U.S. Organ Procurement Organizations are Strong, CMS Rule Threatens Future Success of Donation System

47 out of 56 OPOs broke records recovering organs for transplant in 2023, yet nearly half could be decertified in 2026

MCLEAN, Va., Feb. 08, 2024 (GLOBE NEWSWIRE) -- The Association of Organ Procurement Organizations (AOPO) is calling on the Centers for Medicare and Medicaid (CMS) to deliver a plan to stabilize the organ donation and transplantation system and protect the lives of transplant patients as the specter of widespread decertification of the organizations that oversee organ donation looms.

Under new performance metrics established by CMS, an estimated 42% of the nation’s nonprofit organ procurement organizations (OPOs) could be decertified and dissolved in 2026. AOPO is raising concerns about the serious impact mass decertification would have on the system, especially the health of patients, as 2024 — the year during which OPOs’ performance will be evaluated — begins.

Called the “Final Rule,” the CMS metrics include evaluation criteria that are out of an OPO’s control, such as the non-utilization of organs by transplant centers. CMS has yet to offer guidance to OPOs on the realistic implementation of this rule without interrupting patient care.

OPOs are drivers of innovation in the nation’s organ donation and transplant system. In 2023, OPOs recovered more than 43,000 organs from deceased donors used for successful transplant procedures, an achievement that marks 13 consecutive years of growth. Despite its strength, the organ donation and transplantation system AOPO has made strides in improving is at risk of being destabilized and dismantled.

AOPO is among the strongest proponents of modernization in our system. We strongly support initiatives by CMS, the Health Resources and Services Administration (HRSA), and Organ Procurement and Transplant Network (OPTN) to increase the number of transplants by introducing new technologies, streamlining operations and enhancing accountability.

However, in these enthusiastic efforts to improve the U.S. organ donation and transplant system, our nation is now at risk of disrupting the care of more than 100,000 people currently waiting for transplants. We must plan carefully and strategically for change or risk threatening the lives of these Americans.

OPOs are Stronger than Ever

For decades, the organ donation and transplantation community has demonstrated its health and strength, reaching new heights in an area of medicine once believed to be impossible.

In 2023, OPOs recovered 43,603 organs from deceased donors that were later used for successful transplant procedures, exceeding a goal set by CMS of 41,000 transplants by 2026. Of our nation’s 56 OPOs, 47 of them — or 84% — broke records in the number of organs recovered and transplanted from deceased donors over the previous year.

This record growth means the OPO community is well on its way to achieving the goal we set in 2021 of 50,000 organs transplanted in 2026 — 9,000 more than CMS’ benchmark. We are keeping this pace despite considerable obstacles in recent years, including the rising numbers of organs we recover going unused.

This success, along with the 850,000+ organs transplanted from deceased donors in the past 40 years, has been possible thanks to the dedication of thousands of OPO workers living and working in communities across the country. OPO team members are compassionate people who counsel and comfort grieving families during the most difficult moments of their lives. They are responsible for recovering organs from donors, coordinating organ offers with transplant centers, and then transporting them to patients in time. Many have deeply personal stories which motivate them to be involved in this life-saving work.

Our field is strong because of the humanity and care we bring, and we continue to work around the clock each day of the year to honor the decisions of donors and save the lives of thousands of Americans each year.

CMS “Final Rule” Threatens System Stability

OPOs continue to save lives year over year with full awareness that performance metrics established in 2020 by CMS, referred to as the “Final Rule,” threatens their very existence. This rule revised the method by which CMS measures the performance of OPOs for purposes of recertification, and the new, complex process it establishes poses a serious risk of disrupting our country’s organ donation and transplantation system.

Under the Final Rule, an estimated 42% of the country’s OPOs could be decertified and dissolved in 2026, presenting a real risk of systemic disruption. Many record-breaking OPOs are among this group. The OPOs that are not shut down would either face competitive bidding for their service areas or would be expected to take over the service areas of decertified OPOs.

While CMS will regularly inform OPOs of their performance and evaluate potential improvements before taking enforcement action, CMS has yet to issue guidelines on the post-decertification landscape. Details remain unclear on the competitive bidding process or how CMS will guarantee that OPOs can meet the challenges of expanding into new service areas of a decertified OPO and managing the increased caseload without disrupting patient care and facing potential decertification in the future.

For decades, OPOs have built trust in their communities that makes donation possible. This includes working with the local hospitals that refer potential organ donors and cultivating relationships with families that authorize donation. These connections run deep and are not easily transferable to a new entity.

It’s highly likely that the existing inequities in organ donation and transplant that we are working as a community to address, including racial and socio-economic determinants of health, will be exacerbated and further entrenched by these anticipated disruptions.

Our community is rightly concerned about what vast decertification foretells about the future of the organ donation and transplantation system, and the impact it will have on the donor families we serve and the transplant patients whose lives we are working to save.

The Non-Use of Organs is Rising

The non-utilization of organs recovered by OPOs and declined by transplant centers poses the most critical challenge to the donation and transplantation system today.

In 2023, the non-utilization rate of kidneys reached a record high of 28%, resulting in the loss of thousands of viable organs that could have saved lives. Last year, more than 8,500 kidneys that were recovered by OPOs and offered to transplant centers for patients in need were ultimately declined and unused.

Under the Final Rule, OPOs are held responsible for a “transplant rate,” which measures the rate at which transplant centers accept recovered organs that go on to be transplanted. However, after an organ is recovered, an OPO has little to no control over whether it is actually used for transplantation. The “transplant rate,” reflects a transplant center’s decision, not OPO performance, but it still significantly impacts an OPO’s ranking.

This issue is highly concerning, most importantly because of its consequences for patients. Non-utilization leads to the unnecessary deaths of thousands of transplant patients each year who placed trust in our donation and transplant system to save their lives.

American Transplant Patients are at Risk

Right now, the Final Rule is the leading factor in determining the future of availability and accessibility of life-saving organs for Americans in need of a transplant. However, CMS has yet to share a plan for how a transition after vast decertification would unfold.

AOPO has raised concern about the lack of a plan with CMS multiple times, most recently in December 2023. Our concern was echoed by more than 40 members of Congress who penned a joint letter in December requesting comprehensive guidance from CMS regarding how the final rule will be implemented. To date, CMS has yet to substantively respond.

Even under the best circumstances, it takes tremendous coordination and several years to successfully merge two OPOs. The consequences if these mergers are not handled carefully and correctly could be steep, including the unnecessary loss of organs that could save patients’ lives.

There is growing concern among OPOs, transplant centers, public officials and patients that a long period of instability could follow these closures and, for transplant patients, any delay can be life-threatening. If nearly half of the country’s OPOs close in 2026, as is presently forecasted, hundreds of thousands of Americans currently registered on the transplant waitlist, and those yet to be referred for transplant, are at risk of experiencing serious disruptions in care.

CMS Must Act to Save Lives

There is considerable uncertainty around how this new recertification process will work and numerous unanswered questions. Our members are seeking clarity on the ground rule for competition; the process by which proactive mergers can take place, and how OPOs that want to acquire decertified OPOs can do so; and, perhaps most importantly, what the process looks like for an OPO faced with decertification.

Accordingly, AOPO is asking CMS to deliver a plan on how it intends to address the very real consequences of its policy and ensure the stability of the organ donation and transplantation system in the short and long term. A disruption of the magnitude anticipated from the Final Rule is unacceptable, but most of all, it is preventable.

U.S. organ donation and transplantation policy must be sustainable, driven by medical expertise, and ensure stability for the thousands of Americans whose lives depend on it. Our nation is obligated to fulfill the decisions of donors who have declared their intention to give life after death and the hopes of patients ready to receive that gift. An infringement on that right in the way of delays, lack of clarity, and trivial disputes is unacceptable.

Decertification will be based on 2024 performance, and data collection for this process is well underway. Without any guidance from CMS on the complex details of how this will be administered, AOPO and the wider donation and transplantation community is highly concerned. We continue to call on CMS to prioritize this issue and provide immediate and comprehensive guidance regarding how the final rule will be implemented.

About the Association of Organ Procurement Organizations (AOPO)
The Association of Organ Procurement Organizations (AOPO) is the not-for-profit trade association leading the nation’s organ donation community to save and improve lives through organ, eye, and tissue donation. Founded in 1984, AOPO advances organ donation and transplantation by driving continual improvement of the donation process, collaborating with stakeholders, and sharing successful practices with its 48 member OPOs. AOPO envisions a future where every opportunity for donation results in lives saved. For more information, please visit www.aopo.org.

Jenny Daigle