2026 Medicare Part D Opioid Safety Edits Guidelines and Submission Instructions
Relevant to: PDP, PACE, Part D
Each week, we scan the latest CMS memos to find the most important ones that apply for PACE programs. Below is a summary of what you need to know.
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Introduction
The CMS has issued important guidelines for Medicare Part D sponsors regarding opioid safety edits for the contract year 2026. These safety edits are designed to oversee prescription opioid use and ensure safe dispensing practices for beneficiaries. The instructions highlight measures such as care coordination edits and hard safety edits tailored to prevent the overuse of opioids while maintaining access to necessary medications for those in need.
Key Dates and Deadlines
- Memo Date: July 3, 2025
- Submission Period: August 12, 2025 – August 19, 2025, 5:00 p.m. EDT
PACE Compliance
This memo is relevant to PACE programs because it requires PACE plans to submit opioid safety edit information in HPMS. The Centers for Medicare & Medicaid Services (CMS) mandates that all PACE Organization contracts submit these safety edit details to ensure compliance, regardless of the pharmacy claim adjudication method used by the plan.
Plans must:
- Use the Opioid Safety Edits module within HPMS to provide necessary details on opioid care coordination edits, hard MME edits, and opioid naïve 7-day supply edits.
- Submit this information between August 12, 2025, and August 19, 2025, by 5:00 p.m. EDT.
- Follow instructions as outlined in the 2026 HPMS Plan User Guide for submitting and revising opioid safety edits.
- Ensure submission of the information is done even if the plan does not adjudicate claims at the point of sale.
For PACE plans, the implementation of these edits aims to balance patient care by prompting additional safety reviews of opioid prescriptions, which should be in line with patient needs and minimize burden on healthcare providers.
Required Actions
1. Part D sponsors should submit opioid safety edit information in the HPMS Opioid Safety Edits module between August 12, 2025, and 5:00 p.m. EDT on August 19, 2025. Refer to the Opioid Safety Edits Module Plan User Guide for detailed instructions.
2. For any revisions after initial submission, sponsors must email PartD_OM@cms.hhs.gov with specified details such as contract ID, revision intentions, proposed implementation date, and justification for the change to the opioid safety edits.
3. Ensure pharmacists and customer service representatives are informed about the possibility of claim rejections due to the opioid naïve edit for new enrollees, and guide them on utilizing override codes when necessary.
FAQs
- “What are the CMS guidelines for opioid safety edits in Medicare Part D plans?”
- “How can Part D sponsors submit opioid safety edit information for CY 2026?”
- “Which patient exemptions are considered in the opioid safety edit specifications?”
- “Can opioid safety edits be revised after initial submission?”
