Passage of the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act—a Chance to Celebrate and Reflect

Beginning in 2023, the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act (H.R. 5534; also known as the Immuno bill) will add a new Medicare option solely to cover immunosuppressive drugs for kidney transplant recipients.1 Patients may enroll beginning 36 months after a transplant if they have no other health insurance and are otherwise ineligible for Medicare. Enrollees will pay a monthly premium equal to 35% of standard immunosuppressive drug costs currently estimated to be $243/mo. For prevalent kidney transplant recipients who have lost or will lose Medicare benefits due to the 3-year post-transplant time limit on coverage in the Medicare ESKD program, the bill will provide access to essential drugs to prevent allograft rejection for the life of their transplant. An analysis by the Department of Health and Human Services (HHS) estimated that the Immuno bill will prevent approximately 375 allograft failures annually, and the Congressional Budget Office (CBO) projects Medicare savings of $400 million over 10 years.2,3 Legislation proposing extension of immunosuppressive drug coverage have been introduced in Congress for the past two decades, and the passage of the Immuno bill represents a huge victory for current and future transplant recipients. The entire kidney community is indebted to the primary bill sponsors Senator Bill Cassidy, MD (Republican LA); Senator Dick Durbin (Democrat IL); Rep. Michael Burgess, MD (Republican TX); and Rep. Ron Kind (Democrat WI) and the many House and Senate members for their enduring support. The Immuno bill corrects an unintentional gap in Medicare coverage. Since 1973, a diagnosis of kidney failure has conferred Medicare eligibility on people who do not otherwise meet the program’s age or disability requirements. In 1973, only 2000 transplants were performed annually, and the major emphasis was on ensuring access to lifesaving dialysis. Although the costs of kidney transplantation exclusive of immunosuppressive drugs were covered for 1 year, the ongoing requirement for immunosuppressive drugs was not considered. At that time, only 40% of transplants functioned beyond 1 year, the available immunosuppressive drugs (azathioprine and corticosteroids) were relatively inexpensive, and it was thought that transplant recipients who survived would return to work and would be able to pay for their medications. Immunosuppressive drugs were not covered by Medicare until 1984 when the National Organ Transplantation Act authorized payment for immunosuppressive drugs for 1 year for Medicare-insured patients. Correcting this historical error in Medicare policy proved to be a formidable task because extending immunosuppressive drug coverage incurs an upfront cost with uncertain long-term savings. Estimating the cost savings of preventing transplant failure by extending immunosuppressive drug coverage is challenging because patients may understandably be reluctant to disclose information about their inability to afford their medications. On the basis of improved long-term transplant outcomes and evidence that for most patients, transplantation was a better and far less costly treatment than dialysis, the time limit for immunosuppressive coverage was extended from 1 to 3 years between 1992 and 1995. In 2000, a cost estimate of extending lifelong immunosuppressive coverage to Medicare-eligible patients commissioned by the Institute of Medicine reported net 5-year costs of $566 million or about 2% of the annual ESKD budget.4 Proposals to shift spending within Medicare’s ESKD program to cover these additional projected costs proved divisive. In 2009, the Immuno bill was included in the House amendment to the Affordable Care Act (ACA). However, the offset to pay for it involved