proposed rule to establish criteria and procedures by which health care technologies could be considered "reasonable and necessary" (Federal Register 54:4302-4318, 1989). The proposed rule solicited comments on, among other topics, (1) criteria for coverage decisions and "the identification and selection of health care technologies for national coverage decisions," and (2) "methods for assuring appropriate public participation in the various phases of the technology assessment process."
The rule also proposed that cost-effectiveness of technologies be a criterion for coverage (see Leaf, 1989). At the time of this writing, the proposed rule is still pending. Based on the Notice of Proposed Rule Making, the final rule will likely require not only that a technology be reasonably safe, demonstrably effective, noninvestigational, and acceptable to the medical community, but also cost-effective.