The Basics

This standard requires that the organization's decisions about coverage be based on an assessment of peer-reviewed the medical literature, plus any of these four options that apply to a particular coverage decision:

• published practice guidelines, or
• a comparison of efficacy and side effects and drug interactions among alternative drugs, or
• prospects for patient compliance, or
• a thorough evaluation of all the benefits, risks, and potential consumer outcomes.

While this kind of evaluation can be outsourced to an external entity, the organization seeking accreditation is nevertheless obligated to know how the edits were developed and who developed them.

The oversight of this process, whether internal or external, rests with the clinical leadership of the organization.  That can be the clinical director or directors, or any committee designated for that purpose.

Management Tips

In developing the policy and procedure supporting this standard, management should be explicit in requiring evidence-based, scientifically valid data be considered in decisions about drug inclusions on the formulary.  In addition, if the organization purchases external criteria and then makes amendments to those criteria, the policy and procedure should describe a mechanism for relying on scientific evidence for those amendments.  Documentation of this process will be very important.  

It will be important that committee minutes demonstrate that the committee considered all of the issues covered by this standard.  Mere consideration of scientific evidence therefore will not be sufficient; discussion should include prospects for patient compliance, drug interactions, and alternatives.

URAC Accreditation Tips

All of the elements of the standard are mandatory.

The documentation required for the initial submission includes the applicable policy and procedure, P & T committee minutes that show the oversight mechanism in action, and perhaps a web link to the formularies.

The on-site review will include an interview of staff members involved in the development and maintenance of clinical criteria for coverage decisions.  In addition, the reviewer will examine a sampling of records demonstrating that the organization considered scientific evidence for drugs not approved on the formulary.  In addition, the reviewer will examine randomly selected coverage decisions and even interview a member of the P & T committee.

[Note as of February 1, 2010: the new version has an odd scoring regimen, one that, as written, would suggest only the first element (an assessment of peer-reviewed the medical literature) is required, and the other four are optional.  We don't believe that to be the intent, and so are going with the above interpretation until we hear otherwise.]