Measuring the burden of illness for end-stage renal disease: some heavy lifting required.

Estimates for the burden of illness (BOI) attributable to end-stage renal disease (ESRD) in Canada are presented in the article by Zelmer. This Commentary describes the methodology of BOI analysis, its role in formulating public policy, and the potential application to improving care for ESRD.

Observation unit treatment of heart failure with nesiritide: results from the proaction trial.

This was a multicenter, randomized, double-blind, placebo-controlled pilot study, evaluating the safety and efficacy of a standard care treatment regimen with the addition of either nesiritide or placebo (SCP) in 237 Emergency Department (ED)/Observation Unit (OU) patients with decompensated heart failure (HF). Efficacy measures included initial admission, length of hospital stay (LOS), and inpatient rehospitalization through 30 days. Compared to the standard care group, patients who also received nesiritide had 11% fewer inpatient hospital admissions at the index ED visit (55% SCP, 49% nesiritide, p = 0.436), and 57% fewer inpatient hospitalizations within 30 days after discharge from the index hospitalization (23% SCP, 10% nesiritide, p = 0.058). The duration of rehospitalization was shorter for nesiritide patients (median LOS 2.5 vs. 6.5 days, p = 0.032). The incidence of symptomatic hypotension was low and did not differ between the groups. This study showed that nesiritide is safe when used in the emergency department, observation units, or similar settings.

Economic analysis of unrelated allogeneic bone marrow transplantation: results from the randomized clinical trial of T-cell depletion vs unmanipulated grafts for the prevention of graft-versus-host disease.

Unrelated-donor marrow transplantation is a potential option for transplant candidates lacking a compatible related donor. The T-cell Depletion Study compared the 3-year disease-free survival for patients receiving T-cell-depleted (TCD) donor marrow (n = 203) vs unmanipulated donor marrow with methotrexate and cyclosporine (M/C) (n = 207). Hospital costs during index admission were documented with billing data, while hospital costs during subsequent 6-month follow-up were estimated from case report forms. Patients with index admission billing were included in the analysis (TCD = 119, M/C = 127). Total hospital length of stay (LOS) was similar across groups, with medians 47.0 days for TCD and 52.0 days for M/C (P = 0.72). Total hospital costs were comparable, 145,115 dollars vs 141,981 dollars (P = 0.63) for TCD and M/C, respectively. However, controlling for site and patient characteristics, TCD was associated with a 12.1% reduction in LOS for the index admission (95% CI -19.4%, -4.3%). Independent of treatment, HLA matching (6/6) was associated with an 8.6% (95% CI -17.4%, +1.2%) reduction in the index admission LOS, while cost was lower by 15.8% (95% CI -26.7%, -3.3%). Treatment costs were similar for TCD and M/C study groups. Savings on reduced cost for treating acute graft-versus-host disease were likely offset by increase in serious infections in the TCD arm.

Economic issues in the treatment and prevention of deep vein thrombosis from a managed care perspective.

Treatment and prevention of deep vein thrombosis (DVT) raise a number of important economic issues. Economic burden of the disease is a primary concern. Enrollment trends indicate that the patient population mix in managed care health plans is changing. Health plans are enrolling a growing number of members who are at higher risk for DVT. Accordingly, managed care health plans will increasingly need to focus attention on the development of high-quality and cost-effective strategies for treatment and prevention of DVT. It is widely agreed that the use of low-molecular-weight heparin (LMWH) is safe and effective, and there is also good evidence that its use is cost effective in selected indications. The shift from inpatient to outpatient treatment that is made possible by substitution of LMWH for conventional unfractionated heparin brings with it a need to restructure healthcare delivery resources. This may have substantial economic impact on both providers and health plan members. Growing recognition of the DVT risk associated with various disease states, as well as the costly long-term sequelae of DVT, is spurring a trend to broader use of LMWH for prophylaxis. The relative cost effectiveness of prevention depends on the tradeoff between an expenditure that is made today and an uncertain future benefit. What is needed now is better evidence as a basis for decisions regarding DVT prophylaxis and clinical studies that track the long-term clinical and economic impact of DVT.

Cost for inpatient care of venous thrombosis: a trial of enoxaparin vs standard heparin.

BACKGROUND: Enoxaparin, a low-molecular-weight heparin administered to hospitalized patients once or twice daily, has shown efficacy and safety equivalent to unfractionated heparin in the treatment of acute venous thromboembolic disease. Although the cost of either enoxaparin regimen is greater than that of unfractionated heparin, the overall cost of care for each of these 3 treatment strategies is unknown. METHODS: A cost minimization analysis of a 3-month, partially blinded, randomized, controlled efficacy and safety trial of anticoagulant therapy for deep vein thrombosis. Three hundred thirty-nine hospitalized patients with symptomatic lower extremity deep vein thrombosis were randomly assigned to initial therapy with subcutaneous enoxaparin either once (n = 112) or twice (n = 123) daily, or with dose-adjusted intravenous unfractionated heparin (n = 104), followed by long-term oral anticoagulant therapy. Estimated 1997 total cost from a third-party payer perspective for the 3-month episode of care was calculated by assigning standard unit costs to counts of medical resources used by each patient in the clinical trial. RESULTS: Average total cost for the 3-month episode of care was similar across all 3 treatment regimens: once-daily dose of enoxaparin, $12,166 (95% confidence interval [CI], $10,744-$13,588); twice-daily dose of enoxaparin, $11,558 (95% CI, $10,201-$12,915); and unfractionated heparin, $12,146 (95% CI, $10,670-$12,622). Bootstrapped estimates and sensitivity analyses did not significantly change findings. CONCLUSIONS: There was no significant difference in the overall cost for the 3-month episode of care for patients treated with either enoxaparin or unfractionated heparin. Additional acquisition costs for anticoagulant medication among patients treated with enoxaparin were offset by savings associated with lower incidence of hospital readmission and shorter duration of venous thromboembolism-related readmissions.

Relationship of hemoglobin A1c, age of diabetes diagnosis, and ethnicity to clinical outcomes and medical costs in a computer-simulated cohort of persons with type 2 diabetes.

OBJECTIVE: To project the impact of maintaining long-term glycemic control (i.e., a sustained reduction in glycosylated hemoglobin (hemoglobin A1c [HbA1c]) on the lifetime incidence and direct medical costs of complications in persons with type 2 diabetes. STUDY DESIGN, PATIENTS, AND METHODS: Computer simulation of hypothetical patient cohorts using a published model developed by the National Institutes of Health. RESULTS: Across all HbA1c levels, Hispanics had the highest and whites had the lowest complication rates. With lower maintained HbA1c, the absolute decrease in complication rates was greatest and the reduction in direct medical expenditures was highest among Hispanics (18% vs 15% for blacks and 12% for whites). Complication rates and costs were most dramatically reduced when lower levels of HbA1c were maintained among persons with a younger age at diagnosis. CONCLUSIONS: Maintaining long-term glycemic control reduces complication rates and costs for medical care for all ethnic groups regardless of age at diagnosis. Relatively greater benefit is achieved by interventions targeting Hispanics and younger, newly diagnosed persons.

A prospective study of the cost-utility of the multichannel cochlear implant.

CONTEXT: Prior clinical studies have indicated that cochlear implantation provides benefits to individuals with advanced sensorineural hearing loss who are unable to gain effective speech recognition with hearing aids. OBJECTIVE: To determine the cost per quality-adjusted life-year (QALY) for adults receiving multichannel cochlear implants. DESIGN: Prospective 12-month multicenter study using preference-based quality-of-life measures and total cost determinations, comparing profoundly hearing-impaired adult subjects with and without cochlear implants. SETTING: Hospital-based and patient-resource clinics. PATIENTS: Severely to profoundly hearing-impaired adult recipients of a cochlear implant and adults eligible for the device who had not yet received it. MAIN OUTCOME MEASURE: Clinical assessment of implant participants included medical and audiologic (speech understanding) data at the time of enrollment, 6 months, and 12 months. All participants' health-utility was assessed at the time of enrollment, 6 months, and 12 months using the Health Utility Index. One-year medical resource utilization and cost data included bills related to implants, patient diaries, charge estimates from clinical sites, and published literature. A decision model was developed to determine cost per QALY. RESULTS: Of the 84 enrolled adults, 62 (75%) completed the study. Mean health-utility scores at the time of enrollment were identical between groups. The marginal 12-month health-utility gain for implant recipients was 0.20; 90% of this improvement was achieved within 6 months. For patients with a mean 22-year life expectancy, the marginal cost per QALY was $14,670. CONCLUSIONS: Overall, multichannel cochlear implants significantly improved recipients' performance on measures of speech understanding and ratings of health-utility within 6 months of implantation. The multichannel cochlear implant yielded a very favorable cost per QALY.

The cost-effectiveness of a new chlorhexidine delivery system in the treatment of adult periodontitis.

BACKGROUND: Periodontal treatment is costly. The authors assessed the potential economic impact of a new periodontal chemotherapeutic, testing the hypothesis that its adjunctive use would result in reduced periodontal surgical needs. METHODS: An economic model estimated treatment needs following two clinical trials of the adjunctive use of a chlorhexidine, or CHX, -containing chip compared with scaling and root planing, or SRP, alone. Needs were based on periodontal status at nine months and a probabilistic algorithm; costs were assigned on the basis of a national dental survey and an average wholesale price of the CHX chip. RESULTS: The base case model projected significantly more maintenance procedures and significantly fewer periodontal surgical procedures for patients treated with SRP and the CHX chip compared with patients who were treated with SRP alone (54.4 percent vs. 46.4 percent, P = .014; 29.2 percent vs. 35.5 percent, P = .015, respectively). Average total costs of care for patients treated with SRP and CHX chip were $737 +/- $244 compared with $734 +/- $239 for patients treated with SRP alone. Sensitivity analyses to account for variations in practice patterns did not appreciably alter the results. When data were analyzed after only three or six months of treatment, the significant differences in treatment needs disappeared. CONCLUSIONS: The CHX chip is a new, apparently cost-effective treatment option for non-surgical periodontal therapy. Adjunctive use of the CHX chip could reduce periodontal surgical needs significantly at little or no additional cost. CLINICAL IMPLICATIONS: Results suggest that incorporating the CHX chip into routine practice requires a new algorithm for management of periodontal disease. To obtain full clinical benefit, treatment needs to be continued for nine months.

Cost-effectiveness of long-term intrathecal morphine therapy for pain associated with failed back surgery syndrome.

A decision analytic study was conducted using computer simulation to project the outcomes in a simulated cohort of patients whose treatment for back surgery had failed. The objective of this study was to estimate the direct cost of intrathecal morphine therapy (IMT) delivered via an implantable pump relative to alternative therapy (medical management) over a 60-month course of treatment. IMT administered by way of an implantable pump can provide effective pain relief for selected patients whose less invasive treatment modalities have failed. Previous research suggested that a pump implant is less costly than alternative methods providing comparable analgesia for treatment exceeding 12 to 18 months. However, those analyses did not include the cost of complications or pump replacement. Scenarios representing the course of IMT, devised by a panel of experts, were represented as treatment pathways in a Monte Carlo simulation. Adverse event rates were drawn from published data supplemented by expert judgment. Direct costs were based on a health insurer paid claims perspective (direct costs) discounted at a 5% annual rate. The cost-effectiveness of IMT was calculated based on a report of 65% to 81% "good to excellent" pain relief relative to alternative (medical) management. With both adverse event probabilities and costs set at most likely (base case) values, the expected total cost of IMT over 60 months was $82,893 (an average of $1382 per month). In a sensitivity analysis, the best case (low adverse event rate, low cost) estimate was $53,468 ($891/mo), whereas the worst case (high adverse event rate, high cost) estimate was $125,102 ($2085/mo). Cost-effectiveness estimates ranged from $7212 (best case) to $12,276 (worst case) per year of pain relief. Results from a computer simulation designed to collect the costs not included in previous empiric research indicate that IMT appears to be cost-effective when compared with alternative (medical) management for selected patients when the duration of therapy exceeds 12 to 22 months.

A comparison of resource use and cost in direct access versus physician referral episodes of physical therapy.

BACKGROUND AND PURPOSE: Access to physical therapy in many states is contingent on prescription or referral by a physician. Other states have enacted direct access legislation enabling consumers to obtain physical therapy without a physician referral. Critics of direct access cite potential overutilization of services, increased costs, and inappropriate care. METHODS AND RESULTS: Using paid claims data for the period 1989 to 1993 from Blue Cross-Blue Shield of Maryland, a direct access state, we compiled episodes of physical therapy for acute musculoskeletal disorders and categorized them as direct access (n = 252) or physician referral (n = 353) using algorithms devised by a clinician advisory panel. Relative to physician referral episodes, direct access episodes encompassed fewer numbers of services (7.6 versus 12.2 physical therapy office visits) and substantially less cost ($1,004 versus $2,236). CONCLUSION AND DISCUSSION: Direct access episodes were shorter, encompassed fewer numbers of services, and were less costly than those classified as physician referral episodes. There are several potential reasons why this may be the case, such as lower severity of the patient's condition, overutilization of services by physicians, and underutilization of services by physical therapists. Concern that direct access will result in overutilization of services or will increase costs appears to be unwarranted.

Complex decisions about an uncomplicated therapy: reimbursement for long-term oxygen therapy in Catalonia (Spain).

Therapies used in the management of chronic diseases cause specific problems regarding reimbursement policy. Oxygen therapy is an example of such treatments that receive little attention from health care policy makers, due to their low cost to the health care budget and to their little importance from a social point of view. In this paper, we analyze the problems posed by this therapy in the Catalan health care system, as an example of the several aspects implied in the reimbursement of such kind of therapies. A technology assessment of this therapy was carried out showing that a change in the reimbursement of long-term home oxygen therapy (LTOT) was needed. Slow diffusion of new oxygen delivery modalities and over-prescription of LTOT were among the problems observed. The new system proposed is presented, and some preliminary results and consequences of the role of technology assessment in health care policy-making are discussed.

The cost of a preventable disease: estimated U.S. national medical expenditures for congenital syphilis, 1990.

Reported cases of congenital syphilis have increased rapidly in recent years. The purpose of this study was to estimate first-year medical care expenditures among 1990 incident cases of infants diagnosed with congenital syphilis. The authors used a synthetic estimation model to calculate expenditures for congenital syphilis as the number of treated cases multiplied by cost per case. The number of cases was derived from surveillance data adjusted for underreporting and presumptive (false-positive) treatment. Cost per case was based on expected hospital and physician charges applied to case treatment protocols appropriate to case severity. Base-case estimated first-year medical expenditure for 1990 treated cases (N = 4,400) in 1990 was +12.5 million. In sensitivity analysis, estimates ranged from +6.2 million to +47 million. Substantial reduction in congenital syphilis treatment costs could be achieved through targeted public health interventions consisting of prenatal maternal screening and contact tracing of males testing positive for syphilis. Physicians should be aggressive in presumptive treatment of newborns, since this usually prevents future disability but represents a small portion of total national expenditure for congenital syphilis. More precise data on severe cases resulting in long-term disability are needed to make reliable cost estimates.

The production of dialysis by for-profit versus not-for-profit freestanding renal dialysis facilities.

OBJECTIVE: A study was conducted to determine whether for-profit and not-for-profit freestanding renal dialysis facilities differ with respect to efficiency in the production of dialysis treatments. DATA SOURCES/STUDY SETTING: National data on 1,224 Medicare-certified freestanding dialysis facilities were obtained from the Health Care Financing Administration's (HCFA) 1990 Independent Renal Dialysis Facility Cost Report. Data on Medicare patients receiving care at these facilities during 1990 were obtained from HCFA's End Stage Renal Disease (ESRD) Program Management and Medical Information System (PMMIS). STUDY DESIGN: Ordinary least squares regression (OLS) was used to estimate the association between monthly output of dialysis treatments in 1990 and (a) facility capital and labor inputs, (b) facility ownership characteristics, and (c) case-mix characteristics. DATA COLLECTION/EXTRACTION METHODS: Facility and patient level data were extracted from the Facility Cost Report and the PMMIS databases, respectively. Patient level data were aggregated by facility and merged with facility level data. PRINCIPAL FINDINGS: For-profit sole proprietorships, for-profit partnerships and for-profit corporations each produced significantly more dialysis treatments per month than not-for-profits, adjusting for quantities of resource inputs and case-mix characteristics. CONCLUSION: For-profit facilities appear to be more efficient producers of dialysis treatments than not-for-profits. Further study should address whether other factors such as differences in severity of disease or in quality of care are responsible for these observations.

Strategic activity and financial performance of U.S. rural hospitals: a national study, 1983 to 1988.

This study examines the effect of 13 strategic management activities on the financial performance of a national sample of 797 U.S. rural hospitals during the period of 1983-1988. Controlled for environment-market, geographic-region, and hospital-related variables, the results show almost no measurable effect of strategic adoption on rural hospital profitability and liquidity. Where statistically significant relationships existed, they were more often negative than positive. These findings were not expected; it was hypothesized that positive effects across a broad range of strategies would emerge, other things being equal. Discussed are possible explanations for these findings as well as their implication for a rural health policy relying on individual rural hospital strategic adaptation to environmental change.

The economic cost of migraine. Present state of knowledge.

The costs of medical care and lost productivity associated with migraine headache impose an economic burden on society. Knowledge of the costs that can be attributed to migraine would provide a basis for evaluating alternative diagnosis and treatment strategies. The most widely used approaches to analyzing the cost of illness analysis are the willingness-to-pay and human capital methods. Using these as a framework, all recent published studies (from 1980 to the present) relevant to the economic cost of migraine were reviewed. The literature reviewed demonstrates that the economic burden of migraine headache is substantial. To estimate the cost of migraine to society more precisely, data are needed on incidence and prevalence among carefully selected samples representative of the underlying population. Use of medical care must be expressed as units of specific types of services rendered over known periods. Health insurance coverage, an important determinant of access to care, should also be known. Absenteeism and work losses must be linked to occupation and earnings levels.

The relationship of provider organizational status and erythropoietin dosing in end stage renal disease patients.

Controversy exists as to whether provider organizational characteristics such as profit status and setting are associated with the content of medical care or efficiency with which care is rendered. Following FDA approval of human recombinant erythropoietin (EPO) for use in clinical practice, Medicare approved coverage for beneficiaries in its end stage renal disease program and established a fixed payment per dose. Because cost of EPO administration varied positively with dose, providers could realize larger profit with prescription of smaller doses. We used Medicare claims data to assess EPO use by renal dialysis providers one year after FDA approval (June 1990) as a function of provider ownership (for-profit, not-for-profit, government agency) and setting (hospital-based, free-standing). Mean dose of EPO was 236 units greater (P = 0.0001) for not-for-profit freestanding facilities, 593 units greater (P = 0.0001) for government facilities, and 555 units greater for not-for-profit hospitals (P = 0.0001) than among for-profit freestanding providers. With fixed payment per dose of EPO, for-profit, freestanding providers prescribed EPO more often and administered smaller doses than not-for-profit or government providers, behavior that is consistent with profit maximization.

Effect of recombinant erythropoietin on hospital admissions, readmissions, length of stay, and costs of dialysis patients.

To examine the effects of recombinant human erythropoietin (rHuEPO) on hospital utilization, hospital costs, and Medicare reimbursements for hospital care, a longitudinal, matched cohort study was conducted using Medicare claims data of 23,806 Medicare-eligible, dialysis patients who received rHuEPO, did not have a transplant, and were alive for 18 mo or longer and 22,720 controls matched on age, sex, race, cause of ESRD, and dialysis modality. The relative odds (rHuEPO versus control) of admission for all causes and for specific causes over 9 mo, adjusted for admission in the prior 9 mo and the per patient change in total admissions, inpatient days, hospital costs, and Medicare hospital payments between the prior 9-mo period and the subsequent 9-mo period was examined. The adjusted relative odds (95% confidence interval) of admission (rHuEPO versus control) was: higher and statistically significant for all causes, 1.08 (1.03 to 1.14); seizure, 1.52 (1.28 to 1.75); vascular access revision, 1.11 (1.06 to 1.17), and heart failure, 1.17 (1.09 to 1.26); higher but not statistically significant for angina, 1.09 (0.99 to 1.20) and stroke, 1.08 (0.86 to 1.31); and lower but not statistically significant for myocardial infarction, 0.91 (0.72 to 1.10); peripheral vascular disease, 0.81 (0.60 to 1.02); anemia, 0.86 (0.56 to 1.17); and depression, 0.89 (0.37 to 1.40). The mean change per 1,000 patients in admissions was less by 38 (P = 0.03) because of fewer readmissions, and in days was 1,309 less (P < 0.001), for patients treated with rHuEPO versus controls. The mean change per patient in hospital costs was $371 less and was statistically significant (P = 0.03) and in Medicare hospital payments was $132 less but was not statistically significant (P = 0.43) for patients treated with rHuEPO versus controls. rHuEPO was associated with an increase in the probability of hospital admission (particularly admissions potentially related to adverse effects) but a decrease in readmissions, overall admissions, hospital days, and cost to hospitals in this cohort of patients surviving for 18 mo. Although not realized short term, Medicare savings from potential rHuEPO-related reductions in hospital care may be long term through future adjustments in diagnosis-related group-based hospital payment.

A review of the first year of Medicare coverage of erythropoietin.

Recombinant human erythropoietin (rHuEPO) is a new drug for treating anemia associated with end stage renal disease (ESRD). In a study of rHuEPO diffusion, costs, and effectiveness, we analyze ESRD program data and all claims submitted to Medicare for reimbursement of rHuEPO administered to ESRD dialysis patients. Access to rHuEPO was rapid and extensive during the first year of Medicare coverage. Dosing of rHuEPO and achieved hematocrit were lower than expected based on the results of clinical trials. rHuEPO cost Medicare $144 million in its first year. The analysis of insurance claims data allowed effective monitoring of access, costs, and effectiveness of this new biotechnology.

Rural hospital administrators and strategic management activities.

This study examines the association of characteristics of rural hospital administrators and the adoption of seven strategic activities in a national sample of 797 U.S. rural hospitals during the period 1983-1988. Based on the premise that managerial activities can affect organizational change, we test five hypotheses relating head administrator characteristics to strategic adaptation, controlling for environment-market and hospital-related variables. Bivariate analysis of the strategic adoption showed a positive association with administrative turnover and a negative association with head administrator age. Multivariate logistic regression showed that only high levels of turnover were associated with strategic activities, net of control variables. The implications of these findings and the lack of predictive power of other rural hospital administrator characteristics--especially affiliation with the American College of Healthcare Executives--are discussed within the context of a "strategic management policy" for rural hospitals.