PROJECT SUMMARY/ABSTRACT
Representing ~3% of the U.S. population, non-elderly disabled Medicare beneficiaries (henceforth “disabled
beneficiaries”) account for ~25% of overdose deaths and hospitalizations related to prescription opioids.
Among disabled beneficiaries, opioid-related harms are concentrated in the 20-25% who are prescribed long-
term opioid therapy, primarily for chronic pain. We will first examine effects of a recent, important policy
intervention – Medicare Part D opioid safety edits – on an understudied, high-risk cohort of disabled
beneficiaries who are prescribed long-term, high-dose opioid therapy (Aim 1). Effective January 1, 2019,
Medicare Part D plans are required to incorporate a set of enhanced safety edits into their drug utilization
review systems. The most salient is a “care coordination edit” alerting pharmacists when daily doses of opioid
prescriptions exceed 90 morphine milligram equivalence. The new Medicare Part D opioid safety policy is
intended to identify overprescribing through pharmacist-prescriber consultation without directly restricting
patient access (intended beneficial effect). It may also encourage the initiation of buprenorphine for opioid use
disorder treatment in lieu of high-dose opioid regimes (beneficial spillover effect). However, the possible
misinterpretation of the 90-MME threshold as a “hard stop”, coupled with administrative burdens, may prompt
rapid dose reduction and abrupt discontinuation (unintended detrimental effect). Furthermore, overrepresented
among disabled beneficiaries, racial/ethnic minority patients and rural patients may be less likely to benefit
from the Medicare Part D opioid safety policy and more susceptible to unintended harms (Aim 2). The
Medicare Part D opioid safety policy is now playing out against a backdrop of the COVID-19 pandemic. To
minimize potential disruptions to health care, the federal government has made temporary changes to the
Medicare telehealth and opioid regulations, which may facilitate the beneficial effects of the Medicare Part D
opioid safety policy and alleviate the detrimental policy effects (Aim 3). We will use 2017-22 Medicare claims
data and a quasi-experimental design. We will assess appropriate opioid tapering (intended beneficial effect),
inappropriate opioid tapering (unintended detrimental effect), buprenorphine initiation (beneficial spillover
effect), and opioid-related adverse events in emergency department and inpatient settings (downstream
effect). We aim to: 1. Examine effects of the first-year, pre-pandemic implementation of the Medicare Part D
opioid safety policy on disabled beneficiaries who are prescribed long-term, high-dose opioid therapy; 2.
Compare racial/ethnic and rural-urban differences in policy effects; 3. Extend Aims 1 and 2 to the pandemic
and post-pandemic eras to elucidate the interaction of the Medicare Part D opioid safety policy with flexibilities
provided during the COVID-19 emergency and beyond. Our findings will enable policymakers to develop
clinically and culturally nuanced policies and practices tailored to the disabled population, the racial/ethnic
minority patients and rural patients, and the evolving pandemic/post-pandemic environment.
