May 06, 2022
3 min read

CMS releases proposed rule for expanded drug coverage for transplant patients

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CMS has released a proposed rule setting eligibility requirements for a new law offering immunosuppressive drug coverage for more patients with a kidney transplant.

Congress approved the expanded coverage in December 2020. The rule would take effect in January.

Patients diagnosed with end-stage kidney disease who are older than 65 years automatically receive lifetime immunosuppressive drug coverage from Medicare if they received a kidney transplant. However, when an individual younger than 65 years old receives a kidney transplant, Medicare coverage ends 3 years after unless the individual is eligible for Medicare on another basis, such as age or disability.

Advocates for extending the drug coverage have said the 3-year limit of Medicare benefits has led patients unable to find insurance to cut back on their doses because of the high cost of the drugs, leading to rejection of the transplant and going back to dialysis.

“With transplant patients suffering disproportionately from the adverse effects of COVID-19, this legislation is more critical now than ever,” the National Kidney Foundation said in a statement after the U.S. House passed the legislation in 2020. “Patients must be reassured that they will have access to their life-saving immunosuppressive drugs and that they will not need to worry about skipping doses because they can’t afford the costs.”

Individuals younger than 65 years old who received a transplant would not be eligible for Medicare coverage for any services or drug prescriptions other than the immunosuppressive drug coverage.

Cost of coverage

Extending the immunosuppressive drug coverage would pose an additional cost to Medicare, but the program would also save money by a reduction in the number of patients returning to dialysis because of graft failure, according to a report released by HHS in 2019. “ ... The federal investment required to cover the costs of extending coverage for immunosuppressive drugs would grow at a slower rate than the savings generated by averting cases of reversion to dialysis, resulting in net savings of $0.1 million in the fifth year of policy implementation and increasing in each subsequent year resulting in an accumulated 10-year savings of approximately $73.4 million,” according to the report. “If trends remain as they have, the annual savings to Medicare would continue to increase each year, as would the accumulated net savings.”

CMS said it estimated growth of 250 enrollees each year after the start of the program in January.

“Health care is not just about mending bones or dispensing pills. It is about giving people peace of mind that comes with having coverage when you need it,” Xavier Becerra, HHS Secretary, said in a press release announcing the proposed rule. “That’s why we’re proposing this rule today to help reduce delays, eliminate gaps and expand access to care for people with Medicare.”


The new law gives HHS authority to use special enrollment periods for Medicare beneficiaries for exceptional conditions, like a transplant, so that patients who want the expanded coverage can enroll immediately after the transplant vs. waiting for the next open enrollment period for Medicare benefits, Becerra said.

“CMS is committed to ensuring that people eligible for Medicare have timely access to this vital coverage. This proposed rule, if finalized, will reduce the time it takes for people to receive Medicare coverage after they enroll and advances CMS’ strategic vision of expanding access to quality, affordable health coverage and care,” Chiquita Brooks-LaSure, CMS Administrator, said in the release. “CMS is grateful to Congress for allowing us to establish special enrollment periods for Medicare that will help eliminate coverage gaps and late enrollment penalties for people meeting exceptional conditions.”

If the proposed policy is finalized, eligible individuals can enroll in the new immunosuppressive drug benefit beginning in October 2022 and coverage would start as early as Jan. 1, 2023, according to the release.

Comments on the proposed rule, which can be downloaded at, must be received by 5 p.m. on June 27. Comments can be sent electronically to


Fact sheet: Implementing certain provisions of the Consolidated Appropriations Act, 2021 and other revisions to Medicare enrollment and eligibility rules (CMS-4199-P) Published April 22, 2022. Accessed May 5, 2022.