"For 2025, Bickell expects the market for kidneys to be very strong."
Alas, it's a story about kidney beans, from RealAgriculture.com:
Edible Bean School: Genetics and markets drive kidney bean opportunity
Earlier related post: (different market, same joke)
Here's a new paper (in final form, online ahead of print) on how organ transplants are regulated. The paper uses an experiment to make several points about the design of current regulations. One of them is that transplant centers are incentivized to be risk averse, since they are measured only by the outcomes of the transplants they perform, and not on the outcomes for patients they decline to transplant (so they are reluctant to transplant risky kidneys or risky patients).
Regulation of Organ Transplantation and Procurement: A Market-Design Lab Experiment by Alex Chan and Alvin E. Roth, Journal of Political Economy, online ahead-of-print .
Abstract: We conduct a lab experiment that shows that current rules regulating transplant centers (TCs) and organ-procurement organizations (OPOs) create perverse incentives that inefficiently reduce both organ recovery and beneficial transplantations. We model the decision environment with a two-player multiround game between an OPO and a TC. In the condition that simulates current rules, OPOs recover only the highest-quality kidneys and forgo valuable recovery opportunities, and TCs decline some beneficial transplants. Alternative regulations that reward TCs and OPOs together for health outcomes in their entire patient pool lead to behaviors that increase organ recovery and appropriate transplants.
Here's what transplants look like in our experimental environment:
Here's yesterday's HRSA press release. (Item 2, Supporting OPTN IT Modernization, might be of most interest to most readers of this blog.)
U.S. Department of Health and Human Services
Health Resources and Services Administration
FOR IMMEDIATE RELEASE
HRSA NEWS ROOM
Contact: HRSA PRESS OFFICE
Phone: 301-443-3376
Email: Press@hrsa.gov
As part of the Administration’s efforts,
for the first time in the program’s nearly 40-year history, HRSA has awarded
separate contracts to reform the organ procurement and transplant network.
Multiple vendors will support improving quality and patient safety, modernizing
IT, bolstering communications with patients, and more
Today, the Health Resources and
Services Administration (HRSA) at the Department of Health and Hunan Services
(HHS) announced the first ever multi-vendor contract awards to modernize the
nation’s organ transplant system to improve transparency, performance,
governance, and efficiency of the organ donation and transplantation system for
the more than 100,000 people on the organ transplant waitlist.
The Organ Procurement and
Transplantation Network (OPTN) has long faced critiques about lack of
transparency, potential for conflicts of interest, IT reliability issues and
other structural challenges. As part of the Administration’s transformation of
the OPTN, for the first time in 40 years, multiple contractors will provide
their expertise and proven experience to improve the national organ transplant
system. This transition from a single vendor to multiple vendors to support
OPTN operations is a critical step in advancing innovation in the transplant
system to better serve patients and their families and implements the
bipartisan Securing the U.S. Organ Procurement and Transplantation Network Act
signed by the President in September 2023.
“With the life of more than
100,000 Americans at stake, no organ donated for transplantation should go to
waste,” said HHS Secretary Xavier Becerra. “For too long, our organ
transplant system has fallen short, mired in monopoly. The Biden-Harris
Administration has reformed OPTN to require accountability in the operation of
organ procurement that our transplant patients and their families demand.”
“One person is added to the
waitlist every 10 minutes. Each one relies on and deserves the best care
possible,” said HRSA Administrator Carole Johnson. “Today’s action marks a
significant advancement in the Biden-Harris Administration’s commitment to
doing what it takes to make sure the nation’s organ matching system works for
patients, donors, and the families who depend on the OPTN for that life-saving
call.”
HRSA is announcing multiple OPTN
modernization awards to support critical actions, including:
In August 2024, HRSA announced
that the OPTN Board of Directors—the governing board that develops national
organ allocation policy—is now separately incorporated and independent from the
Board of longtime OPTN contractor, the United Network for Organ Sharing (UNOS).
HRSA awarded an OPTN Board Support contract to a new vendor, American
Institutes for Research, to support the newly incorporated OPTN Board of
Directors.
HRSA launched the OPTN
Modernization Initiative in March 2023, including making proposals to reform
the decades old OPTN statute and increase funding for the program to better
serve patients and families. Within a year, HRSA worked closely with bipartisan
leaders in Congress to secure passage of the Securing the U.S. OPTN Act and
substantially boost funding to support modernization efforts. Today’s awards
represent a key step forward in this work.
###########
Here's the full list (from OrangeSlices AI):
14 Prime awardees named for $440M in HHS HRSA OPTN Operations Transition IDIQs
The total ceiling for Domain 1 is $30M, Domain 2 is $145M, Domain 3 is $235M, and Domain 4 is $40M. The following awardee information is provided for the HRSA procurement:
1. ABT GLOBAL
Total IDIQ Maximum Not to Exceed/Ceiling: Domain 1 – $30M
2. ARBOR RESEARCH COLLABORATIVE FOR HEALTH
Total IDIQ Maximum Not to Exceed/Ceiling: Domain 1 – $30M
3. GUIDEHOUSE DIGITAL LLC
Total IDIQ Maximum Not to Exceed/Ceiling: Domain 1, 2, 4 – $215M
4. MAXIMUS FEDERAL SERVICES
Total IDIQ Maximum Not to Exceed/Ceiling: Domain 1, 2 – $175M
5. RAND CORPORATION
Total IDIQ Maximum Not to Exceed/Ceiling: Domain 1 – $30M
6. CUSTOMER VALUE PARTNERS
Total IDIQ Maximum Not to Exceed/Ceiling: Domain 2, 4 – $185M
7. GENERAL DYNAMICS INFORMATION TECHNOLOGY INC
Total IDIQ Maximum Not to Exceed/Ceiling: Domain 2, 3 – $380M
8. KPMG LLP
Total IDIQ Maximum Not to Exceed/Ceiling: Domain 2 – $145M
9. UNITED NETWORK FOR ORGAN SHARING
Total IDIQ Maximum Not to Exceed/Ceiling: Domain 2 – $145M
10. ACCENTURE FEDERAL SERVICES LLC
Total IDIQ Maximum Not to Exceed/Ceiling: Domain 3 – $235M
11. LEIDOS INC
Total IDIQ Maximum Not to Exceed/Ceiling: Domain 3 – $235M
12. SAPIENT GOVERNMENT SERVICES INC
Total IDIQ Maximum Not to Exceed/Ceiling: Domain 3 – $235M
13. DELOITTE CONSULTING LLP
Total IDIQ Maximum Not to Exceed/Ceiling: Domain 4 – $40M
14. HIGHLIGHT TECHNOLOGIES INC
Total IDIQ Maximum Not to Exceed/Ceiling: Domain 4 – $40M
The IDIQs include a base ordering period of one year staring on 9/25/2024 and 4 option periods.
Solicitation: 75R60224R0008, OPTN Operations Transition Indefinite-Delivery-Indefinite-Quantity (IDIQ)
Agency: HEALTH AND HUMAN SERVICES HEALTH RESOURCES AND SERVICES ADMINISTRATION
Here's an article in JAMA by a Michigan doctor and his Congresswoman, on the lack of regulation for some substances of human origin.
Urgent Need for Regulatory Oversight of Human Cells, Tissues, and Cellular and Tissue–Based Products, by Robert P. Dickson, MD; Deborah A. Dingell, MS, JAMA. 2024;331(20):1703-1704. doi:10.1001/jama.2024.6834
" In 2021, an outbreak of M tuberculosis occurred in the US when contaminated bone graft material was implanted into 113 patients, 77% of whom developed clinically apparent tuberculosis.
...
[Again in 2023] "the Centers for Disease Control and Prevention (CDC) had identified additional tuberculosis-infected patients who had received implants of the same product, harvested from the same donor. At final count, 36 patients in 7 states had undergone implantation of bone graft tissue contaminated with M tuberculosis.
...
"Given the rigorous safety testing required of most medical therapies, how could 2 lethal outbreaks of tuberculosis occur in as many years, arising from the same product, distributed by the same company?
"The answer lies in the FDA’s designation of this product as a human cells, tissues, and cellular and tissue–based product (HCT/P) (Table). This class of therapies, which includes bone grafts, skin grafts, and stem cells, is not subject to the same regulatory standards as pharmaceuticals, biological products (such as blood products and monoclonal antibodies), or organ transplants. This designation has profound regulatory and clinical consequences
Patients waiting for deceased donor kidneys are given priority in part by how long they have been on dialysis, while patients waiting for livers are prioritized according to how sick they are, sickest first. When the wait is long, not everyone has an equal chance of surviving long enough to receive an organ. Here's a paper that suggests that service in random order (SIRO) has desirable equity properties. Efficiency depends on how patients' welfare and future prospects change while they wait.
Equity and Efficiency in Dynamic Matching: Extreme Waitlist Policies, by Afshin Nikzad and Philipp Strack, Management Science, forthcoming, Published Online:3 Oct 2023https://doi.org/10.1287/mnsc.2023.01212
Abstract: Waitlists are commonly used to allocate scarce resources, such as public housing or organs. Waitlist policies attempt to prioritize agents who wait longer by assigning them priority points (à la first come, first served). We show that such point systems can lead to severe inequality across the agents’ assignment probabilities unless they use randomization. In particular, deterministic point systems lead to a more unequal allocation than any other rule that prioritizes earlier arrivals, an axiom that ensures that agents who wait longer are treated (weakly) better. Among the policies abiding by this axiom, we show that service in random order (SIRO) leads to the most equal allocation. From a utilitarian perspective, we show that the planner faces no trade-off between equity and efficiency when the flow utility from waiting is nonnegative or negative and increasing over time. In these cases, SIRO is also the most efficient policy. However, when the flow cost of waiting increases over time, then the planner may face an efficiency–equity trade-off: SIRO remains the most equitable policy but may not be the most efficient one.
1. Introduction: Waitlists are a common way to allocate scarce resources, such as public housing,1 organs,2 or services such as call center support.3 There are many ways to decide who among the waiting agents receives an object once it becomes available. Some waitlists operate in a service-in-random-order (SIRO) manner and use lotteries to allocate objects to waiting agents, such as in the Diversity Immigrant Visa Program in the United States4 or Beijing’s license plate allocation.5 Many other waitlists follow designs akin to first come, first served (FCFS), in which whoever has waited for the longest time receives (priority points for) an object. For example, in the national kidney transplant waitlist in the United States, enrolled patients earn priority points for each day that they remain on the waitlist.6 Such rules ensure that an agent who waits longer is not treated worse than an agent with a shorter waiting time and otherwise identical characteristics.
"Prioritizing agents with longer waiting times, however, has a drawback: it implies that an agent with a longer lifetime, that is, an agent who can wait longer for an object, has a higher probability of receiving an object. This naturally leads to inequality in assignment probabilities across agents with varying lifetimes. For example, a first-come, first-served list would lead to many of the sickest patients never receiving an organ as they depart the system before having waited long enough to receive an organ. Such equity concerns, for example, play an important role in the context of organ allocations (Organ Procurement and Transplantation Network 2015). The high-level question we ask here is, what policy induces the least inequality among policies that give priority to agents who arrive earlier? Furthermore, is minimizing inequality aligned with the objective of a planner who maximizes the average of the agents’ utilities, or are there efficiency–equity trade-offs to be considered here?"
Forbes has a long, interesting, somewhat breathless story about the progress and promise of freezing organs for transplants, including not only the usual eight organs, but also bone marrow/blood stem cells. It focuses on one of the entrepreneurs in the field, Dr. Sebastian (Seb) Giwa, and his colleague Jedd Lewis among others
New Breakthroughs In Cryopreservation Poised To Transform Organ Transplantation, by Alex Zhavoronkov, PhD, Jul 5, 2023
"To understand how this came about I delved into the career of the founder and CEO of Sylvatica Biotech, Dr. Sebastian Giwa (called “Seb” by his friends). Seb is credited by many as the chief architect of the surge of scientific interest in cryopreservation over the last several years.
 |
BRIDGET BENNETT |
"Trying to donate organs (without cryopreservation) is a lot like trying to donate perishable (non-canned) food: there are certainly a lot of starving people in the world, but good luck finding a recipient for every single ounce before it expires.
...
"[Organ Preservation Alliance] partnered ... to publish position papers, including a peer-reviewed article in Nature Biotechnology outlining the need for an organ cryopreservation research effort. The paper was co-authored with all of the major U.S. transplant societies and a star-studded lineup of scientists including Robert Langer, George Church, and Ed Boyden, and even Nobel Prize-winning economist Alvin Roth – whose work has focused on finding new ways to ameliorate the organ shortage. It is currently in the top 1% of the most widely read scientific articles published since its release.
...
"Donor bone marrow is lifesaving for many kinds of cancers and a variety of other blood diseases. Successful bone marrow transplants have been performed since the 1950s, but the challenge is finding a source of bone marrow to transplant – especially since donors and recipients must be matched for genetic factors even more precisely than some organ transplants.
...
" if bone marrow could be cryogenically banked, why not procure it from deceased organ donors who were already providing hearts, livers, and other organs for transplantation? There are nearly 40,000 such donors worldwide each year, and each could potentially donate enough marrow for multiple patients in need. For many patients, when a transplant was needed the matching bone marrow would already be available in the bone marrow bank.
"From the perspective of the deceased organ donor and the OPOs, this would be like providing an opportunity to donate an additional lifesaving organ. Traditionally, each donor can provide up to eight lifesaving vital organs: a heart, two lungs, two kidneys, a liver, intestines, and a pancreas. In essence, bone marrow would be the ninth. And if a donor could provide bone marrow to multiple recipients, this might even double the number of lives that each donor could save.
...
"Alex: What’s something we haven’t covered that excites you about what cryopreservation can do for the organ shortage?
"Seb: In the long-term, one of the things that I’m most excited about is how these technologies can remove barriers to developing transplant systems in new countries. Most of the world still doesn’t have access to deceased donor transplantation. For instance, Africa has 16% of the world’s population but only 0.5% of transplants are done there. Meanwhile the U.S. has less than 5% of the world’s population but does about 25% of the world’s transplants. Many developed countries, like my father’s home country Ghana, have limited live kidney donation programs. But they don’t have deceased donor programs, which are needed to carry out large numbers of kidney and liver transplants as well as any sort of heart or lung transplantation.
"That’s partly because the logistical demands to source organ donations prospectively require so much infrastructure: a waitlist, rapid matching of donors to recipients, OPOs that need to be overstaffed in order to deal with unpredictable surges in organs available, rushed activities that require tight coordination between donor hospitals, OPOs, transplant centers, and even third party service providers like organ couriers. Many organs have also needed expensive transportation (private jets and helicopters).
"It’s a very different situation when there’s a source of cryopreserved hearts, livers, etc., that can be donated in a much more flexible way and are simply waiting to be matched to patients. Even things like Doctors without Borders and perhaps “OPOs without Borders” become possible for transplantation, helping train and develop new organ recovery, heart, lung, and liver transplant programs. So many more possibilities open up when you don’t need to create every part of a transplant system from scratch and have all of those parts acting in synchrony on Day 1."
**************
Here's the original article referred to:
The promise of organ and tissue preservation to transform medicine
Sebastian Giwa, Jedediah K Lewis, Luis Alvarez, Robert Langer, Alvin E Roth, George M Church, James F Markmann, David H Sachs, Anil Chandraker, Jason A Wertheim, Martine Rothblatt, Edward S Boyden, Elling Eidbo, W P Andrew Lee, Bohdan Pomahac, Gerald Brandacher, David M Weinstock, Gloria Elliott, David Nelson, Jason P Acker, Korkut Uygun, Boris Schmalz, Brad P Weegman, Alessandro Tocchio, Greg M Fahy, Kenneth B Storey, Boris Rubinsky, John Bischof, Janet A W Elliott, Teresa K Woodruff, G John Morris, Utkan Demirci, Kelvin G M Brockbank, Erik J Woods, Robert N Ben, John G Baust, Dayong Gao, Barry Fuller, Yoed Rabin, David C Kravitz, Michael J Taylor & Mehmet Toner
Nature Biotechnology 35, 530–542 (2017) doi:10.1038/nbt.3889
Published online 07 June 2017
Here's a report of two Organ Procurement Organizations with very different rates of recovery of organs:
Variability in Organ Procurement Organization Performance by Individual Hospital in the United States, by Wali Johnson, MD1; Kathryn Kraft, MD2; Pranit Chotai, MD3; Raymond Lynch, MD4; Robert S. Dittus, MD5; David Goldberg, MD6; Fei Ye, PhD7; Brianna Doby, BA8; Douglas E. Schaubel, PhD9; Malay B. Shah, MD2; Seth J. Karp, MD1, JAMA Surg. Published online February 8, 2023. doi:10.1001/jamasurg.2022.7853
"Design, Setting, and Participants A retrospective cross-sectional analysis was performed of organ donation across 13 different hospitals in 2 donor service areas covered by 2 organ procurement organizations (OPOs) in 2017 and 2018 to compare donor potential to actual donors. More than 2000 complete medical records for decedents were reviewed as a sample of nearly 9000 deaths. Data were analyzed from January 1, 2017, to December 31, 2018.
"Exposure Deaths of causes consistent with donation according to medical record review, ventilated patient referrals, center acceptance practices, and actual deceased donors.
"Main Outcomes and Measures Potential donors by medical record review vs actual donors and OPO performance at specific hospitals.
"Results Compared with 242 actual donors, 931 potential donors were identified at these hospitals. This suggests a deceased donor potential of 3.85 times (95% CI, 4.23-5.32) the actual number of donors recovered. There was a surprisingly wide variability in conversion of potential donor patients into actual donors among the hospitals studied, from 0% to 51.0%. One OPO recovered 18.8% of the potential donors, whereas the second recovered 48.2%. The performance of the OPOs was moderately related to referrals of ventilated patients and not related to center acceptance practices.
"Conclusions and Relevance In this cross-sectional study of hospitals served by 2 OPOs, wide variation was found in the performance of the OPOs, especially at individual hospitals. Addressing this opportunity could greatly increase the organ supply, affirming the importance of recent efforts from the federal government to increase OPO accountability and transparency.
**********
And here's an accompanying editorial:
It Is Time for the Light to Shine on Organ Procurement Organizations by Robert M. Cannon, MD, MS1; Jayme E. Locke, MD, MPH1 JAMA Surg. Published online February 8, 2023. doi:10.1001/jamasurg.2022.7857
"Many explanations have been put forth as to why some OPOs carry out their mandate more effectively than others. One argument is that mechanisms of death in some parts of the country are more conducive to organ donations than in others. We have refuted this phenomenon as a significant factor in OPO performance variability in our previous work.3 Others have even tried to place the blame for poorly performing OPOs at the feet of “risk-averse” transplant centers, a factor that the data presented in this current study also refute. The cold truth is that we have no good understanding of why some OPOs are better than others, or even what an acceptable level of OPO performance should be, because the environment in which OPOs operate is so completely obscure."
Here's the report of an investigation into organ procurement costs and finances:
Cost Structures of US Organ Procurement Organizations by Held, Philip J. PhD1; Bragg-Gresham, Jennifer L. PhD2; Peters, Thomas G. MD3; McCormick, Frank PhD4; Chertow, Glenn MD, MPH1; Vaughan, William P. BS5; Roberts, John P. MD, Transplantation. 2021;105(12):2612-2619. doi:10.1097/TP.0000000000003667.
Abstract: "Background. The goal is to provide a national analysis of organ procurement organization (OPO) costs.
"Methods. Five years of data, for 51 of the 58 OPOs (2013-2017, a near census) were obtained under a FOIA. OPOs are not-for-profit federal contractors with a geographic monopoly. A generalized 15-factor cost regression model was estimated with adjustments to precision of estimates (P) for repeated observations. Selected measures were validated by comparison to IRS forms.
"Results. Decease donor organ procurement is a $1B/y operation with over 26 000 transplants/y. Over 60% of the cost of an organ is overhead. Profits are $2.3M/OPO/y. Total assets are $45M/OPO and growing at 9%/y. "Tissue" (skin, bones) generates $2-3M profit/OPO/y. A comparison of the highest with the lower costing OPOs showed our model explained 75% of the cost difference. Comparing costs across OPOs showed that highest-cost OPOs are smaller, import 44% more kidneys, face 6% higher labor costs, report 98% higher compensation for support personnel, spend 46% more on professional education, have 44% fewer assets, compensate their Executive Director 36% less, and have a lower procurement performance (SDRR) score.
"Conclusions. Profits and assets suggest that OPOs are fiscally secure and OPO finances are not a source of the organ shortage. Asset accumulation ($45M/OPO) of incumbents suggests establishing a competitive market with new entrants is unlikely. Kidney-cost allocations support tissue procurements. Professional education spending does not reduce procurement costs. OPO importing of organs from other OPOs is a complex issue possibly increasing cost ($6K/kidney)."
...
"CONCLUSION
"In the United States, deceased-donor organ recovery costs total $1B per year and represent approximately one-third the cost of an organ transplant procedure. Direct and indirect costs are reported on CMS required OPO cost reports, confirming that over half of all costs are indirect, such as the costs of organ procurement personnel, professional education, and other personnel expenses. Kidney cost increases over the 5-y study period seem reasonable compared with all medical care cost increases but increased at rates in excess of the cost increases transplant centers experienced for transplant procedures. And, kidney importation (from other OPOs) adds substantially to cost adding $4K-$6K per organ. OPO revenue over expense is largely due to profits from tissue recovery activities. Cost variations of over 100% across areas suggest less than socially efficient cost controls. The strong financial position of OPOs suggests that fiscal limits are not a likely explanation for the shortage of organs for transplantation.
"In considering individual OPOs, 2 levels of kidney costs (>$40K/kidney and <$40K) disclosed both statistically and clinically significant differences. The highest-cost OPOs (>$40K/kidney) are associated with higher direct costs (including more imported organs), higher compensation for support staff and procurement coordinators, higher professional education spending, and lower total assets, fewer organs procured, and lower performance measures-among other factors. Assessment of structural factors such as these may lead to opportunities to decrease cost and improve efficiencies. The US OPO enterprise is substantial, yet future OPO efficiency and performance improvements through competition appear unlikely considering OPO assets, current practices, and regulatory oversight issues. The inefficient financial incentives built into the U.S. OPO structure include both monopoly markets and self-reported cost reimbursement. These characteristics do not compel critical assessment, which could lead to organizational changes and more effective mission capability."
| 1 | Proposal to Substantially Revise The National Kidney Allocation System (Kidney Transplantation Committee)  | Proposal (1.81 MB) | 9/21/2012 - 12/14/2012 |
| 7 | Proposal to Clarify Priority Status for Prior Living Organ Donors Who Later Require a Kidney Transplant (Kidney Transplantation Committee) | Proposal (313 K) | 3/16/2012 - 6/25/2012 |
| 8 | Proposal to Establish Kidney Paired Donation (KPD) Policy (Kidney Transplantation Committee) | Proposal (669 K) | 3/16/2012 - 6/25/2012 |
| 9 | Proposal to Include Bridge Donors in the OPTN Kidney Paired Donation (KPD) Program (Kidney Transplantation Committee) | Proposal (646 K) | 3/16/2012 - 6/25/2012 |
Posts
All Comments
