CMS Issues Memorandum on New Opioid Safety Edit Submission Guidelines for Medicare Part D Sponsors in 2026

• On July 3, 2025, CMS announced new opioid safety edit submission guidelines for Medicare Part D sponsors for 2026.  
• Medicare Part D sponsors must have concurrent drug utilization review systems designed to ensure that, before a prescription is dispensed, a review of the prescribed drug therapy is performed.  
• Sponsors must implement opioid safety edits — with exemptions for specific patient populations, such as hospice or cancer patients. The safety edits must include:  
  • A care coordination edit based on a cumulative morphine milligram equivalent (MME) 90 MME per day,  
  • A hard safety edit limiting initial opioid prescriptions for acute pain to no more than a 7-day supply (opioid naïve), and  
  • An optional hard MME edit at 200 MME/day.
• Sponsors must submit opioid safety edit data via the HPMS Opioid Safety Edits module between August 12 and August 19, 2025. PACE organizations must also submit data regardless of the claims adjudication method.
• The edits prompt additional safety reviews by prescribers and pharmacists to ensure appropriate opioid use while minimizing burden and maintaining clinical judgment. They are not prescribing limits but tools to balance opioid overuse prevention with patient access.  
• Part D plan sponsors must have a mechanism to allow opioid safety alerts to be overridden at the point-of-sale (POS) when an enrollee is exempt.  

More on This Topic: 

• Memorandum
• Additional CMS educational materials 

For questions, please reach out to Vicky Jucelin.