Improving Drug Utilization Review Controls in Part D
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.
Downloads
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CY 2025 Opioid Safety Edit Submission Instructions (PDF) -
Frequently Asked Questions about Formulary-Level Opioid Point-of-Sale Safety Edits (July 5, 2024) (PDF) -
CY 2024 OMS Technical Guidance (2024_04) (ZIP) -
CY 2024 Opioid Safety Edit Submission Instructions (PDF) -
2024 Patient Safety Memo 20240424 (PDF) -
2023 Patient Safety Memo 04.20.2023 (PDF) -
CY 2023 Part D DMP Guidance (April 20, 2023) (ZIP) -
CY 2023 OMS Technical Guidance (2023_04) (ZIP) -
CY 2023 Drug Management Program Notices (ZIP) -
CY 2023 Opioid Safety Edit Reminders and Recommendations (PDF) -
Medicare Part D Opioid Policies: Information for Pharmacists (December 19, 2022) (PDF) -
Medicare Part D Opioid Policies: Information for Prescribers (December 19, 2022) (PDF) -
Safer Use of Opioid Pain Medication (October 2021) (PDF) -
Overutilization Contacts (05012024) (ZIP) -
Overutilization Contacts (12042023) (ZIP) -
Frequently Asked Questions (FAQs) About Drug Management Programs (DMP) (November 28, 2022) (PDF)