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HMA Executive Summary and Report

Executive Summary: Challenges and Considerations to the Organ Procurement Organizations Conditions for Coverage Rule

Background

  • False data and unsubstantiated assertions have been the hallmark of the political attack on the non-profit organ donation system. The HMA reports states, Based on data from the International Registry in Organ Donation and Transplantation, the U.S. has the highest number of organ donors per million population and the highest number of kidney, liver, and heart transplants per million population. In 2022, 42,887 organ transplants were performed in the country, which reflected a 3.7% increase over the previous year. Since 2012 transplants have increased by over 50% as America leads the world in this medical category.

Reliable and Timely Data

  • Among the many shortcomings of the Centers for Medicare and Medicaid Services (CMS approach to the governing Rule is the medically indefensible use of death certificates as a performance metric. HMA: “It is vital to utilize a data source to evaluate OPOs; however, utilizing death certificate data does not provide the level of clinical detail needed to accurately reflect the number of viable organs that can be transplanted. In accordance with the National Academies of Science, Engineering, and Medicine (NASEM), SID&T urges that patient-level data be collected and used as the measure denominator.”

  • Only a tiny percentage (.003) of deaths occur in a manner suitable for donation, yet CMS holds to a false measure. HMA: “Utilizing death certificate data, approximately 55% of the 140 deaths reviewed were deemed “potential donors.” Whereas an analysis applied OPO evaluation of clinical exclusion characteristics to determine donor potential determined that only 10% were truly eligible donors.”

Metrics for Evaluation

  • In a performance evaluation metric that defies all logic and the designated roles of donation and transplant participants, OPOs can face decertification over transplant rates that they simply do not control. HMA: “This measure (RULE) will hold OPOs accountable for transplant centers which are responsible for determining whether a patient is added to the national waiting list that UNOS manages and whether to accept or decline organ offers for their patients. This measure puts the OPOs and transplant centers at odds while compromising patient care. It is essential that CMS develop and design measures that align and appropriately hold OPOs and transplant centers for their performance.” Congress must act to follow their study to ensure sound performance metrics and logical alignment of all parties in the donation and transplant ecosystem with the imposition of a superior review organization and process.

  • Since 2020, CMS and HHS have failed in their oversight of the system. HMA: “Additionally, HHS should hold the appropriate entities of the organ transplantation system accountable for achieving demonstrable performance improvement. The government should facilitate quality improvement efforts that foster greater systemness and accountability for the highest possible performance among all donor hospitals, OPOs, and transplant centers.”
    Science in Donation & Transplant advocates peer-reviewed science-based federal legislation incorporating the reforms outlined in the landmark NASEM report.

  • HMA: We agree with NASEM that a consensus-based process be utilized to develop the donation rate measure and that it be one of many measures in a dashboard of metrics to assess OPO performance. We urge that the dashboard include elements to address disparities, referrals responded to, and others. SID&T also recommends that the dashboard be available to patients.

Decertification: healthcare system is managed this illogically. HMA: “It is essential that special attention be given to spreading best practices in organ procurement and transplantation that reduce and eliminate inequities and disparities.”

Conclusion

  • SID&T believes there is little evidence to support the idea that HHS/CMS grasped the enormity of the problems their flawed Rule has caused. Therefore it proposes federal legislation that codifies many NASEM recommendations and creates a truly aligned system. HMA: Given the CMS rule does not provide guidance around the decertification of OPOs, SID&T urges that HHS provide guidance and for Congress take action to ensure there is no disruption with the organ donor transplant ecosystem by legislating NASEM’s recommendations implementing continuous improvement efforts across the entire system.

  • CMS has set the system up for chaos in the years ahead by codifying the decertification of 40% of the nation’s non-profit organ procurement organizations based on unjustifiable performance standards with no guidance. Nothing in the CMS rule guides the decertification of OPOs. SID&T urges HHS to provide guidance and Congress to take action to ensure there is no disruption in the organ donor transplant ecosystem.

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.