Immunosuppressants are a protected drug class under the Medicare Part D benefit, meaning that all drugs in this class must be present on all plan formularies. However, the presence of a drug on a plan formulary does not equate to coverage for individual beneficiaries. Medicare Part D plan sponsors are only obligated to cover medications when used for FDA-approved indications or for off-label indications supported by at least one of the two CMS-approved compendia (AHFS-Drug Information or Micromedex). We present a case series of five transplant recipients for whom coverage one of the core immunosuppressant medications was denied under the Medicare Part D plan: azathioprine for a lung transplant recipient (n=2), mycophenolate mofetil for a lung transplant recipient (n=1), mycophenolic acid for a heart transplant recipient (n=1), and sirolimus for a heart transplant recipient (n=1). These five patients carried Medicare Advantage plans (n=1) or stand-alone Medicare Part D plans (n=4). In all cases, the denial of coverage was upheld through the appeals process. These patients ultimately had to pay cash for their medication or seek to obtain it through alternate sources such as patient assistance programs. Coverage vulnerabilities of this type exist for at least one immunosuppressant drug in all non-kidney transplant groups. This case series is evidence of the gap that exists between current Medicare Part D policy and the clinical needs of non-kidney transplant recipients.

CITATION INFORMATION: Potter L., Garrity E. Medicare Part D Plans Deny Coverage for Off-Label and Off-Compendia Immunosuppressant Use: A Case Series Am J Transplant. 2017;17 (suppl 3).

« Back to 2018 American Transplant Congress