Medical technology and inequity in health care: the case of Korea.
There has been a rapid influx of high cost medical technologies into the Korean hospital market. This has raised concerns about the changes it will bring for the Korean health care sector. Some have questioned whether this diffusion will necessarily have positive effects on the health of the overall population. Some perverse effects of uncontrolled diffusion of technologies have been hinted in recent literature. For example, there is a problem of increasing inequity with the adoption of expensive technologies. Utilization of most of the expensive high technology services is not covered by national health insurance schemes; examples of such technologies are Ultra Sonic, CT Scanner, MRI, Radiotherapy, EKG, and Lithotripter. As a result, the rich can afford expensive high technology services while the poor cannot. This produces a gradual evolution of classes in health service utilization. This study examines how health service utilization among different income groups is affected by the import of high technologies. It discusses changes made within the health care system, and explains the circumstances under which the rapid and excessive diffusion of medical technologies occurred in the hospital sector. (+info)
The cost-effectiveness of ibutilide versus electrical cardioversion in the conversion of atrial fibrillation and flutter to normal rhythm.
Atrial fibrillation and atrial flutter are cardiac rhythm disorders that are often symptomatic and may interfere with the heart's function, limiting its effectiveness. These arrhythmias are responsible for a large number of hospitalizations at a significant cost to the healthcare system. Electrical cardioversion (EC) is the most common nonpharmacologic intervention used to convert atrial fibrillation and atrial flutter to normal rhythm. Electrical cardioversion is highly successful in converting patients to normal rhythm; however, it is more traumatic and resource intensive than pharmacologic treatment. Recently, a new rapid-acting drug, ibutilide, was approved for the conversion of atrial fibrillation and atrial flutter. Ibutilide is administered through intravenous infusion and does not require anesthetization of the patient, as is required for EC. A decision-tree model was developed to estimate the cost-effectiveness of ibutilide therapy compared with EC therapy. Clinical outcomes were based on a phase III trial of ibutilide, and resource use was based on the literature and physician clinical judgment. A stepped conversion regimen of first-line ibutilide followed by EC for patients who fail to convert is less expensive and has a higher conversion rate than first-line EC. Sensitivity analysis shows that our results are robust to changes in cost and effectiveness estimates. (+info)
Technology assessment, coverage decisions, and conflict: the role of guidelines.
As pressure grows for health plans to be accountable for increasing quality of care within a cost-control environment, coverage of new technologies becomes a particularly challenging issue. For a number of reasons, health plans have adopted evidence-based methods for guiding technology decisions. The implementation of these methods has not been free of controversy, and conflicts have arisen between plans and proponents of technologies who often use the political and legal arena in an attempt to secure coverage. Unless these conflicts are resolved, the healthcare system may have difficulty meeting cost and quality objectives. Technology assessment and coverage process guidelines and flexible coverage approaches may be possible ways of resolving these conflicts. (+info)
Technology assessment of medical devices at the Center for Devices and Radiological Health.
We reviewed the Food and Drug Administration's regulatory process for medical devices and described the issues that arise in assessing device safety and effectiveness during the postmarket period. The Center for Devices and Radiological Health (CDRH), an organization within the Food and Drug Administration, has the legal authority and responsibility for ensuring that medical devices marketed in the United States are both reasonably safe and effective for their intended use. This is an enormous challenge given the diversity of medical devices and the large number of different types of devices on the market. Many scientific and regulatory activities are necessary to ensure device safety and effectiveness, including technology assessment, albeit in a manner quite different from that of conventional technology assessment. The basic approach taken at the CDRH to ensure device safety and effectiveness is to develop an understanding of the way in which a medical device works and how it will perform in clinical situations. (+info)
Role of technology assessment in health benefits coverage for medical devices.
With the profusion of new medical technology, managed care organizations are faced with the challenge of determining which medical devices and services warrant health benefits coverage. To aid in this decision-making process, managed care companies turn to technology assessment, a process that differs from the Food and Drug Administration's review of medical devices. Health plans typically use a structured approach to implementing coverage requirements in employer group benefits contracts and use technology assessment to evaluate the scientific evidence of effectiveness to support coverage decisions. Also important is the societal context for decisions regarding coverage for new technologies and the options being considered by policy makers for accountability in technology assessment by private insurers and health plans. (+info)
Transmyocardial laser revascularization: a qualitative systematic review.
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)
The limited state of technology assessment for medical devices: facing the issues.
Medical devices are an integral part of clinical practice and account for a substantial proportion of the national health budget. Clinical testing and regulation of medical devices, however, is vastly different from and inferior to the testing and regulation of drugs. As managed care organizations begin to exert controls on device use, providers are being caught between the policies of their organizations and the demands of device manufacturers and patients, who want wider access to devices. We outline several reasons for the poor state of medical device evaluations and the dangers of using devices without adequate information, and include the recently developed device assessment and reporting guidelines created by the Task Force on Technology Assessment of Medical Devices. (+info)
Healthcare technology assessment: methods, framework, and role in policy making.
This activity is designed for healthcare organization managers and clinicians, particularly those involved in technology-related decisions, including coverage decisions, technology acquisition, practice guideline development, and evidence-based medicine. GOAL: To provide a basic understanding of the principles, methods, and systematic framework of healthcare technology assessment. OBJECTIVES: 1. Understand the role of healthcare technology assessment in policy making and the technical properties and impact assessed. 2. Become familiar with the categories and basic attributes of methods used in healthcare technology assessment. 3. Comprehend the ten-step framework for conducting a healthcare technology assessment. (+info)