagine and would make government's role in financing care more visible and explicit.     

Costs of introducing pneumococcal,rotavirus and a second dose of measles vaccine into the Zambian immunisation programme: Are expansions sustainable?

BackgroundIntroduction of new vaccines in low- and lower middle-income countries has accelerated since Gavi, the Vaccine Alliance was established in 2000. This study sought to (i) estimate the costs of introducing pneumococcal conjugate vaccine, rotavirus vaccine and a second dose of measles vaccine in Zambia; and (ii) assess affordability of the new vaccines in relation to Gavi’s co-financing and eligibility policies.MethodsData on ‘one-time’ costs of cold storage expansions, training and social mobilisation were collected from the government and development partners. A detailed economic cost study of routine immunisation based on a representative sample of 51 health facilities provided information on labour and vaccine transport costs. Gavi co-financing payments and immunisation programme costs were projected until 2022 when Zambia is expected to transition from Gavi support. The ability of Zambia to self-finance both new and traditional vaccines was assessed by comparing these with projected government health expenditures.Results‘One-time’ costs of introducing the three vaccines amounted to US$ 0.28 per capita. The new vaccines increased annual immunisation programme costs by 38%, resulting in economic cost per fully immunised child of US$ 102. Co-financing payments on average increased by 10% during 2008–2017, but must increase 49% annually between 2017 and 2022. In 2014, the government spent approximately 6% of its health expenditures on immunisation. Assuming no real budget increases, immunisation would account for around 10% in 2022. Vaccines represented 1% of government, non-personnel expenditures for health in 2014, and would be 6% in 2022, assuming no real budget increases.ConclusionWhile the introduction of new vaccines is justified by expected positive health impacts, long-term affordability will be challenging in light of the current economic climate in Zambia. The government needs to both allocate more resources to the health sector and seek efficiency gains within service provision.     

Universal health insurance in Canada

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.     

Health care administration in the United States and Canada: micromanagement, macro costs.

A decade ago, U.S. health administration costs greatly exceeded Canada's. Have the computerization of billing and the adoption of a more business-like approach to care cut administrative costs? For the United States and Canada, the authors calculated the 1999 administrative costs of health insurers, employers' health benefit programs, hospitals, practitioners' offices, nursing homes, and home care agencies; they analyzed published data, surveys of physicians, employment data, and detailed cost reports filed by hospitals, nursing homes, and home care agencies; they used census surveys to explore time trends in administrative employment in health care settings. Health administration costs totaled at least dollar 294.3 billion, dollar 1,059 per capita, in the United States vs. dollar 9.4 billion, dollar 307 per capita, in Canada. After exclusions, health administration accounted for 31.0 percent of U.S. health expenditures vs. 16.7 percent of Canadian. Canada's national health insurance program had an overhead of 1.3 percent, but overhead among Canada's private insurers was higher than in the U.S.: 13.2 vs. 11.7 percent. Providers' administrative costs were far lower in Canada. Between 1969 and 1999 administrative workers' share of the U.S. health labor force grew from 18.2 to 27.3 percent; in Canada it grew from 16.0 percent in 1971 to 19.1 percent in 1996. Reducing U.S. administrative costs to Canadian levels would save at least dollar 209 billion annually, enough to fund universal coverage.     

The arguments against a national health program: science or ideology?

This article provides empirical information that questions some of the major arguments put forward against the establishment of a comprehensive and universal health program in the United State. The positions that (1) "Americans do not want a further expansion of government roles in their lives," (2) "a National Health Program would further increase the rate of growth of health expenditures," (3) "the federal deficit is too large and needs to be reduced before establishing a National Health Program," and (4) "people do not want to pay higher taxes," are shown to be ideological rather than scientific. The author presents evidence that questions each of these assumptions.     

Data requirements to measure progress on the objectives for the nation in health promotion and disease prevention

The Reagan Administration has adopted the policy guidelines developed over the previous few years in the disease prevention and health promotion initiative of the Carter Administration. Broad national consensus had been sought in the formulation of 226 measurable objectives for the decade. We classify the prevention objectives according to their position in an implied causal chain: 1) improved programs, 2) increased public and professional awareness, 3) reduced risk factors, and 4) improved health status. Prior to 1980, the data systems and periodic surveys sponsored by federal agencies and national organizations covered only four of the 42 objectives in the public and professional awareness category, whereas at least half of the objectives in each of the other three categories were covered by available national data sources, mostly federal. Sample surveys are needed to measure the majority of the currently unmeasured objectives in all four categories. Private and state health interview surveys are needed to supplement the federal capacity, especially in the face of federal cutbacks in survey capacity.