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Updated: Sep 12, 2025

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Published on: February 28, 2012
Medicare coverage gap status, adherence to oral anticoagulation, and stroke rates in patients with atrial
Josephine Harrington1, Rohin K Reddy2, Anthony Carnicelli3
1Department of Medicine, University of Colorado School of Medicine, Aurora, CO; Colorado Prevention Center, Aurora, CO.
Insights
Medicare Part D
Area of Science:
- Cardiovascular Medicine
- Health Policy
- Pharmacoeconomics
Background:
- The Medicare Part D coverage gap significantly increased out-of-pocket prescription costs for beneficiaries before 2025.
- The impact of this coverage gap on oral anticoagulant (OAC) use and stroke risk in atrial fibrillation (AF) patients was previously unknown.
Purpose of the Study:
- To investigate the effect of the Medicare Part D coverage gap on OAC prescription fills.
- To determine the association between the coverage gap, OAC use, and stroke risk in patients with AF.
Main Methods:
- Analysis of 2016-2018 Medicare claims data for patients with AF.
- Assessment of OAC prescription fill rates (proportion of days covered) before, during, and after the coverage gap.
- Evaluation of stroke risk associated with entering, being within, and exiting the coverage gap.
Main Results:
- Entering the coverage gap led to a 16% median decrease in OAC days covered.
- OAC use declined further even after exiting the gap, with a 70% proportion of days covered post-gap.
- Patients entering the gap faced significantly higher stroke risk (HR 2.21 in-gap, HR 3.13 combined in/post-gap).
Conclusions:
- Reduced OAC use during the Medicare Part D coverage gap is linked to increased stroke risk.
- This elevated stroke risk persisted throughout the year, even after coverage was restored.
- Healthcare policy changes, like the coverage gap, can have significant, unintended public health consequences.
Background:
Prior to 2025, Medicare Part D included a coverage gap during which beneficiaries were responsible for substantially higher portions of medication costs. The impact of this on oral anticoagulant (OAC) prescription fills and subsequent stroke in patients with atrial fibrillation (AF) is not known.
Methods:
Using Centers for Medicare and Medicaid Services claims data from 2016 to 2018, we evaluated OAC prescription fills in patients with AF by assessing their proportion of days covered on OAC before, during, and after their coverage gap. Hazard of stroke was assessed for patients who entered the coverage gap before entering, while in, and after exiting, the gap.
Results:
Patients who entered the coverage gap had a 16% decrease in median proportion of days covered from pregap (0.92 [interquartile range 0.80, 0.97]) to in-gap (0.76 [0.41, 0.98]). Proportion of days covered continued to drop for patients who entered and then left the coverage gap, despite regaining coverage (pregap: 0.95 [0.85, 0.98]; in-gap: 0.88 [0.55, 0.97]; postgap: 0.70 [0.00, 1.00]). Patients who entered the gap were at significantly higher risk for stroke while in the gap (HR 2.21, 95% CI 1.91-2.54) and during the combined in-gap and postgap periods (HR 3.13, 95% CI 2.71-3.62).
Conclusions:
OAC use decreased upon entering the coverage gap and was associated with an increased stroke risk, that persisted for the rest of the calendar year. Health policy decisions regarding Medicare can have unintended adverse public health consequences, highlighting the importance of assessing the impact of such policy changes.
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