CMS Part D Rules for Opioid Dispensing Safety Edits

New CMS Part D rules for opioid dispensing safety edits went into effect Jan. 1, which now require hard safety edits for seven-day initial fill limits for opioid prescriptions for the treatment of acute pain and an opioid care coordination edit at 90 morphine milligram equivalents (MME) per day for certain beneficiaries.

Per the October 23, 2018 memo to all Part D sponsors from Amy Larrick Chavez-Valdez, Director of the CMS Medicare Drug Benefit and C & D Data Group:

“CMS expects sponsors to implement the following formulary-level opioid safety edits in 2019:

  • Soft edit for concurrent opioid and benzodiazepine use,
  • Soft edit for duplicative long-acting (LA) opioid therapy,
  • Care coordination edit at 90 morphine milligram equivalents (MME),
  • Hard edit at 200 MME or more (optional), and,
  • Hard edit 7 day supply limit for initial opioid fills (opioid naïve).

In response to the inquiries about the opioid safety edits, we are issuing these frequently asked questions (FAQs) as supplemental guidance along with a summary of preliminary lessons learned from the pilot.”

The memo builds on the The CY 2019 Call Letter, which provided detailed guidance on opioid safety edits.

The memo provides key takeaways from the pilot program, which will be updated as CMS collects further data on the program. In the memo CMS also emphasizes that the supply limits and the care coordination safety edits are not intended to create “additional, cumbersome documentation requirements surrounding the care coordination edit consultation or redundant consultations as discussed below.” CMS states that it does not expect the pharmacist to do extra work to identify exclusions if not already known.

Download a PDF of the memo:

And read more about pharmacy edits in the January/February 2019 cover story: “The World of Edits Pharmacy.”