CMS Announces New Guidelines on High-Dose Opioids

By: Jody Lutz

Reading Time: 3 minutes

This month the Center for Medicare & Medicaid Services (CMS) published new limits for high-dose opioid prescriptions for Medicare Part D users. The announcement is part of the 2019 Medicare Advantage and Part D Rate Announcement and Call Letter.

The policy also follows the CDC opioid prescribing guidelines for primary care physicians released last year. High dosage thresholds outlined include parameters for prescriptions greater than 90 MME, which state a pharmacist should consult with prescriber and document the discussion. At 200 MME, a hard cap is implemented that can only be overridden by the plan sponsor. Additional guidelines for opioid naïve patients were also included, limiting initial opioid prescriptions to no more than a 7 days’ supply for the treatment of acute pain.

CMS Centers for Medicare & Medicaid Services

The Medicare announcement focused on several areas and was broken down by patient type:

  • New opioid users
  • Chronic opioid users
  • Users with uncoordinated care
  • Users concurrently using opioids and benzodiazepines

Exclusions to the limits outlined include:

  • Long-term care facility residents
  • Hospice, palliative, end-of-life care
  • Medication Assisted Treatment patients

Special consideration is identified for high risk users: beneficiaries consider at significant risk (using high levels of opioids from multiple prescribers and pharmacies). Additionally, the concurrent use of Opioids and Benzodiazepines was mentioned in several areas.

Care Coordination was highlighted as, “CMS believes it is important that MA-PDs set expectations for prescribers to implement the CDC’s recommendations as a best practice through their provider contracts. PDPs should also reinforce these messages through interactions with prescribers as an integral component of sponsors’ drug utilization management program.”

CMS also set expectations for prescriber to implement the CDC recommendations as a “best practice” through provider contracts.

Responses have been mixed for the plan. The Pain News Network reported that over 1,200 people left public comments in the Federal Register after the proposed changes were announced changes in March, most of them sharply critical of rules that would make it harder for Medicare patients to obtain high doses of opioid pain medication. A joint letter opposing the rule changes was also submitted by 180 doctors and academics, including some who helped draft the CDC guidelines. The letter points out that a steep reduction in high dose prescribing since 2010 has not reduced the number of opioid overdoses. And it faults CMS for being focused on reducing the number of high dose prescriptions – not the quality of patient care. 

Referencing back to last summer's  HHS OIG Data Brief • July 2017 • OEI-02-17-00250 it’s interesting to reflect what these data points identified and where we are going on this road to ending the opioid epidemic in America.

Opioids in Medicare Part D: Concerns about Extreme Use and Questionable Prescribing has several key take aways:

  • One in three Medicare Part D beneficiaries received a prescription opioid in 2016
  • About 500,000 beneficiaries received high amounts of opioids
  • Almost 90,000 beneficiaries are at serious risk; some received extreme amounts of opioids, while others appeared to be doctor shopping
  • About 400 prescribers had questionable opioid prescribing patterns for beneficiaries at serious risk


The national conversation regarding opioid prescription management will continue. Follow along with AffirmHealth as we examine these issues and many more.

At AffirmHealth, we understand that developing and enacting prescribing protocols takes considerable time and effort. We partner with organizations to build and implement risk-informed protocols tailored to the practice. Our new product Shield is a software platform to help manage, facilitate and measure prescribing compliance using those protocols. We would welcome the opportunity to partner with your organization.

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