A multicenter case series documenting Medicare Part D plan denials of immunosuppressant drug coverage for organ transplant recipients

© 2020 The American Society of Transplantation and the American Society of Transplant Surgeons..

Medicare Part D plans make coverage decisions according to FDA-labeled indications and off-label uses endorsed by two CMS-recognized compendia. Patients who rely on Medicare Part D for immunosuppressive drug coverage are at risk for denied coverage when these medications are prescribed off-label. The purpose of this multicenter collaboration was to assemble a case series documenting situations where immunosuppressive therapies prescribed for transplant patients were denied by Medicare Part D prescription drug plans. This case series documents 66 instances in 39 patients where immunosuppressive drug claims were denied coverage due to off-label use not endorsed by the compendia. Patients were recipients of lung (n = 28, 72%), heart (n = 7, 18%), or liver (n = 4, 10%) transplants. Denied claims were for mycophenolate mofetil (n = 22, 33%), azathioprine (n = 18, 27%), sirolimus (n = 15, 23%), mycophenolate sodium (n = 5, 8%), everolimus (n = 5, 8%), and belatacept (n = 1, 1%). Most denials were upheld across all the levels of attempted appeal, including those escalated to a Medicare Administrative Law Judge. This case series demonstrates a critical flaw in the construct of the Medicare Prescription Drug Benefit. The currently referenced compendia are not up to date and do not reflect best practices in organ transplantation.

Medienart:

E-Artikel

Erscheinungsjahr:

2021

Erschienen:

2021

Enthalten in:

Zur Gesamtaufnahme - volume:21

Enthalten in:

American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons - 21(2021), 2 vom: 19. Feb., Seite 889-896

Sprache:

Englisch

Beteiligte Personen:

Lushin, Erin N [VerfasserIn]
McDermott, Jennifer K [VerfasserIn]
Truax, Crystal [VerfasserIn]
Lourenco, Laura M [VerfasserIn]
Mariski, Mark [VerfasserIn]
Melaragno, Jennifer I [VerfasserIn]
Potter, Lisa M [VerfasserIn]

Links:

Volltext

Themen:

Case Reports
Ethics and public policy
Immunosuppressant
Immunosuppression / immune modulation
Immunosuppressive Agents
Insurance
Law / legislation
Multicenter Study
Off-label drug use
Prescription Drugs

Anmerkungen:

Date Completed 18.06.2021

Date Revised 24.01.2023

published: Print-Electronic

Citation Status MEDLINE

doi:

10.1111/ajt.16321

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM315474637