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.
The CMS launched its Overutilization Monitoring System in 2013 to identify high-risk patients among the 42 million beneficiaries who receive prescription drugs through the Medicare Part D program so that interventions could be carried out.
But 95 percent of these patients who were been diagnosed with opioid use disorder or overdose did not meet the federal agency's criteria for those who overuse opioids, and half of those who were identified as overusers did not develop the disorder or overdose.
“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 Wei, an assistant professor of pharmaceutical outcomes and policy in the UF College of Pharmacy and lead author of the study, in a news release. “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.”
In 2016, the U.S. Government Accountability Office reported one-third of individuals participating in Medicare Part D received at least one opioid prescription.
Almut Winterstein, an author on the study, is the Professor and Chair in the Department of Pharmaceutical Outcomes and Policy at the UF College of Pharmacy. She said one of the biggest failings of the monitoring program is that doesn't account for illicit drug use - like unprescribed medications or heroin.
"They have to consider ways of capturing illicit opioid use because that seems to have become an increasingly important and concerning element in this,” Winterstein said.
Wei cautioned state and government leaders against relying solely on OMS prescription dispensing data when writing policies to combat the nation’s opioid epidemic. The researcher said other prescription drug monitoring programs, like the one in Florida, use similar criteria.
“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.
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 not have cancer or 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.