sification for having or not having a serious or complex medical condition. Careful consideration must be given to determining the appropriate intervals between identification and screening of patient populations for the presence of a new condition that might be serious and complex, the continuation of an existing serious and complex condition, and the resolution of a condition previously determined to be serious and complex in nature.

Health care plans and HCFA must also be cognizant of the limitations of data that is collected, analyzed, or interpreted retrospectively. Examples of such data might be submission of information about claims and claims resolution data. Reliance on retrospective data may result in significant delays in identifying beneficiaries with serious and complex medical conditions. Furthermore, use of retrospective data to predict future events has the potential for misclassification of patients as having or not having a serious and complex medical condition.

Health plans and HCFA should also be aware of the challenges inherent in the process of data collection, management, analysis, and interpretation. The potential for errors and biases is present at each step and could result in misclassification of patients with serious and complex medical conditions. The collection of timely information that is of sufficient sensitivity and specificity to reduce the number of false-positive and false-negative classifications as serious and complex imposes significant burdens and will require allocation of adequate resources and professionally trained staff.

Clinical research relevant to defining patient populations as having serious and complex conditions and developing the most effective care protocols to respond to patient needs is evolving rapidly, but only preliminary results are available. For example, research in correlating patient volume with patient outcomes, differentiating access to services as a function of health plan benefits, and addressing variations in quality of care has just begun to yield meaningful results about particular groups of patients. The committee anticipates that this research will continue to evolve and will provide more definitive conclusions to guide the efforts of health plans to identify patients with serious and complex medical conditions and ensure appropriate levels of treatment and care management. As the science base is strengthened, so too will be the ability of HCFA and health plans to correctly identify patients with serious and complex medical conditions who would benefit from broad strategies of care management.

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