UF study questions accuracy of CMS opioid safeguards

A new study by University of Florida researchers questions the accuracy of the criteria used by the Centers for Medicare and Medicaid Services to identify patients at risk of opioid abuse and overdose.

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Yu-Jung “Jenny” Wei, Ph.D., an assistant professor in the UF College of Pharmacy, led a study published in the Journal of the American Medical Association that questions the accuracy of CMS’ criteria for flagging patients at risk of opioid abuse and overdose.

The CMS launched its Overutilization Monitoring System, or OMS, in 2013 to identify such high-risk patients among the millions of beneficiaries who receive prescription drugs through the Medicare Part D program. The CMS required Medicare Part D sponsors to implement interventions for these patients.

UF College of Pharmacy researchers found the majority, at least 95 percent, of these patients who had been diagnosed with opioid use disorder or overdose did not meet CMS’ opioid overutilization criteria. In addition, half of the opioid overutilizers identified by CMS did not develop opioid use disorder or overdose during the study period. The findings were published in JAMA.

“The CMS criteria do not appear to be a good clinical marker for identifying patients at risk for opioid-related adverse events,” said Yu-Jung “Jenny” Wei, Ph.D., an assistant professor of pharmaceutical outcomes and policy in the UF College of Pharmacy and lead author of the study. “If the criteria are not accurate, there is potential to miss a lot of people who are at risk and might need help. Patients may also be flagged as overutilizers who are not abusing opioids.”

UF researchers used data from a nationally representative sample of Medicare beneficiaries from 2011 through 2014, including between 142,036 and 190,320 beneficiaries who had at least one opioid prescription filled every six months. The beneficiaries had to be continuously enrolled in Medicare Parts A, B and D and have no cancer nor be receiving hospice care. Opioid overutilizers were identified consistent with the OMS criteria as receiving a daily morphine equivalent dose greater than 90 mg from more than three prescribers and three pharmacies or a dose greater than 90 mg from more than four prescribers.

The Medicare Part D program provides prescription drugs to more than 42 million beneficiaries. In 2016, the U.S. Government Accountability Office reported one-third of individuals participating in Medicare Part D received at least one opioid prescription.

Wei cautions state and government leaders from relying solely on OMS prescription dispensing data when writing policies to combat the nation’s opioid epidemic.

“As we are developing solutions to the opioid crisis, it is important for policymakers, health care providers and health insurance companies to be aware that solely relying on opioid prescription data is likely to be ineffective in identifying the high-risk populations for interventions,” Wei said.

Contributing authors for this study include: Cheng Chen, BS.Pharm.; Amir Sarayani, Pharm.D.; and Almut Winterstein, Ph.D.