Medicare opioid safety policy shows initial success but effectiveness diminishes over time

A new study led by researchers at the Harvard Pilgrim Health Care Institute found that a 2019 Medicare opioid safety policy showed initial reductions in opioid prescribing to high-risk populations. However, the policy's effectiveness diminished over time.

The study was published in JAMA Internal Medicine on February 10.

Medicare provides coverage for 9 million U.S. adults with disabilities under the age of 65. Despite representing only 3% of the U.S. population, these beneficiaries account for 25% of opioid-related overdose deaths and hospitalizations. On January 1, 2019, the Centers for Medicare & Medicaid Services (CMS) required all Medicare Part D plans to implement an opioid safety policy. This policy limits new opioid users to a 7-day supply and restricts prescriptions to no more than 90 morphine milligram equivalents daily.

Harvard Pilgrim Health Care Institute researchers and collaborators examined whether the policy led to shorter initial opioid prescriptions and reduced progression to long-term use among new users, as well as fewer high-dosage prescriptions from multiple prescribers among long-term users, without disrupting stable high-dose opioid therapy or causing adverse events.

As the ongoing opioid crisis impacts high-risk groups such as disabled Medicare beneficiaries, it is imperative to evaluate policies designed to reduce these harms. We have the data and the methods to produce evidence that policymakers should consider when adjusting these policies to the unique needs of these vulnerable populations."

Hefei Wen, Harvard Medical School assistant professor of population medicine at the Harvard Pilgrim Health Care Institute and lead author of the study

The study analyzed a rolling cohort of Medicare beneficiaries with disabilities using Optum's deidentified Clinformatics Data Mart database. The analysis covered a 31-month pre-policy period (June 2016 to December 2018) and a 33-month post-policy implementation period (January 2019 to September 2021). The team prioritized two cohorts within the study population: new users, identified by an initial opioid fill after a 3-month opioid-free period; and long-term users, defined by an opioid duration of 60 days or longer with 80 or more total days' supply within a 4-month window.

Results suggest that the 2019 Medicare opioid safety policy reduced the length of initial opioid prescriptions and the frequency of high-dose prescriptions from multiple-prescribers among Medicare beneficiaries with disabilities. While the 7-day safety edit led to immediate and sustained reductions in initial opioid prescriptions exceeding 7 days, these reductions diminished by the end of the study period. The 90-MME limit resulted in an immediate reduction in concurrent multiple-prescriber high-dosage episodes; though this effect was reversed when COVID-19 flexibilities rolled back the 90-MME edit. These findings, the researchers say, show that the work to curtail the opioid crisis should remain ongoing, evolving, and evidence-based.

"While our analysis reveals immediate reductions in high-risk opioid prescribing, our analyses show that these reductions diminished over time, highlighting the need for further research to understand crucial downstream policy effects and subpopulations at risk," added Dr. Wen. "Policymakers and insurers should consider additional clinical and culturally nuanced interventions that address medical and social risk factors of opioid misuse."