Effect of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) on the incidence of invasive cervical cancer.

The Clinical Laboratory Improvement Act of 1988 (CLIA '88) mandates strict, new quality-control measures for laboratories that interpret cervical cytology smears. Proposed regulations include proficiency testing of cytotechnologists and remediation for technologists and laboratories that fail to meet proposed proficiency standards. Proponents of the new regulations argue that these measures will reduce deaths from cervical cancer by reducing the false-negative rate of the Papanicolaou (Pap) test, but opponents argue that the regulations will increase the price of processing Pap tests and thereby reduce access to cervical cancer screening for high-risk, vulnerable populations. To examine these claims the authors used David Eddy's published simulation to model the natural history and detection of cervical neoplasia, and developed a new model to examine the health consequences of diminished access to Pap testing. The authors estimated the false-negative rate of the Pap test and the price elasticity of demand for preventive services on the basis of the published literature, and modeled the entire range of published or quoted predictions about the impact of CLIA '88 on accuracy and price. The results show that, if effects on access are ignored, reducing the false-negative rate from 15% to 5% would prevent 66 invasive cancers per 100,000 average risk women screened. However, under moderate assumptions regarding the effect of price on access, the regulations would prevent only 11 (instead of 66) cancers per 100,000 eligible women. The regulatory effect is very sensitive to the degree of improvement in the false-negative rate and increase in price that the regulations cause. Over the range of assumptions and predictions encountered in the literature and tested in our analysis, the proposed regulations could greatly reduce or greatly increase the incidence of invasive cancer, especially among high-risk and uninsured women. The implementation of the regulations should be delayed until new information regarding the actual false-negative rate of the Pap test allow a more precise estimate of the potential impact on the incidence of cervical cancer.