CMS Pub. 100-18, ch. 7, § 20.3

A Part D sponsor must have concurrent DUR systems, policies, and procedures designed to

ensure that a review of the prescribed drug therapy is performed before each prescription is

dispensed to an enrollee in a sponsor’s Part D plan, typically at the point-of-sale or point of

distribution.

The Part D sponsor’s concurrent DUR program must include, but is not limited to, the following

checks each time a prescription is dispensed:

• Screening for potential drug therapy problems due to therapeutic duplication

• Age/gender-related contraindications

• Over-utilization and under-utilization

• Drug-drug interactions

• Incorrect drug dosage or duration of drug therapy

• Drug-allergy contraindications

• Clinical abuse/misuse

Part D sponsors should maintain written concurrent DUR policies and procedures that explain

the level of the DUR checks (i.e., whether they are imposed at the pharmacy and/or plan level),

systems logic for establishing the edits, thresholds used to trigger the edits, and accompanying

pharmacy messaging. These policies should detail how the aforementioned elements were

established (e.g., thresholds used are based upon relevant clinical and drug information

references), validated and revised. Sponsors’ DUR policies should also address pharmacy

requested overrides and detail how pharmacy override requests are evaluated and approved.

Moreover, sponsors’ policies should explain how trends in override requests (both approved and

unapproved) are monitored and considered in ongoing formulary management.

Part D sponsors should be able to demonstrate how information obtained from their DUR

program is used in their overall quality assurance system and improves their enrollees’ quality

of care.