The Basics

This standard establishes strict guidelines for the clinical review criteria that the organization uses in its drug utilization management program.  Those clinical criteria must be:

• the product, at least in part, of the effort of appropriate prescribing providers;
• based on current clinical principles;
• the subject of an annual review by the organization and actively practicing doctors and pharmacists;
• approved by senior clinical leadership, either the Medical Director, another senior clinical staff person, or a clinical committee such as P & T committee.

Management Tips

The organization's policy and procedure addressing clinical review criteria must clearly identify who is to be involved in the criteria's development.  That identification should include the names of qualifications of the reviewers.  The policy and procedure also should include a clear description of the process used in the development of the criteria, how often the criteria will be evaluated, and specifically who or what body will conduct periodic evaluations.  It is important to note that his clinical oversight is required even if the clinical review criteria are purchased from an outside vendor.

The annual review of clinical criteria need not happen all at once.  In fact, it is a best practice to stagger the review of criteria throughout the year.  A master index of all the criteria and their respective review dates will be an important tool to make sure no criteria fall through the cracks.

URAC Accreditation Tips

Six of the seven elements in this standard are mandatory; the remaining element is weighted 4.

At the initial document submission level, the organization should provide the applicable policy and procedure, job descriptions of the prescribers and pharmacists involved in development of the criteria, and meeting minutes or other documentation of the approval of clinical criteria.

During the on-site review, the reviewer will conduct an interview of the senior clinical staff person during which his or her involvement in the oversight of the clinical review criteria will be one subject.  In addition, the reviewer will want to see documentation of the tracking system that the organization uses to make sure all criteria are approved on an annual basis.  If the clinical criteria are purchased, a contract of purchase may also be reviewed during the on-site review.  Finally, the reviewer will almost surely not only interview drug utilization management staff members, but also observe such staff members at their desks doing their jobs.  One of the things the reviewer will look for is access to and use of clinical review criteria by utilization management staff.