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Improving Drug Utilization Review Controls in Part D

Guidance for Part D plan sponsors containing information about the Medicare Part D opioid overutilization policies and announcing new strategies to further help Medicare Part D sponsors prevent and combat opioid overuse including additional safety alerts at the time of dispensing as a proactive step to engage both patients and prescribers about overdose risk and prevention.

Issued by: Centers for Medicare & Medicaid Services (CMS)

Issue Date: August 03, 2020

This page contains information about Medicare Part D opioid overutilization policies including:

Drug Management Programs

Section 1860D-4(c)(5)(A) of the Social Security Act permits Part D sponsors to establish drug management programs (DMPs) for beneficiaries who are at risk for misuse or abuse of frequently abused drugs (FADs). CMS codified the framework for DMPs in the 2019 Parts C & D Final Rule, available at: https://www.gpo.gov/fdsys/pkg/FR-2018-04-16/pdf/2018-07179.pdf. The rule codified many aspects of CMS’ earlier retrospective Part D Opioid Drug Utilization Review (DUR) policy and the Overutilization Monitoring System (OMS), with adjustments as needed to comply with the Comprehensive Addiction and Recovery Act of 2016 (CARA), by integrating them into the DMP provisions. Thus, this rule addressed beneficiaries who are at risk due to obtaining opioids from multiple prescribers and/or pharmacies.

Beginning January 1, 2022, all Part D sponsors are required to have a DMP, and to include beneficiaries with a history of opioid-related overdose in their DMP pursuant to the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act. CMS codified these requirements and other policy changes in the 2022 Parts C & D Final Rule, available at: https://www.govinfo.gov/content/pkg/FR-2021-01-19/pdf/2021-00538.pdf.

Additional information about DMPs, including program guidance, FAQs, OMS technical guidance, and beneficiary notices are located below in the Downloads section.

Opioid Safety Alerts 

Effective January 1, 2019, CMS announced strategies to further help Medicare Part D sponsors prevent and combat opioid overuse, including additional safety alerts at the time of dispensing as a proactive step to engage both patients and prescribers about overdose risk and prevention. These safety alerts were announced in the 2019 Medicare Parts C&D Final Call Letter, available at: https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2019.pdf (PDF)

Additional information about opioid safety edits, including policy guidance, FAQs, and technical guidance are located below in the Downloads section.

Educational materials for Medicare Part D opioid overutilization policies are also located below in the Downloads section.

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DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.