The URAC PBM Standards: Module 4: Drug Utilization Management

Not surprisingly, these standards track closely the URAC Health Utilization Management (HUM) standards. Of particular note is the fact that 14 of the module’s 27 standards (52 percent) are mandatory, an unusually high percentage when compared to the other modules. This reflects the committee’s awareness that weaknesses in these processes are more likely to have a dangerous impact on the health and safety of consumers. The mandatory standards are:

• DrUM 1 – DrUM Program Components, which requires the PBM to develop and implement P&Ps that address criteria for optimal drug use and evaluating the available drug submission data.
• DrUM 2 - Coverage Decisions Based on Clinical Information, requiring that such decisions be based upon such considerations as peer-reviewed literature, practice guidelines, and other markers of appropriateness.
• DrUM 4 – Prospective, Concurrent and Retrospective DrUM, requiring that the PBM ensure DUM mechanisms that address such thirteen issues, such as therapeutic appropriateness, over- and under-utilization, proper generic use, and drug-disease contraindications.
• DrUM 5 - Consumer Safety, requiring that the PBM have distinct processes for identifying and rectifying consumer safety issues.
• DrUM 8 - Prospective Reviewer Qualifications, imposing minimum qualifications for prospective reviewers.
• DrUM 9 – Automated Review, which requires PBMs with automated review process to “define the algorighmic protocol being use and validate the initial automated algorithm.” This automated process will need to be reviewed regularly to assure that it’s working properly, that it is up-to-date with current evidence-based knowledge, and examines the rate of appeals.
• DrUM 10 - Review of Automated Review Non-Certifications, requiring that PBMs "have policies and procedures in place to provide oversight of the automated review process and its linkage to the appeals process."
• DrUM 19 - Appeals, requiring that the PBM "provide access to a formal appeal process if a request for a noncovered drug is denied."
• DrUM 20 - Appeals Process Consumer Rights, which requires that PBMs "provide information to the consumer on how to request an exception or appeal."
• DrUM 21 – Non-Certification Appeals Process, specifying that the PBM’s have both a standard appellate process for non-urgent cases and an expedited appellate process for urgent situations. The PBM will need to make the written P&Ps describing these appellate processes available to consumers upon request.
• DrUM 22 - Appeals Process, which fleshes out the essential components of a PBM appeals process.
• DrUM 23 – Appeal Peer Review Qualifications, establishing very specific requirements for the PBM’s appellate reviewers, most notably that they be active, board-certified (where applicable) MDs, DOs, pharmacists, or clinical peers who weren’t involved and don’t work under anybody who was involved in the earlier decision.
• DrUM 24– Expedited Appeals Process Timeframe, requiring notice of the decision in the expedited appeal within 72 hours of the request for review and a written confirmation within 3 days.
• DrUM 25 - Standard Appeals Process Timeframe, requiring that the PBM's standard appeals process be "completed, and written notification of the appeal decision issued,within 30 calendar days of the receipt of the request for appeal."