Transplant
Medicare Part D Plans Can Deny Coverage of Select Immunosuppressant Medications in Solid Organ Transplant Recipients
An alarming problem has emerged with some solid organ transplant recipients experiencing immunosuppressant medication claim denials by Medicare Part D plans. Affected patients are those who convert from some other insurance (ie, private insurance or state Medicaid) to Medicare after their transplant and, therefore, rely on Medicare Part D for immunosuppressant drug coverage.
Insurance companies who offer Medicare Part D plans must follow the rules described in the Medicare Prescription Drug Benefit Manual.1 Although the Manual mandates that all immunosuppressant medications are on plan formularies, Part D plans are only required to cover immunosuppressant medications when used for indications approved by the Food and Drug Administration (FDA) or for off-label indications supported by the Centers for Medicare & Medicaid Services (CMS)-approved compendia (Drugdex® and AHFS Drug Information®).
Dr. Jennifer McDermott
A recent study examining the extent of the problem demonstrated non-renal organ transplant recipients are frequently prescribed and maintained on at least one medication vulnerable to Medicare Part D claim denials at 1 year posttransplant (lung: 71.1%; intestine: 39.7%; pancreas: 36.8%; liver: 19.7%; heart: 18.5%).2 Lung transplant recipients are most vulnerable since no immunosuppressant is FDA-approved for use in lung transplantation, and CMS-approved compendia only support off-label use for tacrolimus and cyclosporine in this population. Therefore, mycophenolate mofetil, mycophenolic acid, azathioprine, everolimus, and sirolimus are vulnerable to denial by Medicare Part D plans when used in lung transplant recipients. Over 95% of lung transplant recipients are maintained on an anti-metabolite, with the majority (88%) maintained on mycophenolate, so this is frequently impacted.2,3 While the transplant community is aware of this issue and has begun work to correct it, it has yet to be solved.2,4 In the meantime, if transplant recipients have been denied for this off-label and off-compendia reason, and appeals of those decisions have also been denied, options for obtaining the denied immunosuppressant medication include discount programs, foundation/grant funding, and industry-sponsored assistance programs.
Jennifer K. McDermott, PharmD
NetWork Member
1. Prescription Drug Benefit Manual. Centers for Medicare & Medicaid Services. Chapter 6: Part D Drugs and Formulary Requirements. Available at: https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Part-D-Benefits-Manual-Chapter-6.pdf
2. Potter LM et al. Transplant recipients are vulnerable to coverage denial under Medicare Part D. Am J Transplant. 2018;18:1502.
3. Valapour M et al. OPTN/SRTR 2016 Annual Data Report: Lung. Am J Transplant. 2018;18 (Suppl 1): 363.
4. Immunusuppressant Drug Coverage Under Medicare Part D Benefit. American Society of Transplantation. Available at: www.myast.org/public-policy/key-position-statements/immunosuppressant-drug-coverage-under-medicare-part-d-benefit.