February 1, 2022 – Centers for Medicare & Medicaid Services US Department of Health and Human Services: Request for Information
Science in Donation and Transplant (SID&T) is a non-profit organization devoted to the support and education of members and stakeholders in the donation and transplant communities and founded on the belief that donors and transplant recipients alike deserve a well-aligned, peer reviewed science-based system. SID&T advocates in concert with leading medical practitioners for enhanced coordination and alignment among organ procurement organizations (OPOs) and transplant centers. Our goal is to ensure that the metrics and measures used to credential, license, designate and certify donation and transplant organizations are grounded in science and protected from political whim and private financial influence.
We, and many peers in the field, know from fact-based experience that improving accessibility and outcome for patients and the overall efficiency and effectiveness of the donation and transplant system requires certain CMS encouraged goals:
Encouraging the proper alignment and cooperation among Organ Procurement Organizations, Transplant Centers, Hospitals and community partners.
Recognizing that the certification and decertification metrics for OPOs need revision. Transplant centers need to be part of the equation as they, not OPOs, control the outcome. Decertifying OPOs based on transplant rates fails both public policy and basic logic tests.
The many questions raised by the Rule’s failure to address all of the critical criteria and timeframe questions of potential de-certification of up to two-thirds of existing OPOs, and the potential negative impact this poses to the most at-risk populations, demand the establishment of a National Task Force of science-based experts and community stakeholders to study the issues and make recommendations.
The truly sensitive nature of organ donation and procurement begs for CMS to protect, nurture and improve the community-based non-profit system.
We are concerned that most of the entities headed for de-certification under the latest data publication from CMS are OPOs whose service area demographics are disproportionately minority. First, the research has not been done to determine if these OPOs are being fairly evaluated given the impact on their certification on factors they cannot control such as transplant rates.
Second, given the multi-year time frame for the successful integration of “friendly” OPO mergers, frightening questions are raised about how those populations will be served. OPOs may have higher net numbers, but lower numbers of minorities donating and being transplanted.
Finally, given CMS’ one year timeframe for improvement, what high performing OPO will take over a lower performing area given the extraordinary cost and logistical issues which experience shows take years to work through? There is an extraordinary cost associated with decertification. Who will be responsible for the fiscal issues related to physical facilities, buildings, labor, affiliates, and contractors? Is the door being opened to an avalanche of potential lawsuits given the uncertainty around these issues?
SID&T does not support that portion of CMS’s well-meaning but misguided effort to improve donation by mandating the closure of donation organizations thereby putting more focus on quantity than quality. We urge CMS to focus instead on researching and testing best practices, supporting these, and measuring performance based on adherence by ALL participants in the donation and transplant system to aligned action plans. We support science over the likely chaos caused by widespread decertification and the planned phased mass closures of community-based donation organizations.
Science in Donation and Transplant is a non-profit devoted to the support and education of members and stakeholders in the donation and transplant communities. Donors and transplant recipients alike deserve a well-aligned, science-based system. We advocate in concert with leading medical practitioners for enhanced coordination and alignment among organ procurement organizations and transplant centers. Our goal is ensuring that the metrics and measures used to credential, license, designate and certify donation and transplant organizations are grounded in science and protected from political whim and private financial influence.