As the Director of Living Kidney Donor Transplant and the Director of Quality Enhancement and Process Improvement of University Transplant Institute of San Antonio, I am writing to you to request that CMS conduct a comprehensive study of the potential impact of the transplant-related provisions in the 2022 IPPS Proposed Rule on patient access to transplantation and to delay implementation of these provisions of the Proposed Rule until that study is completed.

Over the past several years, CMS has made it clear that it recognizes the significant clinical and cost effectiveness and advantages of kidney transplantation over other forms of treatment for ESRD-eligible Medicare beneficiaries. In fact, CMS has instituted major regulatory changes to increase access to transplantation. The substantial limitations on Medicare payment for the costs associated with procuring organs for transplantation that are now proposed are completely inconsistent with these initiatives: These extraordinary payment cuts threaten to significantly disrupt the organ procurement programs operated by Transplant Centers, which currently procure 36% of deceased donor organs. Such disruption will undercut CMS efforts to increase access to transplantation and rather will increase wait times, waitlist mortality and morbidity for ESRD-eligible Medicare beneficiaries.

I am particularly concerned about the proposed change that would require a Transplant Center that procures an organ that is subsequently transplanted elsewhere to determine the insurance status of the recipient. The current rule, which essentially assumes that the recipient is a Medicare beneficiary, was intended to incentivize hospitals with Transplant Centers to institute effective organ procurement programs. Our own hospital has done so: We procure an estimated 100 organs per year that are transplanted by other Transplant Centers. Precipitously eliminating this longstanding incentive has the potential to undermine the financial viability of these organ procurement efforts.

Also, under this proposal, our administrative costs would increase, because we would be responsible for obtaining evidence of the Medicare status of the recipients of all of the organs that we procure and that are transplanted elsewhere. Contrary to the assertions in the Proposed Rule, there is no established system for obtaining this information, and obtaining evidence of Medicare liability-- especially when Medicare is functioning as a Secondary Payer (MSP) will be time consuming and complex.

Finally, unlike other changes proposed in the IPPS Proposed Rule, the proposed limitations on payment of organ acquisition costs were not included in the hospital-specific analysis that most hospitals rely on in assessing IPPS proposed changes For this reason, many hospitals that operate Medicare-certified Transplant Centers still may be unaware that these changes could significantly impact their patients and their transplant programs.

I strongly urge CMS to study the potential impact of all of the proposed changes that would limit Medicare payment for the costs of acquiring organs for transplantation on access to transplantation and to refrain from implementing any of these changes pending the completion of the study.