Showing posts with label transplants. Show all posts
Showing posts with label transplants. Show all posts

Wednesday, January 28, 2026

Redesigning transplant and OPO center incentives (Chan and Roth in JAMA; Bae, Sweat, Melcher and Ashlagi in JAMA Surgery)

 

Chan A, Roth AE. Reimagining Transplant Center Incentives Beyond the CMS IOTA Model. JAMA. Published online January 26, 2026. doi:10.1001/jama.2025.26194 

 "On July 1, 2025, the Centers for Medicare & Medicaid Services (CMS) launched the Increasing Organ Transplant Access (IOTA) model, a national experiment in revising how transplant centers are evaluated and paid.

"For decades, transplant centers were primarily judged by 1-year graft and patient survival for patients who underwent a transplant. That standard, designed to safeguard quality, sometimes constrained access to transplants by rewarding risk avoidance rather than expansion. This contributed to persistent kidney shortages, alongside continued organ nonutilization.1

"The IOTA model marks a deliberate rebalancing. CMS is tying payment not primarily to short-term survival, but to 3 domains: achievement (60 points for transplant volume), efficiency (20 points for kidney offer acceptance), and quality (20 points for graft survival).

...

"A kidney transplant begins with an organ procurement organization (OPO). Yet OPOs remain outside the IOTA payment framework, perpetuating fragmentation between procurement and transplant.

"Recent experience with OPO performance metrics illustrates how narrow incentives can distort behavior. After CMS introduced tier-based OPO evaluations in 2021, lower-performing OPOs increased organ recovery, which also sharply increased discards, reliance on higher-risk organs, and out-of-sequence kidney placements,3 raising concerns about fairness to waitlisted patients.4 

...

"Emerging economic and experimental research suggests that joint accountability—rewarding procurement and transplant entities together for improving population health—can both shift recovery, discard, and transplant numbers and produce improved gains in patient health (Table).1 Without such system-level metrics spanning OPOs and transplant centers, IOTA will operate within a fragmented ecosystem where incentives push procurement and transplant in different, sometimes counterproductive, directions."

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See also

Bae H, Sweat KR, Melcher ML, Ashlagi I. Organ Procurement Following the Centers for Medicare and Medicaid Services Performance Evaluations. JAMA Surg. 2026;161(1):97–100. doi:10.1001/jamasurg.2025.5074 


 

Friday, January 16, 2026

Offering deceased donor transplants out of sequence when there is a chance the organ will (otherwise) be unutilized (Ashlagi and Roth in AJOB)

 Itai Ashlagi and I weigh in on recent controversy about "out of sequence" offers of organs for transplant, with some ideas about how the current system might be redesigned and maintained so as to reduce organ discards while maintaining transparency about how and to whom organs are offered.

 Itai Ashlagi and Alvin E. Roth (2026). Out of Sequence Offers: Towards Efficient, Equitable Organ Allocation. The American Journal of Bioethics, 26(1), 5–8. https://doi.org/10.1080/15265161.2026.2594937  

"Organs for transplant are very scarce compared to the need, and so the allocation of organs from deceased donors raises questions about both efficiency and fairness. Because offers of organs take time to consider, and because the viability of organs from deceased donors decreases over time, efficiency sometimes requires increasing the chance of reaching a patient who will accept the organ while it remains viable. So fairness and efficiency, concerning who gets to consider the next offer, and the probability that the organ on offer will be accepted in time for it to be transplanted, may sometimes be in conflict, or at least appear to be. And even the appearance of unfairness may undercut trust in the system of organ donation and transplantation. 

"This conflict between fairness and efficiency has resulted in controversy about offers made “out of sequence” (Covered in a lead article in the NYT article (Times 2025)) 

...

"Collecting data is essential for both efficiency and transparency. It is unfair to future patients not to have transparent allocation systems that can be studied with precision (with causal inference from experimentation), so that it can be improved over time. It is also unfair to future patients who will join increasingly congested waiting lists as a result of the failure to utilize a large number of transplantable organs.

Public data about transplant centers’ performance and patients’ waiting times would further allow patients to choose, based on their own preferences, a transplant center that fits their need. 

...

"Policies to expedite the placement of marginal quality organs that can be tested over time and studied with experiments include when to determine an organ is hard-to-place and when and how to adapt the priority list.

"In summary, it is sometimes desirable to expedite an organ that risks being unused, by offering it to a patient or transplant center that is likely to accept it if the offer is received in a timely way. But it is important to make sure that this flexibility does not promote unfairness to patients or transplant centers. Increasing the transparency and efficiency of the system for expediting organs can address both these issues."

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The same issue of the journal contains a number of articles discussing organ allocation out of sequence  

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Earlier:

Friday, May 23, 2025  Deceased organ allocation: deciding early when to move fast

Thursday, January 15, 2026

Transplant problems and public support for organ donation

 The Kidney Transplant Collaborative is worried about the status of kidney transplants in the US.  Here's the statement they published this month, which expresses concern about a drop in deceased donations.

LOSING TRANSPLANTS FOR ALL THE WRONG REASONS: A STATISTICAL ANALYSIS OF THE REDUCTION IN KIDNEY TRANSPLANTS IN RESPONSE TO REPORTS OF OPO FAILURES


"The kidney transplant waitlist has long exceeded the supply of available kidney organs. The waitlist today includes more than 94,000 Americans, with more than 28,000 deceased and living kidney transplants occurring in 2025. Even more troubling, recent events seem to have led to a decline in overall kidney transplants from 2024 to 2025, driven by a decline in deceased donor transplants. This represents the first time in the 21st century that we see an annual isolated decline in deceased donations and deceased donor kidney transplants, even while living donor kidney transplants increase and the kidney discard rate declines, the latter reflecting increased use of available deceased donor kidneys.

...

"What has caused this unprecedented and isolated decline in deceased kidney donations? While policymakers have been appropriately focused on maintaining the integrity of the
deceased donor process, an unanticipated effect of recent oversight efforts of the kidney transplant system and accompanying negative media reports has shaken the deceased donor
landscape and may have possibly caused the reduction in deceased donor rates.
Given this emerging trend, the importance of increasing living donation has come into even sharper focus. Policymakers and all stakeholders in the kidney transplant process will need to focus on the impact of the recent oversight efforts and take clear measures to responsibly increase kidney transplant rates, most likely via a focus on living kidney donor supportive policy.

...

"Unreported until now, however, is the negative impact that this recent Congressional focus may be having on kidney transplant levels themselves. The impact is measurable – from 2024 to 2025, there were 116 fewer kidney transplants. This is due to 218 fewer deceased donor kidney transplants and an increase of 102 living donor kidney transplants for 2025 as compared to 2024 – the first time this century that there appears to be an isolated decline of deceased kidney donations driving the decrease in overall kidney transplants.

...

"Recent, highly publicized revelations involving OPOs have had a serious and harmful effect on public trust in organ donation. As a result, fewer individuals and families appear willing to consent to organ donation after death. Data from the OPTN Transplant Metrics National Dashboard shows that the number of kidneys recovered from deceased donors remained steady during the first half of 2025. However, beginning in June 2025, the number of deceased donors began to decline, and that decline has continued to accelerate. In 2025, a total of 15,274 deceased donors underwent kidney recovery, compared to 15,937 during 2024 for a net percentage change of negative 4.2%."

HT: Martha Gershun
 



 

Monday, November 10, 2025

Are transplants too scarce, or not scarce enough? A surprising debate about India

 India, now the most populous country in the world, does the third highest number of kidney transplants in the world (although their rate of transplantation per million population is quite low).  So transplants are nevertheless very scarce in India compared to the need, which is the situation worldwide.

Earlier this year, however, a paper by three veteran (non-Indian) transplant professionals who have headed large organizations expressed repugnance for the volume of transplants in India, and the fact that it depends mostly on living donor transplantation (LDT), suggesting it can be viewed as "both alarming and reprehensible."  Their paper's title makes it clear how they view it. 

Domínguez-Gil, Beatriz, Francis L. Delmonico, and Jeremy R. Chapman. "Organ transplantation in India: NOT for the common good." Transplantation 109, no. 2, February, 2025: 240-242. 

"The field of organ transplantation has evolved very differently across the world under the influence of different national healthcare financing systems. Healthcare is, in most countries, financed by taxation and thus through governmental budgets, in combination with private funds, mostly through contributory health insurance systems (eg, Australia, Canada, Europe, New Zealand, South America, and the United States). But across much of Asia, tertiary healthcare services, such as transplantation, are almost entirely dependent on the private finances of individuals. The impressive growth in Indian organ transplantation has been accomplished in for-profit hospitals, which have expanded Indian transplantation into 807 facilities, mostly associated with the major corporate hospital chains.6 Organ transplantation, in a part of the world where one-fifth of all people live, is thus largely not for the common good, but a treatment available for those with ample monetary resources." 

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 This was followed by a firm rebuttal by distinguished Indian transplant professionals.  Their title makes their view equally clear:

Rela, Mohamed, Ashwin Rammohan, Vivek Kute, Manish R. Balwani, and Arpita Ray Chaudhury. "Organ Transplantation in India: INDEED, for the Common Good!." Transplantation 109, no. 6 (2025): e340-e342. 

 "We were deeply concerned by the article “Organ Transplantation in India: NOT for the Common Good” by Domínguez-Gil et al,  which we felt provided an unfairly critical view of the current state of organ transplantation in India. We aim to provide a point-by-point rebuttal based on actual figures and ground-reality rather than tabloid-press articles as cited by the authors.
 

"It is true that in the past 5 y, there has been an extraordinary growth in the number of transplantations in India (more than those achieved over several decades by European countries). While it is natural to be wary of this astronomical increase in transplant numbers, the authors’ assumption that this growth is likely nefarious reflects an outdated western mindset, rather than a true understanding of over 2 decades of massively coordinated effort by the Government of India, transplant professionals and all other stakeholders in the country. 

...

" The development of LDT has been presented with a negative connotation. This shows a scant understanding of the geo-socio-political idiosyncrasies prevalent in the Asian region, and unlike the west, its conventional dependence on LDT.

 ...

"The authors have further confused LDT and deceased donor transplantation with regards to foreigners having access to organs in India. The authors’ accusation of deceased donor organs being preferentially allocated to foreigner is presumptuous at best. The current organ allocation system under the aegis of the Government of India and state-wise organ transplant governing bodies is a very transparent process—and is reserved for Indian nationals.

...

" Transplant tourism being equated with organ commerce is erroneous, the authors’ fail to understand that many poor countries find India a more financially viable destination to get a transplant than countries in the west. Even affordable Governments in the middle east are moving to the east for transplantation, where the ministries have a direct tie-up with transplant units. 

"While it should be conceded that transplantation in India may not be available to all, true social upliftment necessitates broader initiatives beyond just immediate transplant availability: that of addressing poverty. Nonetheless, access to transplants for the underprivileged has greatly improved over the past decade. There are several public sector hospitals in the country that routinely provide transplantation services. In 2023, in the state of Tamil Nadu, 35.1% of all deceased donor renal transplants were performed for free in public sector hospitals (Table 1). 5 While traditionally, the private pay-from-pocket healthcare has been only for those with the resources, the central and several state governments (Tamil Nadu, Andhra Pradesh, Gujarat, etc) sponsor an all-inclusive healthcare state insurance for the poor, which includes transplantation at any approved private hospital in the state; which includes LDT.

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I'm on my way to a conference in Cairo that is motivated in part by concern that healthcare in low and middle income countries has been impeded by some of the international healthcare organizations' lack of understanding or empathy for their situations. 

Wednesday, December 18, 2024

New rules for evaluating transplant centers

 Historically, transplant centers ('hospitals') have been primarily evaluated on the one year graft survival on the transplants that they do.*  Now Medicare announces it will test a new model, that will emphasize the number of transplants conducted ("achievement"), in addition to somewhat less emphasis on the ratio of deceased donor kidneys accepted or rejected ("efficiency") and graft survival ("quality").

Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model.  A Rule by the Centers for Medicare & Medicaid Services on 12/04/2024 

"a. Proposed IOTA Model Overview

"End-Stage Renal Disease (ESRD) is a medical condition in which a person's kidneys cease functioning on a permanent basis, leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life.[2]

"The best treatment for most patients with kidney failure is kidney transplantation. Nearly 808,000 people in the United States are living with ESRD, with about 69 percent on dialysis and 31 percent with a kidney transplant.[3]

"Relative to dialysis, a kidney transplant can improve survival, reduce avoidable health care utilization and hospital acquired conditions, improve quality of life, and lower Medicare expenditures.[4 5]

"However, despite these benefits of kidney transplantation, evidence shows low rates of ESRD patients placed on kidney transplant hospitals' waitlists, a decline in living donors over the past 20 years, and underutilization of available donor kidneys, coupled with increasing rates of donor kidney discards, and wide variation in kidney offer acceptance rates and donor kidney discards by region and across kidney transplant hospitals.[6 7] 

...

"The IOTA Model will be a mandatory model that will begin on July 1, 2025, and end on June 30, 2031, resulting in a 6-year model performance period comprised of 6 individual performance years (“PYs”). The IOTA Model will test whether performance-based incentives paid to, or owed by, participating kidney transplant hospitals can increase access to kidney transplants for patients with ESRD, while preserving or enhancing quality of care and reducing Medicare expenditures. CMS will select kidney transplant hospitals to participate in the IOTA Model through the methodology proposed in section III.C.3.d of this final rule. As this will be a mandatory model, the selected kidney transplant hospitals will be required to participate. CMS will measure and assess the participating kidney transplant hospitals' performance during each PY across three performance domains: achievement, efficiency, and quality.

"The achievement domain will assess each participating kidney transplant hospital on the overall number of kidney transplants performed during a PY, relative to a participant-specific target. The efficiency domain will assess the kidney organ offer acceptance rate ratios of each participating kidney transplant hospital relative to a national ranking or the participating kidney transplant hospital's past organ offer acceptance rate ratio. The quality domain will assess the quality of care provided by the participating kidney transplant hospitals via a composite graft survival ratio. Each participating kidney transplant hospital's performance score across these three domains will determine its final performance score and corresponding amount for the upside risk payment that CMS would pay to the participating kidney transplant hospital, or the downside risk payment that would be owed by the participating kidney transplant hospital to CMS. The upside risk payment will be a lump sum payment paid by CMS after the end of a PY to a participating kidney transplant hospital with a final performance score of 60 or greater. Conversely, beginning in PY 2, the downside risk payment will be a lump sum payment paid to CMS by any participating kidney transplant hospital with a final performance score of 40 or lower. There is no downside risk payment for PY 1 of the model.

...

"The three performance domains will include: (1) an achievement domain worth up to 60 points, (2) an efficiency domain worth up to 20 points, and (3) a quality domain worth up to 20 points.

"The achievement domain will assess the number of kidney transplants performed by each IOTA participant for attributed patients, with performance on this domain worth up to 60 points. The final performance score will be heavily weighted on the achievement domain to align with the IOTA Model's goal to increase access to kidney transplants to improve the quality of care and reduce Medicare expenditures. The IOTA Model theorizes that improvement activities, including those aimed at reducing unnecessary deceased donor discards and increasing living donors, may help increase access to kidney transplants."

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CMS gives a high level overview here: Increasing Organ Transplant Access (IOTA) Model

and later today there's a webinar you can register for:

"The CMS Innovation Center will be hosting a welcome webinar to present an overview of the model on December 18, 2024, from 2 to 3 p.m. ET. Register to attend: https://cms.zoomgov.com/webinar/register/WN_hvGDyZTxQ5eNhX1OBolevA
 

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*see Wednesday, October 2, 2024 Regulation of Organ Transplantation and Procurement (Chan and Roth in the JPE)

That paper suggests desirable regulations  would coordinate transplant and OPO incentives, and link them both to the health outcomes of all patients attributable to a given transplant center (and not just those patients who were transplanted). 

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quick update (from the Q&A following the webinar): 

this is viewed as an experiment on roughly half the transplant centers, but there isn't currently a commitment about what to do after the projected 6 years of the experiment.

. all transplant patients are considered, but payments are only for Medicare fee for service patients

achievement: . each center's target for annual transplants will be it's average number over the three years ending a year before the beginning of the experiment...(at least that was the answer for the first year).

    . both deceased and living donor outcomes will be included in the achievement metric.

quality: .the first year will consider one-year graft survival, and year n will consider graft survival for the first n years.

OPOs: there are no requirements for OPOs within the IOTA model 

risk adjustment: not for year 1, they are hoping to have risk adjustment measures in subsequent years.

Sunday, November 17, 2024

Opt-out defaults do not increase organ donation rates, in Public Health

 No one said market design was going to be easy...(well, some people did, but it turns out it isn't.)

Dallacker, M., L. Appelius, A. M. Brandmaier, A. S. Morais, and R. Hertwig. "Opt-out defaults do not increase organ donation rates." Public Health 236 (2024): 436-440. 

"Objectives: To increase organ donation rates, many countries have switched from an opt-in (‘explicit consent’) default for organ donation to an opt-out (‘presumed consent’) default. This study sought to determine the extent to which this change in default has led to an increase in the number of deceased individuals who become organ donors.
 

"Study design: Longitudinal retrospective analysis.
 

"Methods: We conducted a retrospective analysis of within-country longitudinal data to assess the effect of changing the organ donation default policy from opt-in to opt-out. Our analysis focused on the longitudinal deceased donor rates in five countries (Argentina, Chile, Sweden, Uruguay, Wales) that had adopted this change. Using a Bayesian aggregated binomial regression model, we estimated the odds of organ donation within each country over time, as well as the effect of the policy switch.
 

"Results: Switching from an opt-in to an opt-out default did not result in an increase in donation rates when averaged across countries. Moreover, the opt-out default did not lead to even a gradual increase in donations: there was no discernible difference in the linear rate of change of donations after the change in default. Finally, the COVID-19 pandemic was associated with a reduction in the odds of donation across all five countries.
 

Conclusions: Our longitudinal analysis suggests that changing to an opt-out default does not increase organ donation rates. Unless flanked by investments in healthcare, public awareness campaigns, and efforts to address the concerns of the deceased's relatives, a shift to an opt-out default is unlikely to increase organ donations."

 


...

"Family objections, often a significant barrier to deceased organ donation, should also be addressed. In many countries—including Chile, Sweden, and Wales—the consent of next of kin is necessary for organ donation. The veto power given to families has also been cited as a reason why the opt-out default does not significantly improve donation rates over the opt-in system.27,28 Considering expressed preferences, whether of the deceased or their relatives, overrides the default. Ultimately, the implications for transplantation outcomes between opt-in and opt-out defaults only differ in the rare cases when no explicit statements of preference were made by either the deceased or their relatives. A previous cross-country scenario analysis has shown that, when family preferences are honoured, shifting from an opt-in to an opt-out default alone would only increase organ recovery by 0%–5%.29 

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 HT: Frank McCormick


Related:

Monday, July 22, 2024 Don't take "No" for an answer in deceased organ donor registration (a paper forthcoming after ten+ years)