Influencing clinical and coverage decisions in the '90s.

The 1980s witnessed the transfer from providers to payers of much decision-making authority regarding the availability and utilization of technology. During the 1990s, this trend will continue and be amplified. Four developments from the '80s will become important factors in decision making in the '90s. In order of descending importance those developments are:

* Outcomes research

* Shared decision making

* Clinical guidelines

* Cost-effectiveness analysis (CEA)

Cost-Effectiveness Analysis

CEA is the white elephant of the group. It is always touted as being a very valuable decision-making tool by "others," but no one takes ownership of it and puts it to good use. Payers and providers alike will experiment with CEA and determine what value it may have for their decision-making processes. Of course, the first payer to enter the cost-effectiveness lab is HCFA.

With so much talk about cost-effectiveness, why hasn't it become a more pervasive factor in decision making? First, those who are grinding out decisions regarding the appropriate utilization of health care technology are consumed by the exigencies of evaluating the safety and effectiveness of new technologies and of new uses for old technologies. Second, a proper CEA is a fairly complex, resource-intensive process that is made even more complex by the diversity of customers for the analysis. For example, in conducting a CEA on laporascopic cholecystectomy, the potential savings due to increased productivity because of a patient's quicker return to work will be more important to an employer than to an individual HMO. Third, while the evaluation of effectiveness is controversial enough in terms of appropriate methods, data considered, etc., CEA is even more controversial. Thus, the appropriate method and data to consider are even more in the eye of the beholder. Disagreement over cost data used, inclusion or exclusion of certain costs, etc. can cloud discussion of a CEA done even by respected researchers. CEA, for the near term, will be applied predominantly as an educational tool to sensitize providers about the cost implications of the decisions that they are making.

Clinical Guidelines

The issue of general medical acceptability will continue to be an important factor in decision making in the '90s. The clinical guidelines developed by medical associations and specialty societies are the most important measures of medical acceptability. They are important because they afford the opportunity for "expert" interpretation of available outcomes data. In the development of clinical guidelines, some groups are clearly driven more by scientific concerns than by political or socioeconiomic ones. In technology assessment and clinical guideline development, those groups that are not based in rigorous scientific decision making soon lose their credibility and, thus, any useful function.

Presently, consideration of available clinical guidelines and position statements is important in the development of coverage policy. Most assuredly, if a coverage decision is challenged, consideration of the positions of recognized medical organizations will be a component of that challenge. As organized outcomes database become more prevalent during the '90s, the impact and influence of clinical guidelines will wane, unless it is clear that those guidelines are firmly rooted in such outcomes data.

Shared Decision Making

The involvement of patients in decisions regarding their own care increased somewhat during the 1980s. Programs such as patient package inserts and patient medication instructions provided a modicum of information to patients and thus a moderate increase in participation. The 1990s promise to bring further and significant input of patients into decisions regarding their own health care.

Proceeding from the debate over the appropriate management of benign prostatic hypertrophy (BPH), Drs. Mulley and Wennberg developed an interactive videotape to provide patients directly with information about the available therapeutic options. In the case of BPH, outcomes data are provided on the benefits and adverse events associated with transurethral resection of the prostate and with "watchful waiting." Patients using the videotape are provided with discussion by other patients of their personal decisions and the outcomes associated with those decisions.

This shared decision-making model appears to be most applicable to "quasi-elective, quasi-necessary" procedures. A better understanding by patients of the probabilities of benefits and risks associated with particular interventions may serve to appropriately moderate and modulate the utilization of health care technology. The shared decision-making model is not widely known at the present time within the practicing health care community. However, the model holds great potential to significantly influence health care decision making by the end of the '90s. Indeed, it may represent the second opinion that the health care system has been searching for--i.e., the opinion of the patient.

Outcomes Data

It will come as no surprise to those who have followed health care in the '80s to learn that outcomes research will flourish in the 1990s. Large database will be developed by various constituents of the health care community. These databased will collect information regarding the benefits, adverse effects, and adverse events that attend the utilization of health care technologies, both old and new. All of these data will be particularly useful in the managed care sector.

Managed care is fundamentally a system that aims to ensure that the care that a patient receives is medically reasonable, necessary, safe, and effective. Thus, success in managed care depends directly on the quality and the quantity of data available to support various decision-making processes. Those processes are the process of technology assessment, and that feeds into the development of clinical guidelines and coverage policy. All three of these entities feed into utilization management decisions. Questions in utilization management often identify new issues and, thus, start the technology assessment process over again. The availability of cold hard data is essential to appropriate decision making all along this continuum of managed care.

Conclusion

The data provided by outcomes research will have a significant and substantial impact on health care decision making by the end of the 1990s. My long shot pick of the decade is that the shared decision-making model of Mulley and Wennberg will have great influence in decisions involving proposed interventions that range from "quasi-elective, quasi-necessary" to "potentially life-saving with high risks." Clinical guidelines will continue to be developed well into the 1990s as a response to and refutation of criticisms regarding variable, inappropriate, and excessive utilization of health care technology. The credibility of these guidelines will correlate directly with the extent to which they have been based upon outcome data. Cost-effectiveness analysis will continue to search for a home in health care decision making. At present, it is difficult to predict whether that home will or will not be in an influential and prominent neighborhood.

William T McGivneys, PhD, is Head, Technology Assessment and Policy, Aetna Health Plans, Harford, Conn.