The Basics

This standard describes the minimum requirements for the written notification of the organization's non-certification decision.  The PBM must send that notification to both the consumer and the prescriber. 

• First, it must include the "principal reason" for the non-certification.  To qualify as a "principal reason", the reason must explain why the consumer is not meeting the clinical guideline.  A general statement that the drug is not medically necessary or that the consumer does not meet guidelines will not be sufficient.  There will need to be some reason that connects the patient's situation with the failure to meet guidelines.
• Second, the written notification needs to explain to the consumer and prescriber that they can obtain a more detailed clinical description of the reason, known as a "clinical rationale", if they submit a request to the PBM.  The letter also must explain how to submit such a request.  The clinical rationale is more specific than the "principal reason" in explaining the specific reasons why clinical review criteria were not met.
• Finally, the written notification must explain how the consumer and/or prescriber would go about initiating an appeal from the PBM's decision.

Management Tips

It will not be sufficient to have your template letter comply with the standard.  Rather, in addition to a compliance template written notification of non-certification, you will also need a policy and procedure that clearly describes the minimum requirements for that written notification.

In addition, it will be important to make sure that the physicians or pharmacists making the non-certification decisions are sufficiently trained in how to write a "principal reason" in a way that qualifies under this standard.  Many reviewers, when pressed for time, will simply say something like "does not meet criteria."  However, URAC has made it clear that this will not qualify as a "principal reason."

URAC Accreditation Tips

The five elements of this standard are each weighted 4.

The documentation required for the desktop review is the applicable policy and procedure and the template letter.

During the on-site review, the reviewer will examine case files of denials of requests for certification to determine whether the written notifications have been sent to both the patient and prescriber and whether those written notifications contain the necessary components as required by the standard.  In addition, the reviewer will be looking for examples of cases where the prescriber or patient asked for a written description of the clinical review criteria upon which a non-certification was based.