A federal policy to reduce opioid-related harm among some of the nation’s most vulnerable patients succeeded in curbing high-risk prescribing practices, but its longer-term impact looks less promising, new Duke research finds.
The study — part of a four-year research award from the U.S. National Institute on Drug Abuse (NIDA) originating at Emory University with co-investigators from Harvard and Duke — examines a 2019 Medicare safety policy designed to prevent opioid overdoses alongside extensive disruptions that followed during the COVID-19 pandemic, including expanded telehealth and temporary regulatory flexibility.
Researchers focused on non-elderly Medicare beneficiaries with disabilities — a population that represents just 3% of the U.S. but accounts for roughly a quarter of opioid-related hospitalizations and overdose deaths.
“This is a group with disproportionately high risk,” said senior co-investigator Dr. Frank Wharam, professor in the Division of General Internal Medicine, referencing the prevalence of chronic pain and long-term, high-dose opioid therapy among disabled beneficiaries. “Understanding how policy changes affect both prescribing and patient outcomes is critical.”
Policy Aimed at Reducing Risk
Implemented in January 2019, the Medicare policy introduced two key “safety edits”: limiting initial opioid prescriptions to a seven-day supply and restricting high daily doses — measured in morphine milligram equivalents — particularly when patients received prescriptions from multiple providers.
The analysis included two distinct patient groups: those newly prescribed opioids and those already receiving long-term opioid therapy.
Using a large national claims database, researchers conducted an interrupted time-series analysis of Medicare Advantage beneficiaries under age 65 with disability status, spanning June 2016 through September 2021. The study compared opioid prescribing patterns before and after the policy took effect while capturing shifts during the COVID-19 pandemic.
Sharp Drop in Longer Prescriptions
Among patients new to opioids, the policy was associated with a dramatic and sustained decline in prescriptions exceeding a seven-day supply. At the start of the post-policy period, the likelihood of receiving a longer prescription dropped by nearly 47%, a reduction that remained largely stable through the end of the study.
The policy also produced a more modest initial decline in the transition from short-term to long-term opioid use — down nearly 14% immediately after implementation. However, that effect weakened over time and was no longer statistically significant by the end of the study period.
“These findings suggest the policy was effective at changing prescribing behavior,” Dr. Wharam said. “However, when looking at an adverse opioid-related outcome — conversion to long-term opioid use — we saw improvements only in the first year or so after the policy began.”
COVID-19 Disruptions Reversed Some Gains
For patients already on long-term opioid therapy, the policy’s high-dose safeguards also showed early success. The number of high-dosage prescriptions involving multiple prescribers dropped by more than 36% immediately after implementation.
But that progress was undone during the COVID-19 pandemic. Temporary policy changes that relaxed prescribing restrictions — including those intended to facilitate access via telehealth — effectively reversed the reductions in high-dose, multi-prescriber opioid use.
“The pandemic created a natural experiment,” the authors note. “It highlights how quickly policy gains can be lost when safeguards are lifted.”
Balancing Safety and Pain Management
The findings underscore the complexity of opioid policy, particularly for patients with chronic pain and disability. While stricter prescribing rules may reduce the risk of misuse and overdose, they can also carry unintended consequences — such as undertreatment of pain or inappropriate tapering of long-term medications.
“Our results point to both the promise and the limitations of supply-side interventions,” the researchers conclude. “Policies targeting prescribing are important, but they are not sufficient on their own.”
The study calls for additional strategies to address the broader clinical and social factors driving opioid-related harm in this high-risk population, including improved pain management, care coordination, and support for behavioral health.
As policymakers continue to grapple with the opioid crisis, the research offers a clear takeaway: reducing risk requires more than restricting prescriptions — it demands sustained, multifaceted solutions tailored to the patients most affected, Dr. Wharam added.