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November 5, 1997

Investigational Treatments: Process, Payment, and Priorities

Author Affiliations

Minnesota Center for Health Care Ethics Minneapolis

JAMA. 1997;278(17):1403-1404. doi:10.1001/jama.1997.03550170033022

To the Editor.  —Health plans customarily have excluded coverage for investigational interventions and covered most proven interventions. Although the distinction between investigational and proven has been pivotal, it remains blurry and notoriously unhelpful. The lack of an agreed-on definition of investigational, for example, has been the source of innumerable legal challenges brought—usually successfully—by patients, often of coverage denials for investigational interventions.While Dr Eddy's1 proposed process is the clearest yet for making defensible judgments about which interventions are investigational, it ultimately may not help health plans make better coverage decisions. The problem goes beyond the term investigational to the distinction itself: even if it could be unambiguously drawn via precise agreed-on definitions and criteria, the investigational vs proven distinction would be an inadequate framework for making coverage decisions. Coverage decisions no longer are, nor should they be, based on a judgment regarding the investigational status of an intervention. Many investigational interventions are