Practice patterns, case mix, Medicare payment policy, and dialysis facility costs.
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OBJECTIVE: To evaluate the effects of case mix, practice patterns, features of the payment system, and facility characteristics on the cost of dialysis. DATA SOURCES/STUDY SETTING: The nationally representative sample of dialysis units in the 1991 U.S. Renal Data System's Case Mix Adequacy (CMA) Study. The CMA data were merged with data from Medicare Cost Reports, HCFA facility surveys, and HCFA's end-stage renal disease patient registry. STUDY DESIGN: We estimated a statistical cost function to examine the determinants of costs at the dialysis unit level. PRINCIPAL FINDINGS: The relationship between case mix and costs was generally weak. However, dialysis practices (type of dialysis membrane, membrane reuse policy, and treatment duration) did have a significant effect on costs. Further, facilities whose payment was constrained by HCFA's ceiling on the adjustment for area wage rates incurred higher costs than unconstrained facilities. The costs of hospital-based units were considerably higher than those of freestanding units. Among chain units, only members of one of the largest national chains exhibited significant cost savings relative to independent facilities. CONCLUSIONS: Little evidence showed that adjusting dialysis payment to account for differences in case mix across facilities would be necessary to ensure access to care for high-cost patients or to reimburse facilities equitably for their costs. However, current efforts to increase dose of dialysis may require higher payments. Longer treatments appear to be the most economical method of increasing the dose of dialysis. Switching to more expensive types of dialysis membranes was a more costly means of increasing dose and hence must be justified by benefits beyond those of higher dose. Reusing membranes saved money, but the savings were insufficient to offset the costs associated with using more expensive membranes. Most, but not all, of the higher costs observed in hospital-based units appear to reflect overhead cost allocation rather than a difference in real resources devoted to treatment. The economies experienced by the largest chains may provide an explanation for their recent growth in market share. The heterogeneity of results by chain size implies that characterizing units using a simple chain status indicator variable is inadequate. Cost differences by facility type and the effects of the ongoing growth of large chains are worthy of continued monitoring to inform both payment policy and antitrust enforcement. (+info)
The US Food and Drug Administration investigational device exemptions (IDE) and clinical investigation of cardiovascular devices: information for the investigator.
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The conduct of a clinical investigation of a medical device to determine the safety and effectiveness of the device is covered by the investigational device exemptions (IDE) regulation. The purpose of IDE regulation is "to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use, and to that end to maintain optimum freedom for scientific investigators in their pursuit of this purpose" (Federal Food, Drug, and Cosmetic Act). Conducting a clinical investigation may require an approved IDE application. The US Food and Drug Administration encourages early interaction with the agency through the pre-IDE process during the development of a device or technology and during the preparation of an IDE application. This facilitates approval of the IDE application and progression into the clinical investigation. This paper reviews the terminology and applicability of the IDE regulation and the type of study that requires an IDE application to the Food and Drug Administration. The pre-IDE process and the development of an IDE application for a significant risk study of a cardiovascular device are discussed. (+info)
The impact of reimbursement changes for intracoronary stents on providers and Medicare.
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CONTEXT: New Medicare reimbursement policies will move stents into a different diagnosis-related group (DRG) than conventional balloon angioplasty (percutaneous transluminal coronary angioplasty [PTCA]). OBJECTIVE: To examine the financial impact on hospitals and Medicare of these planned changes, taking into account costs, reimbursement, and the cost-offset effect of prevented complications. DESIGN: The economic impact of proposed reimbursement changes was modeled by using a retrospective clinical and economic data set from a single institution. PATIENTS AND METHODS: A total of 421 consecutive interventional cases from 1996 were examined by using actual cost data. The new, proposed revenues were assigned to these cases. From the hospitals' perspective, the focus was on contribution margin (the difference between revenues and costs), risk adjusted for case-mix severity. From Medicare's perspective, the focus was on expenditures. Various assumptions were adopted for two clinical variables: the effectiveness of stents in preventing the major PTCA-related complications of myocardial infarction and coronary artery bypass graft surgery and the relative proportions of myocardial infarction and coronary artery bypass graft surgery in the mix of complications. Under current Medicare DRG policies, coronary artery bypass graft surgery is highly profitable for hospitals, whereas myocardial infarction as a complication of PTCA has a negative financial impact. RESULTS: Under the new Medicare reimbursement policies, hospitals experience higher profitability with stents than with conventional PTCA under most assumed levels of clinical effectiveness and mixes of myocardial infarction and coronary artery bypass graft surgery. For Medicare, under most circumstances (including percentages of stent use and levels of clinical effectiveness that represent contemporary practice) stents lead to greater expenditures. CONCLUSIONS: Medicare reimbursement changes will substantially realign previously misaligned financial and clinical incentives for hospitals. The immediate effect on hospitals will be to enhance profitability, whereas the effect on Medicare will be to increase expenditures. (+info)
Appropriate and necessary healthcare: new language for a new era.
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Conceptual and language changes are necessary to accompany the paradigm shift from fee-for-service medicine to managed care. Medical necessity is an inadequate and ambiguous term defined differently by providers, payers, patients, and legislators. The attempt by legislators in Minnesota to develop a universal standard benefits set for healthcare services strikingly underscores the need to define relevant terminology to accompany the transition to managed care. We suggest the term appropriate and necessary healthcare as a state-of-the-art term for the new era of managed care. (+info)
Transmyocardial laser revascularization: a qualitative systematic review.
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OBJECTIVE: To evaluate the status of transmyocardial laser revascularization (TMLR) from an evidence-based perspective to help hospitals make resource management decisions. STUDY DESIGN: Qualitative systematic review of the clinical literature. METHODS: We searched the reference databases MEDLINE, BIOSIS, EMBASE, SciSearch, and Current Contents to identify all articles related to TMLR published between January 1985 and March 1997. We collected, analyzed, and summarized clinical studies in evidence tables. RESULTS: The cumulative evidence available in the medical literature regarding the safety and effectiveness of TMLR encompasses approximately 2000 patients treated worldwide, primarily those with medically refractory angina. Preliminary data suggest that TMLR has an acceptable survival rate and effectively relieves angina in approximately 75% of patients. Data showing improved myocardial perfusion, cardiac function, or prognosis are inconclusive. The mechanism by which TMLR relieves angina is not yet known. CONCLUSIONS: Early evidence regarding TMLR suggests it will be useful for treating patients with end-stage coronary artery disease. Definitive recommendations await critical analysis of the results of ongoing randomized clinical trials, post-market surveillance studies, and third-party payer acceptance. (+info)
Capitation among Medicare beneficiaries.
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CONTEXT: The Medicare program has promoted capitation as a way to contain costs. About 15% of Medicare beneficiaries nationwide are currently under capitation, but tremendous regional variation exists. PRACTICE PATTERN EXAMINED: The proportion of Medicare beneficiaries who have enrolled in risk-contract plans in individual states and in the 25 largest metropolitan areas in the United States. DATA SOURCE: Health Care Financing Administration data files. RESULTS: Medicare beneficiaries are most likely to be under capitation in Arizona (38%) and California (37%). Eight other states have capitation rates greater than 20%: Colorado, Florida, Rhode Island, Oregon, Washington, Pennsylvania, Massachusetts, and Nevada. Thirty states, largely in the Great Plains area and the southern United States, have capitation rates less than 10%. Four major metropolitan areas have market penetration rates greater than 40%: San Bernardino, California; San Diego, California; Phoenix, Arizona; and Miami, Florida. Little penetration exists outside of metropolitan areas. CONCLUSION: Capitation in Medicare is a regional and predominantly an urban phenomenon. (+info)
A comparison of the national registry of myocardial infarction 2 with the cooperative cardiovascular project.
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OBJECTIVES: This study was performed to evaluate whether or not the simpler case identification and data abstraction processes used in National Registry of Myocardial Infarction two (NRMI 2) are comparable with the more rigorous processes utilized in the Cooperative Cardiovascular Project (CCP). BACKGROUND: The increased demand for quality of care and outcomes data in hospitalized patients has resulted in a proliferation of databases of varying quality. For patients admitted with myocardial infarction, there are two national databases that attempt to capture critical process and outcome data using different case identification and abstraction processes. METHODS: We compared case ascertainment and data elements collected in Medicare-eligible patients included in the industry-sponsored NRMI 2 with Medicare enrollees included in the Health Care Financing Administration-sponsored CCP who were admitted during identical enrollment periods. Internal and external validity of NRMI 2 was defined using the CCP as the "gold standard." RESULTS: Demographic and procedure use data obtained independently in each database were nearly identical. There was a tendency for NRMI 2 to identify past medical histories such as prior infarct (29% vs. 31%, p < 0.001) or heart failure (21% vs. 25%, p < 0.001) less frequently than the CCP. Hospital mortality was calculated to be higher in NRMI 2 (19.7% vs. 18.1%, p < 0.001) due mostly to the inclusion of noninsured patients 65 years and older in NRMI 2. CONCLUSIONS: We conclude that the simpler case ascertainment and data collection strategies employed by NRMI 2 result in process and outcome measures that are comparable to the more rigorous methods utilized by the CCP. Outcomes that are more difficult to measure from retrospective chart review such as stroke and recurrent myocardial infarction must be interpreted cautiously. (+info)
Medicaid eligibility expansion in Florida: effects on maternity care financing and the delivery system.
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CONTEXT: In July 1989, the income limit on Medicaid eligibility for pregnant women in Florida was increased from 100% to 150% of the poverty level. This change may have led to substantial shifts in the financing of pregnancy-related care, and also may have had distinct effects on different providers in the health care delivery system. METHODS: Matched birth and death certificates, hospital discharge abstracts, Medicaid eligibility records and encounter records from county public health departments were used to estimate changes in the flows of funds and services by major payer groups during the period preceding the expansion (July 1988-June 1989) and for calendar year 1991. A total of 188,793 births in the first period and 193,292 in the second were examined. RESULTS: The number of births financed annually by Medicaid in Florida increased by 47% following the eligibility expansion, from 47,400 in 1988-1989 to 69,600 in 1991. This increase stemmed largely from covered births to women who otherwise would have been uninsured. Seventy-three percent of the additional 22,200 deliveries funded through Medicaid in 1991 are attributed to women who were eligible as a result of the expansions. The additional prenatal care financed by Medicaid was delivered almost entirely by county public health departments, which increased their capacity by more than 100%, from 177,000 visits in 1988-1989 to 433,000 in 1991. Medicaid payments for maternity care increased 39%, from $135 million to $187 million, while payments made by the uninsured dropped by 29%. These changes resulted in a 5% rise in hospital revenues, despite little change in the number of admissions. CONCLUSIONS: The Medicaid expansion benefited low-income pregnant women and hospitals in Florida. It is unknown whether the private delivery system would have accommodated the increased demand in the absence of the public health system response. (+info)