Circuit Court rulings involving CPSC were cited by the court in the benzene case to illustrate the evidence requirements that the court felt are necessary to determine if a proposed initiative is "reasonably necessary" when the proposed standard's benefits are balanced against the costs, or burden, of compliance with the standard. The Supreme Court will deterThe rulings cited in the OSHA opinion as guiding the determinations were: 1. Aqua Slide 'N' Dive v. Consumer Product Safety Commission, 569 F. 2d. 832 (5th Cir. 1978), and 2. D. D. Bean & Sons v. Consumer Product Safety Commission. 574 F. 2d 643 (1st Cir. 1978). mine if OSHA's statutory language requires it to go beyond the data it has used in the past and follow the guidelines established by the CPSC rulings for the use of costs v. benefits comparisons in its decisionmaking procedures. The available evidence strongly indicates that there is mounting legislative and judicial pressure to formalize the use of CEA/CBA in many decisionmaking areas in the Federal Government. To date, most of this pressure has been focused on the regulatory agencies. It is uncertain at this time if these pressures will expand into the health care system. 66-220 0 - 80 - 13 Other Volumes of the Assessment In addition to the present report, several background papers were prepared in conjunction with OTA's assessment The Implications of Cost-Effectiveness Analysis of Medical Technology, and these are available separately. The findings and options of the assessment are in large part derived from the information generated by the background efforts. Background Paper #1: Methodological Issues and Literature Review, includes an in-depth examination of the decisionmaking context and methodology discussions presented in this report. A critique of the literature, a bibliography of over 600 items, and abstracts of over 70 studies and other articles are also included. In order to investigate the applicability of techniques to assess the costs and benefits of medical technology, 19 case studies were prepared. All 19 are available individually. In addition, 17 of the cases are available in a collected volume, Background Paper #2: Case Studies of Medical Technologies. Some of the cases represent formal cost-effectiveness analysis (e.g., the case on bone marrow transplants), while others represent net cost or "least cost" analysis (e.g., the case on certain respiratory therapies). Other cases illustrate various issues such as the difficulty of conducting cost-effectiveness analysis in the absence of adequate efficacy and safety information (e.g., the case on breast cancer surgery), or the role and impact of formal analysis on policymaking (e.g., the case on end-stage renal disease interventions). The 17 case studies in Background Paper #2 and their authors are: Artificial Heart Deborah P. Lubeck John P. Bunker Automated Multichannel Chemistry Analyzers Milton C. Weinstein Laurie A. Pearlman Bone Marrow Transplants Stuart O. Schweitzer C. C. Scalzi Breast Cancer Surgery Karen Schachter Duncan Neuhauser Cardiac Radionuclide Imaging William B. Stason Cervical Cancer Screening Cimetidine and Peptic Ulcer Disease John P. Bunker End-Stage Renal Disease Interventions Richard A. Rettig Gastrointestinal Endoscopy Jonathan A. Showstack Sharon Solkowitz Orthopedic Joint Prosthetic Implants Periodontal Disease Interventions Richard M. Scheffler Sheldon Rovin Selected Respiratory Therapies Richard M. Scheffler Morgan Delaney The 18th case study is published separately as Background Paper #3: The Efficacy and Cost-Effectiveness of Psychotherapy. That study assesses methodological and substantive issues relating to the scope of psychotherapy, the evaluation of psychotherapeutic efficacy, and the applicability of cost-effectiveness and cost-benefit analysis in assessing psychotherapy. It was prepared by Leonard Saxe on the basis of a report prepared for OTA by Brian Yates and Frederick Newman. The 19th case study was prepared for OTA by Judith Wagner and is published separately as Background Paper #5: Assessment of Four Common X-Ray Procedures. Background Paper #4: The Management of Health Care Technology in Ten Countries is an analysis of Ambulatory medical care: Medical goods and services rendered to a patient not admitted to a hospital or other inpatient health care facility, including such items as physician office visits, outpatient laboratory diagnostic services, and outpatient prescription drugs. Biomedical and behavioral research: A combination of biological, medical, psychological, social, and physical scientific investigations focused on eradicating disease and generating new scientific knowledge. Capitation financing method: The method of paying for medical care on a fixed, periodic prepayment basis per individual enrolled in a health plan. Payment by "capitation" implies that the amount paid by the individual is independent of the number of services that individual has received. CEA/CBA: A composite term referring to a family of analytical techniques that are employed to compare costs and benefits of programs or technologies. Literally, the term as used in this assessment means "cost-effectiveness analysis/cost-benefit analysis." Certificate of need (CON): A regulatory planning mechanism required by the National Health Planning and Resources Development Act to control |