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

doi:10.1111/ajt.14703

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Transplant recipients are vulnerable to coverage denial under Medicare Part D

Journal article

Open access

Peer reviewed

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 and David A Axelrod

American journal of transplantation, Vol.18(6), pp.1502-1509

06/2018

DOI: 10.1111/ajt.14703

PMID: 29446874

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Abstract

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.

Centers for Medicare and Medicaid Services, U.S

United States

Humans

Transplant Recipients

Immunosuppressive Agents - administration & dosage

Medicare Part D

United States Food and Drug Administration

Details

Title: Subtitle: Transplant recipients are vulnerable to coverage denial under Medicare Part D
Creators: Lisa M Potter - Department of Pharmacy, University of Chicago Medicine, Chicago, IL, USA
Angela Q Maldonado - Transplant Surgery, Vidant Medical Center, Greenville, NC, USA
Krista L Lentine - Saint Louis University Center for Abdominal Transplantation, Saint Louis University School of Medicine, St. Louis, MO, USA
Mark A Schnitzler - Saint Louis University Center for Abdominal Transplantation, Saint Louis University School of Medicine, St. Louis, MO, USA
Zidong Zhang - Saint Louis University Center for Abdominal Transplantation, Saint Louis University School of Medicine, St. Louis, MO, USA
Gregory P Hess - Scientific Studies & Projects, Symphony Health, Conshohocken, PA, USA
Edward Garrity - Division of Lung Transplantation, University of Chicago Medicine, Chicago, IL, USA
Bertram L Kasiske - Scientific Registry of Transplant Recipients, Minneapolis Medical Research Foundation, Minneapolis, MN, USA
David A Axelrod - Transplant and Hepatobiliary Surgery, Lahey Clinic, Burlington, MA, USA
Resource Type: Journal article
Publication Details: American journal of transplantation, Vol.18(6), pp.1502-1509
DOI: 10.1111/ajt.14703
PMID: 29446874
NLM abbreviation: Am J Transplant
ISSN: 1600-6135
eISSN: 1600-6143
Publisher: United States
Language: English
Date published: 06/2018
Academic Unit: Surgery
Record Identifier: 9984051511902771

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