ESRD Patients and the Medicare Part D Coverage Gap: A Qualitative Study

Background and Purpose: The 2007 Medicare Part D benefit, for patients who were not eligible for a low income subsidy, was structured to pay for approximately 75% of annual drug costs for the first $2,500 spent and 95% of spending over $5,450. However, Medicare provides no coverage for spending between $2,500 and $5,450, a period known as the coverage gap. Patients with End Stage Renal Disease (ESRD) receiving kidney dialysis are especially likely to experience this gap because of costly dialysis-related drugs and the importance of these drugs in maintaining patients' health. It was projected that 70% of ESRD patients would reach the gap in 2006 and that those who did would, on average, reach the gap by June. Patients without supplementary insurance (including Medicaid), must bear the full costs of their prescription drugs for a substantial part of the year with implications for medication adherence and, consequently, with overall health. Researchers from social work, pharmacy, and dietetics conducted a qualitative inquiry to explore ESRD patients' experiences in this coverage gap. The primary research questions explored: strategies for managing costs; the decision-making process about medication adherence; and sources of support.

Methods: A grounded theory approach guided this study. Twelve patients who have experienced the coverage gap were interviewed in individual, cross-sectional, face-to-face, semi-structured interviews lasting approximately 60 minutes. The dialysis clinic administration identified patients who met the inclusion criteria, conducted the informed consent, and with the patient's permission, provided contact information to the researchers who followed up by phone to schedule the interview. Some family caregivers involved in medication management and finances also participated. After prior ethnography was conducted, interviews were conducted in three different clinics while patients received their dialysis; two patients who received peritoneal dialysis were interviewed at home.

Results: Data analysis was conducted using constant comparison which generated the following themes: the experience of hitting the gap, including how they found out and whether they had prior warning; strategies used for managing, including social support, changes in medications, including generics, and cutting back on other necessities; and physical and emotional consequences of these strategies. Of great importance was the role of social workers in preparing for the coverage gap via case management and advocacy; a good relationship with a physician, nurse, and/or pharmacist to help make decisions about medication management, especially regarding generic medication; and social support of family and friends, who as caregivers often needed assistance with these decisions.

Conclusion and Implications: Implications include the importance of teaching resource coordination; the role of education and advocacy; the impact of policy on practice; and the value of professionals as sources of both information/expertise and social support. Implications for future research include the relevance of social work background in qualitative research with seriously ill patients; and the value of participants' voices in setting policy such as the coverage gap that has physical, emotional, and social implications for patients.