This report reviews U.S. patent law as it relates to the patentability of micro-organisms, cells, plants, and animals; as well as specific areas of concern, including deposit requirements and international considerations. The report includes a range of options for congressional action related to the patenting of animals, intellectual property protection for plants, and enablement of patents involving biological material.
Policy interest in Medicare’s payment policies regarding recombinant erythropoietin has arisen chiefly because of the biologic’s expense. Because of concern about the implications of recombinant erythropoietin use for Medicare expenditures, the House Ways and Means Committee, Subcommittee on Health, requested OTA to examine alternative payment policies that Medicare might adopt to pay for the biologic. In responding to that request, this Special Report reviews clinical and economic issues regarding the use of recombinant erythropoietin and develops a series of options for Congressional consideration.
This Special Report analyzes policy and research issues raised in considering Medicare coverage of preventive services. OTA examines how decisions are currently made about coverage of specific preventive services under Medicare and lays out options for altering the process and criteria governing those decisions. The Special Report also reviews and critiques ongoing demonstration projects and summarizes the results of OTA studies of the costs and effectiveness of specific preventive services for the elderly.