While the Proposed Rule Impact Analysis details the dollar impact of most of the policy and payment changes that CMS is proposing for FY 2022, the Impact Analysis does not calculate the impact of the transplant-related provisions of the Proposed Rule. For Transplant Centers that include active organ donor programs, the impact can amount to millions of dollars. Because the proportion of transplant recipients covered by Medicare is lower for extra-renal than for renal organs and because Medicare Advantage recipients will not “count” as Medicare patients for the purposes of determining the Medicare ratio under the new rules, it is anticipated that Medicare payment for extra-renal organs will be especially adversely impacted.
In addition, the Proposed Rule would place an extraordinary administrative burden on Transplant Centers, which would be required to trace organs recovered in their hospital and transplanted elsewhere and contact the other transplant program to determine the insurance coverage for every recipient of a deceased donor organ recovered at their hospital. OPOs do not have the expertise to ascertain or question primary insurance types, question retroactive eligibility periods for kidney transplants, nor to obtain the evidence proposed to ascertain if a recipient transplanted indeed has a Medicare Secondary Liability. Therefore, this enormous burden will almost certainly fall on Transplant Center administrative staff. For recipients with Medicare as a Secondary Payor (MSP), the Transplant Center would need to determine not only whether the recipient is eligible for MSP coverage, but whether Medicare actually makes a payment in its capacity as a Secondary Payer within the allowable period covered by the Medicare cost report. Different rules would apply to Medicare Advantage recipients, depending on whether the organ involved is a kidney or extra-renal organ. Recent changes to organ allocation policies have broadened the distribution of organs to include so many more potential transplant hospitals and have multiplied the number of OPOs from which transplant centers accept organs, significantly increasing the number of organs subject to the proposed change and increasing the complexity of the administrative burden.
Because the Proposed Rule likely is designed to reduce the proportion of organ acquisition costs paid by the Medicare program (especially for extra-renal organs), it is anticipated that, if the Proposed Rule is adopted without change, Transplant Centers will need to renegotiate their contracts with non-Medicare payers, to increase organ acquisition costs payable from these sources. However, there is no guarantee that private payers will be willing to increase global payments to offset further losses from Medicare.
IMPACT ON ACCESS TO TRANSPLANTATION
The current policy has led hospital and transplant leaders to take an active role in systems, processes, and training to improve organ donation referrals, authorization, and management practices. This system works: In 2020, 35% of deceased organ livers and lungs; 36% of deceased donor kidneys; 38% of hearts; 41% of pancreas; and 48% of intestines were retrieved as the result of the efforts of Transplant Centers. The ability to “count” all donor organs provided to other transplant centers as Medicare organs has been a critical driver of these efforts and of new innovative partnerships between Transplant Centers and OPOs to increase organ yield.
IMPACT ON THE MEDICARE PROGRAM
The 2019 AAKH notes “In 2016, Medicare fee-for service spent approximately $114 billion to cover people with kidney disease, representing more than one in five dollars spent by the traditional Medicare program.” Transplantation of ESRD patients is by far the most cost effective and clinically superior treatment option ESRD patients. If adopted, the Proposed Rule will increase Medicare expenditures on kidney disease as a reduction in available donor kidneys will drive increases in morbidity, mortality and prolong already long waiting times.
OUR REQUEST OF CMS
ASTS and a number of other groups plan to request that CMS conduct a study of the potential impact of the Proposed Rule on transplantation and to consider alternative approaches, and that the agency refrain from implementing transplant-related provisions of the Proposed Rule in FY 2022, pending the completion of the study. ASTS also plans to respond to CMS’ solicitation of comments on the need to update the professional fees payable for kidney procurement.
OUR REQUEST OF YOU
We are requesting that Transplant Leaders take the following Six Steps Immediately: