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Clinical Practice Guideline

Overview

A good working definition for practice guidelines is that they are “standardized specifications for care developed by a formal process that incorporates the best scientific evidence of effectiveness with expert opinion.” Practice guidelines should be specific for a condition or procedure, and they should be based on clinical research literature and the collective judgments of expert physicians.

Policy

There are several characteristics that should be common to useful guidelines. Guidelines should be comprehensive and include all likely indications for the procedure. In addition, they should specify the conditions for which the procedure is, or is not, recommended. They should be so sufficiently detailed that they adequately describe the features that distinguish one indication from another. Moreover, guidelines should clearly indicate the circumstances under which a procedure is appropriate, inappropriate, or equivocal, as when there is no clear consensus of opinion. Guidelines should include all other relevant factors in assessing the appropriateness of a procedure, including the risk of the procedure, the severity of the disease and co-morbidity. Finally, guidelines must be manageable; they should not be so complex that they are unusable.

In short, medical practice guidelines may come in myriad forms and may serve a variety of functions. They may be designed to be used by practicing physicians, or by a host of other parties, including providers, payors and patients. The distinction between practice guidelines and other forms of medical literature is, however, unclear.

Excerpt from John C. West, The Legal Implications of Medical Practice Guidelines, J. HEALTH L. 1 (Apr. 1994).

Agency Guidelines

Clinical-practice guidelines inform clinical decisions by providing criteria for diagnosis, management, and treatment of specific diseases and medical conditions. These guidelines are intended to summarize and integrate the best scientific evidence into their recommendations and standardize medical care. Structured appropriately, clinical guidelines increase overall efficiency, enhance quality, and reduce complications in healthcare delivery. When used to limit competition, however, through the exercise of market power—such as by raising prices, excluding competitors or raising rivals’ costs, suppressing innovation, and creating entry barriers—their creation and use can give rise to antitrust issues.

Most, if not all, professional medical specialty associations have established guideline committees or panels that develop practice guidelines pertinent to their areas of specialization. Since the 1990s, evidence-based guidelines have had a pronounced effect on healthcare, influencing not only clinical practice decision making (increasingly, by limiting clinical discretion), but also coverage of treatments by payors and to some extent, legal standards of care.

Future Direction

Given the ever-increasing importance of evidence-based medicine, providers and payors must pay attention to the possible anticompetitive development and application of clinical guidelines. Clinical guideline development is a form of standard setting whereby a small group of specialists makes decisions for the medical market, thereby effectively preempting market choice. As such, this process may be subject to the antitrust laws, no differently than all other types of standard setting. Accordingly, clinical standards, as with any other standards, can be misused to foreclose competition.

Excerpt from Mark L. Mattioli & Richard Wolfram, Evidence-Based Clinical Guidelines: A Rx for Better Quality, an Opportunity for Exclusionary Conduct Under the Antirust Laws, or a Little of Both?, 14 AHLA CONNECTIONS 12, 12-13 (August 2010).