Medicare Formulary Coverage and Restrictions for Opioid Potentiators from 2013 to 2017

  • Aishwarya Vijay
  • Joseph S. Ross
  • Nilay D. Shah
  • Molly M. Jeffery
  • Sanket S. Dhruva
Concise Research Reports


In 2015, 38% of adults used prescription opioids, with slightly higher rates among older adults.1 Risks of opioids have been well-described and are greater among older adults and when used concurrently with three commonly prescribed “opioid potentiator” drug classes: benzodiazepines, non-benzodiazepine sedative hypnotics, and gabapentinoids.2, 3 These drugs also have risks when used on their own; in particular, there has been an increasing risk of death associated with benzodiazepine use.4

Medicare formulary coverage and utilization management strategies, including quantity limits, prior authorization, and step therapy, offer opportunities to limit potentially unsafe use of opioid potentiators, similar to coverage restrictions of opioids.5Based on Centers for Disease Control guidelines that propose more limited opioid availability and the fact that formulary restrictions are infrequently used to control opioid prescribing, Medicare recently proposed formulary changes to...



During the conduct of this work, Dr. Dhruva was supported by the National Clinician Scholars Program and the Department of Veterans Affairs. Ms. Vijay received a student research grant provided by the Yale School of Medicine Office of Student Research.

Compliance with Ethical Standards

Conflict of Interest

Over the past 36 months, Dr. Ross received support through Yale University from the Food and Drug Administration as part of the Centers for Excellence in Regulatory Science and Innovation (CERSI) program, from Johnson and Johnson to develop methods of clinical trial data sharing, from Medtronic, Inc. and the Food and Drug Administration (FDA) to develop methods for postmarket surveillance of medical devices, from the Blue Cross Blue Shield Association to better understand medical technology evaluation, from the Centers for Medicare and Medicaid Services (CMS) to develop and maintain performance measures that are used for public reporting, from the Agency for Healthcare Research and Quality (AHRQ) to examine community predictors of healthcare quality, and from the Laura and John Arnold Foundation, which established the Collaboration for Research Integrity and Transparency (CRIT) at Yale University. Dr. Shah received support from the Food and Drug Administration as part of the Centers for Excellence in Regulatory Science and Innovation (CERSI) program, through the Mayo Clinic from the Centers for Medicare and Medicaid Services (CMS), Agency for Healthcare Research and Quality (AHRQ), National Science Foundation, and Patient-centered Outcomes Research Institute (PCORI). All remaining authors declare that they do not have a conflict of interest.


The authors assume full responsibility for the accuracy and completeness of the ideas presented, which do not represent the views of the Department of Veterans Affairs or any other supporting institutions


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    Han B, Compton WM, Blanco C, Crane E, Lee J, Jones CM. Prescription opioid use, misuse, and use disorders in US adults: 2015 National Survey on Drug Use and Health. Ann. Intern. Med. 2017;167(5):293–301.CrossRefGoogle Scholar
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    National Institutes of Health. Benzodiazepines and Opioids. 2018. Accessed: October 26, 2018.
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    Gomes T, Greaves S, van den Brink W, et al. Pregabalin and the Risk for Opioid-Related Death: A Nested Case–Control Study. Ann. Intern. Med. 2018.Google Scholar
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    National Institutes of Health. Overdose Death Rates. 2018. Accessed: October 26, 2018.
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    Samuels EA, Ross JS, Dhruva SS. Medicare formulary coverage restrictions for prescription opioids, 2006 to 2015. Ann. Intern. Med. 2017;167(12):895–896.CrossRefGoogle Scholar
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    Centers for Medicare and Medicaid Services. 2019 Medicare Advantage and Part D Advance Notice Part II and Draft Call Letter. 2018. Accessed: October 26, 2018.

Copyright information

© Society of General Internal Medicine (This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply) 2019

Authors and Affiliations

  • Aishwarya Vijay
    • 1
  • Joseph S. Ross
    • 2
    • 3
    • 4
  • Nilay D. Shah
    • 5
    • 6
  • Molly M. Jeffery
    • 5
    • 6
  • Sanket S. Dhruva
    • 7
    • 8
  1. 1.Yale School of MedicineNew HavenUSA
  2. 2.Center for Outcomes Research and EvaluationYale-New Haven Health SystemNew HavenUSA
  3. 3.Section of General Internal Medicine, Department of Internal Medicine, School of MedicineYale UniversityNew HavenUSA
  4. 4.Department of Health Policy and Management, School of Public HealthYale UniversityNew HavenUSA
  5. 5.Division of Health Care Policy and ResearchMayo ClinicRochesterUSA
  6. 6.Robert D. and Patricia E. Kern Center for the Science of Health Care DeliveryMayo ClinicRochesterUSA
  7. 7.San Francisco Veterans Affairs Medical CenterSan FranciscoUSA
  8. 8.Department of MedicineUniversity of California, San Francisco School of MedicineSan FranciscoUSA

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