In a bold move to increase organ transplantation, the Centers for Medicare and Medicaid Services (CMS or Medicare) has finalized a proposal “to remove the requirements at § 482.82 (conditions of participation for transplant centers) that require transplant centers to submit clinical experience, outcomes, and other data in order to obtain Medicare re-approval.” The American Society of Nephrology (ASN) and other members of the kidney community advocated for this change to reduce the unintended consequences associated with the re-approval process.
In a bold move to increase organ transplantation, the Centers for Medicare and Medicaid Services (CMS or Medicare) has finalized a proposal “to remove the requirements at § 482.82 (conditions of participation for transplant centers) that require transplant centers to submit clinical experience, outcomes, and other data in order to obtain Medicare re-approval.” The American Society of Nephrology (ASN) and other members of the kidney community advocated for this change to reduce the unintended consequences associated with the re-approval process.
The move will eliminate a duplicative requirement on transplant programs to submit data and other information more than once for ‘re-approval’ by Medicare. Re-approval has led to transplant programs avoiding performing transplants for certain patients, causing some organs to go unused. Medicare will maintain requirements for data submission, clinical experience, and outcome requirements for a transplant center’s initial Medicare approval.
In November 2018, ASN joined other members of the kidney community supporting this change in comment letters on the proposal. Medicare justified finalizing the move by pointing out that several major organizations representing transplant surgeons and other healthcare professionals strongly supported the proposal to remove these requirements for Medicare re-approval. ASN and others also agreed with Medicare’s analysis of the unintended consequences that were occurring because of the Medicare re-approval requirements and agreed that eliminating this requirement would improve transplantation in the United States.
In a complementary step, Medicare removed the mitigating factor and systems improvement agreement requirements for Medicare re-approval as the move to eliminate the reporting requirements, mentioned above, made the mitigating factors and system improvement requirements obsolete. Medicare reminded the community that transplant outcomes will still be available every six months on the Scientific Registry for Transplant Recipients (SRTR) website.
Medicare is also renaming “transplant centers” as “transplant programs” for every organ. A transplant program (each organ type would be a transplant program) will exist within a transplant hospital. Medicare indicated that this was consistent with other terminology used elsewhere in regulations and that the Agency hoped to remove any confusion. Medicare will also change “beneficiaries” to “recipients” for individuals receiving transplants.
These changes will take effect November 29, 2019.
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