Since 1993, section 1927(g) of the Act has required each state to develop a DUR program targeted, in part, at reducing clinical abuse and misuse of outpatient prescription drugs covered under the State’s Medicaid Program. Medicaid DUR is a structured, ongoing program that interprets patterns of drug use in Medicaid programs and includes prospective drug review, retrospective drug use review, data assessment of drug use against predetermined standards, and ongoing educational outreach activities conducted by Medicaid state agencies, managed health care systems, pharmacy benefit managers (PBMs), academic institutions and/or other applicable stakeholders. The Medicaid DUR Program promotes patient safety through state-administered utilization management tools and systems that interface with the claims processing systems. Additionally, consistent with 42 CFR §438.3(s)(4) and (5) the Centers for Medicare and Medicaid Services (CMS) requires any Managed Care Organization (MCO) that includes covered outpatient drugs to operate a DUR program that complies with section 1927(g)(3)(D) and 42 CFR 456, subpart K. The MCO DUR program must be as comprehensive as the states FFS program.
Value-based Purchasing (VBP) and Drug Utilization Review (DUR) Proposed Regulation
Notice of Proposed Rulemaking – On June 17, 2020, CMS put on display a Notice of Proposed Rulemaking (NPRM) CMS-2482-P which proposes to advance CMS’ efforts to support state flexibility to enter innovative value-based purchasing arrangements (VBPs) with drug manufacturers for new expensive therapies, and to provide manufacturers with regulatory flexibility to enter into VBPs with commercial payers, which will benefit Medicaid programs. It also creates minimum standards in state Medicaid Drug Utilization Review (DUR) programs designed to reduce opioid-related fraud, misuse and abuse and proposes changes to coordination of benefits (COB) and third party liability (TPL) rules related to the special treatment of certain types of care and payment in Medicaid and Children’s Health Insurance Program (CHIP).
Prospective DUR (ProDUR)
ProDUR involves state Medicaid agencies electronic monitoring system to screen prescription drug claims to identify problems such as:
- Potential and actual adverse effects
- Therapeutic duplication
- Drug-disease interactions and contraindications
- Incorrect dosage, frequency or duration of treatment
- Drug allergy
- Clinical misuse or abuse
- Drug-drug interactions
- Medication appropriateness
- Incorrect drug dosage, duration or overutilization and underutilization of drug treatment
- Pregnancy alerts
Retrospective DUR (RetroDUR)
RetroDUR involves state Medicaid agencies ongoing and periodic review of claims data to identify patterns of:
- Therapeutic appropriateness
- Adverse events
- Appropriate use of generic products
- Incorrect duration of treatment
- Inappropriate or medically unnecessary care
- Gross overuse
Educational programs through Medicaid state agencies, managed health care systems, PBMs, academic institutions and/or other applicable stakeholders to improve prescribing on common drug therapy problems, provide for active and ongoing outreach to educate practitioners on common drug therapy problems with the goals of improving prescribing or dispensing practices and increasing patients medication compliance and over-all health.
42 CFR Subpart K – Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims Section 456.700-456.725 provides the requirements for the DUR program.
Please direct all communications to the CMSDUR@cms.hhs.gov resource mailbox.