# Impact of Medicare Part D opioid safety policies on disabled beneficiaries before and during the COVID-19 pandemic

> **NIH NIH R01** · HARVARD PILGRIM HEALTH CARE, INC. · 2022 · $701,067

## Abstract

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 ...

## Key facts

- **NIH application ID:** 10345593
- **Project number:** 1R01DA055131-01
- **Recipient organization:** HARVARD PILGRIM HEALTH CARE, INC.
- **Principal Investigator:** Hefei Wen
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $701,067
- **Award type:** 1
- **Project period:** 2022-08-15 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10345593

## Citation

> US National Institutes of Health, RePORTER application 10345593, Impact of Medicare Part D opioid safety policies on disabled beneficiaries before and during the COVID-19 pandemic (1R01DA055131-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10345593. Licensed CC0.

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