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. 2012 Aug;60(8):1408-17.
doi: 10.1111/j.1532-5415.2012.04073.x. Epub 2012 Jul 12.

Association between the Part D coverage gap and adverse health outcomes

Jennifer M Polinski  1 , William H Shrank, Robert J Glynn, Haiden A Huskamp, M Christopher Roebuck, Sebastian Schneeweiss
Affiliations

Association between the Part D coverage gap and adverse health outcomes

Jennifer M Polinski et al. J Am Geriatr Soc. 2012 Aug.

Abstract

Objectives: To determine whether Part D coverage gap entry is associated with risk of death or hospitalization for cardiovascular outcomes.

Design: Prospective cohort study. Beneficiaries entered the study upon reaching the coverage gap spending threshold and were observed until an outcome reaching the threshold for catastrophic coverage occurred or year's end. Nine thousand four hundred thirty-six exposed individuals (those who were responsible for drug costs in the gap) were compared with 9,436 unexposed individuals (those who received financial assistance) based on propensity score (PS) or high-dimensional propensity score (hdPS).

Setting: Medicare Part D drug insurance.

Participants: Three hundred three thousand nine hundred seventy-eight Medicare beneficiaries aged 65 and older in 2006 and 2007 with linked prescription and medical claims who enrolled in stand-alone Part D or retiree drug plans and reached the gap spending threshold.

Measurements: Rates of death and hospitalization for any of five cardiovascular outcomes, including acute coronary syndrome with revascularization (ACS), after reaching the coverage gap spending threshold were compared using Cox proportional hazards models.

Results: In PS-matched analyses, exposed beneficiaries had higher, albeit not significantly so, hazard of death (hazard ratio (HR) = 1.25, 95% confidence interval (CI) = 0.98-1.59) and ACS (HR = 1.16, 95% CI = 0.83-1.62) than unexposed beneficiaries. hdPS-matched analyses minimized residual confounding and confirmed results (death: HR = 0.99, 95% CI = 0.78-1.24; ACS: HR = 1.07, 95% CI = 0.81-1.41). Exposed beneficiaries were no more or less likely to experience other outcomes than were those who were unexposed.

Conclusion: During the short-term coverage gap period, having no financial assistance to pay for drugs was not associated with greater risk of death or hospitalization for cardiovascular causes, although long-term health consequences remain unclear.

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Conflict of interest statement

Conflict of interest:

Dr. Polinski is a consultant to Buccaneer Computer Systems and Service, Inc, a contractor for the Centers for Medicare and Medicaid Services. Within the past 5 years, Dr. Polinski’s spouse was employed as an engineer by DePuy Orthopaedics, a subsidiary of Johnson & Johnson, and had Johnson & Johnson stock totaling < $3100 in value. Dr. Shrank is a consultant to United Healthcare, which has a Part D business, but his consulting is unrelated. Dr. Shrank has received research funding from CVS Caremark, Aetna and Express Scripts, which also have Part D business. Dr. Glynn has worked on grants to the Brigham & Women's Hospital, his employer, from Astra Zeneca and Novartis related to the design, statistical monitoring, and analysis of clinical trials in the setting of cardiovascular drugs. Dr. Glynn also signed a consulting agreement to give a one-time Grand Rounds talk on comparative effectiveness research methods at Merck. At the time of the study, Mr. Roebuck was an employee of CVS Caremark. Dr. Schneeweiss is a paid member of the Scientific Advisory Board of HealthCore and a consultant to World Health Information Science Consultants, LLC. Dr. Schneeweiss is Principal Investigator of the Brigham and Women’s Hospital DEcIDE Center on Comparative Effectiveness Research funded by AHRQ and the DEcIDE Methods Center. Dr. Schneeweiss received funding through investigator-initiated grants awarded to his employer, Brigham and Women’s Hospital from Pfizer, Novartis, and Boehringer-Ingelheim. Opinions expressed here are only those of the authors and not necessarily those of the agencies.

Figures

Figure 1
Figure 1
Survival function estimates: drug discontinuation since reaching the coverage gap spending threshold
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References

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