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On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) released a final rule implementing changes to the conditions for coverage (CfCs) for Organ Procurement Organizations (OPOs). The rule will have a significant impact on the structure of the organ donation field in 2026 when it is expected that approximately half of all OPOs will be slated for decertification.

Impact of CMS Organ Procurement Organization Certification Changes

 Background

OPO Tier GraphOn November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) released a final rule implementing changes to the conditions for coverage (CfCs) for Organ Procurement Organizations (OPOs). The rule will have a significant impact on the structure of the organ donation field in 2026 when it is expected that approximately half of all OPOs will be slated for decertification. While there is plenty of controversy over the data used to calculate donation potential, how donors and organs are counted, and the use of a single year of performance, the provisions that require decertification programs who are performing below the median for all OPOs are the most impactful for the health care community served by OPOs. Based on the most recent data available, 42% of OPOs would be decertified automatically and another 32% could lose their contracts in a bidding process yet undefined. Because the data used to calculate organ donor potential comes from death certificates which require +12 months to gather, 2024 donation performance will be used to determine decertification in 2026.

The need to finish in at least the top half, if not top quarter means every OPO is looking to increase the number of donors in 2024.

Impact on Donor Hospitals

As OPOs look to improve their donation rates, hospitals can expect to see several changes in the types of cases OPOs pursue and the tactics they employ to make donation successful. OPOs are pursuing significantly more non-brain-dead cases or donation after circulatory death (DCD) donors. DCD donors as a percentage of all donations increased from 25% in 2020 to 35% in 2023. OPOs are pursuing older potential donors with most now following referrals for brain death declarations in individuals greater than 75 years old. Potential donors that test positive for HIV or hepatitis are now being pursued. Even if recovery of transplantable organs is a remote possibility, OPOs have an extremely high incentive to pursue these opportunities.

Hospitals can expect to see a higher level of OPO activity in their facilities. Your OPO may become more insistent on converting potential cases into authorized cases. The highest performing OPOs are involved earlier in the ICUs, well before brain death is declared or the decision to withdraw care is made. Ensuring that a potential donor’s decision as expressed by being a registered donor, are honored in all cases, including DCD opportunities will be common. Pursuing registered donors in the face of family opposition and pressing hard to obtain release from coroners and medical examiners may also be part of your OPO’s strategy. These changes in practice have the potential to strain relationships between OPO personnel and hospital staff if collaboration is not managed appropriately.

Impact on Transplant Hospitals

OPOs have always had a strong incentive to maximize the gift of donation by making every effort to find a home for all organs they recover, but the new metrics now put them at risk of decertification if transplant programs do not use the organs they recover. Non usable/non transplantable kidneys recovered have more than doubled in the last four years and OPOs are becoming increasingly desperate to find programs that will transplant these lifesaving gifts. Moving donors to a central location (Donor Care Units  or DCU) for management and recovery has shown great promise in improving organ utilization. Expect your transplant program to see more offers from OPOs across the country and more pressure and support from your local OPO to transplant more organs. Your OPO will likely pursue setting up a DCU which means potential donors may be moved from your hospital to other locations.

Hospital Response

At this point it is impossible to predict what might replace half of the OPOs in a single year, but the high level of uncertainty undoubtedly means it is in the best interests of hospitals within an OPO’s service area to see it be successful and avoid decertification, preventing a disruption in the communities they both serve. In addition, scrutiny of the donation system is beginning to shift from OPOs and United Network for Organ Sharing (UNOS) to donor hospitals and transplant programs. Already, the Organ Procurement and Transplantation Network (OPTN) has enacted new metrics for transplant programs and calls for hospitals to track and report their donor potential to CMS are becoming louder at the national level.

Per the 2022 National Academy of Science Engineering and Medicine (NASEM) report, “There is a need to reduce variations in the performance of donor hospitals, OPOs, and transplant centers in order to increase equity, efficiency, usefulness, reliability, predictability, and trustworthiness of the transplantation system. Creating standardized, consensus-based metrics to compare performance of donor hospitals, OPOs, and transplant centers needs to be a priority for HHS and the OPTN.”

In addition, the draft Organ Transplantation Transparency, Accessibility, and Reform Act, (OTTAR) of 2023, will further hold hospitals accountable for missed referrals to the OPO as it aims to address the need for transparency and accountability in the nation’s organ procurement and transplantation system. This bill calls for better data collection and transparency across the transplant system and provides focused support for enhancing transplant access for at-risk and underserved kidney patients.

Donor hospitals can help improve donation significantly through participation in improvement projects like End Stage Renal Disease Treatment Choices Learning Collaborative (ETCLC), which is the CMS National Collaborative for donor hospitals, transplant programs and OPOs. Increased involvement and support for organ donation from senior management has shown to significantly increase donation. For transplant hospitals, investment in increased transplant capacity and growth of your transplant programs would help your local OPO. Additionally, an emphasis on utilizing donor councils to enhance engagement of physicians and champions to drive process improvement and accountability for donation and transplantation outcomes is imperative to moving the entire donation and transplant system forward.

Increasing donation and transplant in your hospital ultimately helps your OPO avoid decertification, which is secondary to the benefits for patients waiting for a lifesaving transplant or families who have suffered the loss of a loved one. Communication between hospitals and OPOs will be crucial over the next year as the pressures to increase donation and transplant significantly increase.

Steps To Take

 

 

 

Helpful Resources

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A Special Thanks to This Series’ Contributors

Deanna Fenton
About the Editor |
Deanna Fenton

Deanna is a knowledgeable and versatile professional with diverse experiences in healthcare, client relations, marketing, project management and demonstrated skills in leadership and advocacy. Prior to joining The Alliance, she worked in Hospital Development at her local OPO in the state of New Jersey where she served as the clinical liaison to a number of Level 1 Trauma & Neuroscience centers as well as community hospitals. Her personal connection as a donor family and friend fuels her passion to support her colleagues across the donation-transplantation continuum through the development of valuable educational resources that ultimately boost performance and improve outcome measures. Deanna holds a Bachelor of Arts in Psychology and a minor degree in Public Health from Montclair State University. In her spare time, Deanna enjoys visiting vineyards, spending time with her family, and traveling in hopes of visiting all seven wonders of the world.

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