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

Award Number: R01DA055131
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2022
PERIOD OF PERFORMANCE END DATE: 06/30/2025

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2025	EMORY UNIVERSITY	201 DOWMAN DR NE	ATLANTA	GA	30322	DEKALB	USA	Drug Use and Addiction Research Programs	000	4	1/28/2026	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2026	2024	HARVARD PILGRIM HEALTH CARE INC	1 WELLNESS WAY	CANTON	MA	02021	NORFOLK	USA	Drug Use and Addiction Research Programs	001	3	2/12/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $568,105 )
2025	2025	EMORY UNIVERSITY	201 DOWMAN DR NE	ATLANTA	GA	30322	DEKALB	USA	Drug Use and Addiction Research Programs	001	4	8/25/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$568,105
2025	2024	HARVARD PILGRIM HEALTH CARE INC	1 WELLNESS WAY	CANTON	MA	02021	NORFOLK	USA	Drug Use and Addiction Research Programs	000	3	8/25/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $568,105

Issue Date FY: 2024 ( Subtotal = $637,123 )
2024	2024	HARVARD PILGRIM HEALTH CARE INC	1 WELLNESS WAY	CANTON	MA	02021	NORFOLK	USA	Drug Use and Addiction Research Programs	000	3	6/24/2024	NON-COMPETING CONTINUATION	$637,123
														Subtotal = $637,123

Issue Date FY: 2023 ( Subtotal = $627,760 )
2023	2023	HARVARD PILGRIM HEALTH CARE INC	1 WELLNESS WAY	CANTON	MA	02021	NORFOLK	USA	Drug Use and Addiction Research Programs	000	2	6/29/2023	NON-COMPETING CONTINUATION	$627,760
														Subtotal = $627,760

Issue Date FY: 2022 ( Subtotal = $701,067 )
2022	2022	HARVARD PILGRIM HEALTH CARE INC	93 WORCESTER ST	WELLESLEY	MA	02481	NORFOLK	USA	Drug Use and Addiction Research Programs	000	1	8/10/2022	NEW	$701,067
														Subtotal = $701,067

Grand Total All Awards = $2,534,055

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

Award Number: R01DA055131

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/15/2022

PERIOD OF PERFORMANCE END DATE: 06/30/2025

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