OBJECTIVE: To review progress made in health insurance coverage following the 1984 Conference on Financing Quality Health Care for Persons with Diabetes.

CATEGORY: Expert opinion.

CONCLUSION: The diabetes community has made some progress in influencing coverage decisions by the reimbursement community, but much more still needs to be done.

RECOMMENDATION: Since many coverage decisions are made locally, data collection and advocacy are needed at that level. The involvement of government relations, public policy, and advocacy committees of the American Diabetes Association affiliates is needed.

ABSTRACT: The author provides an update of accomplishments and work still to be done in each of the topic areas for the 1984 Conference on Financing Quality Health Care for Persons with Diabetes. He notes that the American Diabetes Association (ADA) estimated that 5 to 8 percent of all persons with diabetes (i.e., 550,000 to 880,000 persons) have no health insurance. He discusses legislation under consideration that would encourage states to establish health insurance risk pools. The author notes that reimbursement for patient education is usually not covered by third parties despite agreement that it is integral to care and evidence that it reduces hospitalizations. He reviews efforts by the diabetes community to justify coverage for outpatient education and notes that the Health Care Financing Administration (HCFA) issued a memorandum to a regional administrator that outpatient hospital and rural health education should be reimbursed under Part B of Medicare. The author points out that Medicare is still not paying for teaching programs except those based in hospitals or rural health clinics. He reports that the American Diabetes Association has begun discussions with HCFA about covering free-standing programs that are the sole educational programs in a community. The author also notes that preconference surveys found that important durable equipment and supplies were frequently not covered. He reports that the ADA has begun discussions with HCFA about broadening Medicare coverage to all people with diabetes who require insulin. In addition, the Office of Health Technology Assessment is reviewing continuous subcutaneous insulin infusion pumps, whose purchase is not covered by Medicare. 1 figure, 1 table, 9 references.

254

TITLE: Ambulatory Medical Care for Diabetes. Janes, G.R. In: Diabetes in America. 2d ed. National Diabetes Data Group, ed. National Institute of Diabetes and Digestive and Kidney Diseases. NIH Publication No. 95-1468. 1995: 541-552.

OBJECTIVE: To review survey data on ambulatory care for persons with diabetes.

CATEGORY: Expert opinion.

CONCLUSION: Patients with diabetes account for a disproportionate amount of ambulatory care services.

RECOMMENDATION: None.

ABSTRACT: The author assessed data from the National Health Interview Survey (NHIS); National Ambulatory Medical Care Survey (NAMCS), which samples office-based physicians; and the National Medical Expenditure Survey concerning the impact of diabetes on the ambulatory medical care system. Per the 1990 NHIS, persons with diabetes accessed ambulatory care 96.1 million times, averaging 15.5 visits per person, compared with 5.5 visits per person in the general population. Rates were somewhat higher for women than men and for whites versus blacks. Per the NAMCS for 1981 and 1985, diabetes ranked second (excluding well-baby and pregnancy visits) to hypertension among frequently cited principal diagnoses associated with the patient's primary complaint during return office visits (for 1989 and 1990 it ranked third after these exclusions). Between 1981 and 1990, the number of visits by persons with diabetes to an office-based physician increased 44 percent, versus an increase of 20 percent in the population at large. According to the 1990 NHIS, 96 percent of patients with diabetes indicated that as an inpatient or outpatient they had seen or talked with a physician or an assistant within the past year. Patients with type 2 diabetes saw a physician more frequently than those with type 1 diabetes; frequency of visits increased with age. Per NAMCS, in 1990-1991, only 8 percent of visits by patients with diabetes were made to a specialist in diabetes/endocrinology; in the 1989 NHIS, fewer than 50 percent of patients recalled seeing an ophthalmologist in the previous year, only 21 percent a dietitian/nutritionist, and only 17 percent a podiatrist. Mean length of physician visits (per NAMCS) for diabetes increased from 15.3 minutes in 1981 to 17.5 minutes in 1990. The percentage of visits paid for by patients decreased from 1985 to 1990, while the percentage paid by Medicare and commercial insurance (other than Blue Cross-Blue Shield) increased. 6 figures, 13 tables, 2 appendices, 12 references.

255

TITLE: Ambulatory Nutrition Care: Adults-Diabetes Mellitus. Disbrow, D.D. VIII. Journal of the American Dietetic Association. 89(4):S35-S39. April 1989.

OBJECTIVE: To describe through a literature review the economics, benefits, and costs of diabetes education programs.

CATEGORY: Expert opinion.

CONCLUSION: Evaluations of structured programs to provide diabetes education in outpatient settings have found improved clinical outcomes and cost savings from reduced use of health services.

RECOMMENDATION: The cost of various nutrition services for patients with diabetes is very important information to provide to third party payers; dietitians need to report the costs of services provided.

ABSTRACT: The author summarizes economic, benefit, and cost analyses of diabetes education programs. Reported costs per patient for outpatient diabetes education programs have ranged from $100 to $770. The North Dakota Diabetes Education Program (1982) was found by Blue Cross of North Dakota to be cost-saving; in 1985, Medicare and 18 insurance companies agreed to cover the service. Programs in Maine and Rhode Island and at Grady Memorial Hospital in Atlanta were also found to be cost-saving. A meta-analysis of 47 studies found that diabetes education had a moderate effect on all outcomes examined. The research suggests that opportunities for frequent contact and reinforcing the education principles over a long time have the greatest impact. The author states that there is considerable evidence that large savings in health dollars can be achieved by delivering diabetes education programs in the outpatient setting rather than during hospitalizations, but she points out that the validity of the research results has been questioned. Kaplan and Davis (1986) criticized reports used to support the resolution of the American Diabetes Association for third party reimbursement of outpatient diabetes education and nutrition counseling, finding fault with the study designs, cost analyses, follow-up, and extrapolation of results. 2 tables, 22 references.

256

TITLE: Amputation in the Diabetic Population: Incidence, Causes, Cost, Treatment, and Prevention. Fylling, C.P.; Knighton, D.R. Journal of Enterostomal Therapy.16(6): 247255. November-December 1989.

OBJECTIVE: To summarize the current medical literature on the criteria for nontraumatic amputation and proposed interventions to reduce its incidence.

CATEGORY: Expert opinion.

CONCLUSION: Amputation is a complex problem for the patient, the health care system, and the country.

RECOMMENDATION: Every effort should be made to reduce the incidence of amputation; this can only be achieved by identifying the causative problems and designing interventions to solve those problems.

ABSTRACT: Patients with diabetes or with peripheral vascular disease are primary candidates for amputation. In the United States, there were 118,000 amputations of the lower limb in 1983. The authors found that contralateral amputation is common (e.g., 42 percent of patients in 1 study required an amputation of the other leg within 1 to 3 years of the first amputation). Death frequently occurs soon after an amputation (50 percent died in 3 years in 1 study). The cost of amputation is high (over 50,000 lower extremity amputations in 1985 cost a total of about $500 million for direct medical care, not including rehabilitation). Diabetes mellitus is by far the most common primary indication for lower extremity amputation; ischemia without diabetes ranks second. Amputations should be performed at the lowest level consistent with function (with the intent to maintain or restore the best function with the least loss of tissue). The most frequently cited criteria for amputation are gangrene, infection, and nonhealing ulcers. Modern prevention of amputation in the patient with diabetes includes state-of-the-art noninvasive vascular testing, angiography, distal vascular reconstruction procedures, infection control, total contact casting as appropriate, growth factors to enhance healing, orthopedic shoes, and patient education. 5 tables, 109 references.

257

TITLE: Applying Recent Findings to Clinical Care in Type II Diabetes. Williams, R. PharmacoEconomics. 8 (Supplement 1): 80-84. 1995.

OBJECTIVE: To discuss the economics of applying findings from major clinical trials to the care of patients with diabetes.

CATEGORY: Expert opinion.

CONCLUSION: The economic arguments for applying the results of major diabetes studies from the United States and the United Kingdom are compelling in the long term but require considerable short-term investment. This level of investment may be beyond the means of many developing countries.

RECOMMENDATION: None.

ABSTRACT: The economic consequences of diabetes vary in different parts of the world, due to differences in disease burdens (the epidemiologic transition) and differences in who bears the burden of the costs of diabetes (the individual, their families, or society). It has often been argued that advances in diabetes therapy, particularly advances in preventing complications, will reduce the cost of care. The effects of preventive measures on quality of life and on indirect costs, however, are likely to be much greater than on direct costs. Unfortunately, there are wide disparities in estimates of indirect costs and severe methodological difficulties in making these estimates. Application of the Diabetes Control and Complications Trial (DCCT) conducted in the United States and the United Kingdom Prospective Diabetes Study (UKPDS) (a study of the effectiveness of various oral hypoglycemic regimens versus dietary therapy alone in type 2 diabetes) to practice in developing countries will have economic consequences that are largely inconceivable, let alone sustainable. Analysis of the economic consequences of the DCCT, which confirmed the benefit of intensive therapy, found that the benefits of reduced complications outweighed the costs of more intensive treatment in the long term. In the UKPDS, glycemic control was significantly better in the groups treated with insulin or with oral hypoglycemic agents than in those treated with diet alone. Both the DCCT findings and early results of the UKPDS show that "higher tech" solutions are more effective. The economic case for implementing available interventions is usually less convincing for type 2 diabetes than for type 1, in part because the time that persons can remain free of complications is much less with type 2. The capacity for developing countries to make short-term investments is severely limited and will be further taxed as noncommunicable diseases such as diabetes become more prevalent. 2 tables, 15 references.

258

TITLE: Assessing the Costs and Benefits of Medical Research: The Retinopathy Study. Drummond, M.F.; Davies, L.M.; Ferris, F.L. Social Science and Medicine. 34(9): 973-981. May 1992.

OBJECTIVE: To develop and test a methodology for assessing the social costs and benefits of medical research. The Retinopathy Study is used as an example.

CATEGORY: Expert opinion.

CONCLUSION: It is possible to develop and test a methodology of assessing the costs and benefits of medical research that does not have the defects of earlier approaches. Using this method, the Retinopathy Study was extremely cost beneficial, with $10.5 million in research costs generating a net savings of $2,816 million to society.

RECOMMENDATION: With some modification, the methodology described can be applied prospectively to assess not only how many resources should be invested in a specific clinical trial but also to determine the payoff from investing resources in promoting the dissemination of results or in changing incentives to encourage the adoption of new, cost-effective clinical practices.

ABSTRACT: The authors retrospectively assessed the costs and benefits of the Retinopathy Study, a major clinical trial funded by the National Eye Institute between 1972 and 1981. The impact of the study, which was a randomized, controlled clinical trial of photocoagulation for severe retinopathy, on clinical practice for both proliferative and nonproliferative retinopathy was examined. Decision analysis was used to assess the expected costs and consequences of laser photocoagulation for persons with proliferative retinopathy in two alternatives: with and without the clinical trial. It was estimated that the trial, which cost $10.5 million, would provide a net savings to society of $2,816 million over 22 years' use of photocoagulation therapy, most of that figure coming from the avoidance of lost production. The government would save $2,249 million; patients, $1,339 million; and third party payers would incur a net cost of $772 million because of an increase in the use of photocoagulation. Even excluding the costs of lost productivity, there would be a net savings of $231 million to society over the same time period. In addition, there would be a net gain to the population of patients with retinopathy of 279,000 vision years. Sensitivity analysis showed the results were most affected by the assumptions about the likely impact of the trial on clinical practice, the effectiveness of the therapy, and the view taken on the relevance of including productivity losses. 2 figures, 4 tables, 25 references.

259

TITLE: Cardiovascular Complications of Diabetes Mellitus: What We Know and What We Need to Know about Their Prevention. Savage, P.J. Annals of Internal Medicine. 124 (1 Part 2): 123-126. January 1, 1996.

OBJECTIVE: To review the problem of cardiovascular disease in persons with diabetes. To discuss the questions related to prevention of cardiovascular complications of diabetes that must be addressed by future clinical trials.

CATEGORY: Expert opinion.

CONCLUSION: Persons with diabetes are at substantially increased risk for cardiovascular complications, particularly those related to atherosclerosis.

RECOMMENDATION: Until new clinical trials determine whether optimal glucose concentration normalizes the risk of cardiovascular disease and whether this approach is the most cost-effective intervention, existing guidelines for the control of cardiovascular disease risk factors in patients with diabetes should be strictly followed.

ABSTRACT: The author reviews the existing literature on the etiology of cardiovascular disease in persons with diabetes and discusses future research needs relevant to prevention. Many studies have demonstrated an association between overt diabetes and cardiovascular disease. In developed countries, the risk of cardiovascular disease is increased two- to four-fold among patients with diabetes. Up to 75 percent of deaths among patients with type 2 diabetes in the United States are attributed to ischemic heart disease or other heart and vascular diseases. The cardiovascular complications of diabetes are increasingly important because of population trends (rapid growth among the elderly and minorities) and because success in reducing microvascular complications will increase the numbers at risk for macrovascular complications. The Diabetes Control and Complications Trial did not establish that the macrovascular complications of diabetes can be reduced by controlling glucose concentrations, and questions about the relationship of hyperglycemia to risk for cardiovascular disease remain unanswered. Because of concern about medical care costs, consideration must be given to issues of relative efficacy, relative cost, and the patient burden from different interventions in developing a cardiovascular disease reduction program effective for most patients with diabetes. As the average patient with diabetes sees a physician less than one hour annually, without a major expansion in care there will be severe limits in the complexity of any program that could be implemented. Key questions to be answered are whether optimal glucose control normalizes the risk of cardiovascular disease and whether controlling glucose concentration is the most cost-effective intervention to prevent cardiovascular complications. 2 tables, 29 references.

260

TITLE: Case Management and Quality of Care for Diabetic Patients. Korn, A. Diabetes Care. 15(Supplement 1): 59-61. March 1992.

OBJECTIVE: To describe a clinically sensitive case management process and its impact on quality of care.

CATEGORY: Expert opinion.

CONCLUSION: All patients may benefit from case management if it is accomplished through a peer-driven process.

RECOMMENDATION: None.

ABSTRACT: The author describes the elements of a clinically sensitive case management process and its potential impact on the quality of care of patients with diabetes. Case management, which he also calls managed care, is designed to achieve the best possible clinical outcome for each episode of patient care at a cost that represents the best value to the patient and benefit plan. The overall process must be ongoing and dynamic; a commitment to flexibility is required of payers so that, as feasible, benefits may be matched to clinical need in a sensitive, efficient manner. To achieve the best possible clinical outcome, case management must focus on the medical necessity of services. Interpretation of medical necessity should include a peer review. The value of a given treatment plan must also be evaluated from a financial as well as a clinical perspective. To serve the patient's best interests, the treatment plan should focus on the long-term outcome. But good case management must look at both short- and long-term values; price is only one determinant of cost over time. Clinical criteria are an evolving part of the case management process. Applying appropriateness criteria for specific therapies results in a risk-benefit analysis for a particular patient. Appropriateness criteria are gaining increased acceptance within the provider and payer communities. Case management has the potential to affect the quality of care of patients with diabetes, including aspects of individual patient treatment plans and laboratory screening procedures, patient compliance monitoring, and hospital utilization. 6 references.

261

TITLE: Clinical Economics: A Guide to the Economic Analysis of Clinical Practices. Eisenberg, J.M. Journal of the American Medical Association (JAMA). 262(20): 28792886. November 24, 1989.

OBJECTIVE: To provide information for clinicians on how economic techniques can be applied to their medical practice to improve decision making about ways to use resources in the hope of improving health.

CATEGORY: Expert opinion.

CONCLUSION: The clinical economic techniques reviewed may help clinicians reach the societal goal of achieving the greatest benefit for the most people.

RECOMMENDATION: None.

ABSTRACT: The author provides a broad overview of the principles of economic analysis and how they can be used to make intelligent choices between alternative uses of resources. These decisions must consider both cost and outcome because there are only limited resources available; tradeoffs and choices are inevitable. The author describes three dimensions of economic analysis applied to medical care: type of analysis (cost identification, cost-effectiveness, and cost benefit), point of view (society, patient, payer, and provider), and type of costs and benefits (direct medical, direct nonmedical, indirect, and intangible). Cost identification simply asks what the cost is; this analysis can guide medical practice only if a service has both lower cost and better or equal outcomes than the alternatives. Cost-effective analysis measures the net cost of offering a service and the outcomes obtained. It does not, however, assess whether outcomes are worth the cost. Cost-benefit analysis forces an explicit decision about whether the cost is worth the benefit. In terms of point of view, the author notes the bias that generally favors medical care for identifiable victims. He also discusses sensitivity analysis, which determines the degree to which uncertainty can influence conclusions about the economic impact of clinical decisions. The principles and methods of clinical economics equip physicians to be more critical users of information about the costs and effects of clinical practice. 4 figures, 2 tables, 44 references.

262

TITLE: A Clinician's Guide to Cost-Effective Analysis. Detsky, A.S.; Naglie, I.G. Annals of Internal Medicine. 113(2): 147154. July 15, 1990.

OBJECTIVE: To show how economic analysis can be used to help decision makers set priorities for funding health care programs.

CATEGORY: Expert opinion.

CONCLUSION: Policymakers will be better able to set priorities for funding if their perspective and objectives follow some of the principles of a cost-effectiveness analysis.

RECOMMENDATION: Clinicians should understand cost-effectiveness analysis, even though they do not use it in their clinical practice.

ABSTRACT: The authors examine fundamental ideas about efficiency analysis in health care, which includes cost-effectiveness, cost-benefit, and cost-November/Decemberutility analysis. They provide examples to define cost effectiveness analysis and to show how it can be employed to allocate scarce health care resources across competing uses. Using this technique to set priorities assumes the decision maker has one objective, to maximize net health benefit to a target population from a fixed amount of resources, and that the decision maker values health benefits accruing to all persons in the target population equally. Cost-effectiveness analysis of a health care intervention requires comparing it with alternative methods of dealing with the patients in a given health state (e.g., comparison of drugs for patients with hypertension). The tension between the extra costs of an intervention and the extra clinical benefits brings forth the issue of setting priorities. Ratios of extra costs required to achieve one extra unit of clinical outcome are derived; these may be cost-effectiveness, cost-utility, or cost-benefit ratios. When units of clinical outcome can be measured in direct clinical terms (e.g., premature deaths avoided), cost-effectiveness ratios will be estimated. If clinical outcome units also consider utility or quality of life, cost-utility ratios are estimated. Incremental (marginal) cost-effectiveness or cost-utility ratios can be used to set priorities. The type of economic analysis discussed in this paper has a very limited role for individual clinicians caring for individual patients and is more appropriate for decisions affecting populations. 4 tables, 17 references.

263

TITLE: Cost Concepts for Diabetes Educators: An Introduction. Tobin, C.T. Diabetes Educator. 16(6): 456, 459. November-December 1990.

OBJECTIVE: To introduce diabetes educators to decision analysis tools for business that are currently used in the health care setting.

CATEGORY: Expert opinion.

CONCLUSION: Understanding economic analysis and incorporating it into diabetes management practices enables diabetes educators to use cost terminology and analysis correctly, to evaluate the diabetes literature, to develop accurate cost data for individual services, and to enhance the credibility of reimbursement proposals to third party payers.

RECOMMENDATION: It is more practical for health care professionals to learn business language than for policymakers or decision makers to learn the language of education and diabetes.

ABSTRACT: Lack of third party reimbursement for outpatient education is a common problem for diabetes educators. When developing a proposal to have this service reimbursed, educators must understand the concerns of insurers. The author provides an overview of economic analysis so that diabetes educators can improve their communication with policymakers. She discusses four types of economic analysis: cost identification, cost-effectiveness, cost benefit, and cost utility. Cost identification identifies the lowest cost of available alternatives. Cost-effectiveness provides the least costly alternative to achieve an outcome. Cost benefit determines whether a benefit is worth the cost. Cost utility adjusts outcome for quality and measures costs in dollars (e.g., cost of quality-adjusted life-years). The more diabetes educators know and understand about reimbursement and cost analysis, the more they will be able to activate their policymakers and third party payers and to make more informed decisions affecting their patient population. 1 table, 4 references.

264

TITLE: Cost of Diabetes Care. In: Clinical Diabetes Mellitus: A Problem-Oriented Approach. InZwaag, R.V.; Connor, M.; Dickson, H.D.; Runyan, J.W. (eds.) New York, NY: Thieme Medical Publishers. 1991. pp. 717-722.

OBJECTIVE: To discuss direct and indirect costs for patients with diabetes.

CATEGORY: Expert opinion.

CONCLUSION: Medical care costs are increasing and will continue to increase, but attempts are being made to change these trends through government regulations, preventive care, and new methods of health care delivery. Hospitalization costs related to the treatment of diabetes complications are a major component of the total cost of diabetes.

RECOMMENDATION: None.

ABSTRACT: The authors define direct costs as those associated with diagnosis and treatment of diabetes, and indirect costs as those associated with loss of productivity from work, disability, and early mortality. The authors discuss direct costs of diagnostic tests, home glucose monitoring (urine and blood tests), and physician visits in 1987. The American Diabetes Association (ADA) reported for that year that 63 percent of persons with diabetes used home urine tests ($.10 per test) and 16 percent used home glucose tests ($.83 per test); of the home-monitoring group, 64 percent tested once a day. National Ambulatory Medical Care Survey data published in 1981 found diabetes ranked second to hypertension for disease-coded physician visits. Diabetes had the highest proportion of return visits (.94), indicating a recurring expense for patients with diabetes. The authors analyze hospitalization data from two Memphis, Tennessee, providers. At the Baptist Memorial Hospital in 1988, circulatory disorders and hyperosmolar coma were the most expensive major complications of diabetes in terms of average length of stay and charge per day. Although average charges per day for most disorders were less for patients with diabetes, total charges were greater because lengths of stay were longer. Much earlier, the Memphis Chronic Disease Program demonstrated that hospital days can be reduced with a system of decentralized clinics using specially trained nurses as primary care providers. The total charges per patient in that program averaged $611 per year (1977 dollars), in the range of national per capita expenditures for medical care in that period. Blindness, kidney disease, limb amputation, myocardial infarction, and stroke are expensive conditions that also should be considered in the direct costs of diabetes. In 1975, the direct cost of diabetes was estimated at $2.52 billion, and the indirect costs at $2.82 billion. A 1987 report estimated direct costs for the disease of $9.6 billion and indirect costs of $10.8 billion. The authors note that the greatest benefit from prevention programs may derive from educational efforts directed to juvenile patients and pregnant women with diabetes. 4 tables, 15 references.

265

TITLE: Cost-Effectiveness of Diabetes Education. Assal, J-P. PharmacoEconomics. 8 (Supplement 1): 68-71. 1995.

OBJECTIVE: To present an argument for diabetes education.

CATEGORY: Expert opinion.

CONCLUSION: Resources spent on patient education lead to substantial savings over the longer term.

RECOMMENDATION: Investment in patient education is needed.

ABSTRACT: A review by Bartlett (1995) showed average savings of $3 to $4 per $1 invested in patient health education. Diabetes education is also cost effective, but many patients do not have adequate access to such a program. In addition, educational programs on diabetes often do not include the poorly motivated or poorly educated, the elderly and isolated, and patients in denial. Physicians and allied health professionals have not been prepared through their education and training to educate their patients. The methodology required to educate patients about diabetes must be based on active learning by health professionals. Initially, education specialists need to supervise the educational programs for these professionals. Major investment in patient education by health care policymakers and administrators appears to be warranted. Without such investment there is little prospect of substantial improvement in the delivery of health education to the population with diabetes. 1 figure, 1 table, 15 references.

266

TITLE: The Cost-Effectiveness of Preventive Care for Diabetes Mellitus. Elixhauser, A. Diabetes Spectrum. 2(6): 349-353. November/December 1989.

OBJECTIVE: To summarize the literature on the costs associated with diabetes and to evaluate the economic aspect of programs for preventing its complications.

CATEGORY: Expert opinion.

CONCLUSION: Most of the programs were found to be effective in reducing morbidity, mortality, and costs associated with diabetes, but the strength of these findings is limited by study deficiencies.

RECOMMENDATION: More accurate assessment of the clinical and economic impact that interventions have on preventing complications of diabetes is needed.

ABSTRACT: The author summarizes the literature on the costs of diabetes and interventions against the disease. Five types of interventions are examined from an economic point of view: primary prevention, screening for gestational diabetes, glucose monitoring, changes in structure of medical care services, and educational or behavioral interventions. The main types of economic evaluation discussed are cost-of-illness studies, cost-benefit analysis (CBA), cost-effectiveness analysis (CEA), and cost-utility analysis (CUA). All of the studies examined in this analysis were deficient in some way, limiting valid conclusions. The cost-of-diabetes studies examined only the primary diagnosis to avoid counting resource use twice, but this approach underestimates costs — diabetes is a secondary diagnosis in 2.5 times as many hospital discharges as it is a primary diagnosis and it is reported as a secondary cause of death 3.5 times more often than as a primary cause. Studies to evaluate the cost-effectiveness of interventions are flawed by weak study design, lack of validation for the methodology used, failure to outline potentially relevant costs and consequences, use of a restricted range of costs, failure to report intervention costs, attributing changes to global measures without ruling out alternative explanations, failure to provide justification that the patient group examined was representative of the larger group with which it was compared, and failure to take into account false-negative screening results. Suggestions for improving the studies include allowance for false-negative screening results, adherence to performance standards (e.g., assessment of nonmedical direct and indirect costs), and adherence to the same research-design criteria governing studies of medical interventions. 3 tables, 49 references.

267

TITLE: The Costs of Diabetes and Its Complications. Leese, B. Social Science and Medicine. 35(10): 1303-1310. November 1992.

OBJECTIVE: To review studies of the costs of diabetes and its complications.

CATEGORY: Expert opinion.

CONCLUSION: Major gaps exist in the data on the economics of diabetes, particularly on the indirect costs of the disease and the marginal benefits and costs of investing (e.g., providing funding for prevention and treatment) in diabetes.

RECOMMENDATION: Cost-effectiveness studies must be performed for diabetes interventions to provide a basis for attempts to reduce the costs of the disease and to ensure that persons with diabetes are treated with efficacy and equity.

ABSTRACT: The author reviews several studies of the costs of diabetes and its complications in order to locate gaps in the data, particularly for the United Kingdom. Results of studies on the economics of diabetes are presented in five categories: direct costs, indirect costs, psychological costs, cost of treatment of complications, and cost-effectiveness. Numerous direct-cost studies are reviewed; in Britain, people with diabetes consume 4 to 5 percent of all health care resources. Few studies have included calculations of indirect costs because of the difficulty in assigning monetary values for such studies (e.g., to time lost from work, early retirement, and premature death). Psychological costs have rarely been considered in economic analyses. Complications are the most important contributors to the costs of diabetes, but lack a great deal of investigation from an economic perspective. Most studies of the economics of diabetes have been conducted in the United States, where health care is provided very differently than in the United Kingdom, making comparisons unreliable. Most studies also lack suitable retrospective data, and needed long-term prospective studies are difficult to set up and expensive to run. The literature lacks evidence on the efficacy and cost-effectiveness of interventions to reduce the burdens of diabetes and its complications. 50 references.

268

TITLE: Diabetes Care in Health Maintenance Organizations. Geffner, D. Diabetes Care. 15(Supplement 1): S44-S50. March 1992.

OBJECTIVE: To review the history of health maintenance organizations (HMOs) and to describe the organization of the CIGNA Health plans of California; to describe how HMOs have dealt with health education, drug prescriptions, cost containment, and other issues.

CATEGORY: Expert opinion.

CONCLUSION: HMOs theoretically offer a system of delivering care that is accessible, affordable, and of good quality to patients with diabetes.

RECOMMENDATION: None.

ABSTRACT: The author reviews the historical development of HMOs and describes developments in managed care. Within CIGNA Health plans of California, provisions for access to care for patients with diabetes are described and details of cost containment practices presented. In both the staff model HMO and at the independent practice association (IPA) model, primary care physicians are responsible for the care of patients with diabetes. Most HMOs provide health education and nutrition counseling and at CIGNA Health plans of California, there is unlimited access (with no copayments) to health education programs. Cost containment is an underlying precept of the HMO model. While fee-for-service plans reward maximum use of resources, in the HMO setting, financial incentives favor conservation of resources. Financial incentives include bonuses to physicians for surpluses and responsibility and financial risks for deficits. Other administrative constraints in the outpatient setting for the use of services include prior authorization for elective hospitalization and expensive diagnostic and therapeutic procedures, concurrent utilization review, mandatory second opinions, and drug formularies. Nonfinancial measures to improve cost-effectiveness can also improve quality; they include specialized clinics with integrated personnel, easy referral to specialists, exposure to patient education opportunities, and peer review. Studies have shown that HMO patients are less likely to be hospitalized and undergo fewer outpatient procedures and laboratory testing with the same health care outcomes. Whether differences in rates of utilization in the outpatient setting represent overutilization in the fee-for-service system or underutilization in the HMO setting is not known. 62 references.

269

TITLE: Diabetes Guidelines, Outcomes, and Cost-Effectiveness Study: A Protocol, Prototype, and Paradigm. Carey, M. Journal of the American Dietetic Association. 95(9): 976-978. September 1995.

OBJECTIVE: To review several articles in the September 1995 issue of the Journal of the American Dietetic Association that report the findings of the diabetes guidelines, outcomes, and cost-effectiveness studies.

CATEGORY: Expert opinion.

CONCLUSION: Medical nutrition therapy provided by dietitians to persons with type 2 diabetes is clinically beneficial and cost effective.

RECOMMENDATION: Future challenges include long-term management of diseases using medical nutrition therapy, quality of life, and segmenting study subjects according to variables likely to affect outcomes, such as duration of disease.

ABSTRACT: The author comments on several articles in the referenced journal issue that address practice guidelines for medical nutrition therapy in patients with diabetes. Monk et al. (1995) discussed the development of the guidelines. Following a randomized, controlled clinical trial, Franz et al. (1995) concluded that medical nutrition therapy provided by dietitians significantly improves medical and clinical outcomes and is, therefore, beneficial to persons with type 2 diabetes. A second study by Franz et al. (1995) found that medical nutrition therapy is cost effective for type 2 diabetes. Using fasting plasma glucose levels as the primary indicators and a 6-month time frame, they found that basic nutrition care cost $5.32 per unit of outcome and practice guidelines (expanded) nutrition care cost $4.20 per unit. 23 references.

270

TITLE: Diabetes, Health Insurance, and Health-Care Reform. Herman, W.H.; Dasbach, E.J. Diabetes Care. 17(6): 611-613. June 1994.

OBJECTIVE: To outline the health insurance issues that faced patients with diabetes in 1994.

CATEGORY: Expert opinion.

CONCLUSION: The United States needs a new health insurance system. Many persons with diabetes have no health insurance, have inadequate coverage, or receive less than optimum care.

RECOMMENDATION: A new health insurance system should provide coverage that is not employment based, disregards preexisting conditions, is rated on community rather than individual health care usage, and will provide for health education, supplies, equipment, and preventive services.

ABSTRACT: The authors summarize the underlying issues influencing health care reform in 1994 by outlining information from several studies. The authors state that in 1988, 17 percent of children or adolescents under age 18 had no health insurance. For 1989, they report that among persons with diabetes, 13.5 percent of those aged 18 to 64 and 1.2 percent aged 65 and over were not insured. Among people aged 18 to 64, those with diabetes were more likely to have Medicare or Medicaid coverage than those without diabetes. However, fewer than one-half of all people with annual incomes below the federally defined poverty level receive Medicaid benefits, and approximately one-fourth of practicing physicians do not accept Medicaid patients. In 1987, 46 percent of the uninsured population were working adults, 7 percent were nonworking spouses, and 24 percent were children of working adults; 13 percent of those under age 65 were underinsured. A survey in the 1980s revealed that many primary care providers did not adhere to consensus guidelines for care of diabetes. A 1993 report found that fewer than half of all patients with diabetes received annual dilated-eye examinations. These data show that the United States needs a better health insurance system that will provide broader and more adequate coverage for patients with diabetes. Coverage should provide for preventive care, health education, and management by a multidisciplinary team. 21 references.

271

TITLE: Diabetes in a Managed Care System. Quickel, K. Annals of Internal Medicine. 124(1 Part 2): 160-163. January 1, 1996.

OBJECTIVE: To analyze the effects of managed care strategies on the care of persons with diabetes.

CATEGORY: Expert opinion.

CONCLUSION: Managed care programs have the potential to provide excellent care for persons with diabetes if clear evidence is presented to them that costs can be cut and quality improved.

RECOMMENDATION: The diabetes community must work with managed care organizations to develop diabetes care programs that are cost effective and result in improved outcomes.

ABSTRACT: The author provides a general review of managed care, then examines the care of patients with diabetes in that setting. Managed care uses payment incentives, provider designation, coverage policies, and traditional insurance mechanisms. Payment incentives effectively limit use of some services, particularly inpatient hospitalization. While payment incentives have the positive effect of encouraging routine initiation of insulin therapy on an outpatient basis, they may also adversely affect the care of some patients with diabetes who would benefit from hospitalization. There is evidence of deficient knowledge of diabetes among primary care physicians, but no direct studies have compared the quality (by process or outcome) of diabetes care provided by primary care physicians with that given by specialists. Provider designations will likely adversely affect the care of patients with complex diabetes, especially those with type 1 diabetes. However, structured programs provided by managed care programs, such as eye care, may improve some aspects of diabetes care. Acute care needs and the care of documented complications are generally well covered under managed care. Coverage of self-management training and nutrition counseling are inconsistently covered, however. As care of patients with diabetes costs three times as much as care of those without diabetes, managed care programs tend to exclude patients with diabetes. Preexisting condition exclusions by managed care plans may leave persons with diabetes without health insurance for necessary services. 1 table, 35 references.

272

TITLE: Diabetes Mellitus and the St. Vincent Declaration: The Economic Implications. Leese, B. PharmacoEconomics. 7(4): 292-307. April 1995.

OBJECTIVE: To examine the social and economic factors that affect diabetes mellitus and how the St. Vincent Declaration (St. Vincent, Italy, 1989) addresses them.

CATEGORY: Expert opinion.

CONCLUSION: The cost of providing more services to people with diabetes is a major barrier to implementing the St. Vincent Declaration.

RECOMMENDATION: None.

ABSTRACT: The St. Vincent Declaration (1989) set forth two general goals and several 5-year targets for improving quality of life and life expectancy for people with diabetes mellitus and reducing the disease's complications. The authors examine social and economic factors affecting diabetes mellitus and how the declaration addresses them. One problem with chronic diseases is that money spent on prevention will not achieve savings for 20-30 years and thus has little appeal for governments. In Britain, type 2 diabetes often remains undiagnosed, and systematic screening in general practice will reveal many undiagnosed cases. A U.S. report indicates that increasing age, decreasing income, poor education, poor diet, obesity, race, and heredity are risk factors for diabetes. The cost-of-illness approach, including direct, indirect, and psychological costs, can be used for diabetes. Indirect costs include losses in productivity from short-term illness, early retirement, and death before retirement. In general, about 55 percent of total costs are direct and 45 percent are indirect (psychological costs are usually disregarded). A standardized method of collecting data for economic evaluations of the disease does not yet exist. Prevention of diabetes would lead to cost savings and improve quality of life for patients. There have been few cost-effectiveness analyses of diabetes mellitus. Financial considerations are a major barrier to implementing the St. Vincent Declaration. Diagnosing and treating more people with diabetes will add costs, but benefits may not be seen for many years. However, prospects are good for reducing costs of complications in the long term. The authors discuss primary, secondary, and tertiary prevention. With patient compliance, complications would be reduced and costs lowered. The St. Vincent Declaration has been an impetus for further research and refinement of databases, which are essential to effectively monitor improvements in service provision and outcomes. 1 table, 1 figure 104 references.

273

TITLE: Diabetes Patient Education Programs: Quality and Reimbursement. Wheeler, M.L.; Warren-Boulton, E. Diabetes Care. 15(Supplement 1): S36-S40. March 1992.

OBJECTIVE: To describe a quality assurance process for diabetes education programs and to evaluate the impact of recognition by the American Diabetes Association (ADA) on reimbursement for these programs.

CATEGORY: Expert opinion.

CONCLUSION: Reimbursement for ADA-recognized education programs is inconsistent and unpredictable.

RECOMMENDATION: Professionals in the diabetes community and third party payers should work together to clarify coding and coverage issues related to the delivery of outpatient education services in all appropriate settings. Programs seeking reimbursement should achieve positive review of quality assurance from an external source. Medicare should reimburse hospital-based programs and extend coverage to alternative programs such as those in the physician's office.

ABSTRACT: The authors detail the components of a quality assurance mechanism for patient education programs in diabetes, including a description of the recognition program of the ADA. Results of a 1990 survey evaluating the impact of ADA recognition on reimbursement are presented. A survey of 120 recognized programs from 40 states showed reimbursement by third party payers to be inconsistent and largely unpredictable. Programs in 17 states showed disparity in Medicare reimbursement coverage, with recognized programs in 9 states showing no Medicare activity at all. Medicaid provided very limited coverage for diabetes education; no recognized programs were reimbursed in 23 states. Blue Cross/Blue Shield provided no reimbursement for recognized programs in 15 states, and 17 states had inconsistent coverage by these carriers. Further effort is needed to clarify, for both providers and payers, coding and coverage issues related to the delivery of the specific components of acceptable, reimbursable education services. Specific recommendations are made, particularly with reference to Medicare coverage. Diabetes education is provided most effectively and efficiently in the outpatient setting; Medicare should appropriately reimburse hospital-based outpatient education programs as well as education programs in alternative sites. 4 tables, 9 references.

274

TITLE: Diabetic Dyslipidemia: A Case for Aggressive Intervention in the Absence of Clinical Trial and Cost-effectiveness Data. Lewis, G.F. Canadian Journal of Cardiology. 11(Supplement C): 24C-28C. May 1995.

OBJECTIVE: To provide a rationale for aggressively treating dyslipidemia in patients with diabetes in the absence of clinical trials and cost-effectiveness data.

CATEGORY: Expert opinion.

CONCLUSION: The evidence is overwhelming that patients with diabetes have a high rate of coronary artery disease, that traditional risk factors for coronary artery disease operate in diabetes, and that dyslipidemia in people with diabetes is highly prevalent and atherogenic.

RECOMMENDATION: Compelling clinical trial evidence is needed to support treating dyslipidemia in people with diabetes to reduce the incidence of coronary artery disease in the population.

ABSTRACT: People with diabetes have a twofold to fourfold increase in incidence of atherosclerotic cardiovascular disease. Atherosclerotic complications account for up to 80 percent of all deaths for people with diabetes; about 75 percent of these deaths are due to coronary artery disease. In 1992, people with diabetes made up 4.5 percent of the United States population, but they accounted for 14.6 percent of health care expenditures. People with diabetes who do not have complications incur few additional costs versus those without diabetes. Once complications occur, however, individual costs are high. The traditional risk factors for atherosclerotic cardiovascular disease (age, hypertension, left ventricular hypertrophy, hyperlipidemia, and smoking) operate in people with diabetes but do not account for the total increase in atherosclerotic cardiovascular disease; diabetes itself confers an independent additional risk. The most common lipid abnormalities in type 2 diabetes and poorly controlled type 1 diabetes are hypertriglyceridemia and low high-density lipoprotein. Treating dyslipidemia with conservative measures (diet, weight loss, aerobic exercise, improving glycemic control, etc.) and pharmacological management has been effective in correcting lipid levels. The author reports that few trials of lipid-lowering therapy have included patients with diabetes or demonstrated the cost-effectiveness of lipid-lowering therapy in reducing atherosclerotic cardiovascular disease. 1 table, 35 references.

275

TITLE: Economic Costs of Diabetes. Lipsett, L.F. Pediatric and Adolescent Endocrinology. 11: 143-148. 1983.

OBJECTIVE: To review estimates of the direct and indirect costs of diabetes in the United States.

CATEGORY: Expert opinion.

CONCLUSION: The economic burden of diabetes is significant, with the total cost of diabetes estimated at $9.7 billion in 1980.

RECOMMENDATION: Indirect costs of diabetes due to morbidity might be reduced through improving the accessibility of health services and creating greater awareness of diabetes complications.

ABSTRACT: The author reviews recent estimates of the direct and indirect costs of diabetes in the United States. The human capital approach (Rice 1966), which has been used by most economists in estimating the economic burden of disease in this country, includes estimates of both direct and indirect costs (time lost from work, losses to the economy from premature mortality). Estimates of the cost of diabetes grew from $2.6 billion in 1969 to $9.7 billion in 1980. In 1969, morbidity accounted for 56 percent of the total economic cost of diabetes and mortality accounted for 43 percent. In 1980, morbidity accounted for over 85 percent of costs and mortality just 15 percent. Siebert (unpublished data) estimated the annual costs per patient for outpatient dialysis, renal transplant, and home dialysis to be $23,088, $19,000, and $12,400, respectively, for patients with diabetes and end-stage renal disease. Patients with diabetes account for one-fourth of entrants into end-stage renal disease programs. In 1973, only 57 percent of adults with diabetes were estimated to have had an eye examination during the preceding 2 years, only 52 percent an electrocardiogram, and only 41 percent a glaucoma test. 1 figure, 1 table, 17 references.

276

TITLE: The Economic Costs of NIDDM. Songer, T.J. Diabetes-Metabolism Reviews. 8(4): 389-404. December 1992.

OBJECTIVE: To review basic concepts in health economic research and how they have been applied to issues involving type 2 diabetes.

CATEGORY: Expert opinion.

CONCLUSION: Health Economics data provide relevant information for decisions made by governments and health agencies about diabetes.

RECOMMENDATION: Developing a better means of identifying persons with type 2 diabetes could help a great deal to highlight the epidemiologic and economic components of the disease.

ABSTRACT: The author discusses three broad kinds of health economic approaches: descriptive, evaluative, and explanatory. Descriptive approaches include cost-of-illness studies and assessments of patients' costs and concerns. Cost-of-illness studies usually include direct and indirect costs; intangible or psychosocial costs are normally not included. Although the literature on the cost of diabetes is fairly extensive, data specific to type 2 diabetes are uncommon. Costs and concerns of patients include direct payments by individuals for health care or insurance as well as sacrifices (losses) in time; little has been published in this area relative to diabetes. Evaluative approaches include cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis. Cost-benefit analysis considers monetary cost versus monetary benefits; there is no measure of health gained. Both cost-effectiveness analysis and cost-utility analysis consider monetary cost minus monetary benefit versus health gained (measures for cost-effectiveness analysis include years of life, disability prevented, etc.; for cost-utility analysis the measure is quality-adjusted life-years). Explanatory approaches include examinations of incentives, demand, and supply. Economic incentives might change the price of a healthy or an unhealthy activity, or they might change an individual's knowledge about the consequences of activities. The author suggests including an economic component in the evaluation of intervention programs to prevent type 2 diabetes. He points out that in most scenarios, prevention does not save money. Referencing Weinstein (1990), he states that the economic issue is not whether prevention saves money, but whether prevention improves health at a reasonable cost. 4 figures, 4 tables, 83 references.

277

TITLE: Economic Implications of IGT Intervention: The Case of a "Phantom Alternative"? Gafni, A. Diabetic Medicine. 13(3 Suppl 2): S25-S28. March 1996.

OBJECTIVE: To assess whether it is possible to perform an economic evaluation of primary strategies for preventing diabetes in patients with impaired glucose tolerance (IGT) or whether such strategies represent "phantom alternatives" (illusionary choices that look real but are unavailable at the time a decision is made).

CATEGORY: Expert opinion.

CONCLUSION: At present, an economic evaluation of primary prevention strategies cannot be performed, even for the purpose of determining the strategies' technical efficiency.

RECOMMENDATION: Effectiveness-type clinical trials should be designed, based on existing evidence in favor of possible interventions, to test properly the effectiveness of potential primary intervention strategies.

ABSTRACT: The methodologies of economic evaluations of health care interventions are reviewed and the economic questions to be answered are discussed. Key issues are (1) the identification of the cluster of technically efficient programs for each disease level and (2) the determination of the optimal mix of interventions. The author argues that no comprehensive descriptions have yet been put forward about primary prevention strategies for diabetes. Satisfactory evidence of the effectiveness of existing preventive strategies, their impact on quality of life, or their acceptance by individuals, also is not available. Evidence is also lacking on effective methods for identifying high-risk individuals. The author concludes that, because of these deficiencies, no economic evaluation of primary prevention strategies can be performed. 12 references.

278

TITLE: Emotional Side Effects of Diabetes Educational Program (letter; comment). Conget, J.I.; Esmatjes, E.; Ferrer, J.; De Pablo, J.; Gomis, R. Diabetes Care. 13(8): 901-902. August 1990.

OBJECTIVE: To argue that an intensive diabetes educational program can produce severe adverse emotional effects in predisposed patients and to recommend a psychological assessment before program participation.

CATEGORY: Expert opinion.

CONCLUSION: Following their participation in a health education program, patients with chronic diseases and premorbid personalities have exhibited psychological disorders.

RECOMMENDATION: A psychological assessment should be performed before a diabetes education program begins to rule out patients at high risk of developing emotional disorders. Select patients would be given special educational techniques.

ABSTRACT: The authors respond to an article by Rubin et al. (Diabetes Care. 12(10): 673-679. 1989) on the effects of diabetes education. They agree with Rubin et al. that an intensive diabetes education program evaluated by those investigators improved the emotional status of participants and that this improvement contributed markedly to improved metabolic control. However, the authors argue that intensive diabetes educational programs can also produce severe adverse emotional effects in predisposed patients. They illustrate their point with the history of a 19-year-old patient who exhibited disturbed behavior following such a program. They recommend a preprogram psychological assessment to rule out patients at high risk for emotional disturbances. They note that psychological disorders have been described in patients with chronic diseases and premorbid personalities after their inclusion in a health education program. In a reply, Rubin et al. argue that the disorder of the patients described by Conget et al. might not have been caused by the educational program. Rather than preprogram assessment, they suggest close monitoring during and after the program. 6 references.

279

TITLE: Estimating the Impact of Total Illness Burden on Patient Outcomes among Patients with Non-Insulin Dependent Diabetes: A Comparison of Three Co-Morbidity Measures (abstract). Greenfield, S.; Sullivan, L.M.; Dukes, K.A.; D'Agostino, R.; Dittus, R.; Wagner, E.; Kaplan, S.H. AHSR FHSR Annual Meeting Abstract Book. 12: 85. 1995.

OBJECTIVE: To compare three different measures used to assess total disease burden in patients with type 2 diabetes.

CATEGORY: Expert opinion.

CONCLUSION: The Total Illness Burden Index provided the most accurate assessment of total illness burden. This index may reveal a formerly underestimated disease burden among women and minorities and may decrease distortions in assessing quality of care.

RECOMMENDATION: None.

ABSTRACT: The investigators compared the accuracy of three comorbidity measures in estimating the burden of diabetes in two populations of patients with type 2 diabetes included in the Type II Diabetes Patient Outcome Research Team (PORT) study. One group of patients (n = 1,738) was from the Group Health Center of Puget Sound (Washington state); the other (n = 790), from the Regenstrief Health Center in Indianapolis. The measures were a simple count of diagnoses (NDX), the Charlson Index (CI), which is a weighted measure, and the Total Illness Burden Index (TIBI), an aggregated patient-reported measure of severity scores for each of 15 body systems. The groups differed significantly in terms of race, socioeconomic level, and presence of diabetes complications. Compared with the Puget Sound group, patients from Regenstrief had lower annual incomes, less education, a longer duration of diabetes, more diabetes-related complications, and were more likely to be female and African American. In multivariate models, the authors found that TIBI explained a greater proportion of the variation in PFI10, office visits, and restricted activity days than did the other two measures. Results were not explained by multi-collinearity. Sex was significantly related to the TIBI but not to the CI. Race and income were significantly related to each of the measures.

280

TITLE: Financial Implications of Implementing Standards of Care for Diabetic Eye Disease. Rand, L. Diabetes Care. 15(Supplement 1): S32-S35. March 1992.

OBJECTIVE: To review the practical financial implications of implementing published care standards for diabetic eye disease.

CATEGORY: Expert opinion.

CONCLUSION: Several economic factors influence the implementation of guidelines for eye care for patients with diabetes and will greatly influence how effective these guidelines will be in reducing blindness due to retinopathy.

RECOMMENDATION: Factors affecting the full implementation of eye care standards must be addressed, particularly in terms of prepaid health care organization standards and regional variations in resource availability.

ABSTRACT: The author reviews the financial implications of implementing the American Diabetes Association (ADA) guidelines for retinopathy screening. Broad financial issues related to practice patterns are discussed, and no specific dollar projections on potential cost savings are made. ADA guidelines emphasize the role of the primary physician in coordinating the total health care of persons with diabetes mellitus. The financial implications of physicians' taking this role are enormous, not only because of liability issues, but also because of cost escalations resulting from increased testing and referral. Full implementation of each of the specific ADA guidelines for retinopathy screening will result in increased costs. Implementation of annual ophthalmic exams, for example, is expected to increase the cost of care by at least 30 percent, as only one-half of patients with diabetes currently receive annual care. However, increased costs of care may be offset by decreases in disability payments: a 1990 study showed screening for retinopathy resulted in net annual savings of $62 million to $109 million to the federal government when disability payments were considered. The available guidelines are excellent and their implementation should reduce visual loss from retinopathy. The financial impact of implementing these guidelines, however, both in terms of manpower and dollars, is wide-ranging and will greatly influence how effective they will be in reducing blindness due to retinopathy. Low-cost screening strategies must be developed, particularly for low-risk groups. 15 references.

281

TITLE: The Health Belief Model and Adolescents with Insulin-Dependent Diabetes Mellitus. Bond, G.G.; Aiken, L.S.; Somerville, S.C. Health Psychology. 11(3): 190198. 1992.

OBJECTIVE: To test the utility of the health belief model for predicting both behavioral adherence to the diabetic regimen and glycemic control among adolescents with type 1 diabetes.

CATEGORY: Expert opinion.

CONCLUSION: Compliance was positively associated with two of three constructs (cues, benefits-costs) of a modified health belief model. Compliance was not significantly related to metabolic control.

RECOMMENDATION: None.

ABSTRACT: Fifty-six adolescents (mean age: 14.2 years) with type 1 diabetes were included in this study; 43 percent were male and 91 percent were white. All participants had type 1 diabetes for at least 1 year (mean: 5.8 years) and were attending school. The study protocol had four components: (1) a children's self-administered questionnaire that covered the health belief model for diabetes, (2) three telephone interviews on compliance in which the adolescent recalled the day's regimen-related events in sequence, (3) three parent telephone interviews on compliance in which the parent recalled his or her child's regimen-related events, and (4) a glycosylated hemoglobin blood test for each adolescent four to six weeks after completion of the last compliance interview. Because of the small sample size, a measurement model containing the five constructs of the health belief model (susceptibility, severity, costs, benefits, and cues) could not be estimated. Instead, the authors used a benefits-costs construct, a perceived threat construct (severity plus susceptibility), and a construct of perceived cues to action as their model. Benefits refer to a conviction that the preventive regimen is effective, costs are difficulties or barriers in undertaking the regimen, threat is perceived susceptibility combined with viewing the disease as severe (severity), and cues involve willingness to seek help or medical treatment after symptoms (e.g., cold sweats) are experienced. Data obtained from parents about compliance were not used because the parents, in 70 percent of the cases, were unaware of the details of their children's daily routines. The authors found that as a child's age increased, adherence to the exercise, injection, and frequency components of the regimen decreased. Compliance was positively associated with cues to action and with perceived benefits-costs. The greatest compliance was achieved with high benefits-costs and low threat. Glycosylated hemoglobin did not correlate significantly with either age or disease duration. Poor metabolic control was associated with high threat and cues. Better metabolic control was associated with lower carbohydrate consumption. 2 figures, 5 tables, 45 references.

282

TITLE: Health-Insurance Coverage for Adults with Diabetes in the U.S. Population. Harris, M.I.; Cowie, C.C.; Eastman, R. Diabetes Care. 17(6): 585-591. June 1994.

OBJECTIVE: To compare health insurance coverage for adults with diabetes with coverage for adults without diabetes.

CATEGORY: Expert opinion.

CONCLUSION: Health care coverage in the United States is similar in adult patients with and without diabetes, but in the 18 to 64 age group, persons with diabetes are more likely to depend on government-funded insurance than those without diabetes.

RECOMMENDATION: None.

ABSTRACT: As part of the 1989 National Health Interview Survey, 2,405 adults with diagnosed diabetes and 20,131 adults with no known diabetes were asked about their health care insurance coverage. Coverage was similar for persons with diabetes and those without diabetes (92.0 versus 86.8 percent). About 600,000 persons with diabetes had no insurance coverage. Among persons under age 65, 26.4 percent of those with diabetes relied on government-funded medical care, compared with 8.3 percent of persons without diabetes; for private health insurance, the proportions were 69.3 percent and 78.6 percent, respectively (p < .001 for both comparisons). Reasons given by adults with diabetes aged 18 to 64 for not having private insurance included cost; having other coverage; being unable to obtain insurance because of poor health, illness, or age; and unemployment. Among persons aged 65 and over, 69.2 percent of those with diabetes and 79.9 percent of those without diabetes had private insurance (p < .001). In this age group, more than half of persons with type 2 diabetes had no coverage for insulin or prescription drugs; only 13.5 percent of those with diabetes of any type had dental coverage. Among younger diabetes patients (aged 18 to 64 years), 23 percent of type 1 patients, about 26 percent of insulin-using type 2 patients, and 32 percent of noninsulin-using type 2 patients had no coverage for prescription medicines. Uninsured diabetes patients under age 65 were more likely than those who were insured to be of minority ethnicity, have less than a high school education, have annual family incomes less than $25,000, report more episodes of hyperglycemia and glycosuria, and have less preventive care. Because government-funded insurance programs provide coverage for 57 percent of adults with diabetes, changes in government health care policies could have a major impact on this patient group. 6 figures, 2 tables, 13 references.

283

TITLE: Insurance Coverage for People with Diabetes: Third Party Reimbursement for Diabetes Education and Technologies. Sinnock, P.; Bauer, D. Diabetes Dateline. 4(5): 1-2. September-October 1983.

OBJECTIVE: To discuss the status of insurance reimbursement for outpatient education, new technologies, services, and equipment for persons with diabetes.

CATEGORY: Expert opinion.

CONCLUSION: Medicare is the largest insurer of persons with diabetes. Per the Medicare Part A Intermediary Manual, patient education programs appear to be covered, but just five states have obtained Medicare reimbursement for patient education programs.

RECOMMENDATION: More efforts are needed to foster an understanding among third party payers of the potential cost benefits of patient education, technologies, and services for diabetes care.

ABSTRACT: Educational activities can improve the ability of people with diabetes to care for themselves and to comply with medically prescribed treatment protocols, which in turn can lead to a reduction in diabetes morbidity, mortality, and related costs. Medicare is the largest insurer of persons with diabetes; in 1978, it covered 41.3 percent of patients with diabetes aged 20 or over and 95.9 percent of those aged 65 or over. Five states have obtained reimbursement under Medicare for diabetes outpatient education; programs must be therapeutic rather than preventive, provided by a Medicare-certified hospital or rural health center, and have physician referral and involvement. As of September 1983, 11 Blue Cross/Blue Shield plans, 6 commercial insurers, and 1 Medicaid program also reimbursed outpatient diabetes education. There is little uniformity nationwide of coverage for diabetes-related technologies and services among third party payers; of the four major payer groups, only Medicare has a national office that can serve as an arbitrator. Third party reimbursement of diabetes-related technologies, services, and equipment seems to depend on the type of insurance, the state of residence, and the item or procedure to be covered.

284

TITLE: Intensive Ambulatory Treatment of Insulin-Dependent Diabetes. Felig, P.; Bergman, M. Annals of Internal Medicine. 97(2): 225-230. August 1982.

OBJECTIVE: To determine whether an intensive management program should be preferred over a conventional management program in the treatment of type 1 diabetes.

CATEGORY: Expert opinion.

CONCLUSION: In many patients, intensive management is superior to conventional management in terms of lowering blood glucose concentrations and improving the metabolic state. Net savings from intensive management will be substantial if reducing blood glucose is effective in preventing or delaying complications or reducing hospitalization for diabetic ketoacidosis or hypoglycemia.

RECOMMENDATION: Additional observations on safety and efficacy are needed before insulin pump treatment can be considered routine. Prospective studies are needed that compare morbidity and mortality attributable to hypoglycemia during conventional treatment with morbidity and mortality during intensive treatment.

ABSTRACT: The authors reviewed available data on the efficacy of intensive management regimens for type 1 diabetes. Intensive management is defined as self-monitoring of blood glucose (SMBG) and adjusting insulin doses based on this monitoring. In intensive management, insulin is administered in a continuous subcutaneous infusion with portable insulin pumps or given as two or more manual injections per day. Conventional management involves one or two insulin injections daily, urine glucose monitoring by the patient, and blood glucose measurement by the physician during office visits. Opinions on the desired frequency of SMBG differ, but the favored approach is four times daily (before main meals and at bedtime) plus occasionally during the night. Drawbacks of intensive management include possible hypoglycemia, adverse psychological effects due to preoccupation with the care of diabetes, and the need for multiple blood tests and frequent contact with health professionals. In one study, although 34 percent of patients reported fewer hypoglycemic reactions with intensive therapy, 20 percent noted an increase. Additional observations are needed to determine the safety and efficacy of the insulin pump. In the hospital setting, the insulin pump lowers the blood glucose as well as does manually injected insulin; in the outpatient setting, data are less conclusive. Potential adverse effects of the pump include hyperglycemia, hypoglycemia, and cutaneous complications at the needle site. No long-term data are available to determine the effectiveness of intensive therapy in preventing or delaying long-term complications of diabetes. Some studies have shown a progression of eye disease and only a transient reduction of proteinuria with improved blood glucose control. 50 references.

285

TITLE: Intensive Insulin Therapy: Part I. Basic Principles. Hirsch, I.B.; Herter, C.D. American Family Physician. 45(5): 2141-2147. May 1992.

OBJECTIVE: To review insulin therapy in patients with type 1 or type 2 diabetes.

CATEGORY: Expert opinion.

CONCLUSION: Meticulous glycemic control has beneficial effects on diabetic complications, but neither advanced retinopathy nor advanced nephropathy seems affected by improved glycemic control.

RECOMMENDATION: None.

ABSTRACT: The authors review the basic approach to intensive insulin therapy for both type 1 diabetes and type 2 diabetes: Intensive therapy includes a multicomponent insulin regimen; balancing of food intake, activity, and insulin dosage; daily home blood glucose monitoring; and individualized blood glucose goals but not tight glycemic control. A team approach to therapy is beneficial; teams typically include a physician, a nurse, and a nutritionist but could also include a social worker or a psychologist, an exercise physiologist, a pharmacist, and a physician's assistant or a certified nurse practitioner. The authors provide a table comparing time to onset, time to peak concentration, and duration of effect for different animal and human insulin preparations. Animal insulin is bioavailable for a longer time but is also associated with higher circulating anti-insulin antibodies. Intraindividual variation in absorption of insulin is about 25 percent. Absorption is affected by the site of injection and exercise; premeal insulin injections should be timed based on blood glucose. The incidence and progression of retinopathy and glycosylated hemoglobin are positively associated. However, some patients experience a transient increase in retinopathy progression with improved glycemic control, which is thought to be a consequence of retinal ischemia. Microalbuminuria is reduced with glycemic control, but advanced nephropathy is not affected. Nerve function improves with better glycemic control. Individualized glycemic goals are required because of the risk of developing hypoglycemia following treatment. The relationship between glycemic control and complications from diabetes is under study. 2 tables, 22 references.

286

TITLE: Intensive Insulin Therapy: Part II. Multicomponent Insulin Regimens. Hirsch, I.B.; Herter, C.D. American Family Physician. 45(6): 2643-2648. June 1992.

OBJECTIVE: To review optimum regimens for insulin treatment of type 1 and type 2 diabetes.

CATEGORY: Expert opinion.

CONCLUSION: A variety of approaches may be used to provide insulin therapy in patients with diabetes.

RECOMMENDATION: Additional studies are required to investigate combination therapy with insulin and sulfonylureas for patients with type 2 diabetes.

ABSTRACT: The authors review optimal insulin therapy for diabetes mellitus. Twenty-one percent of patients with type 1 diabetes are on once-daily insulin injections, despite their proven inefficiency. Many patients administer short- and intermediate-acting insulin prior to breakfast and supper, which requires that the mid-day meal be precisely timed and which may result in nocturnal hypoglycemia. In these patients, a bedtime snack to eliminate nocturnal hypoglycemia is likely to cause fasting hyperglycemia. Another regimen uses only the short-acting insulin for the suppertime dose, with the intermediate-acting insulin given at bedtime. For individuals with unpredictable schedules, a regimen of short-acting insulin prior to breakfast, lunch, and supper and intermediate-acting insulin with a bedtime snack permits more control. A variation of this regimen uses the same three doses of short-acting insulin with long-acting insulin administered prior to breakfast and supper. Continuous subcutaneous infusion of insulin is also available to maintain basal blood concentrations of insulin. For type 2 diabetes, diet and exercise are the primary treatments, followed, if adequate blood glucose control is not achieved, by sulfonylureas. Up to one-third of patients initially fail to respond adequately to sulfonylureas, and 5 to 10 percent of initial responders later stop responding to the drug; these patients require insulin therapy. Moderate hyperglycemia (fasting blood glucose of 140 to 200 mg/dL) is managed with once-daily injection of intermediate- or long-acting insulin. For severe hyperglycemia (fasting blood glucose greater than 200 mg/dL), at least twice-daily intermediate-acting insulin is required. Using insulin and sulfonylurea in combination remains controversial. 6 figures, 1 table, 13 references.

287

TITLE: Is Glycohemoglobin Testing Useful in Diabetes Mellitus? Lessons from the Diabetes Control and Complications Trial. Goldstein, D.E.; Little, R.R.; Wiedmeyer, H.M.; England, J.D.; Rohlfing, C.L.; Wilke, A.L. Clinical Chemistry. 40(8): 1637-1640. August 1994.

OBJECTIVE: To evaluate glycohemoglobin testing in the management of patients with diabetes mellitus as a model of laboratory testing cost analysis.

CATEGORY: Expert opinion.

CONCLUSION: Glycohemoglobin testing in patients with diabetes mellitus provides an objective measure of a patient's risk for developing diabetes complications and may prove cost effective through savings incurred by the prevention of these complications.

RECOMMENDATION: Those involved in medical cost containment must weigh short-term costs (e.g., laboratory studies) against long-term benefits.

ABSTRACT: The authors discuss testing for glycohemoglobin in patients with diabetes mellitus as a model for determining whether laboratory tests cost or save money. The Diabetes Control and Complications Trial provided strong evidence that glycemic control as assessed by glycohemoglobin testing predicts risk for developing diabetic complications. The authors point out that knowing a patient's glycohemoglobin would help the patient and health provider make changes in treatment that would lower the glycohemoglobin and thereby decrease risks of complications. Larsen et al. (1990) performed a study in which 240 patients with type 1 diabetes were randomly assigned to a treatment group in which glycohemoglobin test results were made known to patients and health providers or to a control group in which these results were not made known. After 12 months, glycohemoglobin values were substantially lower in the treatment group. Data from the Diabetes Control and Complications Trial and Larsen et al. study argue strongly for the routine use of glycohemoglobin testing, but despite widely published recommendations, only about 25 percent of patients with diabetes undergo this testing regularly. The authors argue that the costs of increased glycohemoglobin testing and of other aspects of intensive therapy should be offset by savings in other areas (e.g., laser therapy, kidney dialysis). 24 references.

288

TITLE: Managed Care Approaches to Diabetes Mellitus. Fore, W.W. Hospital Practice. 31(7): 115-117. July 15, 1996.

OBJECTIVE: To review approaches by managed care organizations to the management of diabetes.

CATEGORY: Expert opinion.

CONCLUSION: As more managed care organizations implement prevention programs, information on optimum methods of care and cost reduction should become available.

RECOMMENDATION: None.

ABSTRACT: Most managed care organizations now have insured populations with the same prevalence of diabetes as the general population. Managed care information systems have confirmed that the costs of caring for enrollees with diabetes are four times those for members without diabetes. The author states that 90 percent of managed care patients with diabetes have type 2, which has a mortality of approximately 50 percent from coronary artery disease and stroke. Ninety percent of managed care patients with diabetes have type 2. Implementation of intensive treatment may not realize cost savings for 12 to 16 years, while most managed care organizations have annual budgeting and can expect one-third of their members to change plans annually. Even so, additional resources are being allotted to the care of patients with diabetes. Managed care organizations are initiating various programs to improve outcomes and reduce cost of care, including home or workplace visits from nurses and dietitians, follow-up telephone calls from nurses and educators, and providing telephone access to a computer system than can advise patients on insulin dosage. It appears that many managed care organizations are focusing on preventing the complications of diabetes. The pharmaceutical industry plans to expand its role in the long-term

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The Economics of Diabetes Mellitus: An Annotated Bibliography

The Economics of Diabetes Mellitus:
An Annotated Bibliography