Transplant recipients are vulnerable to coverage denial under Medicare Part D

Lisa M. Potter, Angela Q. Maldonado, Krista L. Lentine, Mark A. Schnitzler, Zidong Zhang, Gregory P. Hess, Edward Garrity, Bertram L. Kasiske, David A. Axelrod

Research output: Contribution to journalArticlepeer-review

15 Scopus citations


Transplant immunosuppressants are often used off-label because of insufficient randomized prospective trial data to achieve organ-specific US Food and Drug Administration (FDA) approval. Transplant recipients who rely on Medicare Part D for immunosuppressant drug coverage are vulnerable to coverage denial for off-label prescriptions, unless use is supported by Centers for Medicare & Medicaid Services (CMS)–approved compendia. An integrated dataset including national transplant registry data and 3 years of dispensed pharmacy records was used to identify the prevalence of immunosuppression use that is both off-label and not supported by CMS-approved compendia. Numbers of potentially vulnerable transplant recipients were identified. Off-label and off-compendia immunosuppression regimens are frequently prescribed (3-year mean: lung 66.5%, intestine 34.2%, pancreas 33.4%, heart 21.8%, liver 16.5%, kidney 0%). The annual retail cost of these at-risk medications exceeds $30 million. This population-based study of transplant immunosuppressants vulnerable to claim denials under Medicare Part D coverage demonstrates a substantial gap between clinical practice, current FDA approval processes, and policy mandates for pharmaceutical coverage. This coverage barrier reduces access to life-saving medications for patients without alternative resources and may increase the risk of graft loss and death from medication nonadherence.

Original languageEnglish (US)
Pages (from-to)1502-1509
Number of pages8
JournalAmerican Journal of Transplantation
Issue number6
StatePublished - Jun 2018


  • ethics and public policy
  • immunosuppressant
  • immunosuppression/immune modulation
  • insurance
  • insurance – public
  • law/legislation
  • off-label drug use

ASJC Scopus subject areas

  • Immunology and Allergy
  • Transplantation
  • Pharmacology (medical)


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