There are few more delicate, precious and lifesaving conversations in the medical field than at the moment of the organ donation decision. Rightly, the approach was long since made to keep this a non-profit community-based process. It has worked. Donation and transplant are a rare medical area where America leads the world. But good is the enemy of the best and the entire integrated industry from Organ Procurement Organizations, to transplant centers, and donor hospitals can (and we would say must) improve.
In 2022 a landmark study mandated and funded by Congress was released by the National Academies of Sciences, Engineering, and Medicine Study (NASEM) “Realizing the Promise of Equity in the Organ Transplantation System.” Coupled with the Centers for Medicare and Medicaid accepting Requests for Information on their current governing Rule, the time is right now for science-based improvements in the field.
It is indeed a life and death matter for Federal oversight to now more than ever be encouraging cooperation and best practices among Organ Procurement Organizations, transplant centers and donor hospitals.
We urge all stakeholders, from the industry to Congress to the Centers for Medicare and Medicaid in the Department of Health and Human Services to work together in implement the following reforms. Lives depend on it.
Saving Lives
The recently released landmark study by the National Academies of Sciences, Engineering, and Medicine Study (NASEM) mandated by Congress is right on point when it proposes “calling for better alignment and accountability among organ procurement organizations, transplant centers and hospitals, and adopting logical and proven metrics to evaluate the performance of the various components of the donation and transplant system.”
Organ procurement organizations are certified based upon organ donation which they control and transplant rates which they do not.
Better alignment of the system and performance metrics will dramatically reduce the number of good organs that go unused for transplant.
Good kidneys are often not used.
United States Transplant Centers reject organs at a much higher rate than Europe. Again, de-certifying OPOs based on transplant rate which they do not control is an illogical answer to improving patient results. Better alignment, coordination and metrics among OPOs transplant centers and the donor hospital is the right approach.
In fact, Donate Life America’s analysis shared with CMS through SID&T’s RFI response shows that under the Rule the numbers of future donations will lag behind the curve expected under the previous Rule.
NASEM recommends increasing the utilization rate of donated organs. We again strongly agree that results show (in their words) “It is too easy for transplant centers to decline usable organs, and accountability for transplant center decision making is lacking.”
Alignment And The Metrics Used To Encourage Efficiency
SID&T advocates for better alignment among the donation and transplant entities. We strongly support NASEM’s “Statement of Task” from their study “Realizing the Promise of Equity in the Organ Transplantation System.”:
“Better align the performance metrics of various stakeholders within the Organ Procurement and Transplantation Network (OPTN) - donor service areas, organ procurement organizations, and transplant centers - to maximize donor referrals, evaluations, procurement and organ placement/allocation while minimizing organ discard rates.”
CMS needs to improve the performance metrics in the Rule. We have advocated for this NASEM study conclusion.
“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.”
SID&T concurs that CMS needs to focus on the entire system, that indeed transplant center performance varies widely and directly impacts the donation rate that just OPO’s are judged upon.
Health Equity
SID&T supports this health equity recommendation of the NASEM study as cited in their announcement webinar.
“Within 1 to 2 years, HHS should publish a strategy with specific proposed requirements, regulations, payment structures, and other changes that will lead to the elimination of disparities.”
The critical area of health equity is addressed by NASEM. SID&T recognizes and advocates for reform of CMS’ current Rule which does nothing to address racial reality. In fact, their decertification metrics may exacerbate this NASEM conclusion:
Unless the current RULE is amended, OPO’s serving communities of color may well be de-certified based on faulty metrics and their territory assigned to an OPO with no track record in health equity.
Instead of adopting protocols to improve donation and transplant in diverse areas, including those that primarily serve communities of color, federal regulators in the prior administration chose to mandate that a set percentage of the 57 current lifesaving nonprofits be closed every cycle regardless of overall performance. The Rule ignores both common sense and sound public health policy by decertifying these organizations based in large part on transplant rates, a factor over which OPOs have no control. As a result, this blanket standard will disproportionately impact OPOs aiding under-resourced and underserved minority populations and the so-called “reform” disadvantages those communities further.
It is no coincidence that a significant number of the OPOs in the current “Tier 3” category are located in areas with correspondingly low access to healthcare in general, and serve higher proportions of the economically disadvantaged and people of color. Transplant disparity is a symptom of systemic racism that must be diagnosed with specificity, with treatments targeted to the disease and its symptoms. When there is dysfunction, whether it be in a patient or a healthcare system, shooting the patient or the OPO is never the answer. The NASEM report does not recommend that closure of OPOs is the cure, but rather that aligned, targeted measures, development of best practices, and enforcement of those practices is the cure
Death Certificates
Making Sense of Death Certificates
Whether from SID&T or the recent NASEM study or many of the Request for Information responses to CMS on the organ donation and transplant Rule, there are too many clear examples of the Federal government threatening the using poor standards and metrics for certifying or decertifying Organ Procurement Organizations.
Among the more egregious examples is the use of death certificates in judging organ procurement performance.
A very small percentage of overall deaths, those observed and ventilated for instance, will potentially qualify for organ donation. Death Certificates are a completely unreliable gauge of potential qualified donors.
Science in Donation and Transplant strongly supports verifiable medical record data and observed and verified ventilated deaths for determining donor eligibility.
Let’s look at a truly independent source for more on this issue:
New York Times health columnist Jane Brody in a recent essay rightly stressed that death certificates' lack important information. The article entitled:
Having accurate death records saves lives. When the Death Certificate Omits the True Cause of Death
https://www.nytimes.com/2022/02/14/well/death-certificate-cause.html
In Brody’s column, Dr. James Gill, the chief medical examiner for the state of Connecticut, has stated that the certificate’s cause of death “can be seriously misleading information.”
What goes into a death certificate? Primarily, name, cause of death, and time of death.
That’s it. Vital underlying issues like cancer or sepsis is uneven at best. Death certificate data is notoriously inaccurate. Using death record data that is known to be unreliable does not advance the goal of providing a uniform calculation of donors.
The metrics used will be important in the future analysis of areas of improvement. We and others urge CMS to implement accurate and reliable measurement methods.
Death certificates as they are clearly do not meet the threshold of accurate and reliable methods for assessing an OPOs performance. The role of the OPO is equally as important as the role of the donor hospital and transplant center.
Hospitals must promptly notify their respective OPOs of individuals whose death is imminent or who have died in the hospital. The OPO cannot start the donor assessment process without timely notification from the hospital. Even if the hospital clinicians believe the patient's medical condition may rule them out as donors, the hospitals hold this obligation.
Hospitals are also required to provide OPOs with timely and meaningful access to donor medical records. Then the OPO may begin the critical process of assessing donor suitability and confirming donor authorization.
Transplant centers play the third vital role in maximizing successful organ transplantation. They decide what organs to transplant into which patient.
All three entities must work together to ensure all federal regulations are being met. But the introduction of unreliable death certificates as a basis for judging OPO performance creates an unrealistic expectation that skews the OPOs numbers. The new rule calculates the donation rate by counting all donors from whom an organ has been "transplanted" instead of simply "recovered."
The new rules fail to acknowledge donor hospitals' and transplant centers’ roles in ensuring successful organ donation and transplantation.
The measurement only unfairly reflects the transplant acceptance rate, not the effort made by the OPO in procuring and offering the maximum number of organs.
OPOs do not play a role in the acceptance rate of good organs by transplant centers but they are held solely accountable. In fact, under the Rule a set percentage of OPOs, currently 27% (twenty-seven) will be decertified based on a transplant rate they have no control over. That coupled with the fact that certification rankings may well be based on two-year-old data calls into question even more of CMS’ metrics.
Because the metrics used will be important in the future analysis of areas of improvement, CMS should have implemented accurate and reliable measurement methods. Yet, they did not.
There is a better way. And it’s supported by medical professionals and hospitals throughout the nation.
Again, Science in Donation and Transplant strongly supports verifiable medical record data and observed and verified ventilated deaths for determining donor eligibility.
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.